WO2025083471A1

WO2025083471A1 - Valvular prosthesis with decoupling member

Info

Publication number: WO2025083471A1
Application number: PCT/IB2024/000603
Authority: WO
Inventors: Hikmat Hojeibane; Alexandre HADIR; Mehdi BORDJI
Original assignee: Open Stent Solutions Sas
Current assignee: Open Stent Solutions Sas
Priority date: 2023-10-18
Filing date: 2024-10-18
Publication date: 2025-04-24
Anticipated expiration: 2026-04-18

Abstract

Provided herein are devices and methods of valvular prostheses having a planar configuration during the delivery phase and a final closed folded configuration during deployment at the tissue targeted site. The stent can comprise an inner valve support for interfacing with valve prosthetic leaflets and an external cage. The cage can decouple the movement of the native heart valve from the inner valve support and the valve prosthetic leaflets.

Description

VALVULAR PROSTHESIS WITH DECOUPLING MEMBER

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 63/591,436, filed October 18, 2023, which application is incorporated herein by reference.

BACKGROUND

[0002] Heart Valve Disease (HVD) affects many people globally. HVD can manifest in abnormal valve leaflet tissue in various ways, including excess tissue growth, tissue degradation, tissue rupture, tissue hardening, tissue calcification, abnormal tissue re-positioning in response to cardiac configuration during different stages of the cardiac cycle, for example annular dilation or ventricular reshaping. Such abnormal tissue often leads to degradation of valve function, for example, leakage, backflow as a result of valve insufficiency, resistance to blood forward flow as a result of valve stenosis, and the like. In some instances, treatment can include replacement of the failing native valve with an artificial prosthetic valve.

[0003] The heart comprises a left atrium (LA) that receives oxygenated blood from the lungs via the pulmonary veins (PV) and pumps this oxygenated blood through the mitral valve (MV) into the left ventricle (LV). When the left ventricle (LV) contracts, it allows blood to flow outwardly through the aortic valve (AV).

[0004] The left atrioventricular (AV valve) valve, also called the Mitral valve, poses unique anatomical obstacles, rendering percutaneous mitral valve replacement significantly more challenging. The mitral valve’s annulus has a non-circular D-shape or kidney-like shape, with a non- planar, saddle-like, geometry that often lacks symmetry. Such anatomical variation and nonsymmetry makes it difficult to deliver a centrally expanding replacement valve utilizing a centrally expanding distal tip. In addition, anchoring the device by capturing the leaflets with hooks or loops can be hazardous and prone to failure.

[0005] The mitral valve (MV) comprises a pair of leaflets that meet evenly, or “coapf ’ to close. The ventricular side of the leaflets are attached to the surrounding heart structures of the left ventricle via an annular region of tissue referred to as the annulus (AN) found on the left atrium. The annulus is a fibrous ring of dense connective tissue which is distinct from both the leaflet tissue as well as the adjoining muscular tissue of the heart wall.

SUMMARY

[0006] Described herein are valvular prosthesis and methods of delivery thereof. [0007] Provided herein is an intraluminal support structure for deployment into a heart valve of a subject. The intraluminal support structure can comprise an inner valve support. The intraluminal support structure can comprise an external decoupling cage coupled to the inner valve support and comprising a plurality of sinusoidal decoupling members, an inflow crown, and an outflow crown. In some cases, the sinusoidal decoupling members are configured to decouple the inner valve support from a motion of the annulus, the ventricle, or both when the external decoupling cage is deployed into a heart valve annulus. In some cases, the intraluminal support structure has an undeployed planar configuration and a deployed ring configuration for deployment in the heart valve.

[0008] In some cases, the intraluminal support structure is configured to be delivered via a catheter. In some cases, the inflow crown is configured to face the atrial side of the heart and the outflow crown is configured to face the ventricular side of the heart when the intraluminal support is deployed into the heart valve. In some cases, the plurality of sinusoidal decoupling members comprise varying patterns optimized for anchoring and flexibility based on a shape of the heart valve of the subject. In some cases, the external decoupling cage has an hourglass shape with a narrow middle portion configured to conform to a native annulus shape. In some cases, the narrow middle portion is disposed closer to the outflow crown than the inflow crown. In some cases, segments of the inner valve support are welded together. In some cases, the intraluminal support structure is laser-cut from a single sheet.

[0009] The intraluminal support structure can further comprise anchoring barbs disposed along and extending from the external decoupling cage. In some cases, the anchoring barbs are disposed at an about 45 degree angle relative to a plane of the external decoupling cage.

[0010] The intraluminal support structure can further comprise a covering. In some cases, the covering comprises a biocompatible material.

[0011] In some cases, the plurality of sinusoidal decoupling members originate at a level higher than an atrial cusp of the heart valve when the intraluminal support structure is deployed into the heart valve. In some cases, the external decoupling cage is coupled to the inner valve support via a plurality of connectors. In some cases, the plurality of connectors comprise straight connectors between the inner valve support and the external decoupling cage. In some cases, the plurality of connectors comprise articulated connectors configured to adjust a radial separation distance between the inner valve support and the external decoupling cage. In some cases, the plurality of sinusoidal decoupling members are configured to one or more of compress, expand, or translate in response to motion of the heart valve. [0012] In some cases, the intraluminal support structure is comprised of a plurality of circumferential sections. In some cases, the intraluminal support structure is comprised of three circumferential sections. In some cases, two adjacent circumferential sections of the plurality of sections is separated by at least one post. In some cases, two adjacent circumferential sections of the plurality of sections is separated by two posts. In some cases, each circumferential section comprises a set of rails inferior to the outflow crown when the intraluminal support structure is deployed into the heart valve. In some cases, the set of rails is expandable.

[0013] In some cases, the intraluminal support structure comprises at least one scaffold panel having a first free end and a second free end when the scaffold panel is in the undeployed planar configuration, wherein the first and second free ends are configured to be coupled to each other to form into the ring when the intraluminal support is placed into the deployed ring configuration. In some cases, the inner valve support is configured to support at least one prosthetic valve leaflet. In some cases, the plurality of sinusoidal decoupling members are coupled to the inflow crown and to posts.

[0014] Described herein is a valvular prosthetic. The valvular prosthetic can comprise an intraluminal support structure as described above. The valvular prosthetic can comprise at least one prosthetic valve leaflet.

[0015] In some cases, the one or more prosthetic valve leaflets are inserted into a circumferential section of one or more circumferential sections separated by posts and comprising the intraluminal support structure. In some cases, the at least one prosthetic valve leaflet comprises a same number of prosthetic valve leaflets as the circumferential sections separated by posts. In some cases, the at least one prosthetic valve leaflet comprises one or more of biological tissue, polymer, or a hybrid of biological tissue and polymer.

[0016] Provided herein is a method of deploying a valvular prosthetic to a heart valve. The method can comprise advancing a distal end of a delivery catheter to the heart valve. In some cases, a valvular prosthetic is helically wrapped around the delivery catheter in a planar configuration of the valvular prosthetic. In some cases, the valvular prosthetic comprises the intraluminal support structure described above and at least one prosthetic valve leaflet. The method can comprise locking a first end of the valvular prosthetic into a second end of the valvular prosthetic by sliding a locking mechanism on the first end into a locking mechanism on the second end via a deployment mechanism on the delivery catheter, thereby placing the valvular prosthetic into the deployed ring configuration. [0017] In some cases, the heart valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve. The method can further comprise anchoring the valvular prosthetic in the heart valve via anchoring barbs after creating the ring configuration of the valvular prosthetic. The method can further comprise removing the distal end of the delivery catheter from the heart valve.

[0018] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

INCORPORATION BY REFERENCE

[0019] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The subject matter of PCT/IB2022/000431, filed July 25, 2022, which claims priority to U.S. Provisional Application 63/311,650, filed on February 18, 2022 and US. Provisional Application 63/225,969, filed on July 27, 2021, are incorporated herein by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings (also “Figure” and “FIG.” herein), of which:

[0021] FIGS. 1A-1E show perspective top (FIGS. 1A-1B, IE), top (FIG. 1C), and side (FIG. ID) views of an example stent in accordance with example embodiments described herein.

[0022] FIG. 2A shows a schematic or top view of an example unrolled stent in accordance with example embodiments described herein.

[0023] FIGS. 2B-2F show a schematic or top views of components of the stent of FIG. 2A in accordance with example embodiments described herein. [0024] FIGS. 3A-3D show perspective (FIG. 3A), flat side (FIGS. 3B, 3D), and perspective side (FIG. 3C) views of T-connectors for use with example stents in accordance with example embodiments described herein.

[0025] FIG. 4 shows a perspective view of an example anchoring barb for use with example stents in accordance with example embodiments described herein.

[0026] FIGS. 5A-5B show top views of posts of an example unrolled stent in accordance with example embodiments described herein.

[0027] FIG. 6A shows a perspective side view of a three-dimensional multilayered planar view of an example unrolled stent in accordance with example embodiments described herein.

[0028] FIGS. 6B-6C show a side (FIG. 6B) and perspective side (FIG. 6C) views of a curvature of an example stent in accordance with example embodiments described herein.

[0029] FIG 7 shows a side view of an example deployed stent with a covering in accordance with example embodiments described herein.

[0030] FIG. 8 shows a side view of an example deployed stent in a native annulus in accordance with example embodiments described herein.

[0031] FIGS. 9A-9F show flat (FIG. 9A-9B), top-down (FIG. 9E), side (FIG. 9C), and perspective (FIGS. 9D, 9F) views of example prosthetic valve leaflets in accordance with example embodiments described herein.

DETAILED DESCRIPTION

[0032] The present disclosure relates generally to medical implants and to methods and systems for delivery of medical implants into a human body. More particularly, the present disclosure relates to methods and systems for the trans-catheter delivery of cardiac valve implants to a human heart.

[0033] Trans-catheter therapies for structural heart diseases may raise the need for the delivery of large devices (e.g., stents) through native vessels, cardiac walls and the cardiac septum. However, radial crimping and radial deployment (e.g., expansion) of these devices can creates a rigid and relatively large stem inside the device's delivery sheath. Furthermore, the large size (diameter) of the devices can leave large orifices in the cardiac septum at the end of the procedure. The limitations, both in rigidity and size, may result in limited movement and maneuverability during the procedure. They can also predispose the stents to fracture.

[0034] There is an unmet need for a stent that is more flexible in its deployed state and thinner or smaller in its delivery state to allow for easier maneuverability through the tortuous anatomy. Increased stent flexibility can increase the capability of delivery and deployment of stents. [0035] While flexibility is important, scaffolding in the deployed state can also be beneficial by increasing the stability of the stent within the delivery site.

[0036] This dual need for flexibility during delivery and high scaffolding during deployment state presents an unsolved problem in the art as the two characteristics are inversely proportional. Specifically, as stent flexibility is increased, scaffolding may be decreased and similarly, as scaffolding is increased, flexibility may be decreased. Accordingly, there remains a need for a stent having a high degree of flexibility in the delivery profile state and high scaffolding in the final state. [0037] Additionally, many devices designed to treat cardiac valvular disease may fall short in addressing variation in annulus anatomy as well as the dynamic motion of the valve which could result in leakage and stent fracture after chronic implantation. These failures may be due to the lack of a pressure absorbing structure that decouples the valve from the annular and ventricular wall motion or from the way such an absorbing structure is attached to the valvular prostheses which can lead to long term fatigue failures.

[0038] Devices that attempt to address some valvular motion have been designed with a metallic structure that may rely on welding of certain components around the valve to provide an isolation between the cardiac wall motion and the prosthetic valve. Such welds can lead to fractures in the stent over time.

[0039] Accordingly, there is an unmet need to have valvular prostheses that 1) are flexible during their delivery stage, 2) are sufficiently scaffolded for stability in their deployed stage, 3) are nonwelded to avoid fractures, and 4) are able to absorb the impact of the native heart valve to minimize fatigue.

[0040] Provided herein is a valvular prosthesis having a planar (e.g., unrolled) configuration during the delivery phase and a final closed folded configuration during deployment at the tissue targeted site. The planar stent may be fit with valve prosthetic leaflets to form a valvular prosthesis that may be delivered by transcatheterization. The stent can comprise an inner valve support for interfacing with the valve prosthetic leaflets and an external cage.

[0041] By being delivered in a planar, or multilayered planar configuration, the valvular prostheses described herein can be flexible during delivery and take up a minimal amount of space (considering 3-dimensional space). The design of the stent, as shown in the figures and describes below, can be scaffolded in the final ring shape. In some cases, the cage can comprise a single sheet. The single sheet can be laser cut. The cage can avoid being welded by being formed of a single sheet. The cage can protect the inner valve support and the valve prosthetic leaflets from motions of the native heart valve. The cage can decouple the movement of the native heart valve from the inner valve support and the valve prosthetic leaflets. Accordingly, the cage can be an external decoupling cage.

[0042] In some cases, the valvular prosthesis can form a prosthetic valve in the form of, for example, semilunar valves, pulmonary valves, aortic valves, atrioventricular valves (AV valves), mitral valves, bicuspid valves, tricuspid valves, sphincter, cervix, or any combination thereof.

[0043] Disclosed herein is a method for delivering and deploying an intraluminal support structure as described herein. The method can comprise loading the valvular prosthesis to a delivery catheter. The method can comprise introducing the catheter into the body and advancing the loaded catheter through the body lumen and anatomical tissue until reaching the delivery site (implantation site). The method can comprise deploying the valvular prosthesis at the delivery site and maneuvering the deployed stent to its final implanted location. The method can comprise withdrawing the catheter from the body lumen.

Devices

[0044] Described herein is a valvular prosthesis comprising one or more leaflet structures and an intraluminal support structure (e.g., stent). The stent can comprise an inner valve support and an external decoupling cage. The stent can transition from a multilayered planar structure in its undeployed form to a ring or cylinder structure in its deployed form.

[0045] In some cases, the dimensions of the stents described herein may vary depending on the size of the annulus and thus the stent to be used. In some cases, the maximum dimensions of the stents may be constant, and the stents may be adjustable depending on the size of the annulus.

[0046] In some cases, the dimensions of the inner frame can be similar to the dimensions of the leaflet valve structure comprising multiple leaflets.

[0047] In some cases, a height of the inner frame may be from about 12 mm to about 22 mm. In some cases, a height of the leaflet structure may be from about 12 mm to about 14 mm, about 12 mm to about 16 mm, about 12 mm to about 18 mm, about 12 mm to about 20 mm, about 12 mm to about 22 mm, about 14 mm to about 16 mm, about 14 mm to about 18 mm, about 14 mm to about 20 mm, about 14 mm to about 22 mm, about 16 mm to about 18 mm, about 16 mm to about 20 mm, about 16 mm to about 22 mm, about 18 mm to about 20 mm, about 18 mm to about 22 mm, or about 20 mm to about 22 mm. In some cases, a height of the leaflet structure may be about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm. In some cases, a height of the leaflet structure may be at least about 12 mm, about 14 mm, about 16 mm, about 18 mm, or about 20 mm. In some cases, a height of the leaflet structure may be at most about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0048] In some cases, a diameter of the inner frame may be from about 20 mm to about 75 mm. In some cases, a diameter of the inner frame may be from about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 35 mm, about 20 mm to about 40 mm, about 20 mm to about 45 mm, about 20 mm to about 50 mm, about 20 mm to about 55 mm, about 20 mm to about 60 mm, about 20 mm to about 65 mm, about 20 mm to about 70 mm, about 20 mm to about 75 mm, about 25 mm to about 30 mm, about 25 mm to about 35 mm, about 25 mm to about 40 mm, about 25 mm to about 45 mm, about 25 mm to about 50 mm, about 25 mm to about 55 mm, about 25 mm to about 60 mm, about 25 mm to about 65 mm, about 25 mm to about 70 mm, about 25 mm to about 75 mm, about 30 mm to about 35 mm, about 30 mm to about 40 mm, about 30 mm to about 45 mm, about 30 mm to about 50 mm, about 30 mm to about 55 mm, about 30 mm to about 60 mm, about 30 mm to about 65 mm, about 30 mm to about 70 mm, about 30 mm to about 75 mm, about 35 mm to about 40 mm, about 35 mm to about 45 mm, about 35 mm to about 50 mm, about 35 mm to about 55 mm, about 35 mm to about 60 mm, about 35 mm to about 65 mm, about 35 mm to about 70 mm, about 35 mm to about 75 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 40 mm to about 65 mm, about 40 mm to about 70 mm, about 40 mm to about 75 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm, about 45 mm to about 65 mm, about 45 mm to about 70 mm, about 45 mm to about 75 mm, about 50 mm to about 55 mm, about 50 mm to about 60 mm, about 50 mm to about 65 mm, about 50 mm to about 70 mm, about 50 mm to about 75 mm, about 55 mm to about 60 mm, about 55 mm to about 65 mm, about 55 mm to about 70 mm, about 55 mm to about 75 mm, about 60 mm to about 65 mm, about 60 mm to about 70 mm, about 60 mm to about 75 mm, about 65 mm to about 70 mm, about 65 mm to about 75 mm, or about 70 mm to about 75 mm. In some cases, a diameter of the inner frame may be about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm. In some cases, a diameter of the inner frame may be at least about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, or about 70 mm. In some cases, a diameter of the inner frame may be at most about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm.

[0049] In some cases, a circumference of the inner frame may be from about 70 mm² to about 220 mm². In some cases, a circumference of the inner frame may be from about 70 mm² to about 100 mm², about 70 mm² to about 130 mm², about 70 mm² to about 160 mm², about 70 mm² to about 190 mm², about 70 mm² to about 220 mm², about 100 mm² to about 130 mm², about 100 mm² to about 160 mm², about 100 mm² to about 190 mm², about 100 mm² to about 220 mm², about 130 mm² to about 160 mm², about 130 mm² to about 190 mm², about 130 mm² to about 220 mm², about 160 mm² to about 190 mm², about 160 mm² to about 220 mm², or about 190 mm² to about 220 mm². In some cases, a circumference of the inner frame may be about 70 mm², about 100 mm², about 130 mm², about 160 mm², about 190 mm², or about 220 mm². In some cases, a circumference of the inner frame may be at least about 70 mm², about 100 mm², about 130 mm², about 160 mm², or about 190 mm². In some cases, a circumference of the inner frame may be at most about 100 mm², about 130 mm², about 160 mm², about 190 mm², or about 220 mm². The circumference may be 78 mm². [0050] In some cases, the dimensions of the stents described herein differ depending on the part of the stent due to the curvature of the stent from the atrial to the ventricular side. Using FIG. ID as a reference, there may be four or more diameters. The first diameter may be the diameter of the topmost part (e.g., the atrial side). The second diameter may be the diameter of the atrial-side bulge (e.g., external curvature). The third diameter may be the diameter at the dotted line where the coupling cage curves inwards. The fourth diameter may be the diameter of the ventricular-side external curvature and lower-most part.

[0051] In some cases, the stent in its ring configuration may have a first diameter of from about 40 mm to about 60 mm. In some cases, the stent in its ring configuration may have a first diameter of from about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm, about 50 mm to about 55 mm, about 50 mm to about 60 mm, or about 55 mm to about 60 mm. In some cases, the stent in its ring configuration may have a first diameter of about 40 mm, about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the stent in its ring configuration may have a first diameter of at least about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the stent in its ring configuration may have a first diameter of at most about 45 mm, about 50 mm, about 55 mm, or about 60 mm.

[0052] In some cases, the stent in its ring configuration may have a second diameter of from about 40 mm to about 60 mm. In some cases, the stent in its ring configuration may have a second diameter of from about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm, about 50 mm to about 55 mm, about 50 mm to about 60 mm, or about 55 mm to about 60 mm. In some cases, the stent in its ring configuration may have a second diameter of about 40 mm, about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the stent in its ring configuration may have a second diameter of at least about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the stent in its ring configuration may have a second diameter of at most about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the stent in its ring configuration may have a second diameter of about 54 mm.

[0053] In some cases, the stent in its ring configuration may have a third diameter of from about 35 mm to about 55 mm. In some cases, the stent in its ring configuration may have a third diameter of from about 35 mm to about 40 mm, about 35 mm to about 45 mm, about 35 mm to about 50 mm, about 35 mm to about 55 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, or about 50 mm to about 55 mm. In some cases, the stent in its ring configuration may have a third diameter of about 35 mm, about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the stent in its ring configuration may have a third diameter of at least about 35 mm, about 40 mm, about 45 mm, or about 50 mm. In some cases, the stent in its ring configuration may have a third diameter of at most about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the stent in its ring configuration may have a third diameter of about 46 mm.

[0054] In some cases, the stent in its ring configuration may have a fourth diameter of from about 40 mm to about 60 mm. In some cases, the stent in its ring configuration may have a fourth diameter of from about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm, about 50 mm to about 55 mm, about 50 mm to about 60 mm, or about 55 mm to about 60 mm. In some cases, the stent in its ring configuration may have a fourth diameter of about 40 mm, about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the stent in its ring configuration may have a fourth diameter of at least about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the stent in its ring configuration may have a fourth diameter of at most about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the stent in its ring configuration may have a fourth diameter of about 56 mm.

[0055] In some cases, the stent in its ring configuration may have a height (from the atrial to the ventricular side or from the inflow to the outflow crown) of from about 20 mm to about 35 mm. In some cases, the stent in its ring configuration may have a height of from about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 35 mm, about 25 mm to about 30 mm, about 25 mm to about 35 mm, or about 30 mm to about 35 mm. In some cases, the stent in its ring configuration may have a height of about 20 mm, about 25 mm, about 30 mm, or about 35 mm. In some cases, the stent in its ring configuration may have a height of at least about 20 mm, about 25 mm, or about 30 mm. In some cases, the stent in its ring configuration may have a height of at most about 25 mm, about 30 mm, or about 35 mm.

[0056] In some cases, the length of the stent may be reduced by at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, and/or up to about 80% when transitioning between the open planar configuration and the ring configuration. [0057] In some cases, a height of the stent may not substantially change between the open planar configuration and the ring configuration.

[0058] In some cases, the external cage may be provided from materials such as, for example, biological tissue, engineered materials, grown materials, transplanted tissue, biocompatible polymeric materials, nitinol, or any combination thereof. In some cases, the leaflets may be provided from materials such as, for example, biological tissue, engineered materials, grown materials, transplanted tissue, biocompatible polymeric materials, nitinol, or any combination thereof.

[0059] The stent or intraluminal support structure may be coated with one or more of an agent, a medication, a drug, an eluting medicament, a controlled release medicament, a controlled release agent, or any combination thereof.

[0060] FIGS. 1A-1E show perspective top (FIGS. 1A-1B, IE), top (FIG. 1C), and side (FIG. ID) views of stent 100. FIGS. 1A-1B show stent 100 comprising decoupling cage 102, welded bodies 104, sinusoidal decoupling members 106, atrial flanges 108, articulated connectors 110, posts 112, inner frame valvular support 116, and outer cage 118. The inner frame valvular support 116 and outer cage 118 can comprise decoupling cage 102. The sinusoidal decoupling members 106 can be disposed on the outer cage 118. FIG. 1C shows stent 100 comprising decoupling cage 102, sinusoidal decoupling members 106, and inner frame valvular support 116. FIG. ID shows stent 100 comprising decoupling cage 102, sinusoidal decoupling members 106, and distal attachment 114. FIG. IE shows prosthetic leaflet valves 122 inside stent 100 comprising decoupling cage 102 and anchoring barbs 120.

[0061] In some cases, decoupling cage 102 can decouple the prosthetic valve from the annulus and the ventricle motion. The cage 102 can also preserves the configuration of the prosthetic valve leaflets. In some cases, the configuration can be oval, round, concentric, elliptical, or any other configuration that fits into the heart valve. The decoupling from the natural motion can help maintain the hemodynamic functionality of the valve by minimizing the occurrence of internal leakages. Without such a barrier/cage, any ovality or variable wall motion may alter the coaptation of the valve and its ability to seal properly, resulting in inner and/or paravalvular leaks. The decoupling can also help the stent to deform around calcifications without impacting the shape of the prosthetic valve leaflets 122.

[0062] The decoupling cage 102 may have an hour-glass shape with the middle portion conforming well to the native annulus as well as a larger portion that sits under the annulus to help anchor the valve into the native valve. Strong anchoring can result in long-term performance of the valve and maintenance of the position of the valve for proper hemodynamic functionality and minimization of leakages. In some cases, the hour-glass design narrowing area may be inferior to the middle (e.g., closer to the ventricular side), thereby having a lower ventricular protrusion. This narrowing area is shown below in the midline in FIG. ID as a dotted line.

[0063] The decoupling member structure (e.g., decoupling cage 102) can comprise sinusoidal waves/members 106 connecting the inflow flange/crown (atrial side) 108 with the outflow flange/crown (ventricular side). By connecting to both the top and bottom, the sinusoidal members 106 can absorb the shock of the compression of the native valve onto the valvular prosthesis during heart pumping. Instead of being forcibly flexed by heart pumping, the decoupling cage 102, due to the sinusoidal members 106, can be flexible in the midsection and narrowed section and can be adjusted to be stiffer or more flexible in various parts of the sinusoid depending on native heart pressure. The sinusoids can also be optimized through varying amplitude, frequency, and thickness to allow for improved shock absorption from the native heart valve, especially in the lower ventricular portion. Additionally, the sinusoidal design allows for expansion and compression of the stent to respond to the pumping of the heart.

[0064] A sinusoidal design 106 can allow the shape of the decoupling member 102 to be optimized towards anchoring and the flexibility of the decoupling member can help to separate the cardiac wall motion from the valve prosthetic leaflets. The decoupling cage 102 can be made flexible while being attached to both the atrial as well as the ventricular crowns of the metallic structure. Such a design can allow it to be more solid and less prone to fatigue issues. The sinusoidal members 106 can help with fatigue because they can assist with torsion movement and absorption of pressure/constraint from the native ventricle. The sinusoidal members 106 can also make it more secure and stable during loading and placement of the valve inside the diseased valve.

[0065] The inflow crown can sit in the atrium just above the annulus. The outflow crown can sit just below the annulus and in the ventricle. The sinusoidal patterns 106 and connections to the inflow and outflow crowns may not be welded. The sinusoidal patterns 106 and connections to the inflow and outflow crowns may be laser cut from a single flat sheet. In some cases, the cage may be attached to the valve leaflets without welding. Welding of nitinol components can present with fatigue issues during long term implantation. The cut from a single flat sheet can resemble a ribbonlike design. The ribbon-like design can be loaded onto the delivery catheter as described below. [0066] In some cases, stent 100 can comprise one or more welded bodies 104. In some cases, the welded bodies 104 may comprise two parallel lines with external connectors on each side. In some cases, the welded bodies are welded onto the stent frame. In some cases, the welded bodies do not comprise the outer cage 118, nor its connection to inner frame 116. As discussed above, the decoupling cage can be formed of a single sheet, and the welded bodies can be welded to the single sheet. The welded bodies 104 can be used to weld together sections of the inner frame 116, but the inner frame may be already attached to the outer cage 118.

[0067] There may be one or more types of welded bodies 104. There may be 1, 2, 3, 4, 5, or more types of welded bodies 104. In some cases, the welded body may have a left loop in addition to its two connectors. In some cases, there may be a compression wire for compressing the stent during delivery. When releasing the compression wire, the cage can expand at the end of the procedure. The loops on the welded bodies can be where the compression wire ends. The loops can be used to temporarily block a knot of the wire from until it can be connected to the wire coming from the catheter. The welded body 104 may have a right book loop in addition to its two connectors. The welded body 104 may not have a loop in addition to its two connectors. Examples of welded bodies can be seen in FIGS. 2C-2F.

[0068] In some cases, the decoupling cage 102 may comprise multiple segments or sections surrounding the prosthetic valve leaflets 122. The decoupling cage 102 may comprise 1, 2, 3, 4, 5. 6, or more segments surrounding the prosthetic valve leaflets 122. In some cases, each segment may be separated by posts 112. In some cases, the segments may span, or substantially span, the circumference of the decoupling cage 102. In some cases, the posts 112 can be perpendicular to the circumference of the decoupling cage 102. In some cases, posts 112 can comprise two or more parallel, or substantially parallel, lines. In some cases, each section may comprise separate rails as described further below.

[0069] In some cases, stent 100 may comprise connectors between the inner frame 116 and the outer cage 118. In some cases, the connectors are straight. In some cases, the connectors are articulated to enhance the separation between the inner frame 116 and the outer cage 118. By increasing the separation, the articulated connectors 110 can increase the decoupling between inner frame valvular support 116 (and thus prosthetic leaflet valves 122 inside of the inner frame 116) and the outer cage 118. Increasing the decoupling can improve the isolation of the leaflet valves 122 from the native anatomy. This can allow the prosthetic valve leaflets 122 to maintain their shape regardless of the overlying anatomical configuration surrounding the valvular prosthetic. The shape of the prosthetic valve leaflets 122 can be oval, circular, elliptical, or another shape as desired. The leaflets 122 are discussed further below.

[0070] The decoupling member 102 can also incorporate anchoring barbs 120 that may be placed around the outer frame 118 to provide added anchoring security and minimize valve migration over time. In some cases, the anchoring barbs 120 can comprise short protrusions into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. The anchoring barbs 120 can be from about 5 mm to about 15 mm. The anchoring barbs 120 can be from about 5 mm to about 7 mm, about 5 mm to about 9 mm, about 5 mm to about 11 mm, about 5 mm to about 13 mm, about 5 mm to about 15 mm, about 7 mm to about 9 mm, about 7 mm to about 11 mm, about 7 mm to about 13 mm, about 7 mm to about 15 mm, about 9 mm to about 11 mm, about 9 mm to about 13 mm, about 9 mm to about 15 mm, about 11 mm to about 13 mm, about 11 mm to about 15 mm, or about 13 mm to about 15 mm. The anchoring barbs 120 can be about 5 mm, about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm. The anchoring barbs 120 can be at least about 5 mm, about 7 mm, about 9 mm, about 11 mm, or about 13 mm. The anchoring barbs 120 can be at most about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm.

[0071] In some cases, anchoring barbs 120 can be straight. In some cases, anchoring barbs 120 can be hook-shaped. The hook-shaped design can help to grasp tissue and minimize dislodgement. This design may be similar to the thorns of the prickly pear cactus. These barbs can be designed to catch the large anterior valve, stabilizing it, and minimize movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction.

[0072] FIG. 2A shows a schematic or top view of unrolled stent 200 comprising decoupling cage 202, sinusoidal decoupling members 204, left welded body 206, central welded body 208, right welded body 210, locking area 212, distal attachment 214, posts 216, proximal attachments 218, inflow crown 220, outflow crown 222, window 224, rails 226, articulated connectors 228, overlapping area 230, Type A T connector 232, Type B T connector 234, Type C T connector 236, and anchoring barb 238. FIGS. 2B-2F show a schematic or top view of components of the unrolled stent 200 of FIG. 2A. FIG. 2B shows decoupling cage 202 comprising sinusoidal decoupling members 204, locking area 212, distal attachment 214, posts 216, proximal attachments 218, inflow crown 220, outflow crown 222, window 224, rails 226, articulated connectors 228, and overlapping area 230. FIG. 2C shows left welded body 206, FIG. 2D shows central welded body 208, and FIG. 2E shows right welded body 210. FIG. 2F shows decoupling cage 202 and a welded body 212, wherein welded body 212 can comprise any of left welded body 206, central welded body 208, and/or right welded body 210.

[0073] In some cases, decoupling cage 202 can decouple the prosthetic valve from the annulus and the ventricle motion. The cage 202 can also preserves the configuration of the prosthetic valve leaflets. In some cases, the configuration can be oval, round, concentric, elliptical, or any other configuration that fits into the heart valve. The decoupling from the natural motion can help maintain the hemodynamic functionality of the valve by minimizing the occurrence of internal leakages. Without such a barrier/cage, any ovality or variable wall motion may alter the coaptation of the valve and its ability to seal properly, resulting in inner and/or paravalvular leaks. The decoupling can also help the stent to deform around calcifications without impacting the shape of the prosthetic valve leaflets.

[0074] The decoupling cage 202 may have an hour-glass shape with the middle portion conforming well to the native annulus as well as a larger portion that sits under the annulus to help anchor the valve into the native valve. Strong anchoring can result in long-term performance of the valve and maintenance of the position of the valve for proper hemodynamic functionality and minimization of leakages. In some cases, the hour-glass design narrowing area may be inferior to the middle (e.g., closer to the ventricular side), thereby having a lower ventricular protrusion. This narrowing area is shown below in the midline in FIG. ID as a dotted line.

[0075] The decoupling member structure (e.g., decoupling cage 202) can comprise sinusoidal waves/members 204 connecting the inflow flange/crown (atrial side) 220 with the outflow flange/crown (ventricular side) 222. By connecting to both the top and bottom, the sinusoidal members 204 can absorb the shock of the compression of the native valve onto the valvular prosthesis during heart pumping. Instead of being forcibly flexed by heart pumping, the decoupling cage 202, due to the sinusoidal members 204, can be flexible in the midsection and narrowed section and can be adjusted to be stiffer or more flexible in various parts of the sinusoid depending on native heart pressure. The sinusoids can also be optimized through varying amplitude, frequency, and thickness to allow for improved shock absorption from the native heart valve, especially in the lower ventricular portion. Additionally, the sinusoidal design allows for expansion and compression of the stent to respond to the pumping of the heart.

[0076] A sinusoidal design 204 can allow the shape of the decoupling member 202 to be optimized towards anchoring and the flexibility of the decoupling member can help to separate the cardiac wall motion from the valve prosthetic leaflets. The decoupling cage 202 can be made flexible while being attached to both the atrial as well as the ventricular crowns of the metallic structure. Such a design can allow it to be more solid and less prone to fatigue issues. The sinusoidal members 204 can help with fatigue because they can assist with torsion movement and absorption of pressure/constraint from the native ventricle. The sinusoidal members 204 can also make it more secure and stable during loading and placement of the valve inside the diseased valve.

[0077] The inflow crown can sit in the atrium just above the annulus. The outflow crown can sit just below the annulus and in the ventricle. The sinusoidal patterns 204 and connections to the inflow and outflow crowns may not be welded. The sinusoidal patterns 204 and connections to the inflow and outflow crowns may be laser cut from a single flat sheet. In some cases, the cage may be attached to the valve leaflets without welding. Welding of nitinol components can present with fatigue issues during long term implantation. The cut from a single flat sheet can resemble a ribbonlike design. The ribbon-like design can be loaded onto the delivery catheter as described below.

[0078] In some cases, stent 200 can comprise one or more welded bodies. In some cases, the welded bodies may comprise two parallel lines with external connectors on each side. In some cases, the welded bodies are welded onto the stent frame. In some cases, the welded bodies do not comprise the outer cage, nor its connection to inner frame. As discussed above, the decoupling cage can be formed of a single sheet, and the welded bodies can be welded to the single sheet. The welded bodies can be used to weld together sections of the inner frame, but the inner frame may be already attached to the outer cage.

[0079] There may be one or more types of welded bodies. There may be 1, 2, 3, 4, 5, or more types of welded bodies. In some cases, the welded body may be left welded body 206, and may have a left loop in addition to its two connectors. The welded body may be right welded body 210, and may have a right book loop in addition to its two connectors. The welded body may be a central welded body 208, and may not have a loop in addition to its two connectors. The welding details are shown in FIG. 2F. The welded bodies can be welded with a laser. The welded bodies can be welded with a 180-degree arc of a laser. The overall welding arc may be from about 180 degrees to about 240 degrees. The welded bodies can be perpendicular to the posts and locking mechanism.

[0080] The first and second ends of decoupling cage 202 can be configured to be coupled to each other to form into a ring when deployed, similar to stent 100. The second free end can comprise a locking area 212 with a tight gap. The first free end can comprise a one or more welded T hooks 232, 234, and/or 236 that slidably couple to the locking area in a first direction perpendicular to the first axis. In some cases, the first free end and the second free end are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first free end or the second free end are not perpendicular to the first axis. There can be an angle between the main axis of the stent and the locking mechanism. Locking area 212 can be adjacent the window 224 and parallel to the posts 216.

[0081] In some cases, the T hooks may be welded to the opposite end relative to the locking area 212. The T hooks can be folded over to approach the window 224. The T hooks can slide down the window 224 into the locking area 212. The lower T hooks (e.g., Type C 236 and Type B 234) enter the window 224 and locking area 212 before the Type A T connector 232. To improve engagement of the locking area 212, Type B 234 and C 236 T connectors may have angled arms (e.g., the top part of the “T”) instead of horizontal arms, as shown in FIG. 3C. The arms may be angled away from the base of the T. Type C T connector 236 may have longer arms than Type B T connector 234 to catch the frame. Each subsequent type (B, then A) can have shorter arms to tighten the locking connection and thus the ring. The locking mechanism is shown in FIG. 3D.

[0082] When the ring is closed, the overlapping area 230 can be external to the remainder of the ring, as the locking occurs just prior to the overlapping area 230 on the scaffold.

[0083] In some cases, the decoupling cage 202 may comprise multiple segments or sections surrounding the prosthetic valve leaflets. The decoupling cage 202 may comprise 1, 2, 3, 4, 5. 6, or more segments surrounding the prosthetic valve leaflets. In some cases, each segment may be separated by posts 216. In some cases, the segments may span, or substantially span, the circumference of the decoupling cage 202. In some cases, the posts 216 can be perpendicular to the circumference of the decoupling cage 202. In some cases, posts 216 can comprise two or more parallel, or substantially parallel, lines.

[0084] Decoupling cage 202 can comprise rails 226. In some cases, each set of rails may be separated by posts 216. In some cases, the rails may span, or substantially span, the circumference of the decoupling cage 202. In some cases, the rails 226 can be parallel to the circumference of the decoupling cage 202. In some cases, rails 226 can comprise two or more parallel, or substantially parallel, lines. In some cases, rails 226 can be adjustable or expandable. For example, the sections of the rails nearest the posts may be bunched up in a neutral configuration and open like springs when stretched. This can be used to increase the size of the inner frame as desired to accommodate smaller or larger leaflet prosthetics. In some cases, the rails can be expanded via use of a balloon once the stent 200 is in its ring configuration. In some cases, the rails 226 are curved. In some cases, the rails 226 are substantially straight.

[0085] The stent 200 may have attachment pieces to hook onto a delivery device. Stent 200 may have one or more distal attachments 214 to hook onto a distal portion of a delivery device. Stent 200 may have one or more proximal attachments 218 to hook onto a distal portion of a delivery device that is proximal to the hook that 214 latches on to.

[0086] In some cases, stent 200 may comprise connectors between the inner frame and the outer cage. In some cases, the connectors are straight. In some cases, the connectors are articulated to enhance the separation between the inner frame and the outer cage. By increasing the separation, the articulated connectors 228 can increase the decoupling between inner frame valvular support (and thus prosthetic leaflet valves inside of the inner frame) and the outer cage. Increasing the decoupling can improve the isolation of the leaflet valves from the native anatomy. This can allow the prosthetic valve leaflets to maintain their shape regardless of the overlying anatomical configuration surrounding the valvular prosthetic. The shape of the prosthetic valve leaflets can be oval, circular, elliptical, or another shape as desired.

[0087] The decoupling member 202 can also incorporate anchoring barbs 238 that may be placed around the outer frame 118 to provide added anchoring security and minimize valve migration over time. In some cases, the anchoring barbs 238 can comprise short protrusions into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. The anchoring barbs 238 can be from about 5 mm to about 15 mm. The anchoring barbs 238 can be from about 5 mm to about 7 mm, about 5 mm to about 9 mm, about 5 mm to about 11 mm, about 5 mm to about 13 mm, about 5 mm to about 15 mm, about 7 mm to about 9 mm, about 7 mm to about 11 mm, about 7 mm to about 13 mm, about 7 mm to about 15 mm, about 9 mm to about 11 mm, about 9 mm to about 13 mm, about 9 mm to about 15 mm, about 11 mm to about 13 mm, about 11 mm to about 15 mm, or about 13 mm to about 15 mm. The anchoring barbs 238 can be about 5 mm, about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm. The anchoring barbs 238 can be at least about 5 mm, about 7 mm, about 9 mm, about 11 mm, or about 13 mm. The anchoring barbs 238 can be at most about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm.

[0088] In some cases, anchoring barbs 238 can be straight. In some cases, anchoring barbs 238 can be hook-shaped. The hook-shaped design can help to grasp tissue and minimize dislodgement. This design may be similar to the thorns of the prickly pear cactus. These barbs can be designed to catch the large anterior valve, stabilizing it, and minimize movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction.

[0089] FIGS. 3A-3D show perspective (FIG. 3A), flat side (FIGS. 3B, 3D), and perspective side (FIG. 3C) views of T-connectors of stent 200. FIGS. 3A-3D show Type A T connectors 232, Type B T connector 234, and Type C T connector 236. [0090] The first and second ends of decoupling cage 202 can be configured to be coupled to each other to form into a ring when deployed, similar to stent 100. The second free end can comprise a locking area 212 with a tight gap. The first free end can comprise a one or more welded T hooks 232, 234, and/or 236 that slidably couple to the locking area in a first direction perpendicular to the first axis. In some cases, the first free end and the second free end are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first free end or the second free end are not perpendicular to the first axis. There can be an angle between the main axis of the stent and the locking mechanism. Locking area 212 can be adjacent the window 224 and parallel to the posts 216.

[0091] In some cases, the T hooks may be welded to the opposite end relative to the locking area 212. The T hooks can be folded over to approach the window 224. The T hooks can slide down the window 224 into the locking area 212. The lower T hooks (e.g., Type C 236 and Type B 234) enter the window 224 and locking area 212 before the Type A T connector 232. To improve engagement of the locking area 212, Type B 234 and C 236 T connectors may have angled arms (e.g., the top part of the “T”) instead of horizontal arms, as shown in FIG. 3C. The arms may be angled away from the base of the T. Type C T connector 236 may have longer arms than Type B T connector 234 to catch the frame. Each subsequent type (B, then A) can have shorter arms to tighten the locking connection and thus the ring. The locking mechanism is shown in FIG. 3D.

[0092] FIG. 4 shows anchoring barb 238 of stent 200. Anchoring barbs 238 may be placed around the decoupling cage 202 to provide added anchoring security and minimize valve migration over time. In some cases, the anchoring barbs 238 can comprise short protrusions into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. In some cases, anchoring barbs 238 can be straight. In some cases, anchoring barbs 238 can be hook-shaped. The hook-shaped design can help to grasp tissue and minimize dislodgement. This design may be similar to the thorns of the prickly pear cactus. As shown in FIG. 4, the anchoring barbs are angled away from the curve of the decoupling structure 202, curved, and with a sharp inner point.

[0093] The barbs 238 may have an angle relative to the scaffold of the stent of from about 35 degrees to about 50 degrees. The barbs 238 may have an angle relative to the scaffold of the stent of from about 35 degrees to about 40 degrees, about 35 degrees to about 45 degrees, about 35 degrees to about 50 degrees, about 40 degrees to about 45 degrees, about 40 degrees to about 50 degrees, or about 45 degrees to about 50 degrees. The barbs 238 may have an angle relative to the scaffold of the stent of about 35 degrees, about 40 degrees, about 45 degrees, or about 50 degrees. The barbs 238 may have an angle relative to the scaffold of the stent of at least about 35 degrees, about 40 degrees, or about 45 degrees. The barbs 238 may have an angle relative to the scaffold of the stent of at most about 40 degrees, about 45 degrees, or about 50 degrees.

[0094] In some cases, there can be straight barbs. In some cases, the straight barbs reach out from the decoupling cage 202. In some cases, the straight barbs reach out from a base of the hooked barbs. The angle of the straight barbs relative to the scaffold of the stent may be similar to the angle of the hooked barbs.

[0095] These barbs can be designed to catch the large anterior valve, stabilizing it, and minimize movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction. [0096] The anchoring barbs 238 can be from about 5 mm to about 15 mm. The anchoring barbs 238 can be from about 5 mm to about 7 mm, about 5 mm to about 9 mm, about 5 mm to about 11 mm, about 5 mm to about 13 mm, about 5 mm to about 15 mm, about 7 mm to about 9 mm, about 7 mm to about 11 mm, about 7 mm to about 13 mm, about 7 mm to about 15 mm, about 9 mm to about 11 mm, about 9 mm to about 13 mm, about 9 mm to about 15 mm, about 11 mm to about 13 mm, about 11 mm to about 15 mm, or about 13 mm to about 15 mm. The anchoring barbs 238 can be about 5 mm, about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm. The anchoring barbs 238 can be at least about 5 mm, about 7 mm, about 9 mm, about 11 mm, or about 13 mm. The anchoring barbs 238 can be at most about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm.

[0097] FIGS. 5A-5B show top views of posts of an unrolled stent 200. FIG. 5A shows an improperly created post (e.g., shaping or manufacturing defect) with non-parallel bars, whereas FIG. 5B shows a properly created post with parallel bars. The parallel bars can help to keep a cross- sectional plane of the ring stent in a single plane rather than folded, which can help to stabilize the placement of the leaflet valves within the stent.

[0098] FIG. 6A shows a perspective side view of a three-dimensional multilayered planar view of an unrolled stent 300 comprising sinusoidal decoupling members 302. FIGS. 6B-6C show a side (FIG. 6B) and perspective side (FIG. 6C) views of a curvature of the sinusoidal decoupling members 302 of stent 300.

[0099] FIG 7 shows a side view of deployed stent 400 with a covering. Deployed stent 400 can comprise covering decoupling cage 402 and covering 404. The stent 400 and decoupling cage 402 can be similar to those disclosed herein. Covering 404 can help to seal the stent. This can occur by helping to minimize paravalvular leaks by having a constant and close contact with the annulus and the ventricular wall during the systolic and diastolic phases of the cardiac cycle. Covering 404 can comprise a biocompatible layer such as PET, PTFE, Polyurethanes, etc. [0100] FIG. 8 shows a schematic of a side view of deployed stent 500 in a native annulus. FIG. 8 shows sinusoidal decoupling members 502, an atrial cusp of the valve 504, decoupling cage 506, and native annulus 508. The stent 500, sinusoidal decoupling members 502, and decoupling cage 506 can be similar to those disclosed herein. The atrial cusp of the valve 504 shows how a stent as described herein sits or originates below the atrial cusp of the valve 504. In some cases, the stent originates above the atrial cusp of the valve. The originating side can be the inflow side. In some cases, the native annulus 508 can be at around the middle of the height of the stent. In some cases, the native annulus 508 can be superior to the middle of the height of the stent. In some cases, the native annulus 508 can be inferior to the middle of the height of the stent.

Leaflets

[0101] In some cases, the intraluminal support structure comprises a leaflet structure attached or attachable to an inner surface of the scaffold panel as shown in FIG. IE. The leaflet structure can comprise one or more leaflets and can be connectable to one or more posts on the stent. The leaflet structure may comprise one, two, three, or more separate leaflets which may be independently attached to the scaffold.

[0102] In some cases, a height of the leaflet valve structure comprising multiple leaflets may be from about 12 mm to about 22 mm. In some cases, a height of the leaflet structure may be from about 12 mm to about 14 mm, about 12 mm to about 16 mm, about 12 mm to about 18 mm, about 12 mm to about 20 mm, about 12 mm to about 22 mm, about 14 mm to about 16 mm, about 14 mm to about 18 mm, about 14 mm to about 20 mm, about 14 mm to about 22 mm, about 16 mm to about 18 mm, about 16 mm to about 20 mm, about 16 mm to about 22 mm, about 18 mm to about 20 mm, about 18 mm to about 22 mm, or about 20 mm to about 22 mm. In some cases, a height of the leaflet structure may be about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm. In some cases, a height of the leaflet structure may be at least about 12 mm, about 14 mm, about 16 mm, about 18 mm, or about 20 mm. In some cases, a height of the leaflet structure may be at most about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0103] In some cases, a diameter of the leaflet valve structure comprising multiple leaflets may be from about 20 mm to about 75 mm. In some cases, a diameter of the leaflet valve structure may be from about 20 mm to about 25 mm, about 20 mm to about 30 mm, about 20 mm to about 35 mm, about 20 mm to about 40 mm, about 20 mm to about 45 mm, about 20 mm to about 50 mm, about 20 mm to about 55 mm, about 20 mm to about 60 mm, about 20 mm to about 65 mm, about 20 mm to about 70 mm, about 20 mm to about 75 mm, about 25 mm to about 30 mm, about 25 mm to about 35 mm, about 25 mm to about 40 mm, about 25 mm to about 45 mm, about 25 mm to about 50 mm, about 25 mm to about 55 mm, about 25 mm to about 60 mm, about 25 mm to about 65 mm, about 25 mm to about 70 mm, about 25 mm to about 75 mm, about 30 mm to about 35 mm, about 30 mm to about 40 mm, about 30 mm to about 45 mm, about 30 mm to about 50 mm, about 30 mm to about 55 mm, about 30 mm to about 60 mm, about 30 mm to about 65 mm, about 30 mm to about 70 mm, about 30 mm to about 75 mm, about 35 mm to about 40 mm, about 35 mm to about 45 mm, about 35 mm to about 50 mm, about 35 mm to about 55 mm, about 35 mm to about 60 mm, about 35 mm to about 65 mm, about 35 mm to about 70 mm, about 35 mm to about 75 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm, about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 40 mm to about 65 mm, about 40 mm to about 70 mm, about 40 mm to about 75 mm, about 45 mm to about 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm, about 45 mm to about 65 mm, about 45 mm to about 70 mm, about 45 mm to about 75 mm, about 50 mm to about 55 mm, about 50 mm to about 60 mm, about 50 mm to about 65 mm, about 50 mm to about 70 mm, about 50 mm to about 75 mm, about 55 mm to about 60 mm, about 55 mm to about 65 mm, about 55 mm to about 70 mm, about 55 mm to about 75 mm, about 60 mm to about 65 mm, about 60 mm to about 70 mm, about 60 mm to about 75 mm, about 65 mm to about 70 mm, about 65 mm to about 75 mm, or about 70 mm to about 75 mm. In some cases, a diameter of the leaflet valve structure may be about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm. In some cases, a diameter of the leaflet valve structure may be at least about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, or about 70 mm. In some cases, a diameter of the leaflet valve structure may be at most about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm.

[0104] In some cases, a circumference of the leaflet valve structure comprising multiple leaflets may be from about 70 mm² to about 220 mm². In some cases, a circumference of the leaflet valve structure may be from about 70 mm² to about 100 mm², about 70 mm² to about 130 mm², about 70 mm² to about 160 mm², about 70 mm² to about 190 mm², about 70 mm² to about 220 mm², about 100 mm² to about 130 mm², about 100 mm² to about 160 mm², about 100 mm² to about 190 mm², about 100 mm² to about 220 mm², about 130 mm² to about 160 mm², about 130 mm² to about 190 mm², about 130 mm² to about 220 mm², about 160 mm² to about 190 mm², about 160 mm² to about 220 mm², or about 190 mm² to about 220 mm². In some cases, a circumference of the leaflet valve structure may be about 70 mm², about 100 mm², about 130 mm², about 160 mm², about 190 mm², or about 220 mm². In some cases, a circumference of the leaflet valve structure may be at least about 70 mm², about 100 mm², about 130 mm², about 160 mm², or about 190 mm². In some cases, a circumference of the leaflet valve structure may be at most about 100 mm², about 130 mm², about 160 mm², about 190 mm², or about 220 mm². The circumference may be 78 mm².

[0105] FIGS. 9A-9F show flat (FIG. 9A-9B), top-down (FIG. 9E), side (FIG. 9C), and perspective (FIGS. 9D, 9F) views of prosthetic valve leaflets. FIG. 9A shows a leaflet 600. FIG. 9B shows a support body 610 comprising body 612 and skirt 614. FIG. 9C-9E show different views of combined leaflets 702 into a single valvular component 700. FIG. 9F shows the valvular component 700 planted into stent 100, creating a full valvular prosthesis 800. FIG. 9F shows leaflets 702, decoupling cage 102, and sinusoidal decoupling members 106. The valvular component 700 may instead be planted into stent 200, or any of the other stents disclosed herein.

[0106] In some cases, each of the leaflets in the biological valvular component (e.g., prosthetic leaflets) may be composed of two parts assembled together. The two parts can be the leaflet 600 itself (FIG. 9A) and the support body 610 (FIG. 9B). The support body 610 can comprise a body 612 and a skirt 614.

[0107] The leaflet 600 can be attached to a frame trough of the support body 610 rather than directly to the frame. This can allow for longer durability of the valve, as the support body can absorb most of the strain and protect the leaflet itself.

[0108] In some cases, the leaflet structure comprises a plurality of coapting leaflets centrally positioned in a frame, wherein the leaflets are sufficiently pliable to open and close in response to hemodynamic forces and wherein the frame is sufficiently stiff to at least partially resist deformation resulting from hemodynamic forces after implantation.

[0109] The valve structure can comprise one or more connecting skirts 614. In some cases, the one or more central leaflet cusps are inserted into an arch of the one or more valve support bodies. In some embodiments, the one or more connecting skirts are attached to the one or more valve support bodies. The one or more connecting skirts 614 can be configured to compensate for a diameter discrepancy between a central orifice of a heart valve and a diameter of the valve structure.

[0110] In some cases, one or more of the one or more support bodies, the one or more central leaflet cusps, or the one or more connecting skirts comprise hybrid tissue, including but not limited to a hybrid of biological tissue and polymers.

[0111] In some cases, the devices disclosed herein may describe or show devices with three leaflet structures, however the valvular prostheses described herein may have more or fewer than three leaflet structures. [0112] When multiple leaflets 600 are combined together, they can form the overall biological valvular component 700 with leaflets 702. As shown in FIGS. 9C-9E, the leaflets meet together, in some cases at posts as shown in FIG. 9F. The part at which they meet together can be the external- most part of each section of the valvular component 700, and the middle of each leaflet can be the inner-most part of each section of the valvular component 700. The middle part of the leaflet may come together during contraction of the heart where the three leaflets meet in the middle of the valve. This may be the inner-most part of each section of the valve. In some cases, there may be spacing in the center of where the leaflets 702 meet. This can help provide flexibility to the valvular component 700.

[0113] The labeling of stents with different numbers does not indicate that the stents are only usable with the features they are used to demonstrate. Rather, any stent numbered or described herein can be used with any feature described herein.

Methods

[0114] Described herein are methods of delivering and deploying the stents and valvular prosthetic devices described herein. As part of deploying, the stents and valvular prosthetic devices described herein can be locked from a planar configuration into a ring or cylinder configuration.

Locking Methods

[0115] Provided herein are locking mechanisms and methods to be used with one or more of the stents described herein. Described herein are intraluminal support structures for insertion into a heart valve of a subject, comprising a scaffold panel having a first free end and a second free end when the scaffold pattern is in a planar configuration. The scaffold pattern in the planar configuration can further comprise a first axis spanning from the first free end to the second free end.

[0116] The first and second ends of a decoupling cage can be configured to be coupled to each other to form into a ring when deployed, similar to stent 100 or 200. The second free end can comprise a locking area (e.g., 212 of FIG. 2A) with a tight gap. The first free end can comprise a one or more welded T hooks (e.g., 232, 234, and/or 236 of FIG. 2A) that slidably couple to the locking area in a first direction perpendicular to the first axis. In some cases, the first free end and the second free end are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first free end or the second free end are not perpendicular to the first axis. There can be an angle between the main axis of the stent and the locking mechanism. [0117] As shown in FIGS. 3C-3D, in some cases, the T hooks may be welded to the opposite end relative to the locking area 212 of FIG. 2 A. The T hooks can be folded over to approach the window 224 of FIG. 2A. The T hooks can slide down the window 224 into the locking area 212. The lower T hooks (e.g., Type C 236 and Type B 234) enter the window 224 and locking area 212 before the Type A T connector 232. To improve engagement of the locking area 212, Type B 234 and C 236 T connectors may have angled arms (e.g., the top part of the “T”) instead of horizontal arms. The arms may be angled away from the base of the T. Type C T connector 236 may have longer arms than Type B T connector 234 to catch the frame. Each subsequent type (B, then A) can have shorter arms to tighten the locking connection and thus the ring.

[0118] When the ring is closed, the overlapping area (e.g., 230 of FIG. 2A) can be external to the remainder of the ring, as the locking occurs just prior to the overlapping area 230 on the scaffold. [0119] Locking mechanisms can be perpendicular to circumferential rail. Locking mechanisms can be perpendicular to upper inflow crown. Locking mechanisms can be perpendicular to lower outflow crown. Locking mechanisms can be parallel to the stent posts.

Delivery Methods

[0120] The method can comprise loading the valvular prosthesis to a delivery catheter. In some cases, the valvular prosthesis can be loaded helically around the delivery catheter. The delivery catheter may have two or more clips. One of the clips may be disposed proximate the distal tip of the delivery catheter. At least one of the clips may be disposed proximal the first clip. The valvular prosthesis can be clipped into the chips and the clips can be rotated such that a first free end of the device and a second free end of the device are rotated relative to each other to create a helix. The method can comprise introducing the catheter into the body and advancing the loaded catheter through the body lumen and anatomical tissue until reaching the delivery site (implantation site). The method can comprise deploying the valvular prosthesis at the delivery site and maneuvering the deployed stent to its final implanted location. The method can comprise withdrawing the catheter from the body lumen. In some cases, deploying can comprise connecting the proximal clip(s) to the distal clip such that the proximal end of the planar device approaches the distal end of the planar device.

[0121] The method may comprise implanting any one of the intraluminal support structures described previously with a delivery catheter having a proximal end, a distal end, and an elongated carrier region near the distal end. The delivery catheter can comprise a distal coupler configured to releasably attach the free first end of the scaffold panel of the stent and a proximal coupler configured to releasably attach the second end of the scaffold panel, where the distal and proximal couplers may releasably hold the scaffold panel in a helically wrapped configuration within the elongated carrier region prior to release the form the ring configuration.

[0122] In some cases, the distal coupler may be configured to both translate along and rotate about a longitudinal axis of the catheter. The delivery catheter can comprise an outer shaft, a medial shaft, and an inner shaft coaxially disposed within a central passage of the outer shaft. The distal coupler may be carried on a distal region of the middle shaft and the proximal coupler may be carried on a distal region of the outer shaft.

[0123] In some cases, a distal end of the delivery catheter is advanced to the valve annulus, and the scaffold panel is deployed from the elongated carrier region of the delivery catheter, allowing the scaffold panel to transition to form a ring or cylinder within the valve annulus.

[0124] In some cases, the stent is pre-shaped as a ring and deploying the stent comprises allowing the scaffold panel to transition into the ring or cylinder. The delivery catheter may twist and axially compress the free ends of the scaffold panel to effect or assist the transition of the planar configuration into the ring.

[0125] In some cases, loading a stent as described herein onto a delivery catheter can comprise rotating the clip or proximal coupler along the outer shaft of the delivery catheter relative to the distal coupler prior to attaching the stent. In some cases, the proximal section of the delivery catheter rotates less than about 60 degrees, less than about 120 degrees, less than about 180 degrees, less than about 240 degrees, less than about 300 degrees, or less than about 360 degrees. In some cases, the delivery catheter rotates greater than about 0 degrees, greater than about 60 degrees, greater than about 120 degrees, greater than about 180 degrees, greater than about 240 degrees, or greater than about 300 degrees. In some cases, the delivery catheter rotates 180 degrees.

[0126] After loading is completed, the proximal section of the delivery catheter holding one end of a stent with a proximal locking element can slide or translate towards the fixed end of the delivery catheter holding the other end of a stent with distal locking element. When the delivery catheter reaches the end of the distal fixed end, the proximal section of the delivery catheter can rotate clockwise. In some cases, the proximal section of the delivery catheter rotates less than about 60 degrees, less than about 120 degrees, less than about 180 degrees, less than about 240 degrees, less than about 300 degrees, or less than about 360 degrees. In some cases, the delivery catheter rotates greater than about 0 degrees, greater than about 60 degrees, greater than about 120 degrees, greater than about 180 degrees, greater than about 240 degrees, or greater than about 300 degrees. In some cases, the delivery catheter rotates 180 degrees. The delivery catheter can rotate clockwise a similar amount as it rotated counterclockwise prior to loading.

[0127] In some embodiments, the stent implant is kept circumferentially constrained during the loading phase onto delivery system. In some embodiments, stent implant is kept circumferentially constrained during the deployment phase from the delivery system into the heart valve. The stent structure can then be locked into a cylindrical shape via the locking mechanisms discussed above. When locked into a cylindrical shape, the diameter can originally be smaller than the mitral annulus to be treated. The stent can then be released. The stent diameter can increase on release. The stent diameter can be released by self-actuation. The stent diameter can be released by an external actuation system, for example a balloon catheter.

[0128] In some cases, the stents described herein can be beneficial because they allow for a one- size-fits-all delivery system, because the final shape of the folded configuration may not depend on the delivery system. A single delivery system can be used on stents of different sizes and conformations.

Definitions

[0129] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and/or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0130] ‘ ‘Intraluminal support structure” and “stent” can be used interchangeably herein. “Planar” and “unrolled” can be used interchangeably herein. Although the unrolled structure may not be fully flat or planar, it is a linear structure relative to the ring structure of the deployed device.

[0131] Within the context of this application the term "open" in reference to a configuration of the support structure refers to a non-tubular or non-cylindrical structure, for example such as a stent or valve. The term "open" may be utilized to interchangeably refer to a single layer planar structure that is substantially flat or to a multilayered planar structure that is substantially flat.

[0132] Throughout this application, various embodiments may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0133] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “approximately”, “about”, and “substantially” as used herein include the recited numbers, and also represent an amount close to the stated amount that still performs a desired function or achieves a desired result. The term “about” or “approximately” may mean within an acceptable error range for the particular value, which will depend in part on how the value is measured or determined, e.g., the limitations of the measurement system. For example, the terms “approximately”, “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. For example, “about” may mean within 1 or more than 1 standard deviation, per the practice in the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. As used herein, the term “about” a number refers to that number plus or minus 10% of that number. The term “about” a range refers to that range minus 10% of its lowest value and plus 10% of its greatest value. Where particular values are described in the application and claims, unless otherwise stated the term “about” meaning within an acceptable error range for the particular value may be assumed.

[0134] As used in the specification and claims, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a sample” includes a plurality of samples, including mixtures thereof.

[0135] The terms “determining,” “measuring,” “evaluating,” “assessing,” “assaying,” and “analyzing” are often used interchangeably herein to refer to forms of measurement. The terms include determining if an element is present or not (for example, detection). These terms can include quantitative, qualitative or quantitative and qualitative determinations. Assessing can be relative or absolute. “Detecting the presence of’ can include determining the amount of something present in addition to determining whether it is present or absent depending on the context.

[0136] The terms “subject,” “individual,” or “patient” are often used interchangeably herein. A “subject” can be a biological entity containing expressed genetic materials. The subject can be a mammal. The mammal can be a human. The subject may be diagnosed or suspected of being at high risk for a disease. In some cases, the subject is not necessarily diagnosed or suspected of being at high risk for the disease.

[0137] As used herein, the terms “treatment” or “treating” are used in reference to a pharmaceutical or other intervention regimen for obtaining beneficial or desired results in the recipient. Beneficial or desired results include but are not limited to a therapeutic benefit and/or a prophylactic benefit. A therapeutic benefit may refer to eradication or amelioration of symptoms or of an underlying disorder being treated. Also, a therapeutic benefit can be achieved with the eradication or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement is observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder. A prophylactic effect includes delaying, preventing, or eliminating the appearance of a disease or condition, delaying or eliminating the onset of symptoms of a disease or condition, slowing, halting, or reversing the progression of a disease or condition, or any combination thereof. For prophylactic benefit, a subject at risk of developing a particular disease, or to a subject reporting one or more of the physiological symptoms of a disease may undergo treatment, even though a diagnosis of this disease may not have been made.

[0138] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

[0139] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the present disclosure and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. An intraluminal support structure for deployment into a heart valve of a subject, the intraluminal support structure comprising:

(a) an inner valve support; and

(b) an external decoupling cage coupled to the inner valve support and comprising a plurality of sinusoidal decoupling members, an inflow crown, and an outflow crown, wherein the sinusoidal decoupling members are configured to decouple the inner valve support from a motion of the annulus, the ventricle, or both when the external decoupling cage is deployed into a heart valve annulus; wherein the intraluminal support structure has an undeployed planar configuration and a deployed ring configuration for deployment in the heart valve.

2. The intraluminal support structure of claim 1, wherein the intraluminal support structure is configured to be delivered via a catheter.

3. The intraluminal support structure of claim 1 or 2, wherein the inflow crown is configured to face the atrial side of the heart and the outflow crown is configured to face the ventricular side of the heart when the intraluminal support is deployed into the heart valve.

4. The intraluminal support structure of any one of claims 1 to 3, wherein the plurality of sinusoidal decoupling members comprise varying patterns optimized for anchoring and flexibility based on a shape of the heart valve of the subject.

5. The intraluminal support structure of any one of claims 1 to 4, wherein the external decoupling cage has an hourglass shape with a narrow middle portion configured to conform to a native annulus shape.

6. The intraluminal support structure of claim 5, wherein the narrow middle portion is disposed closer to the outflow crown than the inflow crown.

7. The intraluminal support structure of any one of claims 1 to 6, wherein segments of the inner valve support are welded together.

8. The intraluminal support structure of any one of claims 1 to 7, wherein the intraluminal support structure is laser-cut from a single sheet.

9. The intraluminal support structure of any one of claims 1 to 8, further comprising anchoring barbs disposed along and extending from the external decoupling cage.

10. The intraluminal support structure of claim 9, wherein the anchoring barbs are disposed at an about 45 degree angle relative to a plane of the external decoupling cage.

11. The intraluminal support structure of any one of claims 1 to 10, further comprising a covering.

12. The intraluminal support structure of claim 11, wherein the covering comprises a biocompatible material.

13. The intraluminal support structure of any one of claims 1 to 12, wherein the plurality of sinusoidal decoupling members originate at a level higher than an atrial cusp of the heart valve when the intraluminal support structure is deployed into the heart valve.

14. The intraluminal support structure of any one of claims 1 to 13, wherein the external decoupling cage is coupled to the inner valve support via a plurality of connectors configured to decouple a motion of the external decoupling cage from a motion of the inner valve.

15. The intraluminal support structure of claim 14, wherein the plurality of connectors comprise straight connectors between the inner valve support and the external decoupling cage.

16. The intraluminal support structure of claim 14, wherein the plurality of connectors comprise articulated connectors configured to adjust a radial separation distance between the inner valve support and the external decoupling cage.

17. The intraluminal support structure of any one of claims 1 to 16, wherein the plurality of sinusoidal decoupling members are configured to one or more of compress, expand, or translate in response to motion of the heart valve.

18. The intraluminal support structure of any one of claims 1 to 17, wherein the intraluminal support structure is comprised of a plurality of circumferential sections.

19. The intraluminal support structure of claim 18, wherein the intraluminal support structure is comprised of three circumferential sections.

20. The intraluminal support structure of claim 18 or 19, wherein two adjacent circumferential sections of the plurality of sections is separated by at least one post.

21. The intraluminal support structure of claim 20, wherein two adjacent circumferential sections of the plurality of sections is separated by two posts.

22. The intraluminal support structure of claim 20 or 21, wherein each circumferential section comprises a set of rails inferior to the outflow crown when the intraluminal support structure is deployed into the heart valve.

23. The intraluminal support structure of claim 22, wherein the set of rails is expandable.

24. The intraluminal support structure of any one of claims 1 to 23, wherein the intraluminal support structure comprises at least one scaffold panel having a first free end and a second free end when the scaffold panel is in the undeployed planar configuration, wherein the first and second free ends are configured to be coupled to each other to form into the ring when the intraluminal support is placed into the deployed ring configuration.

25. The intraluminal support structure of any one of claims 1 to 24, wherein the inner valve support is configured to support at least one prosthetic valve leaflet.

26. The intraluminal support structure of any one of claims 1 to 25, wherein the plurality of sinusoidal decoupling members are coupled to the inflow crown and to posts.

27. A valvular prosthetic, comprising:

(a) the intraluminal support structure of any of one claims 1 to 26; and

(b) at least one prosthetic valve leaflet.

28. The valvular prosthetic of claim 27, wherein the one or more prosthetic valve leaflets are inserted into a circumferential section of one or more circumferential sections separated by posts and comprising the intraluminal support structure.

29. The valvular prosthetic of claim 28, wherein the at least one prosthetic valve leaflet comprises a same number of prosthetic valve leaflets as the circumferential sections separated by posts.

30. The valvular prosthetic of any one of claims 27 to 29, wherein the at least one prosthetic valve leaflet comprises one or more of biological tissue, polymer, or a hybrid of biological tissue and polymer.

31. A method of deploying a valvular prosthetic to a heart valve, the method comprising:

(a) advancing a distal end of a delivery catheter to the heart valve, wherein a valvular prosthetic is helically wrapped around the delivery catheter in a planar configuration of the valvular prosthetic, wherein the valvular prosthetic comprises the intraluminal support structure of any of one claims 1 to 26 and at least one prosthetic valve leaflet;

(b) locking a first end of the valvular prosthetic into a second end of the valvular prosthetic by sliding a locking mechanism on the first end into a locking mechanism on the second end via a deployment mechanism on the delivery catheter, thereby placing the valvular prosthetic into the deployed ring configuration.

32. The method of claim 31, wherein the heart valve is selected from the group consisting of a mitral valve, an aortic valve, a pulmonary valve, and a tricuspid valve.

33. The method of claim 31 or 32, further comprising anchoring the valvular prosthetic in the heart valve via anchoring barbs after creating the ring configuration of the valvular prosthetic.

34. The method of any one of claims 31 to 33, further comprising removing the distal end of the delivery catheter from the heart valve.