Valve prosthesis with decoupling member

Abstract

This document provides an apparatus and method for a valve prosthesis having a planar configuration during delivery and a final closed folded configuration during deployment at a tissue target site. The stent may include an inner valve support for interfacing with the valve prosthesis leaflets and an outer cage. The cage decouples the movement of the native heart valve from the inner valve support and the valve prosthesis leaflets.

Description

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

[0002] Heart valve disease (HVD) affects many people worldwide. HVD can manifest in various ways in abnormal valve leaflet tissue, including excessive tissue growth, tissue degeneration, tissue rupture, tissue sclerosis, tissue calcification, and abnormal tissue repositioning due to cardiac conformation during different phases of the cardiac cycle, such as annular dilation or ventricular remodeling. This abnormal tissue often leads to valvular dysfunction, such as leakage, backflow due to valvular insufficiency, and resistance to forward blood flow due to valvular stenosis. In some cases, treatment may include replacing the failing native valve with a prosthetic valve.

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

[0004] The left atrioventricular (AV) valve (also known as the mitral valve) presents unique anatomical challenges, making percutaneous mitral valve replacement significantly more difficult. The mitral annulus is non-circular, D-shaped or kidney-shaped, and has a typically asymmetrical, non-planar, saddle-shaped geometry. This anatomical variation and asymmetry makes it difficult to deliver the centrally dilated replacement valve using the distal tip of the centrally dilated valve. Furthermore, anchoring the device by capturing the leaflets with hooks or rings can be dangerous and prone to failure.

[0005] The mitral valve (MV) consists of a pair of evenly opposed or "joined" leaflets that close together. The ventricular side of the leaflets attaches to the peripheral cardiac structures of the left ventricle via a ring-shaped tissue region on the left atrium called the valve annulus (AN). The valve annulus is a fibrous ring of dense connective tissue, distinct from the leaflet tissue of the heart wall and the adjacent muscle tissue. Summary of the Invention

[0006] This article describes valve prostheses and their delivery methods.

[0007] This document provides an intraluminal support structure for deployment in a heart valve of a subject. The intraluminal support structure may include an inner valve support member. The intraluminal support structure may include an outer decoupling cage coupled to the inner valve support member and including a plurality of sinusoidal decoupling members, an inflow coronary, and an outflow coronary. In some cases, the sinusoidal decoupling members are configured to decouple the inner valve support member from the motion of the annulus, the ventricle, or both when the outer decoupling cage is deployed into the heart valve annulus. In some cases, the intraluminal support structure has a non-deployed planar configuration and a deployed annular configuration for deployment in the heart valve.

[0008] In some cases, the intraluminal support structure is configured for delivery via catheter. In some cases, when the intraluminal support is deployed into the heart valve, the inflow coronary is configured to face the atrial side of the heart and the outflow coronary is configured to face the ventricular side of the heart. In some cases, the plurality of sinusoidal decoupling components include different patterns optimized for anchoring and flexibility based on the shape of the subject's heart valve. In some cases, the external decoupling cage has an hourglass shape, with a narrow central portion configured to conform to the shape of the native valve annulus. In some cases, the narrow central portion is positioned closer to the outflow coronary than the inflow coronary. In some cases, segments of the internal valve support are welded together. In some cases, the intraluminal support structure is laser-cut from a single sheet of material.

[0009] In some cases, the intraluminal support structure may further include anchoring barbs disposed along and extending therefrom the external decoupling cage. In some cases, the anchoring barbs are disposed at an angle of approximately 45 degrees relative to the plane of the external decoupling cage.

[0010] The intraluminal support structure may also include a covering. In some cases, the covering includes a biocompatible material.

[0011] In some cases, when the intraluminal support structure is deployed into the heart valve, the plurality of sinusoidal decoupling members originate at a level higher than the atrial apex of the heart valve. In some cases, the external decoupling cage is coupled to the internal valve support via a plurality of connectors. In some cases, the plurality of connectors includes a straight connector between the internal valve support and the external decoupling cage. In some cases, the plurality of connectors includes a hinged connector configured to adjust the radial spacing between the internal valve support and the external decoupling cage. In some cases, the plurality of sinusoidal decoupling members are configured to compress, expand, or translate one or more times in response to movement of the heart valve.

[0012] In some cases, the intraluminal support structure comprises multiple circumferential segments. In some cases, the intraluminal support member comprises three circumferential segments. In some cases, two adjacent circumferential segments of the multiple segments are separated by at least one strut. In some cases, two adjacent circumferential segments of the multiple segments are separated by two struts. In some cases, when the intraluminal support structure is deployed into the heart valve, each circumferential segment includes a set of tracks below the outflow coronary. In some cases, the set of tracks is expandable.

[0013] In some cases, the intraluminal support structure includes at least one stent support panel having a first free end and a second free end when the stent support panel is in the undeployed planar configuration, wherein the first free end and the second free end are configured to couple to each other to form a ring when the intraluminal support is placed in the deployment annular configuration. In some cases, the internal 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 coronal portion and the strut.

[0014] This document describes a valve prosthesis. The valve prosthesis may include an intraluminal support structure as described above. The valve prosthesis may include at least one prosthetic valve leaflet.

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

[0016] This document provides a method for deploying a valve prosthesis to a heart valve. The method may include advancing the distal end of a delivery catheter into the heart valve. In some cases, the valve prosthesis is helically wound around the delivery catheter in a planar configuration of the valve prosthesis. In some cases, the valve prosthesis includes the intraluminal support structure described above and at least one prosthetic valve leaflet. The method may include locking the first end to the second end via a deployment mechanism on the delivery catheter, thereby positioning the valve prosthesis in the deployment annular configuration.

[0017] In some cases, the heart valve is selected from the group consisting of the mitral valve, aortic valve, pulmonary valve, and tricuspid valve. In some cases, the method may further include anchoring the valve prosthesis in the heart valve via anchoring barbs after forming the annular configuration of the valve prosthesis. In some cases, the method may further include removing the distal end of the delivery catheter from the heart valve.

[0018] Additional aspects and advantages of this disclosure will become apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. It will be appreciated that this disclosure is capable of having other and different embodiments, and that several details thereof can be modified in various obvious ways without departing from this disclosure. Therefore, the drawings and descriptions should be considered illustrative in nature and not restrictive.

[0019] Incorporation All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference, as if each individual publication, patent, or patent application were expressly and separately indicated to be incorporated by reference. The subject matter of PCT / IB2022 / 000431, filed July 25, 2022, is incorporated herein by reference, claiming priority to U.S. Provisional Application 63 / 311,650, filed February 18, 2022, and U.S. Provisional Application 63 / 225,969, filed July 27, 2021. Attached Figure Description

[0020] The novel features of this disclosure are specifically set forth in the appended claims. A better understanding of the features and advantages of this disclosure will be obtained by referring to the following detailed description and accompanying drawings (also referred to herein as “drawings” and “figures”), which illustrate illustrative embodiments utilizing the principles of this disclosure, in which: Figures 1A to 1E A perspective top view of an example bracket according to an example embodiment described herein is shown. Figures 1A to 1B , Figure 1E Top view () Figure 1C ) and side view ( Figure 1D ).

[0021] Figure 2A A schematic or top view of an example unfolding bracket according to an example embodiment described herein is shown.

[0022] Figures 2B to 2F Example embodiments according to the description herein are shown. Figure 2A A schematic diagram or top view of the components of the support.

[0023] Figures 3A to 3DA perspective view of a T-shaped connector used with an example bracket according to an example embodiment described herein is shown. Figure 3A ), planar side view ( Figure 3B , Figure 3D ) and perspective side view ( Figure 3C ).

[0024] Figure 4 A perspective view of an example anchoring barb used with an example bracket according to an example embodiment described herein is shown.

[0025] Figures 5A to 5B A top view of the strut of an example unfolding support according to an example embodiment described herein is shown.

[0026] Figure 6A A perspective side view of a three-dimensional multi-layer planar diagram of an example unfolding bracket according to an example embodiment described herein is shown.

[0027] Figures 6B to 6C A side view of the curvature of an example bracket according to an example embodiment described herein is shown. Figure 6B ) and perspective side view ( Figure 6C ).

[0028] Figure 7 A side view of an example deployment bracket with a cover, according to an example embodiment described herein, is shown.

[0029] Figure 8 A side view of an example deployment bracket in a native lobe ring is shown, according to an example embodiment described herein.

[0030] Figures 9A to 9F A plan view of an example prosthetic valve leaflet according to an example embodiment described herein is shown. Figures 9A to 9B Top-down view Figure 9E ), side view ( Figure 9C ) and perspective ( Figure 9D , Figure 9F ). Detailed Implementation

[0031] This disclosure generally relates to medical implants and methods and systems for delivering medical implants into the human body. More specifically, this disclosure relates to methods and systems for delivering a heart valve implant via a catheter into a human heart.

[0032] Transcatheter treatment of structural heart disease may increase the need for delivering large devices (e.g., stents) through native vessels, the heart wall, and the cardiac septum. However, the radial crimping and radial deployment (e.g., expansion) of these devices can create a rigid and relatively large core within the delivery sheath. Furthermore, the large size (diameter) of the device may leave a large orifice in the cardiac septum at the end of the procedure. These limitations in rigidity and size can result in limited mobility and maneuverability during the procedure. They may also make stents prone to breakage.

[0033] The need for stents that are more flexible in the deployment state and thinner or smaller in the delivery state for easier manipulation through tortuous anatomy remains unmet. Increasing stent flexibility can improve stent delivery and deployment capabilities.

[0034] While flexibility is important, support in the deployment state can also benefit by increasing the stability of the support within the delivery site.

[0035] The dual requirement of being flexible during delivery and having high support during deployment is an unresolved problem in the art, as these two characteristics are inversely proportional. Specifically, as support flexibility increases, support may decrease, and similarly, as support increases, flexibility may decrease. Therefore, there remains a need for a support that is highly flexible in its delivery profile and has high support in its final state.

[0036] Furthermore, many devices designed to treat valvular heart disease may be inadequate in addressing variations in valve annular anatomy and dynamic valve motion, which can lead to leakage and stent breakage after long-term implantation. These failures may be due to the lack of pressure-absorbing structures that decouple the valve from the motion of the valve annulus and ventricular wall, or because the way such absorbent structures are attached to the valve prosthesis may lead to long-term fatigue failure.

[0037] Devices attempting to address certain valve movements are designed with metallic structures that may rely on welding components around the valve to provide isolation between the heart wall movement and the prosthetic valve. Over time, such welding can lead to stent fracture.

[0038] Therefore, there is an unmet need for valve prostheses that 1) are flexible during their delivery phase, 2) are adequately stent-supported for stability during their deployment phase, 3) are not welded to avoid breakage, and 4) can absorb the impact of the native heart valve to minimize fatigue.

[0039] This document provides a valve prosthesis having a planar (e.g., unfolded) configuration during delivery and a final closed folded configuration during deployment at the tissue target site. A planar stent can mate with the valve prosthesis leaflets to form a valve prosthesis that can be delivered via a catheter. The stent may include an inner valve support for interfacing with the valve prosthesis leaflets and an outer cage.

[0040] By delivering the valve prosthesis described herein in a planar or multi-planar configuration, it can be flexible during delivery and occupy a minimal amount of space (considering three-dimensional space). As shown in the figures and described below, the stent can be designed to support the stent in a final annular shape. In some cases, the cage may comprise a single sheet. The single sheet can be laser-cut. The cage can avoid welding by being formed from a single sheet. The cage can protect the inner valve support and the valve prosthesis leaflets from the motion of the native heart valve. The cage can decouple the motion of the native heart valve from the inner valve support and the valve prosthesis leaflets. Therefore, the cage can be an externally decoupled cage.

[0041] In some cases, valve prostheses can be formed in the form of, for example, semilunar valves, pulmonary valves, aortic valves, atrioventricular valves (AV valves), mitral valves, bicuspid valves, tricuspid valves, sphincter valves, cervical valves, or any combination thereof.

[0042] This document discloses a method for delivering and deploying an endoluminal support structure as described herein. The method may include loading a valve prosthesis into a delivery catheter. The method may include introducing the catheter into the body and advancing the loaded catheter through body cavities and anatomical tissues until reaching the delivery site (implantation site). The method may include deploying the valve prosthesis at the delivery site and manipulating the deployed stent to its final implantation location. The method may include withdrawing the catheter from the body cavity.

[0043] Device This article describes a valve prosthesis comprising one or more leaflet structures and an intraluminal support structure (e.g., a stent). The stent may include an inner valve support and an outer decoupling cage. The stent can be transformed from a multi-layered planar structure in its undeployed form to an annular or cylindrical structure in its deployed form.

[0044] In some cases, the stent size described herein can vary depending on the size of the valve annulus and therefore the size of the stent to be used. In other cases, the maximum stent size can remain constant, and the stent can be adjustable according to the size of the valve annulus.

[0045] In some cases, the size of the inner frame can be similar to that of a leaflet valve structure that includes multiple leaflets.

[0046] In some cases, the height of the inner frame can be from about 12 mm to about 22 mm. In some cases, the height of the leaflet structure can be from about 12 mm to about 14 mm, from about 12 mm to about 16 mm, from about 12 mm to about 18 mm, from about 12 mm to about 20 mm, from about 12 mm to about 22 mm, from about 14 mm to about 16 mm, from about 14 mm to about 18 mm, from about 14 mm to about 20 mm, from about 14 mm to about 22 mm, from about 16 mm to about 18 mm, from about 16 mm to about 20 mm, from about 16 mm to about 22 mm, from about 18 mm to about 20 mm, from about 18 mm to about 22 mm, or from about 20 mm to about 22 mm. In some cases, the height of the leaflet structure can be from about 12 mm, from about 14 mm, from about 16 mm, from about 18 mm, from about 20 mm, or from about 22 mm. In some cases, the height of the leaflet structure can be at least from about 12 mm, from about 14 mm, from about 16 mm, from about 18 mm, or from about 20 mm. In some cases, the height of the leaflet structure can be up to about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0047] In some cases, the diameter of the inner frame can be from about 20 mm to about 75 mm. In some cases, the diameter of the inner frame can be approximately 20 mm to approximately 25 mm, approximately 20 mm to approximately 30 mm, approximately 20 mm to approximately 35 mm, approximately 20 mm to approximately 40 mm, approximately 20 mm to approximately 45 mm, approximately 20 mm to approximately 50 mm, approximately 20 mm to approximately 55 mm, approximately 20 mm to approximately 60 mm, approximately 20 mm to approximately 65 mm, approximately 20 mm to approximately 70 mm, approximately 20 mm to approximately 75 mm, approximately 25 mm to approximately 30 mm, approximately 25 mm to approximately 35 mm, approximately 25 mm to approximately 40 mm, approximately 25 mm to approximately 45 mm, approximately 25 mm to approximately 50 mm, approximately 25 mm to approximately 55 mm, approximately 25 mm to approximately 60 mm, approximately 25 mm to approximately 65 mm, approximately 25 mm to approximately 70 mm, approximately 25 mm to approximately 75 mm, approximately 30 mm to approximately 35 mm, approximately 30 mm to approximately 40 mm, approximately 30 mm to approximately 45 mm, approximately 30 mm to approximately 50 mm, approximately 30 mm to approximately 55 mm. 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 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, or about 70 mm to about 75 mm.In some cases, the diameter of the inner frame can be approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, approximately 70 mm, or approximately 75 mm. In some cases, the diameter of the inner frame can be at least approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, or approximately 70 mm. In some cases, the diameter of the inner frame can be at most approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, approximately 70 mm, or approximately 75 mm.

[0048] In some cases, the circumference of the inner frame can be approximately 70 mm. 2 Approximately 220 mm 2 In some cases, the circumference of the inner frame can be approximately 70 mm. 2 approximately 100 mm 2 Approximately 70 mm 2 Approximately 130 mm 2 Approximately 70 mm 2 Approximately 160 mm 2 Approximately 70mm 2 Approximately 190 mm 2 Approximately 70 mm 2 Approximately 220 mm 2 Approximately 100 mm 2 Approximately 130 mm 2 Approximately 100 mm 2 Approximately 160 mm 2 Approximately 100 mm 2 Approximately 190 mm 2 Approximately 100 mm 2 Approximately 220 mm 2 Approximately 130 mm 2 Approximately 160 mm 2 Approximately 130 mm 2 Approximately 190mm 2 Approximately 130 mm 2 Approximately 220 mm 2 Approximately 160 mm 2 Approximately 190 mm 2 Approximately 160 mm 2 Approximately 220 mm 2 or approximately 190 mm 2 Approximately 220 mm2 In some cases, the circumference of the inner frame can be approximately 70 mm. 2 Approximately 100 mm 2 Approximately 130 mm 2 Approximately 160mm 2 Approximately 190 mm 2 or approximately 220 mm 2 In some cases, the circumference of the inner frame can be at least approximately 70 mm. 2 Approximately 100mm 2 Approximately 130 mm 2 Approximately 160 mm 2 or approximately 190 mm 2 In some cases, the circumference of the inner frame can be up to approximately 100 mm. 2 Approximately 130 mm 2 Approximately 160 mm 2 Approximately 190 mm 2 or approximately 220 mm 2 The circumference can be 78 mm. 2 .

[0049] In some cases, due to the curvature of the stent from the atrial to the ventricular side, the stent dimensions described in this article vary depending on the stent section. Figure 1D For reference, there may be four or more diameters. The first diameter may be the diameter of the uppermost portion (e.g., the atrial side). The second diameter may be the diameter of the atrial side bulge (e.g., the external curvature). The third diameter may be the diameter at the dashed line where the coupling cage bends inward. The fourth diameter may be the diameter of the ventricular side external curvature and the lowest portion.

[0050] In some cases, the first diameter of the stent in its annular configuration can be from about 40 mm to about 60 mm. In some cases, the first diameter of the stent in its annular configuration can be from about 40 mm to about 45 mm, from about 40 mm to about 50 mm, from about 40 mm to about 55 mm, from about 40 mm to about 60 mm, from about 45 mm to about 50 mm, from about 45 mm to about 55 mm, from about 45 mm to about 60 mm, from about 50 mm to about 55 mm, from about 50 mm to about 60 mm, or from about 55 mm to about 60 mm. In some cases, the first diameter of the stent in its annular configuration can be from about 40 mm, from about 45 mm, from about 50 mm, from about 55 mm, or from about 60 mm. In some cases, the first diameter of the stent in its annular configuration can be at least from about 40 mm, from about 45 mm, from about 50 mm, or from about 55 mm. In some cases, the first diameter of the support in its annular configuration can be up to about 45 mm, about 50 mm, about 55 mm, or about 60 mm.

[0051] In some cases, the second diameter of the stent in its annular configuration can be from about 40 mm to about 60 mm. In some cases, the second diameter of the stent in its annular configuration can be from about 40 mm to about 45 mm, from about 40 mm to about 50 mm, from about 40 mm to about 55 mm, from about 40 mm to about 60 mm, from about 45 mm to about 50 mm, from about 45 mm to about 55 mm, from about 45 mm to about 60 mm, from about 50 mm to about 55 mm, from about 50 mm to about 60 mm, or from about 55 mm to about 60 mm. In some cases, the second diameter of the stent in its annular configuration can be from about 40 mm, from about 45 mm, from about 50 mm, from about 55 mm, or from about 60 mm. In some cases, the second diameter of the stent in its annular configuration can be at least from about 40 mm, from about 45 mm, from about 50 mm, or from about 55 mm. In some cases, the second diameter of the stent in its annular configuration can be at most from about 45 mm, from about 50 mm, from about 55 mm, or from about 60 mm. In some cases, the second diameter of the support in its annular configuration can be approximately 54 mm.

[0052] In some cases, the third diameter of the stent in its annular configuration can be from about 35 mm to about 55 mm. In some cases, the third diameter of the stent in its annular configuration can be from about 35 mm to about 40 mm, from about 35 mm to about 45 mm, from about 35 mm to about 50 mm, from about 35 mm to about 55 mm, from about 40 mm to about 45 mm, from about 40 mm to about 50 mm, from about 40 mm to about 55 mm, from about 45 mm to about 50 mm, from about 45 mm to about 55 mm, or from about 50 mm to about 55 mm. In some cases, the third diameter of the stent in its annular configuration can be from about 35 mm, from about 40 mm, from about 45 mm, from about 50 mm, or from about 55 mm. In some cases, the third diameter of the stent in its annular configuration can be at least from about 35 mm, from about 40 mm, from about 45 mm, or from about 50 mm. In some cases, the third diameter of the stent in its annular configuration can be up to about 40 mm, about 45 mm, about 50 mm, or about 55 mm. In some cases, the third diameter of the stent in its annular configuration can be about 46 mm.

[0053] In some cases, the fourth diameter of the stent in its annular configuration can be from about 40 mm to about 60 mm. In some cases, the fourth diameter of the stent in its annular configuration can be from about 40 mm to about 45 mm, from about 40 mm to about 50 mm, from about 40 mm to about 55 mm, from about 40 mm to about 60 mm, from about 45 mm to about 50 mm, from about 45 mm to about 55 mm, from about 45 mm to about 60 mm, from about 50 mm to about 55 mm, from about 50 mm to about 60 mm, or from about 55 mm to about 60 mm. In some cases, the fourth diameter of the stent in its annular configuration can be from about 40 mm, from about 45 mm, from about 50 mm, from about 55 mm, or from about 60 mm. In some cases, the fourth diameter of the stent in its annular configuration can be at least from about 40 mm, from about 45 mm, from about 50 mm, or from about 55 mm. In some cases, the fourth diameter of the stent in its annular configuration can be up to about 45 mm, about 50 mm, about 55 mm, or about 60 mm. In some cases, the fourth diameter of the stent in its annular configuration can be about 56 mm.

[0054] In some cases, the height of the stent in its annular configuration (from the atrial side to the ventricular side or from the inflow coronary to the outflow coronary) can be from about 20 mm to about 35 mm. In some cases, the height of the stent in its annular configuration can be from about 20 mm to about 25 mm, from about 20 mm to about 30 mm, from about 20 mm to about 35 mm, from about 25 mm to about 30 mm, or from about 30 mm to about 35 mm. In some cases, the height of the stent in its annular configuration can be from about 20 mm, about 25 mm, about 30 mm, or about 35 mm. In some cases, the height of the stent in its annular configuration can be at least about 20 mm, about 25 mm, or about 30 mm. In some cases, the height of the stent in its annular configuration can be at most about 25 mm, about 30 mm, or about 35 mm.

[0055] In some cases, when switching between an open planar configuration and a ring configuration, the length of the support can 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%.

[0056] In some cases, the height of the support may not change significantly between the open planar configuration and the annular configuration.

[0057] In some cases, the outer cage may be provided with materials such as biological tissue, engineered materials, growth materials, transplanted tissue, biocompatible polymer materials, nitinol, or any combination thereof. In some cases, the leaflets may be provided with materials such as biological tissue, engineered materials, growth materials, transplanted tissue, biocompatible polymer materials, nitinol, or any combination thereof.

[0058] The stent or intraluminal support structure may be coated with one or more of the following: reagents, drugs, pharmaceuticals, eluting drugs, controlled-release drugs, controlled-release agents, or any combination thereof.

[0059] Figures 1A to 1E A perspective top view of the bracket 100 is shown. Figures 1A to 1B , Figure 1E Top view () Figure 1C ) and side view ( Figure 1D ). Figures 1A to 1B A stent 100 is shown, comprising a decoupling cage 102, a welded body 104, a sinusoidal decoupling member 106, an atrial flange 108, a hinged connector 110, a strut 112, an inner frame valve support 116, and an outer cage 118. The inner frame valve support 116 and the outer cage 118 may include the decoupling cage 102. The sinusoidal decoupling member 106 may be disposed on the outer cage 118. Figure 1CThe stent 100 is shown, which includes a decoupling cage 102, a sinusoidal decoupling member 106, and an inner frame valve support 116. Figure 1D A support 100 is shown, which includes a decoupling cage 102, a sinusoidal decoupling member 106, and a distal attachment 114. Figure 1E The prosthetic leaflet valve 122 inside the stent 100 is shown, which includes a decoupling cage 102 and anchoring barbs 120.

[0060] In some cases, the decoupling cage 102 can decouple the prosthetic valve from the annulus and ventricular motion. The cage 102 can also maintain the configuration of the prosthetic valve leaflets. In some cases, this configuration can be oval, circular, concentric, elliptical, or any other configuration suitable for the heart valve. Decoupling from natural motion helps maintain the valve's hemodynamic function by minimizing the occurrence of internal leakage. Without this barrier / cage, any ellipticity or variable wall motion can alter the valve's engagement and its ability to properly seal, leading to internal and / or perivalvular leakage. Decoupling can also facilitate stent deformation around calcified sites without affecting the shape of the prosthetic valve leaflets 122.

[0061] The decoupling cage 102 can have an hourglass shape, with the central portion conforming well to the native valve annulus and the larger portion located below the annulus to help anchor the valve to the native valve. Strong anchoring allows the valve to maintain its long-term performance and position for proper hemodynamic function and minimizes leakage. In some cases, the hourglass design stenosis area can be lower than the center (e.g., closer to the ventricular side), thus having a lower ventricular bulge. This stenosis area... Figure 1D The area below the center line is shown as a dashed line.

[0062] The decoupling component structure (e.g., decoupling cage 102) may include a sinusoidal member 106 connecting the inflow flange / coronation (atrial side) 108 to the outflow flange / coronation (ventricular side). By connecting to the top and bottom, the sinusoidal member 106 can absorb the impact of the native valve compressing onto the valve prosthesis during cardiac pumping. The decoupling cage 102, due to the sinusoidal member 106, can be flexible in the intermediate and stenotic sections and can be adjusted to be stiffer or more flexible in different portions of the sinusoid based on native cardiac pressure, rather than being forcibly bent by cardiac pumping. The sinusoid can also be optimized by varying its amplitude, frequency, and thickness to allow for improved shock absorption of the native cardiac valve, particularly in the lower ventricular portion. Additionally, the sinusoidal design allows the stent to expand and compress in response to cardiac pumping.

[0063] The sinusoidal design 106 allows the shape of the decoupling member 102 to be optimized for anchoring, and the flexibility of the decoupling member helps to separate heart wall motion from the valve prosthesis leaflets. The decoupling cage 102 can be made flexible, attaching to both the atrial and ventricular coronary structures of the metal structure. This design makes it more robust and less prone to fatigue. The sinusoidal members 106 can help alleviate fatigue because they can help with torsional motion and absorb pressure / constraint from the native ventricle. The sinusoidal members 106 also make the loading and placement of the valve within the diseased valve safer and more stable.

[0064] The inflow coronary can be located in the atrium directly above the valve annulus. The outflow coronary can be located directly below the valve annulus and in the ventricle. The sinusoidal pattern 106 and its connection to the inflow and outflow coronaries can be made without welding. The sinusoidal pattern 106 and its connection to the inflow and outflow coronaries can be laser-cut from a single flat sheet. In some cases, the cage can be attached to the valve leaflets without welding. Welding of Nitinol components may present fatigue problems during long-term implantation. Cutting from a single flat sheet can resemble a strip design. The strip design can be loaded onto a delivery catheter, as described below.

[0065] In some cases, the support frame 100 may include one or more welded bodies 104. In some cases, the welded body 104 may include two parallel lines, each with an external connector on one side. In some cases, the welded body is welded to the support frame. In some cases, the welded body does not include the outer cage 118, nor its connection to the inner frame 116. As discussed above, the decoupled cage may be formed from a single sheet, and the welded body may be welded to that single sheet. The welded body 104 may be used to weld sections of the inner frame 116 together, but the inner frame may already be attached to the outer cage 118.

[0066] One or more types of weldment bodies 104 may be present. One, two, three, four, five, or more types of weldment bodies 104 may be present. In some cases, the weldment body may have a left loop in addition to its two connectors. In some cases, a compression wire may be present for compressing the stent during delivery. When the compression wire is released, the cage can expand at the end of the procedure. The loop on the weldment body may be where the end of the compression wire is located. The loop may be used to temporarily hold a knot in the wire until the knot can be connected to the wire from the catheter. The weldment body 104 may also have a right loop in addition to its two connectors. The weldment body 104 may not have a loop in addition to its two connectors. Examples of weldment bodies can be found in [reference needed]. Figures 2C to 2F .

[0067] In some cases, the decoupling cage 102 may include multiple segments or sections surrounding the prosthetic valve leaflet 122. The decoupling cage 102 may include one, two, three, four, five, six, or more segments surrounding the prosthetic valve leaflet 122. In some cases, each segment may be separated by struts 112. In some cases, the segments may span or substantially span the circumference of the decoupling cage 102. In some cases, the struts 112 may be perpendicular to the circumference of the decoupling cage 102. In some cases, the struts 112 may include two or more parallel or substantially parallel lines. In some cases, each segment may include a separate track, as further described below.

[0068] In some cases, the stent 100 may include a connector between the inner frame 116 and the outer cage 118. In some cases, the connector is straight. In some cases, the connector is hinged to enhance the separation between the inner frame 116 and the outer cage 118. By increasing the separation, the hinged connector 110 can increase the decoupling between the inner frame valve support 116 (and thus the prosthetic leaflet 122 within the inner frame 116) and the outer cage 118. Increased decoupling can improve the isolation of the leaflet 122 from the native anatomy. This can allow the prosthetic valve leaflet 122 to retain its shape regardless of the overlying anatomical configuration surrounding the valve prosthesis. The shape of the prosthetic valve leaflet 122 can be oval, round, elliptical, or another shape as required. The leaflet 122 will be discussed further below.

[0069] The decoupling member 102 may also incorporate an anchoring barb 120, which may be positioned around the outer frame 118 to provide additional anchoring security and minimize valve migration over time. In some cases, the anchoring barb 120 may include a short protrusion into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. The anchoring barb 120 may be from about 5 mm to about 15 mm. The anchoring barb 120 may be from about 5 mm to about 7 mm, from about 5 mm to about 9 mm, from about 5 mm to about 11 mm, from about 5 mm to about 13 mm, from about 5 mm to about 15 mm, from about 7 mm to about 9 mm, from about 7 mm to about 11 mm, from about 7 mm to about 13 mm, from about 7 mm to about 15 mm, from about 9 mm to about 11 mm, from about 9 mm to about 13 mm, from about 9 mm to about 15 mm, from about 11 mm to about 13 mm, from about 11 mm to about 15 mm, or from about 13 mm to about 15 mm. The anchoring barb 120 can be approximately 5 mm, approximately 7 mm, approximately 9 mm, approximately 11 mm, approximately 13 mm, or approximately 15 mm. The anchoring barb 120 can be at least approximately 5 mm, approximately 7 mm, approximately 9 mm, approximately 11 mm, or approximately 13 mm. The anchoring barb 120 can be at most approximately 7 mm, approximately 9 mm, approximately 11 mm, approximately 13 mm, or approximately 15 mm.

[0070] In some cases, the anchoring barb 120 can be straight. In other cases, the anchoring barb 120 can be hook-shaped. The hook-shaped design can help to grip the tissue and minimize displacement. This design can be similar to the spines of a cactus. These barbs can be designed to grip the large anterior valve, thereby stabilizing it and minimizing movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction.

[0071] Figure 2A A schematic diagram or top view of a deployable support 200 is shown, which includes a decoupling cage 202, a sinusoidal decoupling member 204, a left welded body 206, a center welded body 208, a right welded body 210, a locking region 212, a distal attachment 214, a support column 216, a proximal attachment 218, an inflow crown 220, an outflow crown 222, a window 224, a track 226, a hinged connector 228, an overlapping region 230, a type A T-connector 232, a type B T-connector 234, a type C T-connector 236, and an anchoring barb 238. Figures 2B to 2F It shows Figure 2A A schematic diagram or top view of the components of the unfolding support 200. Figure 2BA decoupling cage 202 is shown, which includes a sinusoidal decoupling member 204, a locking region 212, a distal attachment 214, a support 216, a proximal attachment 218, an inflow crown 220, an outflow crown 222, a window 224, a track 226, a hinge connector 228, and an overlapping region 230. Figure 2C The left weldment 206 is shown. Figure 2D The central welded body 208 is shown, and Figure 2E The right welded body 210 is shown. Figure 2F The decoupling cage 202 and the welded body 212 are shown, wherein the welded body 212 may include any one of the left welded body 206, the center welded body 208 and / or the right welded body 210.

[0072] In some cases, the decoupling cage 202 can decouple the prosthetic valve from the annulus and ventricular motion. The cage 202 can also maintain the configuration of the prosthetic valve leaflets. In some cases, this configuration can be oval, circular, concentric, elliptical, or any other configuration suitable for the heart valve. Decoupling from natural motion helps maintain the valve's hemodynamic function by minimizing the occurrence of internal leakage. Without this barrier / cage, any ellipticity or variable wall motion can alter the valve's engagement and its ability to properly seal, leading to internal and / or perivalvular leakage. Decoupling can also facilitate stent deformation around calcified sites without affecting the shape of the prosthetic valve leaflets.

[0073] The decoupling cage 202 can have an hourglass shape, with the central portion conforming well to the native valve annulus and the larger portion located below the annulus to help anchor the valve to the native valve. Strong anchoring allows the valve to maintain its long-term performance and position for proper hemodynamic function and minimizes leakage. In some cases, the stenosis area in the hourglass design can be lower than the center (e.g., closer to the ventricular side), thus having a lower ventricular bulge. This stenosis area... Figure 1D The area below the center line is shown as a dashed line.

[0074] The decoupling component structure (e.g., decoupling cage 202) may include a sinusoidal member 204 connecting the inflow flange / coronation (atrial side) 220 to the outflow flange / coronation (ventricular side) 222. By connecting to the top and bottom, the sinusoidal member 204 can absorb the impact of the native valve compressing onto the valve prosthesis during cardiac pumping. The decoupling cage 202, due to the sinusoidal member 204, can be flexible in the intermediate and stenotic sections and can be adjusted to be stiffer or more flexible in different portions of the sinusoid based on native cardiac pressure, rather than being forcibly bent by cardiac pumping. The sinusoid can also be optimized by varying its amplitude, frequency, and thickness to allow for improved shock absorption of the native cardiac valve, particularly in the lower ventricular portion. Additionally, the sinusoidal design allows the stent to expand and compress in response to cardiac pumping.

[0075] The sinusoidal design 204 allows the shape of the decoupling member 202 to be optimized for anchoring, and the flexibility of the decoupling member helps to separate heart wall motion from the valve prosthesis leaflets. The decoupling cage 202 can be made flexible, attaching to both the atrial and ventricular coronary structures of the metal structure. This design makes it more robust and less prone to fatigue. The sinusoidal members 204 can help alleviate fatigue because they can help with torsional motion and absorb pressure / constraint from the native ventricle. The sinusoidal members 204 also make the loading and placement of the valve within the diseased valve safer and more stable.

[0076] The inflow coronary can be located in the atrium directly above the valve annulus. The outflow coronary can be located directly below the valve annulus and in the ventricle. The sinusoidal pattern 204 and its connection to the inflow and outflow coronaries can be made without welding. The sinusoidal pattern 204 and its connection to the inflow and outflow coronaries can be laser-cut from a single flat sheet. In some cases, the cage can be attached to the valve leaflets without welding. Welding of Nitinol components may present fatigue problems during long-term implantation. Cutting from a single flat sheet can result in a strip-like design. The strip-like design can be loaded onto a delivery catheter, as described below.

[0077] In some cases, the support frame 200 may include one or more welded bodies. In some cases, the welded body may include two parallel lines, each with an external connector on one side. In some cases, the welded body is welded to the support frame. In some cases, the welded body does not include the outer cage or its connection to the inner frame. As discussed above, the decoupled cage may be formed from a single sheet, and the welded body may be welded to that single sheet. The welded body may be used to weld sections of the inner frame together, but the inner frame may already be attached to the outer cage.

[0078] One or more types of welded bodies may exist. One, two, three, four, five, or more types of welded bodies may exist. In some cases, a welded body may be a left welded body 206, and may also have a left ring in addition to its two connectors. A welded body may be a right welded body 210, and may also have a right ring in addition to its two connectors. A welded body may be a center welded body 208, and may not have a ring in addition to its two connectors. Figure 2F The welding details are shown. The weldment can be performed using a laser. The weldment can be performed using a 180-degree arc of the laser. The entire welding arc can be from approximately 180 degrees to approximately 240 degrees. The weldment can be perpendicular to the support and locking mechanism.

[0079] The first and second ends of the decoupling cage 202 can be configured to couple to each other to form a loop upon deployment, similar to the support 100. The second free end may include a locking region 212 with a tight gap. The first free end may include one or more welded T-hooks 232, 234, and / or 236 slidably coupled to the locking region in a first direction perpendicular to the first axis. In some cases, the first and second free ends are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first or second free ends are not perpendicular to the first axis. An angle may exist between the main axis of the support and the locking mechanism. The locking region 212 may be adjacent to the window 224 and parallel to the support column 216.

[0080] In some cases, the T-hooks can be welded to the opposite end relative to the locking region 212. The T-hooks can be folded to approach the window 224. The T-hooks can slide down into the locking region 212 along the window 224. The lower T-hooks (e.g., type C 236 and type B 234) enter the window 224 and locking region 212 before the type A T-connector 232. To improve engagement of the locking region 212, type B T-connectors 234 and type C T-connectors 236 can have angled arms (e.g., the top of the "T") instead of horizontal arms, such as... Figure 3C As shown. The arm can be angled away from the base of the T. The C-type T-connector 236 can have a longer arm than the B-type T-connector 234 to grip the frame. Each subsequent type (B, then A) can have a shorter arm to tighten the locking connection and thus tighten the ring. Figure 3D The locking mechanism is shown in the image.

[0081] When the ring is closed, the overlapping area 230 can be outside the rest of the ring because locking occurs just before the overlapping area 230 when the support is in place.

[0082] In some cases, the decoupling cage 202 may include multiple segments or sections surrounding the prosthetic valve leaflets. The decoupling cage 202 may include one, two, three, four, five, six, or more segments surrounding the prosthetic valve leaflets. In some cases, each segment may be separated by struts 216. In some cases, the segments may span or substantially span the circumference of the decoupling cage 202. In some cases, the struts 216 may be perpendicular to the circumference of the decoupling cage 202. In some cases, the struts 216 may include two or more parallel or substantially parallel lines.

[0083] The decoupling cage 202 may include tracks 226. In some cases, each set of tracks may be separated by struts 216. In some cases, the tracks may span or substantially span the circumference of the decoupling cage 202. In some cases, the tracks 226 may be parallel to the circumference of the decoupling cage 202. In some cases, the tracks 226 may include two or more parallel or substantially parallel lines. In some cases, the tracks 226 may be adjustable or expandable. For example, the sections of the tracks closest to the struts may be clustered together in a neutral configuration and open like a spring when stretched. This can be used to increase the size of the inner frame as needed to accommodate smaller or larger leaflet prostheses. In some cases, the tracks may be expanded by using a balloon once the support 200 is in its annular configuration. In some cases, the tracks 226 are curved. In some cases, the tracks 226 are substantially straight.

[0084] The bracket 200 may have attachments to hook onto the delivery device. The bracket 200 may have one or more distal attachments 214 to hook onto the distal portion of the delivery device. The bracket 200 may have one or more proximal attachments 218 to hook onto the distal portion of the hook of the delivery device near the latch of 214.

[0085] In some cases, the stent 200 may include a connector between the inner frame and the outer cage. In some cases, the connector is straight. In some cases, the connector is hinged to enhance the separation between the inner frame and the outer cage. By increasing the separation, the hinged connector 228 can increase the decoupling between the inner frame valve support (and therefore the prosthetic leaflet valve within the inner frame) and the outer cage. Increased decoupling can improve the isolation of the leaflet valve from the native anatomy. This can allow the prosthetic valve leaflet to retain its shape regardless of the overlying anatomical configuration surrounding the valve prosthesis. The shape of the prosthetic valve leaflet can be oval, round, elliptical, or another shape as required.

[0086] The decoupling member 202 may also incorporate an anchoring barb 238, which may be positioned around the outer frame 118 to provide additional anchoring security and minimize valve migration over time. In some cases, the anchoring barb 238 may include a short protrusion into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. The anchoring barb 238 may be from about 5 mm to about 15 mm. The anchoring barb 238 may be from about 5 mm to about 7 mm, from about 5 mm to about 9 mm, from about 5 mm to about 11 mm, from about 5 mm to about 13 mm, from about 5 mm to about 15 mm, from about 7 mm to about 9 mm, from about 7 mm to about 11 mm, from about 7 mm to about 13 mm, from about 7 mm to about 15 mm, from about 9 mm to about 11 mm, from about 9 mm to about 13 mm, from about 9 mm to about 15 mm, from about 11 mm to about 13 mm, from about 11 mm to about 15 mm, or from about 13 mm to about 15 mm. The anchoring barb 238 can be approximately 5 mm, approximately 7 mm, approximately 9 mm, approximately 11 mm, approximately 13 mm, or approximately 15 mm. The anchoring barb 238 can be at least approximately 5 mm, approximately 7 mm, approximately 9 mm, approximately 11 mm, or approximately 13 mm. The anchoring barb 238 can be at most approximately 7 mm, approximately 9 mm, approximately 11 mm, approximately 13 mm, or approximately 15 mm.

[0087] In some cases, the anchoring barb 238 can be straight. In other cases, the anchoring barb 238 can be hook-shaped. The hook-shaped design can help to grip the tissue and minimize displacement. This design can be similar to the spines of a cactus. These barbs can be designed to grip the large anterior valve, thereby stabilizing it and minimizing movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction.

[0088] Figures 3A to 3D A perspective view of the T-shaped connector of the bracket 200 is shown. Figure 3A ), planar side view ( Figure 3B , Figure 3D ) and perspective side view ( Figure 3C ). Figures 3A to 3D Type A T-connector 232, Type B T-connector 234 and Type C T-connector 236 are shown.

[0089] The first and second ends of the decoupling cage 202 can be configured to couple to each other to form a loop upon deployment, similar to the support 100. The second free end may include a locking region 212 with a tight gap. The first free end may include one or more welded T-hooks 232, 234, and / or 236 slidably coupled to the locking region in a first direction perpendicular to the first axis. In some cases, the first and second free ends are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first or second free ends are not perpendicular to the first axis. An angle may exist between the main axis of the support and the locking mechanism. The locking region 212 may be adjacent to the window 224 and parallel to the support column 216.

[0090] In some cases, the T-hooks can be welded to the opposite end relative to the locking region 212. The T-hooks can be folded to approach the window 224. The T-hooks can slide down into the locking region 212 along the window 224. The lower T-hooks (e.g., type C 236 and type B 234) enter the window 224 and locking region 212 before the type A T-connector 232. To improve engagement of the locking region 212, type B T-connectors 234 and type C T-connectors 236 can have angled arms (e.g., the top of the "T") instead of horizontal arms, such as... Figure 3C As shown. The arm can be angled away from the base of the T. The C-type T-connector 236 can have a longer arm than the B-type T-connector 234 to grip the frame. Each subsequent type (B, then A) can have a shorter arm to tighten the locking connection and thus tighten the ring. Figure 3D The locking mechanism is shown in the image.

[0091] Figure 4 An anchoring barb 238 of the stent 200 is shown. The anchoring barb 238 can be positioned around the decoupling cage 202 to provide additional anchoring security and minimize valve migration over time. In some cases, the anchoring barb 238 may include a short protrusion into the ventricle to minimize the risk of left ventricular outflow tract (LVOT) obstruction. In some cases, the anchoring barb 238 may be straight. In some cases, the anchoring barb 238 may be hook-shaped. A hook-shaped design can help secure tissue and minimize displacement. This design can resemble the spines of a cactus. Figure 4 As shown, the anchoring barb is bent at an angle away from the decoupling structure 202 and has a curved shape and a sharp inner end.

[0092] The angle of the barb 238 relative to the support of the stent can be approximately 35 degrees to approximately 50 degrees. The angle of the barb 238 relative to the support of the stent can be approximately 35 degrees to approximately 40 degrees, approximately 35 degrees to approximately 45 degrees, approximately 35 degrees to approximately 50 degrees, approximately 40 degrees to approximately 45 degrees, approximately 40 degrees to approximately 50 degrees, or approximately 45 degrees to approximately 50 degrees. The angle of the barb 238 relative to the support of the stent can be approximately 35 degrees, approximately 40 degrees, or approximately 45 degrees. The angle of the barb 238 relative to the support of the stent can be at least approximately 35 degrees, approximately 40 degrees, or approximately 45 degrees. The angle of the barb 238 relative to the support of the stent can be at most approximately 40 degrees, approximately 45 degrees, or approximately 50 degrees.

[0093] In some cases, straight barbs may be present. In some cases, the straight barbs extend from the decoupling cage 202. In some cases, the straight barbs extend from the base of the hook-shaped barbs. The angle of the straight barbs relative to the support of the bracket may be similar to the angle of the hook-shaped barbs.

[0094] These barbs can be designed to grip the large anterior valve, thereby stabilizing it and minimizing movement toward the outflow tract, thus significantly reducing the risk of LVOT obstruction.

[0095] The anchoring barb 238 can be from about 5 mm to about 15 mm. The anchoring barb 238 can be from about 5 mm to about 7 mm, from about 5 mm to about 9 mm, from about 5 mm to about 11 mm, from about 5 mm to about 13 mm, from about 5 mm to about 15 mm, from about 7 mm to about 9 mm, from about 7 mm to about 11 mm, from about 7 mm to about 13 mm, from about 7 mm to about 15 mm, from about 9 mm to about 11 mm, from about 9 mm to about 13 mm, from about 9 mm to about 15 mm, from about 11 mm to about 13 mm, from about 11 mm to about 15 mm, or from about 13 mm to about 15 mm. The anchoring barb 238 can be from about 5 mm, from about 7 mm, from about 9 mm, from about 11 mm, from about 13 mm, or from about 15 mm. The anchoring barb 238 can be at least from about 5 mm, from about 7 mm, from about 9 mm, from about 11 mm, or from about 13 mm. The anchoring barb 238 can be up to about 7 mm, about 9 mm, about 11 mm, about 13 mm, or about 15 mm.

[0096] Figures 5A to 5B A top view of the support column of the unfolded support 200 is shown. Figure 5A This illustrates a poorly formed strut with non-parallel bars (e.g., a forming or manufacturing defect), while Figure 5BA properly formed strut with parallel bars is shown. The parallel bars can help keep the cross-section of the annular stent within a single plane rather than folding it, which can help stabilize the placement of the leaflet valve within the stent.

[0097] Figure 6A A perspective side view of a three-dimensional multi-layer planar view of an unfolding support 300 including a sinusoidal decoupling member 302 is shown. Figures 6B to 6C A side view showing the curvature of the sinusoidal decoupling member 302 of the support 300 is shown. Figure 6B ) and perspective side view ( Figure 6C ).

[0098] Figure 7 A side view of a deployment stent 400 with a cover is shown. The deployment stent 400 may include a cover decoupling cage 402 and a cover 404. The stent 400 and the decoupling cage 402 may be similar to those disclosed herein. The cover 404 may help seal the stent. This can be achieved by maintaining continuous and close contact with the valve annulus and ventricular wall during the systolic and diastolic phases of the cardiac cycle to help minimize paravalvular leakage. The cover 404 may include a biocompatible layer such as PET, PTFE, polyurethane, etc.

[0099] Figure 8 A side view schematic diagram of the deployment bracket 500 in the native valve annulus is shown. Figure 8 The diagram illustrates a sinusoidal decoupling member 502, an atrial valve tip of valve 504, a decoupling cage 506, and a native annulus 508. The stent 500, sinusoidal decoupling member 502, and decoupling cage 506 may be similar to those disclosed herein. The atrial valve tip of valve 504 illustrates how the stent, as described herein, may be located below or originate from the atrial valve tip of valve 504. In some cases, the stent originates above the atrial valve tip of the valve. The origin side may be the inflow side. In some cases, the native annulus 508 may be located near the midpoint of the stent's height. In some cases, the native annulus 508 may be above the midpoint of the stent's height. In some cases, the native annulus 508 may be below the midpoint of the stent's height.

[0100] petals In some cases, the intraluminal support structure includes a leaflet structure attached to or potentially attachable to the inner surface of the stent support panel, such as... Figure 1E As shown. The leaflet structure may include one or more leaflets and may be attached to one or more struts on the support. The leaflet structure may include one, two, three or more individual leaflets that can be independently attached to the support.

[0101] In some cases, the height of the leaflet valve structure, which includes multiple leaflets, can be from about 12 mm to about 22 mm. In some cases, the height of the leaflet structure can be from about 12 mm to about 14 mm, from about 12 mm to about 16 mm, from about 12 mm to about 18 mm, from about 12 mm to about 20 mm, from about 12 mm to about 22 mm, from about 14 mm to about 16 mm, from about 14 mm to about 18 mm, from about 14 mm to about 20 mm, from about 14 mm to about 22 mm, from about 16 mm to about 18 mm, from about 16 mm to about 20 mm, from about 16 mm to about 22 mm, from about 18 mm to about 20 mm, from about 18 mm to about 22 mm, or from about 20 mm to about 22 mm. In some cases, the height of the leaflet structure can be from about 12 mm, from about 14 mm, from about 16 mm, from about 18 mm, from about 20 mm, or from about 22 mm. In some cases, the height of the leaflet structure can be at least about 12 mm, about 14 mm, about 16 mm, about 18 mm, or about 20 mm. In other cases, the height of the leaflet structure can be at most about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0102] In some cases, the diameter of a leaflet valve structure, which includes multiple leaflets, can be from about 20 mm to about 75 mm. In some cases, the diameter of the leaflet valve structure can be approximately 20 mm to approximately 25 mm, approximately 20 mm to approximately 30 mm, approximately 20 mm to approximately 35 mm, approximately 20 mm to approximately 40 mm, approximately 20 mm to approximately 45 mm, approximately 20 mm to approximately 50 mm, approximately 20 mm to approximately 55 mm, approximately 20 mm to approximately 60 mm, approximately 20 mm to approximately 65 mm, approximately 20 mm to approximately 70 mm, approximately 20 mm to approximately 75 mm, approximately 25 mm to approximately 30 mm, approximately 25 mm to approximately 35 mm, approximately 25 mm to approximately 40 mm, approximately 25 mm to approximately 45 mm, approximately 25 mm to approximately 50 mm, approximately 25 mm to approximately 55 mm, approximately 25 mm to approximately 60 mm, approximately 25 mm to approximately 65 mm, approximately 25 mm to approximately 70 mm, approximately 25 mm to approximately 75 mm, approximately 30 mm to approximately 35 mm, approximately 30 mm to approximately 40 mm, approximately 30 mm to approximately 45 mm, approximately 30 mm to approximately 50 mm, approximately 30 mm to approximately 55 mm. 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 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 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, the diameter of the leaflet / valve structure can be approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, approximately 70 mm, or approximately 75 mm. In some cases, the diameter of the leaflet / valve structure can be at least approximately 20 mm, approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, or approximately 70 mm. In some cases, the diameter of the leaflet / valve structure can be at most approximately 25 mm, approximately 30 mm, approximately 35 mm, approximately 40 mm, approximately 45 mm, approximately 50 mm, approximately 55 mm, approximately 60 mm, approximately 65 mm, approximately 70 mm, or approximately 75 mm.

[0103] In some cases, the circumference of a leaflet valve structure, which includes multiple leaflets, can be approximately 70 mm. 2 Approximately 220mm 2 In some cases, the circumference of the leaflet valve structure can be approximately 70 mm. 2 approximately 100 mm 2 Approximately 70 mm 2 Approximately 130mm 2 Approximately 70 mm 2 Approximately 160 mm 2 Approximately 70 mm 2 Approximately 190 mm 2 Approximately 70 mm 2 Approximately 220 mm 2 Approximately 100 mm 2 Approximately 130mm 2 Approximately 100 mm 2 Approximately 160 mm 2 Approximately 100 mm 2 Approximately 190 mm 2 Approximately 100 mm 2 Approximately 220 mm 2 Approximately 130 mm 2 Approximately 160 mm 2 Approximately 130 mm 2 Approximately 190 mm 2 Approximately 130 mm 2 Approximately 220 mm 2 Approximately 160 mm 2 Approximately 190 mm 2 Approximately 160 mm 2 Approximately 220 mm 2 or approximately 190 mm2 Approximately 220 mm 2 In some cases, the circumference of the leaflet valve structure can be approximately 70 mm. 2 Approximately 100 mm 2 Approximately 130 mm 2 Approximately 160 mm 2 Approximately 190 mm 2 or approximately 220 mm 2 In some cases, the circumference of the leaflet valve structure can be at least about 70 mm. 2 Approximately 100 mm 2 Approximately 130 mm 2 Approximately 160 mm 2 or approximately 190 mm 2 In some cases, the circumference of the leaflet valve structure can be up to approximately 100 mm² or approximately 130 mm². 2 Approximately 160 mm 2 Approximately 190 mm 2 or approximately 220mm 2 The circumference can be 78 mm. 2 .

[0104] Figures 9A to 9F A plan view of the prosthetic valve leaflets is shown. Figures 9A to 9B Top-down view Figure 9E ), side view ( Figure 9C ) and perspective ( Figure 9D , Figure 9F ). Figure 9A Leaflet 600 is shown. Figure 9B A support 610 including a main body 612 and a skirt 614 is shown. Figures 9C to 9E Different views of the leaflets 702 combined into a single valve component 700 are shown. Figure 9F The illustration shows the valve component 700 being implanted into the stent 100 to form a complete valve prosthesis 800. Figure 9F The leaflet 702, decoupling cage 102, and sinusoidal decoupling member 106 are shown. The valve component 700 can be replaced with an implantable stent 200 or any of the other stents disclosed herein.

[0105] In some cases, each of the leaflets in a bioprosthetic valve component (e.g., a prosthetic leaflet) may consist of two parts assembled together. These two parts may be the leaflet 600 itself ( Figure 9A ) and support 610 ( Figure 9B The support 610 may include a main body 612 and a skirt 614.

[0106] The leaflet 600 can be attached to the frame groove of the support 610, rather than directly to the frame. This allows the valve to have greater durability because the support can absorb most of the strain and protect the leaflet itself.

[0107] In some cases, the leaflet structure includes multiple conjoined leaflets located at the center of the frame, wherein the leaflets are flexible enough to open and close in response to hemodynamic forces, and wherein the frame is rigid enough to at least partially resist deformation caused by hemodynamic forces after implantation.

[0108] The valve structure may include one or more connecting skirts 614. In some cases, one or more central leaflet tips are inserted into the arches of one or more valve supports. In some embodiments, one or more connecting skirts are attached to one or more valve supports. The one or more connecting skirts 614 may be configured to compensate for the diameter difference between the central foramen of the heart valve and the diameter of the valve structure.

[0109] In some cases, one or more of the support, one or more central leaflet tips, or one or more connecting skirts may include mixed tissues, including but not limited to a mixture of biological tissues and polymers.

[0110] In some cases, the devices disclosed herein may describe or demonstrate devices with a three-leaflet structure, but the valve prostheses described herein may have more or fewer three-leaflet structures.

[0111] When multiple leaflets 600 are combined together, they can form the entire biological valve component 700 with leaflets 702. For example... Figures 9C to 9E As shown, the leaflets cluster together, and in some cases, cluster together at the support, such as... Figure 9F As shown. The portion where they converge can be the outermost part of each segment of valve component 700, and the middle of each leaflet can be the innermost part of each segment of valve component 700. The middle portions of the leaflets can converge during cardiac systole, with the three leaflets converging in the middle of the valve. This can be the innermost part of each segment of the valve. In some cases, there may be a gap at the center where the leaflets 702 converge. This can help provide flexibility to valve component 700.

[0112] Labeling brackets with different markings does not indicate that the brackets may only be used with the functions they are intended to demonstrate. Rather, any bracket numbered or described herein may be used with any of the features described herein.

[0113] method This paper describes methods for delivering and deploying the stents and valve prostheses described herein. As part of the deployment, the stents and valve prostheses described herein can be locked from a planar configuration to an annular or cylindrical configuration.

[0114] Locking method This document provides locking mechanisms and methods for use with one or more of the stents described herein. This document describes an endoluminal support structure for insertion into a heart valve of a subject, the endoluminal support structure including a stent support panel having a first free end and a second free end when in a planar configuration. The stent support panel in the planar configuration may further include a first axis extending from the first free end to the second free end.

[0115] The first and second ends of the decoupling cage can be configured to couple with each other to form a loop during deployment, similar to bracket 100 or 200. The second free end may include a locking region with a tight gap (e.g., Figure 2A (212). The first free end may include one or more welded T-hooks (e.g., in a first direction perpendicular to the first axis) that are slidably coupled to the locking region. Figure 2A (e.g., 232, 234, and / or 236). In some cases, the first and second free ends are parallel to each other and perpendicular to the first axis. In some cases, one or more of the first or second free ends are not perpendicular to the first axis. An angle may exist between the main axis of the bracket and the locking mechanism.

[0116] like Figures 3C to 3D As shown, in some cases, T-hooks can be welded to relative to Figure 2A The opposite ends of the locking area 212. The T-hook can be folded to access... Figure 2A Window 224. A T-hook can slide down along window 224 into locking region 212. Lower T-hooks (e.g., type C 236 and type B 234) enter window 224 and locking region 212 before type A T-connector 232. To improve engagement in locking region 212, type B T-connector 234 and type C T-connector 236 can have angled arms (e.g., the top of the "T") instead of horizontal arms. The arms can be angled away from the base of the T. Type C T-connector 236 can have longer arms than type B T-connector 234 to grip the frame. Each subsequent type (B, then A) can have shorter arms to tighten the locking connection and thus tighten the ring.

[0117] When the loop is closed, the overlapping region (e.g., Figure 2A 230) can be outside the rest of the ring because locking occurs just before the overlapping area 230 when the bracket is supported.

[0118] The locking mechanism can be perpendicular to the circumferential track. The locking mechanism can be perpendicular to the upward flow into the coronal portion. The locking mechanism can be perpendicular to the downward flow out of the coronal portion. The locking mechanism can be parallel to the support strut.

[0119] delivery method This method may include loading a valve prosthesis into a delivery catheter. In some cases, the valve prosthesis may be loaded spirally around the delivery catheter. The delivery catheter may have two or more clamps. One of the clamps may be positioned near the distal tip of the delivery catheter. At least one of the clamps may be positioned proximal to the first clamp. The valve prosthesis may be clamped in the clamps, and the clamps may be rotated such that a first free end and a second free end of the device rotate relative to each other to form a spiral. This method may include introducing the catheter into the body and advancing the loaded catheter through the body cavity and anatomical tissue until reaching the delivery site (implantation site). This method may include deploying the valve prosthesis at the delivery site and manipulating the deployed stent to its final implantation position. This method may include withdrawing the catheter from the body cavity. In some cases, deployment may include connecting a proximal clamp to a distal clamp such that the proximal end of the planar device is close to the distal end of the planar device.

[0120] The method may include implanting any of the previously described endoluminal support structures using a delivery catheter having a proximal end, a distal end, and an elongated carrier region near the distal end. The delivery catheter may include: a distal coupler configured to releasably attach a first free end of a stent support panel of a stent; and a proximal coupler configured to releasably attach a second end of the stent support panel, wherein the distal and proximal couplers may releasably retain the stent panel in a helical wound configuration within the elongated carrier region prior to release from the annular configuration.

[0121] In some cases, the distal coupler can be configured to translate along and rotate about the longitudinal axis of the catheter. The delivery catheter may include an outer axis, an intermediate axis, and an inner axis, the inner axis being coaxially disposed within the central channel of the outer axis. The distal coupler may be mounted on the distal region of the intermediate axis, and the proximal coupler may be mounted on the distal region of the outer axis.

[0122] In some cases, the distal end of the delivery catheter is advanced into the valve annulus, and the stent support panel unfolds from the elongated carrier region of the delivery catheter, thereby allowing the stent support panel to change to form a ring or cylinder within the valve annulus.

[0123] In some cases, the stent is pre-formed into a ring, and stent deployment involves allowing the stent support panel to transform into a ring or cylinder. The delivery catheter can be twisted and axially compressed at the free end of the stent support panel to achieve or facilitate the transformation from a planar configuration to a ring.

[0124] In some cases, loading a stent, as described herein, onto the delivery catheter may include rotating a clamp or proximal coupler relative to the distal coupler along the outer axis of the delivery catheter prior to attaching the stent. In some cases, the proximal segment of the delivery catheter is rotated 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 is rotated 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 is rotated 180 degrees.

[0125] After loading, the proximal segment of the delivery catheter retainer, at the end with the proximal locking element, can slide or translate toward the fixed end of the delivery catheter retainer, at the other end with the distal locking element. When the delivery catheter reaches the distal fixed end, the proximal segment of the delivery catheter can rotate clockwise. In some cases, the proximal segment 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 more than about 0 degrees, more than about 60 degrees, more than about 120 degrees, more than about 180 degrees, more than about 240 degrees, or more than about 300 degrees. In some cases, the delivery catheter rotates 180 degrees. The delivery catheter can rotate clockwise by a similar amount as it would have rotated counterclockwise before loading.

[0126] In some embodiments, the circumferentially restrained stent implant is maintained during the loading phase onto the delivery system. In some embodiments, the circumferentially restrained stent implant is maintained 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 mechanism discussed above. When locked into a cylindrical shape, the diameter may initially be smaller than the mitral valve annulus to be treated. The stent can then be released. The stent diameter may be increased during release. The stent diameter can be released by self-actuation. The stent diameter can be released by an external actuation system (e.g., a balloon catheter).

[0127] In some cases, the scaffolds described herein can be advantageous because they allow for versatile systems, since the final shape of the folded configuration may not depend on the delivery system. A single delivery system can be used for scaffolds of different sizes and shapes.

[0128] definition Unless otherwise defined, all technical terms, symbols, and other technical, scientific, or professional terms used herein are intended to have the same meaning as 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 convenience of reference, and such definitions included herein should not necessarily be construed as indicating a material difference from the meaning commonly understood in the art.

[0129] The terms "intraluminal support structure" and "support" are used interchangeably in this document. The terms "planar" and "unfolding" are also used interchangeably in this document. Although the unfolding structure may not be completely flat or planar, it is a linear structure relative to the annular structure of the unfolding device.

[0130] In the context of this application, the term "open" in reference to the configuration of a support structure refers to a non-tubular or non-cylindrical structure, such as a stent or valve. The term "open" can be used interchangeably to refer to a substantially flat single-layer planar structure or a substantially flat multi-layer planar structure.

[0131] Throughout this application, various embodiments may be presented in a range format. It should be understood that the range format is for convenience and brevity only and should not be construed as a rigid limitation on the scope of this disclosure. Therefore, a range description should be considered to have all possible subranges of the specific disclosure, as well as individual numerical values ​​within those ranges. For example, a description of a range such as 1 to 6 should be considered to have specific subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0132] The scope disclosed herein also covers any and all overlapping, subranges, and combinations thereof. Languages ​​such as “up to,” “at least,” “greater than,” “less than,” and “between” include the referenced numerical values. Numerical values ​​beginning with terms such as “approximately,” “about,” and “substantially” as used herein include the referenced numerical values ​​and also indicate quantities that are close to the stated quantity and still perform the desired function or achieve the desired result. The terms “about” or “approximately” can mean within an acceptable margin of error for a particular value, which will depend in part on how the value is measured or determined, for example, limitations of the measurement system. For example, the terms “approximately,” “about,” and “substantially” can refer to quantities less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. For example, according to practice in the art, “about” can mean within one or more standard deviations. Alternatively, “about” can 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” refers to a number plus or minus 10% of that number. The term "about" refers to a range that is 10% of its minimum value plus 10% of its maximum value. Where a particular value is described in the application and claims, the term "about" may be assumed to mean within an acceptable margin of error for that particular value, unless otherwise stated.

[0133] As used in the specification and claims, unless the context clearly indicates otherwise, the singular forms “a / an” and “the” include a plural of indicators. For example, the term “sample” includes multiple samples, including mixtures thereof.

[0134] The terms “determine,” “measure,” “assess,” “evaluate,” “analyze,” and “analyze” are generally used interchangeably in this document to refer to the form of measurement. These terms include determining the presence of an element (e.g., detecting). These terms can include quantitative determination, qualitative determination, or a combination of both. Evaluation can be relative or absolute. In addition to determining whether something is present or absent based on context, “detecting presence” can also include determining the quantity present.

[0135] The terms “subject,” “individual,” or “patient” are generally used interchangeably in this document. A “subject” can be a biological entity containing the expressed genetic material. A subject can be a mammal. A mammal can be a human. A subject may be diagnosed or suspected of being at high risk for a disease. In some cases, a subject may not necessarily be diagnosed or suspected of being at high risk for a disease.

[0136] As used herein, the term "treatment / treating" refers to a drug or other intervention intended to achieve a beneficial or desired outcome in a recipient. Beneficial or desired outcomes include, but are not limited to, therapeutic benefits and / or preventative benefits. A therapeutic benefit may refer to the eradication or improvement of an underlying condition or its symptoms that are being treated. Additionally, a therapeutic benefit may be achieved by eradicating or improving one or more physical symptoms associated with an underlying condition to the point that improvement is observed in the subject, although the subject may still be troubled by the underlying condition. Preventative effects include delaying, preventing, or eliminating the onset of a disease or condition, delaying or eliminating the onset of symptoms of a disease or condition, slowing, terminating, or reversing the progression of a disease or condition, or any combination thereof. For preventative benefits, treatment may be administered to subjects at risk of developing a specific disease or to subjects who report one or more physical symptoms of a disease (even if a diagnosis of the disease may not yet be made).

[0137] The chapter titles used in this article are for organizational purposes only and should not be construed as limiting the topics described.

[0138] While preferred embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many variations, alterations, and substitutions will now be apparent 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 the practice of the present disclosure. The appended claims are intended to define the scope of the present disclosure and thereby cover methods and structures within the scope of these claims and their equivalents.

Claims

1. An intraluminal support structure for deployment in a heart valve of a subject, the intraluminal support structure comprising: (a) Internal valve support; as well as (b) An external decoupling cage coupled to the internal valve support and including a plurality of sinusoidal decoupling members, an inflow coronary portion and an outflow coronary portion, wherein the sinusoidal decoupling members are configured to decouple the internal valve support from the motion of the valve annulus, the ventricle or both when the external decoupling cage is deployed into the heart valve annulus; The intraluminal support structure has a non-deployed planar configuration and a deployed annular configuration for deployment in the heart valve.

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

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

4. The intraluminal support structure according to any one of claims 1 to 3, wherein the plurality of sinusoidal decoupling components comprises different patterns optimized based on the shape of the heart valve of the subject to achieve anchoring and flexibility.

5. The intraluminal support structure according to any one of claims 1 to 4, wherein the external decoupling cage has an hourglass shape, wherein the narrow middle portion is configured to conform to the shape of the original valve ring.

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

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

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

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

10. The intracavitary support structure according to claim 9, wherein the anchoring barb is arranged at an angle of approximately 45 degrees relative to the plane of the outer decoupling cage.

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

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

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

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

15. The intraluminal support structure of claim 14, wherein the plurality of connectors includes a straight connector between the inner valve support and the outer decoupling cage.

16. The intraluminal support structure of claim 14, wherein the plurality of connectors includes a hinged connector configured to adjust the radial spacing between the inner valve support and the outer decoupling cage.

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

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

19. The intracavitary support structure according to claim 18, wherein the intracavitary support member comprises three circumferential sections.

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

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

22. The intraluminal support structure according to claim 20 or 21, wherein when the intraluminal support structure is deployed in the heart valve, each circumferential segment includes a set of tracks below the outflow coronary.

23. The intraluminal support structure according to claim 22, wherein the set of tracks is expandable.

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

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

27. A valve prosthesis comprising: (a) The intraluminal support structure according to any one of claims 1 to 26; as well as (b) At least one prosthetic valve leaflet.

28. The valve prosthesis of claim 27, wherein the one or more prosthetic valve leaflets are inserted into one or more circumferential segments separated by struts and the one or more circumferential segments include the intraluminal support structure.

29. The valve prosthesis of claim 28, wherein the at least one prosthetic valve leaflet comprises the same number of prosthetic valve leaflets as the number of circumferential segments separated by struts.

30. The valve prosthesis according to 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 mixture of biological tissue and polymer.

31. A method of deploying a valve prosthesis to a heart valve, the method comprising: (a) Advancing the distal end of the delivery catheter to the heart valve, wherein the valve prosthesis is helically wound around the delivery catheter in a planar configuration of the valve prosthesis, wherein the valve prosthesis includes an intraluminal support structure as described in any one of claims 1 to 26 and at least one prosthetic valve leaflet; (b) The first end is locked into the second end by sliding the locking mechanism on the first end of the valve prosthesis into the locking mechanism on the second end of the valve prosthesis via the deployment mechanism on the delivery catheter, thereby placing the valve prosthesis in the deployment ring configuration.

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

33. The method of claim 31 or 32, further comprising anchoring the valve prosthesis in the heart valve via anchoring barbs after forming the annular configuration of the valve prosthesis.

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

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