Valve prosthesis with dividing member

Abstract

Provided herein are devices and methods for valve prostheses having a planar configuration during the delivery phase and a final closed-fold configuration during deployment at a tissue-targeting site. The stent may comprise an internal valve support for interlocking with the valve prosthesis leaflets and an external cage. The cage can isolate the movement of the natural heart valve from the internal valve support and the valve prosthesis leaflets. In some cases, the intraluminal support structure has a non-deploying planar configuration and a deployment ring configuration for deployment within the heart valve.

Description

[Technical Field]

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

[0002] High valvular heart disease (HVD) affects many people worldwide. HVD can manifest as abnormal valve leaflet tissue in various ways, including excessive tissue growth, tissue deterioration, tissue rupture, tissue hardening, tissue calcification, and repositioning of abnormal tissue in response to cardiac composition between different stages of the cardiac cycle, such as annular dilation or ventricular reshaping. Such abnormal tissue often leads to deterioration of valve function, such as leakage, regurgitation as a result of valve insufficiency, resistance to blood flow as a result of valve stenosis, and equivalents. In some cases, treatment may involve replacing the dysfunctional natural 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 this oxygenated blood into the left ventricle (LV) through the mitral valve (MV). When the left ventricle (LV) contracts, it allows blood to flow outward through the aortic valve (AV).

[0004] The left atrioventricular (AV) valve, also known as the mitral valve, presents unique anatomical obstacles that make percutaneous mitral valve replacement significantly more difficult. The mitral valve annulus often has a non-circular D-shape or kidney-like shape, with a non-planar saddle-like geometric shape that lacks symmetry. Such anatomical variations and asymmetries make it difficult to deliver a centrally expanding replacement valve using the centrally expanding distal tip. In addition, tethering the device by capturing the valve leaflets with a hook or loop is risky and prone to failure.

[0005] The mitral valve (MV) comprises a pair of leaflets that close by joining or "jointing" uniformly. The ventricular side of the leaflets attaches to the pericardial structures of the left ventricle via a ring-shaped region of tissue called the annulus (AN), located on the left atrium. The annulus is a fibrous ring of high-density connective tissue, which is distinct from both the leaflet tissue and the adjacent muscular tissue of the heart wall. [Overview of the project] [Means for solving the problem]

[0006] This specification describes a flap prosthesis and a method for delivering the same.

[0007] Provided herein are intraluminal support structures for deployment into a target heart valve. The intraluminal support structure may comprise an internal valve support. The intraluminal support structure may comprise an external separation cage coupled to the internal valve support, comprising a plurality of sinusoidal separation members, an inflow coronary portion, and an outflow coronary portion. In some cases, the sinusoidal separation members are configured to separate the internal valve support from the movement of the annulus, ventricle, or both, when the external separation cage is deployed into the heart valve annulus. In some cases, the intraluminal support structure has a non-deployment planar configuration and a deployment ring configuration for deployment within the heart valve.

[0008] In some cases, the intraluminal support structure is configured to be delivered via a catheter. In some cases, the inflow coronary portion is configured to face the atrial side of the heart when the intraluminal support is deployed within the heart valve, and the outflow coronary portion is configured to face the ventricular side of the heart. In some cases, multiple sinusoidal segmentation members have a variation pattern optimized for anchoring and flexibility based on the shape of the heart valve in question. In some cases, the external segmentation cage has an hourglass shape with a narrow central portion configured to conform to the shape of the natural valve annulus. In some cases, the narrow central portion is positioned closer to the outflow coronary portion than to the inflow coronary portion. In some cases, the compartments of the internal valve support are welded together. In some cases, the intraluminal support structure is laser-cut from a single sheet.

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

[0010] The intraluminal support structure may further include a covering material. In some cases, the covering material may be made of a biocompatible material.

[0011] In some cases, multiple sinusoidal segmentation members originate from a level higher than the atrial leaflets of the heart valve when the intraluminal support structure is deployed within the heart valve. In some cases, the external segmentation cage is coupled to the internal valve support via multiple connectors. In some cases, the multiple connectors include linear connectors between the internal valve support and the external segmentation cage. In some cases, the multiple connectors include articulated connectors configured to adjust the radial separation distance between the internal valve support and the external segmentation cage. In some cases, the multiple sinusoidal segmentation members are configured to compress, expand, or translate in response to the movement of the heart valve.

[0012] In some cases, the intraluminal support structure consists of multiple circumferential divisions. In some cases, the intraluminal support structure consists of three circumferential divisions. In some cases, two adjacent circumferential divisions of the multiple divisions are separated by at least one column. In some cases, two adjacent circumferential divisions of the multiple divisions are separated by two columns. In some cases, each circumferential division has a set of rails below the outflow coronary portion when the intraluminal support structure is deployed in the heart valve. In some cases, the set of rails is expandable.

[0013] In some cases, the intraluminal support structure comprises at least one scaffolding panel having a first free end and a second free end when the scaffolding panel is in a non-deployed planar configuration, wherein the first and second free ends are configured to connect with each other and form a ring when the intraluminal support is in a deployed ring configuration. In some cases, the internal valve support is configured to support at least one prosthetic valve leaflet. In some cases, a plurality of sinusoidal segmentation members are connected to the inflow coronal and stomatal portions.

[0014] The invention described herein is 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, one or more prosthetic leaflets are separated by a stipule and inserted into a circumferential segment of one or more circumferential segments constituting an intraluminal support structure. In some cases, at least one prosthetic leaflet comprises the same number of leaflets as the circumferential segments separated by the stipule. In some cases, at least one prosthetic leaflet comprises one or more of biological tissue, polymer, or a hybrid of biological tissue and polymer.

[0016] Provided herein is a method for deploying a valve prosthesis onto a heart valve. The method may include advancing the distal end of a delivery catheter to the heart valve. In some cases, the valve prosthesis is spirally wrapped around the delivery catheter in a planar configuration of the valve prosthesis. In other cases, the valve prosthesis comprises an intraluminal support structure as described above and at least one prosthetic valve leaflet. The method may include sliding a locking mechanism on a first end into a locking mechanism on a second end via a deployment mechanism on the delivery catheter, thereby locking the first end of the valve prosthesis into a deployment ring configuration of the valve prosthesis within the second end of the valve prosthesis.

[0017] In some cases, the heart valve is selected from the group consisting of the mitral valve, aortic valve, pulmonary valve, and tricuspid valve. The method may further include the step of creating a ring configuration for the valve prosthesis and then securing the valve prosthesis within the heart valve via an anchoring return. The method may further include the step of removing the distal end of the delivery catheter from the heart valve.

[0018] Additional aspects and advantages of this disclosure will be readily apparent to those skilled in the art from the following detailed description, which shows and describes only illustrative embodiments of this disclosure. As will be recognized, other different embodiments are possible, and some of their details are modifiable in various obvious ways without departing from this disclosure. Therefore, the drawings and description are to be considered illustrative and not restrictive in nature.

[0019] (Integrated by reference) All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application is incorporated by specific and individual reference. The subject matter of U.S. Provisional Application No. 63 / 311,650, filed on 18 February 2022, and PCT / IB2022 / 000431, filed on 25 July 2022, claiming priority to U.S. Provisional Application No. 63 / 225,969, filed on 27 July 2021, is incorporated herein by reference. [Brief explanation of the drawing]

[0020] Novel features of this disclosure are described in detail in the appended claims. A deeper understanding of the features and advantages of this disclosure will be obtained by referring to the following detailed description, which describes illustrative embodiments in which the principles of this disclosure are utilized, and to the accompanying drawings (also referred to herein as "Figure" and "FIG.").

[0021] [Figure 1A]Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of an exemplary stent according to an exemplary embodiment described herein. [Figure 1B] Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of an exemplary stent according to an exemplary embodiment described herein. [Figure 1C] Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of an exemplary stent according to an exemplary embodiment described herein. [Figure 1D] Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of an exemplary stent according to an exemplary embodiment described herein. [Figure 1E] Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of an exemplary stent according to an exemplary embodiment described herein.

[0022] [Figure 2A] Figure 2A shows a schematic or top view of an exemplary retracted stent according to an exemplary embodiment described herein.

[0023] [Figure 2B] Figures 2B-2F show schematic or top views of the components of the stent in Figure 2A according to the exemplary embodiments described herein. [Figure 2C] Figures 2B-2F show schematic or top views of the components of the stent in Figure 2A according to the exemplary embodiments described herein. [Figure 2D] Figures 2B-2F show schematic or top views of the components of the stent in Figure 2A according to the exemplary embodiments described herein. [Figure 2E] Figures 2B-2F show schematic or top views of the components of the stent in Figure 2A according to the exemplary embodiments described herein. [Figure 2F]Figures 2B-2F show schematic or top views of the components of the stent in Figure 2A according to the exemplary embodiments described herein.

[0024] [Figure 3A] Figures 3A–3D show a perspective view (Figure 3A), a plan view (Figures 3B, 3D), and a perspective view (Figure 3C) of a T-connector for use with an exemplary stent according to an exemplary embodiment described herein. [Figure 3B] Figures 3A–3D show a perspective view (Figure 3A), a plan view (Figures 3B, 3D), and a perspective view (Figure 3C) of a T-connector for use with an exemplary stent according to an exemplary embodiment described herein. [Figure 3C] Figures 3A–3D show a perspective view (Figure 3A), a plan view (Figures 3B, 3D), and a perspective view (Figure 3C) of a T-connector for use with an exemplary stent according to an exemplary embodiment described herein. [Figure 3D] Figures 3A–3D show a perspective view (Figure 3A), a plan view (Figures 3B, 3D), and a perspective view (Figure 3C) of a T-connector for use with an exemplary stent according to an exemplary embodiment described herein.

[0025] [Figure 4] Figure 4 shows a perspective view of an exemplary mooring return for use with an exemplary stent, according to an exemplary embodiment described herein.

[0026] [Figure 5A] Figures 5A-5B show top views of the column portion of an exemplary dissected stent according to an exemplary embodiment described herein. [Figure 5B] Figures 5A-5B show top views of the column portion of an exemplary dissected stent according to an exemplary embodiment described herein.

[0027] [Figure 6A] Figure 6A shows a perspective side view of a three-dimensional multilayer plan view of an exemplary retracted stent according to an exemplary embodiment described herein.

[0028] [Figure 6B] Figures 6B-6C show a side view (Figure 6B) and an oblique side view (Figure 6C) of the curvature of an exemplary stent according to the exemplary embodiments described herein. [Figure 6C] Figures 6B-6C show a side view (Figure 6B) and an oblique side view (Figure 6C) of the curvature of an exemplary stent according to the exemplary embodiments described herein.

[0029] [Figure 7] Figure 7 shows a side view of an exemplary deployed stent with a covering material according to an exemplary embodiment described herein.

[0030] [Figure 8] Figure 8 shows a side view of an exemplary deployed stent with a natural valve ring, according to an exemplary embodiment described herein.

[0031] [Figure 9A] Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Figure 9B] Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Figure 9C] Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Figure 9D] Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Figure 9E]Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Figure 9F] Figures 9A–9F show a plan view (Figures 9A–9B), top and bottom view (Figure 9E), side view (Figure 9C), and perspective view (Figures 9D, 9F) of an exemplary prosthetic valve leaflet according to an exemplary embodiment described herein. [Modes for carrying out the invention]

[0032] Detailed explanation This disclosure relates, in general, to medical implants and methods and systems for the delivery of medical implants into the human body. More specifically, this disclosure relates to methods and systems for the transcatheter delivery of cardiac valve implants into the human heart.

[0033] Transcatheter ablation for structural heart disease may increase the need for delivery of large devices (e.g., stents) through natural blood vessels, heart walls, and cardiac septa. However, radial compression and radial expansion (e.g., dilation) of these devices can create a rigid and relatively large cardiac axis inside the device delivery sheath. Furthermore, the large size (diameter) of the device may leave a large orifice within the cardiac septum at the end of the procedure. Limitations in both rigidity and size can result in limited movement and maneuverability during the procedure. They can also make the stent more prone to rupture.

[0034] There is an unmet need for stents that are more flexible in their deployed state, thinner or smaller in their delivery state, and allow for easier maneuverability through serpentine biological structures. Increased stent flexibility can increase the ability of stent delivery and deployment.

[0035] While flexibility is important, scaffolding support in the deployed state can also be beneficial by increasing the stability of the stent within the delivery site.

[0036] The dual need for flexibility during delivery and high scaffolding support in the deployed state presents an unresolved problem in the art because the two properties are inversely proportional. Specifically, as stent flexibility increases, scaffolding support may decrease, and similarly, as scaffolding support increases, flexibility may decrease. Therefore, the need remains for a stent that has high flexibility in the delivery profile state and high scaffolding support in the final state.

[0037] In addition, many devices designed to treat heart valve disease may be inadequate in addressing fluctuations within the annular biostructure and the dynamic movement of the valve, which can lead to leakage and stent rupture after long-term implantation. These failures may result from the lack of pressure-absorbing structures that isolate the valve from the annular and ventricular wall movement, or from the way such absorbent structures are attached to the valve prosthesis, which can lead to long-term fatigue failure.

[0038] Devices attempting to address certain valve movements are designed using metal structures that may rely on welding certain components around the valve to provide isolation between the heart wall movement and the prosthetic valve. Such welds can, over time, lead to fracture in the stent.

[0039] Therefore, there is an unmet need for a valve prosthesis that is 1) flexible during its delivery phase, 2) sufficiently scaffolded for stability during its deployed phase, 3) not welded to avoid fracture, and 4) capable of absorbing the impact on the natural heart valve and minimizing fatigue.

[0040] Provided herein are valve prostheses having a planar (e.g., unfolded) configuration during the delivery phase and a final closed-fold configuration during deployment at a tissue-targeting site. The planar stent may form a valve prosthesis that is fitted to a valve leaflet and delivered by transcatheter placement. The stent may comprise an internal valve support for interlocking with the valve leaflet and an external cage.

[0041] By being delivered in a planar or multi-layer planar configuration, the valve prostheses described herein can be flexible during delivery and occupy a minimal amount of space (considering three-dimensional space). The stent design can be scaffolded in a final ring shape, as shown in the figures and described below. In some cases, the cage can consist of a single sheet. The single sheet can be laser-cut. By forming the cage from a single sheet, welding can be avoided. The cage can protect the internal valve support and valve prosthesis leaflets from the movement of the natural heart valve. The cage can isolate the movement of the natural heart valve from the internal valve support and valve prosthesis leaflets. Therefore, the cage can be an external isolation cage.

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

[0043] Disclosed herein are methods for delivering and deploying intraluminal support structures as described herein. The method may include the step of loading a valve prosthesis into a delivery catheter. The method may include the step of introducing the catheter into the body and advancing the loaded catheter through body lumens and anatomical tissues until it reaches the delivery site (implantation site). The method may include the step of deploying the valve prosthesis at the delivery site and maneuvering the deployed stent to its final implantation site. The method may include the step of withdrawing the catheter from the body lumen. (device)

[0044] Described herein are valve prostheses comprising one or more valve leaflet structures and an intraluminal support structure (e.g., a stent). A stent may comprise an internal valve support and an external separation cage. A stent can transition from a multilayer planar structure in its non-deployed form to a ring or cylindrical structure in its deployed form.

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

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

[0047] In some cases, the height of the inner frame may be approximately 12 mm to 22 mm. In some cases, the height of the valve leaflet structure may be approximately 12 mm to 14 mm, approximately 12 mm to 16 mm, approximately 12 mm to 18 mm, approximately 12 mm to 20 mm, approximately 12 mm to 22 mm, approximately 14 mm to 16 mm, approximately 14 mm to 18 mm, approximately 14 mm to 20 mm, approximately 14 mm to 22 mm, approximately 16 mm to 18 mm, approximately 16 mm to 20 mm, approximately 16 mm to 22 mm, approximately 18 mm to 20 mm, approximately 18 mm to 22 mm, or approximately 20 mm to 22 mm. In some cases, the height of the valve leaflet structure may be approximately 12 mm, approximately 14 mm, approximately 16 mm, approximately 18 mm, approximately 20 mm, or approximately 22 mm. In some cases, the height of the valve leaflet structure may 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 valve leaflet structure may be up to about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0048] In some cases, the diameter of the inner frame may be approximately 20mm to 75mm. In other cases, the diameter of the inner frame may be approximately 20mm to 25mm, approximately 20mm to 30mm, approximately 20mm to 35mm, approximately 20mm to 40mm, approximately 20mm to 45mm, approximately 20mm to 50mm, approximately 20mm to 55mm, approximately 20mm to 60mm, approximately 20mm to 65mm, approximately 20mm to 70mm, approximately 20mm to 75mm, approximately 25mm to 30mm, approximately 25mm to 35mm, approximately 25mm to 40mm, approximately 25mm to 45mm, approximately 25mm to 50mm, approx. 25mm ~ approx. 55mm, approx. 25mm ~ approx. 60mm, approx. 25mm ~ approx. 65mm, approx. 25mm ~ approx. 70mm, approx. 25mm ~ approx. 75mm, approx. 30mm to about 50mm, about 30mm to about 55mm, about 30mm to about 60mm, about 30mm to about 65mm, about 30mm to about 70mm, about 30mm to about 75mm, about 35mm to about 40mm, about 35mm to about 45mm, about 35mm to about 5 0mm, about 35mm to about 55mm, about 35mm to about 60mm, about 35mm to about 65mm, about 35mm to about 70mm, about 35mm to about 75mm, about 40mm to about 45mm, about 40mm to about 50mm, about 40mm to about 55mm, about 4 0mm to about 60mm, about 40mm to about 65mm, about 40mm to about 70mm, about 40mm to about 75mm, about 45mm to about 50mm, about 45mm to about 55mm, about 45mm to about 60mm, about 45mm to about 65mm, about 45mm to about 70 The diameter of the inner frame may be approximately 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm, 60mm, 60mm, 65mm, 70mm, or 70mm.In some cases, the diameter of the inner frame may be at least about 20mm, about 25mm, about 30mm, about 35mm, about 40mm, about 45mm, about 50mm, about 55mm, about 60mm, about 65mm, or about 70mm. In some cases, the diameter of the inner frame may be at most about 25mm, about 30mm, about 35mm, about 40mm, about 45mm, about 50mm, about 55mm, about 60mm, about 65mm, about 70mm, or about 75mm.

[0049] In some cases, the circumference of the inner frame is about 70mm 2 to about 220mm 2 . In some cases, the circumference of the inner frame is about 70mm 2 to about 100mm 2 , about 70mm 2 to about 130mm 2 , about 70mm 2 to about 160mm 2 , about 70mm 2 to about 190mm 2 , about 70mm 2 to about 220mm 2 , about 100mm 2 to about 130mm 2 , about 100mm 2 to about 160mm 2 , about 100mm 2 to about 190mm 2 , about 100mm 2 to about 220mm 2 , about 130mm 2 to about 160mm 2 , about 130mm 2 to about 190mm 2 , about 130mm 2 to about 220mm 2 , about 160mm 2 to about 190mm 2 , about 160mm 2 to about 220mm 2 , or about 190mm 2 to about 220mm 2 . In some cases, the circumference of the inner frame is about 70mm 2 , about 100mm 2 , about 130mm 2, about 160mm 2 , about 190mm 2 , or approximately 220mm 2 This may also be the case. In some cases, the circumference of the inner frame is at least about 70 mm. 2 Approximately 100mm 2 , about 130mm 2 , about 160mm 2 , or approximately 190mm 2 This is also acceptable. In some cases, the circumference of the inner frame may be up to approximately 100 mm. 2 , about 130mm 2 , about 160mm 2 , about 190mm 2 , or approximately 220mm 2 This is also acceptable. The circumference is 78 mm. 2 That's fine.

[0050] In some cases, the dimensions of the stent described herein differ depending on the portion of the stent, due to the curvature of the stent from the atrial to the ventricular side. Using Figure 1D as a reference, there may be four or more diameters. The first diameter may be the diameter of the uppermost component (e.g., the atrial side). The second diameter may be the diameter of the atrial bulge (e.g., the external curvature). The third diameter may be the diameter at the dotted line where the divided cage curves inward. The fourth diameter may be the diameter of the ventricular external curvature and the lowermost component.

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

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

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

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

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

[0056] In some cases, the length of the stent may be reduced by at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, and / or up to about 80% when transitioning between an open planar configuration and a ring configuration.

[0057] In some cases, the height of the stent may not change substantially between the open-plan configuration and the ring configuration.

[0058] In some cases, the outer cage may be made from materials such as biological tissue, tissue engineering material, grown material, transplanted tissue, biocompatible polymer material, nitinol, or any combination thereof. In some cases, the valve leaflets may be made from materials such as biological tissue, tissue engineering material, grown material, transplanted tissue, biocompatible polymer material, nitinol, or any combination thereof.

[0059] The stent or intraluminal support structure may be coated with one or more of the following: active substances, therapeutic agents, drugs, eluting agents, controlled-release agents, controlled-release active substances, or any combination thereof.

[0060] Figures 1A-1E show a perspective top view (Figures 1A-1B, 1E), a top view (Figure 1C), and a side view (Figure 1D) of the stent 100. Figures 1A-1B show the stent 100 comprising a dividing cage 102, a welded body 104, a sinusoidal dividing member 106, an atrial flange 108, an articulated connector 110, a column 112, an internal frame valve support 116, and an external cage 118. The internal frame valve support 116 and the external cage 118 can constitute the dividing cage 102. The sinusoidal dividing member 106 can be positioned on the external cage 118. Figure 1C shows the stent 100 comprising the dividing cage 102, the sinusoidal dividing member 106, and the internal frame valve support 116. Figure 1D shows a stent 100 comprising a dividing cage 102, a sinusoidal dividing member 106, and a distal attachment portion 114. Figure 1E shows the prosthetic valve leaflet 122 inside the stent 100, comprising the dividing cage 102 and an anchoring return 120.

[0061] In some cases, the severing cage 102 can sever the prosthetic valve from the annulus and ventricular motion. The cage 102 can also preserve the structure of the prosthetic valve leaflets. In some cases, the structure can be oval, round, concentric, elliptical, or any other structure that fits into the heart valve. Severing from natural motion can help maintain the hemodynamic functionality of the valve by minimizing the occurrence of internal leakage. Without such a barrier / cage, any degree of ovality or variable wall motion can alter the valve's ability to join and properly seal, resulting in internal and / or perivalvular leakage. Severing can also help deform the stent around calcification without affecting the shape of the prosthetic valve leaflets 122.

[0062] The segmentation cage 102 may have an hourglass shape, comprising a central portion that fits well with the natural valve annulus, and a larger portion that sits beneath the annulus and helps to anchor the valve within the natural valve. This firm anchoring can result in long-term valve performance and maintenance of valve position for proper hemodynamic functionality and minimal leakage. In some cases, the stenotic area of ​​the hourglass design may be located below the center (e.g., closer to the ventricular side), thereby having a lower ventricular protrusion. This stenotic area is shown as a dotted line below the midline in Figure 1D.

[0063] The segmentation member structure (e.g., segmentation cage 102) may include a sinusoidal wave / member 106 connecting the inlet flange / coronal portion (atrial side) 108 and the outlet flange / coronal portion (ventricular side). By connecting both the upper and lower portions, the sinusoidal wave member 106 can absorb the impact of compression from the natural valve exerted on the valve prosthesis during cardiac output. Instead of being forcibly flexed by cardiac output, the segmentation cage 102 can be flexible in the central and stenotic portions due to the sinusoidal wave member 106, and can be adjusted to be more rigid or more flexible in various parts of the sinusoidal wave portion depending on the natural cardiac pressure. The sinusoidal wave portion can also be optimized by varying its amplitude, frequency, and thickness to allow for improved shock absorption from the natural heart valve, particularly in the lower ventricular portion. In addition, the sinusoidal wave design allows for expansion and compression of the stent in response to cardiac output.

[0064] The sinusoidal design 106 can allow the shape of the separator member 102 to be optimized toward anchoring, and the flexibility of the separator member can help separate cardiac wall motion from the valve prosthetic leaflets. The separator cage 102 can be made flexible while being attached to both the atrium and ventricular coronary portions of the metal structure. Such a design can be made more rigid and less susceptible to fatigue problems. The sinusoidal members 106 can help reduce fatigue because they can assist in the absorption of torsional movement and pressure / restraint from the natural ventricle. The sinusoidal members 106 can also be made more secure and stable during valve loading and installation inside the affected valve.

[0065] The inflow coronary portion can be seated in the atrium directly above the annulus. The outflow coronary portion can be seated directly below the annulus and within the ventricle. The sinusoidal pattern 106 and the connections to the inflow and outflow coronary portions do not need to be welded. The sinusoidal pattern 106 and the connections to the inflow and outflow coronary portions may be laser-cut from a single flat sheet. In some cases, the cage may be attached to the leaflets without welding. Welding of the nitinol components may present fatigue problems during long-term implantation. Cutting from a single flat sheet may resemble a ribbon-like design. The ribbon-like design can be loaded onto a delivery catheter as described below.

[0066] In some cases, the stent 100 may comprise one or more welded bodies 104. In some cases, the welded bodies 104 may comprise two lines parallel to the external connectors on each side. In some cases, the welded bodies are welded onto the stent frame. In some cases, the welded bodies do not comprise either the outer cage 118 or its connection to the inner frame 116. As discussed above, the partition cage may be formed from a single sheet, and the welded bodies may be welded to the single sheet. The welded bodies 104 may be used to weld together the partitions of the inner frame 116, although the inner frame may already be attached to the outer cage 118.

[0067] One or more types of welded bodies 104 may exist. 1, 2, 3, 4, 5, or more types of welded bodies 104 may exist. In some cases, the welded body may have a left loop in addition to its two connectors. In some cases, a compression wire may be present to compress the stent during delivery. Releasing the compression wire allows the cage to expand at the end of the procedure. The loop on the welded body may be the end of the compression wire. The loop may be used to temporarily disconnect the knot of the wire until it can be connected to the wire arising from the catheter. The welded body 104 may have a right hook loop in addition to its two connectors. The welded body 104 may not have a loop in addition to its two connectors. Embodiments of the welded body can be seen in Figures 2C-2F.

[0068] In some cases, the dividing cage 102 may comprise multiple compartments or sections surrounding the prosthetic valve leaflet 122. The dividing cage 102 may comprise one, two, three, four, five, six, or more compartments surrounding the prosthetic valve leaflet 122. In some cases, each compartment may be separated by a column 112. In some cases, the compartments may span or substantially span the circumference of the dividing cage 102. In some cases, the column 112 may be perpendicular to the circumference of the dividing cage 102. In some cases, the column 112 may comprise two or more parallel or substantially parallel lines. In some cases, each section may comprise a separate rail, as further described below.

[0069] 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 linear. In some cases, the connector is articulated to improve the separation between the inner frame 116 and the outer cage 118. By increasing the separation, the articulated connector 110 can increase the separation between the inner frame valve support 116 (and thus the prosthetic valve leaflets 122 inside the inner frame 116) and the outer cage 118. Increasing the separation can improve the isolation of the valve leaflets 122 from the natural biostructure. This can allow the prosthetic valve leaflets 122 to maintain their shape regardless of the anatomical structures surrounding and covering the valve prosthesis. The shape of the prosthetic valve leaflets 122 can be oval, round, elliptical, or another shape, as desired. The valve leaflets 122 are discussed further below.

[0070] The dividing member 102 may also incorporate a mooring return 120, which is mounted around the outer frame 118 and can provide additional mooring fixation, potentially minimizing valve movement over time. In some cases, the mooring return 120 may have a short projection into the ventricle, which can minimize the risk of left ventricular outflow tract (LVOT) obstruction. The mooring return 120 can be approximately 5 mm to 15 mm in length. The mooring return 120 can be approximately 5mm to 7mm, 5mm to 9mm, 5mm to 11mm, 5mm to 13mm, 5mm to 15mm, 7mm to 9mm, 7mm to 11mm, 7mm to 13mm, 7mm to 15mm, 9mm to 11mm, 9mm to 13mm, 9mm to 15mm, 11mm to 13mm, 11mm to 15mm, or 13mm to 15mm. The mooring return 120 can be approximately 5mm, 7mm, 9mm, 11mm, 13mm, or 15mm. The mooring return 120 can be at least approximately 5mm, 7mm, 9mm, 11mm, or 13mm. The mooring return 120 can be approximately 7mm, 9mm, 11mm, 13mm, or 15mm in diameter.

[0071] In some cases, the mooring barb 120 can be straight. In other cases, the mooring barb 120 can be hook-shaped. A hook-shaped design may help to grip the tissue and minimize detachment. This design may be analogous to the spines of a prickly pear cactus. These barbs can be designed to catch on a large anterior valve, stabilize it, minimize movement toward the outflow tract, and thus significantly reduce the risk of LVOT injury.

[0072] Figure 2A shows a schematic or top view of a disembodied stent 200, comprising a dividing cage 202, a sinusoidal dividing member 204, a left welded body 206, a central welded body 208, a right welded body 210, a locking area 212, a distal attachment 214, a column 216, a proximal attachment 218, an inlet corona 220, an outlet corona 222, a window 224, a rail 226, an articulated connector 228, an overlapping area 230, a type A T-connector 232, a type B T-connector 234, a type C T-connector 236, and a mooring return 238. Figures 2B-2F show schematic or top views of the components of the disembodied stent 200 in Figure 2A. Figure 2B shows a dividing cage 202 comprising a sinusoidal dividing member 204, a locking area 212, a distal mounting portion 214, a column portion 216, a proximal mounting portion 218, an inlet corona portion 220, an outlet corona portion 222, a window 224, a rail 226, an articulated connector 228, and an overlapping area 230. Figure 2C shows the left welded body 206, Figure 2D shows the central welded body 208, and Figure 2E shows the right welded body 210. Figure 2F shows the dividing cage 202 and the welded body 212, which may comprise the left welded body 206, the central welded body 208, and / or the right welded body 210.

[0073] In some cases, the severing cage 202 can sever the prosthetic valve from the annulus and ventricular motion. The cage 202 can also preserve the structure of the prosthetic valve leaflets. In some cases, the structure can be oval, round, concentric, elliptical, or any other structure that fits into the heart valve. Severing from natural motion can help preserve the hemodynamic function of the valve by minimizing the occurrence of internal leakage. Without such a barrier / cage, any degree of ovality or variable wall motion can alter the valve's ability to join and properly seal, resulting in internal and / or perivalvular leakage. Severing can also help deform the stent around calcification without affecting the shape of the prosthetic valve leaflets.

[0074] The segmentation cage 202 may have an hourglass shape, comprising a central portion that fits well with the natural valve annulus, and a larger portion that sits beneath the annulus and helps to anchor the valve within the natural valve. This firm anchoring can result in long-term valve performance and maintenance of valve position for proper hemodynamic functionality and minimal leakage. In some cases, the stenotic area of ​​the hourglass design may be located below the center (e.g., closer to the ventricular side), thereby having a lower ventricular protrusion. This stenotic area is shown as a dotted line below the midline in Figure 1D.

[0075] A segmentation member structure (e.g., a segmentation cage 202) may include a sinusoidal wave / member 204 connecting the inlet flange / coronal (atrial) portion 220 and the outlet flange / coronal (ventricular) portion 222. By connecting both the upper and lower portions, the sinusoidal wave member 204 can absorb the impact of compression from the natural valve exerted on the valve prosthesis during cardiac output. Instead of being forcibly flexed by cardiac output, the segmentation cage 202 can be flexible in the central and stenotic portions due to the sinusoidal wave member 204, and can be adjusted to be more rigid or more flexible in various parts of the sinusoidal wave portion depending on the natural cardiac pressure. The sinusoidal wave portion can also be optimized by varying its amplitude, frequency, and thickness to allow for improved shock absorption from the natural heart valve, particularly in the lower ventricular portion. In addition, the sinusoidal wave design allows for expansion and compression of the stent in response to cardiac output.

[0076] The sinusoidal design 204 can allow the shape of the separator member 202 to be optimized toward anchoring, and the flexibility of the separator member can help separate cardiac wall motion from the valve prosthetic leaflets. The separator cage 202 can be made flexible while being attached to both the atrium and ventricular coronary portions of the metal structure. Such a design can be made more rigid and less susceptible to fatigue problems. The sinusoidal members 204 can help reduce fatigue because they can assist in the absorption of torsional movement and pressure / restraint from the natural ventricle. The sinusoidal members 204 can also be made more secure and stable during valve loading and installation inside the affected valve.

[0077] The inflow coronary portion can be seated in the atrium directly above the annulus. The outflow coronary portion can be seated directly below the annulus and within the ventricle. The sinusoidal pattern 204 and the connections to the inflow and outflow coronary portions do not need to be welded. The sinusoidal pattern 204 and the connections to the inflow and outflow coronary portions may be laser-cut from a single flat sheet. In some cases, the cage may be attached to the leaflets without welding. Welding of the nitinol components may present fatigue problems during long-term implantation. Cutting from a single flat sheet may resemble a ribbon-like design. The ribbon-like design can be loaded onto a delivery catheter as described below.

[0078] In some cases, the stent 200 may comprise one or more welded bodies. In some cases, the welded bodies may comprise two lines parallel to the external connectors on each side. In some cases, the welded bodies may be welded onto the stent frame. In some cases, the welded bodies may not comprise an outer cage or its connection to an inner frame. As discussed above, the partition cage may be formed from a single sheet, and the welded bodies may be welded to a single sheet. The welded bodies may be used to weld together the partitions of the inner frame, although the inner frame may already be attached to the outer cage.

[0079] One or more types of welded bodies may exist. 1, 2, 3, 4, 5, or more types of welded bodies may exist. In some cases, a welded body may be a left welded body 206, which may have a left loop in addition to its two connectors. A welded body may be a right welded body 210, which may have a right hook loop in addition to its two connectors. A welded body may be a central welded body 208, which may or may not have a loop in addition to its two connectors. Welding details are shown in Figure 2F. The welded bodies may be welded using a laser. The welded bodies may be welded using a 180-degree arc laser. The overall weld arc may be approximately 180 to 240 degrees. The welded bodies may be perpendicular to the column and locking mechanism.

[0080] The first and second ends of the dividing cage 202, like those of the stent 100, are configured to connect with each other when deployed, forming a ring. The second free end may include a locking area 212 with a tight gap. The first free end may include one or more welded T-hooks 232, 234, and / or 236 that are slidably coupled to the locking area 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 other 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 stent and the locking mechanism. The locking area 212 may be adjacent to the window 224 and parallel to the column 216.

[0081] In some cases, the T-hook may be welded to the end opposite the locking area 212. The T-hook can be folded to approach the window 224. The T-hook can slide along the window 224 into the locking area 212. The lower T-hook (e.g., type C236 and type B234) enters the window 224 and locking area 212 before the type A T-connector 232. To improve engagement with the locking area 212, type B234 and C236 T-connectors may have an angled arm (e.g., the upper part of the "T") instead of a horizontal arm, as shown in Figure 3C. The arm may be angled away from the base of the T. The type C T-connector 236 may have a longer arm than the type B T-connector 234 for hooking onto the frame. Each subsequent type (B, then A) may have a shorter arm for tightening the locking connection, and therefore the ring. The locking mechanism is shown in Figure 3D.

[0082] When the ring is closed, the overlapping area 230 may be outside the rest of the ring because the locking occurs immediately before the overlapping area 230 on the scaffolding.

[0083] In some cases, the dividing cage 202 may comprise multiple compartments or sections surrounding the prosthetic valve leaflets. The dividing cage 202 may comprise one, two, three, four, five, six, or more compartments surrounding the prosthetic valve leaflets. In some cases, each compartment may be separated by a column 216. In some cases, the compartments may span or substantially span the circumference of the dividing cage 202. In some cases, the column 216 may be perpendicular to the circumference of the dividing cage 202. In some cases, the column 216 may comprise two or more parallel or substantially parallel lines.

[0084] The dividing cage 202 may comprise rails 226. In some cases, each set of rails may be separated by a column 216. In some cases, the rails may extend around the circumference of the dividing cage 202, or substantially so. In some cases, the rails 226 may be parallel to the circumference of the dividing cage 202. In some cases, the rails 226 may comprise two or more parallel or substantially parallel lines. In some cases, the rails 226 may be adjustable or expandable. For example, the rail section closest to the column may, in the neutral configuration, be bundled together and, when extended, spring open. This can be used, if desired, to increase the size of the internal frame and accommodate smaller or larger leaflet prostheses. In some cases, the rails may be expanded via the use of balloons once the stent 200 is in its ring configuration. In some cases, the rails 226 are curved. In some cases, the rails 226 are substantially straight.

[0085] The stent 200 may have attachment pieces for hooking onto a delivery device. The stent 200 may have one or more distal attachments 214 for hooking onto the distal portion of the delivery device. The stent 200 may have one or more proximal attachments 218 for hooking onto the distal portion of the delivery device, located proximal to the location where the hooks 214 hook.

[0086] In some cases, the stent 200 may include a connector between the medial frame and the lateral cage. In some cases, the connector is linear. In other cases, the connector is articulated to improve the separation between the medial frame and the lateral cage. By increasing the separation, the articulated connector 228 can increase the separation between the medial frame valve support (and thus the prosthetic valve inside the cusp medial frame) and the lateral cage. Increasing the separation can improve the isolation of the valve leaflets from the natural biostructure. This can allow the prosthetic valve leaflets to maintain their shape regardless of the anatomical structures surrounding and covering the valve prosthesis. The shape of the prosthetic valve leaflets can be oval, round, elliptical, or another shape, as desired.

[0087] The dividing member 202 may also incorporate a mooring return 238, which is mounted around the outer frame 118 and can provide additional mooring fixation, potentially minimizing valve movement over time. In some cases, the mooring return 238 may have a short projection into the ventricle, which can minimize the risk of left ventricular outflow tract (LVOT) obstruction. The mooring return 238 can be approximately 5 mm to 15 mm in length. The mooring bar 238 can be approximately 5mm to 7mm, 5mm to 9mm, 5mm to 11mm, 5mm to 13mm, 5mm to 15mm, 7mm to 9mm, 7mm to 11mm, 7mm to 13mm, 7mm to 15mm, 9mm to 11mm, 9mm to 13mm, 9mm to 15mm, 11mm to 13mm, 11mm to 15mm, or 13mm to 15mm. The mooring bar 238 can be approximately 5mm, 7mm, 9mm, 11mm, 13mm, or 15mm. The mooring bar 238 can be at least approximately 5mm, 7mm, 9mm, 11mm, or 13mm. The mooring return 238 can be approximately 7mm, 9mm, 11mm, 13mm, or 15mm in length.

[0088] In some cases, the mooring barb 238 can be straight. In other cases, the mooring barb 238 can be hook-shaped. A hook-shaped design may help to grip the tissue and minimize shedding. This design may be analogous to the spines of a prickly pear cactus. These barbs can be designed to catch on a large anterior apical valve, stabilizing it and minimizing movement toward the outflow tract, thus significantly reducing the risk of LVOT injury.

[0089] Figures 3A-3D show perspective views (Figure 3A), plan view (Figures 3B, 3D), and perspective view (Figure 3C) of the T-connector of stent 200. Figures 3A-3D show type A T-connector 232, type B T-connector 234, and type C T-connector 236.

[0090] The first and second ends of the dividing cage 202, like those of the stent 100, are configured to connect with each other when deployed, forming a ring. The second free end may include a locking area 212 with a tight gap. The first free end may include one or more welded T-hooks 232, 234, and / or 236 that are slidably coupled to the locking area 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 other 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 stent and the locking mechanism. The locking area 212 may be adjacent to the window 224 and parallel to the column 216.

[0091] In some cases, the T-hook may be welded to the end opposite the locking area 212. The T-hook can be folded to approach the window 224. The T-hook can slide along the window 224 into the locking area 212. The lower T-hook (e.g., type C236 and type B234) enters the window 224 and locking area 212 before the type A T-connector 232. To improve engagement with the locking area 212, type B234 and C236 T-connectors may have an angled arm (e.g., the upper part of the "T") instead of a horizontal arm, as shown in Figure 3C. The arm may be angled away from the base of the T. The type C T-connector 236 may have a longer arm than the type B T-connector 234 for hooking onto the frame. Each subsequent type (B, then A) may have a shorter arm for tightening the locking connection, and therefore the ring. The locking mechanism is shown in Figure 3D.

[0092] Figure 4 shows the anchoring barbs 238 of the stent 200. The anchoring barbs 238 are positioned around the fragmentation cage 202 and can provide additional anchoring fixation, potentially minimizing valve migration over time. In some cases, the anchoring barbs 238 have a short projection into the ventricle, which can minimize the risk of left ventricular outflow tract (LVOT) obstruction. In some cases, the anchoring barbs 238 can be straight. In some cases, the anchoring barbs 238 can be hook-shaped. A hook-shaped design can help grasp tissue and minimize detachment. This design may be analogous to the spines of a prickly pear cactus. As shown in Figure 4, the anchoring barbs are angled and curved away from the curve of the fragmentation structure 202 and have an acute medial point.

[0093] The return 238 may have an angle of approximately 35 to 50 degrees relative to the stent scaffolding. The return 238 may have an angle of approximately 35 to 40 degrees, approximately 35 to 45 degrees, approximately 35 to 50 degrees, approximately 40 to 45 degrees, approximately 40 to 50 degrees, or approximately 45 to 50 degrees relative to the stent scaffolding. The return 238 may have an angle of approximately 35 degrees, approximately 40 degrees, approximately 45 degrees, or approximately 50 degrees relative to the stent scaffolding. The return 238 may have an angle of at least approximately 35 degrees, approximately 40 degrees, or approximately 45 degrees relative to the stent scaffolding. The return 238 may have an angle of at most approximately 40 degrees, approximately 45 degrees, or approximately 50 degrees relative to the stent scaffolding.

[0094] In some cases, a straight return may be present. In some cases, the straight return extends outward from the dividing cage 202. In some cases, the straight return extends outward from the base of the hook-shaped return. The angle of the straight return with respect to the stent scaffolding may be similar to the angle of the hook-shaped return.

[0095] These valves can be designed to catch on the large anterior leaflet valve, stabilize it, minimize its movement toward the outflow tract, and thus significantly reduce the risk of LVOT injury.

[0096] The mooring bar 238 can be approximately 5mm to approximately 15mm. The mooring bar 238 can be approximately 5mm to approximately 7mm, approximately 5mm to approximately 9mm, approximately 5mm to approximately 11mm, approximately 5mm to approximately 13mm, approximately 5mm to approximately 15mm, approximately 7mm to approximately 9mm, approximately 7mm to approximately 11mm, approximately 7mm to approximately 13mm, approximately 7mm to approximately 15mm, approximately 9mm to approximately 11mm, approximately 9mm to approximately 13mm, approximately 9mm to approximately 15mm, approximately 11mm to approximately 13mm, approximately 11mm to approximately 15mm, or approximately 13mm to approximately 15mm. The mooring bar 238 can be approximately 5mm, approximately 7mm, approximately 9mm, approximately 11mm, approximately 13mm, or approximately 15mm. The mooring bar 238 can be at least approximately 5mm, approximately 7mm, approximately 9mm, approximately 11mm, or approximately 13mm. The mooring return 238 can be approximately 7mm, 9mm, 11mm, 13mm, or 15mm in length.

[0097] Figures 5A and 5B show top views of the column section of the disassembled stent 200. Figure 5A shows a poorly constructed column section with non-parallel bars (e.g., forming or manufacturing defects), while Figure 5B shows a properly constructed column section with parallel bars. Parallel bars can help maintain a single plane in the cross-sectional area of ​​the ring stent rather than folding, which can help stabilize the placement of the valve leaflets within the stent.

[0098] Figure 6A shows a perspective side view of a three-dimensional multilayer plan view of a disassembled stent 300 equipped with a sinusoidal segmentation member 302. Figures 6B-6C show a side view (Figure 6B) and a perspective side view (Figure 6C) of the curvature of the sinusoidal segmentation member 302 of the stent 300.

[0099] Figure 7 shows a side view of the deployed stent 400 with a covering. The deployed stent 400 may comprise a covered segmentation cage 402 and a covering material 404. The stent 400 and segmentation cage 402 may be similar to those disclosed herein. The covering material 404 may help seal the stent. This may be achieved by helping to minimize perivalvular leakage by having constant and close contact with the valve annulus and ventricular wall during the systolic and diastolic phases of the cardiac cycle. The covering material 404 may comprise a biocompatible layer such as PET, PTFE, or polyurethane.

[0100] Figure 8 shows a schematic side view of the stent 500 deployed within the natural valve annulus. Figure 8 shows the sinusoidal segmentation member 502, the atrial leaflets of the valve 504, the segmentation cage 506, and the natural valve annulus 508. The stent 500, the sinusoidal segmentation member 502, and the segmentation cage 506 can be similar to those disclosed herein. The atrial leaflets of the valve 504 show how the stent, as described herein, sits below or originates from the atrial leaflets of the valve 504. In some cases, the stent originates above the atrial leaflets of the valve. The originating side can be the inflow side. In some cases, the natural valve annulus 508 can be located approximately in the middle of the stent's height. In some cases, the natural valve annulus 508 can be located above the middle of the stent's height. In some cases, the natural valve annulus 508 can be located below the middle of the stent's height. valve leaflet

[0101] In some cases, the intraluminal support structure comprises a valve leaflet structure attached to or attachable to the inner surface of a scaffold panel, as shown in Figure 1E. The valve leaflet structure may comprise one or more valve leaflets and may be connectable to one or more column portions on the stent. The valve leaflet structure may comprise one, two, three, or more separate valve leaflets, which may be attached independently to the scaffold.

[0102] In some cases, the height of the valve leaflet structure, which has multiple leaflets, may be approximately 12 mm to approximately 22 mm. In some cases, the height of the valve leaflet structure may be approximately 12 mm to approximately 14 mm, approximately 12 mm to approximately 16 mm, approximately 12 mm to approximately 18 mm, approximately 12 mm to approximately 20 mm, approximately 12 mm to approximately 22 mm, approximately 14 mm to approximately 16 mm, approximately 14 mm to approximately 18 mm, approximately 14 mm to approximately 20 mm, approximately 14 mm to approximately 22 mm, approximately 16 mm to approximately 18 mm, approximately 16 mm to approximately 20 mm, approximately 16 mm to approximately 22 mm, approximately 18 mm to approximately 20 mm, approximately 18 mm to approximately 22 mm, or approximately 20 mm to approximately 22 mm. In some cases, the height of the valve leaflet structure may be approximately 12 mm, approximately 14 mm, approximately 16 mm, approximately 18 mm, approximately 20 mm, or approximately 22 mm. In some cases, the height of the valve leaflet structure may 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 valve leaflet structure may be up to about 14 mm, about 16 mm, about 18 mm, about 20 mm, or about 22 mm.

[0103] In some cases, the diameter of the valve leaflet structure, which may have multiple leaflets, may be approximately 20 mm to approximately 75 mm. In other cases, the diameter of the valve leaflet structure may 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 5 0mm, about 25mm to about 55mm, about 25mm to about 60mm, about 25mm to about 65mm, about 25mm to about 70mm, about 25mm to about 75mm, about 30mm to about 35mm, about 30mm to about 40mm, about 30mm to about 45mm, about 3 0mm to about 50mm, about 30mm to about 55mm, about 30mm to about 60mm, about 30mm to about 65mm, about 30mm to about 70mm, about 30mm to about 75mm, about 35mm to about 40mm, about 35mm to about 45mm, about 35mm to about 50 mm, about 35mm to about 55mm, about 35mm to about 60mm, about 35mm to about 65mm, about 35mm to about 70mm, about 35mm to about 75mm, about 40mm to about 45mm, about 40mm to about 50mm, about 40mm to about 55mm, about 40 mm~60mm, 40mm~65mm, 40mm~70mm, 40mm~75mm, 45mm~50mm, 45mm~55mm, 45mm~60mm, 45mm~65mm, 45mm~70 The diameter of the valve leaflet structure may be approximately 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, or 75 mm.In some cases, the diameter of the valve leaflet structure may be at least about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, or about 70 mm. In some cases, the diameter of the valve leaflet structure may be up to about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, or about 75 mm.

[0104] In some cases, the valve leaflet structure has multiple leaflets, and the circumference of the leaflet structure is approximately 70 mm. 2 ~about 220mm 2 This is also possible. In some cases, the circumference of the valve leaflet structure is approximately 70 mm. 2 ~approximately 100mm 2 , about 70mm 2 ~approx. 130mm 2 , about 70mm 2 ~approx. 160mm 2 , about 70mm 2 ~approx. 190mm 2 , about 70mm 2 ~about 220mm 2 Approximately 100mm 2 ~approx. 130mm 2 Approximately 100mm 2 ~approx. 160mm 2 Approximately 100mm 2 ~approx. 190mm 2 Approximately 100mm 2 ~about 220mm 2 , about 130mm 2 ~approx. 160mm 2 , about 130mm 2 ~approx. 190mm 2 , about 130mm 2 ~about 220mm 2 , about 160mm 2 ~approx. 190mm 2 , about 160mm 2 ~about 220mm 2 , or approximately 190mm 2 ~about 220mm 2 This is also possible. In some cases, the circumference of the valve leaflet structure is approximately 70 mm. 2 Approximately 100mm 2 , about 130mm 2, about 160 mm 2 , about 190 mm 2 , or about 220 mm 2 . In some cases, the circumference of the leaflet structure may be at least about 70 mm 2 , about 100 mm 2 , about 130 mm 2 , about 160 mm 2 , or about 190 mm 2 . In some cases, the circumference of the leaflet structure may be at most about 100 mm 2 , about 130 mm 2 , about 160 mm 2 , about 190 mm 2 , or about 220 mm 2 . The circumference may be 78 mm 2 .

[0105] Figures 9A-9F show flat views (Figures 9A-9B), top and bottom views (Figure 9E), side views (Figure 9C), and perspective views (Figures 9D, 9F) of prosthetic valve leaflets. Figure 9A shows leaflet 600. Figure 9B shows a support body 610 comprising a body 612 and a skirt 614. Figures 9C-9E show different views of leaflets 702 assembled into a single valve component 700. Figure 9F shows the valve component 700 embedded within the stent 100 to create a complete valve prosthesis 800. Figure 9F shows the leaflets 702, the segmented cage 102, and the sinusoidal segmented member 106. The valve component 700 may alternatively be embedded within the stent 200 or any other stent disclosed herein.

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

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

[0108] In some cases, the valve leaflet structure comprises multiple jointed leaflets positioned at the center of the frame, the leaflets being sufficiently flexible to open and close in response to hemodynamic forces, and the frame being at least partially rigid enough to resist deformation resulting from hemodynamic forces after implantation.

[0109] The valve structure may comprise one or more connecting skirts 614. In some cases, one or more central valve tips are inserted into the arched portion of one or more valve support bodies. In some embodiments, one or more connecting skirts are attached to one or more valve support bodies. One or more connecting skirts 614 may be configured to compensate for a diameter difference between the central orifice of the heart valve and the diameter of the valve structure.

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

[0111] In some cases, the devices disclosed herein may describe or illustrate devices having three leaflet structures; however, the valve prostheses described herein may have more or fewer three leaflet structures.

[0112] When multiple valve leaflets 600 are combined together, they can form a complete biological valve component 700, accompanied by valve leaflets 702. As shown in Figures 9C-9E, the valve leaflets meet together, in some cases, at the pilar, as shown in Figure 9F. The parts they meet together can be the outermost parts of each section of the valve component 700, and the center of each valve leaflet can be the innermost parts of each section of the valve component 700. The central parts of the valve leaflets may coalesce together during cardiac contraction, and the three valve leaflets meet at the center of the valve. This can be the innermost parts of each section of the valve. In some cases, a gap may exist at the center of where the valve leaflets 702 meet. This can help provide flexibility to the valve component 700.

[0113] The marking of a stent with a different number does not indicate that the stent is only compatible with the feature used to demonstrate it. Rather, any stent numbered or described herein may be used with any feature described herein. (method)

[0114] Described herein are methods for delivering and deploying stents and valve prosthetic devices as described herein. As part of the deployment, stents and valve prosthetic devices as described herein can be locked from a planar configuration to a ring or cylinder configuration. (Latching method)

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

[0116] The first and second ends of the dividing cage, like those of stent 100 or 200, are configured to connect to each other when deployed, forming a ring. The second free end may include a locking area (e.g., 212 in Figure 2A) with a tight gap. The first free end may include one or more welded T-hooks (e.g., 232, 234, and / or 236 in Figure 2A) that are slidably coupled to the locking area 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 other 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 stent and the locking mechanism.

[0117] As shown in Figures 3C-3D, in some cases the T-hook may be welded to the end opposite to the locking area 212 in Figure 2A. The T-hook can be folded to approach the window 224 in Figure 2A. The T-hook can slide along the window 224 into the locking area 212. The lower T-hook (e.g., type C236 and type B234) enters the window 224 and locking area 212 before the type A T-connector 232. To improve engagement with the locking area 212, type B234 and C236 T-connectors may have an angled arm (e.g., the upper part of the "T") instead of a horizontal arm. The arm may be angled away from the base of the T. The type C T-connector 236 may have a longer arm than the type B T-connector 234 to hook onto the frame. Each subsequent type (B, then A) may have a shorter arm for the locking connection, and therefore for tightening the ring.

[0118] When the ring is closed, the overlapping area (e.g., 230 in Figure 2A) may be outside the rest of the ring because the locking occurs just before the overlapping area 230 on the scaffolding.

[0119] The locking mechanism can be perpendicular to the circumferential rail. The locking mechanism can be perpendicular to the upper inlet crown. The locking mechanism can be perpendicular to the lower outlet crown. The locking mechanism can be parallel to the stent column. (Delivery method)

[0120] The method may include the step of 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 clips. One of the clips may be positioned close to the distal end of the delivery catheter. At least one of the clips may be positioned proximal to the first clip. The valve prosthesis may be mounted within the clips, and the clips may be rotated such that the first free end and the second free end of the device rotate relative to each other to create a spiral. The method may include the step of introducing the catheter into the body and advancing the loaded catheter through body lumens and anatomical tissues until it reaches the delivery site (implantation site). The method may include the step of deploying the valve prosthesis at the delivery site and maneuvering the deployed stent to its final implantation site. The method may include the step of withdrawing the catheter from the body lumen. In some cases, the unfolding step may include connecting the proximal clip to the distal clip so that the proximal end of the planar device approaches the distal end of the planar device.

[0121] The method may include the step of implanting any one of the aforementioned intraluminal 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 comprise a distal connector configured to be releasably attached to a first free end of the stent's scaffold panel, and a proximal connector configured to be releasably attached to a second end of the scaffold panel, wherein the distal and proximal connectors may releasably hold the scaffold panel in a helical winding configuration within the elongated carrier region prior to being released and forming a ring configuration.

[0122] In some cases, the distal connector may be configured to both translate along the longitudinal axis of the catheter and rotate about it. The delivery catheter may comprise an outer shaft, an intermediate shaft, and an inner shaft coaxially positioned within the central passage of the outer shaft. The distal connector may be supported on the distal region of the central shaft, and the proximal connector may be supported on the distal region of the outer shaft.

[0123] In some cases, the distal end of the delivery catheter is advanced to the valve annulus, and the scaffolding panel is unfolded from the extension carrier region of the delivery catheter, allowing the scaffolding panel to transition to form a ring or cylindrical shape within the valve annulus.

[0124] In some cases, the stent is pre-formed as a ring, and the step of deploying the stent includes a step that allows the scaffold panel to transition into a ring or cylindrical shape. A delivery catheter may twist and compress the free end of the scaffold panel axially, resulting in or assisting the transition to a planar configuration into a ring.

[0125] In some cases, the step of loading a stent as described herein onto a delivery catheter may include, prior to attaching the stent, rotating the clip or proximal connector along the outer shaft of the delivery catheter relative to the distal connector. In some cases, the proximal section of the delivery catheter rotates by 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 by 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 by 180 degrees.

[0126] After loading is complete, the proximal section of the delivery catheter, which holds one end of the stent using a proximal locking element, may slide or translate toward the fixed end of the delivery catheter, which holds the other end of the stent using a distal locking element. When the delivery catheter reaches the end of the distal fixed end, the proximal section of the delivery catheter may rotate clockwise. In some cases, the proximal section of the delivery catheter rotates by 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 by 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 by 180 degrees. The delivery catheter may rotate clockwise by an amount similar to the counterclockwise rotation it had before loading.

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

[0128] In some cases, the stents described herein may be beneficial because the final shape of the folded configuration does not depend on the delivery system, thus enabling a versatile delivery system. A single delivery system can be used on stents of different sizes and structures. definition

[0129] Unless otherwise defined, all technical terms, expressions, and other technical and scientific terms or technical terms used herein are intended to have the same meaning as those generally understood by those skilled in the art to which the claimed subject matter relates. Where there is a generally understood meaning, terms are defined herein for clarity and / or for easy reference, and the inclusion of such definitions herein should not necessarily be construed as representing a substantial difference from what is generally understood in the art.

[0130] The terms "intraluminal support structure" and "stent" may be used synonymously in this specification. The terms "planar" and "unrolled" may be used synonymously in this specification. An unrolled structure may not be perfectly flat or planar, but it is linear in relation to the ring structure of the unrolled device.

[0131] In the context of this application, the term "open" referring to the configuration of a support structure refers to, for example, a non-tubular or non-cylindrical structure such as a stent or valve. The term "open" may be used synonymously to refer to a substantially flat, single-layer planar structure or a substantially flat, multi-layer planar structure.

[0132] Throughout this application, various embodiments may be presented in scope form. It should be understood that the scope descriptions are for convenience and simplification only and should not be interpreted as inflexible limitations on the scope of this disclosure. Therefore, scope descriptions should be considered to have all conceivable sub-scopes and individual numerical values ​​within those scopes, as specifically disclosed. For example, a scope description such as 1-6 should be considered to have all specifically disclosed sub-scopes such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, and individual numerical values ​​within those scopes, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the scope.

[0133] The scope disclosed herein also includes any overlaps, sub-scopes, and combinations thereof. Terms such as “up to,” “at least,” “greater than,” “less than,” “between,” and equivalents include the numbers listed. Numbers preceding terms such as “approximately,” “about,” and “substantially,” as used herein, include the numbers listed and still represent quantities that approximate the stated quantity to perform the desired function or achieve the desired result. The terms “about” or “approximately” may mean within an acceptable margin of error for a particular value, which will in part depend on the method by which the value is measured or determined, e.g., the limits of the measurement system. For example, the terms “approximately,” “about,” and “substantially” may refer to quantities that are less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. For example, “about” may mean a standard deviation of 1 or less, or greater than 1, according to the convention of the art. Alternatively, “about” may mean a range of up to 20%, up to 10%, up to 5%, or up to 1% of a given value. As used herein, the term “about” a number refers to a number within ±10% of that number. The term “about” a range refers to that range from -10% of its lowest value to +10% of its highest value. Where a particular value is described in this application and claims, unless otherwise stated, the term “about” may be assumed to mean within an acceptable margin of error for that particular value.

[0134] As used herein and in the claims, the singular forms “a,” “an,” and “the” include plural references unless otherwise clearly determined by the context. For example, the term “sample” includes multiple samples, and also includes mixtures thereof.

[0135] The terms “determining,” “measuring,” “evaluating,” “assessing,” “assaying,” and “analyzing” are often used herein as synonyms to refer to a form of measurement. These terms include determining whether an element is present or not (e.g., detection). These terms can include quantitative, qualitative, or both quantitative and qualitative determinations. Assessments can be relative or absolute. “Detecting the presence of” may, depending on the context, include determining the quantity of something that is present, in addition to determining whether it is present or not.

[0136] The terms “subject,” “individual,” and “patient” are often used synonymously herein. “Subject” can be a biological entity containing 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 particular disease. In some cases, a subject may not necessarily be diagnosed or suspected of being at high risk for that disease.

[0137] As used herein, the terms “treatment” or “treating” are used to refer to a pharmaceutical or other interventional administration plan for obtaining beneficial or desired outcomes in a recipient. Beneficial or desired outcomes include, but are not limited to, therapeutic benefits and / or preventive medical benefits. Therapeutic benefits may refer to the elimination or improvement of the symptom or underlying ailment being treated. Therapeutic benefits may also be achieved with the elimination or improvement of one or more physiological symptoms associated with the underlying ailment, so that improvement is observed in the subject, even though the subject may still be suffering from the underlying ailment. Preventive medical effects include delaying, preventing, and / or eliminating the onset of disease or condition; delaying / or eliminating the onset of symptoms of disease or condition; slowing, interrupting, and / or reversing the progression of disease and / or condition; or any combination thereof. Regarding preventive medical benefits, individuals at risk of developing a particular disease, or those experiencing one or more of the physiological symptoms of the disease, may receive treatment even if they have not been diagnosed with the disease.

[0138] The section headings used in this specification are for organizational purposes only and should not be interpreted as limiting the subject matter being described.

[0139] Preferred embodiments of the Disclosure are shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, alterations, and substitutions will be recalled herein without departing from the Disclosure. It should be understood that various alternatives to the embodiments of the Disclosure described herein may be adopted in practice of the Disclosure. The following claims define the scope of the Disclosure, and the methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims

1. An intraluminal support structure for deployment into the target heart valve, wherein the intraluminal support structure is (a) Inner valve support, (b) An external separation cage coupled to the internal valve support, comprising a plurality of sinusoidal separation members, an inflow coronary portion, and an outflow coronary portion, wherein the sinusoidal separation members are configured to separate the internal valve support from the movement of the annulus, the ventricle, or both, when the external separation cage is deployed within the annulus. Equipped with, The intraluminal support structure comprises a non-expandable planar configuration and an expandable ring configuration for deployment within 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 the inflow coronary portion is configured to face the atrial side of the heart when the intraluminal support is deployed within the heart valve, and the outflow coronary portion 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 segmentation members have a variation pattern optimized for anchoring and flexibility based on the shape of the heart valve of the target.

5. The intraluminal support structure according to any one of claims 1 to 4, wherein the external dividing cage has an hourglass shape with a narrow central portion configured to conform to the shape of the natural valve annulus.

6. The intraluminal support structure according to claim 5, wherein the narrow central portion is positioned closer to the outflow coronal portion than to the inflow coronal portion.

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

8. The intraluminal support structure according to any one of claims 1 to 7, wherein the intraluminal 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 a mooring return positioned along the external dividing cage and extending from the external dividing cage.

10. The intraluminal support structure according to claim 9, wherein the mooring return is positioned at an angle of approximately 45 degrees with respect to the plane of the external dividing cage.

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

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

13. The intraluminal support structure according to any one of claims 1-12, wherein the plurality of sinusoidal segmentation members originate from a level higher than the atrial valve leaflets of the heart valve when the intraluminal support structure is deployed inside the heart valve.

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

15. The intraluminal support structure according to claim 14, wherein the plurality of connectors include a linear connector between the inner valve support and the outer partition cage.

16. The intraluminal support structure according to claim 14, wherein the plurality of connectors include articulated connectors configured to adjust the radial separation distance between the inner valve support and the outer separation cage.

17. The intraluminal support structure according to any one of claims 1 to 16, wherein the plurality of sinusoidal segmentation members are configured to perform one or more of the following in response to the movement of the heart valve: compression, expansion, or translation.

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

19. The intraluminal support structure according to claim 18, wherein the intraluminal support structure comprises three circumferential divisions.

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

21. The intratubular support structure according to claim 20, wherein two adjacent circumferential sections among the plurality of sections are separated by two columnar sections.

22. The intraluminal support structure according to claim 20 or 21, wherein each circumferential section is provided with a set of rails below the outflow coronary portion when the intraluminal support structure is deployed within the heart valve.

23. The set of rails is expandable, in the in-tube support structure according to claim 22.

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

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

26. The plurality of sinusoidal dividing members are connected to the inlet corona and column portions, as described in any one of claims 1-25.

27. It is a flap prosthesis, (a) The intraluminal support structure according to any one of claims 1-26, (b) at least one prosthetic flap tip and A flap prosthesis equipped with the following features.

28. The valve prosthesis according to claim 27, wherein one or more prosthetic valve leaflets are separated by a column and inserted into one or more circumferential sections constituting the intraluminal support structure.

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

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

31. A method for deploying a valve prosthesis onto a heart valve, wherein the method is (a) The distal end of the delivery catheter is advanced to the heart valve, wherein the valve prosthesis is spirally wrapped around the delivery catheter in a planar configuration of the valve prosthesis, and the valve prosthesis comprises the intraluminal support structure described in any one of claims 1-26 and at least one prosthetic valve leaflet. (b) via the deployment mechanism on the delivery catheter, the locking mechanism on the first end is slid into the locking mechanism on the second end, thereby forming the valve prosthesis into the deployment ring configuration, thereby locking the first end of the valve prosthesis into the second end of the valve prosthesis. Methods that include...

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 according to claim 31 or 32, further comprising, after creating the ring configuration of the valve prosthesis, securing the valve prosthesis within the heart valve via a retaining loop.

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

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