Prosthesis with anti-perivalvular leakage component comprising a one-way valve

Abstract

This invention provides a transcatheter valve prosthesis comprising a stent, a prosthetic valve component, and a paravalvular leakage prevention component. The paravalvular leakage prevention component is coupled to the stent and includes an inner skirt, an outer covering, a lumen, an opening, and a one-way valve. The inner skirt is disposed on an inner surface of the stent and has an inflow end and a downstream end. The outer covering surrounds an outer surface of the stent and has an inflow end and a downstream end, the inflow end being coupled to the inflow end of the inner skirt. The lumen is formed between the outer surface of the inner skirt and the inner surface of the outer covering. The opening is disposed between the inner skirt and the outer covering. The one-way valve includes a flap at the opening, the flap being configured to open to allow blood to flow into the lumen but prevent blood from flowing out of the lumen.

Description

Technical Field

[0001] This invention generally relates to prostheses for intervascular delivery. More specifically, the invention relates to valve prostheses having a paravalvular leakage prevention component that helps prevent paravalvular leakage at the site of the deployed valve prosthesis. Background Technology

[0002] The human heart is a four-chambered muscular organ that circulates blood throughout the body during the cardiac cycle. The four main chambers include the right atrium and right ventricle, which supply blood to the lungs, and the left atrium and left ventricle, which supply oxygenated blood received from the lungs to the rest of the body. To ensure blood flows through the heart in one direction, atrioventricular valves (tricuspid and mitral valves) are located at the junction of the atria and ventricles, and semilunar valves (pulmonary and aortic valves) control the exits of the ventricles to the lungs and other parts of the body. These valves contain leaflets or cusps that open and close in response to changes in blood pressure caused by the contraction and relaxation of the heart chambers. The leaflets separate to open and allow blood to flow downstream of the valve, and close to close and prevent backflow or regurgitation upstream.

[0003] Diseases associated with heart valves, such as those caused by damage or defects, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis narrows and hardens the valve, which can prevent blood from flowing to the downstream chambers of the heart at the proper flow rate and may cause the heart to work harder to pump blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, causing blood to flow back and resulting in decreased cardiac efficiency. Valve disease or damage can be congenital, age-related, drug-induced, or in some cases caused by infection, and can cause the heart to enlarge and thicken, thus losing elasticity and efficiency. Some symptoms of heart valve disease can include weakness, shortness of breath, dizziness, syncope, palpitations, anemia, and edema, as well as blood clots that may increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to debilitate and / or be life-threatening.

[0004] Heart valve prostheses have been developed for the repair and replacement of diseased and / or damaged heart valves. These prostheses can be delivered percutaneously in a low-profile or radially compressed configuration, allowing them to be advanced through the patient's vascular system and deployed at the site of the diseased heart valve via a catheter-based system. Once positioned at the treatment site, the prosthesis can expand to engage with tissue in the region of the diseased heart valve, thereby, for example, holding the prosthesis in place.

[0005] However, in some patients, the valve prosthesis may not function as expected after implantation. For example, in some patients, the radial expansion of the valve prosthesis may not conform to the shape of the native valve wall. This can occur when the native valve wall is deformed or severely calcified. In cases where the valve prosthesis does not fit snugly to the native valve wall, paravalvular leakage (PVL) can occur between the valve prosthesis and the native valve wall, and high levels of PVL are associated with increased mortality.

[0006] Therefore, systems and components are needed to improve the seal between the valve prosthesis and the autologous valve wall while maintaining a small compression profile for percutaneous delivery. Summary of the Invention

[0007] This document relates to a transcatheter valve prosthesis comprising a stent, a prosthetic valve assembly, and a paravalvular leakage prevention assembly. The stent includes a radially compressible configuration for delivery within a vascular system and a radially expandable configuration for deployment within an autologous heart valve. The prosthetic valve assembly is disposed within and coupled to the stent. The paravalvular leakage prevention assembly is coupled to the stent. The paravalvular leakage prevention assembly includes an inner skirt, an outer sheath, a lumen, an opening, and a one-way valve. The inner skirt has an inflow end and an opposing downstream end and is disposed on an inner surface of the stent. The inner skirt is formed of a flexible material. The outer sheath has an inflow end and an opposing downstream end, the inflow end being coupled to the inflow end of the inner skirt. The outer sheath is disposed around an outer surface of the stent and is formed of a flexible material. A lumen is formed between the outer surface of the inner skirt and the inner surface of the outer sheath. Openings are provided between the inner skirt and the outer sheath at corresponding inflow ends of the inner skirt and / or corresponding downstream ends of the outer sheath and the outer sheath. The one-way valve includes a flap located at the opening and between the outer surface of the stent and the inner surface of the outer covering. The flap is formed of a flexible material and is configured to open to allow blood to flow into the cavity but prevent blood from flowing out of the cavity.

[0008] Embodiments herein also relate to a transcatheter valve prosthesis comprising a stent, a prosthetic valve component, and a paravalvular leakage prevention component. The stent includes a radially compressible configuration for delivery within a vascular system and a radially expandable configuration for deployment within an autologous heart valve. The prosthetic valve component is disposed within and coupled to the stent. The paravalvular leakage prevention component is coupled to the stent. The paravalvular leakage prevention component includes an inner skirt, an outer envelope, a lumen, an opening, and a one-way duckbill valve. The inner skirt is formed of a flexible material and has an inlet end and an opposing downstream end. The inner skirt is disposed on an inner surface of the stent. The outer envelope is disposed around the outer surface of the stent and has an inlet end and an opposing downstream end, the inlet end being coupled to the inlet end of the inner skirt. The outer envelope is formed of a flexible material. A lumen is formed between the outer surface of the inner skirt and the inner surface of the outer envelope. Openings are provided between the inner skirt and the outer envelope at corresponding inlet ends of the inner skirt and / or corresponding downstream ends of the outer envelope. The one-way duckbill valve includes an inner flap and an outer flap. The inner flap is located near the opening and between the outer surface of the stent and the inner surface of the outer covering. The outer flap is located at the opening and between the outer surface of the stent and the inner surface of the outer covering. Both the inner and outer flaps are formed of a flexible material and are configured to open to allow blood to flow into the lumen but prevent blood from flowing out of the lumen. Attached Figure Description

[0009] The foregoing and other features and advantages of the invention will become apparent from the following description of embodiments illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, are further used to explain the principles of the invention and to enable those skilled in the art to make and use the invention. The drawings are not drawn to scale.

[0010] Figure 1 This is a perspective view of a prosthesis with anti-PVL components according to an embodiment of this document.

[0011] Figure 2 yes Figure 1 A top view of the prosthesis.

[0012] Figure 3 yes Figure 1 A perspective view of the inflow portion of the prosthesis.

[0013] Figure 4 yes Figure 1 Another perspective view of the inflow portion of the prosthesis, in which the structure within the anti-PVL component is shown in dashed lines.

[0014] Figure 5 yes Figure 1 A perspective view of the inflow portion of the prosthesis, in which the flaps of the valve are visible, and the outer covering has been removed for clarity.

[0015] Figure 6It is implanted within the annulus of an autologous aortic valve. Figure 1 A schematic cross-sectional view of the prosthesis.

[0016] Figure 7 yes Figure 1 A perspective view of the inflow portion of the prosthesis, in which the one-way valve of the anti-PVL component is open.

[0017] Figure 8 yes Figure 1 A perspective view of the inflow portion of the prosthesis, in which the one-way valve of the anti-PVL component is closed.

[0018] Figure 9A yes Figure 1 A perspective view of the inflow portion of the prosthesis, with a one-way valve located downstream of the anti-PVL component, and the valve component omitted for clarity.

[0019] Figure 9B yes Figure 9A A side view of the prosthesis.

[0020] Figure 10 yes Figure 1 A perspective view of the prosthesis, in which one-way valves are located at both the inlet and downstream ends of the PVL protection component.

[0021] Figure 11 This is a perspective view of a prosthesis with anti-PVL components according to another embodiment of this article.

[0022] Figure 12 yes Figure 11 Another perspective view of the prosthesis, in which the inner flap of the duckbill valve is shown in dashed lines.

[0023] Figure 12A yes Figure 11 Another perspective view of the prosthesis, in which the outer covering has been removed to show the inner flap of the duckbill valve for clarity.

[0024] Figure 13 yes Figure 11 Another perspective view of the prosthesis, in which the outer flap of the duckbill valve is shown in dashed lines.

[0025] Figure 13A yes Figure 11 Another perspective view of the prosthesis, in which the outer covering has been removed to show the outer flap of the duckbill valve for clarity.

[0026] Figure 14 yes Figure 11 A perspective view of the inflow portion of the prosthesis, with the duckbill valve open.

[0027] Figure 15 yes Figure 11 A perspective view of the inflow portion of the prosthesis, with the duckbill valve closed. Detailed Implementation

[0028] Specific embodiments of the invention will now be described with reference to the accompanying drawings, wherein like reference numerals denote like or functionally similar elements. In the following description, the terms "distal" and "proximal" are used with respect to position or direction relative to blood flow. "Distal" and "towards distal" refer to positions in the downstream direction relative to the direction of blood flow. "Proximal" and "towards proximal" refer to positions in the upstream direction relative to the direction of blood flow.

[0029] The following detailed description is exemplary in nature only and is not intended to limit the invention or its application and uses. Although the embodiments described herein are in the context of treating autologous heart valves such as the aortic valve, the invention can also be used in other heart valve locations and any other bodily pathways where it is considered useful. Furthermore, it is not intended to be limited by any explicit or implied theory present in the foregoing technical field, background art, summary of the invention, or the following detailed description.

[0030] The transcatheter valve prosthesis according to embodiments herein includes a valve prosthesis and a paravalvular leak (PVL) prevention component. The PVL prevention component is typically tissue-formed and highly compressible into a low profile for transcatheter delivery to the desired treatment site. The PVL prevention component is typically positioned at the inlet end of the transcatheter valve prosthesis and includes an inner layer or inner skirt and an outer layer or outer covering, thereby forming a lumen between the outer and inner layers accessible via a one-way valve that allows blood to flow into the lumen but not out. When the lumen is filled with blood, the outer layer expands or dilates radially outward to fill the gaps along the periphery of the transcatheter valve prosthesis and autologous anatomy when the transcatheter valve prosthesis is in a radially expanded configuration at the desired treatment site. Once the lumen is filled with blood, the PVL prevention component is dynamically stable, and the blood pooling within the PVL prevention component will coagulate.

[0031] exist Figure 1 In the illustrated embodiment, the transcatheter valve prosthesis 100 (hereinafter referred to as prosthesis 100 for simplicity) includes a generally tubular stent 102, a prosthesis valve component 104 (hereinafter referred to as valve component 104 for simplicity), and a paravalvular leak prevention component 106 (hereinafter referred to as anti-PVL component 106 for simplicity). The prosthesis 100 is configured to replace and replicate the function of an autologous heart valve.

[0032] In the embodiments described herein, stent 102 has a radially compressible configuration for delivery and a radially expandable configuration for deployment within an autologous heart valve. In some embodiments, stent 102 is a self-expanding frame configured to return from the radially compressible configuration to the radially expandable configuration. In other embodiments, stent 102 may be a balloon-expandable frame that plastically deforms upon expansion from the radially compressible configuration via a balloon or other expansion device to maintain the radially expandable configuration. Stent 102 includes an inflow segment 108 and an outflow segment 110, such as Figure 1 As shown. The stent 102 also includes a plurality of units 112 formed by a plurality of struts 114 arranged relative to each other to provide the prosthesis 100 with the desired compressibility and strength. The units 112 may have a size that varies along the length of the stent 102. The stent 102 may be formed of a variety of materials, including but not limited to stainless steel, nickel-titanium alloys (e.g., NITINOL), or other suitable materials. As used herein, “self-expanding” means a structure that has been formed or processed to have mechanical or shape memory to return to a radially expanding configuration. Mechanical or shape memory can be imparted to the structure forming the stent 102 using techniques known in the art. The stent 102 may take on different forms and features, for example, but not limited to those described in U.S. Patent 7,740,655 to Birdsall and U.S. Patent 8,128,710 to Nguyen et al., each of which is incorporated herein by reference in its entirety.

[0033] In the embodiments described herein, the valve component 104 is disposed within and secured to the tubular support 102. The valve component 104 may include a plurality of individual leaflets 116, which are assembled to mimic the leaflets of an autologous valve, such as… Figure 2 As best shown in the diagram, adjacent pairs of leaflets 116 are attached to each other at their lateral ends to form a commissure. Figure 2 (not shown in the image), wherein the free edges of leaflets 116 form clasping edges that meet in the clasping region, as described in U.S. Patent 8,128,710 to Nguyen et al., which is incorporated herein by reference in its entirety. Components of valve component 104 are formed of materials such as, but not limited to, mammalian tissues such as porcine pericardium, equine pericardium, or bovine pericardium, or synthetic or polymeric materials.

[0034] The PVL-proof component 106 is connected to the tubular support 102 and includes an inner layer or skirt 120, an outer layer or wrapping 122, and a cavity 124 (in Figure 3 The structure is covered by an outer covering 122, has multiple openings 126, and multiple one-way valves 128 (hereinafter referred to as valves 128 for simplicity), such as Figure 3As best shown. The anti-PVL component 106 is configured to fill and seal the gap between the prosthesis 100 and the autologous anatomical structure when the stent 102 is in a radially expanded configuration at the desired treatment location and the outer covering 122 of the anti-PVL component 106 is in an expanded state.

[0035] The inner skirt 120 includes a generally circular inlet end 130 and a downstream end 132 opposite to the inlet end 130, such as Figure 3 As shown. An inner skirt 120 is disposed on the inner surface of the support 102. A downstream end 132 is coupled to the support 102 and to the outer periphery of the leaflet 116. An inflow end 130 is coupled to the inflow end 136 of the outer covering 122 and the support 102, as described below. The inner skirt 120 is formed of a flexible material, such as, but not limited to, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g., porcine pericardium, equine pericardium, or bovine pericardium), or other materials suitable for the purposes described herein. The inflow end 130 of the inner skirt 120 can be coupled to the downstream end 136 of the outer covering 122 and the support 102 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods. Similarly, the downstream end 132 of the inner skirt 120 can be coupled to the support 102 and the leaflet 116 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods. The inner skirt 120 is attached to the support 102 in a “tight” manner, such that the inner skirt 120 does not expand inward when the cavity 124 is filled, as described in more detail below. “Tight” means that the outer surface of the inner skirt 120 abuts the inner surface of the support 102 along its length. This arrangement can be achieved by having little or no slack between the downstream end 132 attachment and the inflow end 130 attachment of the inner skirt 120. This arrangement can also be achieved by having multiple attachments along the length of the inner skirt 120 between the inflow end 130 and the downstream end 132 between the inner skirt 120 and the support 102. As those skilled in the art will understand, other methods of keeping the inner skirt close to the inner surface of the support 102 can also be used.

[0036] Similarly, Figure 3As shown, the outer package 122 includes a generally circular inlet end 136 and an opposing downstream end 138. The outer package 122 also includes a radially contracted state when blood is not received within the lumen 124 and a radially expanded state when blood is received within the lumen 124, causing the outer package 122 to expand or radially expand. The outer package 122 is disposed around the outer surface of the tubular stent 102. As described below, the inlet end 132 of the outer package 122 is coupled to the inlet end 130 of the inner package 120. The downstream end 138 of the outer package 122 is coupled to the stent 102. The outer package 122 is sized such that it has sufficient available material or is relaxed to expand radially outward to a radially expanded state. The outer package 122 may be formed of a flexible and expandable material, such as, but not limited to, silicone, polybutadiene, polyurethane, nylon, natural tissue (e.g., porcine pericardium, equine pericardium, or bovine pericardium), or other materials suitable for the purposes described herein. Non-expandable materials can also be used and can be attached to the stent 102 more loosely than expandable materials. The inlet end 132 of the outer wrapping can be attached to the inlet end 130 of the inner skirt 122 and the tubular stent 102 by means of, but not limited to, sutures, laser or ultrasonic welding or suitable external methods. The downstream end 132 of the outer wrapping 122 can be attached to the tubular stent 102 by means of, but not limited to, sutures, laser or ultrasonic welding or suitable external methods.

[0037] Cavity 124 is therefore formed between the outer surface of the inner skirt 120 and the inner surface of the outer covering 122. For example... Figure 3 As shown, cavity 124 is configured to receive blood through multiple valves 128 at multiple openings 126.

[0038] Similarly, Figure 3As shown, the PVL protection component 106 includes a plurality of openings 126 located between the inner skirt 120 and corresponding plurality of valves 128. In one embodiment, each opening 126 is respectively located at the inflow ends 130, 136 of the inner skirt 120 and the outer cover 122, between the inner skirt 120 and the outer cover 122. Each opening 126 is configured to allow blood flow to the corresponding valve 128 of the PVL protection component 106. Each opening 126 is formed by a cut portion 142 of the inner skirt 120. A first edge 144 and a second edge 146 of each cut portion of the inner skirt 120 are coupled to the inner surface of the support 102 such that each cut portion 142 of the inner skirt 120 is located downstream of the inflow end 136 of the outer cover 122. Therefore, the first edge 144 and the second edge 146 of the incision portion 142 follow the shape of the unit of the stent 102, and the first edge 144 and the second edge 146 are attached to the inner surface of the stent 102 to prevent blood from flowing between the stent 102 and the first edge 144 and the second edge 146. Thus, each opening 126 is defined by the portion of the tubular stent 102 at the incision portion 142 of the inner skirt 120, the inflow end 130 of the inner skirt 120 at the incision portion 142, and the inner surface of the outer wrapping 122 at the incision portion 142. Although three (3) openings are shown equidistantly spaced at the inflow ends 130, 132 of the inner skirt 120 and the outer wrapping 122, respectively, this is not intended to be limiting, and more or fewer openings 126 may be used and provided at any suitable interval at the inflow ends 130, 136 and / or downstream ends 132, 138 of the inner skirt 120 and the outer wrapping 122.

[0039] Next reference Figure 4 and Figure 5 Each of the plurality of valves 128 includes a flap 148. Each flap 148 is generally rectangular in shape and is configured to open to allow blood to flow into the cavity 124 of the PVL protection member 106, and is further configured to close to prevent blood from flowing out of the cavity 124. The flap 148 of each valve 128 is disposed at a corresponding opening 126 of the inner skirt 120, between the outer surface of the support 102 and the inner surface of the outer covering 122. Each flap 148 includes a first end 150 and a second end 152, the first end being coupled to the inflow end 136 of the outer covering 122 at the cut portion 142 of the corresponding opening 126. Each flap 148 is sized to cover the cut portion 142. The portion of the flap 148 spaced apart from the first end 150 extends on the strut 114 of the support 102 defining the opening 126 and is coupled to the inner skirt 120 such that the flap 148 is in a tensioned state and biased to a closed state. More precisely, the first corner 154 and the second corner 156 of the second end 152 of the petal 148 are connected to the inner skirt 120, as shown in the image. Figure 5As shown. Each flap 148 may be formed of a flexible material, such as, but not limited to, silicone, polybutadiene, polyurethane, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g., porcine pericardium, equine pericardium, or bovine pericardium), or other materials suitable for the purposes described herein. The first end 150 of each flap 148 may be attached to the outer covering 122 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods. Although described as separate components, each flap 148 is alternatively shaped as an integral part of the inflow end 136 of the outer covering 122, which extends from the inflow end 132 and folds during assembly to form the flap 148. The first corner 154 and the second corner 156 of the flap 148 may be attached to the inner skirt 120 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods.

[0040] Having understood the components of prosthesis 100, their interactions can now be described to seal prosthesis 100 at desired treatment sites such as autologous aortic valves, as... Figure 6 As shown. The prosthesis 100 is delivered and deployed at the desired treatment site using established procedures. As used herein, “deployment” means that the prosthesis 100 is positioned at the annulus AN of the desired autologous heart valve (such as the autologous aortic valve AV), and the tubular stent 102 is in a radially expanded configuration. However, in some patients, the radial expansion of the tubular stent 102 may not perfectly conform to the shape of the wall of the autologous heart valve. Therefore, as... Figure 7 As best illustrated, once the prosthesis 100 is deployed in the desired treatment position, during the systole, blood is forced through the valve component 104 of the prosthesis 100 (in... Figure 7-8 (Not visible in the image). The higher pressure on the inner surface of the flap 148 relative to the pressure on the outer surface of the flap 148 within the cavity 124 pushes the flap 148 outward. More specifically, portions of the flap 148 between the inflow end 132 of the outer covering 122 and the first bend 154, between the first bend 154 and the second bend 156, and between the second bend 156 and the inflow end 132 of the outer covering 122 are pushed outward, thereby creating gaps at these locations between the inner surface of the flap 148 and the outer surface of the support 102. These gaps allow blood BF to flow into the cavity 124 of the anti-PVL component 106. The blood BF entering the cavity 124 causes the outer covering 122 to expand radially outward or to a radially expanded state. As the outer covering 122 expands or extends to a radially expanded state, the outer covering 122 of the anti-PVL component 106 conforms to or fills the gaps in the shape of the autologous anatomical structure, thereby preventing blood flow between the walls of the prosthesis 100 and the autologous aortic valve AV. Figure 6As shown. It should be understood that once the pressure inside cavity 124 equals the pressure outside cavity 124, blood will stop flowing into cavity 124.

[0041] When the heart relaxes and the pressure outside chamber 124 decreases, the valve component 104 of the prosthesis 100 (in) Figure 7-8 (Not visible in the middle) closes to prevent upstream backflow or reflux, and the relatively large pressure within cavity 124 pushes valve 148 radially inward against the outer surface of support 102 and inner skirt 120. The radial inward movement of valve 148 closes valve 128 and prevents blood BF from flowing out of cavity 124, as... Figure 8 As shown.

[0042] Furthermore, once cavity 124 is filled with blood BF, it becomes dynamically stable to minimize movement of the prosthesis 100 at the desired treatment location and promote healing and inward ingrowth. Further, over time, the blood trapped within cavity 124 will coagulate to form a permanent seal between the walls of the prosthesis 100 and the autologous anatomy. In other words, due to the one-way valve 128, cavity 124 will not pulsate between larger and smaller radial dimensions. Instead, cavity 124 will fill to radial expansion and then remain radially expanded.

[0043] Although it is described herein that the support 102 has three (3) openings 126 and three corresponding valves 128 at the inlet end 108, this is not intended to be limiting, and it should be understood that more or fewer openings 126 and corresponding valves 128 may be used. Furthermore, it should be understood that the valves 128 may be located at other locations of the PVL protection component, some of which are described below as non-limiting examples.

[0044] In alternative configurations, such as Figure 9A and Figure 9B As shown, multiple valves 128' are respectively disposed at the downstream ends 132 and 138 of the inner skirt 120 and the outer covering 122. In one embodiment, the valves 128' may be formed similarly to valves 128, except at the downstream ends of the inner skirt 120 and the outer covering 132. In another embodiment, the inner skirt 120 and the outer covering 132 are single pieces surrounding the upstream end of the support 102, such as... Figure 9B As shown. The downstream end 132 of the inner skirt 120 is connected to the inner surface of the support 102, and the downstream end 138 of the outer cover 122 is connected to the support 102. An opening 126' is formed at a location where a portion of the inner skirt 120 is not connected to the inner surface of the support 102. Therefore, each opening 126' is respectively provided at the downstream ends 132 and 138 of the inner skirt 120 and the outer cover 122, between the inner skirt 120 and the outer cover 122. Each opening 126' is configured to allow blood flow to a corresponding valve 128' of the anti-PVL component 106.

[0045] Each valve 128' includes a flap 148'. Each flap 148' includes a first end 150' and a second end 152', the first end being coupled at an opening 126' to a downstream end 138 of the outer covering 122. As described above, each flap 148' may be integral with the outer covering 122 and folded back and tucked between the outer covering 122 and the support 102 in an upstream direction. The portion of each flap 148' spaced apart from the first end 150' (in this example, a first bend 154' and a second bend 156' for the second end 152 of each flap 148') is coupled to the inner skirt 120.

[0046] For valves 128' respectively located at the downstream ends 132 and 138 of the inner skirt 120 and the outer wrapping 122, and with the prosthesis 100 delivered and deployed at the desired treatment location, the pressure at the inflow end 108 of the tubular stent 102 decreases as the heart relaxes. The relatively higher pressure at the downstream ends 132 and 138 of the inner skirt 120 and the outer wrapping 122, and more specifically on the inner surface of each flap 148' of each one-way valve 128', pushes each flap 148' outward toward the inner surface of the outer wrapping 122, thereby producing the effect described above. Figure 1-8 The gap described in the embodiment. The corresponding valve 128' therefore opens to allow blood to flow into the cavity 124 of the anti-PVL component 106. As blood enters the cavity 124, the outer covering 122 expands radially outward to a radially expanded state, and when the outer covering 122 expands radially, it conforms to the shape of the autologous anatomy to prevent blood from flowing between the walls of the prosthesis 100 and the autologous valve. When the heart contracts, blood is forced through the prosthesis 100 and the pressure outside the cavity 124 decreases. The relatively high pressure inside the cavity 124 pushes each flap 148' radially inward against the outer surface of the tubular support 102 and the inner skirt 120. Each flap 148' pushed radially outward closes the corresponding valve 128' and prevents blood from flowing out of the cavity 124.

[0047] Although multiple valves 128, 128' have been described as being respectively located at either the inflow end 130, 136 or the downstream end 132, 138 of the inner skirt 120 and the outer enclosure 122, this is not intended to be limiting. Valves 128, 128' can be used in any combination at both the inflow end 130, 136 and the downstream end 132, 138 of the inner skirt 120 and the outer enclosure 122, as... Figure 10 shown. Specifically, Figure 10The prosthesis 100 is shown, which has three (3) one-way valves 128 at the inflow ends 130, 136 of the inner skirt 120 and the outer wrapping 122, and three (3) one-way valves 128' at the downstream ends 132, 138 of the inner skirt 120 and the outer wrapping 122. Figure 10 Not all valves 128, 128' are shown because some valves are not visible due to their location on an unseen side of the stylist 100. Furthermore, for clarity, Figure 10 The prosthesis 100 with the outer covering 122 removed is shown. Figure 10 In this embodiment, valves 128 are evenly distributed around the circumference of the inflow end of the prosthesis 100, and valves 128' are evenly distributed around the downstream ends 132, 138 of the inner skirt 120 and the outer covering 122. However, this is not intended to be limiting, and any number of valves can be used, and these valves may or may not be evenly distributed around the circumference. Furthermore, Figure 10 Each inflow valve 128 is shown offset circumferentially from each downstream valve 128'. However, this is not intended to be limiting and other arrangements, such as circumferential alignment of valves 128 and 128', can be used.

[0048] According to another embodiment of this document, a transcatheter valve prosthesis 200 is in Figure 11 As shown in the diagram. The transcatheter valve prosthesis 200 (hereinafter referred to as prosthesis 200 for simplicity) includes a generally tubular stent 202, a prosthesis valve component 204 (hereinafter referred to as valve component 204 for simplicity), and a paravalvular leakage prevention component 206 (hereinafter referred to as anti-PVL component 206 for simplicity). The anti-PVL component 206 includes an inner skirt 220, an outer covering 222, and a lumen 224 (in... Figure 11 Invisible in the middle but Figure 12 (See image) Multiple openings 226 and corresponding multiple one-way duckbill valves 228. The stent 202, valve component 204, anti-PVL component 206, inner skirt 220, outer covering 222, cavity 224 and multiple openings 226 are similar to those of the stent 102, valve component 104, anti-PVL component 106, inner skirt 120, outer covering 122, cavity 124 and multiple openings 126 of the prosthesis 100. Therefore, the construction and alternatives of the tubular stent 202, valve component 204, anti-PVL component 206, inner skirt 220, outer covering 222, cavity 224 and multiple openings 226 will not be repeated. However, the prosthesis 200 differs from the prosthesis 100 in that the prosthesis 200 includes multiple one-way duckbill valves 228 at the multiple openings 226.

[0049] like Figure 11As shown, the PVL protection component 206 includes a plurality of openings 226 disposed between the inner skirt 220 and the corresponding plurality of valves 228. Although shown as three (3) openings 226 equidistantly spaced at the inflow end 230 of the inner skirt 220 and the inflow end 232 of the outer wrap 222, it should be understood that more or fewer openings 126 may be used. Furthermore, the plurality of openings 226 may be disposed at any suitable intervals at the inflow ends 230, 232 and / or downstream ends 236, 236 of the inner skirt 220 and the outer wrap 222.

[0050] Next reference Figure 12 and Figure 12A Each of the plurality of one-way duckbill valves 228 (hereinafter referred to as duckbill valve 228 for simplicity) includes as follows Figure 12A The inner lobe plate 248 is best shown in the middle and as shown in the middle. Figure 13A The outer flap 250 is best shown in the diagram. The inner flap 248 and corresponding outer flap 250 of each duckbill valve 228 are configured to open to allow blood to flow into the cavity 224 of the anti-PVL component 206. The inner flap 248 and corresponding outer flap 250 of each duckbill valve 228 are further configured to close to prevent blood from flowing out of the cavity 224. The inner flap 248 and outer flap 250 of each duckbill valve 228 may be formed of a flexible material, non-limiting examples of which include silicone, polybutadiene, polyurethane, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g., porcine pericardium, equine pericardium, or bovine pericardium), or other materials suitable for the purposes described herein.

[0051] The inner flap 248 of each duckbill valve 228 is positioned adjacent to the corresponding opening 226 between the outer surface of the bracket 202 and the inner surface of the outer covering 222, such as Figure 12 and Figure 12A As shown. Each inner flap 248 includes a first end 252 and an opposing second end 254, the first end being coupled to the inlet end 236 of the outer covering 222, adjacent to the cut portion 242 of the inner skirt 220. Each inner flap 248 also includes a first edge 256 and an opposing second edge 258, each of the first and second edges being attached along the strut 214 of the support 202. Figure 12 and Figure 12AAs shown, the inner flap 248 is angled toward the opening 226 in a first direction. The first end 252 can be attached to the outer covering 222, and the first edge 256 and the second edge 258 can be attached to the strut 214 of the support 202 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods. Although described as separate components, each inner flap 248 may alternatively be an integral part of the inner skirt 220, extending from the inflow end 230 of the inner skirt 220, and folded during assembly to form the inner flap 248.

[0052] Each duckbill valve 228 has its outer flap 250 positioned at a corresponding opening 226, located between the outer surface of the tubular support 202 and the inner surface of the outer covering 222. Figure 13 and Figure 13A As shown. Each outer flap 250 includes a first end 260 and an opposing second end 262, the first end being connected to the inlet end 236 of the outer covering 222 at the cut portion 242 of the inner skirt 220. Each outer flap 250 also includes a first edge 264 and a second edge 266, each of the first and second edges being connected to a corresponding strut 214 of the support 202. Figure 13 As shown by the dashed lines, the second edge 258 of the inner flap 248 is attached to the corresponding strut 214 of the stent 202 below the outer flap 250. Furthermore, the outer flap 20 is angled toward the inner flap 248 such that the outer flap 250 overlaps with the inner flap 248. In the illustrated embodiment, the overlap is in an overlapping region 268 defined by the first edge 264 of the outer flap 250, the second edge 258 of the inner flap 248, and the second ends 254, 262 of the inner flap 248 and the outer flap 250. Furthermore, the second ends 254, 262 of the inner flap 248 and the outer flap 250 are not attached to each other to allow blood flow through them, as explained in more detail below. The first end 260 can be attached to the outer covering 222, and the first edge 264 and the second edge 266 can be attached to the corresponding strut 214 of the stent 202 by means of, but not limited to, sutures, laser or ultrasonic welding, or suitable external methods. Although each outer flap 250 is described as a separate component, alternatively, each outer flap 250 may be an extension of the inflow end 232 of the outer wrapping 222, which is folded during assembly to form the outer flap 250.

[0053] The interactions of the components of prosthesis 200 can now be described to seal prosthesis 200 at the desired treatment location. The established procedure is used to deliver and deploy prosthesis 200 at the desired treatment location. Figure 14 As shown, once the prosthesis 200 is deployed in the desired treatment location and during systole, the heart contracts and forces blood through the valve component 204 of the prosthesis 200 (in Figure 14-15(Not visible in the image). Pressure on the inner surface of the outer flap 250 pushes each outer flap 250 outward, thereby opening the duckbill valve. The opened duckbill valve 228 allows blood flow (BF) between the corresponding inner flap 248 and outer flap 250, and into the cavity 224 of the anti-PVL component 206. More specifically, blood flows into the corresponding opening 226, through the corresponding strut 214 and the second edge 258 of the inner flap 248, through the overlapping area 268 between the inner flap 248 and the outer flap 250, and into the cavity 224 between the separated second ends 254, 262 of the inner flap 248 and the outer flap 250, as shown. Figure 14 As shown. Blood fills cavity 224 and causes the outer covering 222 to expand radially outward to a radially expanded state. The outer covering 222 conforms to the shape of the autologous anatomy and prevents blood from flowing between the prosthesis 200 and the autologous heart valve wall. (See next for reference.) Figure 15 When the heart relaxes, the pressure outside chamber 224 decreases, and the relatively high pressure inside chamber 224 closes the corresponding duckbill valve 228. More specifically, the pressure on the outer surface of the outer flap 250 pushes the outer flap 250 radially inward against the outer surfaces of the stent 202, the inner skirt 220, and the inner flap 248 to close the corresponding duckbill valve 228. The closed duckbill valve 228 prevents blood flow (BF) from leaving chamber 224.

[0054] When filled with blood-filled bromide (BF), cavity 224 becomes dynamically stable. This stability promotes healing and inward growth of the prosthesis 200 at the desired treatment site. Over time, the blood trapped within cavity 224 will coagulate to form a permanent seal between the walls of the prosthesis 200 and the autologous anatomy. In other words, due to the one-way valve 128, cavity 124 will not pulsate between larger and smaller radial dimensions. Instead, cavity 124 will fill to radial expansion and then remain radially expanded.

[0055] Although described herein as having three (3) openings 226 and three corresponding duckbill valves 228 at the inflow ends 230, 236 of the inner skirt 220 and the outer wrapping 222, it should be understood that more or fewer openings 226 and corresponding duckbill valves 228 may be used. Furthermore, the plurality of duckbill valves 228 may be located at the inflow ends 230, 236 and / or downstream ends 232, 238 of the inner skirt 220 and the outer wrapping 222 in any combination. When the plurality of duckbill valves are provided at the downstream ends 232, 238, the downstream end 232 of the inner skirt 220 is coupled to the inner surface of the tubular support 202, and the downstream end 238 of the outer wrapping 222 is coupled to the outer surface of the tubular support 202 along a common line, and the plurality of openings are formed at locations where a portion of the inner skirt 220 is not attached to the inner surface of the support 202, as described above with reference to FIG9.

[0056] While various embodiments have been described above, it should be understood that they are presented as illustrative and exemplary of the invention and not as limitations. It will be apparent to those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. Therefore, the breadth and scope of the invention should not be limited to any of the exemplary embodiments described above, but should be defined solely by the appended claims and their equivalents. It should also be understood that each feature of each embodiment discussed herein and each feature of each reference cited herein can be used in combination with features of any other embodiments. All patents and publications discussed herein are incorporated herein by reference in their entirety.

Claims

1. A transcatheter valve prosthesis, comprising: A stent having a radially compressible configuration for delivery within a vascular system and a radially expandable configuration for deployment within an autologous heart valve; A prosthetic valve component, wherein the prosthetic valve component is disposed within the stent and fixed to the stent; as well as A valve leakage prevention component, connected to the bracket, the valve leakage prevention component comprising: An inner skirt, formed of a flexible material and disposed on the inner surface of the support, the inner skirt having an inflow end and an opposing downstream end; An outer wrapping, formed of a flexible material and disposed around the outer surface of the support, the outer wrapping having an inlet end and an opposite downstream end, the inlet end being connected to the inlet end of the inner skirt; A cavity formed between the outer surface of the inner skirt and the inner surface of the outer covering; An opening, wherein the opening is disposed between the inner skirt and the outer covering, the opening being formed by a cut portion of the inner skirt, and the opening being disposed at a corresponding inflow end of the inner skirt and the outer covering and / or a corresponding downstream end of the inner skirt and the outer covering; and A one-way valve includes a flap formed of a flexible material disposed at the opening and between the outer surface of the support and the inner surface of the outer covering. The flap is configured to open to allow blood to flow into the cavity but prevent blood from flowing out of the cavity, wherein when the one-way valve is closed, the flap is pushed radially inward against the outer surface of the support and the inner skirt.

2. The transcatheter valve prosthesis according to claim 1, wherein the anti-valve leakage component includes a plurality of openings located between the inner skirt and the corresponding plurality of one-way valves.

3. The transcatheter valve prosthesis of claim 1, wherein the inflow end of the inner skirt and the outer wrapping is circular, and wherein the opening is formed by a cut portion of the inflow end of the inner skirt, the cut portion being attached to the inner surface of a portion of the stent such that the cut portion of the inflow end of the inner skirt is downstream of the inflow end of the outer wrapping.

4. The transcatheter valve prosthesis of claim 3, wherein the opening is defined by a portion of the stent at the incision portion of the inner skirt, the inflow end of the inner skirt at the incision portion, and the inner surface of the outer covering at the incision portion of the inner skirt.

5. The transcatheter valve prosthesis of claim 4, wherein the first end of the flap of the one-way valve is connected to the inflow end of the outer wrapping at the incision portion of the inner skirt.

6. The transcatheter valve prosthesis of claim 5, wherein a portion of the valve spaced apart from the first end of the valve is attached to the inner skirt.

7. The transcatheter valve prosthesis of claim 1, wherein the downstream end of the inner skirt is coupled to the inner surface of the stent, and the downstream end of the outer cover is coupled to the outer surface of the stent, such that the downstream ends of the inner skirt and the outer cover are coupled to the stent along a common line, wherein the opening is formed at a location where a portion of the inner skirt is not attached to the inner surface of the stent.

8. The transcatheter valve prosthesis of claim 7, wherein the first end of the flap of the one-way valve is coupled at the opening to the downstream end of the outer covering.

9. The transcatheter valve prosthesis of claim 5, wherein a portion of the valve spaced apart from the first end of the valve is attached to the inner skirt.

10. A transcatheter valve prosthesis, comprising: A stent having a radially compressible configuration for delivery within a vascular system and a radially expandable configuration for deployment within an autologous heart valve; A prosthetic valve component, wherein the prosthetic valve component is disposed within the stent and fixed to the stent; as well as A valve leakage prevention component, connected to the bracket, the valve leakage prevention component comprising: An inner skirt, formed of a flexible material, surrounds the inner surface of the support and has an inflow end and an opposite downstream end; An outer wrapping, formed of a flexible material, is disposed around the outer surface of the support and has an inlet end and an opposite downstream end, the inlet end being connected to the inlet end of the inner skirt; A cavity formed between the outer surface of the inner skirt and the inner surface of the outer covering; An opening, wherein the opening is disposed between the inner skirt and the outer covering, the opening being formed by a cut portion of the inner skirt, and the opening being disposed at a corresponding inflow end of the inner skirt and the outer covering and / or a corresponding downstream end of the inner skirt and the outer covering; and A one-way duckbill valve includes an inner flap and an outer flap formed of a flexible material, the inner flap being disposed adjacent to the opening and the outer flap being disposed at the opening, the inner flap and the outer flap being disposed between the outer surface of the tubular support and the inner surface of the outer covering, the inner flap and the outer flap being configured to allow blood to flow into the cavity but prevent blood from flowing out of the cavity, wherein when the one-way duckbill valve is closed, the outer flap is pushed radially inward against the support, the outer surface of the inner skirt and the outer surface of the inner flap.

11. The transcatheter valve prosthesis of claim 10, wherein the anti-perivalve leakage component includes a plurality of openings located between the inner skirt and a plurality of corresponding one-way duckbill valves.

12. The transcatheter valve prosthesis of claim 10, wherein the inflow end of the inner skirt and the outer wrapping is circular, and wherein the opening is formed by a cut portion of the inflow end of the inner skirt, the cut portion being attached to the inner surface of a portion of the stent such that the cut portion of the inflow end of the inner skirt is downstream of the inflow end of the outer wrapping.

13. The transcatheter valve prosthesis of claim 12, wherein the opening is defined by a portion of the stent at the incision portion of the inner skirt, the inflow end of the inner skirt at the incision portion, and the inner surface of the outer covering at the incision portion of the inner skirt.

14. The transcatheter valve prosthesis of claim 13, wherein the first end of the inner flap of the one-way duckbill valve is connected to the inflow end of the outer wrapping, adjacent to the incision portion of the inner skirt.

15. The transcatheter valve prosthesis of claim 14, wherein a first edge of the inner valve flap is coupled to the tubular stent, and an opposing second edge of the inner valve flap is coupled to the tubular stent.

16. The transcatheter valve prosthesis of claim 13, wherein the first end of the outer flap of the one-way duckbill valve is connected to the inflow end of the outer wrapping at the incision portion of the inner skirt.

17. The transcatheter valve prosthesis of claim 16, wherein a first edge of the outer flap is coupled to the tubular stent, and a opposing second edge of the inner flap is coupled to the tubular stent.

18. The transcatheter valve prosthesis of claim 10, wherein the downstream end of the inner skirt is coupled to the inner surface of the stent, and the downstream end of the outer wrapping is coupled to the outer surface of the stent, such that the downstream ends of the inner skirt and the outer wrapping are coupled to the stent along a common line, wherein the opening is formed at a location where a portion of the inner skirt is not attached to the inner surface of the stent.

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