Patent Publication Number: US-2023149160-A1

Title: Prosthesis with anti-paravalvular leakage component including a one-way valve

Description:
FIELD OF THE INVENTION 
     The invention relates generally to prostheses for intervascular delivery. More particularly, the present invention relates to valve prostheses with an anti-paravalvular leakage component to assist in the prevention of paravalvular leakage at the deployed valve prosthesis. 
     BACKGROUND OF THE INVENTION 
     The human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle. The four main chambers include the right atria and right ventricle which supplies the pulmonary circulation, and the left atria and left ventricle which supplies oxygenated blood received from the lungs to the remaining body. To ensure that blood flows in one direction through the heart, atrioventricular valves (tricuspid and mitral valves) are present between the junctions of the atria and the ventricles, and semi-lunar valves (pulmonary valve and aortic valve) govern the exits of the ventricles leading to the lungs and the rest of the body. These valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers. The leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream direction. 
     Diseases associated with heart valves, such as those caused by damage or a defect, can include stenosis and valvular insufficiency or regurgitation. For example, valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve. Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient. A diseased or damaged valve, which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency. Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening. 
     Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such valve prostheses can be percutaneously delivered while in a low-profile or radially compressed configuration so that the valve prosthesis can be advanced through the patient&#39;s vasculature and deployed at the site of the diseased heart valve through catheter-based systems. Once positioned at the treatment site, the valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the valve prosthesis in position. 
     However, in some patients, the valve prosthesis may not perform as desired following implantation. For example, in some patients, the radial expansion of the valve prosthesis may not conform to the shape of the wall of the native valve. This situation may occur when the wall of the native valve is misshapen or heavily calcified. In such cases where the valve prosthesis is not fully coapted to the wall of the native valve, paravalvular leakage (PVL) may occur between the valve prosthesis and the wall of the native valve, and high levels of PVL are associated with increased mortality. 
     Accordingly, there is a need for systems and components to improve sealing of a valve prosthesis to a native valve wall, while maintaining a small compressed profile for percutaneous delivery. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments hereof are directed to a transcatheter valve prosthesis including a stent, a prosthetic valve component, and an anti-paravalvular leakage component. The stent includes a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within a native heart valve. The prosthetic valve component is disposed within and coupled to the stent. The anti-paravalvular leakage component is coupled to the stent. The anti-paravalvular leakage component includes an inner skirt, an outer wrap, a cavity, 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 wrap has an inflow end coupled to the inflow end of the inner skirt and an opposing downstream end. The outer wrap is disposed around an outer surface of the stent and is formed of a flexible material. The cavity is formed between an outer surface of the inner skirt and an inner surface of the outer wrap. An opening is disposed between the inner skirt and the outer wrap at the corresponding inflow ends of the inner skirt and the outer wrap and/or the corresponding downstream ends of the inner skirt and the outer wrap. The one-way valve includes a flap disposed at the opening and between the outer surface of the stent and an inner surface of the outer wrap. The flap is formed of a flexible material and is configured to open to allow blood flow into the cavity but prevent blood flow out of the cavity. 
     Embodiments hereof are also directed to a transcatheter valve prosthesis including a stent, a prosthetic valve component, and an anti-paravalvular leakage component. The stent includes a radially compressed configuration for delivery within a vasculature and a radially expanded configuration for deployment within a native heart valve. The prosthetic valve component is disposed within and coupled to the stent. The anti-paravalvular leakage component is coupled to the stent. The anti-paravalvular leakage component includes an inner skirt, an outer wrap, a cavity, an opening, and a one-way duckbill valve. The inner skirt is formed of a flexible material and has an inflow end and an opposing downstream end. The inner skirt is disposed on an inner surface of the stent. The outer wrap is disposed around an outer surface of the stent and has an inflow end coupled to the inflow end of the inner skirt and an opposing downstream end. The outer wrap and is formed of a flexible material. The cavity is formed between an outer surface of the inner skirt and an inner surface of the outer wrap. An opening is disposed between the inner skirt and the outer wrap at the corresponding inflow ends of the inner skirt and the outer wrap and/or the corresponding downstream ends of the inner skirt and the outer wrap. The one-way duckbill valve includes an inner flap and an outer flap. The inner flap is disposed adjacent the opening and between the outer surface of the stent and an inner surface of the outer wrap. The outer flap is disposed at the opening and between the outer surface of the stent and an inner surface of the outer wrap. The inner and the outer flaps are each formed of a flexible material and are configured to open to allow blood flow into the cavity but prevent blood flow out of the cavity. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments thereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale. 
         FIG.  1    is a perspective illustration of a prosthesis with an anti-PVL component according to an embodiment hereof. 
         FIG.  2    is a top illustration of the prosthesis of  FIG.  1   . 
         FIG.  3    is a perspective illustration of an inflow portion of the prosthesis of  FIG.  1   . 
         FIG.  4    is another perspective illustration of the inflow portion of the prosthesis of  FIG.  1   , with the structure within an anti-PVL component is shown in phantom. 
         FIG.  5    is a perspective illustration of the inflow portion of the prosthesis of  FIG.  1   , wherein a flap of a valve is visible and the outer wrap has been removed for clarity. 
         FIG.  6    is a schematic sectional illustration of the prosthesis of  FIG.  1    implanted within an annulus of a native aortic valve. 
         FIG.  7    is a perspective illustration of the inflow portion of the prosthesis of  FIG.  1   , with the one-way valve of the anti-PVL component open. 
         FIG.  8    is a perspective illustration of the inflow portion of the prosthesis of  FIG.  1   , with the one-way valve of the anti-PVL component closed. 
         FIG.  9 A  is a perspective illustration of the inflow portion of the prosthesis of  FIG.  1   , with one-way valves disposed at the downstream end of the anti-PVL component and the valve component omitted for clarity. 
         FIG.  9 B  is a side illustration of the prosthesis of  FIG.  9 A . 
         FIG.  10    is a perspective illustration of the prosthesis of  FIG.  1   , with one-way valves disposed at both the inflow and downstream ends of the anti-PVL component. 
         FIG.  11    is a perspective illustration of a prosthesis with an anti-PVL component according to another embodiment hereof. 
         FIG.  12    is another perspective illustration of the prosthesis of  FIG.  11   , with an inner flap of a duckbill valve shown in phantom. 
         FIG.  12 A  is another perspective illustration of the prosthesis of  FIG.  11   , with the outer wrap removed for clarity to show the inner flap of the duckbill valve. 
         FIG.  13    is another perspective illustration of the prosthesis of  FIG.  11   , with an outer flap of the duckbill valve shown in phantom. 
         FIG.  13 A  is another a perspective illustration of the prosthesis of  FIG.  11   , with the outer wrap removed for clarity to show the outer flap of the duckbill valve. 
         FIG.  14    is a perspective illustration of the inflow portion of the prosthesis of  FIG.  11   , with the duckbill valve opened. 
         FIG.  15    is a perspective illustration of the inflow portion of the prosthesis of  FIG.  11   , with the duckbill valve is closed. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to blood flow. “Distal” and “distally” refer to positions in the downstream direction with respect to the direction of blood flow. “Proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow. 
     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of embodiments hereof are in the context of treatment of a native heart valve such as an aortic valve, the invention may also be used at other heart valve locations and in any other body passageways where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. 
     A transcatheter valve prosthesis in accordance with embodiments hereof includes a valve prosthesis) and an anti-paravalvular leakage (PVL) component. The anti-PVL component is generally formed of tissue and is highly compressible to a low profile for transcatheter delivery to a desired treatment location. The anti-PVL component is generally disposed at the inflow end of the transcatheter valve prosthesis and includes an inner layer or skirt, and an outer layer or wrap forming a cavity between the outer and inner layers accessible via a one-way valve allowing blood to flow into the cavity but not out of the cavity. When the cavity is filled with blood, the outer layer distends or expands radially outward to fill in gaps along the perimeter of the transcatheter valve prosthesis and a native anatomy when the transcatheter valve prosthesis is in the radially expanded configuration at the desired treatment location. Once the cavity is filled with blood, the anti-PVL component is dynamically stable, and the pooled blood within the anti-PVL component will clot. 
     In an embodiment shown in  FIG.  1   , a transcatheter valve prosthesis  100  (hereafter referred to as prosthesis  100  for simplicity) includes a generally tubular stent  102 , a prosthetic valve component  104  (hereafter referred to as valve component  104  for simplicity), and an anti-paravalvular leakage component  106  (hereafter referred to as anti-PVL component  106  for simplicity). The prosthesis  100  is configured to replace and replicate the function of a native heart valve. 
     In embodiments hereof, the stent  102  has a radially compressed configuration for delivery and a radially expanded configuration for deployment within a native heart valve. In some embodiments, the stent  102  is a self-expanding frame configured to return to a radially expanded configuration from a radially compressed configuration. In other embodiments, the stent  102  may be a balloon expandable frame that plastically deforms to maintain a radially expanded configuration when expanded by a balloon or other expansion device from a radially compressed configuration. The stent  102  includes an inflow section  108  and an outflow section  110 , as shown in  FIG.  1   . The stent  102  further includes a plurality of cells  112  formed by a plurality of struts  114  arranged relative to each other to provide a desired compressibility and strength to the prosthesis  100 . The cells  112  may have sizes that vary along the length of the stent  102 . The stent  102  may be formed of various materials including, but not limited to stainless steel, nickel-titanium alloys (e.g. NITINOL), or other suitable materials. “Self-expanding” as used herein means that a structure has been formed or processed to have a mechanical or shape memory to return to the radially expanded configuration. Mechanical or shape memory may be imparted to the structure that forms the stent  102  using techniques understood in the art. The stent  102  may assume different forms and features described, for example, but not by way of limitation, in U. S. Pat. No. 7,740,655 to Birdsall, and U.S. Pat. No. 8,128,710 to Nguyen et al., each of which is incorporated by reference herein in its entirety. 
     In embodiments hereof, the valve component  104  is disposed within and secured to the tubular stent  102 . The valve component  104  may comprises a plurality of individual leaflets  116  assembled to simulate the leaflets of a native valve, as best shown in  FIG.  2   . Adjoining pairs of the leaflets  116  are attached to one another at their lateral ends to form commissures (not shown in FIG.,  2 ), with free edges of the leaflets  116  forming coapted edges that meet in an area of coaptation, as described in U.S. Pat. No. 8,128,710 to Nguyen et al., previously incorporated by reference herein in its entirety. The components of the valve component  104  are formed of materials such as, but not limited to mammalian tissue such as porcine, equine or bovine pericardium, or a synthetic or polymeric material. 
     The anti-PVL component  106  is coupled to the tubular stent  102  and includes an inner layer or skirt  120 , an outer layer or wrap  122 , a cavity  124  (obscured from view by the outer wrap  122  in  FIG.  3   ), a plurality of openings  126 , and a plurality of one-way valves  128  (hereafter referred to as valves  128  for simplicity), as best shown in  FIG.  3   . The anti-PVL component  106  is configured to fill in and seal gaps between the prosthesis  100  and the native anatomy when the stent  102  is in the radially expanded configuration at a desired treatment location and the outer wrap  122  of the anti-PVL component  106  is in an expanded state. 
     The inner skirt  120  includes a generally circular inflow end  130 , and a downstream end  132  opposite the inflow end  130 , as shown in  FIG.  3   . The inner skirt  120  is disposed on an inner surface of the stent  102 . The downstream end  132  is coupled to the stent  102  and to the outer perimeter of the leaflets  116 . The inflow end  130  is coupled to an inflow end  136  of the outer wrap  122  and the stent  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, equine, or bovine pericardium), or other materials suitable for the purposes described herein. The inflow end  130  of the inner skirt  120  may be coupled to the downstream end  136  of the outer wrap  122  and the stent  102  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. Similarly, the downstream end  132  of the inner skirt  120  may be coupled to the stent  102  and leaflets  116  in a manner such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. The inner skirt  120  is attached to the stent  102  in a “tight” manner such that the inner skirt  120  does not expand inwardly when the cavity  124  is filled, as described in more detail below. By a “tight” manner, it is meant that an outer surface of the inner skirt  120  abuts an inner surface of the stent  102  along the length of the inner skirt  120 . This arrangement can be accomplished by having little or no slack in the inner skirt  120  between the downstream end  132  attachment and the inflow end  130  attachment. It can also be accomplished by having multiple attachments between the inner skirt  120  and the stent  102  along the length of the inner skirt  120  between the inflow end  130  and the downstream end  132 . Other ways to maintain the inner skirt tight against the inner surface of the stent  102  may also be used, as would be understood by those skilled in the art. 
     Also shown in  FIG.  3   , the outer wrap  122  includes the generally circular inflow end  136  and an opposing downstream end  138 . The outer wrap  122  further includes a radially contracted state when blood is not received within the cavity  124  and the radially expanded state when blood is received within the cavity  124  and distends or radially expands the outer wrap  122 . The outer wrap  122  is disposed around an outer surface of the tubular stent  102 . The inflow end  132  of the outer wrap  122  is coupled to the inflow end  130  of the inner wrap  120  as described below. The downstream end  138  of the outer wrap  122  is coupled to the stent  102 . The outer wrap  122  is sized such that the outer wrap  122  has sufficient material available or slack to distend radially outward to the radially expanded state. The outer wrap  122  may be formed of a flexible and expandable material such as, but not limited to silicone, chronoprene, urethane, nylon, natural tissue (e.g. porcine, equine, or bovine pericardium), or other materials suitable for the purposes described herein. Non-expandable materials may also be used and may be attached more loosely to the stent  102  than an expandable material would be. The inflow end  132  of the outer wrap may be coupled to the inflow end  130  of the inner skirt  122  and the tubular stent  102  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. The downstream end  132  of the outer wrap  122  may be coupled to the tubular stent  102  in a manner such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. 
     The cavity  124  is thus formed between the between an outer surface of the inner skirt  120  and an inner surface of the outer wrap  122 . The cavity  124  is configured to receive blood through the plurality of valves  128  at the plurality of openings  126 , as shown in  FIG.  3   . 
     As also shown in  FIG.  3   , the anti-PVL component  106  includes the plurality of openings  126  between the inner skirt  120  and the corresponding plurality of valves  128 . In an embodiment, each opening  126  is disposed at the inflow ends  130 ,  136  of the inner skirt  120  and the outer wrap  122 , respectively, between the inner skirt  120  and the outer wrap  122 . Each opening  126  is configured to allow blood flow to the corresponding valve  128  of the anti-PVL component  106 . Each opening  126  is formed by a cut-out portion  142  of the inner skirt  120 . A first edge  144  and a second edge  146  of each cutout portion of the inner skirt  120  is coupled to the inner surface of the stent  102  such that each cut-out portion  142  of the inner skirt  120  is disposed downstream of the inflow end  136  of the outer wrap  122 . Thus the first and second edges  144 ,  146  of the cut-out portion  142  follow the shape of a cell of the stent  102  and the first and second edges  144 ,  146  are attached to the inner surface of the stent  102  to prevent blood flow between the stent  102  and the first and second edges  144 ,  146 . Thus, each opening  126  is defined by a portion of the tubular stent  102  at the cut-out portion  142  of the inner skirt  120 , the inflow end  130  of the inner skirt  120  at the cut-out portion  142 , and an inner surface of the outer wrap  122  at the cut-out portion  142 . While shown as three (3) openings spaced equally at the inflow ends  130 ,  132  of the inner skirt  120  and the outer wrap  122 , respectively, this is not meant to be limiting, and more or fewer opening  126  may be utilized and disposed with any suitable spacing at the inflow ends  130 ,  136  and/or the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122 . 
     Referring next to  FIGS.  4  and  5   , each valve  128  of the plurality of valves  128  includes a flap  148 . Each flap  148  is a generally rectangular shape and is configured to open to allow blood flow into the cavity  124  of the anti-PVL component  106  and further configured to close to prevent blood flow from 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 stent  102  and the inner surface of the outer wrap  122 . Each flap  148  includes a first end  150  coupled to the inflow end  136  of the outer wrap  122  at the cut-out portion  142  of the corresponding opening  126  and a second end  152 . Each flap  148  is sized to cover the cut-out portion  142 . A portion of the flap  148  spaced from the first end  150  extends over the struts  114  of the stent  102  defining the opening  126  and is coupled to the inner skirt  120  such that the flap  148  is in tension and biased to a closed state. More precisely, a first corner  154  and a second corner  156  of the second end  152  of the flap  148  is coupled to the inner skirt  120 , as best seen in  FIG.  5   . Each flap  148  may be formed of a flexible material such as, but not limited to silicone, chronoprene, urethane, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g. porcine, equine, or bovine pericardium), or other materials suitable for the purposes described herein. The first end  150  of each flap  148  may be coupled to the outer wrap  122  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. While described as a separate component, each flap  148  may alternatively be formed as an integral portion of the inflow end  136  of the outer wrap  122  extending from the inflow end  132  and folded during assembly to form the flap  148 . The first corner  154  and the second corner  156  of the flap  148  may be coupled to the inner skirt  120   122  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. 
     With an understanding of the components of the prosthesis  100 , is now possible to describe their interaction to seal the prosthesis  100  at a desired treatment location, such as a native aortic valve, as shown in  FIG.  6   . The prosthesis  100  is delivered and deployed at the desired treatment location using established procedures. “Deployed” as used herein means that the prosthesis  100  is located at an annulus AN of a desired native heart valve, such as the native aortic valve AV, and the tubular stent  102  is in the radially expanded configuration. However, in some patients, the radial expansion of the tubular stent  102  may not fully conform to the shape of the wall of the native heart valve. Accordingly, and as best shown in  FIG.  7   , once the prosthesis  100  is deployed at the desired treatment location, during systole, blood is forced through the valve component  104  (not visible in  FIGS.  7 - 8   ) of the prosthesis  100 . 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 , forces the flap  148  outward. More particularly, the portions of the flap  148  between the inflow end  132  of the outer wrap  122  and the first corner  154 , between the first corner  154  and the second corner  156 , and between the second corner  156  and the inflow end  132  of the outer wrap  122  are forced outward, thereby creating a gaps between the inner surface of the flap  148  and the outer surface of the stent  102  at those locations. These caps permit blood BF to flow into the cavity  124  of the anti-PVL component  106 . Blood BF entering the cavity  124  distends or expands the outer wrap  122  radially outward to the radially expanded state. As the wrap  122  distends or expands to the radially expanded state, the outer wrap  122  of the anti-PVL component  106  conforms to or fills in gaps in the shape of the native anatomy, thereby preventing blood flow between the prosthesis  100  and the wall of the native aortic valve AV, as shown in  FIG.  6   . It will be understood that once pressure inside the cavity  124  is equal to the pressure outside the cavity  124 , blood will cease to flow into the cavity  124 . 
     When the heart relaxes and the pressure outside the cavity  124  decreases, the valve component  104  (not visible in  FIGS.  7 - 8   ) of the prosthesis  100  closes to prevent regurgitation or backflow upstream and the relatively greater pressure within the cavity  124  forces the flap  148  radially inward against the stent  102  and the outer surface of the inner skirt  120 . Movement of the flap  148  radially inward closes the flap  148  of the valve  128  and prevents blood BF from flowing out of the cavity  124 , as shown in  FIG.  8   . 
     Moreover, once the cavity  124  is filled with blood BF, the cavity  124  becomes dynamically stable to minimize movement of the prosthesis  100  at the desired treatment location and promote healing and ingrowth. Even further, over time, the blood trapped within the cavity  124  will clot to form a permanent seal between the prosthesis  100  and the wall of the native anatomy. In other words, due to the one way valves  128 , the cavity  124  will not pulse between a larger and smaller radial dimension. Instead, the cavity  124  will fill to radially expanded, and then stay radially expanded. 
     While described herein with three (3) openings  126  and three corresponding valves  128  at the inflow end  108  of the stent  102 , this is not meant to be limiting, and it will be understood that more or fewer openings  126  and corresponding valves  128  may be utilized. Moreover, it will be understood that the valves  128  may be disposed at other locations of the anti-PVL component, some non-limiting examples of which are described below. 
     In an alternate configuration, the plurality of valves  128 ′ are disposed at the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122  respectively, as shown in  FIGS.  9 A and  9 B . In an embodiment, the valves  128 ′ can be formed similar to the valves  128 , except at the downstream end of inner skirt  120  and outer wrap  132 . In another embodiment, the inner skirt  120  and the outer wrap  132  are a single piece that wraps around the upstream end of the stent  102 , as shown in  FIG.  9 B . The downstream end  132  of the inner skirt  120  is coupled to the inner surface of the stent  102  and the downstream end  138  of the outer wrap  122  is coupled to the stent  102 . An opening  126 ′ is formed where a portion of the inner skirt  120  is not coupled to the inner surface of the stent  102 . Accordingly, each opening  126 ′ is disposed at the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122 , respectively, between the inner skirt  120  and the outer wrap  122 . Each opening  126 ′ is configured to allow blood flow to the corresponding valve  128 ′ of the anti-PVL component  106 . 
     Each valve  128 ′ includes a flap  148 ′. Each flap  148 ′ includes a first end  150 ′ coupled to the downstream end  138  of the outer wrap  122  at the opening  126 ′ and a second end  152 ′. As explained above, each flap  148 ′ may be integral with the outer wrap  122  and folded back in an upstream direct and tucked between the outer wrap  122  and the stent  102 . A portion of each flap  148 ′ spaced from the first end  150 ′, in this example a first corner  154 ′ and a second corner  156 ′ of the second end  152  of each flap  148 ′, and is coupled to the inner skirt  120 . 
     For valves  128 ′ disposed at the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122 , respectively, and with the prosthesis  100  delivered and deployed at the desired treatment location, as the heart relaxes, pressure at the inflow end  108  of the tubular stent  102  decreases. The relatively higher pressure at the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122 , respectively, and more specifically on the inner surface of each flap  148 ′ of each one-way valve  128 ′, forces each flap  148 ′ outward towards the inner surface of the outer wrap  122 , thereby creating the gaps described above with respect to the embodiment of  FIGS.  1 - 8   . The corresponding valve  128 ′ is thusly opened to permit blood flow into the cavity  124  of the anti-PVL component  106 . The outer wrap  122  expands radially outward to the radially expanded state as blood enters the cavity  124 , and as the outer wrap  122  radially expands, the outer wrap  122  conforms to the shape of the native anatomy to prevent blood flow between the prosthesis  100  and the wall of the native valve. When the heart contracts, blood is forced through the prosthesis  100  and the pressure outside the cavity  124  decreases. The relatively greater pressure within the cavity  124  forces each flap  148 ′ radially inward against the tubular stent  102  and the outer surface of the inner skirt  120 . Each flap  148 ′ forced radially outward closes the corresponding valve  128 ′ and prevents blood from flowing out of the cavity  124 . 
     While the plurality of valves  128 ,  128 ′ have been described as disposed at either the inflow ends  130 ,  136  or the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122  respectively, this is not meant to be limiting and the valves  128 ,  128 ′ may be utilized at both the inflow ends  130 ,  136  and the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122  respectively, in any combination, as shown in  FIG.  10   . In particular,  FIG.  10    shows the prosthesis  100  with three (3) one-way valves  128  at the inflow ends  130 ,  136  of the inner skirt  120  and the outer wrap  122  and three (3) one-way valves  128 ′ at the downstream ends  132 ,  138  of the inner skirt  120  and the outer wrap  122 .  FIG.  10    does not show all of the valves  128 ,  128 ′ because some are hidden from view as being on the side of the prosthesis  100  that is not visible. Also,  FIG.  10    shows the prosthesis  100  with the outer wrap  122  removed for clarity. In the embodiment of  FIG.  10   , the valves  128  are evenly distributed around the circumference of the inflow end of the prosthesis  100  and the valves  128 ′ are evenly distributed around the downstream ends  132 ,  138  of the inner skirt  120  and outer wrap  122 . However, this is not meant be limiting and any number of valves may be used and they may or may not be evenly distributed around the circumference. Also,  FIG.  10    shows each inflow valve  128  circumferentially offset from each downstream valve  128 ′. However, this is not meant to be limiting and other arrangements by be utilized, such as the valves  128 ,  128 ′ circumferentially aligned. 
     A transcatheter valve prosthesis  200  according to another embodiment hereof is shown in  FIG.  11   . The transcatheter valve prosthesis  200  (hereafter referred to as prosthesis  200  for simplicity) includes a generally tubular stent  202 , a prosthetic valve component  204  (hereafter referred to as valve component  204  for simplicity), and an anti-paravalvular leakage component  206  (hereafter referred to as anti-PVL component  206  for simplicity). The anti-PVL component  206  includes an inner skirt  220 , an outer wrap  222 , a cavity  224  (not visible in  FIG.  11    but visible in  FIG.  12   ), a plurality of openings  226 , and a corresponding plurality of one-way duckbill valves  228 . The stent  202 , the valve component  204 , the anti-PVL component  206 , the inner skirt  220 , the outer wrap  222 , the cavity  224  and the plurality of openings  226  are similar to the stent  102 , the valve component  104 , the anti-PVL component  106 , the inner skirt  120 , the outer wrap  122 , the cavity  124  and the plurality of openings  126  of the prosthesis  100 . Therefore, construction and alternatives of the tubular stent  202 , the valve component  204 , the anti-PVL component  206 , the inner skirt  220 , the outer wrap  222 , the cavity  224 , and the plurality of openings  226  will not be repeated. However, the prosthesis  200  differs from the prosthesis  100  in that the prosthesis  200  includes a plurality of one-way duckbill valves  228  at the plurality of openings  226 . 
     As shown in  FIG.  11   , the anti-PVL component  206  includes the plurality of openings  226  are disposed between the inner skirt  220  and the corresponding plurality of valves  228 . While shown as three (3) openings  226  spaced equally at an inflow end  230  of the inner skirt  220  and an inflow end  232  of the outer wrap  222 , it will be understood that more or fewer openings  126  may be utilized. Additionally, the plurality of openings  226  may be disposed with any suitable spacing at the inflow ends  230 ,  232  and/or the downstream ends  236 ,  236  of the inner skirt  220  and the outer wrap  222 . 
     Referring next to  FIGS.  12  and  12 A , each one-way duckbill valve  228  of the plurality of one-way duckbill valves  228  (hereafter referred to as duckbill valve(s)  228  for simplicity) includes an inner flap  248 , as best shown in  FIG.  12 A , and an outer flap  250  as best shown in  FIG.  13 A . The inner flap  248  and the corresponding outer flap  250  of each duckbill valve  228  are configured to open to allow blood flow into the cavity  224  of the anti-PVL component  206 . The inner flap  248  and the corresponding outer flap  250  of each duckbill valve  228  are further configured to close to prevent blood flow from out of the cavity  224 . The inner and outer flaps  248 ,  250  of each duckbill valve  228  may be formed of a flexible material, non-limiting examples of which include silicone, chronoprene, urethane, polyester, nylon, expanded polytetrafluoroethylene (ePTFE), natural tissue (e.g. porcine, equine, or bovine pericardium), or other materials suitable for the purposes described herein. 
     The inner flap  248  of each duckbill valve  228  is disposed adjacent the corresponding opening  226 , between an outer surface of the stent  202  and an inner surface of the outer wrap  222 , as shown in FIGA.  12  and  12 A. Each inner flap  248  includes a first end  252  coupled to an inflow end  236  of the outer wrap  222 , adjacent a cut-out portion  242  of the inner skirt  220 , and an opposing second end  254 . Each inner flap  248  further includes a first edge  256  and an opposing second edge  258 , each attached along a strut  214  of the stent  202 . As can be seen in  FIGS.  12  and  12 A , the inner flap  248  is angled in a first direction towards the opening  226 . The first end  252  may be coupled to the outer wrap  222  and the first edge  256  and the second edge  258  may be coupled to the struts  214  of the stent  202  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable methods. While described as a separate component, each inner flap  248  may alternately be an integral portion of the inner skirt  220 , extending from the inflow end  230  of the inner skirt  220  folded to form the inner flap  248  during assembly. 
     The outer flap  250  of each duckbill valve  228  is disposed at the corresponding opening  226 , between then outer surface of the tubular stent  202  and the inner surface of the outer wrap  222 , as shown in  FIGS.  13  and  13 A . Each outer flap  250  includes a first end  260  coupled to an inflow end  236  of the outer wrap  222  at the cut-out portion  242  of the inner skirt  220  and an opposing second end  262 . Each outer flap  250  further includes a first edge  264  and a second edge  266  each coupled to corresponding struts  214  of the stent  202 . As can be seen in  FIG.  13    by the dashed line, the second edge  258  of the inner flap  248  is attached to the corresponding strut  214  of the stent  202  under the outer flap  250 . Further, the outer flap  20  is angled towards the inner flap  248  such that the outer flap  250  overlaps the inner flap  248 . In the embodiment shown, the overlap is in an overlap 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 and outer flaps  248 ,  250 . Further, the second ends  254 ,  262  of the inner and outer flaps  248 ,  250  are not attached to each other so as to permit blood flow therethrough, as explained in more detail below. The first end  260  may be coupled to the outer wrap  222  and the first edge  264  and the second edge  266  may be coupled to the corresponding struts  214  of the stent  202  by methods such as, but not limited to sutures, laser or ultrasonic welding, or outer suitable 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 wrap  222  folded to form the outer flap  250  during assembly. 
     It is now possible to describe interaction of the components of the prosthesis  200  to seal the prosthesis  200  at a desired treatment location. The prosthesis  200  is delivered and deployed at the desired treatment location using established procedures. As shown in  FIG.  14   , once the prosthesis  200  is deployed at the desired treatment location and during systole, the heart contracts and forces blood through the valve component  204  (not visible in  FIGS.  14 - 15   ) of the prosthesis  200 . Pressure on an inner surface of the outer flap  250  forces each outer flap  250  outward, thereby opening opens the duckbill valve. The open duckbill valve  228  permits blood BF to flow between the corresponding inner and outer flaps  248 ,  250  and into the cavity  224  of the anti-PVL component  206 . More particularly, blood flows into the corresponding opening  226 , over the corresponding strut  214  and second edge  258  of the inner flap  248 , between the inner flap  248  and the outer flap  250  in the overlap region  268 , and into the cavity  224  between the separated second ends  254 ,  262  of the inner and outer flaps  248 ,  250 , as shown in  FIG.  14   . Blood fills the cavity  224  and distends the outer wrap  222  radially outward to the radially expanded state. The outer wrap  222  conforms to the shape of the native anatomy and prevents blood flow between the prosthesis  200  and the wall of the native heart valve. With reference next to FIG,  15 , when the heart relaxes, the pressure decreases outside the cavity  224  and the relatively greater pressure inside the cavity  224  closes the corresponding duckbill valve  228 . More specifically, pressure on an outer surface of the outer flap  250  forces the outer flap  250  radially inward against the stent  202 , the outer surface of the inner skirt  220 , and an outer surface of the inner flap  248  to close the corresponding duckbill valve  228 . The closed duckbill valve  228  prevents blood BF from flowing out of the cavity  224 . 
     The cavity  224  becomes dynamically stable when filled with blood BF. This stability promotes healing and ingrowth of the prosthesis  200  at the desired treatment location. Over time, the blood trapped within the cavity  224  will clot to form a permanent seal between the prosthesis  200  and the wall of the native anatomy. In other words, due to the one way valves  128 , the cavity  124  will not pulse between a larger and smaller radial dimension. Instead, the cavity  124  will fill to radially expanded, and then stay radially expanded. 
     While described herein with three (3) openings  226  and three corresponding duckbill valves  228  at the inflow ends  230 ,  236  of the inner skirt  220  and the outer wrap  222 , it will be understood that more or fewer openings  226  and corresponding duckbill valves  228  may be utilized. Further, the plurality of duckbill valves  228  may be located at the inflow ends  230 ,  236  and/or the downstream ends  232 ,  238  of the inner skirt  220  and the outer wrap  222  in any combination. When the plurality of duckbill valves are disposed at the downstream ends  232 ,  238 , the downstream end  232  of the inner skirt  220  is coupled to the inner surface of the tubular stent  202  and the downstream end  238  of the outer wrap  222  is coupled to the outer surface of the tubular stent  202  along a common line and the plurality of openings are formed where a portion of the inner skirt  220  is not attached to the inner surface of the stent  202 , as described above with respect to  FIG.  9   . 
     While various embodiments have been described above, it should be understood that they have been presented only as illustrations and examples of the present invention, and not by way of limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above- described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety. Date: January  13 ,  2023