Patent Publication Number: US-2022233309-A1

Title: Transcatheter Heart Valves and Methods to Reduce Leaflet Thrombosis

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This Application claims priority, and benefit under 35 U.S.C. § 119(e), to U.S. Provisional Patent Application No. 62/851,383, filed 22 May 2019, the entire contents of which is hereby incorporated by reference as if fully set forth below. 
    
    
     FIELD OF THE DISCLOSURE 
     Embodiments of the present disclosure relate generally to transcatheter heart valves and, more particularly, to transcatheter heart valves with expanding members to displace native heart valve leaflets. 
     BACKGROUND 
     Aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries and high mortality is associated with untreated severe AS. Patients diagnosed with moderate or severe AS undergo surgical aortic valve replacement (SAVR); approximately 67,500 surgeries are performed annually in the US. In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective alternative treatment for patients with severe, symptomatic AS and who are deemed intermediate or high surgical-risk. TAVR is a non-surgical (percutaneous) approach to aortic valve replacement which was first successfully performed in a human in 2002. TAVR procedures are performed by navigating a catheter to the native aortic valve and remotely expanding a valve inside of the native aortic annulus. In most cases, the TAVR is much less traumatic to the patient than a SAVR. 
     Since the inception of TAVR, the technology has advanced to support many commercial devices in the global market. Currently, however, a limited number of replacement valves available on the market. Although the number of devices available is low, the need for TAVR devices is high. Currently, approximately 180,000 patients a year can be considered potential TAVR candidates in the European Union and in Northern-America. This number might increase upwards of 270,000 if indications for TAVR expand to low-risk patients. 
     Despite positive outcomes at 30 days and at one year, improved imaging via four-dimensional, volume-rendered CT (4DCT) has raised concerns of subclinical leaflet thrombosis and reduced leaflet mobility in transcatheter aortic bioprostheses. It is suggested that the rate of leaflet thrombosis in transcatheter heart valves (THV) range from 4.5% to 40%. This leaflet thrombosis is caused by a “neo-sinus” forming between the frame of the THV and the THV&#39;s replacement leaflets. Because the native leaflets can rest on the frame of the THV, a “pocket” is formed where blood is stagnant which promotes thrombosis. Valve thrombosis can lead to an earlier valve failure than structural valve deterioration alone. Lifespan of a THV is particularly important as younger, lower risk patients become candidates for the procedure. Therefore, minimizing the risk factors for early valve thrombosis is key to both preventing early THV failure and to encouraging the medical community to adopt TAVR for younger patients. 
     Another limitation with current THV systems is the lack of mechanisms available to control the deployment height of the device. The deployment height of the THV, and the leaflets, has significant impact on the valve&#39;s function. Slight alterations in the deployment height can affect flow to the coronary arteries and/or alter valvular hemodynamics, which can in turn affect ventricular performance, valve durability/function, and aortic wall strain. What is needed, therefore, is a THV system that reduces the occurrence of leaflet thrombosis and also aids in proper alignment in the native valve. 
     SUMMARY 
     Embodiments of the present disclosure address these concerns as well as other needs that will become apparent upon reading the description below in conjunction with the drawings. Briefly described, of the present disclosure relate generally to transcatheter heart valves and, more particularly, to transcatheter heart valves with expanding members to displace native heart valve leaflets. 
     An exemplary embodiment of the present invention provides a valve. The valve can include a tubular frame comprising an outer surface and defining an inner lumen, the tubular frame having a length along a longitudinal axis of the tubular frame, the length extending from a first end to a second end of the tubular frame. The valve can include a plurality of valve leaflets disposed within the inner lumen. The valve can include an expanding member extending radially outward from the tubular frame at a position along the longitudinal axis of the tubular frame. The expanding member can exert a force on one or more defective valve leaflets when the valve is deployed. 
     In any embodiments described herein, the expanding member can include a plurality of arms. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 1.0 mm. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 3.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can be cylindrical wires. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 1.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 3.0 mm. 
     In any embodiments described herein, the expanding member can be a continuous flange. 
     In any embodiments described herein, the expanding member can extend from 5 mm to 10 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the expanding member can extend from 10 mm to 15 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the plurality of valve leaflets can have a first end and a second end, wherein the first end of the plurality of valve leaflets is proximate the first end of the tubular frame, and wherein the second end of the plurality of valve leaflets extends partially between the first and second end of the tubular frame. 
     In any embodiments described herein, the second end of the plurality of valve leaflets can be positioned approximately halfway between the first and second end of the tubular frame. 
     In any embodiments described herein, the expanding member can extend from the tubular frame at a position proximate the second end of the plurality of valve leaflets. 
     In any embodiments described herein, the expanding member can transition between a collapsed configuration and an expanded configuration. 
     In any embodiments described herein, when the expanding member is in the expanded configuration, the expanding member can curve toward the second end of the tubular frame. 
     In any embodiments described herein, the expanding member can include one or more radiopaque markers. 
     In any embodiments described herein, the outer surface of the tubular frame can be defined by a lattice network. 
     Another exemplary embodiment of the present invention provides a sleeve for a valve. The sleeve for a valve can include a tubular frame comprising an outer surface and an inner surface. The tubular frame can have a length along a longitudinal axis of the tubular frame, the length extending from a first end to a second end of the tubular frame. The sleeve for a valve can include an expanding member extending radially outward from the tubular frame at a position along the longitudinal axis of the tubular frame. The expanding member can exert a force on a defective valve leaflet when the sleeve is deployed. The inner surface can contact an exterior surface of the valve when the sleeve is deployed. 
     In any embodiments described herein, the expanding member can include a plurality of arms. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 1.0 mm. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 3.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can be cylindrical wires. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 1.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 3.0 mm. 
     In any embodiments described herein, the expanding member can be a continuous flange. 
     In any embodiments described herein, the expanding member can extend from 5 mm to 10 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the expanding member can extend from 10 mm to 15 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the expanding member can transition between a collapsed configuration and an expanded configuration. 
     In any embodiments described herein, when the expanding member is in the expanded configuration, the expanding member can curve toward the second end of the tubular frame. 
     In any embodiments described herein, the expanding member can include one or more radiopaque markers. 
     In any embodiments described herein, the outer surface of the tubular frame can be defined by a lattice network. 
     In any embodiments described herein, the inner surface of the tubular frame can include an interior attachment configured to contact the exterior surface of the valve and prevent the tubular frame from moving with respect to the valve. 
     Another exemplary embodiment of the present invention provides a valve system. The valve system can include a stent. The stent can include a stent frame comprising an outer surface and defining an inner lumen, the stent frame having a length along a longitudinal axis of the stent frame, the length extending from a first end to a second end of the stent frame. The stent can include a plurality of valve leaflets disposed within the inner lumen. The valve system can include a tubular frame configured to contact the outer surface of the stent frame, the tubular frame comprising an expanding member extending radially outward from the tubular frame. The expanding member can exert a force on one or more defective valve leaflets when the valve system is implanted. 
     In any embodiments described herein, the expanding member can include a plurality of arms. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 1.0 mm. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 3.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can be cylindrical wires. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 1.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 3.0 mm. 
     In any embodiments described herein, the expanding member can be a continuous flange. 
     In any embodiments described herein, the expanding member can extend from 5 mm to 10 mm from the tubular frame. 
     In any embodiments described herein, the expanding member can extend from 10 mm to 15 mm from the tubular frame. 
     In any embodiments described herein, the plurality of valve leaflets can have a first end and a second end, wherein the first end of the plurality of valve leaflets is proximate the first end of the stent frame, and wherein the second end of the plurality of valve leaflets extends partially between the first and second end of the stent frame. 
     In any embodiments described herein, the tubular frame can be positioned on the outer surface of the stent frame at a position such that the expanding member extends from the tubular frame proximate the second end of the plurality of valve leaflets. 
     In any embodiments described herein, the expanding member can transition between a collapsed configuration and an expanded configuration. 
     In any embodiments described herein, when the expanding member is in the expanded configuration and the tubular frame is in contact with the outer surface of the stent frame, the expanding member can curve toward the second end of the stent frame. 
     In any embodiments described herein, the expanding member can include one or more radiopaque markers. 
     In any embodiments described herein, the tubular frame is defined by a lattice network. 
     In any embodiments described herein, an inner surface of the tubular frame can include an interior attachment configured to contact the outer surface of the stent frame and prevent the tubular frame from moving with respect to the stent frame. 
     Another exemplary embodiment of the present invention provides a method for replacing a defective valve. The method can include delivering a valve proximate to the defective valve. The valve can include a tubular frame comprising an outer surface and defining an inner lumen, the tubular frame having a length along a longitudinal axis of the tubular frame, the length extending from a first end to a second end of the tubular frame, the second end of the tubular frame proximate the defective valve. The valve can include a plurality of valve leaflets disposed within the inner lumen. The valve can include an expanding member having a collapsed configuration and an expanded configuration. In the collapsed configuration, the expanding member can be folded towards the second end of the tubular frame. In the expanded configuration, the expanding member can extend radially outward from the tubular frame. The method can include expanding the expanding member from the collapsed configuration to the expanded configuration. The method can include advancing the second end of the tubular frame between defective leaflets of the defective valve. The expanding member can contact the defective leaflets as the tubular frame is advanced between the defective leaflets. The method can include pushing the defective leaflets against an inner wall of a vessel via the expanding member. 
     In any embodiments described herein, the method can include advancing the valve between the defective leaflets until the expanding member is approximately perpendicular to the tubular frame. The method can include taking a fluorographic image of the valve to confirm the expanding member is approximately perpendicular to the tubular frame. 
     In any embodiments described herein, the method can include taking a fluorographic image of the valve to confirm the expanding member is approximately parallel to an annular plane. 
     In any embodiments described herein, the method can include repositioning the valve when the expanding member is not approximately parallel to the annular plane. 
     In any embodiments described herein, the expanding member can include a plurality of arms. 
     In any embodiments described herein, a width of each arm of the plurality of arms is less than or equal to 1.0 mm. 
     In any embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 3.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can be cylindrical wires. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 1.0 mm. 
     In any embodiments described herein, each arm of the plurality of arms can have a dimeter of less than or equal to 3.0 mm. 
     In any embodiments described herein, the expanding member can be a continuous flange. 
     In any embodiments described herein, the expanding member can extend from 5 mm to 10 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the expanding member can extend from 10 mm to 15 mm from the outer surface of the tubular frame. 
     In any embodiments described herein, the plurality of valve leaflets can have a first end and a second end, wherein the first end of the plurality of valve leaflets is proximate the first end of the tubular frame, and wherein the second end of the plurality of valve leaflets extends partially between the first and second end of the tubular frame. 
     In any embodiments described herein, the second end of the plurality of valve leaflets can be positioned approximately halfway between the first and second end of the tubular frame. 
     In any embodiments described herein, the expanding member can extend from the tubular frame at a position proximate the second end of the plurality of valve leaflets. 
     In any embodiments described herein, when the expanding member is in the expanded configuration, the expanding member can curve toward the second end of the tubular frame. 
     In any embodiments described herein, the expanding member can include one or more radiopaque markers. 
     In any embodiments described herein, the outer surface of the tubular frame can be defined by a lattice network. 
     In any embodiments described herein, the method can include partially unsheathing the valve such that the expanding member is unsheathed, thereby allowing the expanding member to expand into its expanded configuration. 
     In any embodiments described herein, the tubular frame can transition between a collapsed configuration and an expanded configuration. In the expanded configuration, the outer surface of the tubular frame can expand to contact a vessel wall. The method can further include fully unsheathing the valve to allow the tubular frame to expand and contact the vessel wall. 
     In any embodiments described herein, the valve can include an expandable balloon disposed between the plurality of valve leaflets. The tubular frame can transition between a collapsed configuration and an expanded configuration. In the expanded configuration, the outer surface of the tubular frame can expand to contact a vessel wall. The method can include unsheathing the valve, thereby allowing the expanding member to expand into its expanded configuration. The method can include expanding the expandable balloon such that the valve expands and contacts the vessel wall. The method can include removing the expandable balloon from the valve. 
     In any embodiments described herein, the method can include reducing a risk of thrombosis between the plurality of valve leaflets and the tubular frame. 
     In any embodiments described herein, the method can include increasing a flow of blood to a coronary artery. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Reference will now be made to the accompanying figures and diagrams, which are not necessarily drawn to scale, and wherein: 
         FIG. 1A  is a cross-sectional schematic of a prior-art transcatheter heart valve in an aorta; 
         FIG. 1B  is top view of a prior-art transcatheter heart valve; 
         FIG. 2A  is a cross section of an aorta; 
         FIG. 2B  is a cross-sectional schematic of a prior-art transcatheter heart valve in an aorta; 
         FIG. 2C  is a cross-sectional schematic of an exemplary valve, according to some embodiments of the present disclosure; 
         FIG. 3  is a perspective view of an exemplary valve, according to some embodiments of the present disclosure; 
         FIG. 4  is a side view of a collapsed valve within a catheter, according to some embodiments of the present disclosure; 
         FIG. 5  is a side view of a collapsed valve that is partially unsheathed, according to some embodiments of the present disclosure; 
         FIG. 6  is a perspective view of an exemplary valve, according to some embodiments of the present disclosure; 
         FIG. 7  is a side view of a collapsed valve within a catheter, according to some embodiments of the present disclosure; 
         FIG. 8  is a side view of a collapsed valve that is partially unsheathed, according to some embodiments of the present disclosure; 
         FIG. 9  is a perspective view of a valve with an expanding member that is a continuous flange, according to some embodiments of the present disclosure; 
         FIG. 10  is a perspective view of a sleeve for a valve, according to some embodiments of the present disclosure; 
         FIGS. 11A and 11B  are top cross-sectional views of a valve positioned within a valve annulus, according to some embodiments of the present disclosure; 
         FIGS. 12A-12D  depict an exemplary process for inserting and deploying a valve in a valve annulus, according to some embodiments of the present disclosure; and 
         FIG. 13  is a flowchart of an exemplary method for repairing a defective native valve, according to some embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Although certain embodiments of the disclosure are explained in detail, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the disclosure is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. Other embodiments of the disclosure are capable of being practiced or carried out in various ways. Also, in describing the embodiments, specific terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. 
     It should also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. References to a composition containing “a” constituent is intended to include other constituents in addition to the one named. 
     Ranges may be expressed herein as from “about” or “approximately” or “substantially” one particular value and/or to “about” or “approximately” or “substantially” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value. 
     Herein, the use of terms such as “having,” “has,” “including,” or “includes” are open-ended and are intended to have the same meaning as terms such as “comprising” or “comprises” and not preclude the presence of other structure, material, or acts. Similarly, though the use of terms such as “can” or “may” are intended to be open-ended and to reflect that structure, material, or acts are not necessary, the failure to use such terms is not intended to reflect that structure, material, or acts are essential. To the extent that structure, material, or acts are presently considered to be essential, they are identified as such. 
     It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Moreover, although the term “step” may be used herein to connote different aspects of methods employed, the term should not be interpreted as implying any particular order among or between various steps herein disclosed unless and except when the order of individual steps is explicitly required. 
     The components described hereinafter as making up various elements of the disclosure are intended to be illustrative and not restrictive. Many suitable components that would perform the same or similar functions as the components described herein are intended to be embraced within the scope of the disclosure. Such other components not described herein can include, but are not limited to, for example, similar components that are developed after development of the presently disclosed subject matter. Additionally, the components described herein may apply to any other component within the disclosure. Merely discussing a feature or component in relation to one embodiment does not preclude the feature or component from being used or associated with another embodiment. 
     To facilitate an understanding of the principles and features of the disclosure, various illustrative embodiments are explained below. In particular, the presently disclosed subject matter is described in the context of transcatheter heart valves with expanding members to displace native heart valve leaflets. The present disclosure, however, is not so limited and can be applicable in other contexts. For example, the systems and methods described herein may improve other percutaneous surgical approaches. Additionally, although reference is made herein to aortic valve replacement, the systems and methods are not limited to the aortic valve. For example, the systems and methods may also be used to replace other valves, such as the mitral, pulmonic, or tricuspid valve. The devices may also be used to repair or replace implanted bioprostheses when the prosthesis fails. Accordingly, when the present disclosure is described in the context of transcatheter heart valves with expanding members to displace native heart valve leaflets, it will be understood that other embodiments can take the place of those referred to. 
     As stated above, both transcatheter aortic valve replacement (TAVR) and transcatheter pulmonary valve replacement (TPVR) have become viable, and popular, alternatives to surgical replacement for moderate- to low-risk patients suffering from failed valves. Taking TAVR as an example, it is expected that almost 200,000 people a year in Europe and North America may be potential candidates for percutaneous valve replacement. This is good news for these low-risk patients, as the percutaneous approach is less invasive than surgical replacement. 
     Current TAVR methods include inserting a guide wire into the femoral artery. The guide wire is then fed into the aorta and through the aortic valve annulus. A catheter can then be advanced over the guidewire and to the site of the valve. A transcatheter heart valve (THV) can then be inserted through the catheter and into the aortic valve annulus. Once positioned, the catheter can be removed to deploy the THV. Some THVs are self-expanding, meaning that the valve can automatically expand into the native annulus once unsheathed. Other THVs are balloon-expanding, meaning that a balloon can be disposed in the inner frame of the THV and expanded to open the THV. Certain limitations exist with both the design of current THVs and with the method of inserting current THVs. 
       FIG. 1A  is a cross-sectional schematic of a prior-art THV in an aorta  10 , and the figure shows issues associated with current THV designs. As stated above, a THV is inserted into the annulus of the valve and opened between the native leaflets  12 . A frame  14  of the THV abuts the native leaflets  12  and the vessel wall at the valve annulus. The frame  14  is ordinarily a lattice-type structure that enables the THV to both grip the walls of the vessel and to allow a certain amount of blood flow from inside the frame  14  to outside the frame  14 . Within the frame is a plurality of THV leaflets  16  that open and close with the pumping of blood through the THV, as shown by the direction  18  of blood flow. One issue with current THV designs is the occurrence of thrombosis  20  in the area between the THV leaflets  16  and the frame  14 . It has been shown that a main contributor to this formation of thromboses  20  is the lack of proper blood flow through the frame  14 . As can be seen in the figure, the native leaflets  12  remain adjacent to the frame  14  and can block the flow of blood through the frame  14 . As will be described in greater detail herein, this flow stagnation, or “flow stasis,” can cause the thrombus  20  to form between the THV leaflet  16  and the frame  14 .  FIG. 1B  is top view of the existing THV shown in  FIG. 1A . As can be seen the thrombus  20  can impede the opening and closing of the THV leaflets  16  and, therefore, reduce the overall motion of the THV leaflets  16 . 
       FIG. 2A  is a cross section of an aorta  10 , and the figure shows the various structures of the aorta  10  that are considered when implanting a THV. The sinotubular junction  22  is the transition area of the ascending aorta  10  between the tubular portion of the aorta  10  (proximal) and the sinus, for example the sinus of Valsalva  24 . The valve annulus  26  is the opening between the native leaflets  12  that enables the blood to flow proximal through the valve. A THV is positioned within the valve annulus  26 . Coronary arteries, for example coronary ostia  28 , exit the aorta  10  at an area distal to the sinotubular junction  22 .  FIG. 2B  is another cross-sectional schematic of prior-art THVs. When the THV is in place within the valve annulus  26 , the native leaflets  12  rest on the outer surface of the frame  14 . This creates a neo-sinus  30  between the native leaflet  12  and the THV leaflet  16 . The neo-sinus is characterized by an area of flow stasis  32  that can lead to the thrombus described above. 
       FIG. 2C  is a cross-sectional schematic of the valves described herein, and the figure shows a preferred design to reduce the thrombosis between the tubular frame  102  of the valve and the valve leaflets  110 . As shown in the figure, if the native leaflets  12  are removed from the outer surface if the tubular frame  102  and pressed against a vessel wall  34 , an area of cross flow  36  is created. This area of cross flow  36  enables blood to move freely through a porous (e.g., lattice network) tubular frame  102  such that flow stasis is not present, thereby decreasing the likelihood of thrombosis. In some examples described herein, the native leaflets  12  are pushed from the outer surface of the tubular frame  102  by an expanding member  106  extending radially outward from the tubular frame  102 . In the case that the valve  100  is implanted into the aorta  10 , the area of cross flow  36  can also increase blood flow to the coronary arteries. Again, it will be understood that the devices described herein can be used in valves other than the aorta, but the aorta provides a good representation of how the devices can be used within a patient. 
     Various devices and methods are disclosed for providing and delivering valves with expanding members to displace native valve leaflets, and exemplary embodiments of the devices and methods will now be described with reference to the accompanying figures. 
       FIG. 3  is a perspective view of an exemplary valve  100 , according to some embodiments of the present disclosure. A valve  100  can have a tubular frame  102 . The tubular frame  102  is the outer shell of the valve  100  that ultimately fits within the annulus of the native valve. It is contemplated that the tubular frame  102  can have a cylindrical shape, as shown in the figure. It is also contemplated that the tubular frame  102  can have a flare either at a first end  108   a  or a second end  108   b  of the tubular frame  102 . For example, it is contemplated that the tubular frame  102  can have an hourglass shape, wherein the narrower midsection is inserted proximate the valve annulus. The first end  108   a  can then flare proximate the valve annulus, near the sinotubular junction; the second end  108   b  can flare distal to the annulus so as to fit the anatomy of the vessel. It is also contemplated that a tubular frame  102  can have only one flare, either above or below the valve annulus. 
     A tubular frame  102  can have a collapsed configuration and an expanded configuration. If the valve is to be used in a transcatheter approach, the valve can have a collapsed configuration that is able to be inserted through the catheter and an expanded configuration to expand and fill the valve annulus. Typical catheters for TAVR have inner diameters ranging from approximately 3.00 mm to approximately 8.00 mm. Accordingly, it is contemplated that, when the tubular frame  102  is in a collapsed configuration, the valve  100  can have an overall dimeter of from approximately 3.00 mm to approximately 8.00 mm. The native valve annulus of humans can range from approximately 15 mm to approximately 30 mm. Accordingly, it is contemplated that, when the tubular frame  102  is in an expanded configuration, the tubular frame  102  can have a diameter of from approximately 15 mm to approximately 30 mm. When considerations are made for manufacturing the device, it may be beneficial to develop a range of devices that can fit in different sized annuli. For example, a manufacturer could design a plurality of valves  100  sizes such that a physician could pick the size appropriate for the individual patient. As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” can refer to the range of values ±20% of the recited value, e.g. “about 90%” can refer to the range of values from 71% to 99%; “approximately 15 mm” can refer to the range of value from 12 mm to 18 mm. 
     It is contemplated that the tubular frame  102  can be either a self-expanding construct or a balloon-expanding construct, as described above. For self-expanding constructions, the tubular frame  102  can be made from a material capable of recovering its shape automatically once unsheathed. In some examples, the material can be made from a shape memory material, such as Nitinol, and the expanded configuration for a tubular frame  102  can be made by heat setting the material to the expanded configuration. In either self-expanding or balloon-expanding constructs, the tubular frame  102  can include, but is not limited to, Nitinol, stainless steel, MP35N, tungsten, cobalt chromium, and/or the like or any combination or alloy thereof. It is also contemplated that the tubular frame  102  can include polymers, including but not limited to polyamide, polyether ether ketone, and the like. 
     As described above, one way to decrease the occurrence of leaflet thrombosis is to promote blood flow through the tubular frame  102  or, in other words, to decrease flow stasis between the valve leaflets  110  and the tubular frame  102 . Accordingly, the outer surface  112  of the tubular frame  102  can be porous or otherwise allow flow through the feature. The outer surface  112  of the tubular frame  102  can be a braided tube, laser cut metallic tube, laser cut polymeric tube and/or the like. In some examples, the outer surface  112  of the tubular frame  102  can be defined by a lattice network, as shown in  FIG. 3 . A lattice network can be defined by any number of shapes.  FIG. 3  shows an exemplary lattice network having a plurality of diamond sections  114 . The diamond sections  114  can provide pores  116  to allow blood to flow from the inner lumen  118  of the tubular frame  102  to a position outside of the tubular frame  102 . The diamond sections  114  can also facilitate the expansion of the tubular frame  102  from its closed configuration to expanded configuration. Other lattice networks are also contemplated, for example a honeycomb structure (as shown in  FIGS. 6-10 ), triangles, and/or the like. 
     The tubular frame  102  can define an inner lumen  118 . Inside the inner lumen  118  can be a plurality of valve leaflets  110 . In some examples, the valve  100  can include three valve leaflets  110 , as shown in the figure, which corresponds with the anatomy of a native aortic valve. It is contemplated that a configuration could be provided wherein the valve  100  has only two valve leaflets  110  and can operate in the same manner as a three-leaflet configuration, consider for example if the valve  100  is replacing a bicuspid valve. The materials used for valve leaflets  110  can include animal materials, including but not limited to porcine pericardium tissue or allograft human tissue. The valve leaflets  110  can include synthetic polymers, engineered tissues, and/or the like. In some examples, each valve leaflet  110  can be connected to the tubular frame  102  via attachment arms  120 . The attachment arms  120  can include adhesives to connect the valve leaflets  110  to the tubular frame  102 , or the valve leaflets  110  can be connected mechanically, for example by sutures, hooks, wire loops, or other clasps that hold the valve leaflets  110  to the tubular frame  102 . 
     In some examples, the valve leaflets  110  can extend the entire length  111  of the tubular frame  102 . In other examples, it is contemplated that the length of the leaflets  110  is shorter than the length  111  of the tubular frame  102 . For example, it is contemplated that the leaflets  110  can be positioned at some point in between the first end  108   a  and second end  108   b  of the tubular frame  102 . In some examples, the valve leaflets  110  can have a first end  122   a  that is proximate the first end  108   a  of the tubular frame  102 , and the valve leaflets  110  can have a second end  122   b  that ends at a position between the first end  108   a  and second end  108   b  of the tubular frame  102 . The second end  122   b  of the valve leaflets  110 , for example, can be approximately halfway between the first end  108   a  and second end  108   b  of the tubular frame  102 . As will be described herein, the second end  122   b  of the valve leaflets  110  can be located at the level of an expanding member  106 .  FIG. 3  shows an example where there is a gap between the tubular frame  102  and the valve leaflets  110 . This gap is shown to provide a detailed view of the inner lumen  118  and other features. It is contemplated that the valve leaflets  110  take up the entire inner lumen  118  such that no gap exists. This can prevent the blood from flowing around the valve leaflets  110  instead of through the valve leaflets  110 . 
     In some examples, a valve  100  can have an expanding member  106  extending radially outward from the tubular frame  102 . The expanding member  106  can be the feature of the valve  100  that pushes the native leaflets  12  away, for example into their respective coronary cusps, so that the native leaflets do not contact the outer surface  112  of the tubular frame  102 . For example,  FIG. 2C  depicts an exemplary expanding member  106  pushing the native leaflets  12  away from the tubular frame  102 . The expanding member  106  can be a variety of shapes and designs that serve to exert a force on one or more native valve leaflets when the valve  100  is deployed within the vessel. These shapes can include arms, a continuous flange (e.g., a skirt), flange with apertures, and/or similar shapes or combinations thereof, as will be described in greater detail herein. 
     In some examples, the expanding member  106  can comprise a plurality of arms  124  extending from the tubular frame  102 , as shown in  FIG. 3 . Any number of arms  124  can extend from the tubular frame  102 . In some examples, the arms can be cylindrical, rectangular, flat, pig-tail, or any combination thereof. For example, the arms  124  can be cylindrical wires, as shown in  FIG. 3 . In some examples, the arms  124  can be designed so as to not obstruct vasculature proximate the native valve being replaced. When the valve  100  is being implanted into an aorta, for example, the arms  124  can be designed to not obstruct the flow of blood to the coronary arteries. This can be achieved by providing arms  124  sufficiently spaced around the tubular frame  102  so that the coronary arteries can be avoided, and this positioning can be aided by fluoroscopy. It is also contemplated that the diameter of each individual arm  124  is not greater than the diameter of the inner lumen of a coronary artery, thereby minimizing inadvertent blocking of the arteries. For example, the mean lumen diameter of a left coronary artery can be approximately 4.5 mm, and the mean lumen diameter of a right coronary artery can be from approximately 2.5 mm and approximately 4.0 mm. Accordingly, it is contemplated that the diameter (or width if the arms are not cylindrical) of each individual arm  124  can be significantly less than the average lumen diameter of coronary arties. Accordingly, the diameter (or width) of each arm  124  can be equal to or less than 3.00 mm, for example equal to or less than 1.00 mm. The length of each arm  124  can also be customized so that vasculature is not obstructed, as will be described in greater detail herein. The diameter of the arms  124  may be larger if the arms  124  do not reach the surrounding vasculature, for example when the length of each arm  124  is customized to avoid vasculature, if necessary. To this end, it is contemplated that the arms  124  could be larger than 3.00 mm. 
     In some examples, and as shown in  FIG. 3 , the placement of the expanding member  106  on the tubular frame  102  can correspond to the location of the second end  122   b  of the valve leaflets  110 . To illustrate, a first end  122   a  (the top in  FIG. 3 ) of the valve leaflets  110  can be in-plane or substantially in-plane with a first end  108   a  of the tubular frame  102 . A second end  122   b  of the valve leaflets  110  can be positioned partially down the length  111  of the tubular frame  102 , for example, and not limitation, approximately half-way down the frame as shown in  FIG. 3 . In these examples, the expanding member  106  can be positioned such that it is attached to the tubular frame  102  at a position near the second end  122   b  of the valve leaflets  110 . By positioning the expanding member  106  in-plane with the end of the valve leaflets  110 , the expanding member  106  can act as a marker to show proper insertion depth of the valve  100  and as a marker to show if the valve  100  is tilted with respect to the annulus. The expanding member  106  can also include one or more radiopaque markers that assist the physician in placing the valve  100  at the proper depth and angle. 
     The expanding member  106  can have a collapsed configuration and an expanded configuration.  FIG. 3  shows a valve  100  in an expanded configuration, which is the configuration the valve  100  takes when the valve  100  is deployed within a vessel. As described above, the valve  100  can be inserted into a vessel via a catheter. The expanding member  106  can also collapse to fit within the catheter as the valve  100  is advanced into the vessel and before the valve  100  is deployed. The collapsed configuration of an expanding member  106  is shown in greater detail in  FIG. 4 . 
       FIG. 4  is a side view of a collapsed valve  100  within a catheter  402 , according to some embodiments of the present disclosure. As described above, the valve  100  can have a collapsed configuration and an expanded configuration. The collapsed configuration can be facilitated by the lattice-type network of the tubular frame  102 . The expanding member  106  can also have a collapsed configuration to fit within the catheter  402 . The expanding member  106  can be made from a material capable of recovering its shape automatically once unsheathed and allowed to expand. In some examples, the expanding member  106  can be made from a memory shape material, such as Nitinol, and the expanded configuration for the expanding member  106  can be made by heat setting the material to the expanded configuration prior to loading the valve  100  into the catheter  402 . The expanding member  106  can also comprise, but is not limited to, stainless steel, MP35N, tungsten, cobalt chromium, and/or the like or any combination or alloy thereof. In some examples, the expanding member  106  can comprise polymers, as described above in reference to the materials for the tubular frame  102 . 
     The example shown in  FIG. 4  could also include an expandable balloon placed within the plurality of valve leaflets  110 . In balloon-expandable configurations, the valve  100  can be deployed into the vessel and positioned into its implantation site. The valve  100  can then be fully unsheathed, allowing the expanding member  106  to expand into place. The tubular frame  102  can then be expanded into its expanded configuration by opening the expandable balloon, and then the balloon can be removed from inside the valve  100 . 
     As described above, the expanding member  106  can, in some examples, enable the physician to place the valve  100  at the proper height within the annulus. To assist the proper placement of the valve  100 , in some examples the expanding member  106  can be connected to the tubular frame  102  at a location near the second end  122   b  of the valve leaflets  110 . This can provide an area  404  on the tubular frame  102  that is visible on fluoroscopy. This area  404  of where the expanding member  106  meets the tubular frame  102  can be used to check to make sure the valve is (1) inserted at the proper height with respect to the annulus and (2) not tilted with respect to the annulus. 
       FIG. 5  is a side view of a collapsed valve  100  that is partially unsheathed, according to some embodiments of the present disclosure. The valve  100  can be partially unsheathed to allow the expanding member  106  to open into its expanded configuration. In self-expanding constructs, the valve  100  can remain partially sheathed while the valve  100  is positioned. If the self-expanding valve  100  is partially sheathed, the tubular frame  102  can remain collapsed for proper placement.  FIG. 5  also shows an expanded expanding member  106 . The expanding member  106  can have a slight curve toward the second end  108   b  of the tubular frame  102 . Although not required, a downward curve can enable the expanding member  106  to engage the native leaflets within the anatomy before the valve  100  is fully seated. The valve  100  can then be advanced farther until the expanding member  106  is approximately parallel with the annulus (or perpendicular to the tubular frame  102 ). This perpendicular placement of the expanding member  106 , in combination with the area  404  of where the expanding member  106  meets the tubular frame  102 , can be used to ensure the valve  100  is (1) inserted at the proper height with respect to the annulus and (2) not tilted with respect to the annulus. In some examples, the downward curve of the expanding member  106  can also provide mechanical feedback to the physician as the valve  100  is being inserted. The expanding member  106 , for example, can provide some resistance when the expanding member  106  contacts native leaflets, and the expanding member  106  can provide even greater mechanical feedback when the expanding member  106  reaches the level of the annulus. 
     The expanding member  106 , in some examples, can include mechanical features to prevent the valve  100  from being inserted too far into the annulus. One such mechanical feature can include providing stops, which can include tabs, at the area  404  of where the expanding member  106  meets the tubular frame  102 . These stops (not shown in  FIG. 5 ) can be placed on the tubular frame  102  at a position opposite the curvature of the expanding member  106  (i.e., on the top of the arms  124  in the figure). As the valve  100  is inserted into the anatomy, and the expanding member  106  opens and raises as the valve  100  is advanced, the stops can act to prevent the arms from raising above a certain height. The expanding member  106  can also be more rigid at its junction with the tubular frame  102  than at a point farthest from the tubular frame  102 . This can be facilitated by having a thicker material proximate the tubular frame and thinner material away from the tubular frame  102 . Such a configuration can enable the expanding member  106  to gently apply force to the native valve leaflets while also providing rigid support at the perimeter of the valve annulus and preventing the valve  100  from being inserted beyond the annulus. 
       FIG. 6  is a perspective view of an exemplary valve  100 , according to some embodiments of the present disclosure. As described above, the lattice network of the tubular frame  102  is not limited to the diamond lattice shown in  FIGS. 3-5 . It is also contemplated that the lattice network comprises a plurality of honeycomb sections  602  that define the pores  116 . The honeycomb sections  602  can also facilitate the expanded configuration and the collapsed configurations described herein.  FIG. 7  is a side view of a collapsed valve  100  within a catheter  402 , according to some embodiments of the present disclosure. The figure shows how the honeycomb sections  602  can help the valve  100  to collapse to fit into a catheter  402 .  FIG. 8  is a side view of a collapsed valve  100  that is partially unsheathed, according to some embodiments of the present disclosure.  FIG. 8  shows similar features to those shown in  FIG. 5  but with a tubular frame  102  having a honeycomb structure. 
       FIG. 9  is a perspective view of a valve  100  with an expanding member  106  that is a continuous flange  902 , according to some embodiments of the present disclosure. As described above, the shape of the expanding member  106  can take various shapes, as more than one shape can facilitate pushing the native leaflets from the outer surface of the tubular frame  102 . The previous examples, for example  FIGS. 3-8 , show an expanding member  106  comprising a plurality of arms  124 , which is in accordance with some examples.  FIG. 9  shows an expanding member  106  that is a continuous flange  902 . The continuous flange  902  can be similar to a skirt around the tubular frame  102 . In some examples, a continuous flange  902  can also prevent perivalvular leakage, as in the blood must pass through the valve leaflets  110  because flow around the tubular frame  102  is blocked by the continuous flange  902 . It is not required that the continuous flange  902  is solid, as shown in the figure, though it can be. The continuous flange  902  can include holes, apertures, or a lattice network. The lattice network can be the same as the tubular frame  102 , or the expanding member  106  could have a different lattice network than the tubular frame  102 . The continuous flange  902  can also include features to provide friction against the native leaflets, for example ridges, ribs, or the like, so that the continuous flange  902  maintains a grip on the native leaflets. 
       FIG. 10  is a perspective view of a sleeve  1000  for a valve, according to some embodiments of the present disclosure. Certain examples of the present disclosure are able to interact with legacy THV systems to improve the legacy valve and to also decrease the risk of thrombosis in the valve. Take for example a THV that has a stent frame and a plurality of valve leaflets disposed within the stent frame. This construct does not include any feature that pushes the native leaflets away from the stent frame to encourage the area of cross flow  36  descried above in  FIG. 2C .  FIG. 10  shows an exemplary sleeve  1000  that can provide a solution for these legacy THVs. 
     A sleeve  1000  for a valve can have a tubular frame  102  and an expanding member  106 . The sleeve  1000 , however, can be provided without valve leaflets  110  in the inner lumen  118  of the tubular frame  102 . The inner surface  1002  of the sleeve  1000  can contact the exterior surface of a stented valve when the sleeve  1000  is deployed. One way this can be performed is to first implant the sleeve  1000  into the native valve that is being replaced. The expanding member  106  of the sleeve  1000  can push the native leaflets to the vessel wall. The sleeve  1000  can then be expanded in the annulus either by self-expanding or balloon-expanding methods, as described above. A legacy THV can then be inserted into the inner lumen  118  of the tubular frame  102  and expanded to contact the inner surface  1002  of the sleeve  1000 . Alternatively, the sleeve  1000  can be combined with the legacy THV prior to implanting the combined system into the patient. This can either be completed on a back table in an operating room or by manufacturing a stent with the sleeve  1000  already attached to the legacy THV. 
     In some examples of a sleeve  1000  for a valve, the valve can include interior attachments  1004  to contact the exterior surface of the stented valve. The interior attachments  1004  can enable the sleeve  1000  to maintain stable contact with the stented valve residing in the inner lumen  118  of the sleeve  1000 . This can include preventing the sleeve  1000  from rotating with respect to the stented valve and/or preventing the sleeve  1000  from sliding axially (e.g., up and down) the length of the stented frame or vice versa. These interior attachments  1004  can include tabs, hooks, grooves to match with the lattice network of the stented valve, and/or the like. 
       FIGS. 11A and 11B  are top cross-sectional views of a valve  100  positioned within a valve annulus  26 , according to some embodiments of the present disclosure.  FIG. 11A  depicts a tubular frame  102  in a collapsed configuration within the valve annulus  26 . When the tubular frame  102  is collapsed, it can form a bunched configuration like shown in  FIG. 11A . In other examples, the tubular frame  102  is not bunched, but the lattice-type network is instead collapsed upon itself, meaning the tubular frame  102  remains circular when in a collapsed configuration. Examples of this collapsed configuration are shown  FIGS. 4, 5, 7, and 8 . The expanding member  106  in  FIG. 11A  is expanded into its expanded configuration. In other words, the example shown in  FIG. 11A  could depict a partially-unsheathed self-expanding valve  100 , where the tubular frame  102  is collapsed within a catheter and the expanding member  106  is opened to exert a force on the native valve leaflets. The example shown in FIG.  11 A could also depict a fully-unsheathed balloon-expanding valve  100  that has yet to be expanded by the balloon. 
     The expanding member  106  can extend a length  1102  from the tubular frame  102 . The exact length  1102  of the expanding member  106  depends at least on the diameter  1104  of the valve annulus  26  in which the valve  100  is being implanted. To illustrate the length  1102  of the expanding member  106 , reference can be made to the diameter  1106 A of the partially-expanded valve  100 . The diameter  1106 A in  FIG. 11A  refers to a length from a first end of the expanding member  106  to a second end diametrically opposite the first end. The diameter  1106 A would, therefore, be the overall diameter of the valve  100  when the expanding member  106  is expanded but the tubular frame  102  remains collapsed. In any example described herein, the diameter  1106 A of the collapsed valve  100  can be larger than the diameter  1104  of the valve annulus  26 . This of course enables the expanding member  106  to prevent the valve  100  from passing through the valve annulus  26 . At least a portion  1108  of the length  1102  of the expanding member  106  can extend beyond the valve annulus  26 . To ensure the portion  1108  of the length  1102  extends beyond the valve annulus  26 , it is contemplated that the expanding member  106  can extend from the tubular frame  102  at a length  1102  of from 5 mm to 15 mm (e.g., from approximately 5 mm to approximately 10 mm; or from approximately 10 mm to approximately 15 mm). 
       FIG. 11B  depicts a tubular frame  102  and an expanding member  106  that are both in an expanded configuration within the valve annulus  26 . In other words, the example shown in  FIG. 11B  could depict a fully-unsheathed self-expanding valve  100  or could depict a balloon-expanding valve  100  that has been expanded by the balloon. As shown in  FIG. 11B , once the valve  100  is deployed and fully expanded, the tubular frame  102  is approximately the same size as the valve annulus  26 , i.e., it fills the valve. Although the length  1102  of the expanding member  106  can remain the same, the portion  1108  of the length  1102  that extends beyond the valve annulus  26  can be the entire length  1102  of the expanding member  106 . The expansion of the expanding member  106  can further push the native leaflets to the vessel wall. It is also contemplated that the length  1102  of the expanding member  106  can be customized so as to prevent inadvertent blocking of vasculature proximate the valve annulus  26 . A shorter length  1102  can prevent inadvertent blocking of vasculature when the valve  100  is fully expanded, and a longer length  1102  can provide greater axial force to the native valve leaflets. 
       FIGS. 12A-12D  depict an exemplary process for inserting and deploying a valve  100  in a valve annulus  26 , according to some embodiments of the present disclosure. The figures depict a valve  100  being placed in an aortic valve. As described above, however, the present disclosure is not limited to aortic-valve replacement, and the present systems and methods can be used to replace other valves, such as the mitral, pulmonic, or tricuspid valve. 
       FIG. 12A  depicts advancing a collapsed valve  100  via a catheter  402  proximate to a native valve that is being replaced. As can be seen in the figure, the collapsed valve  100  can be fully sheathed, and the expanding member  106  can be collapsed against the tubular frame  102 . The catheter  402  and valve  100  can be inserted into the native valve by advancing the two over a guidewire  1202  placed in the native valve. 
     In  FIG. 12B , the valve  100  is partially unsheathed to allow the expanding member  106  to expand. The example valve  100  in  FIG. 12B  shows a slight curve toward the bottom of the valve  100 , as described above. This slight curve can enable the expanding member  106  to engage the native leaflets  12  when the valve  100  remains above the valve annulus  26 . The valve  100  can next be advanced toward the valve annulus  26 . 
     In  FIG. 12C , the valve  100  is advanced into the valve annulus  26 . As the expanding member  106  contacts the native leaflets  12 , the expanding member  106  can begin to extend and straighten. As is shown in the figure, the expanding member  106  can displace the native leaflets  12  by pushing the native leaflets  12  against the vessel wall  34 . This pushing of the native leaflets  12  can create the area of cross flow  36  (shown in  FIG. 2C ). By pushing the native leaflets  12  away from the tubular frame  102 , the cross flow through the tubular frame  102  can decrease the chance of thrombosis in the area between the valve leaflets  110  and the tubular frame  102 . As will be described in greater detail below, the present system can also be employed within an existing SAVR replacement valve. When reference is made to a native valve, it can be understood that the step can also refer to a defective, existing replacement valve. 
     As described herein, the position of the expanding member  106  can assist the physician in assessing proper placement of the valve  100 . For example, the physician can view the placement of the valve  100  (e.g., under fluoroscopy), and when the expanding member  106  is perpendicular or is approximately perpendicular to the device (as shown in  FIG. 12C ), the physician can be assured the valve is placed at the proper deployment height. The physician can also confirm whether the expanding member  106  is parallel to the valve annulus  26 . As described above, the expanding member  106  can be placed at a position proximate the end of the valve leaflets  110 , and in this scenario, the position of the expanding member  106  can also ensure proper placement of the valve leaflets  110 . 
       FIG. 12C  also shows the valve  100  has exited the catheter  402 . In this example, therefore, the tubular frame  102  can now expand automatically into its expanded configuration if the valve  100  is a self-expanding design; in balloon-expanding designs, a balloon can be expanded to expand the tubular frame  102 . 
     In  FIG. 12D , the valve  100  is deployed at the proper height in the valve annulus  26  and is fully expanded. The tubular frame  102 , therefore, fills the valve annulus  26 . The expanding member  106  can conform to the shape of the shape of the vessel wall  34 . Once fully deployed, the physiology and fluid mechanics of the implanted valve  100  can closely mimic the physiology and fluid mechanics of the native valve. 
       FIG. 13  is a flowchart of an exemplary method  1300  for replacing a defective valve, according to some embodiments of the present disclosure. The method  1300  can begin at block  1305 , where a valve  100  is delivered proximate to the defective valve. The valve  100  delivered to the defective valve can include, for example, a tubular frame  102  comprising an outer surface  112  and defining an inner lumen  118 . The tubular frame  102  can have a length  111  along a longitudinal axis of the tubular frame  102 . The length  111  can extend from a first end  108   a  to a second end  108   b  of the tubular frame  102 . The second end  108   b  of the tubular frame  102  can be proximate the defective valve. The valve  100  can also include a plurality of valve leaflets  110  disposed within the inner lumen  118 . The valve  100  can also include an expanding member  106  having a collapsed configuration and an expanded configuration, wherein, in the collapsed configuration, the expanding member  106  is folded towards the second end  108   b  of the tubular frame  102 . In the expanded configuration, the expanding member  106  can extend radially outward from the tubular frame  102 . 
     At block  1310 , the expanding member  106  is expanded from its collapsed configuration to its expanded configuration. As described herein, the expanding member  106  can be expanded independently of the tubular frame  102 . This enables the expanding member  106  to open into its expanded configuration prior to fully seating the valve  100 . The expanding member  106  can, therefore, exert a force on the defective valve leaflets as the valve  100  is further advanced into the defective valve (for example into the valve annulus). In some examples, the expanding member  106  can be expanded by partially unsheathing the valve  100 . 
     At block  1315 , the second end  108   b  of the tubular frame  102  is advanced between defective leaflets of the defective valve. The expanding member  106  can contact the defective leaflets as the tubular frame  102  is advanced. 
     At block  1320 , the defective leaflets are pushed against a vessel wall  34  (e.g., the inner wall of the vessel) by the expanding member  106 . As described herein, the defective leaflets can therefore be pushed from the outer surface  112  of the tubular frame  102 , and blood can flow through the tubular frame  102 . This can decrease the risk of thrombosis in the area between the valve leaflets  110  and the tubular frame  102 . 
     The method  1300  can end after block  1320 . In some examples, method  1300  can also include taking a fluorographic image of the valve  100  to confirm the expanding member  106  is approximately parallel to the annular plane of the defective valve. The fluorographic image can also confirm whether the expanding member  106  is approximately perpendicular to the tubular frame  102 . This can help ensure proper valve height within the annulus. This step can also confirm the valve  100  is not tilted with respect to the annulus. 
     In some examples, method  1300  can also include fully unsheathing the valve  100 . If the valve  100  is a self-expanding design, the full unsheathing can enable the tubular frame  102  to fully expand and contact the vessel wall. If the valve  100  is a balloon-expanding design, the balloon can be disposed between the plurality of valve leaflets  110 . The entire valve  100  can be unsheathed when the valve is properly inserted, and the balloon can be expanded such that the valve  100  expands and contacts the vessel wall. The balloon can then be removed from the valve  100 . 
     As stated above, throughout this disclosure reference has been made to delivering a valve  100  into a native valve (e.g., the native aorta). The present disclosure, however, is not so limited. It is also contemplated that the systems described herein can be implanted into an existing SAVR replacement valve. The steps described herein can be similar in this scenario, except that the expanding member  106 , for example, could exert a radial force of the defective SAVR valve leaflets. Accordingly, when reference is made above to a defective valve or a defective leaflet, it can be understood to mean a defective native valve or leaflet, or a defective SAVR replacement valve or leaflet. 
     It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purposes of description and should not be regarded as limiting the claims. 
     Accordingly, those skilled in the art will appreciate that the conception upon which the application and claims are based may be readily utilized as a basis for the design of other structures, methods, and systems for carrying out the several purposes of the embodiments and claims presented in this application. It is important, therefore, that the claims be regarded as including such equivalent constructions. 
     Furthermore, the purpose of the foregoing Abstract is to enable the United States Patent and Trademark Office and the public generally, and especially including the practitioners in the art who are not familiar with patent and legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The Abstract is neither intended to define the claims of the application, nor is it intended to be limiting to the scope of the claims in any way. Instead, it is intended that the invention is defined by the claims appended hereto.