Transcatheter heart valve and method to reduce leaflet thrombosis

Abstract

Systems and methods for replacing a defective heart valve are disclosed. The systems and methods include providing a valve having a tubular frame, a plurality of valve leaflets, and a dilation member. The dilation member has a collapsed configuration and an expanded configuration. In the collapsed configuration, the dilation member can be disposed within a catheter such that the valve can be percutaneously positioned at a defective heart valve. In the expanded configuration, the dilation member can be opened to exert a force on one or more native valve leaflets. By exerting the force on the native valve leaflets, the dilation member can squeeze the native valve leaflets away from a surface of the tubular frame. Pushing the native valve leaflets away from the tubular frame enables blood to flow through the tubular frame and reduces the risk of thrombosis between the valve leaflets and the tubular frame.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 851,383, filed May 22, 2019, the entire contents of which are incorporated by reference herein as if fully set forth below. TECHNICAL FIELD

[0003] Embodiments of the present disclosure generally relate to transcatheter heart valves, and more particularly to transcatheter heart valves having expansion members to replace native heart valve leaflets. BACKGROUND

[0004] Aortic valve stenosis (AS) is the most prevalent heart valve disease in developed countries, with high mortality associated with untreated severe AS. Patients diagnosed with moderate or severe AS undergo surgical aortic valve replacement (SAVR). In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective replacement therapy for treating symptomatic severe AS and patients considered to be at intermediate or high surgical risk. TAVR is a non-surgical (percutaneous) aortic valve replacement that was first successfully performed in humans in 2002. The TAVR procedure is performed by navigating a catheter to the native aortic valve and remotely expanding a valve within the native aortic valve annulus. In most cases, TAVR is far less traumatic to the patient than SAVR.

[0005] Since the advent of TAVR, the technology has evolved to support many commercial devices on the global market. However, there is a limited number of replacement valves available in the current market. Despite the small number of available devices, the demand for TAVR devices is high. Currently, approximately 180,000 patients per year in the European Union and North America are considered potential TAVR candidates. If the indications for TAVR were to expand to low-risk patients, this number could increase upwards to 270,000.

[0006] Despite positive outcomes at 30 days and one year, improved imaging through four-dimensional volume rendered CT (4DCT) raised concerns about subclinical leaflet thrombosis and reduced mobility of the leaflets in the transcatheter aortic bio-prosthesis. Leaflet thrombosis rates in transcatheter heart valves (THVs) have been suggested to range from 4.5% to 40%. This leaflet thrombosis is caused by the "neo-cusps" formed between the THV frame and the replaced leaflets of the THV. Because the native leaflets can rest on the frame of the THV, a "pocket" is created where blood stagnates, which promotes thrombosis. Valvular thrombosis can lead to earlier valve failure than structural valve deterioration alone. The longevity of the THV is particularly important because young, lower-risk patients are becoming candidates for the procedure. Therefore, minimizing the risk factors for early valvular thrombosis is key to preventing early THV failure and encouraging the medical community to adopt TAVR for young patients.

[0007] Another limitation of current THV systems is the lack of a mechanism available to control the deployment height of the device. The deployment height of the THV and leaflets has a significant impact on the function of the valve. A slight change in deployment height can affect blood flow to the coronary arteries and / or change the valvular hemodynamics, which in turn can affect ventricular performance, valve durability / function, and aortic wall strain. Thus, there is a need for a THV system that can reduce the occurrence of leaflet thrombosis and also aid in proper alignment in the native valve. SUMMARY

[0008] Embodiments of the present disclosure address these issues and other needs that will become apparent in light of the following description, read in conjunction with the drawings. Briefly described, the present disclosure relates generally to transcatheter heart valves, and more particularly to transcatheter heart valves having expansion members to replace native heart valve leaflets.

[0009] Exemplary embodiments of the present invention provide a valve. The valve can include a tubular frame including an outer surface and defining an inner lumen, the tubular frame having a length along a longitudinal axis of the tubular frame 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 expansion member extending radially outward from the tubular frame at a location along the longitudinal axis of the tubular frame. The expansion member can exert a force on one or more defective valve leaflets when the valve is deployed.

[0010] In any of the embodiments described herein, the expansion member can include a plurality of arms.

[0011] In any of the embodiments described herein, a width of each arm of the plurality of arms can be less than or equal to 1.0 mm.

[0012] In any of the embodiments described herein, each arm of the plurality of arms can have a width of less than or equal to 3.0 mm.

[0013] In any of the embodiments described herein, each arm of the plurality of arms can be a cylindrical wire.

[0014] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter of less than or equal to 1.0 mm.

[0015] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter of less than or equal to 3.0 mm.

[0016] In any of the embodiments described herein, the expansion member can be a continuous flange.

[0017] In any of the embodiments described herein, the expansion member can extend 5 mm to 10 mm from an outer surface of the tubular frame.

[0018] In any of the embodiments described herein, the expansion member can extend 10 mm to 15 mm from an outer surface of the tubular frame.

[0019] In any of the 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 to the first end of the tubular frame, and wherein the second end of the plurality of valve leaflets extends partially between the first end and the second end of the tubular frame.

[0020] In any of the embodiments described herein, the second end of the plurality of valve leaflets can be positioned at approximately half way between the first end and the second end of the tubular frame.

[0021] In any of the embodiments described herein, the expansion member can extend from the tubular frame at a location proximate to the second end of the plurality of valve leaflets.

[0022] In any of the embodiments described herein, the expansion member can transition between a contracted configuration and an expanded configuration.

[0023] In any of the embodiments described herein, the expansion member can curve toward the second end of the tubular frame when the expansion member is in the expanded configuration.

[0024] In any of the embodiments described herein, the expansion member can include one or more radiopaque markers.

[0025] In any of the embodiments described herein, an outer surface of the tubular frame can be defined by a lattice network.

[0026] Another example embodiment of the present invention provides a sleeve for a valve. The sleeve for a valve can include a tubular frame including an outer surface and an inner surface. The tubular frame can have a length along a longitudinal axis of the tubular frame extending from a first end to a second end of the tubular frame. The sleeve for a valve can include a spreading member extending radially outward from the tubular frame at a location along the longitudinal axis of the tubular frame. The spreading member can exert a force on a defective valve leaflet when the sleeve is deployed. The inner surface can contact an outer surface of the valve when the sleeve is deployed.

[0027] In any embodiment described herein, the spreading member can include a plurality of arms.

[0028] In any embodiment described herein, each arm of the plurality of arms can have a width less than or equal to 1.0 mm.

[0029] In any embodiment described herein, each arm of the plurality of arms can have a width less than or equal to 3.0 mm.

[0030] In any embodiment described herein, each arm of the plurality of arms can be a cylindrical wire.

[0031] In any embodiment described herein, each arm of the plurality of arms can have a diameter less than or equal to 1.0 mm.

[0032] In any embodiment described herein, each arm of the plurality of arms can have a diameter less than or equal to 3.0 mm.

[0033] In any embodiment described herein, the spreading member can be a continuous flange.

[0034] In any embodiment described herein, the spreading member can extend 5 mm to 10 mm from the outer surface of the tubular frame.

[0035] In any embodiment described herein, the spreading member can extend 10 mm to 15 mm from the outer surface of the tubular frame.

[0036] In any embodiment described herein, the spreading member can transition between a collapsed configuration and an expanded configuration.

[0037] In any embodiment described herein, the spreading member can curve toward the second end of the tubular frame when the spreading member is in the expanded configuration.

[0038] In any embodiment described herein, the spreading member can include one or more radiopaque markers.

[0039] In any of the embodiments described herein, the outer surface of the tubular frame can be defined by a lattice network.

[0040] In any of the embodiments described herein, the inner surface of the tubular frame can include an internal attachment configured to contact an outer surface of the valve and prevent movement of the tubular frame relative to the valve.

[0041] Another example embodiment of the present application provides a valve system. The valve system can include a stent. The stent can include a stent frame including an outer surface and defining an inner lumen, the stent frame having a length along a longitudinal axis of the stent frame 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 including a flared member extending radially outward from the tubular frame. The flared member can exert a force on one or more defective valve leaflets when the valve system is implanted.

[0042] In any of the embodiments described herein, the flared member can include a plurality of arms.

[0043] In any of the embodiments described herein, each arm of the plurality of arms can have a width less than or equal to 1.0 mm.

[0044] In any of the embodiments described herein, each arm of the plurality of arms can have a width less than or equal to 3.0 mm.

[0045] In any of the embodiments described herein, each arm of the plurality of arms can be a cylindrical wire.

[0046] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter less than or equal to 1.0 mm.

[0047] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter less than or equal to 3.0 mm.

[0048] In any of the embodiments described herein, the flared member can be a continuous flange.

[0049] In any of the embodiments described herein, the flared member can extend 5 mm to 10 mm from the tubular frame.

[0050] In any of the embodiments described herein, the flared member can extend 10 mm to 15 mm from the tubular frame.

[0051] In any of the 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 to the first end of the stent frame, and wherein the second end of the plurality of valve leaflets extends partially between the first end and the second end of the stent frame.

[0052] In any of the embodiments described herein, the tubular frame can be positioned at a location on the outer surface of the stent frame such that the expansion member extends from the tubular frame proximate to the second end of the plurality of valve leaflets.

[0053] In any of the embodiments described herein, the expansion member can transition between a contracted configuration and an expanded configuration.

[0054] In any of the embodiments described herein, the expansion member can curve toward the second end of the stent frame when the expansion member is in the expanded configuration and the tubular frame is in contact with the outer surface of the stent frame.

[0055] In any of the embodiments described herein, the expansion member can include one or more radiopaque markers.

[0056] In any of the embodiments described herein, the tubular frame is defined by a lattice network.

[0057] In any of the embodiments described herein, the inner surface of the tubular frame can include an internal attachment configured to contact the outer surface of the stent frame and prevent movement of the tubular frame relative to the stent frame.

[0058] Another example embodiment of the present disclosure provides a method of replacing a defective valve. The method can include delivering a valve proximate to the defective valve. The valve can include a tubular frame including an outer surface and defining an inner lumen, the tubular frame having a length along a longitudinal axis of the tubular frame extending from a first end to a second end of the tubular frame, the second end of the tubular frame being proximate to the defective valve. The valve can include a plurality of valve leaflets disposed within the inner lumen. The valve can include an expansion member having a contracted configuration and an expanded configuration. In the contracted configuration, the expansion member can be folded toward the second end of the tubular frame. In the expanded configuration, the expansion member can extend radially outward from the tubular frame. The method can include expanding the expansion member from the contracted configuration to the expanded configuration. The method can include advancing the second end of the tubular frame between defective valve leaflets of the defective valve. The expansion member can contact the defective valve leaflets as the tubular frame is advanced between the defective valve leaflets. The method can include urging the defective valve leaflets against an inner wall of the blood vessel via the expansion member.

[0059] In any of the embodiments described herein, the method can include advancing the valve between the defective leaflets until the expansion member is approximately perpendicular to the tubular frame. The method can include taking a fluoroscopic image of the valve to confirm that the expansion member is approximately perpendicular to the tubular frame.

[0060] In any of the embodiments described herein, the method can include taking a fluoroscopic image of the valve to confirm that the expansion member is approximately parallel to the annulus plane.

[0061] In any of the embodiments described herein, the method can include repositioning the valve when the expansion member is not approximately parallel to the annulus plane.

[0062] In any of the embodiments described herein, the expansion member can include a plurality of arms.

[0063] In any of the embodiments described herein, each arm of the plurality of arms can have a width less than or equal to 1.0 mm.

[0064] In any of the embodiments described herein, each arm of the plurality of arms can have a width less than or equal to 3.0 mm.

[0065] In any of the embodiments described herein, each arm of the plurality of arms can be a cylindrical wire.

[0066] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter less than or equal to 1.0 mm.

[0067] In any of the embodiments described herein, each arm of the plurality of arms can have a diameter less than or equal to 3.0 mm.

[0068] In any of the embodiments described herein, the expansion member can be a continuous flange.

[0069] In any of the embodiments described herein, the expansion member can extend 5 mm to 10 mm from an outer surface of the tubular frame.

[0070] In any of the embodiments described herein, the expansion member can extend 10 mm to 15 mm from an outer surface of the tubular frame.

[0071] In any of the 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 to the first end of the tubular frame, and wherein the second end of the plurality of valve leaflets extends partially between the first end and the second end of the tubular frame.

[0072] In any of the embodiments described herein, the second end of the plurality of valve leaflets can be positioned approximately halfway between the first end and the second end of the tubular frame.

[0073] In any of the embodiments described herein, the expansion member can extend from the tubular frame at a location proximate to the second end of the plurality of valve leaflets.

[0074] In any of the embodiments described herein, the expansion member can curve toward the second end of the tubular frame when the expansion member is in the expanded configuration.

[0075] In any of the embodiments described herein, the expansion member can include one or more radiopaque markers.

[0076] In any of the embodiments described herein, the outer surface of the tubular frame can be defined by a lattice network.

[0077] In any of the embodiments described herein, the method can include partially unsheathing the valve so that the expansion member is unsheathed, allowing the expansion member to expand to its expanded configuration.

[0078] In any of the embodiments described herein, the tubular frame can transition between a collapsed configuration and an expanded configuration. In the collapsed configuration, the outer surface of the tubular frame can expand to contact the vessel wall. The method can further include fully unsheathing the valve to allow the tubular frame to expand and contact the vessel wall.

[0079] In any of the 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 collapsed configuration, the outer surface of the tubular frame can expand to contact the vessel wall. The method can include unsheathing the valve, allowing the expansion member to expand to 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.

[0080] In any of the embodiments described herein, the method can include reducing the risk of thrombosis between the plurality of valve leaflets and the tubular frame.

[0081] In any of the embodiments described herein, the method can include increasing blood flow to the coronary arteries. BRIEF DESCRIPTION OF DRAWINGS

[0082] Reference will now be made to the drawings and illustrations, which are not necessarily drawn to scale, in which:

[0083] FIG. 1A is a cross-sectional illustration of a prior art transcatheter heart valve in the aorta;

[0084] FIG. 1B is a top view of a prior art transcatheter heart valve;

[0085] Figure 2A is a cross-section of the aorta;

[0086] FIG. 2B is a cross-sectional schematic view of a prior art transcatheter heart valve in the aorta;

[0087] Figure 2C is a cross-sectional schematic view of an exemplary valve according to some embodiments of the disclosure;

[0088] Figure 3 is a perspective view of an exemplary valve according to some embodiments of the disclosure;

[0089] Figure 4 is a side view of a collapsed valve within a catheter according to some embodiments of the disclosure;

[0090] Figure 5 is a side view of a partially sheathed collapsed valve according to some embodiments of the disclosure;

[0091] Figure 6 is a perspective view of an exemplary valve according to some embodiments of the disclosure;

[0092] Figure 7 is a side view of a collapsed valve within a catheter according to some embodiments of the disclosure;

[0093] Figure 8 is a side view of a partially sheathed collapsed valve according to some embodiments of the disclosure;

[0094] Figure 9 is a perspective view of a valve having expansion members that are continuous flanges according to some embodiments of the disclosure;

[0095] Figure 10 is a perspective view of a sleeve for a valve according to some embodiments of the disclosure;

[0096] Figure 11A and 11B is a top cross-sectional view of a valve within a valve annulus according to some embodiments of the disclosure;

[0097] Figures 12A-12D depicts an exemplary procedure for inserting and deploying a valve in a valve annulus according to some embodiments of the disclosure; and

[0098] Figure 13 is a flowchart of an exemplary method for repairing a defective native valve according to some embodiments of the disclosure. DETAILED DESCRIPTION

[0099] While certain embodiments of the present disclosure have been described herein, other embodiments will be apparent to those skilled in the art. Therefore, the disclosure is not to be limited to the details described above, upon reading the drawings and detailed description, modifications will become apparent to those skilled in the art. Furthermore, in the description above and in the claims below, the terms "a" and "an" are used to mean one or more than one, and the term "at least" is used to mean one or more than one. The terms "including" and "having" are used to mean comprising and should not be interpreted as being restrictive or limiting. The term "or" is used to mean "and / or" both. In addition, where "a" or "an" is used in the claims and "a" or "an" is intended to be construed to mean one or more than one, it will be understood by those skilled in the art that "one" can be appropriately inserted prior to "a" or "an" where one of the plural is intended.

[0100] It should also be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. References to a composition comprising "a" constituent include other constituents in addition to the one named.

[0101] Ranges can be expressed herein as from "about" or "approximately" one particular value and / or to "about" or "approximately" another particular value. Other example embodiments will be within ranges given by the "about" or "approximately" language.

[0102] In this document, recitals such as "have," "has," or "including" are open-ended, intended to have the same meaning as the term "comprising," and do not exclude the presence of additional structural, material, or behavioral acts. Similarly, although the use of "may" or "might" is intended to be open-ended and not to reflect an essential requirement, the absence of such terms is not intended to reflect an essential requirement. Structural, material, or behavioral acts that are currently considered essential are identified as such.

[0103] It should also be understood that a reference to one or more method steps does not preclude the presence of additional method steps, or intervening method steps, between those steps expressly identified. Furthermore, although the term "step" can be used herein to connote differing aspects of the methods employed, this term is not to be construed to imply any particular order among or between the various steps disclosed herein unless and except when the order of the steps is explicitly required.

[0104] The components described below as constituting various elements of the disclosure are intended to be illustrative rather than limiting. Numerous suitable components that perform the same or similar functions as the components described herein are intended to be encompassed within the scope of the disclosure. Such other components not described herein can include, for example, similar components developed later that perform similar functions. Moreover, components described herein can be applied to any other components within the disclosure. The discussion of features or components associated with one embodiment does not preclude that feature or component from being used with or associated with another embodiment.

[0105] To facilitate understanding of the principles and features of the present disclosure, various illustrative embodiments are explained hereinafter. In particular, the subject matter of the present disclosure is described in the context of transcatheter heart valves having expansion members to replace native heart valve leaflets. However, the present disclosure is not limited to this and can be applicable to other contexts. For example, the systems and methods described herein can improve other percutaneous surgical methods. Moreover, while aortic valve replacement is cited herein, the systems and methods are not limited to aortic valves. For example, the systems and methods can also be used to replace other valves, such as a mitral valve, a pulmonary valve, or a tricuspid valve. The device can also be used to repair or replace implanted biological prostheses when the prosthesis fails. Thus, while the present disclosure is described in the context of transcatheter heart valves having expansion members to replace native heart valve leaflets, it will be appreciated that other embodiments can be substituted for those cited.

[0106] As described above, both transcatheter aortic valve replacement (TAVR) and transcatheter pulmonary valve replacement (TPVR) have become viable and popular replacement procedures for low-to-moderate risk patients suffering from failed valves. Taking TAVR as an example, it is estimated that nearly 200,000 people in Europe and North America per year can be potential candidates for percutaneous valve replacement. This is good news for these low-risk patients, as the invasiveness of the percutaneous approach is less than surgical replacement.

[0107] Current TAVR methods include inserting a guidewire into the femoral artery. The guidewire is then sent into the aorta and through the aortic valve annulus. A catheter can then be advanced along the guidewire and to the valve site. A transcatheter heart valve (THV) can then be inserted through the catheter into the aortic valve annulus. Once positioned, the catheter can be removed to deploy the THV. Some THVs are self-expanding, meaning that once sheathed, the valve can automatically expand into the native valve annulus. Other THVs are balloon-expandable, meaning that a balloon can be set in the inner frame of the THV to expand to open the THV. There are certain limitations to both the design of current THVs and the methods of inserting current THVs.

[0108] FIG. 1A is a cross-sectional schematic view of a prior art THV in the aorta 10, which illustrates a problem associated with current THV designs. As described above, the THV is inserted into the annulus of the valve and opens between the native leaflets 12. The frame 14 of the THV abuts the native leaflets 12 and the vessel wall at the valve annulus. The frame 14 is typically a lattice-type structure that allows the THV to both grasp the vessel wall and allow some amount of blood to flow from the interior of the frame 14 to the exterior of the frame 14. Located within the frame is a plurality of THV leaflets 16 that open and close as blood is pumped through the THV, as indicated by the direction of blood flow 18. One problem with current THV designs is the occurrence of thrombus 20 in the area between the THV leaflets 16 and the frame 14. It has been shown that a major factor in the formation of thrombus 20 is the lack of proper blood flow through the frame 14. As can be seen from the figure, the native leaflets 12 remain adjacent to the frame 14 and can prevent blood flow through the frame 14. As will be described in greater detail herein, this flow stagnation or "flow stasis" can cause thrombus 20 to form between the THV leaflets 16 and the frame 14. FIG. IB is a top view of the prior art THV shown in FIG. 1A. As can be seen, the thrombus 20 impedes the opening and closing of the THV leaflets 16 and, thus, reduces the overall movement of the THV leaflets 16.

[0109] Figure 2A is a cross-section of the aorta 10 and illustrates various structures of the aorta 10 that are considered when implanting a THV. The sinotubular junction 22 is the transitional area of the ascending aorta 10 between the tubular portion (proximal) of the aorta 10 and the sinus (e.g., the Valsalva sinus 24). The valve annulus 26 is the opening between the native leaflets 12 that allows blood to flow proximally through the valve. The THV is positioned within the valve annulus 26. Coronary arteries, such as the coronary ostia 28, exit the aorta 10 at an area distal to the sinotubular junction 22. FIG. 2B is another cross-sectional schematic view of a prior art THV. 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 leaflets 12 and the THV leaflets 16. The neo-sinus is characterized by including a flow stasis area 32 that can cause the thrombus described above.

[0110] Figure 2Cis a cross-sectional view of a valve described herein, which illustrates a preferred design to reduce thrombosis between the tubular frame 102 and the valve leaflets 110 of the valve. As shown in this figure, if the native leaflets 12 are removed from the outer surface of the tubular frame 102 and pressed against the vessel wall 34, a transverse flow area 36 is created. This transverse flow area 36 enables blood to move freely through the porous (e.g., lattice network) tubular frame 102, such that there is no flow stagnation, thereby reducing the likelihood of thrombosis. In some examples described herein, the native leaflets 12 are pushed away from the outer surface of the tubular frame 102 by expansion members 106 that extend radially outward from the tubular frame 102. In the case where the valve 100 is implanted in the aorta 10, the transverse flow area 36 can also increase blood flow to the coronary arteries. Again, it should be understood that the devices described herein can also be used in valves other than the aortic valve, but the aorta provides a good representation of how the devices are used in the body of a patient.

[0111] Various devices and methods for providing and delivering a valve having expansion members to replace native valve leaflets are disclosed, and exemplary embodiments of these devices and methods will now be described with reference to the drawings.

[0112] Figure 3 is a perspective view of an exemplary valve 100 according to some embodiments of the present disclosure. The 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 a native valve. It is contemplated that the tubular frame 102 can have a cylindrical shape, as shown. It is also contemplated that the tubular frame 102 can have a flared mouth at either the first end 108a or the second end 108b of the tubular frame 102. For example, it is contemplated that the tubular frame 102 can have an hourglass shape, with a narrower middle section inserted near the valve annulus. The first end 108a can then flare open near the valve annulus proximate the sinotubular junction; the second end 108b can flare open distal to the valve annulus, so as to fit the anatomical structure of the vessel. It is also contemplated that the tubular frame 102 can have only one flared mouth, either above or below the valve annulus.

[0113] The tubular frame 102 can have a collapsed configuration and an expanded configuration. If the valve is to be used in a transcatheter method, the valve can have a collapsed configuration that can be inserted through a catheter and an expanded configuration to expand and fill the valve annulus. Typical catheters for TAVR range from about 3.00 mm to about 8.00 mm in inner diameter. Thus, it is contemplated that the valve 100 can have an overall diameter from about 3.00 mm to about 8.00 mm when the tubular frame 102 is in the collapsed configuration. The native valve annulus of a human can range from about 15 mm to about 30 mm. Thus, it is contemplated that the tubular frame 102 can have a diameter from about 15 mm to about 30 mm when the tubular frame 102 is in the expanded configuration. When considering manufacturing the device, it can be beneficial to develop a range of devices that can be installed in different sized annuli. For example, a manufacturer can design multiple sizes of the valve 100 so that a physician can select a size that fits an individual patient. As used herein, the term "about" or "approximately," as applied to any numerical value or range of values, refers to suitable dimensional tolerances that allow the components or collections of components to perform as described herein. More specifically, "about" or "approximately" can refer to a numerical range of ±20% of the value, e.g., "about 90%" can refer to a numerical range of 71% to 99%; "about 15 mm" can refer to a numerical range of 12 mm to 18 mm.

[0114] It is contemplated that the tubular frame 102 can be a self-expanding or balloon-expandable configuration, as described above. For a self-expanding configuration, the tubular frame 102 can be made of a material that is capable of automatically recovering its shape once it is unsheathed. In some examples, the material can be made of a shape memory material (e.g., Nitinol), and the expanded configuration of the tubular frame 102 can be accomplished by heat setting the material to the expanded configuration. In a self-expanding or balloon-expandable configuration, the tubular frame 102 can include, but is not limited to, Nitinol, stainless steel, MP35N, tungsten, cobalt-chrome, and / or similar materials, or any combination or alloy thereof. It is also contemplated that the tubular frame 102 can include a polymer, including but not limited to polyamide, polyether ether ketone, or similar materials.

[0115] As described above, one way to reduce thrombosis of the leaflets is to promote blood flow through the tubular frame 102, or in other words, to reduce flow stasis between the valve leaflets 110 and the tubular frame 102. Thus, 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, a laser cut metal tube, a laser cut polymer tube, and / or similar. In some examples, the outer surface 112 of the tubular frame 102 can be defined by a lattice network, as shown in FIG. 2. The lattice network can be defined by any number of shapes. Figure 3 Figure 3 ​An exemplary lattice network having a plurality of diamond-shaped portions 114 is shown. The diamond-shaped portions 114 can provide apertures 116 to allow blood to flow from the lumen 118 of the tubular frame 102 to a location outside of the tubular frame 102. The diamond-shaped portions 114 can also facilitate expansion of the tubular frame 102 from its closed configuration to an expanded configuration. Other lattice networks can also be contemplated, such as honeycomb structures (as shown), triangles, and / or the like. Figures 6-10

[0116] The tubular frame 102 can define a lumen 118. Inside the lumen 118 can be a plurality of valve leaflets 110. In some examples, the valve 100 can include three valve leaflets 110, as shown, which corresponds to the anatomical structure of a native aortic valve. It is contemplated that a configuration can be provided in which the valve 100 has only two valve leaflets 110 and can operate in the same manner as a three-leaflet configuration, considering, for example, where the valve 100 is replacing a mitral valve. The material for the valve leaflets 110 can include animal material, including but not limited to porcine pericardial tissue or allograft human tissue. The valve leaflets 110 can include synthetic polymers, engineered tissue, and / or the like. In some examples, each valve leaflet 110 can be connected to the tubular frame 102 by an attachment arm 120. The attachment arm 120 can include an adhesive to connect the valve leaflet 110 to the tubular frame 102, or the valve leaflet 110 can be mechanically connected, such as by a suture, a hook, a wire loop, or other clasp that holds the valve leaflet 110 to the tubular frame 102.

[0117] 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 can be shorter than the length 111 of the tubular frame 102. For example, it is contemplated that the leaflets 110 can be positioned at a location between the first end 108a and the second end 108b of the tubular frame 102. In some examples, the valve leaflets 110 can have a first end 122a proximate the first end 108a of the tubular frame 102, and a second end 122b that terminates at a location between the first end 108a and the second end 108b of the tubular frame 102. The second end 122b of the valve leaflets 110 can be, for example, about halfway between the first end 108a and the second end 108b of the tubular frame 102. As will be described herein, the second end 122b of the valve leaflets 110 can be at the height of the expansion member 106. Figure 3 ​An example of a gap between the tubular frame 102 and the valve leaflets 110 is shown. The gap is shown to provide a detailed view of the lumen 118 and other features. It is contemplated that the valve leaflets 110 occupy the entire lumen 118 such that there is no gap. This can prevent blood from flowing around the valve leaflets 110 instead of through the valve leaflets 110.

[0118] In some examples, the valve 100 can have a flared member 106 that extends radially outward from the tubular frame 102. The flared member 106 can be a feature of the valve 100 that pushes the native leaflets 12 away, e.g., into their respective coronary cusps, such that the native leaflets do not contact the outer surface 112 of the tubular frame 102. For example, Figure 2C An example flared member 106 that pushes the native leaflets 12 away from the tubular frame 102 is depicted. The flared member 106 can be various shapes and designs for exerting force on one or more of the native valve leaflets when the valve 100 is deployed inside a blood vessel. These shapes can include arms, continuous flanges (e.g., skirts), flanged flanges, and / or similar shapes or combinations thereof, as will be described in greater detail herein.

[0119] In some examples, the flared member 106 can include a plurality of arms 124 that extend from the tubular frame 102, as shown. Any number of arms 124 can extend from the tubular frame 102. In some examples, the arms can be cylindrical, rectangular, flat, pigtail, or any combination thereof. For example, the arms 124 can be cylindrical wire, as shown. Figure 3 Figure 3 ​In some examples, the arms 124 can be designed to not obstruct the vasculature near the native valve being replaced. For example, when the valve 100 is implanted into the aorta, the arms 124 can be designed to not obstruct blood flow to the coronary arteries. This can be accomplished by providing arms 124 that are spaced sufficiently apart around the tubular frame 102 so as to avoid the coronary arteries, and this positioning can be aided by fluoroscopy. It is also contemplated that each individual arm 124 can have a diameter that is no greater than the diameter of the interior lumen of the coronary arteries, so as to minimize inadvertent obstruction of the coronary arteries. For example, the average interior lumen diameter of the left coronary artery can be approximately 4.5 mm, while the average interior lumen diameter of the right coronary artery can be approximately 2.5 mm to approximately 4.0 mm. Thus, it is contemplated that each individual arm 124 can have a diameter (or width, in the case of arms that are not cylindrical) that is significantly less than the average interior lumen diameter of the coronary arteries. Thus, each arm 124 can have a diameter (or width) that is equal to or less than 3.00 mm, such as equal to or less than 1.00 mm. The length of each arm 124 can also be tailored so that the vasculature is not obstructed, as will be described in greater detail herein. If the arms 124 do not reach the surrounding vasculature, such as when the length of each arm 124 is tailored to avoid the vasculature (if necessary), the diameter of the arms 124 can be greater. To this end, it is contemplated that the arms 124 can be greater than 3.00 mm.

[0120] In some examples, as Figure 3 shown, the placement of the expansion member 106 on the tubular frame 102 can correspond to the location of the second end 122b of the valve leaflets 110. To illustrate, the first end 122a of the valve leaflets 110 (the top in Figure 3 ) can be coplanar or substantially coplanar with the first end 108a of the tubular frame 102. The second end 122b of the valve leaflets 110 can be positioned down the length 111 of the tubular frame 102, such as, but not limited to, approximately at the halfway point of the frame, as Figure 3 shown. In these examples, the expansion member 106 can be positioned such that it is attached to the tubular frame 102 at a location proximate to the second end 122b of the valve leaflets 110. By positioning the expansion member 106 coplanar with this end of the valve leaflets 110, the expansion member 106 can act as a marker to show the proper depth of insertion of the valve 100 and can act as a marker to show whether the valve 100 is tilted with respect to the annulus. The expansion 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.

[0121] The expansion member 106 can have a collapsed configuration and an expanded configuration. Figure 3The valve 100 is shown in an expanded configuration, which is the configuration that the valve 100 takes when it is deployed inside a blood vessel. As described above, the valve 100 can be inserted into a blood vessel via a catheter. As the valve 100 is advanced into the blood vessel and before the valve 100 is deployed, the expansion member 106 can also be collapsed to fit within the catheter. The collapsed configuration of the expansion member 106 is shown in more detail in Figure 4 .

[0122] Figure 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 expansion member 106 can also have a collapsed configuration to fit within the catheter 402. The expansion member 106 can be made of a material that is capable of automatically recovering its shape once it is unsheathed and allowed to expand. In some examples, the expansion member 106 can be made of a shape memory material, such as Nitinol, and the expanded configuration of the expansion member 106 can be accomplished by heat setting the material to the expanded configuration before the valve 100 is loaded into the catheter 402. The expansion member 106 can also include, but is not limited to, stainless steel, MP35N, tungsten, cobalt-chrome, and / or similar materials or any combination or alloy thereof. In some examples, the expansion member 106 can include a polymer, as described above with reference to the material of the tubular frame 102.

[0123] As shown in the example of Figure 4 , the valve 100 can also include an expandable balloon placed within the plurality of valve leaflets 110. In a balloon-expandable configuration, the valve 100 can be deployed into a blood vessel and positioned in its implantation site. The valve 100 can then be fully unsheathed, thereby allowing the expansion member 106 to expand into place. The tubular frame 102 can then be expanded to its expanded configuration by opening the expandable balloon, which can then be removed from inside the valve 100.

[0124] As described above, in some examples, the expansion member 106 can enable a physician to place the valve 100 at the proper height within the annulus. To aid in proper placement of the valve 100, in some examples, the expansion member 106 can be connected to the tubular frame 102 at a location proximate to the second end 122b of the valve leaflets 110. This can provide a region 404 on the tubular frame 102 that is visible in fluoroscopy. The region 404 where the expansion member 106 meets the tubular frame 102 can be used for checking to ensure that the valve: (1) is inserted at the proper height relative to the annulus; and (2) is not tilted relative to the annulus.

[0125] Figure 5This is a side view of a partially sheathed, constricted valve 100 according to some embodiments of the present disclosure. The valve 100 may be partially sheathed to allow the dilator 106 to open into its dilating configuration. In a self-dilating configuration, the valve 100 may remain partially sheathed when the valve 100 is positioned. If the self-dilating valve 100 is partially sheathed, the tubular frame 102 may remain constricted for proper placement. Figure 5 An expanded dilator 106 is also shown. The dilator 106 may have a slight bend toward a second end 108b of the tubular frame 102. While not desirable, the downward bend allows the dilator 106 to engage the natural leaflet within the anatomical structure before the valve 100 is fully in place. The valve 100 can then be advanced further until the dilator 106 is substantially parallel to the valve annulus (or perpendicular to the tubular frame 102). This vertical placement of the dilator 106, combined with the region 404 where the dilator 106 meets the tubular frame 102, can be used to ensure that the valve 100: (1) is inserted at an appropriate height relative to the valve annulus; and (2) is not tilted relative to the valve annulus. In some examples, the downward bend of the dilator 106 may also provide mechanical feedback to the physician as the valve 100 is inserted. For example, the dilator 106 may provide some resistance when it contacts the natural leaflet, and may provide even greater mechanical feedback as it reaches the height of the valve annulus.

[0126] In some examples, the dilation member 106 may include mechanical features to prevent the valve 100 from being inserted too deeply into the valve annulus. One such mechanical feature may include a stop at the region 404 where the dilation member 106 meets the tubular frame 102, the stop including a tab. These stops ( Figure 5 (Not shown in the figure) can be positioned on the tubular frame 102 at a location opposite the bend of the dilator 106 (i.e., at the top of arm 124 in the figure). When the valve 100 is inserted into the anatomical structure and the dilator 106 opens and lifts as the valve 100 advances, a stop can function to prevent the arm from lifting beyond a certain height. The dilator 106 can also be more rigid at its junction with the tubular frame 102 than at its furthest point from the tubular frame 102. This can be facilitated by having a thicker material near the tubular frame and a thinner material further away from the tubular frame 102. This configuration allows the dilator 106 to gently apply force to the natural valve leaflets while also providing rigid support around the valve annulus and preventing the valve 100 from inserting beyond the annulus.

[0127] Figure 6 This 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...Figures 3-5 The illustrated diamond lattice. It is also contemplated that the lattice network includes a plurality of honeycomb portions 602 that define the holes 116. The honeycomb portions 602 can also facilitate the expanded and contracted configurations described herein. Figure 7 is a side view of a contracted valve 100 within a catheter 402 according to some embodiments of the present disclosure. This figure illustrates how the honeycomb portions 602 can assist the valve 100 in contracting to fit into the catheter 402. Figure 8 is a side view of a partially sheathed contracted valve 100 according to some embodiments of the present disclosure. Figure 8 shows features similar to those shown in Figure 5 with the exception that the tubular frame 102 has a honeycomb structure.

[0128] Figure 9 is a perspective view of a valve 100 having an expansion member 106 that is a continuous flange 902 according to some embodiments of the present disclosure. As described above, the shape of the expansion member 106 can take on a variety of shapes as more than one shape can facilitate pushing against the native leaflets from the outer surface of the tubular frame 102. The previous examples, such as Figures 3-8 , show expansion members 106 that include a plurality of arms 124 according to some examples. Figure 9 shows that the expansion member 106 is a continuous flange 902. The continuous flange 902 can be similar to a skirt that surrounds the tubular frame 102. In some examples, the continuous flange 902 can also prevent paravalvular leakage as blood that is blocked from flowing around the tubular frame 102 by the continuous flange 902 must flow through the valve leaflets 110. While the continuous flange 902 can be solid as shown, it is not required to be solid. The continuous flange 902 can include holes, pores, or a lattice network. The lattice network can be the same as the tubular frame 102 or the expansion member 106 can have a different lattice network than the tubular frame 102. The continuous flange 902 can also include features that provide friction on the native leaflets, such as ridges, ribs, or the like, such that the continuous flange 902 maintains a grip on the native leaflets.

[0129] Figure 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 can interact with conventional THV systems to improve conventional valves and also reduce the risk of thrombus formation in the valve. Take the example of a THV having a stent frame and a plurality of valve leaflets disposed within the stent frame. This configuration does not include any features that push the native leaflets away from the stent frame to facilitate the formation of the transverse flow region 36 described in Figure 2C . Figure 10 shows an example sleeve 1000 that can provide a solution for these conventional THVs.

[0130] A cuff 1000 for a valve can have a tubular frame 102 and a dilation member 106. However, the cuff 1000 can not have valve leaflets 110 disposed in the lumen 118 of the tubular frame 102. When the cuff 1000 is deployed, the inner surface 1002 of the cuff 1000 can contact the outer surface of a stented valve. One way this can be performed is to first implant the cuff 1000 in a native valve that is being replaced. The dilation member 106 of the cuff 1000 can push the native valve leaflets against the vessel wall. The cuff 1000 can then be expanded in the annulus by either a self-expanding or balloon expansion method as described above. A conventional THV can then be inserted into the lumen 118 of the tubular frame 102 and expanded to contact the inner surface 1002 of the cuff 1000. Alternatively, the cuff 1000 can be combined with a conventional THV, after which the combined system is implanted in the patient. This can be done on the back table in the operating room, or it can be done by manufacturing a stent with the cuff 1000 already attached to a conventional THV.

[0131] In some examples of a cuff 1000 for a valve, the valve can include internal attachments 1004 to contact the outer surface of a stented valve located in the lumen 118 of the cuff 1000. The internal attachments 1004 can enable the cuff 1000 to maintain stable contact with a stented valve located in the lumen 118 of the cuff 1000. This can include preventing the cuff 1000 from rotating relative to the stented valve and / or preventing the cuff 1000 from sliding axially (e.g., up and down) along the length of the stent frame, or vice versa. These internal attachments 1004 can include tabs, hooks, grooves, and / or the like that mate with the lattice network of the stented valve.

[0132] Figure 11A and 11B is a top cross-sectional view of a valve 100 located within a valve annulus 26 according to some embodiments of the present disclosure. Figure 11A depicts a tubular frame 102 in a contracted configuration within a valve annulus 26. When the tubular frame 102 is contracted, it can form a bundled configuration as shown in Figure 11A In other examples, the tubular frame 102 is not bundled, but the lattice-type network is contracted on itself, meaning that the tubular frame 102 remains circular when in the contracted configuration. Examples of such a contracted configuration are shown in Figure 4 , 5 , 7, and 8. Figure 11A The dilation member 106 in Figure 11A depicts a partially sheathed, self-expanding type valve 100 with the tubular frame 102 contracted within a catheter and the dilation member 106 open to exert force on the native valve leaflets. Figure 11AThe example shown can also depict the fully sheathed balloon expandable valve 100 that has not yet been balloon expanded.

[0133] The expansion member 106 can extend a length 1102 from the tubular frame 102. The exact length 1102 of the expansion member 106 depends at least on the diameter 1104 of the valve annulus 26 in which the valve 100 is implanted. To illustrate the length 1102 of the expansion member 106, reference can be made to the diameter 1106A of the partially expanded valve 100. Figure 11A The diameter 1106A in the can refer to the length from the first end of the expansion member 106 to the second end that is diametrically opposite the first end. Thus, when the expansion member 106 is expanded but the tubular frame 102 remains collapsed, the diameter 1106A will be the overall diameter of the valve 100. In any of the examples described herein, the diameter 1106A of the collapsed valve 100 can be greater than the diameter 1104 of the valve annulus 26. This of course enables the expansion 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 expansion member 106 can extend beyond the valve annulus 26. To ensure that this portion 1108 of the length 1102 extends beyond the valve annulus 26, it is contemplated that the length 1102 to which the expansion member 106 can extend from the tubular frame 102 is 5 mm to 15 mm (e.g., about 5 mm to about 10 mm; or about 10 mm to about 15 mm).

[0134] Figure 11B The tubular frame 102 and the expansion member 106 are depicted both within the valve annulus 26 in the expanded configuration. In other words, Figure 11B The fully sheathed self-expanding valve 100 can be depicted, or the balloon expandable valve 100 can be depicted that has been balloon expanded. As Figure 11B As shown, once the valve 100 is deployed and fully expanded, the tubular frame 102 is about the same size as the valve annulus 26, i.e., the tubular frame fills the valve. Although the length 1102 of the expansion 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 expansion member 106. The expansion of the expansion member 106 can further press the native leaflets against the vessel wall. It is also contemplated that the length 1102 of the expansion member 106 can be tailored to prevent inadvertent occlusion of the vasculature proximate the valve annulus 26. A shorter length 1102 can prevent inadvertent occlusion of the vasculature when the valve 100 is fully expanded, and a longer length 1102 can provide greater axial force to the native valve leaflets.

[0135] Figures 12A-12DAn exemplary procedure for inserting and deploying a valve 100 in a valve annulus 26 is depicted in accordance with some embodiments of the present disclosure. These figures depict a valve 100 placed in an aortic valve. However, as noted above, the present disclosure is not limited to aortic valve replacement, and the present system and method can be used to replace other valves, such as a mitral valve, a pulmonary valve, or a tricuspid valve.

[0136] Figure 12A A contracted valve 100 is advanced via a catheter 402 to the vicinity of a native valve being replaced. As can be seen from the figure, the contracted valve 100 can be fully sheathed, and the expansion member 106 can be contracted over the tubular frame 102. The catheter 402 and valve 100 can be inserted into the native valve by advancing both along a guidewire 1202 placed in the native valve.

[0137] In Figure 12B , the valve 100 is partially unsheathed to allow the expansion member 106 to expand. Figure 12B The exemplary valve 100 in is shown as being slightly curved towards the bottom of the valve 100, as described above. This slight curvature can enable the expansion member 106 to engage the native leaflets 12 when the valve 100 is held above the valve annulus 26. The valve 100 can then be advanced towards the valve annulus 26.

[0138] Figure 12C In Figure 2C , the valve 100 is advanced into the valve annulus 26. As the expansion member 106 contacts the native leaflets 12, the expansion member 106 can begin to extend and straighten. As shown, the expansion 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 a transverse flow area 36 (as shown in By pushing the native leaflets 12 away from the tubular frame 102, transverse flow through the tubular frame 102 can reduce 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 used in existing SAVR replacement valves. When reference is made to a native valve, it will be understood that this step can also refer to a defective existing replacement valve.

[0139] As described herein, the position of the expansion member 106 can help the physician assess the correct placement of the valve 100. For example, the physician can view the placement of the valve 100 (e.g., under fluoroscopy), and when the expansion member 106 is perpendicular or approximately perpendicular to the device (as shown in Figure 12CAt this point (as shown), the physician can ensure that the valve is placed at the proper deployment height. The physician can also confirm that the expansion member 106 is parallel to the valve annulus 26. As described above, the expansion member 106 can be placed at a location proximate to the end of the valve leaflets 110, and in this case, the expansion member 106 can also ensure proper placement of the valve leaflets 110.

[0140] Figure 12C It is also shown that the valve 100 has exited the catheter 402. Thus, in this example, if the valve 100 is a self-expanding design, the tubular frame 102 can now automatically expand to its expanded configuration; in a balloon-expanding design, the balloon can be inflated to expand the tubular frame 102.

[0141] In Figure 12D the valve 100 is deployed at the proper height in the valve annulus 26 and is fully expanded. Thus, the tubular frame 102 fills the valve annulus 26. The expansion member 106 can conform to the shape of the vessel wall 34. Once fully deployed, the physiology and fluid dynamics of the implanted valve 100 can closely mimic that of a native valve.

[0142] Figure 13 is a flowchart of an exemplary method 1300 for replacing a defective valve in accordance with some embodiments of the present disclosure. The method 1300 can begin at block 1305, where a valve 100 is delivered proximate to a defective valve. The valve 100 delivered proximate to the defective valve can include, for example, a tubular frame 102 including 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 108a to a second end 108b of the tubular frame 102. The second end 108b of the tubular frame 102 can be proximate to 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 expansion member 106 having a collapsed configuration and an expanded configuration, where in the collapsed configuration the expansion member 106 is folded toward the second end 108b of the tubular frame 102. In the expanded configuration, the expansion member 106 can extend radially outward from the tubular frame 102.

[0143] At block 1310, the expansion member 106 is expanded from its collapsed configuration to its expanded configuration. As described herein, expansion of the expansion member 106 can be independent of the tubular frame 102. This enables the expansion member 106 to open to its expanded configuration before the valve 100 is fully in place. Thus, as the valve 100 is advanced further into the defective valve (e.g., into the valve annulus), the expansion member 106 can exert force on the defective valve leaflets. In some examples, the expansion member 106 can be expanded by partially unsheathing the valve 100.

[0144] At block 1315, the second end 108b of the tubular frame 102 is advanced between the defective valve leaflets. As the tubular frame 102 is advanced, the expansion member 106 can contact the defective valve leaflets.

[0145] At block 1320, the defective valve leaflets are urged by the expansion member 106 against the blood vessel wall 34 (e.g., the inner wall of the blood vessel). As described herein, the defective valve leaflets can thus be pushed away from the outer surface 112 of the tubular frame 102, and blood can flow through the tubular frame 102. This can reduce the risk of thrombosis in the area between the valve leaflets 110 and the tubular frame 102.

[0146] The method 1300 can end after block 1320. In some examples, the method 1300 can also include taking a fluoroscopic image of the valve 100 to confirm that the expansion member 106 is approximately parallel to the annular plane of the defective valve. The fluoroscopic image can also confirm that the expansion member 106 is approximately perpendicular to the tubular frame 102. This can help ensure proper height of the valve within the annulus. This step can also confirm that the valve 100 is not tilted with respect to the annulus.

[0147] In some examples, the method 1300 can also include fully unsheathing the valve 100. If the valve 100 is a self-expanding design, fully unsheathing can enable the tubular frame 102 to fully expand and contact the blood vessel wall. If the valve 100 is a balloon-expandable design, a balloon can be disposed between the plurality of valve leaflets 110. When the valve is properly inserted, the entire valve 100 can be unsheathed, and the balloon can be expanded such that the valve 100 expands and contacts the blood vessel wall. The balloon can then be removed from the valve 100.

[0148] As described above, the delivery of valve 100 into a natural valve (e.g., the natural aorta) has been referenced throughout this disclosure. However, this disclosure is not limited thereto. It is also conceivable that the system described herein can be implanted into an existing SAVR replacement valve. In this case, the steps described herein can be similar, except that the expansion member 106 can, for example, apply a radial force to the defective SAVR valve leaflet. Therefore, when the above reference is made to a defective valve or defective leaflet, it can be understood that it refers to a defective natural valve or leaflet, or a defective SAVR replacement valve or leaflet.

[0149] It should be understood that the embodiments and claims disclosed herein are not limited to the details of the construction and arrangement of the components set forth in the specification and shown in the drawings. Rather, the specification and drawings provide examples of the contemplated embodiments. Other embodiments are further conceived from the embodiments and claims disclosed herein and can be practiced and performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be construed as limiting the claims.

[0150] Therefore, those skilled in the art will understand that the concepts upon which this application and claims are based can readily be used as the basis for designing other structures, methods, and systems for achieving the objectives of the embodiments and claims set forth in this application. Therefore, it is important that the claims be considered to include such equivalent structures.

[0151] Furthermore, the purpose of this abstract is to enable the general public, especially those skilled in the art unfamiliar with patent and legal terminology, to quickly determine the nature and essence of the technology disclosed in this application through a cursory examination. The abstract is not intended to limit the claims of this application, nor is it intended to restrict the scope of the claims in any way. Rather, the invention is intended to be defined by the appended claims.

Claims

1. A valve, comprising: A tubular frame having a porous outer surface and a length extending from a first end to a second end; A plurality of valve leaflets disposed within the tubular frame, wherein the plurality of valve leaflets have a first end and a second end, wherein the first end of the plurality of valve leaflets is proximate to the first end of the tubular frame, and the second end of the plurality of valve leaflets extends partially between the first end and the second end of the tubular frame; and An expansion member extends radially outward from the tubular frame at a position near the second end of the plurality of valve leaflets along the longitudinal axis of the tubular frame. in: The dilation member is configured to apply a pushing force in a direction away from the tubular frame to one or more defective valve leaflets when the valve is deployed, such that the pushed one or more defective valve leaflets do not contact the porous outer surface of the tubular frame, and the one or more defective valve leaflets are pressed against the vessel wall, thereby creating a transverse flow region that allows blood to move freely through the porous outer surface of the tubular frame.

2. The valve according to claim 1, wherein: The expansion member includes multiple arms; and The tubular frame is configured as a self-expanding structure or a balloon-expanding structure.

3. The valve according to claim 1, wherein, The expansion member includes a plurality of arms that are sufficiently spaced around the tubular frame to avoid the coronary arteries when implanted into the aorta.

4. The valve according to claim 1, wherein, The expansion member includes multiple arms that are sufficiently spaced around the tubular frame to avoid obstructing the coronary arteries when the valve is implanted in the aortic position.

5. The valve according to claim 2, wherein, The width of each of the plurality of arms is less than or equal to 3.0 mm.

6. The valve according to any one of claims 2-5, wherein, Each of the plurality of arms is a cylindrical wire.

7. The valve according to claim 6, wherein, The diameter of each of the plurality of arms is less than or equal to 3.0 mm.

8. The valve according to claim 1, wherein, The expansion member is a continuous flange.

9. The valve according to any one of claims 1-5 and 8, wherein, The expansion member extends 5 mm to 10 mm from the porous outer surface of the tubular frame.

10. The valve according to any one of claims 1-5 and 8, wherein, The expansion member extends 10 mm to 15 mm from the porous outer surface of the tubular frame.

11. The valve according to any one of claims 1-5 and 8, wherein, The first end of the plurality of valve leaflets is close to the first end of the tubular frame.

12. The valve according to claim 11, wherein, The second end of the plurality of valve leaflets is positioned approximately halfway between the first end and the second end of the tubular frame.

13. The valve according to any one of claims 1-5 and 8, wherein, The expansion member is configured to switch between a contraction configuration and an expansion configuration.

14. The valve according to any one of claims 1-4, wherein, The expansion member includes one or more radiopaque markers.

15. A valve, comprising: A tubular frame having a porous outer surface and a length extending from a first end to a second end; Multiple valve leaflets are disposed within the tubular frame; and An expansion member extends radially outward from the porous outer surface of the tubular frame at a position along the longitudinal axis of the tubular frame, from 5 mm to 15 mm. The expansion member is configured as follows: When the valve is deployed, a pushing force is applied to one or more defective valve leaflets in a direction away from the tubular frame, such that the pushed-down one or more defective valve leaflets do not contact the porous outer surface of the tubular frame, and the one or more defective valve leaflets are pressed against the vessel wall, thereby creating a transverse flow region that allows blood to move freely through the porous outer surface of the tubular frame; and It can switch between contractile and expansion configurations; and When the expansion member is in the expansion configuration, the expansion member bends toward the second end of the tubular frame.

16. The valve according to claim 15, wherein, The expansion member includes one or more radiopaque markers.

17. A valve, comprising: A tubular frame, the tubular frame including a porous outer surface and having a length extending from a first end of the tubular frame to a second end; Multiple valve leaflets are disposed within the tubular frame; and An expansion member that extends radially outward from the tubular frame at a position along the longitudinal axis of the tubular frame. The dilation member is configured to apply a pushing force in a direction away from the tubular frame to one or more defective valve leaflets when the valve is deployed, such that the pushed-down one or more defective valve leaflets do not contact the porous outer surface of the tubular frame, and that the one or more defective valve leaflets are pressed against the vessel wall, thereby creating a transverse flow region that allows blood to move freely through the porous outer surface of the tubular frame; and in: The porous outer surface of the tubular frame is defined by a lattice network; and The tubular frame is configured as a self-expanding structure or a balloon-expanding structure.

18. A sleeve for a valve, comprising: A tubular frame including a porous outer surface and an inner surface, the tubular frame having a length along the longitudinal axis of the tubular frame extending from a first end to a second end; and An expansion member extends radially outward from the porous outer surface of the tubular frame at a location along the longitudinal axis of the tubular frame and between the first end and the second end of the tubular frame. The expansion member is configured as follows: When the sleeve is deployed, a pushing force is applied to the defective valve leaflets in a direction away from the tubular frame, such that the defective valve leaflets do not contact the porous outer surface of the tubular frame and are pressed against the vessel wall, thereby creating a transverse flow region that allows blood to move freely through the porous outer surface of the tubular frame; and Switching between contractile and expansion configurations; in: When the expansion member is in the expansion configuration, the expansion member bends toward the second end of the tubular frame; The inner surface of the tubular frame is configured to contact the outer surface of the valve when the sleeve is deployed; and The porous outer surface of the tubular frame is defined by a lattice network.

19. The sleeve for a valve according to claim 18, wherein, The expansion member includes multiple arms.

20. The sleeve for a valve according to claim 19, wherein, The width of each of the plurality of arms is less than or equal to 1.0 mm.

21. The sleeve for a valve according to claim 19, wherein, The width of each of the plurality of arms is less than or equal to 3.0 mm.

22. The sleeve for a valve according to claim 19, wherein, Each of the plurality of arms is a cylindrical wire.

23. The sleeve for a valve according to claim 22, wherein, The diameter of each of the plurality of arms is less than or equal to 1.0 mm.

24. The sleeve for a valve according to claim 22, wherein, The diameter of each of the plurality of arms is less than or equal to 3.0 mm.

25. The sleeve for a valve according to claim 18, wherein, The expansion member is a continuous flange.

26. The sleeve for a valve according to any one of claims 18-25, wherein, The expansion member extends 5 mm to 10 mm from the porous outer surface of the tubular frame.

27. The sleeve for a valve according to any one of claims 18-25, wherein, The expansion member extends 10 mm to 15 mm from the porous outer surface of the tubular frame.

28. The sleeve for a valve according to any one of claims 18-25, wherein, The expansion member includes one or more radiopaque markers.

29. The sleeve for a valve according to any one of claims 18-25, wherein, The inner surface of the tubular frame includes an internal attachment configured to contact the outer surface of the valve and prevent the tubular frame from moving relative to the valve.

30. A valve system comprising: The support includes: A support frame, the support frame including an outer surface and defining an inner cavity, the support frame having a length along a longitudinal axis extending from a first end to a second end of the support frame; and Multiple valve leaflets disposed within the inner cavity; and A tubular frame having a porous outer surface and configured to contact the outer surface of the support frame, the tubular frame including expansion members extending radially outward from the tubular frame. The dilation member is configured to apply a pushing force in a direction away from the tubular frame to one or more defective valve leaflets when the valve system is implanted, such that the pushed-down one or more defective valve leaflets do not contact the porous outer surface of the tubular frame, and that the one or more defective valve leaflets are pressed against the blood vessel wall, thereby creating a transverse flow region that allows blood to move freely through the porous outer surface of the tubular frame; and One or more of the following: The tubular frame is positioned at a location on the outer surface of the stent frame such that the expansion member extends from the tubular frame to near the second end of the plurality of valve leaflets; The expansion member is configured to switch between a contraction configuration and an expansion configuration, wherein when the expansion member is in the expansion configuration and the tubular frame is in contact with the outer surface of the support frame, the expansion member bends toward a second end of the support frame; and The porous outer surface of the tubular frame is defined by a lattice network.

31. The valve system according to claim 30, wherein, The expansion member includes multiple arms.

32. The valve system according to claim 31, wherein, The width of each of the plurality of arms is less than or equal to 1.0 mm.

33. The valve system according to claim 31, wherein, The width of each of the plurality of arms is less than or equal to 3.0 mm.

34. The valve system according to claim 31, wherein, Each of the plurality of arms is a cylindrical wire.

35. The valve system according to claim 34, wherein, The diameter of each of the plurality of arms is less than or equal to 1.0 mm.

36. The valve system of claim 34, wherein, The diameter of each of the plurality of arms is less than or equal to 3.0 mm.

37. The valve system of claim 30, wherein, The expansion member is a continuous flange.

38. The valve system according to any one of claims 30-37, wherein, The expansion member extends 5 mm to 10 mm from the tubular frame.

39. The valve system according to any one of claims 30-37, wherein, The expansion member extends 10 mm to 15 mm from the tubular frame.

40. The valve system according to any one of claims 30-37, wherein, The plurality of valve leaflets have a first end and a second end, wherein the first end of the plurality of valve leaflets is close to the first end of the stent frame, and wherein the second end of the plurality of valve leaflets extends partially between the first end and the second end of the stent frame.

41. The valve system according to any one of claims 30-37, wherein, The expansion member includes one or more radiopaque markers.

42. The valve system according to any one of claims 30-37, wherein, The inner surface of the tubular frame includes an internal attachment configured to contact the outer surface of the support frame and prevent the tubular frame from moving relative to the support frame.

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