Geometric shape corresponding type heart valve replacement device

Abstract

A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more valve leaflets that is movable between an open configuration and a closed configuration. In some embodiments, the frame includes at least two frame sections that are coupled at a pair of cross-linking posts. In some embodiments, the device may be geometrically conformable to accommodate the shape and size of different vascular structures and / or to be sized to change while implanted within a growing patient.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 394,742, filed on August 3, 2022, which is hereby incorporated by reference in its entirety.

[0002] Field The disclosed aspects relate to valve replacement devices.

Background Art

[0003] Background The human heart includes a series of valves that ensure the proper flow of blood through the ventricles. Congenital defects, trauma, or other medical conditions can adversely affect the function of a person's native heart valves. Artificial heart valves have been developed to supplement or completely replace defective native heart valves.

[0004] Summary In one aspect, a valve replacement device is provided. The valve replacement device includes a valve frame defining an opening for fluid passage, valve leaflets coupled to the valve frame, and a sleeve coupled to the valve frame. The valve frame is expandable to allow an increase in the diameter of the opening. The valve frame has a plurality of holes therethrough. The valve leaflets are coupled to the valve frame using at least some of the plurality of holes through the valve frame. The valve leaflets have an open configuration in which the opening is exposed and a closed configuration in which the valve leaflets at least partially cover the opening. The valve leaflets are configured to be movable between the open and closed configurations over a range of opening diameter sizes. The sleeve is coupled to the valve frame using at least some of the plurality of holes through the valve frame. The sleeve has a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame.

[0005] In another aspect, a valve replacement device is provided. The valve replacement device includes a valve frame that defines an opening for fluid passage, a first valve tip coupled to the valve frame, and a second valve tip coupled to the valve frame. The valve frame is expandable to allow an increase in the diameter of the opening. The valve frame has a plurality of holes therethrough. The first and second valve tips are coupled to the valve frame using at least some of the plurality of holes through the valve frame. The first and second valve tips each have an outer edge. The first valve tip has an open configuration in which the opening is exposed and a closed configuration in which the first valve tip at least partially covers the opening. The second valve tip has an open configuration in which the opening is exposed and a closed configuration in which the first and second valve tips contact each other to at least partially cover the opening. The first and second valve tips are configured to be movable between the open and closed configurations over a range of opening diameter sizes. The first and second valve tips have a plurality of valve tip attachment points for connecting the first and second valve tips to the valve frame. The plurality of valve tip attachment points are positioned at non-uniform intervals from the outer edges of the first and second valve tips.

[0006] In another aspect, a valve replacement device is provided. The valve replacement device includes a valve frame that defines an opening for fluid passage, a first valve tip coupled to the valve frame, and a second valve tip coupled to the valve frame. The valve frame is expandable to allow an increase in the diameter of the opening. The valve frame has a plurality of holes therethrough. The first and second valve tips are coupled to the valve frame using at least some of the plurality of holes through the valve frame. The first and second valve tips each have an outer edge. The first and second valve tips each have at least one attachment tab. The first valve tip has an open configuration in which the opening is exposed and a closed configuration in which the first valve tip at least partially covers the opening. The second valve tip has an open configuration in which the opening is exposed and a closed configuration in which the first and second valve tips contact each other to at least partially cover the opening. The first and second valve tips are configured to be movable between the open and closed configurations over a range of opening diameter sizes.

[0007] Since the present disclosure is not limited in this regard, it should be understood that the foregoing concepts, as well as additional concepts to be considered below, may be configured in any suitable combination. Further, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting aspects when considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0008] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in various figures may be represented by the same numeral. For clarity, not all components are labeled in all the drawings. In the drawings:

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[0106] Detailed description Some aspects described herein include heart valve replacement devices that can be adapted to different implantation environments by varying size and / or shape. In some aspects, such geometrically conforming heart valve replacement devices may be adapted to fit different types of vascular structures and / or may be used in patients of different sizes. In some aspects, some of the heart valve replacement devices described herein may be used in growing patients and may grow with the patient.

[0107] In some aspects, it is also contemplated that the device may be used elsewhere in the vasculature away from the heart, for example, as a venous valve prosthesis.

[0108] According to one aspect, some aspects of the heart valve replacement device may also enable heart valve function in a variety of structural environments over a range of sizes. The inventors recognized the need for a heart valve replacement device that can vary in size and / or shape to accommodate different environments.

[0109] According to one aspect, some embodiments of the heart valve replacement device grow with the patient and maintain functionality over a certain size range as the size of the valve opening increases. Current heart valve prosthetics are designed for adults and, depending on the patient and condition, may remain implanted for decades at a time. Adult patients are typically required to undergo regular examinations to ensure that the valve has not narrowed or become displaced to ensure optimal function. In some cases, open-heart surgery may be required to adjust or replace the valve. In adults, the inner lumen diameter of the vasculature and heart size generally do not change significantly from year to year. However, in children, the vasculature and heart size increase significantly as they mature. As a result, the inventors have noticed that children who receive valve replacements with current devices need to undergo multiple procedures to implant an appropriately sized valve replacement device as they grow. The inventors recognized the need for a valve replacement device that is effective over a certain size range.

[0110] Some embodiments described herein are suitable for use in growing patients, but it should be understood that the heart valve replacement devices described herein are not limited to use in growing patients. The device may also be used in non-growing applications. For example, some embodiments may be used as adult transcatheter valves that can be sized after implantation, at least for reasons of addressing prosthesis-patient mismatch and paravalvular leakage that occur in at least existing transcatheter valves.

[0111] In some embodiments, a first valve replacement device may be implanted in the first few years of a patient's life, and a second valve may be disposed inside the initially implanted device so that the patient can avoid repeating open-heart surgery when the device reaches its fully expanded state.

[0112] In some embodiments, the valve replacement device is also contemplated to function as a valve within an expandable conduit, which may be a cylindrical tube connecting two heart structures or other expandable conduit systems. For example, the valve replacement device in some embodiments may be attached to a cylindrical tube made of an expandable synthetic material that acts as the right ventricle to the pulmonary artery catheter. In these embodiments, the valved conduit may be periodically expanded by transcatheter balloon dilation or other methods to accommodate the growth of the patient's body and / or adjusted to match the desired pressure and / or flow conditions.

[0113] Heart valve function can be characterized by different properties. One measure of heart valve function is the regurgitation rate, which is the amount of blood leaking backward through the valve against the intended direction of flow divided by the total amount of blood flowing through the heart valve in one stroke. A healthy and functional valve has a low amount of regurgitation. The inventors have recognized that in some cases, a regurgitation rate of 0% to 20% is desirable. Another measure of heart valve function is the amount of average and maximum intra- and extra-valvular pressure gradients exhibited by the valve. This pressure metric is important because it quantifies the valve function that allows unobstructed forward flow. The inventors have recognized that in some cases, a maximum intra- and extra-valvular pressure gradient of 0 mmHg to 40 mmHg on the right side of the heart and 0 mmHg to 30 mmHg on the left side of the heart is desirable.

[0114] In some embodiments, the valve replacement device includes one or more valve leaflets coupled to a frame. The valve leaflets surround an opening of the device through which blood can flow. The valve leaflets have an open configuration and a closed configuration. In the open configuration, the valve leaflets are spaced apart to expose the opening of the device and allow blood flow through the opening. In the closed configuration, the valve leaflets are joined to close the opening of the device and prevent backflow of blood. The valve leaflets move between the open and closed configurations based on the pressure differential across the valve during the cardiac cycle. In some embodiments, the device includes two valve leaflets. However, other numbers of valve leaflets may be used, such as three, four, five, or more. In some embodiments, the heart replacement device includes only one valve leaflet. The single valve leaflet may extend from one side of the frame to the other. In some embodiments, the valve leaflet is crescent-shaped, for example, a 3 / 4 to 1 / 2 crescent-shaped valve leaflet.

[0115] In some embodiments, the frame may include a pair of semi-elliptical frame sections connected by a pair of commissures. The frame sections curve away from each other laterally outward to form a half-hourglass shape. As the width of the surrounding vasculature expands, at the open ends, the two frame sections spread further apart to increase the opening of the device and correspond to growth by matching the cross-sectional area of the expanding lumen. Each valve leaflet may be attached to the inner perimeter of each of the frame sections to mimic the leaflet-to-vessel wall attachment lines of native venous valves.

[0116] In some embodiments, the device includes an outer frame support coupled to the frame. In some embodiments, the outer frame support may be a semi-rigid cylindrical mesh. The frame is attached inside the outer frame support and thereby held stably. Due to the rigidity of the outer frame support, the outer surface of the outer frame support presses against the inner wall of the vascular structure in which the device is implanted, keeping the lumen of the surrounding vascular structure open and maintaining the orientation and position of the device. The outer frame support can function similar to a stent and enables delivery of the device via catheter delivery or direct surgical implantation. However, it should be understood that in some embodiments, the frame may be used by itself without adding an outer frame.

[0117] According to one aspect, in some embodiments, the frame of the valve replacement device maintains a constant perimeter throughout the growth process (e.g., the valve tip attachment site is non-extensible), i.e., during growth, the perimeter does not stretch or grow longer. Instead, as the frame sections spread apart to accommodate growth, the height of the commissure decreases. In some embodiments of this non-extensible design, accommodation of radial growth is achieved by balloon expanding a plastically deformable material (e.g., steel, cobalt chrome, etc.). As a result, as the valve opening expands, the valve tips attached to the frame sections do not deform (i.e., do not stretch, grow longer, or deploy). The degree of valve tip junction (i.e., the length of the valve tip material in contact with other valve tips in the closed state) may also decrease as the opening expands.

[0118] In some embodiments, the frame sections of the frame are configured to maintain their shape as the device expands to accommodate growth, and thus the valve tips do not spread or stretch during the growth process.

[0119] In an alternative embodiment, rather than maintaining a constant perimeter length of the frame as the aperture of the device increases, the frame may be lengthened as the device increases in size. This may help to reduce the amount of height change that occurs in the device during expansion of the aperture. The frame may be made of any suitable material and / or constructed in any suitable configuration that allows the perimeter of the frame to increase in length as the device increases in size. For example, the frame may be made of an elastic material that can be elastically stretched and lengthened, include telescoping segments, include bio-erodible segments, or include any other suitable mechanism that allows the perimeter of the frame to increase in length as the frame segments move apart from each other.

[0120] In some embodiments, the frame may include segments having a bio-erodible outer sleeve with a core comprising telescoping or collapsible flexible segments. As the outer sleeve is eroded, the core is exposed. As the vascular structure expands, the core can be expanded or deployed by the radial tensile force applied to the frame to expand the frame.

[0121] In some embodiments of the valve replacement device, the frame expands laterally outwardly asymmetrically in that the frame sections move apart at different rates of change. The shape of each frame section is maintained throughout the growth / expansion, but the aperture may become larger in one direction than in the other direction. To achieve the asymmetric expansion, these embodiments may have frame sections made of materials of different stiffnesses or may have angled joints such that expansion is favored on one side over the other.

[0122] The frame and / or external frame support may be self-expanding or may be expanded by other means such as by balloon expansion.

[0123] The valve replacement device may be delivered by minimally invasive means, such as by a transcatheter approach, or may be implanted by open chest surgery.

[0124] In some embodiments, the curved profile of the arc of the frame section can be obtained by projecting an elliptical quadrant onto a cylinder. The cylinder is contemplated to represent the shape of the inner wall of the blood vessel. The radius of the cylinder is equal to the radius of the valve held by the valve frame. The other frame sections coincide with the projected curved profile but are mirrored with respect to the centerline of the cylinder. It should be understood that other frame section shapes and curved profiles are also contemplated. However, it is also contemplated that other possible ways of defining the shape of the frame section are contemplated and the present disclosure is not limited thereto. The frame section may also have other shapes.

[0125] In some embodiments, the valve replacement device may include a reinforcement mechanism such as a strut that connects two frame sections of the valve frame. Such a reinforcement strut may help maintain the shape of the valve frame during expansion. Some embodiments of the valve replacement device may include an upper reinforcement strut that connects two frame sections. This upper reinforcement strut may be attached to the frame at or near the top of the pair of intersections. The upper reinforcement strut may have a length greater than or equal to the perimeter of the frame opening at its maximum expanded diameter. The upper reinforcement strut may form a ring or an ellipse or may be asymmetrically shaped in the fully expanded state. In the unexpanded shape, the upper reinforcement strut may have a undulating profile that extends around the longitudinal axis of the valve replacement device such that, when viewed from above, the upper reinforcement strut has a circular or elliptical or asymmetric profile, regardless of the expanded state of the valve replacement device. In some embodiments, the upper reinforcement strut has undulations that provide a smaller diameter to the upper reinforcement strut before expansion of the frame, but allow the upper reinforcement strut to expand with the frame. The upper reinforcement strut may be composed of a material that has sufficient rigidity to provide reinforcement integrity to the frame when the frame expands, but has sufficient flexibility to allow the upper reinforcement strut to expand by straightening the undulations.

[0126] In other embodiments, the upper reinforcement strut may have a variety of different geometric forms that can be varied depending on the application of the valve replacement device. For example, the upper reinforcement mechanism may be diamond-shaped to allow the valve to be more easily compressed on a catheter for percutaneous transvenous or percutaneous transarterial valve deployment. Other shapes are contemplated and the present disclosure is not limited thereto.

[0127] Other shapes for the upper reinforcement mechanism are contemplated. As an example, the upper reinforcement function may include a plurality of expandable segments that connect frame sections instead of a single ring. These segments may be telescoping segments, or may be foldable or compressible to allow the mechanism to expand. The upper reinforcement strut may take a non-circular shape as long as the mechanism can expand with the frame and fit within the implanted environment.

[0128] Some aspects of the valve replacement device may include a reinforcement mechanism that is not attached to the juncture of the valve frame. As an example, some aspects may have a lower reinforcement strut that connects the respective lower sides of the frame sections to each other. The lower reinforcement strut may also have a corrugated shape, or other ways of being compressed or folded, that allows the lower mechanism to expand with the frame. Similar to the upper reinforcement strut, the lower mechanism may be composed of a material that has sufficient rigidity to provide additional structural strength to the valve frame while having sufficient flexibility to allow the lower reinforcement strut to expand and / or straighten or deploy.

[0129] The lower reinforcement strut may flare beyond the cylindrical surface of the opening of the valve frame to allow for device fixation to the native heart structure, or may be used as a fixation method in other applications, such as for valve-in-stent transcatheter deployment or valve-in-valve transcatheter deployment.

[0130] In other aspects, the lower reinforcement strut may have a variety of different geometric forms that can vary depending on the application of the valve replacement device. For example, the upper reinforcement mechanism may be diamond-shaped to allow the valve to be more easily compressed on the catheter for percutaneous transvenous or percutaneous transarterial valve deployment. Other shapes are contemplated and the present disclosure is not limited thereto.

[0131] The upper reinforcement strut and the lower reinforcement strut, or any other reinforcement strut, may be adjusted to change or control the shape of the valve when the valve expands. The material properties, geometry, thickness, etc. of the reinforcement strut may be modified to obtain a specific opening geometry with expansion. The reinforcement struts may differ in material, geometry, or thickness in order to obtain a specific opening geometry with expansion. One reinforcement strut may differ even in the material or thickness inside the reinforcement strut in order to obtain a unique opening geometry with expansion. In some embodiments, it is contemplated that the reinforcement struts may control the expansion of the frame to make the shape of the opening elliptical, or asymmetrical, or circular. Other shapes are also contemplated. For example, the reinforcement strut may be made thicker in material on one side, or shorter on one side, or made of a more rigid material on one side to ensure that that side does not expand as much as the other side of the frame.

[0132] Although the upper and lower reinforcement mechanisms have been described, it should be understood that some embodiments may include one or both of the upper and lower reinforcement mechanisms. Additionally, some embodiments may include additional mechanisms that may connect frame sections and be located between the upper and lower reinforcement mechanisms.

[0133] In some embodiments, the valve replacement device may include a plurality of holes spaced along the frame. These holes may act as attachment points for sutures and may assist in attaching the valve tip to the frame. In some embodiments, the valve tip has segments of additional protruding material that are attached to the frame via slots that are scattered along the length of the valve tip attachment line and are then mechanically fixed outside the frame.

[0134] Referring to the figures, certain non-limiting aspects are described in more detail. It should be understood that the various systems, mechanisms, and methods described in relation to these aspects may be used individually and / or in any desired combination, as the present disclosure is not limited to only the specific aspects described herein.

[0135] Figure 1A shows one aspect of a valve replacement implanted within a representative blood vessel. The valve replacement device 100 includes a frame 102 and an outer frame support 108. The frame 102 may be symmetric with respect to two frame sections 104 that converge at the commissural posts 110. Each frame section may be a U-shaped arc. The arc of each frame section 104 is backed by a valve leaflet 106. In the closed configuration of the device, the valve leaflets hang down and join to block the opening of the device, being draped over the frame sections 104. As blood flows through the blood vessel (flowing from bottom to top as seen in Figure 1A), the blood flow pushes the valve leaflets apart, exposing the opening and positioning the valve leaflets in the open configuration. When the blood flow begins to slow down, the valve leaflets rejoin to assume the closed configuration, preventing backflow of blood. As seen in Figure 1B, as the blood vessel around the device grows, the device expands along with the blood vessel and continues to function effectively as a replacement valve.

[0136] Figures 2, 3, and 4 show different perspective views of one aspect of the frame as it expands. Frame 102 shows the initial frame, while 102’ shows the frame after some expansion. As best seen in Figures 2 and 3, the opening of the frame expands from the pre-expansion opening 114 to the larger expansion opening 114’. Similarly, commissural post 110 shows the post before expansion, and 110’ shows that post after some expansion. At the pre-expansion baseline, the vertical height (axial length) of the frame may be 5 mm to 50 mm, and the inner diameter may be 5 mm to 50 mm.

[0137] In some embodiments, the ratio of the diameter to the height of the frame may be from about 0.5:1 to 2.5:1, or from 0.6:1 to 2.4:1, or from 0.7:1 to 2.3:1, or from 0.8:1 to 2.2:1, or from 0.9:1 to 2.1:1, or from 1:0 to 2:1, or 1.1:2.0, or from 1.2:1 to 1.9:1, or from 1.3:1 to 1.9:1, or from 1.3:1 to 1.8:1, or from 1.4:1 to 1.7:1, or from 1.5:1 to 1.8:1, or from 1.6:1 to 1.7:1, or from 0.6:1 to 2.5:1, or from 0.7:1 to 2.5:1, or from 0.8:1 to 2.5:1, or from 0.9:1 to 2.5:1, or from 1.0:1 to 2.5:1, or from 1.1:1 to 2.5:1, or from 1.2:1 to 2.5:1, or from 1.3:1 to 2.5:1, or from 1.4:1 to 2.5:1, or from 1.5:1 to 2.5:1, or from 1.6:1 to 2.5:1, or from 1.7:1 to 2.5:1.

[0138] As the frame expands, the two frame sections 104 move laterally away from each other. As the frame sections 104 move apart from each other, the height of the cross-linking posts 110 decreases. FIGS. 5A and 5B show the time progression of a frame expanding from a small-diameter configuration (left) to a large-diameter configuration (right). As can be seen from FIGS. 3 and 4, in some embodiments, as the frame expands, the frame may be expanded uniformly in the entire radial direction. In some embodiments, the spreading mechanism of the frame sections 104 that occurs during growth to expand the entire frame 102 may also maintain the perimeter length of each frame section 104. As seen in FIG. 5B, the pre-expansion opening 114 expands to a larger expansion opening 114' as the frame expands.

[0139] The frame may be made of nitinol, titanium, cobalt-chromium alloy, stainless steel, biodegradable polymer, bioabsorbable polymer, synthetic material, platinum iridium, magnesium or iron alloy, and / or any other suitable material.

[0140] In some embodiments, each valve tip 106 may have a three-quarter to one-half moon shape such that its concaved-out side conforms to the arc of the frame section 104 to which the valve tip is attached. The valve tip 106 may be stitched, adhered, or otherwise attached to the frame section. The length of the concave-in side or free edge 115 of the valve tip (see FIGS. 1A and 1B for an example of the free edge description) may be up to four times the maximum diameter of the valve in the baseline state / configuration, whereas the vertical height of the valve tip may be up to 2.5 times the maximum diameter of the valve in the baseline state / configuration. The center height of the valve tip may range from 0.2 to 0.8 times the height of the valve tip at the cross-linking post. As the frame expands, the valve tip-cross-link attachment angle increases and the free edge 115 of the valve tip becomes straight. The excess valve tip height ensures that there is sufficient engagement for the device to function effectively as a valve throughout the expansion range of the device. The coaption height may be up to three-quarters of the opening diameter before valve frame expansion. The illustrated embodiments show valve tips of equal size and shape that are symmetric with respect to each other, but the valve tips may be of different sizes and / or shapes relative to each other. In some embodiments, one or more smaller valve tips may form a crescent shape in the closed position and one larger valve tip may cover most of the valve opening in the closed position.

[0141] Although the dimensions of the valve tip are presented above, it should be understood that other sizes are contemplated. For example, the length of the free edge of the valve tip may be between two and six times, or other ranges. The vertical height of the valve tip may be between 1.5 and 3.5 times, or between 2.2 and 2.7 times, the diameter of the valve in the baseline configuration. The center height of the valve may be between 0.1 and 1 times the height of the valve tip at the cross-linking post. Other ranges are further contemplated.

[0142] The illustrated embodiments show a design that utilizes two valve tips, but designs that use three or more valve tips with two or more frame sections are also contemplated. Designs that use a single valve tip are also contemplated.

[0143] The valve leaflets can be made of a bioabsorbable polymer, a synthetic polymer, a tissue-engineered construct, a decellularized homologous tissue engineered valve leaflet, a thin film nitinol, an expanded PTFE membrane, a glutaraldehyde-treated bovine pericardium, a glutaraldehyde-treated porcine pericardium, a photooxidized bovine pericardium, a bovine jugular vein valve, or any other suitable composition or material. In some embodiments, the valve leaflets are made of a 0.1 mm thick expanded PTFE membrane (GORE PRECLUDE Pericardial Membrane) having a Young's modulus of approximately 60 MPa under physiological loading. Also contemplated are Young's modulus ranges for the valve leaflet material from 30 MPa to 4 GPa, or from 70 MPa to 4 GPa, or from 100 MPa to 4 GPa, or from 200 MPa to 4 GPa, or from 500 MPa to 4 GPa.

[0144] Figures 6A, 6B, 7A, and 7B show diagrams of the frame and the outer frame support at different stages of expansion according to one embodiment of the device. The outer frame support 108 in this embodiment is a mesh cylinder having open cells. As shown in FIGS. 1A and 1B, the outer frame support provides stability to the device and may also maintain the orientation of the frame with respect to the blood vessel 112. As the frame 102 expands, the mesh tube including the outer frame support 108 also expands, increasing its diameter and possibly reducing the height of the outer frame support while matching the diameter of the blood vessel.

[0145] The illustrated embodiment shows an outer frame support in the form of a mesh cylinder with continuous pores, but it should be understood that the outer frame support may take different forms. The outer frame support may have closed cells, or may have a mixture of continuous and closed cells. The outer frame support may also include a partially solid cylinder with expandable segments, or any other arrangement that allows the outer frame support to expand with the frame.

[0146] In some embodiments, the valve replacement device may include an outer flexible cover that may enclose the outer frame support, or, in the case of no separate outer frame support, may enclose the frame itself. The flexible cover may also prevent the formation of abnormal layers of fibrovascular tissue or granulation tissue, in addition to the internal growth of tissue into the outer frame support. The frame and the flexible cover may be chemically inert, or may be treated with compounds to impart desirable properties including, but not limited to, anti - adhesive or anti - thrombogenic properties.

[0147] Figure 8 shows one embodiment of a valve replacement device implanted in a blood vessel 112. In this embodiment, the outer frame support 108 is fastened to the blood vessel 112 by a series of sutures 118 spaced along the length of the outer frame support 108. The sutures 118 fix the outer frame support to the blood vessel, and as the blood vessel grows, the blood vessel exerts a radially outward force on the outer frame support, expanding the outer frame support and thereby expanding the frame 102. In some embodiments, the outer frame support may include a plurality of holes 116 for receiving such sutures.

[0148] In some embodiments, the outer frame support may be attached to the vasculature only at a single attachment location. For example, the outer frame support may be attached to the vasculature only along a single attachment line along the height of the device. In the embodiment shown in FIG. 9, the outer frame support 108 is attached to the blood vessel 112 along a single line 117. Having a single attachment location between the vasculature and the device may help accommodate axial growth of the vasculature in addition to allowing for changes in the height and diameter of the device. In some embodiments, the device may also include a proximal seal and a distal seal 119 at either axial end of the device. The proximal seal and the distal seal 119 may also prevent paravalvular leakage, stasis of blood flow, or otherwise abnormal blood flow profiles. In some embodiments, the valve may have an outer cover made of an expandable composite material that extends beyond the base of the valve. This material may be used as a sewing ring to secure the valve in the position of the native annulus. This may also be the only site of device attachment.

[0149] FIGS. 10, 11A, and 11B show another embodiment of the frame. In this embodiment, as the frame 202 expands, the frame sections 204 become longer and move apart from each other, increasing the size of the opening 214. 202’ shows the frame 202 after a certain amount of expansion. The frame section 204 represents the position and shape of the frame section before expansion, and 204’ represents the position and shape of the frame section after expansion. In some embodiments, as the opening diameter increases, the height of the commissural posts 210 and the overall height of the frame are maintained.

[0150] For an apparatus having a perimeter length of an elongated frame, in some embodiments, the valve tip is configured to increase in size as the opening diameter increases. For example, in some embodiments, the valve tip may be sutured to the frame section with excess material folded like an accordion between the sutures. As the frame section expands, the spacing between the sutures expands, unfolding the accordion-like pleats to provide an additional section of the valve tip to accommodate the elongation. In other embodiments, the valve tip is normally sutured to the frame section, but the valve tip is particularly flexible or extensible and simply stretches as the frame section expands.

[0151] The illustrated embodiment shows a symmetric valve frame having a circular opening and a uniformly expanding frame section, but it should be understood that the present disclosure is not limited thereto. In other embodiments of the device, the opening may be elliptical or otherwise irregular in shape to accommodate different structural environments and physiological valve applications.

[0152] Figures 12, 13A, 13B, and 13C show embodiments of a frame in which two frame sections expand asymmetrically. Frame 302 begins with a cross-linking post 310 of a certain height, and then, after expansion, frame 302' has a cross-linking post 310' of a reduced height due to the expansion. In these embodiments, the cross-linking post 310 or frame section 304 may be made unequal in some way to produce an asymmetric expansion. They may be flared inwardly between 5 degrees and 45 degrees, flared outwardly between 45 degrees or more, made the height before the valve frame expands non-uniform, made of different thicknesses, or composed of materials with different rigidities. In any case, when frame 302 attempts to expand with the vasculature, the two frame sections separate at different rates laterally, creating an elliptical opening 314.

[0153] Figures 14A through 14D show a frame 402 and aspects of a valve tip 406 that define an oval opening. In this aspect, frame section 404 is wider than in the previous aspect to generate an oval from a top view as seen in FIG. 14B. Crosslinking posts 410 are located on opposite sides along the major axis of the ellipse formed by the opening of the device. When the frame section branches, the opening of the device may remain in the same plane as the vertical cross-section of the surrounding vascular structure. The figures show crosslinking posts of the same height, but in some aspects, the crosslinking posts may not be of equal height or may be flared 5 to 45 degrees inwardly or outwardly. In some aspects, the valve replacement device may be used as an inflow valve. In some aspects, the valve replacement device may mimic the shape of a native atrioventricular valve.

[0154] Figures 15A through 15E show another aspect of a frame 502 that defines an oval opening 514. In this aspect, frame sections 504a and 504b are of different sizes and / or shapes from each other prior to valve frame expansion. As seen in FIG. 15B, only one of the crosslinking posts 510 is positioned on the major axis of the ellipse formed by the opening, while the other crosslinking post is positioned in front of the major axis. Due to the different sizes and / or shapes of the valve frame sections from each other, the valve tips of this aspect are also different from each other to match their respective frame sections. In some aspects, the valve tips may have the same mechanical properties as each other or may have different mechanical properties from each other to suit different applications. For example, to account for differences in size, a larger valve tip may have higher extensibility compared to a smaller valve tip. In other aspects, the crosslinking posts are axially inclined with respect to the surrounding vascular structure. An aspect with inclined crosslinking posts corresponds to a curved flow pattern through the device and may allow the valve function to be maintained in various structural environments depending on the degree of inclination. This inclination may also result in an opening that is not in the same plane as the vertical cross-section of the lumen of the local vascular structure.

[0155] Figures 16A through 16D show another aspect of the frame 602 having the frame section 604. This aspect has an asymmetric frame 602 that defines an oval opening 614. However, in this aspect, both of the interconnecting posts 610 are positioned forward of the major axis of the oval as seen in Figure 16C. Due to this arrangement, the frame 602 is asymmetric, and as a result, one cusp that covers most of the opening is obtained.

[0156] In some aspects, the plane formed by the opening can be orthogonal to the flow of fluid within the surrounding vasculature or offset with respect to the flow of fluid. In some aspects, the plane formed by the opening may be in the same plane as the vertical cross-section of the surrounding vasculature or may be inclined with respect to this vertical cross-section. For example, in the aspect shown in Figure 1A, the plane formed by the opening 114 of the device is in the same plane as the vertical cross-section of the surrounding vasculature, which is the blood vessel 112. Additionally, the plane formed by the opening 114 is also orthogonal to the flow of fluid through the blood vessel 112.

[0157] In some aspects, the valve replacement device includes one or more interconnecting posts that extend in a direction defining a vertical line. The plane formed by the opening can be orthogonal to the direction of the interconnecting posts or inclined with respect to the orthogonal direction. For example, in the aspect shown in Figure 1A, the plane formed by the opening 114 of the device is orthogonal to the vertical direction defined by the direction of the interconnecting posts 110. In contrast, the aspect shown in Figure 17, in which the valve frame has sections 704a, 704b of different lengths, is an example of an inclined opening. The plane 740 defined by the opening 714 is not orthogonal to the vertical direction 720 defined by the direction of the interconnecting posts 710; instead, it is inclined with respect to the orthogonal axis 730.

[0158] In some embodiments, the valve frame may be composed of two or more frame sections. The frame section may form a U-shape having two arms extending away from an intermediate section that forms a base of the first frame section. In some embodiments, the intermediate section is in a single plane. For example, in the embodiments shown in FIGS. 1A and 1B, the valve frame has a frame section having an intermediate section 130 in a single plane. This can also be seen in FIG. 4.

[0159] However, it should be understood that other arrangements are possible. For example, in some embodiments, the intermediate section can be non-planar such that it curves or otherwise shaped so that it does not lie along a single plane. In some embodiments, the intermediate section has a saddle-shaped curve that is either upward facing in the same direction in the U-shape or downward facing in the direction opposite to the U-shape.

[0160] Two exemplary embodiments of valve frame sections with non-planar bases are shown in FIGS. 18 and 19. FIG. 18 is a front view of a valve frame section. Frame section 804a has a U-shape having a first arm 831 and a second arm 832 extending away from an intermediate section 830, and the intermediate section 830 has a saddle-shaped curve facing in the same direction as the U-shape. In the exemplary embodiment shown in FIG. 19, which is also a front view of a valve frame section, frame section 904a has a U-shape having a first arm 931 and a second arm 932 extending away from an intermediate section 930, and the intermediate section 930 has a saddle-shaped curve facing in a direction opposite to the U-shape.

[0161] In some embodiments, the valve frame can be asymmetrically shaped, flared, or asymmetrically extended by angled cross-linking posts, or can have different thicknesses or materials between frame sections. The cross-linking posts may be mirror images of each other with respect to size and / or shape, or they may be different from each other. The valve frame and the two cross-linking posts may exhibit variable bending stiffness to allow the opening shape to change during the cardiac cycle (i.e., a cylindrical opening becomes oval / elliptical under maximum diastolic loading).

[0162] Figures 20A and 20B show a curved profile of one of the frame sections of the valve frame of a valve replacement device according to some embodiments. In this embodiment, the curved profile 908 may be approximately defined by projecting an elliptical quadrant 904 from a plane 902 onto a cylinder 906 that can represent the inner wall of a typical blood vessel. The elliptical profile 903 may have a semi-major axis length equal to the height (H) of the frame and a semi-minor axis with a length equal to the radius (r) of the frame. The cylinder may have a radius equal to the radius of the frame opening. The projected elliptical co-vertices can be aligned with the centerline of the cylinder, the vertices of the ellipse, and the center of the ellipse such that when viewed from the side view of FIG. 20B, they all coincide with the outer edge of the central cross-section of the cylinder. In this configuration, the center of the ellipse from which the elliptical quadrant is derived coincides with a point along the perimeter of the axial end of the cylinder, and the minor and major axes of the ellipse are coaxial with the edge of the cross-section of the cylinder.

[0163] The curved profile 908 can be mirrored about the central plane of the cylinder to generate the curved profile of the opposite frame section.

[0164] It is also contemplated that a composite curve or polynomial spline can be projected onto the cylinder to generate the curved profile of the entire frame.

[0165] FIG. 21 shows one aspect of the valve frame of the valve replacement device in two different states: the unexpanded state 1000a and the expanded state 1000b. In this aspect, the length of the valve frame 1002 is kept constant during the expansion of the valve frame. Instead of increasing the actual length of the frame, the radial increase of the frame is accommodated by reducing the height of the valve frame. FIG. 22 shows a line graph illustrating how the ratio of height to diameter (H / D) of the valve frame aspect, having different baseline height to diameter ratios (HB / DB), changes as the device expands from the baseline diameter DB to the final diameter 2DB. Aspects with baseline HB / DB ratios of 2, 1.7, and 1.5 are shown, although other ratios are contemplated as above.

[0166] One aspect of the valve replacement device was subjected to a hydrodynamic performance test. The valve replacement device was tested at five different expanded states (16 mm, 19.2 mm, 22.4 mm, 25.6 mm, and 28.8 mm) of the valve frame. FIG. 23A is a bar graph and a line graph representing both the measured flow rate, reverse fluid volume, and the valve internal and external pressure gradient (measurement of the pressure drop across the valve during the open phase, systole) on both sides of the valve replacement device having the valve frame of HB / DB = 1.7 of FIG. 22 at different expanded states. This device showed unobstructed forward flow throughout the expansion. As the flow rate was increased to match the increasing valve diameter (to mimic the physiological state in a growing patient), the valve internal and external pressure gradient (Delta P) did not increase with valve expansion.

[0167] Figure 23B shows a line graph representing the change in flow characteristics over time when the valve replacement device is opened and closed. Two valve sizes, 16 mm and 28.8 mm ID, are shown. Figure 23C shows the regurgitation rates measured at various valve diameters and various diastolic pressures (i.e., the pressure load applied to the valve tip in the closed state): 20 mmHg (representing the physiological right heart diastolic pressure) and 80 mmHg (representing the physiological left heart diastolic pressure). Over the full dilation state (i.e., from 1 times to 1.8 times the ID), it was found that the device showed minor valve leakage in the dilated situation. Figure 23D shows the results of a finite element analysis performed to evaluate the magnitude and distribution of stress on the growth-responsive valve in the loaded state (i.e., the valve tip in the closed state). The presented data shows the maximum stress (maximum principal stress, MPa) under a load pressure of 20 mmHg. The data showed that the magnitude of the maximum stress on the valve tip in the closed state was relatively low throughout the expansion from 16 mm to 28.8 mm (1 times to 1.8 times the baseline diameter). Most of the stress was distributed where the deformation was highest, and no stress concentration occurred at the valve tip - frame attachment site. Furthermore, the stress was relatively low at the frame junction, which represents a deviation from the conventional 3-leaflet bio-prosthetic valve design known in the art.

[0168] Figures 24A, 24C, 24E, and 24G show the results of in vivo tests performed by implanting one embodiment of a valve replacement device having an inner diameter of 14 mm into four young lambs. Figures 24B, 24D, 24F, and 24H show the results of in vivo tests in which the same embodiment of the valve replacement device was expanded to 25 mm (1.8 times the baseline diameter) and implanted into four adult sheep. In these studies, the valve replacement device was used to replace the pulmonary valves of the lambs and sheep. Figures 24C and 24D show the changes measured in the right ventricle (proximal to the valve) and pulmonary artery pressure (distal to the valve) during the cardiac cycle of those animals. It was found that there was no gradient across the valve on either side of the valve, regardless of the expanded state of the valve. Figures 24E and 24F show representative flow waveforms of the physiological flow measured on both sides of the valve replacement device during the cardiac cycle. The forward flow of the physiological fluid was not impeded, regardless of the diameter of the opening, and there was no leakage across the valve replacement device during diastole. Figures 24G and 24H show echocardiograms performed to visualize the implanted valve replacement device in vivo. Changes in the frame height and cusp junction height at different states of valve diameter expansion are revealed between the two animal groups.

[0169] Figures 25A - D show one aspect of the valve frame of the valve replacement device. In this aspect, the valve frame 2500 includes an upper reinforcement mechanism such as a reinforcement strut 2504 attached to the intersection 2502 of the frame. The device also includes a lower reinforcement strut 2506 that connects the lower parts of the frame sections. In this aspect, the upper reinforcement strut 2504 has a circular contour in its fully extended state and is attached to the intersection at diametrically opposite points of the ring. The upper reinforcement strut of this aspect includes undulations 2508 that serve to reduce the diameter of the upper reinforcement strut when the mechanism is in the unextended state. When the frame expands, the pair of intersections move apart, increasing the distance between the pair of intersections and applying an expansion stress to the upper reinforcement strut. The undulations allow the upper reinforcement strut to expand with the mechanism by straightening the undulations. The total length of the reinforcement strut may be made equal to or greater than the maximum circumference of the opening so that the frame can expand to the maximum possible circumference without restricting the expansion, interfering with the valve opening, or distorting the geometry of the valve tip attachment frame.

[0170] An annular upper reinforcement strut with undulations is shown in FIGS. 25A, 25C, and 25D, but it should be understood that any shape or arrangement that connects the intersections of the frame sections while allowing the frame to expand is contemplated. For example, instead of an annular shape, the upper reinforcement strut could be elliptical, diamond - shaped, or polygonal, or could include separate connection parts instead of one continuous closed loop. The upper reinforcement strut could be of a telescoping design, made of an elastic material that is reversibly deformable when the reinforcement strut is expanded, or could simply have more, fewer, larger, or smaller undulations than those depicted in the figures.

[0171] Figure 26 shows the attachment zone 2600 of the upper reinforcement strut. In some embodiments, the upper reinforcement strut is attached to the valve frame within 30% of the upper portion of the height of the intersection. However, it should be understood that other embodiments are contemplated where the upper reinforcement strut is attached outside the upper 30% zone of the device.

[0172] In some embodiments, the upper reinforcement strut is attached to the frame at or near the upper pair of intersections.

[0173] As shown in the embodiments of FIGS. 25A - D, the lower reinforcement strut 2506 includes undulations 2508 that allow the lower support mechanism to have a smaller diameter when the valve frame is in its non - expanded configuration. As the diameter of the valve increases and the frame sections separate, the undulations straighten, expanding the diameter of the lower reinforcement strut 2506 and allowing the lower mechanism to expand with the frame.

[0174] A lower reinforcement strut with a distinct teardrop shape extending below the frame of the device is shown, but the lower mechanism can be of any shape that helps the lower mechanism maintain the desired geometric profile of the valve tip attachment frame throughout the expanded state. The lower reinforcement strut may also be used as a fixation site for trans - catheter deployment, or for attachment to native heart structures, or for other uses. For example, the lower support mechanism can be made of a telescoping design, made of an elastic material that is reversibly deformable when the mechanism is expanded, or simply have more, fewer, or larger or smaller undulations.

[0175] Figure 27 shows the attachment zone 2700 of the lower reinforcement strut. Figure 27 shows a top view of the valve frame from Figure 25B superimposed on the side view of Figure 25D. Line 2702 is a virtual axis perpendicular to the virtual line connecting the upper parts of two intersections of the valve frame that passes through the diameter of the opening. Looking at the plan view, if line 2702 is the x-axis and the vertical line 2703 is the y-axis, assuming that 0 degrees starts from the right intersection of line 2702 and the frame (0 degrees of the unit circle) and opens counterclockwise, the attachment zone 2700 is between 280 degrees and 330 degrees. As seen in Figure 27, from 280 degrees to 330 degrees corresponds to the lower part of the arc of the frame section as seen in the side view. In some embodiments, the lower mechanism is attached at 310 degrees, as represented by point 2501.

[0176] It should be understood that other embodiments where the lower reinforcement strut is attached outside the attachment zone 2700 of the device are also contemplated.

[0177] Figure 28 shows side views of the valve frame of Figure 25A at different expansion sizes (12.7 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm, and 24 mm respectively).

[0178] Figure 29 is a graph depicting how the height-to-diameter ratio of the embodiments of Figures 25A - D with reinforcement struts and the embodiment of Figure 21 without reinforcement struts changes with the expansion of the valve diameter. The embodiments with reinforcement struts were expanded via balloon expansion, while the embodiments without reinforcement struts were expanded in 20% increments in the simulation. The solid line represents the behavior of the valve replacement device without reinforcement struts (e.g., Figure 21), while the dashed line represents the behavior of the valve replacement devices of Figures 25A - D with both upper and lower reinforcement struts. The baseline height-to-diameter ratio of each device is 1.7:1 and was expanded such that the baseline diameter doubled. It was found that both of these devices achieve very similar expanding valve frame kinematic profiles where the height-to-diameter ratio decreases as the valve frame diameter increases.

[0179] Figures 30A - B and 31A - B show the results of in vitro hydrodynamic performance tests of a valve replacement device having the valve frame of FIGS. 25A - D. Functional prototypes of the device were tested in a sophisticated simulated circulation flow loop in various expanded states. The device was tested in a baseline configuration (inner diameter 12.7 mm, 1x), then expanded to 23 mm inner diameter (1.8x) with a balloon catheter and retested under physiological pressure and flow conditions. FIG. 30A shows the flow profile across the device at an opening diameter of 12.7 mm during the cardiac cycle. FIG. 30B shows other measurements, including the pressure gradient across the valve on both sides of the valve, the fluid flow profile through the device, and including leakage volume and regurgitation rate. FIG. 31A shows the flow profile across the device at 1.8 times the baseline diameter (23 mm) during the cardiac cycle. FIG. 31B reflects the same type of measurements as FIG. 30B but for the device in the expanded state with an opening diameter of 23 mm. It was found that the function of the valve did not vary with the diameter of each valve tested.

[0180] Figures 32A - 32C show a valve replacement device according to one embodiment implanted in a 25 kg sheep. The unexpanded (12.7 mm) valve replacement device was implanted at the position of the pulmonary valve of a 25 kg sheep. The device was expanded to 16 mm, 18 mm, and 20 mm using transcatheter balloon dilation. FIG. 32A shows the device expanded to 16 mm, FIG. 32B shows the expansion process, and FIG. 32C shows the device after expansion of FIG. 32B at 18 mm. It was found that the valve geometry (valve tip attachment lines and reinforcement struts) corresponded to the geometric profiles before and after expansion. The valve expanded normally under the radial forces generated by a clinical standard balloon catheter in the implanted in vivo setting using the balloon pressure recommended by the balloon manufacturer, and the valve frame maintained its structural integrity even after multiple consecutive expansions.

[0181] Figures 33A - 33D show alternative embodiments of a valve frame 3200 having a shortened lower reinforcement strut 3206. In this embodiment, the undulations of the lower reinforcement strut have shorter teardrop-shaped undulation troughs 3208 that do not extend beyond the bottom of the valve frame.

[0182] Figures 34A - 34D show alternative embodiments of a valve frame 3300 having a plurality of holes 3306 along the frame of the device. Having holes along the frame is intended to provide anchor points for suturing the valve tip to the frame. It should be understood that any number of holes, of any size and spaced at any intervals from each other, may be used. The holes may not be formed directly in the body of the frame, but instead may be formed in sections arising from the frame body.

[0183] Figures 35A - 35D show alternative embodiments of a valve frame 3400 that includes a central reinforcement strut in addition to upper reinforcement struts 3402 and lower reinforcement struts 3406. In this embodiment, the central reinforcement strut 3410 may have two semi-circular portions that connect two frame sections. The portions of the central reinforcement strut 3410 may include undulations 3412 that can reduce the size profile of the central attachment mechanism. Similar to the upper and lower reinforcement struts, the undulations may be straight, allowing the central reinforcement strut to expand with the frame. The central reinforcement strut may have a length equal to or exceeding the perimeter length of the opening at maximum expansion.

[0184] Figures 36A - 36B show alternative embodiments of a valve frame 3500 that has a central reinforcement strut 3510 to assist in reinforcing the frame, in addition to a plurality of holes 3503 along the frame of the device that may also provide anchor points for suturing the valve tip to the frame.

[0185] Aspects are shown without a reinforcement strut or with one or more of upper, central, and lower reinforcement struts, but it should be understood that the contemplated aspects can have any number of reinforcement struts located in any number of locations. The reinforcement struts serve to provide structural support to the frame such that the frame can expand to the fully expanded diameter while at the same time enabling the geometry of the expanded frame to allow for a preserved valve function (e.g., unobstructed forward flow and no or minimal backflow).

[0186] In some aspects, the reinforcement struts and / or valve frame may be constructed from SS-316L or CoCr-MP35N, or any other material having sufficient rigidity to impart structural integrity to the device while at the same time having sufficient ductility to allow the undulations to straighten out with valve frame expansion or to allow for other expansion designs that expand with valve frame expansion. The reinforcement struts may have the same width and wall thickness as the frame or may be thicker or thinner than the frame.

[0187] In some aspects, the reinforcement struts can be cut from a single sheet of material by laser cutting, punching, or other methods. In other aspects, the reinforcement struts need not be formed from a single piece of material. For example, the reinforcement struts can be made from a combination of different materials, such as by connecting one piece of material to another piece of material. The reinforcement struts may have a uniform or non-uniform thickness.

[0188] Figures 37A - 37C show the valve frame 3200 of the aspect of Figure 33A attached to the valve tip 106 to illustrate how the valve tip attaches to the valve frame. For the other aspects of the reinforcement struts shown in Figures 25A, 33A, 34A, 35A, and 36A, the valve tip may be attached to such valve frames in the same orientation as shown in Figures 37A - 37C. Figure 38A shows a front view of the combination of the valve frame and valve tip of Figure 37A in the expanded state, and Figure 38B shows a side view of Figure 38A.

[0189] Figures 39A - 39D show alternative embodiments of the valve replacement device. In this embodiment, the valve frame 3900 includes an upper reinforcement strut 3904 and a lower reinforcement strut 3906 that connect the lower portions of the frame sections. This embodiment is an example of a way to modify the mechanical properties and / or geometric form and / or width or thickness of the frame support mechanism to affect the expanded shape (i.e., the shape of the opening) of the valve frame 3900. In this embodiment, the upper reinforcement strut 3904 has a reduced thickness compared to the thickness of the valve tip attachment line and the thickness of the lower reinforcement strut 3906, and is made less rigid than these other frame components. Although not desired to be constrained by theory, these modifications result in a change in the expansion profile of the device, in which case, due to less constraint, a large radial deformation occurs in the pair of intersections, and an asymmetric / non - circular spread is intended to occur at the upper end of the valve replacement device. The lower reinforcement strut maintains a circular opening at the base of the valve.

[0190] Figures 40A and 40B show alternative embodiments of the valve replacement device. In the illustrated embodiments, the valve replacement device employs the valve frame 3300 shown in FIGS. 34A-34D in combination with two valve tips and a sleeve. In particular, FIG. 40A shows a sleeve 4000 having a first sleeve portion 4003 and a second sleeve portion 4004 that may be coupled to the valve frame 3300, while FIG. 40B shows the valve frame 3300 with the sleeve portions removed for clarity. The valve frame 3300 may include a first valve tip attachment strut 3303 and a second valve tip attachment strut 3304, which may also be referred to herein as the first and second frame sections, respectively. Each of the first and second frame sections may also be described as having a first arm (3310, 3312) and a second arm (3311, 3313) indicated by each side of the "U-shaped" of the first and second frame sections. In one embodiment, as shown in FIG. 40B, the valve replacement device includes first and second valve tips 4001, 4002 that are attached to the frame and form valve tips. The valve frame may also include a gap 4006 disposed between the first and second frame sections of the valve frame. The inventors recognize that the presence of the gap 4006 may result in unintentional fluid leakage through the gap. Thus, the inventors understand that providing a sleeve that extends over the gap may serve as a fluid barrier to prevent fluid flow through the gap. As shown in FIG. 40A, the first and second sleeve portions 4003, 4004 are configured to be aligned with and attached to the first and second frame sections of the valve frame.

[0191] The valve replacement device may be configured to replace the pulmonary valve, but as further discussed below, the valve replacement device may be configured to replace various other native valves.

[0192] As described above, FIGS. 34A - 34D show alternative embodiments of the valve frame 3300. The frame 3300 includes an upper reinforcement strut 3301, a lower reinforcement strut 3302, a first valve tip attachment strut 3303, a second valve tip attachment strut 3304, a cross - link hole 3305, and a plurality of anchor holes 3306 along the valve tip attachment struts 3303 and 3304. Note that the holes not specifically labeled are one of the anchor holes 3306. It is contemplated that including the cross - link hole 3305 and the anchor holes 3306 along the valve tip attachment struts 3303 and 3304 provides anchor points for suturing the valve tips 4001 and 4002, and the sleeves 4003 and 4004 to the frame. It should be understood that since the present disclosure is not so limited in this regard, any number of holes of any size and any spacing from each other may be used.

[0193] In one embodiment, the frame 3300 may be expanded such that, while maintaining the valve function, the inner diameter of the frame is increased up to 1.75 times the un - expanded inner diameter of the frame. In one embodiment, while maintaining the valve function, the inner diameter of the frame may be expanded from 12.7 mm to 22 mm. In other embodiments, the inner diameter of the valve frame may be expanded until the lower reinforcement strut 3302 is approximately straight so that the frame cannot be expanded further. This feature, as will be understood by those skilled in the art, may enable the valve to be used as a prestent and as a landing site for a trans - catheter valve - in - valve procedure. In one embodiment, the inner diameter of the frame 3300 in the un - expanded state is 12.7 mm, and when the lower reinforcement strut 3301 is fully expanded, the inner diameter of the frame 3300 will be 26 mm.

[0194] In one aspect, the frame 3300 is made of a material having high tensile strength, minimal elastic shrinkage force, is resistant to fatigue, and is balloon-expandable. In one aspect, the valve frame 3300 is laser cut from a 316L stainless steel tube, although any other material possessing the desired properties is contemplated. In one aspect, the tube has, in its unexpanded state, a length of 25.10 mm, an inner diameter of 12.7 mm, and an outer diameter of 13.71 mm.

[0195] In one aspect, the upper reinforcement strut 3301, the lower reinforcement strut 3302, and the valve tip attachment struts 3303 and 3304 each have different widths to enable symmetric balloon expansion. In some aspects, it is contemplated that the upper reinforcement strut 3301 each has a width W1, which is 0.55 mm wide in one aspect. The lower reinforcement strut 3302 each has a width W2, which is 0.45 mm wide in one aspect. The valve tip attachment struts 3303 and 3304 each have a width W3, which is 0.40 mm wide in one aspect. The dimensions along the length of the frame can be varied to the desired width, but the wall thickness in the radial direction is relatively constant, which is because, as described above, in one aspect, the frame is laser cut from a single tube.

[0196] FIG. 41 shows one aspect of valve tips 4001 and 4002, which are substantially identical to each other and have a free edge 4102, an outer edge 4104, an attachment tab 4106, an intersection point 4101, an upper fixed point 4103, a lower fixed point 4105, and a plurality of anchor points 4107. Note that points not specifically labeled may be considered anchor points 4107.

[0197] The valve leaflets 4001 and 4002 are configured to mimic the shape of a native human venous valve, and it is desired that this allows the valve function to be maintained over a wide range of dimensions. When implanted, the orientation, position, and shape of the valve leaflets 4001 and 4002 cause the blood flow to flow in one direction and prevent blood flow in the opposite direction. The orientation, position, and shape of the valve leaflets 4001 and 4002 allow blood flow in one direction while preventing blood flow in the other direction as the inner diameter of the opening expands.

[0198] In one aspect, the first valve tip 4001 is attached inside the first valve tip attachment strut 3303 by suturing the intersection point 4101 to the corresponding intersection hole 3305, the upper fixing point 4103, the lower fixing point 4105, and the plurality of anchor points 4107 to the corresponding anchor holes 3306. First, the first valve tip 4001 is fixed to the first valve tip attachment strut 3303 by fastening the upper fixing point 4103 to the corresponding anchor hole 3306. Next, the lower fixing point 4105 is fastened to the corresponding anchor hole 3306. Next, the plurality of anchor points 4107 are attached to the corresponding anchor holes 3306. The attachment tab 4106 is for the assembler to grasp when attaching the first valve tip 4001 to the frame 3300. Since the present disclosure is not so limited, the attachment tab may be of any suitable shape. For example, FIG. 41 shows that the attachment tab 4106 may be substantially rectangular such that the attachable end 4109 forms a substantially linear attachment between the valve tips in the intersection region (the region of the distal frame where the two valve tips converge). However, in other aspects such as FIG. 44, the attachable end 4109' may be substantially curved. The inventors have found that in some aspects, a curved attachable end 4109' may help promote the joining of the valve tips at the intersection. In other aspects, it should be understood that the valve tips may be produced without any attachment tabs. The second valve tip 4002 is attached to the second valve tip attachment strut 3304 using the same method outlined above. The intersection point 4101 on the first valve tip 4001 is then sutured to the corresponding intersection point 4101 on the second valve tip 4002, and then the intersection points 4101 of both valve tips are sutured to the corresponding intersection holes 3305 such that the outer edge 4104 of the first valve tip 4001 contacts and aligns with the outer edge 4104 of the second valve tip 4002. The attachment tabs of both valve tips are removed after the valve tips are attached.

[0199] Although not desired to be bound by theory, the valve tip attachment order is as follows: Ensuring the correct alignment of each of the valve tips 4001 and 4002, The crosslinking point 4101, the upper fixing point 4103, the lower fixing point 4105, and the plurality of anchor points 4107 are stitched without impingement or pinwheeling to avoid areas of localized folding, tension, and stress concentration of the material, and Ensure that the functional surface area of each of the valve tips 4001 and 4002 is appropriate for the device to function over the entire range of the expanded diameter. is used for. In some embodiments, this entire range of the expanded diameter is up to 1.75 times the inner diameter of the unexpanded valve frame 3300. It should be understood that any valve tip attachment process that provides correct alignment and tension of the valve tips is contemplated.

[0200] The first valve tip 4001 and the second valve tip 4002 are contemplated to be attached to the corresponding valve tip attachment struts 3303 and 3304 using intermittent stitching, although any other stitching method including partial intermittent stitching or continuous stitching is also contemplated. Again, without wishing to be bound by theory, intermittent stitching may allow for control of the tension along the length of the attachment of the valve tip to the frame. Also, if one suture fails, the other sutures will hold the valve tip to the frame.

[0201] Returning to FIG. 41, in this embodiment, the free edge 4102 has a U-shaped configuration, the outer edge 4104 has an extended U-shaped configuration, such that the vertical spacing from the free edge 4102 to the outer edge 4104 is greatest at the apex of the free edge 4102. In this embodiment, the outer edge 4104 includes a notch 4108 such that the outer edge 4104 aligns with the corresponding valve tip attachment struts 3303 and 3304. This geometry allows the frame 3300 to expand without stretching the valve tips 4001 and 4002.

[0202] The materials used for the valve leaflets 4001 and 4002 are intended to be oriented such that the most extensible direction is from the free edge 4102 to the outer edge 4104. Such an orientation can be advantageous as it can help increase the amount of leaflet engagement during use (the contact area between valve leaflets 4001 and 4002).

[0203] In one aspect, valve leaflets 4001 and 4002 have minimal extensibility across the width of the leaflet. Such a property can also minimize the bulging of the valve leaflets during use.

[0204] In one aspect, valve leaflets 4001 and 4002 are made of ePTFE membrane, although any suitable material is contemplated including synthetic polymers, tissue-engineered constructs, decellularized homologous tissue engineered valve leaflets, glutaraldehyde-treated bovine pericardium, glutaraldehyde-treated porcine pericardium, photo-oxidized bovine pericardium, bovine jugular vein valve.

[0205] In one aspect, the valve leaflet is 0.1 mm thick, although any other thickness of material that enables proper valve function is contemplated. In one aspect, valve leaflets 4001 and 4002 are 23.56 mm wide, although any other width that enables proper valve function is contemplated. The distance between the lower fixation point 4105 and the bottom of the attachment tab 4106 may be approximately 24.29 mm, although any other distance that enables proper valve function is contemplated. The distance between the lower fixation point 4105 and the apex of the free edge 4102 may be approximately 14.28 mm, although any other distance that enables proper valve function is contemplated. In one aspect, valve leaflets 4001 and 4002 have a surface area of 328 mm 2 of.

[0206] In one aspect, the crosslinking points 4101, the upper fixing points 4103, the lower fixing points 4105, and the plurality of anchor points 4107 are positioned at an optimal distance from the outer edge 4104 to minimize the risk of the suture slipping out. Generally, the more tension is applied to a particular section of the valve tips 4001 and 4002, the farther the crosslinking points 4101, the upper fixing points 4103, the lower fixing points 4105, and the plurality of anchor points 4107 in that region are from the outer edge 4104. In one aspect, a finite element analysis similar to that shown in FIG. 23D may be used to determine how much tension will be applied to a particular section of the valve tips 4001 and 4002 when the valve tips are expanded, and the anchor points 4107 within that particular section may be positioned at an optimal distance from the outer edge 4104 based on this determination. In one aspect, the anchor points 4107 located approximately halfway along the valve tips 4001 and 4002 are the most highly tensioned when the device is in the expanded configuration and are thus positioned farther from the outer edge 4104 than the other anchor points. In one aspect, such anchor points are positioned at a location at least 1.7 mm from the outer edge 4104.

[0207] In this aspect, the crosslinking points 4101, the upper fixing points 4103, the lower fixing points 4105, and the plurality of anchor points 4107 are marked prior to valve assembly. In some aspects, the crosslinking points 4101, the upper fixing points 4103, the lower fixing points 4105, and the plurality of anchor points 4107 may be pre-formed holes.

[0208] As described above, in this aspect, the valve replacement device includes a sleeve. The sleeve may be formed from two separate sleeve portions. FIG. 42 shows an aspect of the first and second sleeve portions 4003 and 4004, and the sleeve portions are substantially identical to each other. The first sleeve portion 4003 includes a first fixed edge 4201 and a second fixed edge 4202, while the second sleeve portion 4004 includes a third fixed edge 4211 and a fourth fixed edge 4212. The sleeve portions 4003 and 4004 also include a suture cuff 4203, suture cuff attachment points 4204, initial anchor points 4205, attachment points 4206, and a plurality of cross-linking attachment points 4207.

[0209] In one aspect, the sleeves 4003 and 4004 enable the device to be fixed to native tissue. The sleeves 4003 and 4004 are configured to prevent blood from leaking around the outside of the valve replacement device when the valve replacement device is attached to native tissue. Employing ePTFE may also prevent ingrowth of tissue, thus allowing the valve replacement device to expand with minimal resistance and avoid damage to surrounding tissue. Such materials may also prevent the formation of abnormal layers of fibro-vascular or granulation tissue.

[0210] In some aspects, the first sleeve portion 4003 may be attached to the outside of the valve frame 3300 by fastening the first sleeve portion 4003 to corresponding anchor holes 3306 in the valve tip attachment struts 3303 and 3304. The first sleeve portion 4003 is aligned such that the first fixed edge 4201 is attached to the first arm 3310 of the first valve tip attachment strut 3303 and the second fixed edge 4202 is attached to the first arm 3312 of the second valve tip attachment strut 3304.

[0211] To attach the first sleeve portion 4003 to the frame 3300, initially the anchor points 4205 are fastened to the frame 3300 at the corresponding anchor holes 3306, aligning the first sleeve portion 4003 correctly, whereby the fixed edges 4201 and 4202 of the first sleeve portion 4003 at least partially enwrap the valve tip attachment struts 3303 and 3304. In some embodiments, the first sleeve portion 4003 may be fastened to the frame 3300 such that the fixed edges 4201 and 4202 are fastened to the valve tip attachment struts 3303 and 3304 but do not partially enwrap them. Next, the first edge 4201 and the second edge 4202 are attached to each of the fixing points 4206 with continuous suture threads, the suture threads attached to the initial anchor points 4205 are removed, and each continuous suture thread is passed through the corresponding anchor hole 3306 and through the corresponding edges 4201 and 4202 of the first sleeve portion 4003 to be fixed to the frame 3300. Then, the continuous suture threads are passed below the cross-linking fixing points 4207 on the sleeve, passed through the cross-linking holes 3305 towards the center of the valve frame, passed above the cross-linking holes 3305 away from the center of the valve frame, passed out through the upper cross-linking fixing points 4207, and tied at the top of the first sleeve portion 4003. The sleeves 4003 and 4004 are attached to the corresponding valve tip attachment struts 3303 and 3304 using continuous suture threads, although any other suturing method including partial intermittent suturing or intermittent suturing is contemplated.

[0212] The second sleeve portion 4004 is attached to the outside of the valve frame 3300 by fastening the second sleeve portion 4004 to corresponding anchor holes 3306 in the valve tip attachment struts 3303 and 3304. The second sleeve portion 4004 is aligned such that a third fixed edge 4211 is attached to a second arm 3311 of the first valve tip attachment strut 3303, and a fourth fixed edge 4212 is attached to a second arm 3313 of the second valve tip attachment strut 3304. The method of attaching the second sleeve portion 4004 to the frame 3300 is substantially the same as the method of attaching the first sleeve portion 4003 to the frame 3300.

[0213] After the first sleeve portion 4003 and the second sleeve portion 4004 are attached to the outside of the frame 3300, the sleeves are attached to each other by suturing a suture cuff fixing point 4204 on the first sleeve portion 4003 to a corresponding suture cuff fixing point 4204 on the second sleeve portion 4004. This may also prevent leakage of blood around the outside of the valve replacement device. This sleeve attachment method is used to ensure proper alignment of each of the sleeves 4003 and 4004. It should be understood that any sleeve attachment method that provides proper alignment is contemplated.

[0214] In this aspect, the valve replacement device is secured to the native tissue by suturing the valve through the suture cuffs 4203 of the sleeves 4003 and 4004 to the native tissue. It is contemplated that the sutures are positioned at a sufficient interval from the lower end of the sleeve to reduce the risk of tearing. In one aspect, this interval is at least 2 mm. The interval between the sutures is small enough to prevent leakage of blood between the sutures. In one aspect, this distance is at most 3 mm. It is contemplated that interrupted horizontal mattress sutures, continuous sutures, or a combination of partial interrupted sutures and continuous sutures are used to fasten the valve replacement device to the native tissue.

[0215] In this aspect, sleeves 4003 and 4004 are generally bell-shaped and vertically symmetric. The suture cuff 4203 extends from the bottom of each of sleeves 4003 and 4004 to the beginning of the bell curve of each of sleeves 4003 and 4004.

[0216] In one aspect, the material of sleeves 4003 and 4004 is oriented such that sleeves 4003 and 4004 are most expandable across their width to enable expansion of the valve. In this aspect, sleeves 4003 and 4004 can expand across their width by an amount sufficient for the valve replacement device to expand to an inner diameter of at least 22 mm. In some aspects, sleeves 4003 and 4004 can expand across their width by an amount sufficient for the valve replacement device to expand to an inner diameter of 26 mm. In this case, since the valve can expand beyond its functional range, it can be used as a prestent and landing zone for a transcatheter valve-in-valve replacement procedure.

[0217] Sleeves 4003 and 4004 may be constructed of an ePTFE stretch tube graft, which has a thin film of ePTFE on the outside. In one aspect, the ePTFE stretch tube graft may be 1 mm thick, although any thickness of tube graft that enables proper sleeve function is contemplated. In some aspects, suitable sleeve thicknesses may be 0.25 mm, 0.5 mm, 0.75 mm, 0.9 mm, 1 mm, 1.1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2 mm or greater, or other suitable sleeve thickness values that may be larger or smaller than those disclosed herein. To construct sleeves 4003 and 4004, cut a tube graft of suitable length in half. Since the ePTFE stretch tube graft is most extensible in the longitudinal direction, each sleeve is cut from the ePTFE tube graft such that the width of each sleeve is in the longitudinal direction of the ePTFE tube graft. The outer film has a more compact microstructure than the rest of the graft, which can minimize the ingrowth of native tissue into sleeves 4003 and 4004 and prevent the expansion of the valve, so the side of sleeves 4003 and 4004 with the film is designated as the side of sleeves 4003 and 4004 facing the native tissue. In some aspects, one or more layers of ePTFE film may be provided on the outer surface of the sleeve. The outer ePTFE film layer may provide advantages such as restricting the ingrowth of native tissue into the sleeve and / or suppressing an excessive fibrotic tissue reaction at the suture line, which may also interfere with the ability to effectively balloon-expand the valve after implantation. In some such aspects, the outer ePTFE film may be adhered to each other and / or to the outer ePTFE of the tube graft.

[0218] In one aspect, sleeves 4003 and 4004 each have a width at the base sufficient to cover at least half of the circumference of valve frame 3300, such that sleeves 4003 and 4004 do not tightly wrap around frame 3300 when the frame is unexpanded. In one aspect, the width at the base is 30 mm. In one aspect, sleeves 4003 and 4004 each have a width at the base sufficient to cover half of the circumference of valve frame 3300, such that sleeves 4003 and 4004 tightly wrap around frame 3300 when the frame is unexpanded. In one aspect, sleeves 4003 and 4004 each have a length sufficient to cover the entire length of valve frame 3300. In one aspect, the length is 30.11 mm. In one aspect, suture cuff 4203 is of a length sufficient to enable an effective placement of suture for securing the valve replacement device to native tissue. In one aspect, the length of the suture cuff is 4.40 mm. The length of the suture cuff may be trimmed (shortened) during the implantation procedure to optimize fixation of the device to native tissue. Note, however, that the length of the suture cuff must extend beyond the lowermost portion of frame 3300 to ensure that the circumferential suture line (the location of device fixation to native tissue) is below the level of the valve opening.

[0219] In some aspects, the sleeves described in the aspects disclosed herein may have a proximal end 4208 and a distal end 4209, where the proximal end is represented by the base of the sleeve where suture cuff 4203 is positioned and the distal end is represented by the region where the superior crosslinking fixation point 4207 is positioned (see FIG. 42). Thus, in some aspects, the proximal end of the sleeve may serve as a suture cuff that is sutured or otherwise attached to the implantation site to fasten the valve replacement device to the desired position relative to the implantation site. In some aspects, the valve replacement device may be attached to the implantation site by the suture cuff alone. Additionally or alternatively, the distal end and / or other portions of the sleeve may be used to attach the valve replacement device to the implantation site, as the present disclosure is not so limited.

[0220] In one aspect, the suture cuff fixation point 4204, the initial anchor point 4205, the fixation point 4206, and several cross-linking fixation points 4207 are pre-marked. However, in other aspects, it should be understood that any of these points may not be pre-marked, or may be pre-formed holes, or all may be pre-marked.

[0221] Figures 43A and 43B show aspects of a valve replacement device similar to those of Figures 40A and 40B, where the valve replacement device includes a valve frame 3300, valve tips 4001, and a sleeve including a first sleeve portion 4003 and a second sleeve portion 4004. Figure 43A shows an aspect where the valve frame 3300 is in an unexpanded position, and thus has a smaller inner diameter than that shown in Figure 43B which shows the valve frame 3300 in an expanded position. In some aspects, the valve frame 3300 may be constructed and arranged such that the opening is substantially annular, for example, in Figures 43A and 43B.

[0222] Referring back to FIGS. 40A - B and 42, the first sleeve portion 4003 may include the first fixed edge 4201 and the second fixed edge 4202, and at the same time the second sleeve portion 4004 may include the third fixed edge 4211 and the fourth fixed edge 4212. In some embodiments, at least one of the first fixed edge 4201 and the second fixed edge 4202 of the first sleeve portion 4003, and at least one of the third fixed edge 4211 and the fourth fixed edge 4212 of the second sleeve portion 4004 may be configured to be aligned and attached with at least one of the first arms (3310, 3312) and the second arms (3311, see 3313 in FIG. 34A) of the first frame section and / or the second frame section of the valve frame 3300. For example, the first fixed edge 4201 and the second fixed edge 4202 of the first sleeve portion 4003 may be respectively aligned and attached with the first arm 3310 of the first frame section and the first arm 3312 of the second frame section. Similarly, in another example, the third fixed edge 4211 and the fourth fixed edge 4212 of the second sleeve portion 4004 may be respectively aligned and attached with the second arm (3311) of the first frame section and the second arm (3313) of the second frame section.

[0223] It should be understood that in some of the embodiments described above, the valve replacement device is configured to replace the pulmonary valve. However, the valve replacement device may also be configured to replace other valves. Configuring the valve replacement device to replace other valves may involve changing some aspects of the valve replacement device, including the size of the device, the material properties of the valve leaflets, and the thickness of the valve leaflets, as will be further considered below.

[0224] The valve replacement device may be expanded or contracted as necessary, depending on the age and build of the patient, or the valve that the device replaces. The following table lists the nominal diameter, maximum functional diameter, and maximum frame diameter for several embodiments of the expanded or contracted valve replacement device. The nominal diameter is the inner diameter of the valve frame 3300 when the valve frame is unexpanded, the maximum functional diameter is the maximum inner diameter at which the valve frame 3300 may be expanded while maintaining the function of the valve, and the maximum frame diameter is the maximum inner diameter at which the valve frame 3300 may be expanded beyond the maximum functional diameter. The aspect ratio of the frame is maintained as the valve replacement device is expanded or contracted such that the ratio of frame length:frame diameter remains the same. Also, it should be understood that the examples listed below are not inclusive such that any suitable scale of the valve replacement device is contemplated.

Table 1

[0225] The appropriate thickness of the valve tips 4003 and 4004 depends on the blood pressure and flow rate encountered when the valve replacement device is implanted, as well as the material properties of the material used for the valve tips. Since various valves in native tissue encounter different blood pressures and flow rates, the range of appropriate material properties and thicknesses of the valve tips varies based on which native valve the valve replacement device replaces. Without wishing to be bound by theory, the following table lists the range of potentially appropriate valve tip thicknesses for different use cases of the valve replacement device.

Table 2

[0226] It should be understood that when the valve replacement device is used as a pulmonary valve conduit, the valve replacement device will be assembled inside a tube positioned outside the heart to connect the right ventricle and the pulmonary artery. In one aspect, the tube may be composed of an expandable synthetic material. In one aspect, the suture cuff of the valve replacement device may be circumferentially sutured inside the expandable synthetic tube such that the position of the suture line is proximal to the center of the tube. In one aspect, the expandable synthetic tube containing the valve replacement device may be sutured to the right ventricle on the proximal side and to the pulmonary artery on the distal side. In one aspect, the tube may be a homograft of the lung or aorta. In one aspect, the native valve leaflets inside the homograft may be resected and the valve replacement device may be circumferentially sutured inside the homograft at the level of the native homograft valve leaflets. In one aspect, the homograft containing the valve replacement device may be sutured to the right ventricle on the proximal side and to the pulmonary artery on the distal side.

[0227] The various aspects of the present disclosure may be used alone, in combination, or in various configurations not specifically considered in the foregoing aspects, and thus, in its application, are not limited to the details and arrangements of the components described in the foregoing description or shown in the drawings. For example, aspects described in one aspect may be combined with aspects described in other aspects in any manner.

[0228] Also, the aspects described herein may be embodied as a method, and examples thereof are presented. The acts performed as part of this method can be ordered in any suitable manner. Accordingly, although shown as sequential operations in the exemplary aspects, aspects may be constructed in which some operations are performed simultaneously, including operations being performed in an order different from that shown.

[0229] Although the present teachings are described in connection with various aspects and examples, it is not intended that the present teachings be limited to such aspects or examples. On the contrary, as will be understood by those skilled in the art, the present teachings embrace various alternative forms, modifications, and equivalents. Accordingly, the foregoing description and drawings are merely illustrative.

Claims

1. A valve replacement device, comprising: A valve frame including first and second frame sections, the valve frame defining an opening for fluid passage, the valve frame being expandable to allow an increase in the diameter of the opening over a range of opening diameters, said valve frame; A gap between the first and second frame sections; At least one valve tip coupled to the valve frame, the at least one valve tip having an open configuration in which the opening is exposed and a closed configuration in which the at least one valve tip at least partially covers the opening, the at least one valve tip being configured to be movable between the open and closed configurations over a range of opening diameters, said valve tip; and, A sleeve extending over the gap between the first and second frame sections, the sleeve functioning as a barrier to impede fluid flow through the gap, the sleeve being coupled to the valve frame, the sleeve having a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame, said sleeve The valve replacement device comprising the above.

2. The valve replacement device according to claim 1, wherein the sleeve includes a first sleeve portion and a second sleeve portion coupled to the valve frame.

3. The first and second sleeve portions are constructed from a section of a tube graft, the section of the tube graft having a longitudinal direction, and The first expandable direction of the sleeve is the longitudinal direction of the section of the tube graft. The device according to claim 2.

4. The valve replacement device according to claim 1, wherein the proximal end of the sleeve is configured to be sutured to the native structure.

5. The valve replacement device according to claim 1, wherein the valve frame is expandable to allow an increase in the diameter of the opening beyond the functional range of at least one valve tip for use as a pre-stent for a transcatheter valve-in-valve replacement procedure.

6. The valve replacement device according to claim 5, wherein the valve frame is expandable to allow an increase in the diameter of the opening to be greater than 22 mm.

7. The valve replacement device according to claim 1, wherein the at least one valve tip maintains a constant surface area as the valve frame expands.

8. The valve frame has a plurality of holes therethrough, The at least one valve tip includes a first valve tip and a second valve tip, The first valve tip has an outer edge coupled to the valve frame using at least some of a plurality of holes through the valve frame, and the second valve tip has an outer edge coupled to the valve frame using at least some of a plurality of holes through the valve frame. The first and second valve tips have a plurality of valve tip attachment points for connecting the first and second valve tips to the valve frame. The plurality of valve tip attachment points are positioned at non-uniform intervals from the outer edges of the first and second valve tips. The valve replacement device according to claim 1.

9. The first and second frame sections are connected by a pair of intersections. The plurality of holes pass through the first and second frame sections and through a pair of intersections. The first valve tip is coupled to the holes of the first frame section and a pair of intersections. The second valve tip is coupled to the holes of the second frame section and a pair of intersections. The valve replacement device according to claim 8.

10. Further comprising a first reinforcement mechanism connecting the pair of intersections. Further comprising a second reinforcement mechanism connecting the first and second frame sections. Here, at least one of the first and second reinforcement mechanisms has a shape different from that of the other of the first and second reinforcement mechanisms. The valve replacement device according to claim 9.

11. The valve replacement device according to claim 1, wherein the valve replacement device is configured to replace a pulmonary valve.

12. The valve frame includes a plurality of holes through the valve frame, at least one valve tip is coupled to the valve frame using at least some of the plurality of holes through the valve frame, and the sleeve is coupled to the valve frame using at least some of the plurality of holes through the valve frame. The valve replacement device according to claim 1.

13. The valve replacement device according to claim 3, wherein the sleeve further includes a film adhered to a section of the tube graft, and the film is configured to minimize ingrowth of native tissue into the sleeve.

14. A valve replacement device, comprising: A valve frame defining an opening for fluid passage, the opening having a diameter along the maximum dimension of the opening, the valve frame being expandable to allow an increase in the diameter of the opening over a range of sizes of the diameter of the opening, the valve frame having a plurality of holes through the valve frame; A first valve tip that is coupled to a valve frame using at least some of a plurality of holes through the valve frame, having an open configuration in which an opening is exposed and a closed configuration that at least partially covers the opening, and having an outer edge; and, A second valve tip that is coupled to the valve frame using at least some of a plurality of holes through the valve frame, having an open configuration in which an opening is exposed and a closed configuration in which the first and second valve tips contact each other to at least partially cover the opening, and having an outer edge, wherein the first and second valve tips are configured to be movable between the open configuration and the closed configuration over a diameter size range of the opening, said second valve tip, comprising, wherein the first and second valve tips have a plurality of valve tip attachment points for connecting the first and second valve tips to the valve frame, the plurality of valve tip attachment points are positioned at non-uniform intervals from the outer edges of the first and second valve tips, said valve replacement device.

15. The valve replacement device according to claim 14, wherein the distance from the valve tip attachment point to the outer edge of the first and second valve tips is greater for the valve tip attachment point that receives a greater tension when the first and second valve tips are coupled to the valve frame than for the valve tip attachment point that receives a smaller tension.

16. The valve replacement device according to claim 15, wherein for the valve tip attachment point that receives the most tension, the distance from the valve tip attachment point to the outer edge of the first and second valve tips is at least 1.7 mm.

17. The valve replacement device according to claim 14, wherein at least some of the plurality of valve tip attachment points are marked on the first and second valve tips prior to connecting the first and second valve tips to the frame.

18. The first and second valve tips further include a notch in the outer edge, the notch enables the first and second valve tips to align with the edge of the valve frame, the valve replacement device according to claim 14.

19. The valve replacement device according to claim 14, wherein the first and second valve tips maintain a constant surface area as the valve frame expands.

20. The valve frame includes first and second frame sections connected by a pair of cross-links, the plurality of holes pass through the first and second frame sections and through the pair of cross-links, the first valve tip is coupled to the holes of the first frame section and the pair of cross-links, and, The second valve tip is coupled to the second frame section and the holes of the pair of intersections. The valve replacement device according to claim 14.

21. Further comprising a first reinforcement mechanism for connecting the pair of intersections, Further comprising a second reinforcement mechanism for connecting the first and second frame sections, wherein at least one of the first and second reinforcement mechanisms has a different shape from the other of the first and second reinforcement mechanisms. The valve replacement device according to claim 20.

22. The valve replacement device according to claim 14, wherein the valve replacement device is configured to replace a pulmonary valve.

23. A valve replacement device, comprising: A valve frame including first and second frame sections, the valve frame defining an opening for fluid passage, the first and second frame sections each having a first and a second arm, and the valve frame being expandable to allow an increase in the diameter of the opening over a range of diameters of the opening; A valve tip coupled to the valve frame, the valve tip having an open configuration in which the opening is exposed and a closed configuration in which the valve tip at least partially covers the opening, and the valve tip being configured to be movable between the open configuration and the closed configuration over a range of diameters of the opening; and A sleeve coupled to the valve frame having a first fixed edge and a second fixed edge, comprising wherein the sleeve has a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame, the first fixed edge is aligned and attached to the first arm of the first frame section, and the second fixed edge is aligned and attached to the first arm of the second frame section. The valve replacement device.

24. The sleeve includes a first sleeve portion and a second sleeve portion, the second sleeve portion having a third fixed edge and a fourth fixed edge, the third fixed edge of the second sleeve portion being aligned and attached to the second arm of the first frame section, and the fourth fixed edge of the second sleeve being aligned and attached to the second arm of the second frame section. The valve replacement device according to claim 23.

25. The valve replacement device according to claim 23, wherein the sleeve further includes a film, where the film is configured to minimize ingrowth of native tissue into the sleeve.

26. The valve replacement device according to claim 23, wherein the valve frame includes a plurality of holes passing through the valve frame, the valve tip is coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, and the sleeve is coupled to the valve frame using at least some of the plurality of holes passing through the valve frame.

27. A valve replacement device, comprising: A valve frame defining an opening for fluid passage, the valve frame being expandable to allow an increase in the diameter of the opening over a range of opening diameters; A valve tip coupled to the valve frame, the valve tip having an open configuration in which the opening is exposed and a closed configuration in which the valve tip at least partially covers the opening, the valve tip being configured to be movable between the open configuration and the closed configuration over a range of opening diameter sizes; and A sleeve coupled to the valve frame having a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame, wherein the proximal end of the sleeve serves as a suture cuff configured to allow the valve replacement device to be attached to the implantation site, and wherein the valve replacement device is configured to be attached to the implantation site solely at the proximal end of the sleeve. The valve replacement device.

28. The valve replacement device according to claim 27, wherein the sleeve further includes a film, wherein the film is configured to minimize ingrowth of native tissue into the sleeve.

29. The valve replacement device according to claim 27, wherein the valve frame includes a plurality of holes passing through the valve frame, the valve tip is coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, and the sleeve is coupled to the valve frame using at least some of the plurality of holes passing through the valve frame.

30. The valve replacement device according to claim 27, wherein the sleeve includes a first sleeve portion and a second sleeve portion coupled to the valve frame.

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