Geometrically adaptive 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 leaflets, the one or more leaflets being movable between an open configuration and a closed configuration. In some embodiments, the frame includes at least two frame sections joined at a pair of joining posts. In some embodiments, the device may be geometrically adaptable to different vasculature shapes and sizes and / or variable in size when implanted into a growing patient.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 394,742, filed on August 3, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The disclosed embodiments relate to valve replacement devices. Background Art

[0004] The human heart includes a series of valves that work to ensure that blood flows correctly through the various chambers of the heart. Birth defects, trauma, or other pathologies may negatively affect the function of a person's natural heart valves. Artificial heart valves have been developed to supplement or completely replace defective natural heart valves. Summary of the invention

[0005] In one embodiment, a valve replacement device is provided. The valve replacement device includes a valve frame defining an opening for fluid passage, valve leaflets connected to the valve frame, and a sleeve connected to the valve frame. The valve frame can be expanded to allow the diameter of the opening to be increased. The valve frame has a plurality of holes passing through the valve frame. The valve leaflets are connected to the valve frame using at least some of the plurality of holes passing through the valve frame. The valve leaflets have an open configuration and a closed configuration, in which the opening is exposed and in which the valve leaflets at least partially cover the opening. The valve leaflets are configured to be able to move between an open configuration and a closed configuration within a diameter size range of the opening. The sleeve is connected to the valve frame using at least some of the plurality of holes passing through the valve frame. The sleeve has a first expandable direction, which is oriented to allow the diameter of the opening of the valve frame to be increased.

[0006] In another embodiment, a valve replacement device is provided. The valve replacement device includes a valve frame defining an opening for fluid passage, a first leaflet coupled to the valve frame, and a second leaflet coupled to the valve frame. The valve frame can be expanded to allow the diameter of the opening to be increased. The valve frame has a plurality of holes passing through the valve frame. The first leaflet and the second leaflet are coupled to the valve frame using at least some of the plurality of holes passing through the valve frame. The first leaflet and the second leaflet each have an outer edge. The first leaflet has an open configuration and a closed configuration, in which the opening is exposed and in which the first leaflet at least partially covers the opening. The second leaflet has an open configuration and a closed configuration, in which the opening is exposed and in which the first leaflet and the second leaflet contact each other to at least partially cover the opening. The first leaflet and the second leaflet are configured to be able to move between the open configuration and the closed configuration within the diameter size range of the opening. The first leaflet and the second leaflet have a plurality of leaflet attachment points for coupling the first leaflet and the second leaflet to the valve frame. The plurality of leaflet attachment points are located at uneven distances from an outer edge of the first leaflet and an outer edge of the second leaflet.

[0007] In another embodiment, a valve replacement device is provided. The valve replacement device includes a valve frame defining an opening for fluid passage, a first leaflet coupled to the valve frame, and a second leaflet coupled to the valve frame. The valve frame can be expanded to allow the diameter of the opening to be increased. The valve frame has a plurality of holes passing through the valve frame. The first leaflet and the second leaflet are coupled to the valve frame using at least some of the plurality of holes passing through the valve frame. The first leaflet and the second leaflet each have an outer edge. The first leaflet and the second leaflet each have at least one attachment protrusion. The first leaflet has an open configuration and a closed configuration, in which the opening is exposed and in which the first leaflet at least partially covers the opening. The second leaflet has an open configuration and a closed configuration, in which the opening is exposed and in which the first leaflet and the second leaflet contact each other to at least partially cover the opening. The first leaflet and the second leaflet are configured to be able to move between the open configuration and the closed configuration within the diameter size range of the opening.

[0008] It should be understood that the aforementioned concepts and the additional concepts discussed below can be arranged in any suitable combination, as the present disclosure is not limited in this respect. In addition, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component illustrated in various figures may be represented by the same reference numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0010] Figure 1A is a partial perspective cross-sectional view of a blood vessel having a valve replacement device implanted therein before dilation;

[0011] Figure 1B yes Figure 1A A partial perspective cross-sectional view of a blood vessel and valve replacement device of FIG. 1 , wherein the device has undergone some expansion;

[0012] Figure 2 yes Figure 1A A three-dimensional view of a frame of a valve replacement device during expansion;

[0013] Figure 3 yes Figure 1A A top view of a frame of a valve replacement device during expansion;

[0014] Figure 4 yes Figure 1A A front view of a frame of a valve replacement device during expansion;

[0015] Figure 5A yes Figure 1A A side view of a frame of a valve replacement device during an increasing phase of expansion from left to right;

[0016] Figure 5B yes Figure 1A A perspective view of a frame of a valve replacement device during an increasing phase of expansion from left to right;

[0017] Fig. 6A is a side view of a frame and outer frame support of a valve replacement device prior to expansion;

[0018] Figure 6B is a side view of a frame and outer frame support of a valve replacement device after some expansion;

[0019] Fig. 7A yes Fig. 6A A top perspective view of the frame and outer frame supports prior to expansion;

[0020] Figure 7B yes Fig. 6A A top perspective view of the frame and outer frame supports after some expansion;

[0021] Figure 8 is a cross-sectional view of one embodiment of a valve replacement device implanted in a blood vessel according to one embodiment;

[0022] Fig. 9 is a cross-sectional view of one embodiment of a valve replacement device implanted in a blood vessel according to another embodiment;

[0023] Fig.10 is a perspective view of one embodiment of a frame of a growth-adaptive valve replacement device during expansion;

[0024] Fig.11A yes Fig.10 Side view of the frame during expansion;

[0025] Fig. 11B yes Fig.10 A front view of the frame during expansion;

[0026] Fig.12 is a perspective view of another embodiment of a frame of a valve replacement device during expansion;

[0027] Fig.13A yes Fig.12 The frame undergoes some expansion in side view;

[0028] Fig. 13B yes Fig.12 The frame undergoes some dilation in the front view;

[0029] Fig. 13C yes Fig.12 The frame undergoes some expansion of the top view;

[0030] Fig.14A is a side view of another embodiment of a frame and leaflets of a valve replacement device;

[0031] Fig. 14B yes Fig.14A A top view of the frame and leaflets;

[0032] Fig. 14C yes Fig.14A Inverted stereogram of the frame and leaflets;

[0033] Fig.14D yes Fig.14A A stereogram of the framework;

[0034] Fig.15A is a front view of another embodiment of a frame of a valve replacement device;

[0035] Fig. 15B yes Fig.15A A top view of the frame;

[0036] Fig. 15C yes Fig.15A A side view of the frame;

[0037] Fig.15D yes Fig.15A A stereogram of the framework;

[0038] Fig.15E yes Fig.15A A bottom-up perspective view of the frame;

[0039] Fig.16A is a side view of another embodiment of a frame of a valve replacement device;

[0040] Fig. 16B yes Fig.16A A front view of the frame;

[0041] Fig. 16C yes Fig.16A A top view of the frame;

[0042] Fig.16D yes Fig.16A An inverted stereogram of the frame;

[0043] Fig.17 is a side view of another embodiment of a valve frame segment;

[0044] Fig.18 is a front view of one embodiment of a valve frame segment;

[0045] Fig.19 is a front view of another embodiment of a valve frame segment;

[0046] Fig. 20A is a graphical visualization of a plan view and a perspective view of a cylinder including an ellipse onto which a portion of the ellipse is projected, wherein the projected curve defines a curvature of one embodiment of a valve frame segment;

[0047] Fig. 20B yes Fig. 20A Graphical visualization of the plan and side views of the cylindrical part;

[0048] Fig.21 is a perspective view of a valve frame of a valve replacement device according to one embodiment in a non-expanded state and an expanded state;

[0049] Fig. 22 is a line graph illustrating height / diameter ratios of different embodiments of valve frames of valve replacement devices having different baseline height to diameter ratios during expansion;

[0050] Fig.23A It depicts the different opening diameters. Fig. 22 A bar graph of both the measured flow rate and pressure change of the entire valve replacement device of the valve frame with HB / DB=1.7;

[0051] Fig. 23B The diagram shows the different opening diameters. Fig. 22A line graph showing the flow rate and flow rate waveform characteristics of a valve replacement device with a valve frame having HB / DB=1.7 as the flow rate changes over the course of a cardiac cycle;

[0052] Fig.23C It is shown that for Fig. 22 A bar graph of regurgitant fractions at two different diastolic pressures (representing right ventricular conditions and left ventricular conditions) for different opening diameters of a valve replacement device having a valve frame with HB / DB=1.7;

[0053] Fig.23D The finite element analysis is used to simulate the Fig. 22 Simulated peak stress (maximum principal stress, MPa) of the entire leaflet of a valve replacement device with a valve frame having HB / DB=1.7 in a closed configuration under a load of 20 mmHg (approximate value of right ventricular conditions);

[0054] Fig.24A is a diagram showing that one embodiment of a valve replacement device is tested in a 20 kg lamb;

[0055] Fig. 24B is a diagram showing that one embodiment of a valve replacement device is tested in a 60 kg sheep;

[0056] Fig.24C is a line graph showing the pressure difference between the right ventricle and the pulmonary artery (transvalvular pressure gradient, DELTA.P) during the cardiac cycle of a 20 kg lamb with an implanted valve replacement device;

[0057] Fig.24D is a line graph showing the pressure difference between the pulmonary artery and the right ventricle (transvalvular pressure gradient, DELTA.P) during the cardiac cycle of a 60 kg sheep with an implanted valve replacement device;

[0058] Fig.24E is a line graph showing the flow velocity waveform and regurgitant volume produced by a valve replacement device in its baseline configuration (1x) during the cardiac cycle of a 20 kg lamb;

[0059] Fig.24F is a line graph showing the flow velocity waveform and regurgitant volume produced by a valve replacement device in its fully expanded configuration (1.8 times) during the cardiac cycle of a 60 kg adult sheep;

[0060] Figure 24G An echocardiogram of one of the 20 kg lambs is shown showing a valve replacement device implanted in its baseline configuration (1X) with an inner diameter (ID) of 14 mm and a diagram of the valve replacement device;

[0061] Fig.24H An echocardiogram of one of the 60 kg sheep is shown showing a valve replacement device dilated to 25 mm (1.8 times) and a diagram of the valve replacement device;

[0062] Fig.25A is a perspective view of one embodiment of a valve frame of a valve replacement device;

[0063] Fig.25B yes Fig.25A A top view of the valve frame;

[0064] Fig.25C yes Fig.25A A front view of a valve frame;

[0065] Fig.25D yes Fig.25A A side view of the valve frame;

[0066] Fig.26 shows side and front views of one embodiment of a valve frame of a valve replacement device, annotated to depict attachment areas for top reinforcing struts;

[0067] Fig. 27 shows top and side views of one embodiment of a valve frame of a valve replacement device, annotated to depict attachment areas for bottom reinforcing struts;

[0068] Fig.28 Shows Fig.25A A side view of a valve frame of the invention, the valve frame expanding to a gradually increasing opening diameter;

[0069] Fig.29 The present invention is a diagram showing an embodiment of a valve replacement device having a plurality of valves ... Fig.25A A scatter plot of the height to diameter ratio of the valve frame of the valve replacement device;

[0070] Fig. 30A Figure 2 shows the flow of a fluid through a baseline diameter during a simulated cyclic flow loop during in vitro fluid dynamics testing. Fig.25A Line graphs of flow velocity waveforms and regurgitant volume of valve replacement devices;

[0071] Fig. 30B is included with Fig.25A A table of data obtained during in vitro testing of a valve replacement device of a valve frame;

[0072] Fig.31A Figure 2 shows that during in vitro hydrodynamic testing, a simulated cyclic flow loop was formed by a flowmeter having an expansion size of 1.8 times the baseline diameter. Fig.25A Line graphs of flow velocity waveforms and regurgitant volume of valve replacement devices with valve frames;

[0073] Fig.31B is contained within a diaphragm having an expanded size of 1.8 times the baseline diameter Fig.25A A table of data obtained during in vitro testing of a valve replacement device of a valve frame;

[0074] Fig.32A is an X-ray of a valve replacement device according to one embodiment, the valve replacement device being implanted in a 25 kg sheep;

[0075] Fig.32B During transcatheter balloon dilatation Fig.32A X-rays of valve replacement devices;

[0076] Fig.32C is in a partially expanded configuration Fig.32A X-rays of valve replacement devices;

[0077] Fig.33A is a perspective view of a valve frame of a valve replacement device according to one embodiment;

[0078] Fig.33B is based on Fig.33A A top view of a valve frame of an embodiment of ;

[0079] Fig.33C is based on Fig.33A Front view of a valve frame of an embodiment of

[0080] Fig.33D is based on Fig.33A A side view of a valve frame of an embodiment of ;

[0081] Fig.34A is a perspective view of one embodiment of a valve frame of a valve replacement device;

[0082] Fig.34B is based on Fig.34A A top view of a valve frame of an embodiment of ;

[0083] Fig.34C is based on Fig.34A A front view of a valve frame of an embodiment of ;

[0084] Fig.34D is based on Fig.34A A side view of a valve frame of an embodiment of ;

[0085] Fig.35A is a perspective view of one embodiment of a valve frame of a valve replacement device;

[0086] Fig.35B is based on Fig.35A A top view of a valve frame of an embodiment of ;

[0087] Fig.35C is based on Fig.35A A front view of a valve frame of an embodiment of the present invention;

[0088] Fig.35D is based on Fig.35A A side view of a valve frame of an embodiment of ;

[0089] Fig.36A is a side view of one embodiment of a valve frame of a valve replacement device;

[0090] Fig.36B yes Fig.36A A front view of a valve frame;

[0091] Fig.37A yes Fig.33A A perspective view of a valve frame of , wherein the leaflets are attached to the frame;

[0092] Fig.37B yes Fig.37A A front view of the arrangement;

[0093] Fig.37C yes Fig.37A A side view of the arrangement;

[0094] Fig.38A is in a state of expansion Fig.37A A front view of the arrangement;

[0095] Fig.38B is in a state of expansion Fig.37A A side view of the arrangement;

[0096] Fig.39A is a perspective view of a valve frame of a valve replacement device according to one embodiment;

[0097] Fig.39B is based on Fig.39A A top view of a valve frame of an embodiment of ;

[0098] Fig.39C is based on Fig.39A A front view of a valve frame of an embodiment of the present invention;

[0099] Fig.39D is based on Fig.39A A side view of a valve frame of an embodiment of ;

[0100] Fig.40A is a perspective view of a valve replacement device according to one embodiment;

[0101] Fig.40B There is no basis for the sleeve Fig.40A A perspective view of a valve replacement device according to an embodiment of the present invention;

[0102] Fig.41 is a side view of a leaflet according to one embodiment;

[0103] Fig.42 is a side view of a sleeve according to one embodiment;

[0104] Fig.43A is a perspective view of a valve replacement device in an unexpanded configuration according to one embodiment;

[0105] Fig.43B is in an expanded configuration Fig.43A A perspective view of a valve replacement device; and

[0106] Fig.44 is a side view of a leaflet according to another embodiment. DETAILED DESCRIPTION

[0107] Some embodiments described herein include heart valve replacement devices that can change size and / or shape to adapt to different implant environments. In some embodiments, such geometrically adaptable heart valve replacement devices may be adapted to cooperate with different types of vasculature and / or be used with patients of different sizes. In some embodiments, some heart valve replacement devices described herein can be used with growing patients and can grow with the patient.

[0108] In some embodiments, it is contemplated that the device may also be used elsewhere in the vascular system besides the heart, for example, as a venous valve prosthesis.

[0109] According to one aspect, some embodiments of heart valve replacement devices can achieve heart valve function in a variety of structural environments within a range of sizes. The inventors have recognized a need for a heart valve replacement device that can change size and / or shape to accommodate changing environments.

[0110] According to one aspect, as the size of the valve opening increases, some embodiments of the heart valve replacement device grow with the patient and remain functional within a size range. Current heart valve prostheses are designed for adults and are intended to be implanted once and maintained for probably decades, depending on the patient and the condition. Adult patients are generally expected to undergo regular checkups to ensure that the valve has not narrowed or shifted, thereby ensuring optimal function. In some cases, open heart surgery may be required to adjust or replace the valve. In adults, the diameter of the vascular cavity and the size of the heart do not usually change significantly from year to year. However, in children, the size of the vascular system and the heart grows significantly as they mature. Therefore, the inventors have recognized that, with current devices, children who have undergone valve replacement must go through multiple processes as they grow to implant a valve replacement device of appropriate size. The inventors have recognized that there is a need for a valve replacement device that is effective within a certain size range.

[0111] Although some embodiments described herein are suitable for use in growing patients, it should be understood that the heart valve replacement devices described herein are not limited to use in growing patients. These devices can also be used in non-growing applications. For example, some embodiments can be used as adult transcatheter valves that can be resized after deployment at least for the purpose of addressing prosthesis-patient mismatch and paravalvular leaks that occur in existing transcatheter valves.

[0112] In some embodiments, a first valve replacement device can be implanted during the first few years of a patient's life, and once that device reaches a fully expanded state, a second valve can be deployed within the initially implanted device to enable the patient to avoid repeat open heart surgery.

[0113] In some embodiments, it is contemplated that the valve replacement device may also be used as a valve within an expandable catheter, which may be a cylindrical tube connecting two cardiac structures or some other expandable catheter system. For example, the valve replacement device of some embodiments may be attached to a cylindrical tube made of an expandable synthetic material that serves as the right ventricle of the pulmonary artery catheter. In these embodiments, the valve catheter may be periodically expanded by transcatheter balloon dilation or other methods to accommodate the patient's somatic cell growth and / or adjusted to match the desired pressure and / or flow conditions.

[0114] Heart valve function can be characterized by different properties. One measure of heart valve function is the regurgitation fraction, which is the amount of blood that leaks backward through the valve against the intended direction of flow divided by the amount of blood that flows through the heart valve in one stroke. Healthy, functioning valves exhibit a small amount of regurgitation. The inventors have appreciated that in some cases, a regurgitation fraction of 0% to 20% is ideal. Another measure of heart valve function is the amount of average and peak transvalvular pressure gradients exhibited by the valve. This pressure metric is important because it quantifies the valve function that allows unimpeded forward flow. The inventors have appreciated that in some cases, a peak transvalvular pressure gradient of 0 mmHg to -40 mmHg is ideal for the right side of the heart, and a peak transvalvular pressure gradient of 0 mmHg to -30 mmHg is ideal for the left side of the heart.

[0115] In some embodiments, the valve replacement device includes one or more leaflets connected to a frame. The leaflets surround an opening of the device through which blood can flow. The leaflets have an open configuration and a closed configuration. In the open configuration, the leaflets separate and expose the opening of the device to allow blood to flow through the opening. In the closed configuration, the leaflets align and block the opening of the device to prevent blood from flowing back. The leaflets move between the open configuration and the closed configuration based on the pressure difference across the valve during the cardiac cycle. In some embodiments, the device includes two leaflets. However, other numbers of leaflets can be used, such as three leaflets, four leaflets, five leaflets or more leaflets. In some embodiments, the heart replacement device includes only one leaflet. A single leaflet can extend from one side of the frame to the other. In some embodiments, the leaflet is a crescent shape, for example, a leaflet of 3 / 4 to 1 / 2 crescent shape.

[0116] In some embodiments, the frame can include a pair of semi-elliptical frame segments joined at a pair of commissures. The frame segments curve laterally outward away from each other to form a semi-hourglass shape. As the surrounding vasculature widens, the two frame segments separate further at the open ends, thereby increasing the opening of the device and matching the cross-sectional area of ​​the expansion cavity to accommodate growth. Each leaflet can be attached to the inner boundary of each of the frame segments to mimic the leaflet vessel wall attachment line of a native venous valve.

[0117] In some embodiments, the device includes an external frame support coupled to the frame. In some embodiments, the external frame support can be a semi-rigid cylindrical mesh. The frame is attached to the interior of the external frame support and is stabilized by the external frame support. Due to the rigidity of the external frame support, the outer surface of the external frame support is pressed against the inner wall of the vascular system in which the device is implanted, thereby keeping the cavity of the surrounding vascular system open and maintaining the orientation and position of the device. The external frame support can act similarly to a stent, allowing the device to be delivered via catheter delivery or direct surgical implantation. However, it should be understood that in some embodiments, the frame can be used alone without the addition of an external frame.

[0118] According to one aspect, in some embodiments, the frame of the valve replacement device maintains a constant boundary length throughout the entire length process (e.g., the area where the leaflets are attached does not stretch), that is, the boundary length does not stretch or extend during growth. Alternatively, as the frame segments stretch to accommodate growth, the height of the commissures decreases. In some embodiments of this non-elongation design, adaptability to radial growth is achieved by balloon expansion of a plastically deformable material (e.g., steel, cobalt chromium, etc.). Therefore, the leaflets attached to the frame segments will not deform (i.e., will not stretch, elongate or expand) when the valve opening expands. The degree of coaptation of the leaflets (i.e., the length of the leaflet material that is in contact with other valve leaflets in the closed state) can decrease as the opening expands.

[0119] In some embodiments, the frame segments of the frame are configured to maintain their shape as the device expands to accommodate growth, and thus the leaflets are not expanded or stretched during growth.

[0120] In alternative embodiments, rather than maintaining a constant border length of the frame as the opening of the device grows, the frame can be extended as the device grows. This can be used to reduce the amount of height change that the device experiences during the opening expansion. The frame can be made of any suitable material and / or can be constructed in any suitable form to allow the frame border to extend as the device grows. For example, the frame can be made of an elastic material that can be elastically stretched and extended, that can include a telescopic section, that can include a bio-erodible section, or that can include any other suitable mechanism that will allow the frame border to extend while the frame sections are spread apart from each other.

[0121] In some embodiments, the frame can include a segment having a bioerodible outer sleeve having a core having a flexible segment that telescopes or folds. When the outer sleeve erodes, the core is exposed. When the vasculature expands, radial tension on the frame causes the core to expand or unfold, thereby allowing the frame to expand.

[0122] In some embodiments of the valve replacement device, the frame expands laterally outward in an asymmetric manner because the frame segments move apart at different rates. The shape of each frame segment can remain unchanged throughout the growth / expansion process, but the opening can grow more in one direction than the other. To achieve asymmetric expansion, these embodiments can have frame segments made of materials of different stiffnesses, or can have angled commissures so that expansion favors one side over the other.

[0123] The frame and / or outer frame supports may be self-expanding or may be expandable by other means, such as by balloon expansion.

[0124] Valve replacement devices may be delivered via minimally invasive approaches, such as by a transcatheter approach, or may be implanted via open heart surgery.

[0125] In some embodiments, the curved profile of the arc segment of the frame segment can be obtained by projecting an elliptical quadrant onto a cylindrical member. It is conceivable that the cylindrical member can represent the shape of the inner wall of the blood vessel. The radius of the cylindrical member will be equal to the radius of the valve held by the valve frame. Another frame segment will match the projected curved profile, but will be mirrored around the centerline of the cylindrical member. It should be understood that other frame segment shapes and curved profiles can also be conceived. However, it is also conceivable that other possible methods of defining the shape of the frame segment can also be conceived, and the current disclosure is not limited thereto. The frame segment can also have other shapes.

[0126] In some embodiments, the valve replacement device may include a reinforcing feature such as a pillar, which connects two frame sections of the valve frame. Such a reinforcing pillar can be used to maintain the shape of the valve frame during expansion. Some embodiments of the valve replacement device may include a top reinforcing pillar connecting two frame sections. The top reinforcing pillar can be attached to the frame at or near the top of the paired commissures. The length of the top reinforcing pillar can be equal to or greater than the circumference of the frame opening at the maximum expansion diameter of the frame opening. The top reinforcing pillar can be formed into a ring or ellipse, or can be shaped in an asymmetric manner in its fully expanded state. In the unexpanded shape, the top reinforcing pillar can have a wavy profile extending around the longitudinal axis of the valve replacement device, so that when viewed from the top, the top reinforcing pillar has a circular or elliptical or asymmetric profile, regardless of the expansion state of the valve replacement device. In some embodiments, the top reinforcing pillar can have an undulating portion that makes the top reinforcing pillar have a smaller diameter before the frame is expanded, but allows the top reinforcing pillar to expand with the frame. The top reinforcing struts may be constructed of a material having sufficient rigidity to provide reinforcing integrity to the frame when the frame is expanded, and having sufficient flexibility to allow the undulations to straighten to allow the top reinforcing struts to expand.

[0127] In other embodiments, the top reinforcement struts can have a variety of different geometries that can vary depending on the application of the valve replacement device. For example, the top reinforcement feature can be diamond-shaped to more easily allow the valve to be compressed on a catheter for percutaneous venous or transarterial valve deployment. Other shapes are also contemplated, and the current disclosure is not limited thereto.

[0128] Other shapes for the top reinforcement feature are also contemplated. For example, the top reinforcement feature may include multiple expandable segments connecting the frame segments rather than a single annular collar. These segments may be telescoping segments, or may be folded or compressed to allow the feature to expand. The top reinforcement struts may also be non-annular shapes as long as the feature can expand with the frame and fit the implant environment.

[0129] Some embodiments of the valve replacement device may include reinforcing features that are not attached to the commissures of the valve frame. For example, some embodiments may have lower reinforcing struts that connect the corresponding lower sides of the frame segments to each other. The lower reinforcing struts may also have an undulating or otherwise compressed or folded shape that allows the lower features to expand with the frame. Similar to the top reinforcing struts, the lower features may be made of a material that has sufficient rigidity to impart additional structural strength to the valve frame and sufficient flexibility to allow the lower reinforcing struts to expand and / or straighten or unfold.

[0130] The lower reinforcing struts may flare beyond the cylindrical surface of the valve frame opening to allow fixation of the device to the native heart structure, or in other applications, the lower reinforcing struts may be used as a fixation method for transcatheter deployment of a valve-in-stent or transcatheter deployment of a valve-in-valve.

[0131] In other embodiments, the lower reinforcement struts can have a variety of different geometries that can vary depending on the application of the valve replacement device. For example, the top reinforcement feature can be diamond-shaped to more easily allow the valve to be compressed on a catheter for percutaneous venous or transarterial valve deployment. Other shapes are also contemplated, and the current disclosure is not limited thereto.

[0132] The top reinforcing strut and the lower reinforcing strut or any other reinforcing strut can also be adjusted to change or control the shape of the valve when the valve expands. The material properties, geometry, thickness, etc. of the reinforcing struts can be modified to achieve a specific opening geometry as the valve expands. The reinforcing struts can also be different in material, geometry or thickness to achieve a specific opening geometry as the valve expands. A reinforcing strut can even be different in material or thickness within the reinforcing strut to achieve a specific opening geometry as the valve expands. In some embodiments, it is conceivable that the reinforcing struts can control the expansion of the frame so that the shape of the opening is elliptical, or asymmetric or circular. Other shapes can also be conceived. For example, the reinforcing struts can be substantially thicker on one side, or shorter on one side, or made of a harder material on one side to ensure that the side does not expand to the same extent as the other side of the frame.

[0133] Although top and lower reinforcement features are described, it should be understood that some embodiments may include one or both of the top and lower reinforcement features. Additionally, some embodiments may include additional features that connect the frame sections and may be located between the top and lower reinforcement features.

[0134] In some embodiments, the valve replacement device can include a plurality of holes spaced along the frame. The holes can be used as anchor points for sutures to help attach the leaflets to the frame. In some embodiments, the leaflets have additional protruding sections of material that are attached to the frame via interspersed slots along the length of the leaflet attachment line and then mechanically fixed to the exterior of the frame.

[0135] Turning to the drawings, specific non-limiting embodiments are further described in detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used alone and / or in any desired combination, as the present disclosure is not limited to the specific embodiments described herein.

[0136] Figure 1A One embodiment of a valve replacement device implanted in a representative blood vessel is shown. The valve replacement device 100 includes a frame 102 and an outer frame support 108. The frame 102 can be symmetrical, having two frame segments 104 that converge at a commissure 110. The frame segments can each be a U-shaped arc segment. The arc segment of each frame segment 104 is lined with a valve leaflet 106. The valve leaflet 106 is suspended from the frame segment 104 so that in the closed configuration of the device, the valve leaflet is suspended and in close contact, thereby blocking the opening of the device. When blood flows through the blood vessel (blood from the vascular cavity such as in Figure 1AAs the blood flow slows, the leaflets contract again to a closed configuration, preventing the backflow of blood. Figure 1B As can be seen in FIG, as the blood vessel surrounding the device grows, the device expands with the blood vessel in a similar manner to continue to effectively function as a replacement valve.

[0137] Figure 2 , Figure 3 and Figure 4 1 shows different perspective views of one embodiment of a frame as it expands. Frame 102 shows the initial frame, while frame 102' shows the frame after some expansion. Figure 2 and Figure 3 As best seen in , the opening of the frame expands from a pre-expansion opening 114 to a larger expanded opening 114'. Similarly, commissure posts 110 show the posts before expansion, and commissure posts 110' show some of the posts after expansion. The frame can have a vertical height (axial length) at its base line before expansion of between 5 mm and 50 mm and an inner diameter of between 5 mm and 50 mm.

[0138] In some embodiments, the framework can have a molecular weight of about 0.5:1 to 2.5:1, or 0.6:1 to 2.4:1, or 0.7:1 to 2.3:1, or 0.8:1 to 2.2:1, or 0.9:1 to 2.1:1, or 1:0 to 2:1, or 1.1:2.0, or 1.2:1 to 1.9:1, or 1.3:1 to 1.9:1, or 1.3:1 to 1.8:1, or 1.4:1 to 1.7:1, or 1.5:1 to 1.8:1, or 1.6:1 1 to 2.5:1, or 1.5:1 to 2.5:1, or 1.6:1 to 2.5:1, or 1.7:1 to 2.5:1, or 0.6:1 to 2.5:1, or 0.7:1 to 2.5:1, or 0.8:1 to 2.5:1, or 0.9:1 to 2.5:1, or 1.0:1 to 2.5:1, or 1.1:1 to 2.5:1, or 1.2:1 to 2.5:1, or 1.3:1 to 2.5:1, or 1.4:1 to 2.5:1, or 1.5:1 to 2.5:1, or 1.6:1 to 2.5:1, or 1.7:1 to 2.5:1.

[0139] As the frame expands, the two frame segments 104 move laterally away from each other. As the frame segments 104 move away from each other, the height of the commissure posts 110 decreases. Figure 5A and Figure 5B The time lapse of the expansion of the framework from a small diameter configuration (left) to a large diameter configuration (right) is shown. Figure 3 and Figure 4As can be seen in FIG. 1 , in some embodiments, when the frame expands, the frame can expand uniformly in all radial directions. In some embodiments, the expansion mechanism of the frame segments 104 that occurs during growth to expand the entire frame 102 can retain the boundary length of each frame segment 104. Figure 5B As can be seen in FIG. 1 , the pre-expanded opening 114 expands to a larger expanded opening 114 ′ as the frame expands.

[0140] The frame may be made of nickel titanium alloy, titanium, cobalt chromium alloy, stainless steel, biodegradable polymers, bioabsorbable polymers, synthetic materials, platinum iridium, magnesium or iron alloys, and / or any other suitable material.

[0141] In some embodiments, each leaflet 106 can have a 3 / 4 to 1 / 2 moon shape, such that the concave side matches the arc segment of the frame segment 104 to which the leaflet is attached. The leaflet 106 can be sutured, adhered, or otherwise attached to the frame segment. The concave side or free edge 115 of the leaflet (for illustrative examples of free edges, see Figure 1A , Figure 1B ) can be up to 4 times the diameter of the valve in a baseline state / configuration, while the leaflet vertical height can be up to 2.5 times the diameter of the valve in a baseline state / configuration. The height of the center of the leaflet can be in the range of 0.2 to 0.8 times the height of the leaflet at the commissure post. As the frame expands, the leaflet-commissure attachment angle increases, causing the free edge 115 of the leaflet to straighten. The excess leaflet height ensures that the device has sufficient apposition to effectively function as a valve throughout the entire range of device expansion. Prior to expansion of the valve frame, the apposition height can be up to three quarters of the opening diameter. Although the depicted embodiments show leaflets of equal size and shape that are symmetrical to each other, the size and / or shape of the valve leaflets can vary from one another. In some embodiments, one larger leaflet can cover a majority of the valve opening in a closed position, wherein one or more smaller leaflets form a crescent-like shape in the closed position.

[0142] Although the dimensions of the leaflets are provided above, it should be understood that other dimensions are also conceivable. For example, the length of the free edge of the leaflet can be between 2 and 6 times or some other range. The vertical height of the leaflet can be between 1.5 and 3.5 times the diameter of the valve in the baseline configuration, or between 2.2 and 2.7 times. The middle height of the valve can be 0.1 to 1 times the height of the leaflet at the commissure. Other ranges are also conceivable.

[0143] Although the depicted embodiment shows a design utilizing two leaflets, designs utilizing three or more leaflets with two or more frame segments are also contemplated. Designs utilizing a single leaflet are also contemplated.

[0144] The leaflets can be made of the following materials: bioabsorbable polymers, synthetic polymers, tissue engineered constructs, decellularized homologous tissue engineered leaflets, nickel titanium alloy films, expanded PTFE membranes, glutaraldehyde-treated bovine pericardium, glutaraldehyde-treated porcine pericardium, photo-oxidized bovine pericardium, bovine jugular vein valves, or any other suitable composition or material. In some embodiments, the leaflets are made of a 0.1 mm thick expanded PTFE membrane (GORE PRECLUDE pericardium) having a Young's modulus of about 60 MPa under physiological loads. Leaflet materials with a Young's modulus in the following ranges can also be envisioned: 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.

[0145] Fig. 6A , Figure 6B , Fig. 7A and Figure 7B 1 shows views of the frame and outer frame support at different stages of expansion according to one embodiment of the device. In this embodiment, the outer frame support 108 is a mesh cylindrical member with open holes. Figure 1A and Figure 1B As shown, the outer frame supports can provide stability to the device and maintain the orientation of the frame relative to the blood vessel 112. As the frame 102 expands, the mesh tubes comprising the outer frame supports 108 can also expand, thereby reducing the height of the outer frame supports while increasing the diameter of the outer frame supports to match the diameter of the blood vessel.

[0146] Although the depicted embodiment shows an external frame support in the form of a mesh cylinder with open pores, it should be understood that the external frame support may also take different forms. The external frame support may have closed pores, or may have a mixture of open and closed pores. The external frame support may also include a partially solid cylinder with an expandable section or any other arrangement that will allow the external frame support to expand with the frame.

[0147] In some embodiments, the valve replacement device may include an outer flexible cover that can be wrapped around the outer frame support or, in the absence of a separate outer frame support, can be wrapped around the frame itself. The flexible cover can prevent tissue ingrowth into the outer frame support and prevent the formation of an abnormal fibrous tubular layer or granulation tissue layer. The frame and flexible cover can be chemically inert, or the frame and flexible cover can be treated with a compound to impart desired properties, including but not limited to anti-adhesion properties or anti-thrombotic properties.

[0148] Figure 8 One embodiment of a valve replacement device implanted in a blood vessel 112 is shown. In this embodiment, the outer frame support 108 is secured to the blood vessel 112 by a series of sutures 118 spaced along the length of the outer frame support 108. The sutures 118 secure the outer frame support to the blood vessel so that when the blood vessel grows, the blood vessel provides a radially outward force on the outer frame support that causes the outer frame support to expand, thereby causing expansion of the frame 102. In some embodiments, the outer frame support can include a plurality of holes 116 to receive such sutures.

[0149] In some embodiments, the outer frame support can be secured to the vasculature at only a single attachment location. For example, the outer frame support can be secured to the vasculature at only a single attachment line along the height of the device. Fig. 9 In the embodiment shown in , the outer frame support 108 is fixed to the blood vessel 112 along a single line 117. Having a single attachment location between the vasculature and the device can help allow changes in the height and diameter of the device, as well as accommodate axial growth of the vasculature. 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 can prevent paravalvular leakage, blood flow stagnation, or other abnormal blood flow distribution. In some embodiments, the valve can have an outer covering made of an expandable synthetic material that extends beyond the base of the valve. The material can be used as a sewing ring to secure the valve in place of the natural valve ring. This may be the only device attachment site.

[0150] Fig.10 , Fig.11A and Fig. 11BAnother embodiment of a frame is shown. In this embodiment, as the frame 202 expands, the frame segments 204 stretch and move apart from each other to increase the size of the opening 214. 202' shows the frame 202 after some expansion. The frame segments 204 represent the position and shape of the frame segments before expansion, while 204' represents the position and shape of the frame segments after some expansion. In some embodiments, the height of the commissure posts 210 and the height of the entire frame in general is maintained as the opening diameter increases.

[0151] In some embodiments, for devices with extended frame border lengths, the leaflets are configured to increase in size as the opening diameter increases. For example, in some embodiments, the leaflets can be sutured to the frame segments, wherein additional material is folded up like an accordion between the sutures. As the frame segments expand, the distance between the sutures increases, allowing the accordion-like folds to unfold, thereby providing additional leaflet segments to accommodate the elongation. In other embodiments, the leaflets are typically sutured to the frame segments, but the leaflets are particularly flexible or expandable and simply stretch as the frame segments expand.

[0152] Although the depicted embodiment depicts a symmetrical valve frame with a circular opening and uniformly expanded frame segments, it should be understood that the current disclosure is not limited thereto. In other embodiments of the device, the opening may be elliptical or other irregular shapes to accommodate different structural environments and physiological valve applications.

[0153] Fig.12 , Fig.13A , Fig. 13B and Fig. 13C An embodiment of a frame is shown in which the two frame segments expand in an asymmetric manner. The frame 302 starts with the commissure posts 310 at one height, and then after expansion, the frame 302' has the commissure posts 310' at a reduced height due to the expansion. In these embodiments, the commissure posts 310 or frame segments 304 may be unequal to some extent to produce an asymmetric expansion. The commissure posts 310 or frame segments 304 may be flared inwardly between or equal to 5 degrees and 45 degrees, flared outwardly between or equal to 45 degrees, may have unequal heights before the valve frame expands, may have different thicknesses, or may be composed of materials with different stiffnesses. In any case, when the frame 302 attempts to expand with the vasculature, the two frame segments separate laterally at different rates, thereby forming an elliptical opening 314.

[0154] FIG. 14A to FIG. 14DAn embodiment of a frame 402 and leaflets 406 defining an elliptical opening is shown. In this embodiment, the frame segment 404 is wider than in the previous embodiment to create a slit as in Fig. 14B The elliptical shape as viewed from a top view in FIG. The commissure posts 410 are located at opposite sides along the major axis of the ellipse formed by the opening of the device. As the frame segments diverge, the opening of the device can remain coplanar with a vertical cross-section of the surrounding vasculature. Although the accompanying drawings show commissure posts of equal height, in some embodiments, the commissure posts can have unequal heights, or the commissure posts can be flared 5 to 45 degrees inward or outward. In some embodiments, the valve replacement device can be used as an inflow valve. In some embodiments, the valve replacement device can mimic the shape of a natural atrioventricular valve.

[0155] FIG. 15A to FIG. 15E Another embodiment of a frame 502 defining an oval opening 514 is shown. In this embodiment, the size and / or shape of the frame segments 504a and 504b are different from each other before the valve frame is expanded. Fig. 15B As can be seen in , only one of the commissure posts 510 is located on the major axis of the ellipse formed by the opening, while the other commissure post is located in front of the major axis. Due to the different sizes and / or shapes of the valve frame segments relative to each other, the leaflets of this embodiment are similarly different from each other to match their corresponding frame segments. In some embodiments, the leaflets can have the same mechanical properties as each other or can have different mechanical properties from each other to accommodate different applications. For example, larger leaflets may be more expandable than smaller leaflets to account for size differences. In other embodiments, the commissure posts are axially tilted relative to the surrounding vasculature. Various embodiments with tilted commissure posts can accommodate tortuous flow patterns through the device and enable valve function to be maintained in various structural environments depending on the degree of tilt. This tilt may produce an opening that is not located in the same plane as a vertical cross-section of the cavity of the local vasculature.

[0156] FIG. 16A to FIG. 16D Another embodiment of a frame 602 having a frame segment 604 is shown. This embodiment has an asymmetric frame 602 defining an oval opening 614. However, in this embodiment, both commissure posts 610 are located Fig. 16C In front of the major axis of the ellipse as observed in. Due to this arrangement, the frame 602 is asymmetrical, resulting in one leaflet covering a majority of the opening.

[0157] In some embodiments, the plane formed by the openings can be orthogonal to the fluid flow in the surrounding vasculature, or can be offset relative to the fluid flow. In some embodiments, the plane formed by the openings can be coplanar with a vertical cross-section of the surrounding vasculature, or can be tilted relative to the vertical cross-section. For example, in Figure 1A In the illustrated embodiment, the plane formed by the openings 114 of the device is coplanar with a vertical cross-section of the surrounding vasculature, which is the blood vessel 112. Additionally, the plane formed by the openings 114 is also orthogonal to the fluid flow through the blood vessel 112.

[0158] In some embodiments, the valve replacement device includes one or more commissure posts extending in a direction defining a vertical direction. The plane formed by the opening can be orthogonal to the direction of the commissure posts, or can be inclined relative to the orthogonal line. For example, in Figure 1A In the illustrated embodiment, the plane formed by the openings 114 of the device is orthogonal to the vertical direction defined by the orientation of the commissure posts 110. Fig.17 In the illustrated embodiment, where the valve frame has segments 704a, 704b of different lengths, this 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 orientation of the commissure posts 710, but is instead inclined relative to the orthogonal line 730.

[0159] In some embodiments, the valve frame can be composed of more than one frame segment. The frame segments can form a U-shape with two arms extending away from a middle segment that forms the base of the first frame segment. In some embodiments, the middle segment lies on a single plane. For example, in Figure 1A and Figure 1B In the embodiment shown, the valve frame has frame sections with a middle section 130 lying on a single plane. This can also be Figure 4 Seen in.

[0160] However, it should be understood that other arrangements are possible. For example, in some embodiments, the middle section can be non-planar, such that the middle section is curved or otherwise shaped so that it does not lie along a single plane. In some embodiments, the middle section has a saddle curve that faces upward in the same direction as the U-shape, or faces downward in the opposite direction to the U-shape.

[0161] exist Fig.18 and Fig.19 Two illustrative embodiments of valve frame segments having non-planar bases are shown in FIG. Fig.18804a has a U-shape including a first arm 831 and a second arm 832 extending away from a middle section 830 which is a saddle curve facing in the same direction as the U-shape. Fig.19 In the illustrative embodiment shown, Fig.19 Also a front view of a valve frame segment, frame segment 904a has a U-shape including a first arm 931 and a second arm 932 extending away from a middle segment 930 having a saddle curve facing in a direction opposite to the U-shape.

[0162] In some embodiments, the valve frame can be shaped in an asymmetrical manner or can expand asymmetrically, or have different thicknesses or materials between frame segments, due to the splayed or tilted commissure posts. The commissure posts can mirror each other in size and / or shape, or the commissure posts can be different from each other. The valve frame and the two commissure posts can exhibit variable bending stiffness to allow the opening shape to change during the cardiac cycle (i.e., the cylindrical opening becomes oblong / elliptical at peak diastolic loads).

[0163] Fig. 20A and Fig. 20B A curved profile of one of the frame segments of a valve frame of a valve replacement device according to some embodiments is shown. In this embodiment, the curved profile 908 can be approximately defined by projecting an elliptical quadrant 904 from a plane 902 onto a cylindrical member 906, which can represent the inner wall of a representative blood vessel. The elliptical profile 903 can have a semi-major axis length equal to the height (H) of the frame and a semi-minor axis whose length is equal to the radius (r) of the frame. The radius of the cylindrical member can be equal to the radius of the frame opening. The common vertex of the projected ellipse can coincide with the centerline of the cylindrical member, the ellipse vertex, and the ellipse center, so that when viewed from Fig. 20B When viewed in side view, they all coincide with the outer edge of the central cross section of the cylindrical member. In this configuration, the center of the ellipse from which the elliptical quadrant is derived coincides with a point along the circumference of the axial end of the cylindrical member, and the minor and major axes of the ellipse are coaxial with the edges of the cross section of the cylindrical member.

[0164] The curvilinear profile 908 may be mirrored about the central plane of the barrel to produce a curvilinear profile for the opposing frame section.

[0165] It is also contemplated that a composite curve or polynomial spline could be projected onto the cylindrical member to produce a curved profile for the entire frame.

[0166] Fig.21An embodiment of a valve frame of a valve replacement device is shown in two different states: an unexpanded state 1000a and an expanded state 1000b. In this embodiment, the length of the valve frame 1002 remains constant during expansion of the valve frame. The radial growth of the frame is accommodated by reducing the height of the valve frame rather than extending the actual length of the valve frame. Fig. 22 A line graph is shown depicting how the height to diameter ratio (H / D) changes for embodiments of valve frames having different baseline height to diameter ratios (HB / DB) as the device expands from a baseline diameter DB to a final diameter 2DB. Although embodiments having baseline HB / DB ratios of 2, 1.7, and 1.5 are shown, other ratios are also contemplated as described above.

[0167] One embodiment of the valve replacement device was tested for fluid dynamics performance. The valve replacement device was tested at five different expansion states of the valve frame (16 mm, 19.2 mm, 22.4 mm, 25.6 mm, and 28.8 mm). Fig.23A It depicts the Fig. 22 Bar graphs of measured flow rate, regurgitant volume, and transvalvular pressure gradient (a measure of the pressure drop across the valve during systole during the opening phase) for the entire valve replacement device with a valve frame having HB / DB=1.7. The device exhibited unimpeded forward flow throughout the expansion process; when the flow rate was increased to match the increased valve diameter (simulating the physiology of a growing patient), the transvalvular pressure gradient (DELTA.P) did not increase with valve expansion.

[0168] Fig. 23B A line graph depicting flow characteristics over time as a valve replacement device is opened and closed is shown. Two valve sizes are depicted, with inner diameters of 16 mm and 28.8 mm, respectively. Fig.23C The regurgitant fraction measured at various valve diameters at different diastolic pressures (i.e., pressure load on the leaflets in the closed state) are shown: 20 mmHg (representing physiological right heart diastolic pressure) and 80 mmHg (representing physiological left heart diastolic pressure). The device was found to exhibit slight valve leakage in the diastolic state at all expansion states (i.e., 1 x internal diameter up to 1.8 x internal diameter). Fig.23DResults of a finite element analysis performed to estimate the magnitude and distribution of stresses on a growth-adaptive valve in a loaded state (i.e., with the leaflets in a closed position) are shown. The data presented indicate peak stresses (maximum principal stresses, MPa) at a load pressure of 20 mmHg. The data show that the magnitude of the peak stresses on the valve leaflets in the closed state are relatively low throughout the expansion from 16 mm to 28.8 mm (from 1 to 1.8 times the baseline diameter). Most of the stress is distributed at locations of greatest deformation, and there is no stress concentration at the locations where the leaflet frame is attached. In addition, the stresses at the frame commissures are relatively low, which is different from conventional three-leaflet bioprosthetic valve designs known in the prior art.

[0169] Fig.24A , Fig.24C , Fig.24E and Figure 24G Shown are the results of in vivo testing performed by implanting one embodiment of a valve replacement device having an inner diameter of 14 mm in four lambs. Fig. 24B , Fig.24D , Fig.24F and Fig.24H Shown are the results of in vivo testing of the same embodiment of the valve replacement device expanded to 25 mm (1.8 times the baseline diameter) and implanted in four adult sheep. In these studies, the valve replacement device was used to replace the pulmonary valves of lambs and sheep. Fig.24C and Fig.24D Shown are measured changes in right ventricular pressure (close to the valve) and pulmonary artery pressure (away from the valve) during the animal's cardiac cycle. It was found that there was no transvalvular gradient across the valve, regardless of the valve dilation state. Fig.24E and Fig.24F Representative flow velocity waveforms of measured physiological flow across a valve replacement device during a cardiac cycle are shown. It has been found that regardless of the diameter of the opening, forward flow of physiological fluid is not impeded and there is no leakage across the valve replacement device in diastole. Figure 24G and Fig.24H An echocardiogram performed to visualize an implanted valve replacement device in vivo is shown. Changes in frame height and leaflet coaptation height at different states of valve diameter expansion became apparent between the two animal groups.

[0170] FIG. 25A to FIG. 25DAn embodiment of a valve frame of a valve replacement device is shown. In this embodiment, a valve frame 2500 includes a top reinforcement feature, such as a reinforcement strut 2504 attached to a commissure 2502 of the frame. The device also includes a lower reinforcement strut 2506 connecting the lower portion of the frame segment. In this embodiment, the top reinforcement strut 2504 has a circular profile in a fully expanded state, and the top reinforcement strut 2504 is attached to the commissure at diametrically opposite points of the annulus. The top reinforcement strut of this embodiment includes an undulating portion 2508, which is used to reduce the diameter of the top reinforcement strut when the feature is in an unexpanded state. As the frame expands, a pair of commissures separate, thereby increasing the distance between a pair of commissures, and applying expansion stress to the top reinforcement strut. The undulating portion allows the top reinforcement strut to expand with the feature by straightening the undulating portion. The total length of the reinforcing struts can be equal to or greater than the maximum possible circumference of the opening to ensure that the frame can expand to the maximum possible circumference without limiting expansion, blocking the valve opening, or distorting the geometry of the leaflet attachment frame.

[0171] Despite Fig.25A , Fig.25C and Fig.25D An annular top reinforcing strut with undulations is depicted in the drawings, but it should be understood that any shape or arrangement of joints that connect the frame segments while allowing the frame to expand is also contemplated. For example, the top reinforcing strut may be elliptical, diamond-shaped, or polygonal rather than annular, or the top reinforcing strut may include separate connecting portions rather than a continuous closed loop. The top reinforcing strut may also have a telescopic design, be made of an elastic material that can reversibly deform when the reinforcing strut expands, or simply have more or fewer or larger or smaller undulations than those depicted in the drawings.

[0172] Fig.26 An attachment area 2600 for the top reinforcement struts is shown. In some embodiments, the top reinforcement struts are attached to the valve frame within 30% of the top height of the commissures. However, it should be understood that other embodiments can also be envisioned in which the top reinforcement struts are attached outside the top 30% region of the device.

[0173] In some embodiments, the top reinforcing brace is attached to the frame at or near the top of the pair of commissures.

[0174] like FIG. 25A to FIG. 25DThe lower reinforcing struts 2506 depicted in the embodiment of include undulations 2508 that allow the lower support features to have a smaller diameter when the valve frame is in its unexpanded configuration. When the frame segments separate as the valve diameter increases, the undulations straighten, thereby expanding the diameter of the lower reinforcing struts 2506 to allow the lower features to expand with the frame.

[0175] Although a lower reinforcing strut is depicted having a distinct teardrop shape extending below the frame of the device, the lower feature can be any shape that allows the lower feature to help maintain the desired geometric profile of the leaflet attachment frame throughout the expanded state. The lower reinforcing strut can also be used as a fixed site for transcatheter deployment or for attachment to a native heart structure or for other applications. For example, the lower support feature can have a telescopic design, the lower support feature can be made of an elastic material that can be reversibly deformed when the feature expands, or the lower support feature can simply have more or less or larger or smaller undulations.

[0176] Fig. 27 An attachment area 2700 for a lower reinforcement brace is shown. Fig. 27 Shown according to Fig.25B A top view of the valve frame. Fig.25B Superimposed on Fig.25D 2702 is an imaginary axis that passes through the diameter of the opening and is perpendicular to an imaginary line connecting the tops of the two commissures of the valve frame. When viewing the top view, if line 2702 is the x-axis and vertical line 2703 is the y-axis, assuming that 0 degrees starts at the right intersection between line 2702 and the frame (0 degrees of the unit circle) and opens in a counterclockwise direction, then attachment area 2700 is between 280 degrees and 330 degrees. Fig. 27 As seen in , 280 to 330 degrees correspond to the lower portion of the arc segment of the frame segment as seen in the side view. In some embodiments, the lower feature is attached at 310 degrees, as represented by point 2501.

[0177] It should be understood that other embodiments are also contemplated in which the lower reinforcement strut is attached externally to the attachment area 2700 of the device.

[0178] Fig.28 The figure shows the different expansion sizes (12.7 mm, 14 mm, 16 mm, 18 mm, 20 mm, 22 mm and 24 mm). Fig.25A Side view of the valve frame.

[0179] Fig.29 A depiction of a structure with reinforcing braces is shown. FIG. 25A to FIG. 25D The height to diameter ratio of the embodiment and the embodiment without reinforcing struts Fig.21 Graph showing how the height to diameter ratio of an embodiment of the invention changes as the valve diameter expands. An embodiment with reinforcing struts is expanded via balloon expansion, while an embodiment without reinforcing struts is expanded in 20% increments in simulation. The solid line represents a valve replacement device without reinforcing struts (e.g., Fig.21 ), while the dotted line represents the performance of a vehicle with both top and bottom reinforcement pillars. FIG. 25A to FIG. 25D The performance of valve replacement devices of the present invention was compared with that of the present invention. Each of these devices had a baseline height to diameter ratio of 1.7:1, and these devices expanded to twice their baseline diameter. It was found that both devices achieved very similar kinematic profiles of the expanded valve frame, wherein the height to diameter ratio decreased as the valve frame diameter increased.

[0180] FIG. 30A to FIG. 30B and FIG. 31A to FIG. 31B Shows that there is FIG. 25A to FIG. 25D Results of in vitro fluid dynamic performance testing of a valve replacement device with a valve frame from the . Functional prototypes of the device were tested in a complex simulated circulatory flow loop at various expansion states. The device was tested in its baseline configuration (12.7 mm inner diameter, 1x), then expanded to 23 mm inner diameter (1.8x) using a balloon catheter and retested under physiological pressure and flow conditions. Fig. 30A The flow distribution throughout the device at an opening diameter of 12.7 mm during the cardiac cycle is shown. Fig. 30B Other measurements are shown, including the transvalvular pressure gradient across the valve, the fluid flow profile through the device, including the leak volume and the regurgitant fraction. Fig.31A Flow distribution across the device at 1.8 times (23 mm) the baseline diameter during the cardiac cycle is shown. Fig.31B Reflects the Fig. 30B Same measurement type, but Fig.31B For the device in the expanded state with an opening diameter of 23 mm, it was found that valve function remained unchanged at each valve diameter tested.

[0181] FIG. 32A to FIG. 32C A valve replacement device according to one embodiment is shown implanted in a 25 kg sheep. An unexpanded (12.7 mm) valve replacement device was implanted in the pulmonary valve position of a 25 kg sheep. The device was expanded to 16 mm, 18 mm, and 20 mm using transcatheter balloon expansion. Fig.32A The device is shown expanded to 16 mm. Fig.32B shows the expansion process, and Fig.32C Shows Fig.32BThe device was at 18 mm after expansion of . It was found that the geometry of the valve (leaflet attachment lines and reinforcing struts) matched the geometric profiles before and after expansion. The valve successfully expanded under radial forces generated by a clinical standard balloon catheter in the in vivo environment of implantation using balloon pressures recommended by the balloon manufacturer, and the valve frame maintained its structural integrity after multiple consecutive expansions.

[0182] FIG. 33A to FIG. 33D An alternative embodiment of a valve frame 3200 is shown having a shortened lower reinforcing strut 3206. In this embodiment, the lower reinforcing strut undulations have shorter teardrop-shaped undulations 3208 that do not extend beyond the bottom of the valve frame.

[0183] FIG. 34A to FIG. 34D An alternative embodiment of a valve frame 3300 is shown having a plurality of holes 3306 along the frame of the device. It is contemplated that having holes along the frame provides anchor points for suturing the leaflets to the frame. It should be understood that any number of holes of any size spaced any distance apart from one another may be used. The holes may not be formed directly into the body of the frame, but may instead be formed in a portion extending from the body of the frame.

[0184] FIG. 35A to FIG. 35D An alternative embodiment of a valve frame 3400 is shown, which includes an intermediate reinforcement strut in addition to the top reinforcement strut 3402 and the lower reinforcement strut 3406. In this embodiment, the intermediate reinforcement strut 3410 can have two semi-annular portions connecting two frame sections. Portions of the intermediate reinforcement strut 3410 can include an undulating portion 3412 that can reduce the size profile of the intermediate attachment feature. Similar to the top reinforcement strut and the lower reinforcement strut, the undulating portion can be straightened to allow the intermediate reinforcement strut to expand with the frame. The length of the intermediate reinforcement strut can be equal to or greater than the circumference of the opening under maximum expansion.

[0185] FIG. 36A to FIG. 36B An alternative embodiment of a valve frame 3500 is shown having a plurality of holes 3503 along the frame of the device, which may provide anchoring points for suturing the leaflets to the frame, and intermediate reinforcing struts 3510 that aid in reinforcing the frame.

[0186] Although embodiments without reinforcing struts or with one or more of top, middle, and lower reinforcing struts have been described, it should be understood that contemplated embodiments may have any number of reinforcing struts located in any number of locations. The reinforcing struts may be used to allow the frame to expand to its fully expanded diameter while providing structural support to the frame such that the geometry of the expanded frame allows for preserved valve function (e.g., unimpeded forward flow and no or minimal regurgitation).

[0187] In some embodiments, the reinforcing struts and / or valve frame can be made of SS-316L or CoCr-MP35N or any other material that has sufficient stiffness to provide structural integrity to the device while having sufficient ductility to allow the undulations to straighten as the valve frame expands, or otherwise allow other expansion designs to expand as the valve frame expands. The reinforcing struts can have the same width and wall thickness as the frame, or can be thicker or thinner than the frame.

[0188] In some embodiments, the reinforcing struts may be laser cut, stamped, or otherwise cut from a single piece of material. In other embodiments, the reinforcing struts need not be formed from a single piece of material. For example, the reinforcing struts may be made from a combination of different materials, such as by joining a single piece of material to another piece of material. The reinforcing struts may have a uniform or non-uniform thickness.

[0189] FIG. 37A to FIG. 37C Attached to the leaflet 106 is shown. Fig.33A FIG. 32 is a diagram of a valve frame 3200 of an embodiment of a valve structure to illustrate how the leaflets may be attached to the valve frame. Fig.25A , Fig.33A , Fig.34A , Fig.35A and Fig.36A In other embodiments of the reinforcement struts shown in FIG. , the leaflets can be FIG. 37A to FIG. 37C A similar orientation as shown in FIG. 1 is attached to such a valve frame. Fig.38A Shown in an expanded state Fig.37A A front view of the valve frame and leaflet combination, and Fig.38B Shows Fig.38A Side view of.

[0190] FIG. 39A to FIG. 39DAn alternative embodiment of a valve replacement device is shown. In this embodiment, the valve frame 3900 includes a top reinforcing strut 3904 and a lower reinforcing strut 3906 connecting the lower portion of the frame segment. This embodiment is an example of how the mechanical properties and / or geometry and / or width or thickness of the frame support feature can be modified to affect the expansion geometry (i.e., the shape of the opening) of the valve frame 3900. In this embodiment, the top reinforcing strut 3904 has a reduced thickness compared to the thickness of the leaflet attachment line and the thickness of the lower reinforcing strut 3906, so that the top reinforcing strut 3904 has less rigidity than these other frame components. Without wishing to be bound by theory, it is conceivable that these modifications result in a change in the expansion profile of the device, wherein a pair of commissures undergo greater deformation in the radial direction due to less constraint, resulting in an asymmetric / non-circular widening at the upper end of the valve replacement device. The lower reinforcing strut maintains a circular opening at the base of the valve.

[0191] Fig.40A and Fig.40B An alternative embodiment of a valve replacement device is shown. In the embodiment shown, the valve replacement device uses FIG. 34A to FIG. 34D The valve frame 3300 shown in FIG. 3300 combines two valve leaflets and a sleeve. In particular, Fig.40A A sleeve 4000 having a first sleeve portion 4003 and a second sleeve portion 4004 is shown, and the sleeve 4000 can be coupled to the valve frame 3300, and Fig.40B The valve frame 3300 is shown with the sleeve portion removed for clarity. The valve frame 3300 may include a first leaflet attachment strut 3303 and a second leaflet attachment strut 3304, which may also be referred to herein as a first frame segment and a second frame segment, respectively. Each of the first frame segment and the second frame segment may also be described as having a first arm 3310, 3312 and a second arm 3311, 3313 represented by each side of the "U-shape" of the first frame segment and the second frame segment. In one embodiment, as Fig.40B As shown, the valve replacement device includes a first leaflet 4001 and a second leaflet 4002 attached to a frame, each forming a valve leaflet. The valve frame may also include a gap 4006 disposed between the first frame segment and the second frame segment of the valve frame. The inventors have recognized that the presence of the gap 4006 may result in unintentional leakage of fluid through the gap. Therefore, the inventors have understood that providing a sleeve extending over the gap may serve as a fluid barrier to hinder fluid flow through the gap. Fig.40AAs shown, the first sleeve portion 4003 and the second sleeve portion 4004 are configured to align with and attach to the first frame segment and the second frame segment of the valve frame.

[0192] The valve replacement device may be configured to replace a pulmonary valve, but as discussed further below, the valve replacement device may be configured to replace a variety of other native valves.

[0193] As mentioned above, FIG. 34A to FIG. 34D An alternative embodiment of a valve frame 3300 is shown. The frame 3300 includes a top reinforcement post 3301, a lower reinforcement post 3302, a first leaflet attachment post 3303, a second leaflet attachment post 3304, a commissure hole 3305, and a plurality of anchoring holes 3306 along the leaflet attachment posts 3303 and 3304. It should be noted that any hole not specifically labeled is one of the anchoring holes 3306. It is contemplated that the commissure holes 3305 and anchoring holes 3306, including along the leaflet attachment posts 3303 and 3304, provide anchoring points for suturing the leaflets 4001 and 4002 and sleeves 4003 and 4004 to the frame. It should be understood that any number of holes of any size and spaced any distance from one another may be used, as the present disclosure is not limited in this regard.

[0194] In one embodiment, the frame 3300 can be expanded so that the inner diameter of the frame can be increased to 1.75 times the unexpanded inner diameter of the frame while maintaining valve function. In one embodiment, the inner diameter of the frame can be expanded from 12.7mm to 22mm while maintaining valve function. In other embodiments, the inner diameter of the valve frame can be expanded until the lower reinforcing struts 3302 are substantially straight so that the frame cannot expand further. As will be appreciated by those skilled in the art, this feature can allow the valve to be used as a pre-stent and as a landing site for valve surgery in a transcatheter valve. In one embodiment, the inner diameter of the frame 3300 in the unexpanded state is 12.7mm, and when the lower reinforcing struts 3301 are fully expanded, the inner diameter of the frame 3300 will be 26mm.

[0195] In one embodiment, the frame 3300 is made of a material with high tensile strength, minimal elastic recoil, the frame 3300 is fatigue resistant and balloon expandable. In one embodiment, the valve frame 3300 is laser cut from a 316L stainless steel tube, although any other material with the desired properties is also contemplated. In one embodiment, the tube is 25.10 mm long, has an inner diameter of 12.7 mm, and has an outer diameter of 13.71 mm in its unexpanded state.

[0196] In one embodiment, the top reinforcing struts 3301, the lower reinforcing struts 3302, and the leaflet attachment struts 3303 and 3304 are each sized to have a different width to allow for symmetrical balloon expansion. In some embodiments, it is contemplated that the top reinforcing struts 3301 each have a width W1, which in one embodiment is 0.55 mm wide. The lower reinforcing struts 3302 each have a width W2, which in one embodiment is 0.45 mm wide. The leaflet attachment struts 3303 and 3304 each have a width W3, which in one embodiment is 0.40 mm wide. While the dimensions along the length of the frame can vary to a desired width, the wall thickness in the radial direction is relatively constant because, as described above, in one embodiment, the frame is laser cut from a single tube.

[0197] Fig.41 An embodiment of one of the leaflets 4001 and 4002 is shown, the leaflets being substantially identical to one another, the leaflets having a free edge 4102, an outer edge 4104, an attachment protrusion 4106, commissures 4101, an upper fixation point 4103, an inferior fixation point 4105, and a plurality of anchor points 4107. It should be noted that any point not specifically labeled may be considered an anchor point 4107.

[0198] It should be understood that the leaflets 4001 and 4002 are configured to mimic the geometry of a natural human venous valve, which enables valve function to be preserved over a wide range of sizes. Once implanted, the orientation, positioning, and geometry of the leaflets 4001 and 4002 will allow blood to flow in one direction while preventing blood from flowing in another direction. When the inner diameter of the valve opening expands, the orientation, positioning, and geometry of the leaflets 4001 and 4002 will allow blood to flow in one direction while preventing blood from flowing in another direction.

[0199] In one embodiment, the first leaflet 4001 is attached to the inner side of the first leaflet attachment strut 3303 by suturing the commissure points 4101 to the corresponding commissure holes 3305, and suturing the upper fixing point 4103, the lower fixing point 4105, and the plurality of anchoring points 4107 to the corresponding anchoring holes 3306. First, the first leaflet 4001 is fixed to the first leaflet attachment strut 3303 by fixing the upper fixing point 4103 to the corresponding anchoring hole 3306. Then, the lower fixing point 4105 is fixed to the corresponding anchoring hole 3306. Then, the plurality of anchoring points 4107 are attached to the corresponding anchoring holes 3306. The attachment protrusion 4106 provides the assembler with something to grip when the assembler attaches the first leaflet 4001 to the frame 3300. The attachment protrusion can be any suitable shape, as the present disclosure is not limited thereto. For example, Fig.41The attachment protrusion 4106 is shown to be substantially rectangular because the attachable end 4109 forms a substantially linear attachment between the leaflets at the commissure (the area in the distal frame where the two valve leaflets converge). Fig.44 In other embodiments, the attachable end 4109' can be substantially curved. The inventors have discovered that in some embodiments, the curved attachable end 4109' can help facilitate the apposition of the leaflets at the commissure. It should be understood that in other embodiments, the leaflets can be produced without any attachment protrusions. The second leaflet 4002 is attached to the second leaflet attachment strut 3304 using the same method outlined above. The commissure points 4101 on the first leaflet 4001 are then sutured to the corresponding commissure points 4101 on the second leaflet 4002, and the commissure points 4101 on the two leaflets are then sutured to the corresponding commissure holes 3305 so that the outer edge 4104 of the first leaflet 4001 is in contact and aligned with the outer edge 4104 of the second leaflet 4002. The attachment protrusions on the two leaflets are removed after the leaflets are attached.

[0200] Without wishing to be bound by theory, this leaflet attachment sequence is used to ensure proper alignment of each of leaflets 4001 and 4002, and to ensure that each of commissures 4101, upper fixation points 4103, lower fixation points 4105, and multiple anchor points 4107 are sutured without any material folding, hitting, or bending to avoid tension and stress concentrations in local areas, and to ensure that the functional surface area of ​​each of leaflets 4001 and 4002 is sufficient for the device to function over the entire range of expanded diameters. In some embodiments, this full range of expanded diameters is up to 1.75 times the inner diameter of the unexpanded valve frame 3300. It should be understood that any leaflet attachment process that provides proper alignment and leaflet tension can be envisioned.

[0201] It is contemplated that the first leaflet 4001 and the second leaflet 4002 are attached to the corresponding leaflet attachment struts 3303 and 3304 using interrupted sutures, although any other suturing methods are contemplated, including the use of partially interrupted sutures or continuous sutures. Again, without wishing to be bound by theory, the interrupted sutures can allow for control of the tension along the length of the leaflet-frame attachment. Furthermore, if one suture fails, the other sutures will secure the leaflet to the frame.

[0202] Back to Fig.41, in this embodiment, free edge 4102 has a U-shaped profile, and outer edge 4104 has an extended U-shaped profile such that the vertical distance from free edge 4102 to outer edge 4104 is greatest at the apex of free edge 4102. In this embodiment, outer edge 4104 includes notches 4108 such that outer edge 4104 is aligned with corresponding leaflet attachment struts 3303 and 3304. This geometry allows frame 3300 to expand without stretching leaflets 4001 and 4002.

[0203] It is contemplated that the material for leaflets 4001 and 4002 is oriented so that the most expandable direction is from free edge 4102 to outer edge 4104. This orientation may be advantageous because it may serve to increase the amount of leaflet coaptation (the contact area between leaflets 4001 and 4002) during use.

[0204] In one embodiment, leaflets 4001 and 4002 have a minimal amount of stretch across the width of the leaflets. This property can minimize any rolling of the leaflets during use.

[0205] In one embodiment, 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 leaflets, glutaraldehyde treated bovine pericardium, glutaraldehyde treated porcine pericardium, photo-oxidized bovine pericardium, bovine jugular vein valve.

[0206] In one embodiment, the leaflets are 0.1 mm thick, although any other material thickness that allows for proper valve function is contemplated. In one embodiment, the leaflets 4001 and 4002 are 23.56 mm wide, although any other width that allows for proper valve function is contemplated. The distance from the lower fixation point 4105 to the bottom of the attachment protrusion 4106 can be approximately 24.29 mm, although any other distance that allows for proper valve function is contemplated. The distance from the lower fixation point 4105 to the apex of the free edge 4102 can be approximately 14.28 mm, although any other distance that allows for proper valve function is contemplated. In one embodiment, the leaflets 4001 and 4002 have a 328 mm 2 surface area.

[0207] In one embodiment, the commissures 4101, upper fixation points 4103, lower fixation points 4105, and multiple anchor points 4107 are located at an optimal distance from the outer edge 4104 to minimize the risk of suture pull-out. Generally, the greater the tension experienced by a particular segment of the leaflets 4001 and 4002, the farther the commissures 4101, upper fixation points 4103, lower fixation points 4105, and multiple anchor points 4107 in that area are from the outer edge 4104. Fig.23D Finite element analysis similar to that shown in can be used to determine how much tension a particular segment of leaflets 4001 and 4002 will be under when the leaflets are expanded, and anchor points 4107 in that particular segment can be positioned at an optimal distance from outer edge 4104 based on that determination. In one embodiment, anchor points 4107 located approximately halfway down the leaflets 4001 and 4002 will be under maximum tension when the device is in the expanded configuration, and are therefore positioned farther from outer edge 4104 than other anchor points. In one embodiment, such anchor points are located at least 1.7 mm from outer edge 4104.

[0208] In this embodiment, the commissure points 4101, the upper fixation points 4103, the lower fixation points 4105, and the plurality of anchor points 4107 are marked prior to valve assembly. In some embodiments, the commissure points 4101, the upper fixation points 4103, the lower fixation points 4105, and the plurality of anchor points 4107 may be pre-formed holes.

[0209] As described above, in this embodiment, the valve replacement device comprises a sleeve. The sleeve may be formed from two separate sleeve parts. Fig.42 An embodiment of a first sleeve portion 4003 and a second sleeve portion 4004 is shown, the sleeve portions being substantially identical to one another. The first sleeve portion 4003 includes a first anchoring edge 4201 and a second anchoring edge 4202, while the second sleeve portion 4004 includes a third anchoring edge 4211 and a fourth anchoring edge 4212. The sleeve portions 4003 and 4004 also include a suture cuff 4203, a suture cuff fixation point 4204, an initial anchor point 4205, a fixation point 4206, and a plurality of commissure fixation points 4207.

[0210] In one embodiment, sleeves 4003 and 4004 allow the device to be fixed to natural tissue. Sleeves 4003 and 4004 are configured to prevent blood from leaking around the outside of the valve replacement device when the device is attached to natural tissue. The use of ePTFE can prevent tissue ingrowth, thereby allowing the valve replacement device to expand with minimal resistance and avoid damage to surrounding tissue. This material can prevent the formation of abnormal fibrous tubular layers or granulation tissue layers.

[0211] In some embodiments, the first sleeve portion 4003 can be attached to the exterior of the valve frame 3300 by securing the first sleeve portion 4003 to corresponding anchoring holes 3306 in the leaflet attachment struts 3303 and 3304. The first sleeve portion 4003 is aligned so that the first anchoring edge 4201 is attached to the first arm 3310 of the first leaflet attachment strut 3303 and the second anchoring edge 4202 is attached to the first arm 3312 of the second leaflet attachment strut 3304.

[0212] To attach first sleeve portion 4003 to frame 3300, initial anchoring points 4205 are secured to frame 3300 at corresponding anchoring holes 3306 to properly align first sleeve portion 4003 so that anchoring edges 4201 and 4202 of first sleeve portion 4003 at least partially wrap around leaflet attachment struts 3303 and 3304. In some embodiments, first sleeve portion 4003 can be secured to frame 3300 so that anchoring edges 4201 and 4202 are secured to leaflet attachment struts 3303 and 3304, rather than partially wrapping around leaflet attachment struts 3303 and 3304. The first edge 4201 and the second edge 4202 are then anchored to the frame 3300 by attaching a continuous suture to each of the fixation points 4206, removing the suture attached to the initial anchor point 4205, and extending each continuous suture upwardly through each of the corresponding anchor holes 3306 along the corresponding edge 4201 and 4202 of the first sleeve portion 4003. The continuous suture is then passed through the lower portion of the commissure fixation points 4207 on the sleeve, through the commissure holes 3305 toward the center of the valve frame, through the upper portion of the commissure holes 3305 away from the center of the valve frame, through the upper commissure fixation points 4207, and tied together at the top of the first sleeve portion 4003. Although the sleeves 4003 and 4004 are attached to the corresponding leaflet attachment struts 3303 and 3304 using a continuous suture, any other suturing methods are contemplated, including consideration of partially interrupted sutures or interrupted sutures.

[0213] The second sleeve portion 4004 is attached to the exterior of the valve frame 3300 by securing the second sleeve portion 4004 to corresponding anchoring holes 3306 in the leaflet attachment struts 3303 and 3304. The second sleeve portion 4004 is aligned so that the third anchoring edge 4211 is attached to the second arm 3311 of the first leaflet attachment strut 3303 and the fourth anchoring edge 4212 is attached to the second arm 3313 of the second leaflet 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.

[0214] After the first sleeve portion 4003 and the second sleeve portion 4004 are attached to the exterior of the frame 3300, the sleeves are attached to each other by suturing the suture cuff fixation points 4204 on the first sleeve portion 4003 to the corresponding suture cuff fixation points 4204 on the second sleeve portion 4004. This can prevent blood from leaking around the exterior 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.

[0215] In this embodiment, the valve replacement device is secured to the native tissue by suturing the valve to the native tissue using the suture cuff 4203 of the sleeves 4003, 4004. It is envisioned that the sutures are located at a distance large enough from the bottom edge of the sleeve to reduce the risk of tearing. In one embodiment, the distance is a minimum of 2 mm. The distance between the sutures is small enough to prevent blood leakage between the sutures. In one embodiment, the distance is a maximum of 3 mm. It is envisioned that the valve replacement device is secured to the native tissue using interrupted horizontal mattress sutures, continuously extending sutures, or a combination of partially interrupted sutures and continuous sutures.

[0216] In this embodiment, sleeves 4003 and 4004 are generally bell-shaped and are bilaterally symmetrical in the vertical direction. A suture cuff 4203 extends from the bottom of each of the sleeves 4003, 4004 to the start of the bell curve on each of the sleeves 4003, 4004.

[0217] In one embodiment, the material used for sleeves 4003 and 4004 is oriented so that sleeves 4003 and 4004 are most extensible in their width to allow valve expansion. In this embodiment, sleeves 4003 and 4004 can expand in their width a distance sufficient to allow the valve replacement device to expand to an inner diameter of at least 22 mm. In some embodiments, sleeves 4003 and 4004 can expand in their width a distance sufficient to allow the valve replacement device to expand to an inner diameter of 26 mm. In this case, the valve can therefore expand beyond its functional range, so the valve can be used as a pre-stent and landing area for valve replacement surgery in a transcatheter valve.

[0218] Sleeves 4003 and 4004 can be constructed of an ePTFE stretched tubular graft having an ePTFE film on the exterior. In one embodiment, the ePTFE stretched tubular graft can be 1 mm thick, but any tubular graft thickness that allows for proper sleeve function is contemplated. In some embodiments, a suitable sleeve thickness can be greater than or equal to 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 any other suitable sleeve thickness value that can be greater than or less than those sleeve thickness values ​​disclosed herein. To construct sleeves 4003 and 4004, a suitable length of tubular graft is cut in half. Since the ePTFE stretched tubular graft is most stretchable in the longitudinal direction, each sleeve is cut from the ePTFE tubular graft such that the width of each sleeve is along the longitudinal direction of the ePTFE tubular graft. Because the outer membrane has a tighter microstructure than the rest of the graft, the outer membrane can minimize the ingrowth of native tissue into the sleeves 4003 and 4004 and allow unimpeded valve expansion, with the side of the sleeves 4003 and 4004 having the membrane being designated as the side of the sleeves 4003 and 4004 facing the native tissue. In some embodiments, one or more layers of ePTFE membrane can be disposed on the outer surface of the sleeve. The outer ePTFE membrane layer can provide benefits, such as limiting the ingrowth of native tissue into the sleeve and / or hindering excessive fibrotic tissue response at the sutures, which can hinder the ability to effectively balloon expand the valve after implantation. In some such embodiments, the outer ePTFE membranes can be bonded to each other and / or to the ePTFE on the exterior of the tubular graft.

[0219] In one embodiment, sleeves 4003 and 4004 each have a width at the base sufficient to cover at least half of the circumference of the valve frame 3300, so that when the frame is not expanded, sleeves 4003 and 4004 are not tightly wrapped around the frame 3300. In one embodiment, the width at the base is 30mm. In one embodiment, sleeves 4003 and 4004 each have a width at the base sufficient to cover half of the circumference of the valve frame 3300, so that when the frame is not expanded, sleeves 4003 and 4004 are tightly wrapped around the frame 3300. In one embodiment, sleeves 4003 and 4004 each have a length sufficient to cover the entire length of the valve frame 3300. In one embodiment, the length is 30.11mm. In one embodiment, the suture cuff 4203 is long enough to allow effective placement of sutures that secure the valve replacement device to natural tissue. In one embodiment, the suture cuff length is 4.40mm. The suture cuff length can be trimmed (shortened) during the implantation process to optimize the fixation of the device to the native tissue. However, it should be noted that the suture cuff length must extend beyond the lowest portion of the frame 3300 to ensure that the circumferential suture line (where the device is fixed to the native tissue) is below the level of the valve opening.

[0220] In some embodiments, a sleeve according to embodiments disclosed herein can have a proximal end 4208 and a distal end 4209, wherein the proximal end is represented by the base of the sleeve where the suture cuff 4203 is located, and wherein the distal end is represented by the area where the upper commissure fixation point 4207 is located (see Fig.42 ). Thus, in some embodiments, the proximal end of the sleeve can be used as a suture cuff that can be sutured or otherwise attached to the implantation site to secure the valve replacement device in a desired position relative to the implantation site. In some embodiments, the valve replacement device can be attached to the implantation site only at the suture cuff. Additionally or alternatively, the distal end and / or other portions of the sleeve can be used to attach the valve replacement device to the implantation site, as the present disclosure is not limited in this regard.

[0221] In one embodiment, the suture cuff fixation points 4204, initial anchor point 4205, fixation point 4206, and several of the commissure fixation points 4207 are pre-marked. However, it should be understood that in other embodiments, none of these points may be pre-marked, or may be pre-formed holes, or all may be pre-marked.

[0222] Fig.43A and Fig.43B Shown with Fig.40A and Fig.40BAn embodiment of a valve replacement device similar to the valve replacement device of , wherein the valve replacement device includes a valve frame 3300, valve leaflets 4001, and a sleeve including a first sleeve portion 4003 and a second sleeve portion 4004. Fig.43A The valve frame 3300 is shown in an unexpanded position such that the inner diameter is less than Fig.43B Embodiment of the inner diameter, Fig.43B The valve frame 3300 is shown in an expanded position. In some embodiments, the valve frame 3300 can be constructed and arranged so that the opening is substantially circular, such as in Fig.43A and Fig.43B middle.

[0223] Return to reference FIG. 40A to FIG. 40B and Fig.42 , the first sleeve portion 4003 may include a first anchoring edge 4201 and a second anchoring edge 4202, and the second sleeve portion 4004 may include a third anchoring edge 4211 and a fourth anchoring edge 4212. In some embodiments, at least one of the first anchoring edge 4201 and the second anchoring edge 4202 of the first sleeve portion 4003 and at least one of the third anchoring edge 4211 and the fourth anchoring edge 4212 of the second sleeve portion 4004 may be configured to be attached to the first frame segment and / or the first arm 3310, 3312 and the second arm 3311, 3313 of the second frame segment of the valve frame 3300 (see Fig.34A ) and is aligned with and attached to at least one of the first arms 3310, 3312 and the second arms 3311, 3313 of the first frame segment and / or the second frame segment of the valve frame 3300. For example, the first anchoring edge 4201 and the second anchoring edge 4202 of the first sleeve portion 4003 can be aligned with and attached to the first arm 3310 and the first arm 3312 of the first frame segment and the second arm 3312 of the frame segment, respectively. Similarly, in another example, the third anchoring edge 4211 and the fourth anchoring edge 4212 of the second sleeve portion 4004 can be aligned with and attached to the second arm 3311 and the second arm 3313 of the first frame segment and the second arm 3313 of the frame segment, respectively.

[0224] It should be understood that in some of the above embodiments, the valve replacement device is configured to replace the pulmonary valve. However, the valve replacement device can 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 proportions of the device, the material properties of the leaflets, and the thickness of the leaflets, as discussed further below.

[0225] The valve replacement device can be appropriately scaled up or down depending on the age and size of the patient or the valve it replaces. The following table lists the nominal diameter, maximum functional diameter, and maximum frame diameter of several embodiments of the valve replacement device that are scaled up or down. The nominal diameter is the inner diameter of the valve frame 3300 when the valve frame is not expanded, the maximum functional diameter is the maximum inner diameter to which the valve frame 3300 can be expanded while maintaining valve function, and the maximum frame diameter is the maximum inner diameter to which the valve frame 3300 can be expanded to exceed the maximum functional diameter. When the valve replacement device is scaled, the frame aspect ratio is maintained so that the frame length:frame diameter ratio remains the same. It should also be understood that the examples listed below are not exhaustive, such that any appropriate scale of the valve replacement device can be envisioned.

[0226] Nominal diameter (ID) Maximum functional diameter (ID) Maximum frame diameter (ID) 8mm 14mm 17mm 10mm 17mm 22mm 12.7mm 22mm 26mm 14mm 24mm 30mm 16mm 28mm 34mm 18mm 32mm 38mm

[0227] The appropriate thickness of leaflets 4003 and 4004 depends on the blood pressure and flow rate that the valve replacement device will encounter when implanted, as well as the material properties of the material used for the leaflets. Because various valves in natural tissue encounter different blood pressures and flow rates, the appropriate material properties and thickness ranges of the leaflets change based on which native valve the valve replacement device is replacing. Without wishing to be bound by theory, the following table lists potential suitable leaflet thickness ranges for different use cases of valve replacement devices.

[0228]

[0229] It should be understood that when the valve replacement device is used as a pulmonary valve catheter, 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 embodiment, the tube can be made of an expandable synthetic material. In one embodiment, the suture cuff of the valve replacement device can be sutured circumferentially to the inside of the expandable synthetic tube so that the position of the suture line is close to the center of the tube. In one embodiment, the expandable synthetic tube containing the valve replacement device can be sutured to the right ventricle proximally and to the pulmonary artery distally. In one embodiment, the tube can be a pulmonary allograft or an aortic allograft. In one embodiment, the natural leaflets inside the allograft can be excised, and the valve replacement device can be sutured circumferentially to the inside of the allograft at the level of the natural allograft leaflets. In one embodiment, the allograft containing the valve replacement device can be sutured to the right ventricle proximally and to the pulmonary artery distally.

[0230] The various aspects of the present invention may be used alone, in combination, or in various arrangements not specifically discussed in the embodiments described above, and therefore the present invention is not limited in its application to the details and arrangements of the components set forth in the foregoing description or illustrated in the accompanying drawings. For example, the various aspects described in one embodiment may be combined in any manner with the various aspects described in other embodiments.

[0231] In addition, the embodiments described herein can be implemented as methods for which examples have been provided. The actions performed as part of the method can be ordered in any suitable manner. Therefore, embodiments can be constructed in which the actions are performed in an order different from the illustrated order, which can include performing some actions simultaneously, even if these actions are shown as sequential actions in illustrative embodiments.

[0232] Although the present teaching has been described in conjunction with various embodiments and examples, it is not intended to limit the present teaching to these embodiments or examples. On the contrary, as will be appreciated by those skilled in the art, the present teaching includes various alternatives, modifications and equivalents. Therefore, the foregoing description and accompanying drawings are only intended as examples.

Claims

1. A valve replacement device, comprising: a valve frame comprising a first frame segment and a second frame segment, the valve frame defining an opening for passage of fluid, the valve frame being expandable to allow an increase in diameter of the opening within a range of diameter sizes of the opening; a gap between the first frame section and the second frame section; at least one valve leaflet coupled to the valve frame, the at least one valve leaflet having an open configuration in which the opening is exposed and a closed configuration in which the at least one valve leaflet at least partially covers the opening, wherein the at least one valve leaflet is configured to be movable between the open configuration and the closed configuration within a range of diameter sizes of the opening; and A sleeve extending across the gap between the first frame segment and the second frame segment, the sleeve acting as a barrier to impede fluid flow through the gap, the sleeve being coupled to the valve frame, wherein the sleeve has a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame.

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 valve replacement device according to claim 2, in, The first sleeve portion and the second sleeve portion are constituted by segments of a tubular graft, the segments of the tubular graft having a longitudinal direction, and Therein, the first expandable direction of the sleeve is the longitudinal direction of the segment of the tubular graft.

4. The valve replacement device according to claim 1, wherein: The proximal end of the sleeve is configured for suturing fixation to a native structure.

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

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

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

8. The valve replacement device according to claim 1, in, The valve frame has a plurality of holes passing through the valve frame, wherein the at least one valve leaflet comprises a first leaflet and a second leaflet, wherein the first leaflet has an outer edge coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, and the second leaflet has an outer edge coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, wherein the first leaflet and the second leaflet have a plurality of leaflet attachment points for coupling the first leaflet and the second leaflet to the valve frame, and Wherein, the plurality of leaflet attachment points are located at uneven distances from an outer edge of the first leaflet and an outer edge of the second leaflet.

9. The valve replacement device according to claim 8, in, The first frame section and the second frame section are connected by a pair of joints, wherein the plurality of holes pass through the first frame section and the second frame section and through the pair of commissures, wherein the first leaflet is coupled to an aperture in the first frame segment and to an aperture in the pair of commissures, and Wherein the second leaflet is coupled to the aperture in the second frame segment and the aperture in the pair of commissures.

10. The valve replacement device according to claim 9, Also included is a first reinforcement feature connecting the pair of commissures, Also included is a second reinforcement feature connecting the first frame section and the second frame section, and in, At least one of the first reinforcement feature and the second reinforcement feature has a different shape than the other of the first reinforcement feature and the second reinforcement feature.

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

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

13. The valve replacement device according to claim 3, wherein: The sleeve further includes a membrane bonded to the segment of the tubular graft, wherein the membrane is configured to minimize ingrowth of native tissue into the sleeve.

14. A valve replacement device, comprising: a valve frame defining an opening for passage of fluid, the opening having a diameter along a maximum dimension of the opening, the valve frame being expandable to allow an increase in the diameter of the opening within a range of diameter sizes of the opening, the valve frame having a plurality of apertures therethrough; a first leaflet coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, the first leaflet having an open configuration in which the opening is exposed and a closed configuration in which the first leaflet at least partially covers the opening, and the first leaflet having an outer edge; as well as a second leaflet coupled to the valve frame using at least some of the plurality of holes passing through the valve frame, the second leaflet having an open configuration in which the opening is exposed and a closed configuration in which the first leaflet and the second leaflet contact each other to at least partially cover the opening and the second leaflet has an outer edge, wherein the first leaflet and the second leaflet are configured to be movable between the open configuration and the closed configuration within a diameter size range of the opening, wherein the first leaflet and the second leaflet have a plurality of leaflet attachment points for coupling the first leaflet and the second leaflet to the valve frame, and Wherein, the plurality of leaflet attachment points are located at uneven distances from an outer edge of the first leaflet and an outer edge of the second leaflet.

15. The valve replacement device according to claim 14, wherein: For a leaflet attachment point that is subject to greater tension when the first leaflet and the second leaflet are connected to the valve frame, the distance from the leaflet attachment point to the outer edge of the first leaflet and the outer edge of the second leaflet is greater than for a leaflet attachment point that is subject to less tension.

16. The valve replacement device according to claim 15, wherein: For the leaflet attachment point that is subject to maximum tension, the distance from the leaflet attachment point to the outer edge of the first leaflet and the outer edge of the second leaflet is at least 1.7 mm.

17. The valve replacement device according to claim 14, wherein: At least some of the plurality of leaflet attachment points are marked on the first leaflet and the second leaflet prior to coupling the first leaflet and the second leaflet to the frame.

18. The valve replacement device according to claim 14, in, The first lobe and the second lobe further include a notch in an outer edge, and The notch allows the first leaflet and the second leaflet to be aligned with an edge of the valve frame.

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

20. The valve replacement device according to claim 14, in, The valve frame includes a first frame segment and a second frame segment connected by a pair of commissures, wherein the plurality of holes pass through the first frame section and the second frame section and through the pair of commissures, wherein the first leaflet is coupled to an aperture in the first frame segment and to an aperture in the pair of commissures, and Wherein the second leaflet is coupled to the aperture in the second frame segment and the aperture in the pair of commissures.

21. The valve replacement device according to claim 20, Also included is a first reinforcement feature connecting the pair of commissures, Also included is a second reinforcement feature connecting the first frame section and the second frame section, and in, At least one of the first reinforcement feature and the second reinforcement feature has a different shape than the other of the first reinforcement feature and the second reinforcement feature.

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 comprising a first frame segment and a second frame segment, the valve frame defining an opening for passage of fluid, the first frame segment and the second frame segment each having a first arm and a second arm, the valve frame being expandable to allow an increase in diameter of the opening within a range of diameter sizes of the opening; valve leaflets coupled to the valve frame, the valve leaflets having an open configuration in which the opening is exposed and a closed configuration in which the valve leaflets at least partially cover the opening, wherein the valve leaflets are configured to be movable between the open configuration and the closed configuration within a range of diameter sizes of the opening; and a sleeve coupled to the valve frame, the sleeve having a first anchoring edge and a second anchoring edge, wherein the sleeve has a first expandable direction oriented to allow an increase in the diameter of the opening of the valve frame, and wherein the first anchoring edge is aligned with and attached to the first arm of the first frame segment, and wherein the second anchoring edge is aligned with and attached to the first arm of the second frame segment.

24. The valve replacement device according to claim 23, wherein: The sleeve comprises a first sleeve portion and a second sleeve portion, wherein the second sleeve portion has a third anchoring edge and a fourth anchoring edge, wherein the third anchoring edge of the second sleeve portion is aligned with and attached to the second arm of the first frame segment, and wherein the fourth anchoring edge of the second sleeve is aligned with and attached to the second arm of the second frame segment.

25. The valve replacement device according to claim 23, wherein: The sleeve further includes a membrane, wherein the membrane 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, wherein the valve leaflets are connected to the valve frame using at least some of the plurality of holes passing through the valve frame, and wherein the sleeve is connected 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 passage of fluid, the valve frame being expandable to allow an increase in diameter of the opening within a range of diameter sizes of the opening; valve leaflets coupled to the valve frame, the valve leaflets having an open configuration in which the opening is exposed and a closed configuration in which the valve leaflets at least partially cover the opening, wherein the valve leaflets are configured to be movable between the open configuration and the closed configuration within a range of diameter sizes of the opening; and a sleeve coupled to the valve frame, wherein the sleeve has 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 attachment of the valve replacement device to an implantation site, And wherein the valve replacement device is configured to be attached to the implantation site only at the proximal end of the sleeve.

28. The valve replacement device according to claim 27, wherein: The sleeve further includes a membrane, wherein the membrane 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, wherein the valve leaflets are connected to the valve frame using at least some of the plurality of holes passing through the valve frame, and wherein the sleeve is connected 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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