Devices and systems for docking a heart valve

Abstract

Expandable stent frames can include a plurality of struts including one or more retaining portions. The one or more retaining portions can be connected to the one or more sealing portions. The one or more retaining portions can be configured to retain the docking station at a deployed position.

Description

DEVICES AND SYSTEMS FOR DOCKING A HEART VALVECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to and all benefit of U.S. Provisional Patent Application Ser. No. 63 / 649,840, filed on May 20, 2024, for DE ICES AND SYSTEMS FOR DOCKING A HEART VALVE, the disclosure of which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates to expandable stents and, in particular, docking stations, delivery systems, and methods for use in implanting a heart valve, e.g., a transcatheter heart valve ("THV").BACKGROUND OF THE INVENTION

[0003] Prosthetic heart valves can be used to treat cardiac valvular disorders. The native heart valves (the aortic, pulmonary, tricuspid and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital, inflammatory, or infectious conditions. Such conditions can eventually lead to serious cardiovascular compromise or death. For many years the definitive treatment for such disorders was the surgical repair or replacement of the valve during open heart surgery.

[0004] A transcatheter technique can also be used for introducing and implanting a prosthetic heart valve using a flexible catheter in a manner that is less invasive than open heart surgery. In this technique, a prosthetic valve can be mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted. Alternatively, the valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter.10005 ] Transcatheter heart valves (TH Vs) may be appropriately sized to be placed inside most native aortic valves. However, with larger native valves, blood vessels, and grafts, aortic transcatheter valves might be too small to secure into the larger implantation or deploymentsite. In this case, the transcatheter valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site to be secured in place.

[0006] Replacing the pulmonary valve, which is sometimes referred to as the pulmonic valve, presents significant challenges. The geometry of the pulmonary artery can vary greatly from patient to patient. Typically, the pulmonary artery outflow tract after corrective surgery is too wide for effective placement of a prosthetic heart valve.SUMMARY

[0007] This summary is meant to provide examples and is not intended to be limiting of the scope of the disclosure in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. The description discloses examples of expandable stents for implantable medical devices. The expandable stents can be constructed in a variety of ways.

[0008] In some examples, an expandable stent includes a plurality of struts defining a flared retaining portion extending to a plurality of apices terminating at an outer diameter of the flared retaining portion.

[0009] In some examples, an expandable stent frame includes a plurality of struts defining a plurality of cells, the expandable frame having an hourglass shaped profile when in an unrestricted expanded condition, with a central waist portion, convex first and second sealing portions, and first and second end retaining portions extending from the convex first and second sealing portions and defining first and second end outer diameters and a height of the expandable stent frame.

[0010] In some examples, an expandable stent frame includes a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion, and a convex first end sealing portion joined with the flared first end retaining portion.

[0011] In some examples, an expandable stent frame includes a plurality of struts defining a first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the first end retaining portion, and a second end retaining portion extending to a second set of apices terminating at a second end outer diameter of the second end retaining portion.

[0012] In some examples, an expandable stent frame includes a plurality of struts defining an hourglass shaped profile when in an unrestricted expanded condition, and defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameterof the flared first end retaining portion, a convex first end sealing portion joined with the flared first end retaining portion, a second set of apices terminating at a second end outer diameter of the flared second end retaining portion, and a convex second end sealing portion joined with the flared second end retaining portion.

[0013] In some examples, an expandable stent frame comprising a plurality of struts defining a first end convex portion extending continuously radially outward from a central waist portion to a first set of apices terminating at a first end outer diameter to define a first end retaining portion.

[0014] In some examples, the convex first end sealing portion has a minimum radius of curvature between about 10 mm and about 12 mm along an entire length of the convex first end sealing portion, and the convex second end sealing portion has a minimum radius of curvature of between about 4 mm and about 7 mm defining a shoulder portion of the convex second end sealing portion.

[0015] In some examples, each apex of the first and second sets of apices has a maximum width between about 1 mm and about 1.5 mm.10016] In some examples, each apex of the first and second sets of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0017] In some examples, the flared first end retaining portion extends at an angle of about 30° to about 40°, or about 30°, with respect to a central longitudinal axis of the hourglass shaped profile.

[0018] In some examples, at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height.

[0019] In some examples, at least one of the first end outer diameter and the second end outer diameter is between 100% and 117.5% of the height.

[0020] In some examples, at least one of the first and second end outer diameters is between about 44 mm and about 49 mm;

[0021] In some examples, at least one of the first and second end outer diameters is between about 44 mm and about 46 mm.

[0022] In some examples, the height of the expanded stent frame is between about 40 mm and about 47 mm.

[0023] In some examples, the height of the expanded stent frame is between about 44 mm and about 46 mm.

[0024] In some examples, the height of the expanded stent frame is about 45 mm.

[0025] In some examples, the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0026] In some examples, the plurality of cells comprises a third row of cells disposed between first and second rows of cells.

[0027] In some examples, a third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0028] In some examples, the first end retaining portion extends at an angle of about 30° to about 50° with respect to a central longitudinal axis of the hourglass shaped profile.

[0029] In some examples, the first end retaining portion extends at an angle of about 30° with respect to a central longitudinal axis of the expandable stent frame.

[0030] In some examples, the first end retaining portion extends at an angle of about 40° to about 50° with respect to a central longitudinal axis of the expandable stent frame.

[0031] In some examples, the first end retaining portion extends at an angle of about 45° with respect to a central longitudinal axis of the expandable stent frame.

[0032] In some examples, the second end retaining portion extends at an angle of about 30° to about 50° with respect to a central longitudinal axis of the expandable stent frame.

[0033] In some examples, the second end retaining portion extends at an angle of about 30° with respect to a central longitudinal axis of the expandable stent frame.

[0034] In some examples, the second end retaining portion extends at an angle of about 40° to about 50° with respect to a central longitudinal axis of the expandable stent frame.

[0035] In some examples, the second end retaining portion extends at an angle of about 45° with respect to a central longitudinal axis of the expandable stent frame.

[0036] In some examples, the first end retaining portion comprises a flared first end retaining portion extending to a first set of apices terminating at the first end outer diameter.

[0037] In some examples, each apex of a first set of apices has a maximum width between about 1 mm and about 1.5 mm.

[0038] In some examples, each apex of a first set of apices has a maximum width of about 1.4 mm.

[0039] In some examples, each apex of a first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0040] In some examples, the convex first end sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0041] In some examples, a radial distance from a first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm.

[0042] In some examples, a radial distance from a first outwardly contoured inflection radius to the first end outer diameter is about 2 mm.

[0043] In some examples, the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at the second end outer diameter.

[0044] In some examples, each apex of a second set of apices has a maximum width between about 1 mm and about 1.5 mm.

[0045] In some examples, each apex of a second set of apices has a maximum width of about 1.4 mm.

[0046] In some examples, each apex of a second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0047] In some examples, the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0048] In some examples, a radial distance from a second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm.

[0049] In some examples, a radial distance from a second outwardly contoured inflection radius to the second end outer diameter is about 2 mm.

[0050] In some examples, at least one of the convex first and second end sealings portions has a minimum radius of curvature between about 10 mm and about 12 mm along an entire length of the convex first end sealing portion.

[0051] In some examples, at least one of the convex first and second end sealings portions has a minimum radius of curvature of about 11.5 mm along an entire length of the convex first end sealing portion.

[0052] In some examples, at least one of the convex first and second end sealings portions has a minimum radius of curvature of less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0053] In some examples, at least one of the convex first and second end sealings portions has a minimum radius of curvature of between about 4 mm and about 7 mm defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0054] In some examples, at least one of the convex first and second end sealings portions has a minimum radius of curvature of about 5.6 mm defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0055] In some examples, the first end convex portion has a substantially continuous radius of curvature of between about 10 mm and about 20 mm.

[0056] In some examples, the first end convex portion has a substantially continuous radius of curvature of about 15 mm.

[0057] In some examples, the first end outer diameter is between about 44 mm and about 52 mm.

[0058] In some examples, the first end outer diameter is about 48 mm.

[0059] In some examples, the plurality of struts further defines a second end convex portion extending continuously radially outward from the central waist portion to a second set of apices terminating at a second end outer diameter to define a second end retaining portion.

[0060] In some examples, the second end convex portion has a substantially continuous radius of curvature of between about 10 mm and about 20 mm.

[0061] In some examples, the second end convex portion has a substantially continuous radius of curvature of about 15 mm.

[0062] In some examples, the second end outer diameter is between about 44 mm and about 52 mm.

[0063] In some examples, the second end outer diameter is about 48 mm.

[0064] In some examples, the first and second sets of apices define a height of the expandable stent frame, wherein the height is between about 35 mm and about 46 mm.

[0065] In some examples, the first and second sets of apices define a height of the expandable stent frame, wherein the height is about 38 mm.

[0066] In some examples, the first and second sets of apices define a height of the expandable stent frame, wherein at least one of the first end outer diameter and the second end outer diameter is at least 115% of the height.

[0067] In some examples, the first and second sets of apices define a height of the expandable stent frame, wherein at least one of the first end outer diameter and the second end outer diameter is between 115% and 150% of the height.

[0068] In some examples, the first and second sets of apices define a height of the expandable stent frame, wherein at least one of the first end outer diameter and the second end outer diameter is between about 120% and about 130% of the height.

[0069] In some examples, the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0070] In some examples, the first row of cells is joined directly with the second row of cells.

[0071] In some examples, axially inner portions of the first and second rows of cells define at least a portion of the central waist portion.

[0072] In some examples, an expandable stent includes the expandable stent frame and a plurality of cover elements each covering at least a portion of a corresponding one of the plurality of apices to provide softened atraumatic engagement of the plurality of apices with tissue at a deployment site when the stent is deployed at the deployment site.

[0073] In some examples, each of the plurality of cover elements comprises at least one of a plastic material, an organic material, an elastomeric material, and a foam material.

[0074] In some examples, each of the plurality of cover elements comprises at least one of a coating, a molding, a wrap, a sleeve, and a sock.

[0075] In some examples, each of the plurality of cover elements comprises a sock of braided polyethylene terephthalate (PET) fabric material.

[0076] In some examples, each of the plurality of cover elements extends over a rounded head portion of a corresponding one of the plurality of apices.

[0077] In some examples, each of the plurality of cover elements is secured to a corresponding one of the plurality of apices by a stitch or suture extending through an aperture in the corresponding one of the plurality of apices.

[0078] In some examples, an expandable stent includes the expandable stent frame and a cover material attached to at least a portion of the expandable stent frame, with the cover material defining a sealing surface for sealing engagement with an implant site.

[0079] In some examples, a cover material is attached to an exterior surface of the expandable stent frame.

[0080] In some examples, a cover material is attached to an interior surface of the expandable stent frame.

[0081] In some examples, the expandable stent is a docking station, wherein an interior surface of the expandable stent defines a valve seat configured to retain an expandable prosthetic valve.

[0082] In some examples, the expandable stent includes at least one radiopaque marker secured to the expandable stent frame and aligned with the valve seat.

[0083] In some examples, the expandable stent includes at least one radiopaque marker secured to the first end retaining portion.

[0084] In some examples, a prosthetic valve assembly includes the expandable stent and a prosthetic valve secured to a valve seat of the expandable stent.

[0085] In some examples, the prosthetic valve comprises an expandable frame.

[0086] In some examples, a system includes a catheter including a sleeve and the expandable stent, wherein the expandable stent is disposed in the sleeve in an unexpanded condition.

[0087] In some examples, a method of installing an expandable stent in a pulmonary artery includes providing an expandable stent frame in a compressed condition within a first tube, inserting the first tube into the pulmonary artery, and deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame does not extend into a right ventricular outflow tract of the pulmonary artery.

[0088] In some examples, a method of installing an expandable stent in a pulmonary artery includes providing an expandable stent frame in a compressed condition within a first tube, inserting the first tube into the pulmonary artery, and deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery. The proximal end of the expandable stent frame has a convex sealing portion having a minimum radius of curvature of at least 10 mm.

[0089] In some examples, a method of installing an expandable stent in a pulmonary artery includes providing an expandable stent frame in a compressed condition within a first tube, inserting the first tube into the pulmonary artery, and deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stentframe aligns with a right ventricular outflow tract of the pulmonary artery. The proximal end of the expandable stent frame is compressed radially inward by the right ventricular outflow tract, such that proximal apices at the proximal end of the expandable stent frame do not engage the right ventricular outflow tract.

[0090] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, leaflet, tissue, etc. being simulated), etc.

[0091] Various features as described elsewhere in this disclosure may be included in the examples summarized here and various methods and steps for using the examples and features may be used, including as described elsewhere herein.

[0092] Further understanding of the nature and advantages of the disclosed inventions can be obtained from the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals.BRIEF DESCRIPTION OF THE DRAWINGS

[0093] To further clarify various aspects of examples of the present disclosure, descriptions of some examples will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only some examples of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures may be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0094] FIG. 1A is a cutaway view of the human heart in a diastolic phase;

[0095] FIG. IB is a cutaway view of the human heart in a systolic phase;

[0096] FIG. 2A is a schematic illustration of a compressed docking station being positioned in a circulatory system;

[0097] FIG. 2B is a schematic illustration of the docking station of FIG. 2A expanded to set the position of the docking station in the circulatory system;

[0098] FIG. 2C is a schematic illustration of an expandable transcatheter heart valve being positioned in the docking station illustrated by FIG. 2B;

[0099] FIG. 2D is a schematic illustration of the transcatheter heart valve of FIG. 2C expanded to set the position of the heart valve in the docking station;

[0100] FIG. 2E illustrates the docking station and transcatheter heart valve deployed in an irregularly shaped portion of the circulatory system;

[0101] FIG. 2F illustrates the docking station and transcatheter heart valve deployed in a pulmonary artery;

[0102] FIG. 3A is a cutaway view of the human heart in a systolic phase with a docking station and deployed in a pulmonary artery;

[0103] FIG. 3B is a cutaway view of the human heart in a systolic phase with a docking station and transcatheter heart valve deployed in a pulmonary artery;

[0104] FIG. 4A is an enlarged schematic illustration of the docking station and transcatheter heart valve of FIG. 3B when the heart is in the systolic phase;

[0105] FIG. 4B is a view taken in the direction indicated by lines 4B-4B in FIG. 4A;

[0106] FIG. 5 is a graph showing a relationship between a docking station diameter and a radial outward force applied by the docking station;

[0107] FIG. 6 is a cutaway view of the human heart in a diastolic phase with a docking station and transcatheter heart valve deployed in a pulmonary artery;

[0108] FIG. 7A is an enlarged schematic illustration of the docking station and transcatheter heart valve of FIG. 6 when the heart is in the diastolic phase;|00109| FIG. 7B is a view taken in the direction indicated by lines 7B-7B in FIG. 7A;

[0110] FIG. 8A is a side view of an example of a frame of a docking station;

[0111] FIG. 8B illustrates a side profile of the frame of illustrated by FIG. 8A;

[0112] FIG. 9 illustrates the docking station frame of FIG. 8A in a compressed state;

[0113] FIG. 10 is a perspective view of an example of a docking station having a plurality of covered cells and a plurality of open cells;

[0114] FIG. 11 illustrates a side profile of the docking station illustrated by FIG. 10 when implanted in a vessel of the circulatory system;

[0115] FIG. 12 illustrates a perspective view of the docking station illustrated by FIG. 10 when implanted in a vessel of the circulatory system, with a portion cut away to illustrate a transcatheter heart valve expanded into place in the docking station;

[0116] FIGS. 13 and 14 illustrate side profiles of the docking station illustrated by FIG. 10 when implanted different sized vessels of the circulatory system with a schematically illustrated transcatheter heart valve having the same size installed or deployed in each docking station;

[0117] FIG. 15 A is a sectional view illustrating a side profile of an example of a docking station placed in a pulmonary artery;

[0118] FIG. 15B is a sectional view illustrating a side profile of an example of a docking station placed in a pulmonary artery and a schematically illustrated valve placed in the docking station;

[0119] FIG. 15C is a sectional view illustrating an example of a docking station placed in a pulmonary artery and a valve placed in the docking station;

[0120] FIG. 16 is a perspective view of an example of a stent frame, shown in an expanded unrestricted condition;

[0121] FIG. 17 is a side view of the stent frame of FIG. 16;

[0122] FIG. 18 is a side view of a stent including the stent frame of FIG. 16;

[0123] FIG. 19 is a top view of the stent frame of FIG. 16;

[0124] FIG. 20 is a perspective view of an example of a stent frame, shown in an expanded unrestricted condition;

[0125] FIG. 21 is a side view of the stent frame of FIG. 20;

[0126] FIG. 22 is a side view of a stent including the stent frame of FIG. 20;

[0127] FIG. 23 is a top view of the stent frame of FIG. 20;

[0128] FIG. 24 is a perspective view of an example of a stent frame, shown in an expanded unrestricted condition;

[0129] FIG. 25 is a side view of the stent frame of FIG. 24;|00130| FIG. 26 is a side view of a stent including the stent frame of FIG. 24;

[0131] FIG. 27 is a top view of the stent frame of FIG. 24;

[0132] FIG. 28 is a perspective view of an example of a stent frame, shown in an expanded unrestricted condition;

[0133] FIG. 29 is a side view of the stent frame of FIG. 28;

[0134] FIG. 30 is a side view of a stent including the stent frame of FIG. 28;

[0135] FIG. 31 is a top view of the stent frame of FIG. 28;

[0136] FIG. 31A is a front view of an apex portion of an example of an expandable stent;

[0137] FIG. 31B is a front view of an apex portion of another example of an expandable stent;

[0138] FIG. 32A is a cutaway view of the human heart in a systolic phase with a docking station being deployed in a pulmonary artery;

[0139] FIG. 32B is a cutaway view of the human heart in a systolic phase with a docking station and deployed in a pulmonary artery;

[0140] FIG. 32C is a cutaway view of the human heart in a systolic phase with a docking station and transcatheter heart valve deployed in a pulmonary artery;

[0141] FIGS. 33-36, and 37A-37C illustrate examples of valve types that may be deployed in a docking station, e.g., one of the docking stations described or depicted herein.DETAILED DESCRIPTION

[0142] The following description refers to the accompanying drawings, which illustrate specific examples of the invention. Other examples having different structures and operation do not depart from the scope of the present disclosure. Some examples set forth in the present disclosure are directed to devices and methods for providing a docking station or landing zone for a transcatheter heart valve ("THV"), e.g., THV 29. In some examples, docking stations for THVs are illustrated as being used within the pulmonary artery, although the docking stations (e.g., docking station 10) may be used in other areas of the anatomy, heart, or vasculature, such as the superior vena cava or the inferior vena cava. Further, the techniques and methods herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. The docking stations described herein can be configured to compensate for the deployed THV being smaller than the space (e.g., anatomy / vasculature / etc.) in which it is to be placed.

[0143] It should be noted that various examples of docking stations and systems for delivery and implant are disclosed herein, and any combination of these options may be made unless specifically excluded. For example, any of the docking stations de vices disclosed, may be used with any type of valve, and / or any delivery system, even if a specific combination is not explicitly described Likewise, the different constructions of docking stations and valves may be mixed and matched, such as by combining any docking station type / feature, valve type / feature, tissue cover, etc., even if not explicitly disclosed. In short, individual components of the disclosed systems may be combined unless mutually exclusive or otherwise physically impossible.

[0144] For the sake of uniformity, in these Figures and others in the application the docking stations are depicted such that the pulmonary bifurcation (at 210 in FIGS. 1A and IB) end is up, while the ventricular end is down. These directions may also be referred to as "distal" as a synonym for up or the pulmonary bifurcation end, and "proximal" as a synonym for down or the ventricular end, which are terms relative to the physician's perspective.

[0145] FIGS. 1A and IB are cutaway views of the human heart H in diastolic and systolic phases, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV ; i.e., the atrioventricular valves. Additionally, the aortic valve AV separates the left ventricle LV from the ascending aorta (not identified) and the pulmonary valve PV, disposed at an opening 212 between the pulmonary artery PA and the right ventricle RV, separates the right ventricle from the pulmonary artery. Each of these valves has flexible leaflets extendinginward across the respective orifices that come together or "coapt" in the flow stream to form the one-way, fluid-occluding surfaces. The docking stations and valves of the present application are described primarily with respect to the pulmonary valve. Therefore, anatomical structures of the right atrium RA and right ventricle RV will be explained in greater detail. It should be understood that the devices described herein may also be used in other areas, e.g., in the inferior vena cava and / or the superior vena cava as treatment for a regurgitant or otherwise defective tri-cuspid valve, in the aorta (e.g., an enlarged aorta) as treatment for a defective aortic valve, in other areas of the heart or vasculature, in grafts, etc.

[0146] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium from above, and the latter from below. The coronary sinus CS is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA. During the diastolic phase, or diastole, seen in FIG. 1 A, the venous blood that collects in the right atrium RA enters the tricuspid valve TV by expansion of the right ventricle RV. In the systolic phase, or systole, seen in FIG. IB, the right ventricle RV contracts to force the venous blood through the pulmonary valve PV and pulmonary artery into the lungs. In some examples, the devices described by the present application are used to replace or supplement the function of a defective pulmonary valve. During systole, the leaflets of the tricuspid valve TV close to prevent the venous blood from regurgitating back into the right atrium RA.

[0147] The pulmonary artery can have a wide variety of different shapes and sizes. For example, the length, diameter, and curvature or contour may vary greatly between pulmonary arteries of different patients. Further, the diameter may vary significantly along the length of an individual pulmonary artery. These differences can be even more significant in pulmonary arteries that suffer from certain conditions and / or have been compromised by previous surgery. For example, the treatment of Tetralogy of Fallot (TOF) or Transposition of the Great Arteries (TGA) often results in larger and more irregularly shaped pulmonary arteries.

[0148] Tetralogy of Fallot (TOF) is a cardiac anomaly that refers to a combination of four related heart defects that commonly occur together. The four defects are ventricular septal defect (VSD), overriding aorta (the aortic valve is enlarged and appears to arise from both the left and right ventricles instead of the left ventricle as in normal hearts), pulmonary stenosis (narrowing of the pulmonary valve and outflow tract or area below the valve that creates an obstruction of blood flow from the right ventricle to the pulmonary artery), and right ventricularhypertrophy (thickening of the muscular walls of the right ventricle, which occurs because the right ventricle is pumping at high pressure).

[0149] Transposition of the Great Arteries (TGA) refers to an anomaly where the aorta and the pulmonary artery are "transposed" from their normal position so that the aorta arises from the right ventricle and the pulmonary artery from the left ventricle.

[0150] Surgical treatment for some conditions involves a longitudinal incision along the pulmonary artery, up to and along one of the pulmonary branches. This incision can eliminate or significantly impair the function of the pulmonary valve. A trans-annular patch is used to cover the incision after the surgery. The trans-annular patch reduces stenotic or constrained conditions of the pulmonary artery PA, associated with other surgeries. However, the impairment or elimination of the pulmonary valve PV can create significant regurgitation and, prior to the present invention, often required later open-heart surgery to replace the pulmonary valve. The trans-annular patch technique can result in pulmonary arteries having a wide degree of variation in size and shape.

[0151] Referring to FIGS. 2A-2F, in some examples an expandable docking station 10 includes one or more sealing portions 410, a valve seat 18, and one or more retaining portions 414. The sealing portion(s) 410 provide a seal between the docking station 10 and an interior surface 416 of the circulatory system. The valve seat 18 provides a supporting surface for implanting or deploying a valve 29 in the docking station 10 after the docking station 10 is implanted in the circulatory system. The retaining portions 414 help retain the docking station 10 and the valve 29 at the implantation position or deployment site in the circulatory system. Expandable docking station 10 and valve 29 as described in the various examples herein are also representative of a variety of docking stations and / or valves that might be known or developed, e.g., a variety of different types of valves could be substituted for and / or used as valve 29 in the various docking stations.

[0152] FIGS. 2A-2D schematically illustrate an exemplary deployment of the docking station 10 and valve 29 in the circulatory system. Referring to FIG. 2A, the docking station 10 is in a compressed form / configuration and is introduced to a deployment site in the circulatory system. For example, the docking station 10, may be positioned at a deployment site in a pulmonary artery by a catheter (e.g., catheter 3600 as schematically shown in FIG. 32A). Referring to FIG. 2B, the docking station 10 is expanded in the circulatory system such that the sealing portion(s) 410 and the retaining portions 414 engage the inside surface 416 of a portion of the circulatory system. Referring to FIG. 2C, after the docking station 10 is deployed, the valve 29 is in a compressed form and is introduced into the valve seat 18 of thedocking station 10. Referring to FIG. 2D, the valve 29 is expanded in the docking station, such that the valve 29 engages the valve seat 18. In the illustrated examples, the docking station 10 is longer than the valve. However, in some examples the docking station 10 can be the same length or shorter than the length of the valve 29. Similarly, the valve seat 18 can be longer, shorter, or the same length as the length of the valve 29.

[0153] Referring to FIG. 2D, the valve 29 has expanded such that the seat 18 of the docking station supports the valve. The valve 29 only needs to expand against the narrow seat 18, rather than against the wider space within the portion of the circulatory system that the docking station 10 occupies. The docking station 10 allows the valve 29 to operate within the expansion diameter range for which it is designed.

[0154] FIG. 2E illustrates that the inner surface 416 of the circulatory system, such as the inner surface of a blood vessel or anatomy of the heart can vary in cross-section size and / or shape along its length. In some examples, the docking station 10 may be configured to expand radially outwardly to varying degrees along its length L to conform to shape of the inner surface 416. In some examples, the docking station 10 may be configured such that the sealing portion(s) 410 and / or the retaining portion(s) engage the inner surface 416, even though the shape of the blood vessel or anatomy of the heart vary significantly along the length L of the docking station. The docking station can be made from a very resilient or compliant material to accommodate large variations in the anatomy. For example, the docking station can be made from a highly flexible metal, metal alloy, polymer, or an open cell foam. Examples of a metals and metal alloys that can be used include, but are not limited to, nitinol, elgiloy, and stainless steel, but other metals and highly resilient or compliant non-metal materials can be used. For example, the docking station 10 can have a frame or portion of a frame (e.g., a self-expanding frame, retaining portion(s), sealing portion(s), valve seat, etc.) made of these materials, e.g., from shape memory materials, such as nitinol. These materials allow the frame to be compressed to a small size, and then when the compression force is released, the frame will self-expand back to its pre-compressed diameter.

[0155] FIG. 2F illustrates the docking station 10 and a valve 29 implanted in a pulmonary artery PA, between the pulmonary bifurcation 210 and the opening 212 to the right ventricle RV. As mentioned above, the shape of the pulmonary artery may vary significantly along its length. In some examples, the docking station 10 may configured to conform to the varying shape of the pulmonary artery PA in the same manner as described with respect to FIG. 2E.

[0156] Referring to FIG. 3 A, a docking station, e.g., a docking station as described with respect to FIGS. 2A-2D, is deployed in the pulmonary artery PA of a heart H. FIG. 3B illustrates avalve 29 deployed in the docking station 10 illustrated by FIG. 3A. In FIGS. 3A and 3B, the heart is in the systolic phase. FIG. 4A is an enlarged representation of the docking station 10 and valve 29 in the pulmonary artery PA of FIG. 3B. When the heart is in the systolic phase, the valve 29 opens. Blood flows from the right ventricle RV and through the pulmonary artery PA, docking station 10, and valve 29 as indicated by arrows 602. FIG. 4B illustrates space 608 that represents the valve 29 being open when the heart is in the systolic phase. FIG. 4B does not show the interface between the docking station 10 and the pulmonary artery to simplify the drawing. The cross-hatching in FIG. 4B illustrates blood flow through the open valve. In some examples, blood is prevented from flowing between the pulmonary artery PA and the docking station 10 by the sealing portion(s) 410 and blood is prevented from flowing between the docking station 10 and the valve 29 by seating of the valve 29 in the seat 18 of the docking station 10. In some examples, blood is substantially only flowing or only able to flow through the valve 29 when the heart is in the systolic phase.

[0157] FIG. 6 illustrates the valve 29, docking station 10 and heart H illustrated by FIG. 3B, when the heart is in the diastolic phase. Referring to FIGS. 7 A and 7B, when the heart is in the diastolic phase, the valve 29 closes. FIG. 7A is an enlarged representation of the docking station 10 and valve 29 in the pulmonary artery P of FIG. 6. Blood flow in the pulmonary artery PA above the valve 29 (i.e. in the pulmonary branch 760) is blocked by the valve 29 being closed and blocking blood flow as indicated by arrow 900. The solid area 912 in FIG. 7B represents the valve 29 being closed when the heart is in the diastolic phase.

[0158] In some examples, the docking station 10 acts as an isolator that prevents or substantially prevents radial outward forces of the valve 29 from being transferred to the inner surface 416 of the circulatory system. In some examples, the docking station 10 includes a valve seat 18 (which is not expanded radially outwardly or is not substantially expanded radially outward by the radially outward force of the THV or valve 29, i.e., the diameter of the valve seat is not increased or is increased by less than 4 mm by the force of the THV), and anchoring / retaining portions 414 and sealing portions 410, which impart only relatively small radially outward forces 720, 722 on the inner surface 416 of the circulatory system (as compared to the radially outward force applied to the valve seat 18 by the valve 29).

[0159] When no docking station is used, stents and frames of THVs are held in place in the circulatory system by a relatively high radial outward force 710 of the stent or frame 712 of the THV acting directly on the inside surface 416 of the circulatory system. If a docking station is used, as in the example illustrated by FIG. 4A, the stent or frame 712 of the valve 29 expands radially outward or is expanded radially outward to impart the high force 710 on the valve seat18 of the docking station 10. This high radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, since the valve seat 18 is not expanded or is not substantially expanded by the force 710, the force 710 is isolated from the circulatory system, rather than being used to secure the docking station in the circulatory system.

[0160] In some examples, the radially outward force 722 of the sealing portions 410 to the inside surface 416 is substantially smaller than the radially outward force 710 applied by the valve 29 to the valve seat 18. In some examples, the radially outward force 722 of the sealing portions 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is not sufficient by itself to retain the position of the valve 29 and docking station 10 in the circulatory system.

[0161] In some examples, the radially outward force 722 of the sealing portions 410 to both the larger vessel 2300 and the smaller vessel is substantially smaller than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel to be adapted by the docking station 10 for valve implantation, the radially outward sealing force 722 can be less than 1 / 2 the radially outward force 710 applied by the valve, less than 1 / 3 the radially outward force 710 applied by the valve, less than 1 / 4 the radially outward force 710 applied by the valve, less than 1 / 8, or even less than 1 / 10 the radially outward force 710 applied by the valve. In some examples, the radially outward force 722 of the sealing portions 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is not sufficient by itself to retain the position of the valve 29 and docking station 10 in the circulatory system. In some examples, the radially outward force 722 is sufficient to retain the position of the valve 29 and docking station 10 in the circulatory system. In an exemplary arrangement, the valve 29 (e.g., a 29 mm size Sapien 3 valve) may apply a radially outward force 710 of about 42 N, and the radially outward force of the deployed docking stations may apply between about 4 N and about 16 N, though other forces are also possible.

[0162] In some examples, the radially outward force 720 of the anchoring / retaining portions 414 to the inside surface 416 is substantially smaller than the radially outward force 710 applied by the valve 29 to the valve seat 18.

[0163] In some examples, the radially outward force 720 of the retaining portions 414 is not sufficient by itself to retain the position of the valve 29 and docking station 10 in the circulatory system. Rather, the pressure of the blood 608 is used to enhance the retention of the retaining portions 414 to the inside surface 416. Referring again to FIG. 3A, when the heart is in the systolic phase, the valve 29 is open and blood flows through the valve as indicated by arrows 602. Since the valve 29 is open and blood flows through the valve 29, the pressure P appliedto the docking station 10 and valve 29 by the blood is low as indicated by the small P and arrow in FIG. 4A. Even though small, the pressure P forces the docking station and its upper retaining portions 414 against the surface 416 generally in the direction indicated by arrow F. This blood flow assisted force F applied by the retaining portions 414 to the surface 416 prevents the docking station 10 and valve 29 from moving in the direction 602 of blood flow in the systolic phase of the heart H.

[0164] Referring to FIG. 7A, when the heart is in the diastolic phase, the valve 29 is closed and blood flow is blocked as indicated by arrow 900. Since the valve 29 is closed and the valve 29 and docking station 10 block the flow of blood, the pressure P applied to the docking station 10 and valve 29 by the blood is high as indicated by the large arrow P in FIG. 7A. This large pressure P forces the lower retaining portions 414 against the surface 416 generally in the direction indicated by the large arrows F. This blood flow assisted force F applied by the retaining portions F to the surface 416 prevents the docking station 10 and valve 29 from moving in the direction indicated by arrow 900.

[0165] Since the force applied by the upper and lower retaining portions 414 is determined by amount of pressure applied to the valve 29 and docking station 10 by the blood, the force applied to the surface 416 is automatically proportioned. That is, the upper retaining portions are less forcefully pressed against the surface 416 when the heart is in the systolic phase than the lower retaining portions are pressed against the surface 416 when the heart is in the diastolic phase. This is because the pressure against the open valve 29 and docking station 10 in the systolic phase is less than the pressure against the closed valve and docking station in the diastolic phase.

[0166] Co-owned U.S. Patent No. 10,363,130 (the “’ 130 Patent”), the entire disclosure of which is incorporated herein by reference, describes and shows several exemplary docking stations comprising expandable frames formed form a lattice of metal strut portions. FIGS. 8A, 8B, 9, and 10 illustrate one such example from the ‘130 Patent of a frame 1500 or body of a docking station 10 having a relatively wider proximal inflow end 12 and distal outflow end 14, and a relatively narrower portion 16 that forms the seat 18 in between the ends 12, 14. The docking station frame 1500 is formed from a plurality of metal struts 1502 that form cells 1504, and has a generally hourglass -shape that has a narrow portion 16, which forms the valve seat 18 when covered by an impermeable material, in between the proximal and distal ends 12, 14. As described below, the valve 29 expands in the narrow portion 16, which forms the valve seat 18.

[0167] FIGS. 8A and 8B illustrate the frame 1500 in its unconstrained, expanded condition. In this example, the retaining portions 414 comprise ends 1510 of the metal struts 1502 at the proximal and distal ends 12, 14. The sealing portion 410 is between the retaining portions 414 and the waist 16. In the unconstrained condition, the retaining portions 414 extend generally radially outward and are radially outward of the sealing portion 410. FIG. 9 illustrates the frame 1500 in the compressed state for delivery and expansion by a catheter. The docking station 10 may be self-expanding, manually expandable (e.g., expandable via balloon), or mechanically expandable. A self-expanding docking station 10 may be made of a shape memory material such as, for example, nitinol.

[0168] FIG. 10 illustrates the frame 1500 with impermeable material 21 attached to the frame 1500 to form the docking station 10. As shown, a band 20 may extend about the waist or narrow portion 16, or may be integral to the waist to form an unexpandable or substantially unexpandable valve seat 18. The band 20 stiffens the waist and, once the docking station is deployed and expanded, makes the waist / valve seat relatively unexpandable in its deployed configuration. A prosthetic valve may be secured in the docking station by expansion of its collapsible frame into the narrow portion 16, which forms the valve seat 18, of the docking station 10. As is explained above, the unexpandable or substantially unexpandable valve seat 18 prevents the radially outward force of the valve 29 from being transferred to the inside surface 416 of the circulatory system. However, in some examples, the waist / valve seat of the deployed docking station may optionally expand slightly in an elastic fashion when the valve is deployed against it. This optional elastic expansion of the waist 18 may put pressure on the valve 29 to help hold the valve 29 in place within the docking station.

[0169] FIG. 11 illustrates the docking station 10 of FIG. 10 implanted in the circulatory system, such as in the pulmonary artery. The sealing portions 410 provide a seal between the docking station 10 and an interior surface 416 of the circulatory system. In the example of FIG. 11, the sealing portion 410 is formed by providing an impermeable material 21 (see FIG. 10) over the frame 1500 or a portion thereof. In particular, the sealing portion 410 can comprise the lower, rounded, radially outward extending portion 2000 of the frame 1500. In some examples, the impermeable material 21 extends from at least the portion 2000 of the frame 1500 to the valve seat 18. This makes the docking station impermeable from the sealing portion 410 to the valve seal 18. As such, all blood flowing in the direction of the inflow end toward the direction of the outflow end 14 is directed to the valve seat 18 (and valve 29 once installed or deployed in the valve seat).

[0170] In an example of a docking station 10, the inflow portion has walls that are impermeable to blood, but the outflow portion walls are relatively open. In one approach, the inflow end portion 12, the mid-section 16, and a portion of the outflow end portion 14 are covered with a blood-impermeable fabric 21, which may be sewn onto the stent or otherwise attached by a method known in the art. The impermeability of the inflow portion of the stent helps to funnel blood into the docking station 10 and ultimately flow through the valve that is to be expanded and secured within the docking station 10.

[0171] From another perspective, this example of a docking station is designed to seal at the proximal inflow section 2000 to create a conduit for blood flow. The distal outflow section, however, is generally left open, thereby allowing the docking station 10 to be placed higher in the pulmonary artery without restricting blood flow. For example, the permeable portion 1400 may extend into the branch of the pulmonary artery and not impede or not significantly impede the flow of blood past the branch. In one example, blood-impermeable cloth, such as a PET cloth for example, or other material covers the proximal inflow section, but the covering does not cover any or at least a portion of the distal outflow section 14. As one non-limiting example, when the docking station 10 is placed in the pulmonary artery, which is a large vessel, the significant volume of blood flowing through the artery is funneled into the valve 29 by the cloth covering 21. The cloth 21 is fluid impermeable so that blood cannot pass through. Again, a variety of other biocompatible covering materials may be used such as, for example, foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.

[0172] In the example illustrated by FIG. 10, more of the docking station frame 1500 is provided with the impermeable material 21, forming a relatively large impermeable portion 1404. In the example illustrated by FIG. 10, the impermeable portion 1404 extends from the inflow end 12 and stops one row of cells 1504 before the outflow end. As such, the most distal row of cells 1504 form a permeable portion 1400. However, more rows of cells 1504 can be uncovered by the impermeable material to form a larger permeable portion. The permeable portion 1400 allows blood to flow into and out of the area 2130 as indicated by arrows 2132. With respect to the inflow end 12, it should be noted that since the cells 1504 are generally diamond shaped, blood is able to flow between the docking station 10 and the surface 416, until the sealing portion 410 is reached. That is, blood can flow into and out of the areas 2100 in some examples.

[0173] The valve seat 18 can provide a supporting surface for implanting or deploying a valve 29 in the docking station 10. The retaining portions 414 can retain the docking station 10 atthe implantation position or deployment site in the circulatory system. The illustrated retaining portions have an outwardly curving flare that helps secure the docking station 10 within the artery. "Outwardly" as used herein means extending away from the central longitudinal axis of the docking station. As can be seen in FIG. 11, when the docking station 10 is compressed by the inside surface 416, the retaining portions 414 engage the surface 416 at an angle a (normal to the surface to the tangent of the midpoint of the surface of the retaining portion 414) that can be between 30 and 60 degrees, such as about 45 degrees, rather than extending substantially radially outward (i.e. A is 0 to 20 degrees or about 10 degrees) as in the uncompressed condition (see FIG. 8B). This inward bending of the retaining portions 414 as indicated by arrow 2020 acts to retain the docking station 10 in the circulatory system. The retaining portions 414 are at the wider inflow end portion 12 and outflow end portion 14 and press against the inner surface 416. The flared retaining portions 414 engage into the surrounding anatomy in the circulatory system, such as the pulmonic space. In some examples, the flares serve as a stop, which locks the device in place. When an axial force is applied to the docking station 10, the flared retaining portions 414 are pushed by the force into the surrounding tissue to resist migration of the stent as described in more detail below. In some examples, the docking station generally has an hourglass shape, with wider distal and proximal end portions that have the flared retaining portion and a narrow, banded waist in between the ends, into which the valve is expanded.

[0174] FIG. 12 illustrates the docking station 10 deployed in the circulatory system and a valve 29 deployed in the docking station 10. After the docking station 10 is deployed, the valve 29 is in a compressed form and is introduced into the valve seat 18 of the docking station 10. The valve 29 is expanded in the docking station, such that the valve 29 engages the valve seat 18.

[0175] The valve 29 may be delivered to the site of the docking station via conventional means, such as by balloon or mechanical expansion or by self-expansion. When the valve 29 is expanded, it nests in the valve seat of the docking station 10. In some examples, the banded waist is slightly elastic and exerts an elastic force against the valve 29, to help hold the THV in place.

[0176] FIGS. 13 and 14 illustrate side profiles of the docking station 10 illustrated by FIG. 10 when implanted in different sized vessels 2300, 2302 of the circulatory system with a schematically illustrated transcatheter heart valve 29 having the same size installed or deployed in each docking station 10. In this example, the docking station 10 both accommodates vessels v2300, 2302 having a variety of different sizes and acts as an isolator that prevents or substantially prevents radial outward forces of the valve 29 from being transferred to thevessels. The valve seat 18 is not expanded radially outwardly or is not substantially expanded radially outward by the radially outward force of the valve 29 and the anchoring / retaining portions 414 and the sealing portions 410 impart only relatively small radially outward force on the vessels 2300, 2302 (as compared to the radially outward force applied to the valve seat 18 by the valve 29), even when the docking station is deployed in a vessel 2302 having a smaller diameter.

[0177] a band 20 maintains a constant or substantially constant diameter of the valve seat 18, even as the proximal and distal ends of the docking station expand to respective diameters necessary to engage with the inside surface 416. The diameter of the pulmonary artery PA can vary considerably from patient to patient, but the valve seat 18 in the deployed configuration consistently has a diameter that is within an acceptable range for the valve 29.

[0178] In the example illustrated by FIGS. 13 and 14, the stent or frame 712 of the valve 29 expands radially outward or is expanded radially outward to import the high force 710 on the valve seat 18 of the docking station 10. This high radially outward force 710 secures the valve 29 to the valve seat 18 of the docking station 10. However, since the valve seat 18 is not expanded or is not substantially expanded by the force 710, the force 710 is isolated from the circulatory system, rather than being used to secure the docking station in the circulatory system.

[0179] In some examples, the radially outward force 722 of the sealing portions 410 to both the larger vessel 2300 and the smaller vessel is substantially smaller than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel to be adapted by the docking station 10 for valve implantation, the radially outward sealing force 722 can be less than 1 / 2 the radially outward force 710 applied by the valve, less than 1 / 3 the radially outward force 710 applied by the valve, less than 1 / 4 the radially outward force 710 applied by the valve, less than 1 / 8, or even less than 1 / 10 the radially outward force 710 applied by the valve. In some examples, the radially outward force 722 of the sealing portions 410 is selected to provide a seal between the inner surface 416 and the sealing portion 410, but is not sufficient by itself to retain the position of the valve 29 and docking station 10 in the circulatory system. In some examples, the radially outward force 722 is sufficient to retain the position of the valve 29 and docking station 10 in the circulatory system.

[0180] In some examples, the docking station 10 illustrated by FIG. 10 also includes anchoring / retaining portions 414 that apply radially outward forces 720 that are substantially smaller than the radially outward force 710 applied by the valve 29 to the valve seat 18. For example, for the smallest vessel to be adapted by the docking station 10 for valve implantation,the radially outward sealing force 720 can be less than 1 / 2 the radially outward force 710 applied by the valve, less than 1 / 3 the radially outward force 710 applied by the valve, less than 1 / 4 the radially outward force 710 applied by the valve, less than 1 / 8, or even less than 1 / 10 the radially outward force 710 applied by the valve.

[0181] In some examples, the radially outward force 720 of the anchoring / retaining portions 414 is not sufficient by itself to retain the position of the valve 29 and docking station 10 in the circulatory system. In some examples, the radially outward force 720 is sufficient to retain the position of the valve 29 and docking station 10 in the circulatory system.

[0182] In some examples, the docking station 10 frame 1500 is made from an elastic or superelastic material or metal. One such metal is nitinol. When the frame 1500 of the docking station 10 is made from a lattice of metal struts, the body can have the characteristics of a spring. Referring to FIG. 5, like a spring, when the frame 1500 of the docking station 10 illustrated by FIGS. 13 and 14 is unconstrained and allowed to relax to its largest diameter the frame of the docking station applies little or no radially outward force. As the frame 1500 of the docking station 10 is compressed, like a spring, the radially outward force applied by the docking station increases. As is illustrated by FIG. 5, in some examples, the relationship of the radially outward force of the docking station frame 1500 to the expanded diameter of the docking station is non-linear, though it can also be linear. In the example illustrated by FIG. 5, the curve 750 illustrates the relationship between the radially outward force exerted by the docking station 10 and the compressed diameter of the docking station. In the region 752, the curve 750 has a low slope. In this region 752 the radially outward force is low and changes only a small amount. In some examples, the region 752 corresponds to a diameter between 25 mm and 40 mm, such as between 27 mm and 38 mm. The radially outward force is small in the region 752 but is not zero. In the region 754, the curve 750 has a higher slope. In this region 754 the radially outward force increases significantly as the docking station is compressed. In some examples, the body of the stent is constructed to be in the low slope region 752 for both a largest vessel 2300 (FIG. 13) accommodated by the docking station 10 and a smallest vessel 2302 (FIG. 14). This allows the sealing portions 710 to apply only a small radially outward force to the inner surface 416 of the circulatory system over a wide range of diameters. Note that in this patent application the size of the anatomy of the circulatory system is referred to by the term "diameter" or "effective diameter." The anatomy of the circulatory system is often not circular. The terms "diameter" and "effective diameter" herein refers to the diameter of a circle or disc that could be deformed to fit within the non-circular anatomy.

[0183] In the example illustrated by FIGS. 13 and 14, the sealing portion 410 and the retaining portions 414 conform to contact each vessel 2300, 2302. However, the valve seat 18 remains the same size, even though the sealing portion 410 and the retaining portions 414 are compressed. In this manner, the docking station 10 adapts a wide variety of different anatomical sizes for implantation of a standard or single sized valve. For example, the docking station may conform to vessel diameters of 25 mm and 40 mm, such as 27 mm and 38 mm and provide a constant or substantially constant diameter valve seat of 24 mm to 30 mm, such as 27 mm to 28 mm. However, the valve seat 18 of the docking station 10 can be adapted for applications where the vessel diameter is larger or smaller than 25 mm to 40 mm and provide valve seats that are larger or smaller than 24 mm to 30 mm.

[0184] For example, the docking station may conform to vessel diameters of 25 mm and 40 mm, such as 27 mm and 38 mm and provide a constant or substantially constant diameter valve seat of 24 mm to 30 mm, such as 27 mm to 28 mm. However, the valve seat 18 of the docking station 10 can be adapted for applications where the vessel diameter is larger or smaller than 25 mm to 40 mm and provide valve seats that are larger or smaller than 24 mm to 30 mm.|00185 | FIGS. 15A-15C illustrate the docking station 10 of FIG. 10 implanted in a pulmonary artery. FIG. 15A illustrates the profile of the docking station 10 implanted in the pulmonary artery PA. FIG. 15B illustrates the profile of the docking station 10 implanted in the pulmonary artery PA with a schematically illustrated valve 29 installed or deployed in the docking station 10. FIG. 15C illustrates the docking station 10 and valve 29 as depicted in FIG. 12 implanted in the pulmonary artery PA. As mentioned above, the shape of the pulmonary artery may vary significantly along its length. In some examples, the docking station 10 is configured to conform to the varying shape of the pulmonary artery PA. The docking station 10 is illustrated as being positioned below the pulmonary artery bifurcation or branch. However, often the docking station 10 will be positioned such that the end 14 extends into the pulmonary artery bifurcation 210. When it is contemplated that the docking station 10 will extend into the pulmonary artery bifurcation, the docking station 10 can have a blood permeable portion 1400 (e.g., as shown in FIG. 12).

[0186] According to an exemplary aspect of the present disclosure, an expandable stent frame, for example, for a prosthetic valve retaining docking station, may be adapted to improve tissuestent interaction. For example, a stent frame may be configured to reduce the concentration of stent retaining forces against the tissue at the implant site and / or to reduce the degree or risk of tissue puncture / penetration or tissue trauma by the stent frame.

[0187] FIGS. 16-31 illustrate various views of some exemplary stent frames 1500a, 1500b, 1500c, 1500d having one or more features adapted to reduce the concentration of stent retaining forces against the tissue at the implant site and / or to reduce the degree or risk of tissue puncture / penetration or tissue trauma by the stent frame. The illustrated stent frames 1500a-d, shown in an unrestricted expanded condition, include a plurality of struts 1502a-d (e.g., formed from a shape memory alloy, such as, for example, nitinol) defining a plurality of cells 1504a-3 (e.g., diamond shaped cells, as shown) and having a generally hourglass shaped profile, with a narrower, generally convex central waist portion 16a-d (which may define a valve seat 18a-d at inner diameter d3, as described herein), medial convex sealing portions 410a-d, and endmost outer radial retaining portions 414a-d extending from the convex sealing portions. As shown, the portions of the struts 1502a-d defining the endmost rows of cells 1504a-d may include apices 1510a-d that define the outer diameters dl, d2 of the distal (outflow) and proximal (inflow) ends 14a-d, 12a-d of the stent frame 1500a-d, respectively.

[0188] In some examples, the sealing and retaining portions of the proximal and distal ends of the stent frame may be substantially the same in shape, contour, and dimension. In other examples, the proximal and distal ends of the stent frame may differ in shape, contour, and dimension, such that the stent frame features described herein may be applied to either or both ends of the stent frame.

[0189] As shown in FIGS. 16-27, either or both ends 12a-c, 14a-c of the stent frame 1500a-c may include flared endmost retaining portions defined by flared apices 1510a-c (e.g., of an endmost row of cells 1504a-c formed by the struts 1502a-c of the stent frame) that extend radially outward from an outwardly contoured inflection radius il (see FIGS. 17, 21, and 25) of a convex sealing portion 410a-c, located medially between the retaining portion 414a-c and the central waist portion 16a-c of the stent frame. According to an exemplary aspect of the present disclosure, in some examples, a radial distance el (see FIGS. 17, 21, and 25) from the outwardly contoured inflection radius il to the terminal end of the corresponding apex 1510a- c may be limited, for example, to minimize degree of penetration or other such trauma to the tissue by the retaining portion apices. For example, the radial distance from the outwardly contoured inflection radius il to the terminal end of the apex 1510a-c may be between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0190] According to another exemplary aspect of the present disclosure, as shown in FIGS. 16-31, in some examples, the apices 1510a-d at either or both ends of the stent frame 1500a-d may be provided with an enlarged or extended width, for example, compared to the widths of the intercell strut junctions of the stent frame. The enlarged or extended apices 1510a-d mayresult in a less concentrated force at the apices against the tissue, to further limit or minimize penetration of the apices into the tissue. In some examples, the apices 1510a-d may have a maximum width between about 1 mm and about 1.5 mm or about 1.4 mm. While the apices 1510a-d may be provided with a substantially uniform width, in some examples, as shown in FIG. 31A, the apex 1510 may include a narrower neck portion 1511 and a wider or enlarged head portion 1512 having a width w2 greater than (e.g., at least 20% greater, or at least 30% greater) a width wl of the neck portion. In such an arrangement, the apices 1510b, 15 lOd may be axially staggered (see, e.g. FIGS. 21 and 29) to provide misalignments or offsets for adjacent head portions 1512b, 1512d, to minimize the compressed or crimped diameter of the stent frame when the stent frame is retained in a catheter.

[0191] According to another exemplary aspect of the present disclosure, in some examples, the apices 1510a-d at either or both ends of the stent frame 1500a-d may be provided with cover elements 1515a-d (see FIGS. 17, 21 , 25, 29) provided in a material selected to provide softened, atraumatic engagement of the apices with the tissue at the deployment site, while still restricting movement or migration of the deployed docking station frame 1500a-d. A variety of suitable cover element materials may be used, including, for example, plastics (e.g., polyethylene terephthalate (PET), polyethylene such as Ultra High Molecular Weight Polyethylene (UHMWPE), or Teflon (PTFE)), organic materials (e.g., cotton), elastomers (e.g., silicone, thermoplastic polyurethane (TPU)), or foam materials (e.g., polyethylene foam).

[0192] The cover element may be provided as a coating, molding, wrap, sleeve, or sock of material at least partially covering the stent frame apex 1510a-d. While the cover elements 1515a-d may be provided on the apices at both ends of the docking station frame 1500a-d, in some implementations, the cover elements are only provided on the apices on the distal end of the docking station frame, for example, to act as a cushion between the apices and thin tissue in the pulmonary artery.

[0193] In an exemplary implementation, as shown in FIG. 3 IB, a cover element 1515 is formed from a sleeve of braided PET fabric material, cut, heat sealed on one end, and inverted (turned inside out such that the seam is on the inside) to form a sock of material sized to fit over the apex 1510, and to extend over at least the tissue engaging end (e.g., head 1512) portion of the apex (e.g., a length of about 2.5 mm). The braided material may be formed from fibers having a linear density of about 22 dtex, approximately 18 filaments per thread / strand, and / or a fabric density of approximately 130 picks per inch (e.g., 127 - 133 picks per inch). The braided fabric may be textured, for example, to enhance tissue ingrowth upon implantation of the stent. The cover element 1515 may be secured to the apex 1510, for example, by a stitch or suture1514 applied through the fabric material. The stitch or suture may additionally pass through an aperture 1513 in the end portion 1512 of the apex 1510 to secure the cover element 1515 in place.

[0194] According to another exemplary aspect of the present disclosure, as shown in FIGS. 16-27, in some examples, the retaining portions 414a-c at either or both ends of the stent frame 1500a-c may be provided with a shallower or more acute flare angle al with respect to a central longitudinal axis X of the stent frame 1500a-c, for example, to provide shallower, less aggressive engagement of the apices 1510a-c with the tissue at the implant site. In some examples, the retaining portion(s) 414a-c may extend at an angle between about 30° and about 40°, or about 30°, with respect to the central longitudinal axis X of the stent frame 1500a-c. In other examples, the retaining portion(s) 414a-c may extend at an angle between about 40° and about 50°, or about 45°, with respect to the central longitudinal axis X of the stent frame 1500a- c.

[0195] In some examples, as shown in FIGS. 28-31, the retaining portions 414d at either or both ends 12d, 14d of the stent frame 1500d may extend substantially continuously from the corresponding convex sealing portion 410d, without an outwardly flared inflection radius between the sealing portion and the retaining portion, such that penetration of the apices 1510d into the tissue at the implant site may be further minimized. In some examples, the angle of incidence al between the retaining portion 414d and the tissue may be less than about 30°, or less than about 15°, or substantially 0° (i.e., substantially parallel with the interior surface of the implant site), minimizing or eliminating force at the apices while still providing maximum outer diameters of the stent 1500d at either or both ends.

[0196] In some examples, as shown in FIGS. 20-23 and 28-31, the struts 1502b, 1502d of a stent frame 1500b, 1500d may form a greater number of apices 1510b, 1510d (e.g., 14 apices on each end, compared to 12 apices per end, as shown in the examples of FIGS. 8A-10, 16-19, and 24-27). By providing an increased number of tissue engaging apices 1510b, 1510d (and cells 1504b, 1504d per row), the stent frame 1500b, 1500d may be provided with increased flexibility and a more uniform distribution of force from the retaining portions 414b, 414d against the tissue at the implant site. In some examples, a different number of cells per row (and corresponding apices) may be provided to affect a desired flexibility and retaining force distribution (e.g., as shown in FIG. 5). In some examples, apices 1510b, 1510d may be axially staggered in length (see, e.g. FIGS. 21 and 29) to provide misalignments or offsets for adjacent apices, to minimize the compressed or crimped diameter of the stent frame when the stent frameis retained in a catheter, which may require reconfiguration of the corresponding catheter to accommodate a larger crimp diameter.

[0197] In some examples, similar to the example shown in FIG. 10 and described in the above incorporated ‘130 Patent, the exemplary stent frames 1500a-d of FIGS. 16-31 may be provided with proximal end apices provided with retaining tabs or extensions 5000a-d, which may extend axially and radially beyond the proximal strut apices to provide limited retaining engagement of the frame 1500a-d by a catheter during deployment of the frame. Aspects of this feature, and the corresponding features of the catheter, are described in greater detail in the above incorporated ‘130 Patent. In some such examples, the retaining tabs 5000a-d may extend radially outward from an outwardly contoured inflection radius i2 (see FIGS. 17, 21, 25, and 29) of the proximal end convex sealing portion 410a-d by a radial distance e2 that extends radially outward of the other apices 1510a-d (e.g., up to about 1 mm radially outward of the other apices), for example, to facilitate retention of the retaining tabs 5000a-d by the catheter prior to deployment. In some examples, the retaining tabs 5000a-d may flare radially outward from the outwardly contoured inflection radius i2 of the proximal end convex sealing portion 410a-d by an angle a2 greater than the flare angle al of the other apices 1510a-c (e.g., about 40° to about 50°, or about 45°), for example, to facilitate retention of the retaining tabs 5000a- d by the catheter prior to deployment.

[0198] In some examples, a stent frame 1500a-d may be utilized as a docking station to secure a prosthetic valve in a vessel or deployment site having a relatively large or irregular crosssection that may present difficulties for direct implantation of a prosthetic valve. As shown in FIGS. 18, 22, 26, and 30, the docking station lOa-d may include a covering material 21a-d (e.g., an impermeable or semi-impermeable fabric) secured to an exterior and / or interior of the docking station frame 1500a-d to provide a tissue sealing surface for the convex sealing portions 410a-d, and / or to provide a sealing surface at the inner diameter d3 of the waist portion 16a-d to define the valve seat 18a-d against which an expandable prosthetic valve may be seated. As shown, this narrowed central waist portion bay be substantially cylindrical to facilitate secure, uniform retention of the expanded prosthetic valve.

[0199] Similar to the example illustrated by FIG. 10 and described above and in the ’ 130 Patent, the cover material 21a-d may extend from the inflow end 12a-d and terminate axially inward of the outflow end 14a-d, such that at least a portion of the distal end cells 1504a-d is uncovered to form a permeable portion of the docking station lOa-d, allowing blood to flow into and out of this distal area.

[0200] In some examples, the stent or docking station lOa-d may include one or more radiopaque markers 1580a-d, secured to one or more locations of the docking station for visualization / location of the docking station or a portion of the docking station during or after deployment. For example, radiopaque markers 1580a-d may be secured to the docking station waist portion 16a-d to facilitate visual confirmation of alignment prosthetic valve within the valve seat 18a-d of the docking station lOa-d, or to retaining tabs 5000a-d to facilitate visual confirmation of release of the docking station frame from the catheter during deployment. Exemplary radiopaque markers and attachment arrangements are described in co-pending PCT application serial nos. PCT / US2021 / 019770, PCT / US2022 / 043296, and PCT / US2024 / 018400, the entire disclosures of each of which are incorporated herein by reference. In an exemplary embodiment, tantalum radiopaque markers are press fit or staked into seating portions (e.g., recesses, apertures) in the retention tabs, as described in the above incorporated PCT application serial no. PCT / US2024 / 018400.

[0201] As described above, in some examples, a stent or docking station (e.g., including the stent frames 1500, 1500a-d shown and described herein) may be deployed in a pulmonary artery PA, as schematically shown in FIGS. 15A-15C, for docking or securing a prosthetic valve 29 provided to functionally replace a defective or dysfunctional native pulmonary valve. Depending on the geometry of the pulmonary artery PA, which may vary considerably as discussed above, the length of the pulmonary artery between the pulmonary bifurcation 210 and the right ventricular outflow tract (RVOT) may be limited. In some applications, engagement of a docking station with the RVOT, a region of higher contractility, and contractile motion of any aligned stent portion, for example, between about 0.5 mm and about 6 mm, may subject the docking station frame to increased cyclical strain and fatigue.

[0202] According to an exemplary aspect of the present disclosure, a stent frame for a docking station may be sized so as to limit or prevent extension of the proximal end of the stent frame into the RVOT when the distal end of the stent frame is positioned to engage the pulmonary artery PA below the pulmonary bifurcation 210.

[0203] In some examples, the stent frame 1500a-d may be provided with a height h (e.g., see FIGS. 17, 21, 25, and 29) between the proximal end 12a-d and the distal end 14a-d, in the unrestricted expanded condition, of between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm, or about 45 mm, or between about 38 mm and about 46 mm, or about 38 mm. In some examples, the height h may be sufficiently limited so as to prevent the stent frame 1500a-d from extending into the RVOT when the distal end of the stent frame is positioned to engage the pulmonary artery PA below the pulmonary bifurcation 210. In someexamples, the stent frame 1500a-d, sized for deployment in the pulmonary artery PA, may have a ratio of an outer diameter (e.g., either or both of the first and second end outer diameters dl, d2) to height of at least substantially 1: 1 (i.e., outer diameter at least substantially as great as the height). For example, an outer diameter dl or d2 may be at least 98% of the height, or between 100% and 117.5% of the height, to maintain sufficient sealing and retaining forces between the expanded stent frame 1500a-d and the implant site, while sufficiently limiting the height h to prevent the stent frame from extending into the RVOT.

[0204] In some examples, a stent frame may be formed a plurality of struts, forming two rows of cells, which may facilitate reduction in the overall height of the unrestricted expanded stent frame. In some examples, as shown in FIGS. 28-31, by forming a stent frame 1500d with two rows of cells 1504d, the proximal and distal apices 1510d (which may, but need not include the retention tabs 5000d) may define a height between about 35 mm and about 46 mm, or about 38 mm. In some examples, an outer diameter dl or d2 of the stent frame 1500d may be at least 115% of the height, or between 115% and 150% of the height, or between about 120% and about 130% of the height.|00205 | In some examples, an expandable stent frame is provided in a compressed condition within a first tube (e.g., of a catheter). The first tube is inserted into the pulmonary artery, and the expandable stent frame is deployed from the first tube and is expanded at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame does not extend into a right ventricular outflow tract of the pulmonary artery.

[0206] According to another exemplary aspect of the present disclosure, an expandable stent frame, for example, for a prosthetic valve retaining docking station, may be provided with a convex proximal sealing portion having a minimum radius of curvature that is large enough to reduce concentrated flexing of the proximal end of the stent frame when the proximal end of the stent frame extends into the right ventricular outflow tract (RVOT), providing increased resistance to fatigue stresses from contractile forces in the RVOT.

[0207] In some examples, as shown in FIGS. 17, 21, and 29, both the proximal and distal convex sealing portions 410b, 410d may have a greater minimum radius of curvature rl, r2 (e.g., at least 10 mm, or between about 10 mm and about 12 mm, or about 11.5 mm, or between about 10 mm and about 20 mm, or about 15 mm), for example, to provide contractile bending forces (e.g., from the RVOT) over an extended curved surface. By comparison, a convex sealing portion having a smaller minimum radius of curvature rl, r2 (e.g., less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm), defining a shoulder portion selectedto provide an increased retention force between the stent frame and the implant site, may be subjected to more concentrated hinged flexure of the stent frame about the reduced radius contour.

[0208] In some examples, as shown in FIG. 25, the proximal convex sealing portion 410c-2, implanted near or at the RVOT, may have a greater minimum radius of curvature r2 (e.g., at least 10 mm, or between about 10 mm and about 12 mm, or about 11.5 mm) for contractile force distribution, and the distal convex sealing portion 410c-l, implanted more remote from the RVOT, may have a smaller minimum radius of curvature rl (e.g., less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm) to provide an increased retention force between the stent frame and the implant site on the downstream end of the stent frame 1500c.

[0209] In some examples, an expandable stent frame is provided in a compressed condition within a first tube (e.g., of a catheter). The first tube is inserted into the pulmonary artery, and the expandable stent frame is deployed from the first tube and is expanded at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery. The proximal end of the expandable stent frame has a convex sealing portion having a minimum radius of curvature of at least 10 mm.

[0210] In some examples, as shown in FIG. 29, at least the proximal convex retaining portion 414d may extend substantially continuously from the corresponding convex sealing portion 410d, without an outwardly flared inflection radius between the sealing portion and the retaining portion, as discussed above. When expanded into retaining engagement with the pulmonary artery PA and / or RVOT, the apices 1510d of the proximal retaining portion 414d may tend to bend inward, such that the apices do not engage, or only incidentally engage, the RVOT, thereby eliminating concentrated hinged flexure at the apices (e.g., at an inflection radius between the convex sealing portion and the apices).

[0211] In some examples, an expandable stent frame is provided in a compressed condition within a first tube (e.g., of a catheter). The first tube is inserted into the pulmonary artery, and the expandable stent frame is deployed from the first tube and is expanded at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery. The proximal end of the expandable stent frame is compressed radially inward by the right ventricularoutflow tract, such that proximal apices at the proximal end of the expandable stent frame do not engage the right ventricular outflow tract.

[0212] Methods of treating a patient (e.g., methods of treating heart valve dysfunction, regurgitation, etc.) may include a variety of steps, including steps associated with introducing and deploying a docking station in a desired location / treatment area and introducing and deploying a valve in the docking station. For example, FIG. 32A illustrates a docking station (e.g., the docking station lO of FIG. 10) being deployed by a catheter 3600. The docking station 10 can be positioned and deployed in a wide variety of different ways. Access can be gained through the femoral vein or access can be percutaneous. Generally, any vascular path that leads to the pulmonary artery may be used. In some examples, a guidewire followed by a catheter 3600 is advanced to the pulmonary artery PA by way of the femoral vein, inferior vena cava, tricuspid valve and right ventricle RV. The docking station 10 can be placed in the right ventricular outflow tract / pulmonary artery PA to create an artificial conduit and landing zone for a valve (e.g., a transcatheter heart valve) 29.

[0213] Referring to FIG. 32B, the docking station illustrated by FIG. 10 is deployed in the pulmonary artery PA of a heart H. FIG. 32C illustrates a generically illustrated valve 29 deployed in the docking station 10. In FIGS. 32A-32C, the heart is in the systolic phase.

[0214] The valve 29 used with the docking station 10 can take a wide variety of different forms. In some examples, the valve 29 is configured to be implanted via a catheter in the heart H. For example, the valve 29 may be expandable and collapsible to facilitate transcatheter application in a heart. However, in some examples, the valve 29 may be configured for surgical application. Similarly, the docking stations described herein may be placed using transcatheter application / placement or surgical application / placement.

[0215] FIGS. 33-37C illustrate a few examples of the many valves or valve configurations that can be used. Any valve type may be used and some valves that are traditionally applied surgically may be modified for transcatheter implantation. FIG. 33 illustrates an expandable valve 29 for transcatheter implantation that is shown and described in U.S. Pat. No. 8,002,825, which is incorporated herein by reference in its entirety. An example of a tri-leaflet valve is shown and described in Published Patent Cooperation Treaty Application No. WO 2000 / 42950, which is incorporated herein by reference in its entirety. Another example of a tri-leaflet valve is shown and described in U.S. Pat. No. 5,928,281, which is incorporated herein by reference in its entirety. Another example of a tri-leaflet valve is shown and described in U.S. Pat. No. 6,558,418, which is incorporated herein by reference in its entirety. FIGS. 34-36 illustrate an example of an expandable tri-leaflet valve 29, such as the Edwards SAPIEN 3Transcatheter Heart Valve. Referring to FIG. 34, in some examples, the valve 29 comprises a frame 712 that contains a tri-leaflet valve 4500 (see FIG. 19) compressed inside the frame 712. FIG. 35 illustrates the frame 712 expanded and the valve 29 in an open condition. FIG. 36 illustrates the frame 712 expanded and the valve 29 in a closed condition. FIGS. 37A, 37B, and 37C illustrate an example of an expandable valve 29 that is shown and described in U.S. Pat. No. 6,540,782, which is incorporated herein by reference in its entirety. An example of a valve is shown and described in U.S. Pat. No. 3,365,728, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 3,824,629, which is incorporated herein by reference in its entirety. Another example of a valve is shown and described in U.S. Pat. No. 5,814,099, which is incorporated herein by reference in its entirety. Any of these or other valves may be used as valve 29 in the various examples disclosed herein.

[0216] The foregoing primarily describes examples of docking stations that are self-expanding. But the docking stations and / or delivery devices shown and described herein can be modified for delivery of balloon-expandable and / or mechanically-expandable docking devices, within the scope of the present disclosure. That is to say, delivering balloon-expandable and / or mechanically-expandable docking stations to an implantation location can be performed percutaneously using modified versions of the delivery devices of the present disclosure. In general terms, this includes providing a transcatheter assembly that can include a delivery sheath and / or additional sheaths as described above. In the case of balloon-expandable docking stations, the devices generally further include a delivery catheter, a balloon catheter, and / or a guide wire. A delivery catheter used in a balloon-expandable type of delivery device can define a lumen within which the balloon catheter is received. The balloon catheter, in turn, defines a lumen within which the guide wire is slideably disposed. Further, the balloon catheter includes a balloon that is fluidly connected to an inflation source. With the docking station mounted on the balloon, the transcatheter assembly is delivered through a percutaneous opening in the patient via the delivery device. Once the docking station is properly positioned, the balloon catheter is operated to inflate the balloon, thus transitioning the docking station to an expanded arrangement.

[0217] While various inventive aspects, concepts and features of the inventions may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within thescope of the present inventions. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions-such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on— may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present inventions even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Parameters identified as “approximate” or “about” a specified value are intended to include both the specified value and values within 10% of the specified value, unless expressly stated otherwise. Further, it is to be understood that the drawings accompanying the present disclosure may, but need not, be to scale, and therefore may be understood as teaching various ratios and proportions evident in the drawings. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention, the inventions instead being set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated.EXAMPLES

[0218] In view of the above described implementations of the disclosed subject matter, this disclosure provides additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0219] Example 1. An expandable stent frame comprising: a plurality of struts defining a plurality of cells, the expandable stent frame having an hourglass shaped profile when in anunrestricted expanded condition, with a central waist portion, convex first and second sealing portions, and a first end retaining portion and a second end retaining portions extending from the convex first and second sealing portions and defining a first end outer diameter and a second end outer diameter and a height of the expandable stent frame; and wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height.

[0220] Example 2. The expandable stent frame of Example 1, wherein the at least one of the first end outer diameter and the second end outer diameter is between 100% and 117.5% of the height.

[0221] Example 3. The expandable stent frame of any of Examples 1-2, wherein the at least one of the first and second end outer diameters is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0222] Example 4. The expandable stent frame of any of Examples 1-3, wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm, or about 45 mm.

[0223] Example 5. The expandable stent frame of any of Examples 1-4, wherein the plurality of cells comprises at least a first row of cells and a second row of cells, the first row of cells defining the first end retaining portion and the convex first sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0224] Example 6. The expandable stent frame of Example 5, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0225] Example 7. The expandable stent frame of Example 6, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0226] Example 8. The expandable stent frame of any of Examples 1-7, wherein the first end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0227] Example 9. The expandable stent frame of any of Examples 1-7, wherein the second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0228] Example 10. The expandable stent frame of any of Examples 1-9, wherein the first end retaining portion comprises a flared first end retaining portion extending to a first set of apices terminating at the first end outer diameter.

[0229] Example 11. The expandable stent frame of Example 10, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0230] Example 12. The expandable stent frame of any of Examples 10-11, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0231] Example 13. The expandable stent frame of any of Examples 10-12, wherein the convex first sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0232] Example 14. The expandable stent frame of Example 13, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0233] Example 15. The expandable stent frame of any of Examples 1-14, wherein the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at the second end outer diameter.|00234| Example 16. The expandable stent frame of Example 15, wherein each apex of the second set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0235] Example 17. The expandable stent frame of any of Examples 15-16, wherein each apex of the second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0236] Example 18. The expandable stent frame of any of Examples 15-17, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0237] Example 19. The expandable stent frame of Example 18, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0238] Example 20. The expandable stent frame of any of Examples 1-19, wherein at least one of the convex first and second sealing portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the convex first end sealing portion.

[0239] Example 21. The expandable stent frame of any of Examples 1-20 wherein at least one of the convex first and second sealing portions has a minimum radius of curvature of lessthan 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the at least one of the convex first and second sealing portions.

[0240] Example 22. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion, and a convex first end sealing portion joined with the flared first end retaining portion by a first outwardly contoured inflection radius; and wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1 .5 mm and about 2.75 mm.

[0241] Example 23. The expandable stent frame of Example 22, wherein the radial distance from the first outwardly contoured inflection radius to the first end outer diameter is about 2 mm.

[0242] Example 24. The expandable stent frame of any of Examples 22-23, wherein the flared first end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.1002431 Example 25. The expandable stent frame of any of Examples 22-24, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0244] Example 26. The expandable stent frame of any of Examples 22-25, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0245] Example 27. The expandable stent frame of any of Examples 22-26, wherein the plurality of struts further defines a second end retaining portion extending to a second end outer diameter and a convex second end sealing portion.

[0246] Example 28. The expandable stent frame of Example 27, wherein the second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0247] Example 29. The expandable stent frame of any of Examples 27-28, wherein the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at the second end outer diameter of the flared second end retaining portion.

[0248] Example 30. The expandable stent frame of Example 29, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0249] Example 31. The expandable stent frame of Example 30, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0250] Example 32. The expandable stent frame of any of Examples 29-31, wherein each apex of the second set of apices has a maximum width between about 1 mm and about 1 .5 mm, or about 1.4 mm.

[0251] Example 33. The expandable stent frame of any of Examples 29-32, wherein each apex of the second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0252] Example 34. The expandable stent frame of any of Examples 27-33, wherein the first and second end retaining portions define a height of the expandable stent frame when in the unrestricted expanded condition, wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height, or between 100% and 117.5% of the height.

[0253] Example 35. The expandable stent frame of any of Examples 27-34, wherein the first and second end retaining portions define a height of the expandable stent frame wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm.

[0254] Example 36. The expandable stent frame of any of Examples 27-35, wherein at least one of the first end outer diameter and the second end outer diameter is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0255] Example 37. The expandable stent frame of any of Examples 27-36, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0256] Example 38. The expandable stent frame of Example 37, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0257] Example 39. The expandable stent frame of Example 38, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0258] Example 40. The expandable stent frame of any of Examples 27-39, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the convex first end sealing portion.

[0259] Example 41. The expandable stent frame of any of Examples 27-40 wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature of less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0260] Example 42. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion, and a convex first end sealing portion joined with the flared first end retaining portion; and wherein the flared first end retaining portion extends at an angle of about 30° to about 40°, or about 30°, with respect to a central longitudinal axis of the expandable stent frame.

[0261] Example 43. The expandable stent frame of Example 42, wherein the convex first end sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0262] Example 44. The expandable stent frame of Example 43, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0263] Example 45. The expandable stent frame of any of Examples 42-44, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0264] Example 46. The expandable stent frame of any of Examples 42-45, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0265] Example 47. The expandable stent frame of any of Examples 42-46, wherein the plurality of struts further defines a second end retaining portion extending to a second end outer diameter and a convex second end sealing portion.

[0266] Example 48. The expandable stent frame of Example 47, wherein the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at the second end outer diameter of the flared second end retaining portion.

[0267] Example 49. The expandable stent frame of Example 48, wherein the flared second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0268] Example 50. The expandable stent frame of any of Examples 48-49, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0269] Example 51. The expandable stent frame of Example 50, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0270] Example 52. The expandable stent frame of any of Examples 48-51, wherein each apex of the second set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0271] Example 53. The expandable stent frame of any of Examples 48-52, wherein each apex of the second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0272] Example 54. The expandable stent frame of any of Examples 47-53, wherein the first and second end retaining portions define a height of the expandable stent frame when in the unrestricted expanded condition, wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height, or between 100% and 117.5% of the height.

[0273] Example 55. The expandable stent frame of any of Examples 47-54, wherein the first and second end retaining portions define a height of the expandable stent frame wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm.

[0274] Example 56. The expandable stent frame of any of Examples 47-55, wherein at least one of the first end outer diameter and the second end outer diameter is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0275] Example 57. The expandable stent frame of any of Examples 47-56, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0276] Example 58. The expandable stent frame of Example 57, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0277] Example 59. The expandable stent frame of Example 58, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0278] Example 60. The expandable stent frame of any of Examples 47-59, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the convex first end sealing portion.

[0279] Example 61. The expandable stent frame of any of Examples 47-60, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature of less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0280] Example 62. An expandable stent frame comprising: a plurality of struts defining a first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the first end retaining portion, and a second end retaining portion extending to a second set of apices terminating at a second end outer diameter of the second end retaining portion; and wherein each apex of the first and second sets of apices has a maximum width between about 1 mm and about 1.5 mm.

[0281] Example 63. The expandable stent frame of Example 62, wherein each apex of at least one of the first and second sets of apices has a maximum width of about 1.4 mm.

[0282] Example 64. The expandable stent frame of any of Examples 62-63, wherein each apex of at least one of the first and second sets of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0283] Example 65. The expandable stent frame of any of Examples 62-64, wherein the first end retaining portion comprises a flared first end retaining portion.

[0284] Example 66. The expandable stent frame of Example 65, wherein the flared first end retaining portion extends at an angle of about 30° to about 40°, or about 30°, with respect to a central longitudinal axis of the expandable stent frame.

[0285] Example 67. The expandable stent frame of any of Examples 65-66, wherein the convex first end sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0286] Example 68. The expandable stent frame of Example 67, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0287] Example 69. The expandable stent frame of any of Examples 62-68, wherein the second end retaining portion comprises a flared second end retaining portion.

[0288] Example 70. The expandable stent frame of Example 69, wherein the flared second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0289] Example 71. The expandable stent frame of any of Examples 69-70, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0290] Example 72. The expandable stent frame of Example 71, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.1002911 Example 73. The expandable stent frame of any of Examples 62-72, wherein the first and second end retaining portions define a height of the expandable stent frame when in the unrestricted expanded condition, wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height, or between 100% and 117.5% of the height.

[0292] Example 74. The expandable stent frame of any of Examples 62-73, wherein the first and second end retaining portions define a height of the expandable stent frame wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm.

[0293] Example 75. The expandable stent frame of any of Examples 62-74, wherein at least one of the first end outer diameter and the second end outer diameter is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0294] Example 76. The expandable stent frame of any of Examples 62-75, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0295] Example 77. The expandable stent frame of Example 76, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0296] Example 78. The expandable stent frame of Example 77, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0297] Example 79. The expandable stent frame of any of Examples 62-78, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the convex first end sealing portion.

[0298] Example 80. The expandable stent frame of any of Examples 62-79, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature of less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the at least one of the convex first and second end sealings portions.

[0299] Example 81. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion; and wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.|00300| Example 82. The expandable stent frame of Example 81, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0301] Example 83. The expandable stent frame of any of Examples 81-82, wherein the flared first end retaining portion extends at an angle of about 30° to about 40°, or about 30°, with respect to a central longitudinal axis of the expandable stent frame.

[0302] Example 84. The expandable stent frame of any of Examples 81-83, wherein the plurality of struts further defines a convex first end sealing portion joined with the flared first end retaining portion.

[0303] Example 85. The expandable stent frame of Example 84, wherein the convex first end sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0304] Example 86. The expandable stent frame of Example 85, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0305] Example 87. The expandable stent frame of any of Examples 81-86, wherein the plurality of struts further defines a flared second end retaining portion extending to a second set of apices terminating at a second end outer diameter of the flared second end retaining portion.

[0306] Example 88. The expandable stent frame of Example 87, wherein the flared second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0307] Example 89. The expandable stent frame of any of Examples 87-88, wherein the plurality of struts further defines a convex second end sealing portion joined with the flared second end retaining portion.

[0308] Example 90. The expandable stent frame of Example 89, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0309] Example 91. The expandable stent frame of Example 90, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0310] Example 92. The expandable stent frame of any of Examples 87-91, wherein the first and second end retaining portions define a height of the expandable stent frame when in the unrestricted expanded condition, wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height, or between 100% and 117.5% of the height.

[0311] Example 93. The expandable stent frame of any of Examples 87-92, wherein the first and second end retaining portions define a height of the expandable stent frame wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm.

[0312] Example 94. The expandable stent frame of any of Examples 87-93, wherein at least one of the first end outer diameter and the second end outer diameter is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0313] Example 95. The expandable stent frame of any of Examples 87-94, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and a convex first end sealing portion, and the second row of cells defining the second end retaining portion and a convex second end sealing portion.

[0314] Example 97. The expandable stent frame of Example 96, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0315] Example 98. The expandable stent frame of Example 97, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0316] Example 99. The expandable stent frame of any of Examples 88-98, wherein the plurality of struts further defines a convex first end sealing portion joined with the flared first end retaining portion and a convex second end sealing portion joined with the flared second end retaining portion.

[0317] Example 100. The expandable stent frame of Example 99, wherein at least one of the convex first and second end sealings portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the convex first end sealing portion.

[0318] Example 101. The expandable stent frame of any of Examples 87-100, wherein each apex of the second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0319] Example 102. An expandable stent frame comprising: a plurality of struts defining a plurality of cells, the expandable frame having an hourglass shaped profile when in an unrestricted expanded condition, with a central waist portion, convex first and second sealing portions, and first and second end retaining portions extending from the convex first and second sealing portions and defining first and second end outer diameters and a height of the expandable stent frame; and wherein the convex first end sealing portion has a minimum radius of curvature between about 10 mm and about 12 mm along an entire length of the convex first end sealing portion, and the convex second end sealing portion has a minimum radius of curvature of between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the convex second end sealing portion.

[0320] Example 103. The expandable stent of Example 101, wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height, or between 100% and 117.5% of the height.

[0321] Example 104. The expandable stent frame of any of Examples 102-103, wherein at least one of the first end outer diameter and the second end outer diameter is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

[0322] Example 105. The expandable stent frame of any of Examples 102-104, wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm.

[0323] Example 106. The expandable stent frame of any of Examples 102-105, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and thesecond row of cells defining the second end retaining portion and the convex second end sealing portion.

[0324] Example 107. The expandable stent frame of Example 106, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

[0325] Example 108. The expandable stent frame of Example 107, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

[0326] Example 109. The expandable stent frame of any of Examples 102-108, wherein the first end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0327] Example 110. The expandable stent frame of any of Examples 102- 109, wherein the second end retaining portion extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

[0328] Example 111. The expandable stent frame of any of Examples 102- 110, wherein the first end retaining portion comprises a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion.

[0329] Example 112. The expandable stent frame of Example 111, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0330] Example 113. The expandable stent frame of any of Examples 111-112, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0331] Example l l4. The expandable stent frame of any of Examples 111-113, wherein the convex first end sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

[0332] Example 115. The expandable stent frame of Example 114, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0333] Example 116. The expandable stent frame of any of Examples 102-115, wherein the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at a second end outer diameter of the flared second end retaining portion.

[0334] Example 117. The expandable stent frame of Example 116, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0335] Example l l8. The expandable stent frame of any of Examples 116-117, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0336] Example 119. The expandable stent frame of any of Examples 116-118, wherein the convex second end sealing portion is joined with the flared second end retaining portion by a second outwardly contoured inflection radius.

[0337] Example 120. The expandable stent frame of Example 119, wherein a radial distance from the second outwardly contoured inflection radius to the second end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

[0338] Example 121. An expandable stent frame comprising a plurality of struts defining a first end convex portion extending continuously radially outward from a central waist portion to a first set of apices terminating at a first end outer diameter to define a first end retaining portion.

[0339] Example 122. The expandable stent frame of Example 121, wherein the first end convex portion has a substantially continuous radius of curvature of between about 10 mm and about 20 mm, or about 15 mm.

[0340] Example 123. The expandable stent frame of any of Examples 121-122, wherein the first end outer diameter is between about 44 mm and about 52 mm, or about 48 mm.

[0341] Example 124. The expandable stent frame of any of Examples 121-123, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0342] Example 125. The expandable stent frame of any of Examples 121-124, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0343] Example 126. The expandable stent frame of any of Examples 121-125, wherein the plurality of struts further defines a second end convex portion extending continuously radially outward from the central waist portion to a second set of apices terminating at a second end outer diameter to define a second end retaining portion.

[0344] Example 127. The expandable stent frame of Example 126, wherein the second end convex portion has a substantially continuous radius of curvature of between about 10 mm and about 20 mm, or about 15 mm.

[0345] Example 128. The expandable stent frame of any of Examples 126-127, wherein the second end outer diameter is between about 44 mm and about 52 mm, or about 48 mm.

[0346] Example 129. The expandable stent frame of any of Examples 126-128, wherein each apex of the second set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

[0347] Example 130. The expandable stent frame of any of Examples 126-129, wherein each apex of the second set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

[0348] Example 131. The expandable stent frame of any of Examples 126-130, wherein the first and second sets of apices define a height of the expandable stent frame, wherein the height is between about 35 mm and about 46 mm, or about 38 mm.

[0349] Example 132. The expandable stent frame of any of Examples 126-131, wherein the first and second sets of apices define a height of the expandable stent frame, wherein at least one of the first end outer diameter and the second end outer diameter is at least 115% of the height, or between 115% and 150% of the height, or between about 120% and about 130% of the height.

[0350] Example 133. The expandable stent frame of any of Examples 126-132, wherein the plurality of cells comprises at least first and second rows of cells, the first row of cells defining the first end retaining portion and the convex first end sealing portion, and the second row of cells defining the second end retaining portion and the convex second end sealing portion.

[0351] Example 134. The expandable stent frame of Example 133, wherein the first row of cells is joined directly with the second row of cells.

[0352] Example 135. The expandable stent frame of any of Examples 133-134, wherein axially inner portions of the first and second rows of cells define at least a portion of the central waist portion.

[0353] Example 136. An expandable stent comprising: the expandable stent of any of Examples 1-135, wherein the plurality of struts defines a flared retaining portion extending to a plurality of apices; and a plurality of cover elements each covering at least a portion of a corresponding one of the plurality of apices to provide softened atraumatic engagement of the plurality of apices with tissue at a deployment site when the stent is deployed at the deployment site.

[0354] Example 137. The expandable stent of Example 136, wherein each of the plurality of cover elements comprises at least one of a plastic material, an organic material, an elastomeric material, and a foam material.

[0355] Example 138. The expandable stent of any of Examples 136-137, wherein each of the plurality of cover elements comprises at least one of a coating, a molding, a wrap, a sleeve, and a sock.

[0356] Example 139. The expandable stent of any of Examples 136-138, wherein each of the plurality of cover elements comprises a sock of braided polyethylene terephthalate (PET) fabric material.

[0357] Example 140. The expandable stent of any of Examples 136-139, wherein each of the plurality of cover elements extends over a rounded head portion of a corresponding one of the plurality of apices.

[0358] Example 141. The expandable stent of any of Examples 136-140, wherein each of the plurality of cover elements is secured to a corresponding one of the plurality of apices by a stitch or suture extending through an aperture in the corresponding one of the plurality of apices.

[0359] Example 142. An expandable stent comprising: a plurality of struts defining a flared retaining portion extending to a plurality of apices terminating at an outer diameter of the flared retaining portion; and a plurality of cover elements each covering at least a portion of a corresponding one of the plurality of apices to provide softened atraumatic engagement of the plurality of apices with tissue at a deployment site when the stent is deployed at the deployment site.

[0360] Example 143. The expandable stent of Example 142, wherein each of the plurality of cover elements comprises at least one of a plastic material, an organic material, an elastomeric material, and a foam material.

[0361] Example 144. The expandable stent of any of Examples 142-143, wherein each of the plurality of cover elements comprises at least one of a coating, a molding, a wrap, a sleeve, and a sock.

[0362] Example 145. The expandable stent of any of Examples 142-144, wherein each of the plurality of cover elements comprises a sock of braided polyethylene terephthalate (PET) fabric material.

[0363] Example 146. The expandable stent of any of Examples 142-145, wherein each of the plurality of cover elements extends over a rounded head portion of a corresponding one of the plurality of apices.

[0364] Example 147. The expandable stent of any of Examples 142-146, wherein each of the plurality of cover elements is secured to a corresponding one of the plurality of apices by a stitch or suture extending through an aperture in the corresponding one of the plurality of apices.

[0365] Example 148. The expandable stent of any of Examples 142-147, further comprising a cover material attached to at least a portion of the expandable stent frame, the cover material defining a sealing surface for sealing engagement with an implant site.

[0366] Example 149. The expandable stent of Example 148, wherein the cover material is attached to an exterior surface of the expandable stent frame.

[0367] Example 150. The expandable stent of any of Examples 148-149, wherein the cover material is attached to an interior surface of the expandable stent frame.

[0368] Example 151. The expandable stent of any of Examples 148-150, wherein the expandable stent is a docking station, and wherein an interior surface of the expandable stent defines a valve seat configured to retain an expandable prosthetic valve.

[0369] Example 152. The expandable stent of Example 151, further comprising at least one radiopaque marker secured to the expandable stent frame and aligned with the valve seat.

[0370] Example 153. The expandable stent of any of Examples 148-152, further comprising at least one radiopaque marker secured to the first end retaining portion.

[0371] Example 154. The expandable stent of any of Examples 148-153, wherein the plurality of struts defines a distal row of cells extending to the plurality of apices, wherein the distal row of cells is not covered by the cover material.

[0372] Example 155. An expandable stent comprising: the expandable stent frame of any of Examples 1-135; and a cover material attached to at least a portion of the expandable stent frame, the cover material defining a sealing surface for sealing engagement with an implant site.

[0373] Example 156. The expandable stent of Example 155, wherein the cover material is attached to an exterior surface of the expandable stent frame.

[0374] Example 157. The expandable stent of any of Examples 155-156, wherein the cover material is attached to an interior surface of the expandable stent frame.

[0375] Example 158. The expandable stent of any of Examples 155-157, wherein the expandable stent is a docking station, and wherein an interior surface of the expandable stent defines a valve seat configured to retain an expandable prosthetic valve.

[0376] Example 159. The expandable stent of Example 158, further comprising at least one radiopaque marker secured to the expandable stent frame and aligned with the valve seat.

[0377] Example 160. The expandable stent of any of Examples 155-159, further comprising at least one radiopaque marker secured to the first end retaining portion.

[0378] Example 161. A prosthetic valve assembly comprising: the expandable stent of any of Examples 136-160; and a prosthetic valve secured to a valve seat of the expandable stent.

[0379] Example 162. The prosthetic valve assembly of Example 161, wherein the prosthetic valve comprises an expandable frame.

[0380] Example 163. A system comprising: a catheter including a sleeve; and the expandable stent of any of Examples 136- 160, wherein the expandable stent is disposed in the sleeve in an unexpanded condition.

[0381] Example 164. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube; inserting the first tube into the pulmonary artery; and deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame does not extend into a right ventricular outflow tract of the pulmonary artery.

[0382] Example 165. The method of Example 164, wherein the expandable stent comprises the expandable stent of any of Examples 136-160.

[0383] Example 166. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube;_inserting the first tube into the pulmonary artery ;_deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery; and_wherein the proximal end of the expandable stent frame has a convex sealing portion having a minimum radius of curvature of at least 10 mm.

[0384] Example 167. The method of Example 166, wherein the expandable stent comprises the expandable stent of any of Examples 136-160.

[0385] Example 168. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube;_inserting the first tube into the pulmonary artery ;_deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location withinthe pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery; and wherein the proximal end of the expandable stent frame is compressed radially inward by the right ventricular outflow tract, such that proximal apices at the proximal end of the expandable stent frame do not engage the right ventricular outflow tract.

[0386] Example 169. The method of Example 168, wherein the expandable stent frame comprises the expandable stent frame of any of Examples 121-135.

[0387] In view of the many possible examples to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated examples should not be taken as limiting the scope of the invention. All combinations or sub-combinations of features of the foregoing examples are contemplated by this disclosure. The scope of the invention is defined by the following claims and the above examples. We therefore claim as our invention all that comes within the scope and spirit of these claims and examples.

Claims

We claim:

1. An expandable stent frame comprising: a plurality of struts defining a plurality of cells, the expandable stent frame having an hourglass shaped profile when in an unrestricted expanded condition, with a central waist portion, convex first and second sealing portions, and a first end retaining portion and a second end retaining portion extending from the convex first and second sealing portions and defining a first end outer diameter and a second end outer diameter and a height of the expandable stent frame; and wherein at least one of the first end outer diameter and the second end outer diameter is at least 98% of the height.

2. The expandable stent frame of claim 1 , wherein the at least one of the first end outer diameter and the second end outer diameter is between 100% and 117.5% of the height.

3. The expandable stent frame of any of claims 1-2, wherein the at least one of the first and second end outer diameters is between about 44 mm and about 49 mm, or between about 44 mm and about 46 mm.

4. The expandable stent frame of any of claims 1-3, wherein the height is between about 40 mm and about 47 mm, or between about 44 mm and about 46 mm, or about 45 mm.

5. The expandable stent frame of any of claims 1-4, wherein the plurality of cells comprises at least a first row of cells and a second row of cells, the first row of cells defining the first end retaining portion and the convex first sealing portion, and the second row of cells defining the second end retaining portion and the convex second sealing portion.

6. The expandable stent frame of claim 5, wherein the plurality of cells comprises a third row of cells disposed between the first and second rows of cells.

7. The expandable stent frame of claim 6, wherein the third row of cells defines a substantially cylindrical central waist portion of the expandable stent frame.

8. The expandable stent frame of any of claims 1-7, wherein at least one of the first and second end retaining portions extends at an angle of about 30° to about 50°, or about 30°, or about 40° to about 50°, or about 45°, with respect to a central longitudinal axis of the expandable stent frame.

9. The expandable stent frame of any of claims 1-8, wherein the first end retaining portion comprises a flared first end retaining portion extending to a first set of apices terminating at the first end outer diameter.

10. The expandable stent frame of claim 9, wherein each apex of the first set of apices has a maximum width between about 1 mm and about 1.5 mm, or about 1.4 mm.

11. The expandable stent frame of any of claims 9-10, wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

12. The expandable stent frame of any of claims 9-11, wherein the convex first sealing portion is joined with the flared first end retaining portion by a first outwardly contoured inflection radius.

13. The expandable stent frame of claim 12, wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm, or about 2 mm.

14. The expandable stent frame of any of claims 1-13, wherein the second end retaining portion comprises a flared second end retaining portion extending to a second set of apices terminating at the second end outer diameter.

15. The expandable stent frame of any of claims 1-14, wherein at least one of the convex first and second sealing portions has a minimum radius of curvature between about 10 mm and about 12 mm, or about 11.5 mm, along an entire length of the at least one of the convex first and second sealing portions.

16. The expandable stent frame of any of claims 1-14 wherein at least one of the convex first and second sealing portions has a minimum radius of curvature of less than 10 mm, or between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the at least one of the convex first and second sealing portions.

17. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion, and a convex first end sealing portion joined with the flared first end retaining portion by a first outwardly contoured inflection radius; and wherein a radial distance from the first outwardly contoured inflection radius to the first end outer diameter is between about 1.5 mm and about 2.75 mm.

18. The expandable stent frame of claim 17, wherein the radial distance from the first outwardly contoured inflection radius to the first end outer diameter is about 2 mm.

19. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion, and a convex first end sealing portion joined with the flared first end retaining portion; and wherein the flared first end retaining portion extends at an angle of about 30° to about 40°, or about 30°, with respect to a central longitudinal axis of the expandable stent frame.

20. An expandable stent frame comprising: a plurality of struts defining a first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the first end retaining portion, and a second end retaining portion extending to a second set of apices terminating at a second end outer diameter of the second end retaining portion; and wherein each apex of the first and second sets of apices has a maximum width between about 1 mm and about 1.5 mm.

21. The expandable stent frame of claim 20, wherein the maximum width of each apex of at least one of the first and second sets of apices is about 1.4 mm.

22. An expandable stent frame comprising: a plurality of struts defining a flared first end retaining portion extending to a first set of apices terminating at a first end outer diameter of the flared first end retaining portion; and wherein each apex of the first set of apices includes a neck portion and an enlarged head portion having a width at least about 20% greater than a width of the corresponding neck portion.

23. An expandable stent frame comprising: a plurality of struts defining a plurality of cells, the expandable frame having an hourglass shaped profile when in an unrestricted expanded condition, with a central waist portion, convex first and second sealing portions, and first and second end retaining portions extending from the convex first and second sealing portions and defining first and second end outer diameters and a height of the expandable stent frame; and wherein the convex first sealing portion has a minimum radius of curvature between about 10 mm and about 12 mm along an entire length of the convex first sealing portion, and the convex second sealing portion has a minimum radius of curvature of between about 4 mm and about 7 mm, or about 5.6 mm, defining a shoulder portion of the convex second sealing portion.

24. An expandable stent frame comprising a plurality of struts defining a first end convex portion extending continuously radially outward from a central waist portion to a first set of apices terminating at a first end outer diameter to define a first end retaining portion.

25. The expandable stent frame of claim 24, wherein the first end convex portion has a substantially continuous radius of curvature of between about 10 mm and about 20 mm, or about 15 mm.

26. The expandable stent frame of any of claims 24-25, wherein the first end outer diameter is between about 44 mm and about 52 mm, or about 48 mm.

27. The expandable stent frame of any of claims 24-26, wherein the plurality of struts further defines a second end convex portion extending continuously radially outward from the central waist portion to a second set of apices terminating at a second end outer diameter to define a second end retaining portion.

28. The expandable stent frame of claim 27, wherein the first and second sets of apices define a height of the expandable stent frame, wherein the height is between about 35 mm and about 46 mm, or about 38 mm.

29. The expandable stent frame of claim 27, wherein the first and second sets of apices define a height of the expandable stent frame, wherein at least one of the first end outer diameter and the second end outer diameter is at least 1 15% of the height, or between 1 15% and 150% of the height, or between about 120% and about 130% of the height.

30. The expandable stent frame of any of claims 27-29, wherein the plurality of struts define a plurality of cells that comprise at least first and second rows of cells, the first row of cells defining the first end retaining portion and the first end convex portion, and the second row of cells defining the second end retaining portion and the second end convex portion.

31. The expandable stent frame of claim 30, wherein the first row of cells is joined directly with the second row of cells.

32. The expandable stent frame of any of claims 30-31, wherein axially inner portions of the first and second rows of cells define at least a portion of the central waist portion.

33. An expandable stent comprising: the expandable stent frame of any of claims 1-32, wherein the plurality of struts defines a flared retaining portion extending to a plurality of apices; and a plurality of cover elements each covering at least a portion of a corresponding one of the plurality of apices to provide softened atraumatic engagement of the plurality of apices with tissue at a deployment site when the stent is deployed at the deployment site.

34. An expandable stent comprising: a plurality of struts defining a flared retaining portion extending to a plurality of apices terminating at an outer diameter of the flared retaining portion; and a plurality of cover elements each covering at least a portion of a corresponding one of the plurality of apices to provide softened atraumatic engagement of the plurality of apices with tissue at a deployment site when the stent is deployed at the deployment site.

35. The expandable stent of claim 34, wherein each of the plurality of cover elements comprises at least one of a plastic material, an organic material, an elastomeric material, and a foam material.

36. The expandable stent of any of claims 34-35, wherein each of the plurality of cover elements comprises at least one of a coating, a molding, a wrap, a sleeve, and a sock.

37. The expandable stent of any of claims 34-36, wherein each of the plurality of cover elements comprises a sock of braided polyethylene terephthalate (PET) fabric material.

38. The expandable stent of any of claims 34-37, wherein each of the plurality of cover elements extends over a rounded head portion of a corresponding one of the plurality of apices.

39. The expandable stent of any of claims 34-38, wherein each of the plurality of cover elements is secured to a corresponding one of the plurality of apices by a stitch or suture extending through an aperture in the corresponding one of the plurality of apices.

40. An expandable stent comprising: the expandable stent frame of any of claims 1-32; and a cover material attached to at least a portion of the expandable stent frame, the cover material defining a sealing surface for sealing engagement with an implant site.

41. The expandable stent of claim 40, wherein the expandable stent is a docking station, and wherein an interior surface of the expandable stent defines a valve seat configured to retain an expandable prosthetic valve, wherein the expandable stent further comprises at least one radiopaque marker secured to the expandable stent frame and aligned with the valve seat.

42. The expandable stent of any of claims 40-41, further comprising at least one radiopaque marker secured to the first end retaining portion.

43. A prosthetic valve assembly comprising: the expandable stent of any of claims 33-42; anda prosthetic valve secured to a valve seat of the expandable stent.

44. A system comprising: a catheter including a sleeve; and the expandable stent of any of claims 33-42, wherein the expandable stent is disposed in the sleeve in an unexpanded condition.

45. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube; inserting the first tube into the pulmonary artery; and deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame does not extend into a right ventricular outflow tract of the pulmonary artery.

46. The method of claim 45, wherein the expandable stent comprises the expandable stent of any of claims 33-42.

47. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube; inserting the first tube into the pulmonary artery; deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery; and wherein the proximal end of the expandable stent frame has a convex sealing portion having a minimum radius of curvature of at least 10 mm.

48. The method of claim 47, wherein the expandable stent comprises the expandable stent of any of claims 33-42.

49. A method of installing an expandable stent in a pulmonary artery, the method comprising: providing an expandable stent frame in a compressed condition within a first tube; inserting the first tube into the pulmonary artery; deploying the expandable stent frame from the first tube and expanding the expandable stent frame at a target location within the pulmonary artery, such that a distal end of the expandable stent frame is positioned below a pulmonary bifurcation of the pulmonary artery, and a proximal end of the expandable stent frame aligns with a right ventricular outflow tract of the pulmonary artery; and wherein the proximal end of the expandable stent frame is compressed radially inward by the right ventricular outflow tract, such that proximal apices at the proximal end of the expandable stent frame do not engage the right ventricular outflow tract.

50. The method of claim 49, wherein the expandable stent frame comprises the expandable stent frame of any of claims 24-32.

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