Prosthetic heart valve

Abstract

A method can include cutting a tube having a first diameter to form a frame having the first diameter, coupling a skirt to the frame, and coupling a plurality of leaflets to the frame. The frame can be compressible from the first diameter to a second diameter less than the first diameter for delivery into a patient via catheterization. The frame can he expandable from the second diameter to a third diameter that is greater than the second diameter. The third diameter can be one of a plurality of working diameters of the frame that can include a smallest working diameter and a largest working diameter, in which the largest working diameter is greater than the first diameter;

Description

PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 719,603, filed on November 12, 2024, and U.S. Provisional Patent Application No. 63 / 686,257, filed on August 23, 2024, each of which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to prosthetic heart valves and methods for fabricating prosthetic heart valves.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.SUMMARY

[0004] Described herein are prosthetic heart valves, delivery apparatus, methods for implanting prosthetic heart valves, and methods for fabricating prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide for improved prosthetic heart valves that are designed have a range of working diameters. Assuch, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0005] A method of fabricating a prosthetic heart valve can include fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter.

[0006] In some examples, the frame can be configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter.

[0007] In some examples, the largest working diameter can be greater than the initial fabricated diameter.

[0008] In some examples, the method can include mounting a skirt in an initial, taut state to the frame in the initial fabricated state.

[0009] In some examples, the skirt in the initial, taut state can include a plurality of weft yams and a plurality of warp yams.

[0010] In some examples, the plurality of weft yarns and the plurality of warp yams can be oriented at a 45 degree angle relative to a longitudinal axis of the frame.

[0011] In some examples, the skirt can be configured to expand to a fully stretched state when the frame is expanded to the largest radially expanded working state.

[0012] In some examples, the plurality of weft yams and the plurality of warp yams of the skirt in the fully stretched state can be configured to be oriented at a 90 degree angle relative to the longitudinal axis of the frame.

[0013] In some examples, the method can include coupling a valvular structure to the frame in the initial fabricated state.

[0014] In some examples, the valvular structure can include a plurality of leaflets.

[0015] In some examples, each of the plurality of leaflets can include a cusp edge portion substantially conforming to a circular arc.

[0016] In some examples, the circular arc can have a diameter substantially equal to the initial fabricated diameter of the frame.

[0017] In some examples, fabricating the frame can include forming a plurality of angled stmts of the frame.

[0018] In some examples, adjacent ones of the plurality of struts can be coupled to form a corresponding one of a plurality of apex regions located at an end portion of the frame.

[0019] In some examples, an angle formed between the adjacent ones of the plurality of struts at each one of the plurality of apex regions can be less than a threshold angle.

[0020] In some examples, the adjacent ones of the plurality of struts at each one of the plurality of apex regions can be configured to pivot as the frame is expanded to the largest radially expanded working state such that the angle formed between the adjacent ones of the plurality of struts is greater than the threshold angle.

[0021] In some examples, the threshold angle can be in a range from 120 degrees to 140 degrees.

[0022] In some examples, fabricating the frame can include cutting a tube having a first diameter to form the frame.

[0023] A prosthetic valve can include an annular frame having an initial fabricated diameter.

[0024] In some examples, the annular frame can include a plurality of struts.

[0025] In some examples, the annular frame can be configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization.

[0026] In some examples, the annular frame can be configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters.

[0027] In some examples, the range of expanded working diameters includes a smallest expanded working diameter and a largest expanded working diameter.

[0028] In some examples, the initial fabricated diameter can be less than the largest expanded working diameter in the range of expanded working diameters.

[0029] In some examples, the prosthetic valve can include a valvular structure coupled to the annular frame.

[0030] In some examples, the initial fabricated diameter can be equal to the smallest expanded working diameter.

[0031] In some examples, adjacent ones of the plurality of struts can form a corresponding one of a plurality of apex regions.

[0032] In some examples, each one of the plurality of apex regions can be disposed at an end portion of the annular frame.

[0033] In some examples, each of the plurality of apex regions can define an angle less than a critical angle when the annular frame is at the initial fabricated diameter.

[0034] In some examples, the annular frame can be configured such that each of the plurality of apex regions defines an angle that is greater than the critical angle when the annular frame is expanded to the largest expanded working diameter.

[0035] In some examples, the prosthetic valve can further include a skirt coupled to the annular frame having the initial fabricated diameter, wherein the skirt can assume an initial, taut state.

[0036] In some examples, the skirt can be configured to assume a fully stretched state when the annular frame is expanded to the largest expanded working diameter.

[0037] In some examples, a prosthetic heart valve can include an annular frame having an expanded state in which the annular frame has a largest expanded working diameter.

[0038] In some examples, the annular frame is compressible to a radially compressed state.

[0039] In some examples, the annular frame can include a central longitudinal axis and a pair of struts oriented at an angle relative to the central longitudinal axis.

[0040] In some examples, the pair of struts can be in a flattened configuration in which the struts of the pair form a substantially 180-degree angle therebetween.

[0041] In some examples, at least one strut of the pair of struts can be configured to form a positive angle with the central longitudinal axis when the annular frame is in the radially compressed state.

[0042] In some examples, the positive angle is in a range from 0.1 degrees to 5 degrees.

[0043] In some examples, the pair of struts can be connected to form an angle therebetween.

[0044] In some examples, the angle can be in a range from 130 degrees to 179 degrees.

[0045] In some examples, the at least one of the pair of struts can be connected to a commissure strut at a junction.

[0046] In some examples, the junction can be disposed further in an outflow direction of the annular frame from an outflow end of a commissure window of the commissure strut.

[0047] In some examples, the annular frame can include a first axial end portion and a second axial end portion.

[0048] In some examples the annular frame can include a first plurality of angled struts defining a first circumferentially extending row at the first axial end portion of the annular frame and a second plurality of angled stmts defining a second circumferentially extending row between the first axial end portion and the second axial end portion.

[0049] In some examples, at least one pair of the first plurality of angled stmts can form a first angle therebetween.

[0050] In some examples, a corresponding pair of the second plurality of angled stmts can form a second angle therebetween.

[0051] In some examples, the first angle can be substantially equal to the second angle.

[0052] In an example, a method of fabricating a prosthetic heart valve can include fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter, mounting a skirt in an initial, taut state to the frame in the initial fabricated state, and coupling a valvular stmcture to the frame in the initial fabricated state. The frame can be configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter. The largest working diameter can be greater than the initial fabricated diameter. The skirt in the initial, taut state can include a plurality of weft yams and a plurality of warp yams oriented at a 45 degree angle relative to a longitudinal axis of the frame. The skirt can be configured to expand to a fully stretched state when the frame is expanded to the largest radially expanded working state. The plurality of weft yarns and the plurality of warp yarns of the skirt in the fully stretched state can be configured to be oriented at a 90 degree angle relative to the longitudinal axis of the frame. The valvular stmcture can include a plurality of leaflets, each with a cusp edge portion substantially conforming to a circular arc having a diameter substantially equal to the initial fabricated diameter of the frame.

[0053] In an example, a method can include cutting a tube having a first diameter to form a frame having the first diameter, coupling a skirt to the frame, and coupling a plurality of leaflets to the frame. The frame can be compressible from the first diameter to a second diameter less than the first diameter for delivery into a patient via catheterization. The frame can be expandable from the second diameter to a third diameter that is greater than the seconddiameter. The third diameter can be one of a plurality of working diameters of the frame that includes a smallest working diameter and a largest working diameter, in which the largest working diameter is greater than the first diameter.

[0054] In an example, a method can include compressing a prosthetic heart valve comprising a frame, a skirt, and a valvular structure from an initial fabricated state to a crimped state, and expanding the prosthetic heart valve from the crimped state to any one of a plurality of working states including a smallest working state and a largest working state. The frame can include a plurality of apex regions and an angle defined by each apex region. The angle defined by each apex region of the prosthetic heart valve in the initially fabricated state can be less than a threshold angle. A diameter of the prosthetic heart valve in the largest working state can be greater than a diameter of the prosthetic heart valve in the initial fabricated state. The angle defined by each apex region of the frame of the prosthetic heart valve in the largest working state can be greater than the threshold angle.

[0055] In an example, a prosthetic valve can include an annular frame with a plurality of struts and a valvular structure coupled to the annular frame. The annular frame can have an initial fabricated diameter. The annular frame can be configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization. The annular frame can be configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter, wherein the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters; and

[0056] In an example, a prosthetic heart valve can include a frame comprising a central longitudinal axis and a plurality of struts oriented at an angle relative to the central longitudinal axis, wherein adjacent ones of the plurality of struts are coupled to form a corresponding one of a plurality of apex regions located at an end portion of the frame, an outer skirt coupled to the frame; and a valvular structure coupled to the frame. The frame can have an initial fabricated diameter. The frame can be compressible from the initial fabricated diameter to a crimped diameter. The frame can be expandable from the crimped diameter to any one of a plurality of working diameters including a smallest working diameter and a largest working diameter. The initial fabricated diameter can be less than the largest working diameter. Each one of the plurality of apex regions can define a first angle. Each one of the plurality of apexregions can be configured to define a second angle greater than the first angle when the frame is expanded to the largest working diameter.

[0057] In an example, a prosthetic heart valve can include a frame, an outer skirt coupled to the frame; and a valvular structure coupled to the frame. The frame can have a first, initial fabricated diameter. The frame can be radially compressible to a second diameter less than the first diameter for delivery into a patient via catheterization. The frame can be radially expandable to any third, final working diameter in a range of working diameters, wherein the third diameter can be greater than the first diameter. The valvular structure can be sized to the first diameter of the frame.

[0058] In an example, a prosthetic heart valve can include a radially compressible and expandable frame, a valvular structure coupled to an inner surface of the frame, and an annular skirt in an initial, taut state coupled to an outer surface of the frame. The frame can have an initial fabricated state in which the frame defines an initial fabricated diameter. The frame can be configured to be radially expandable to a radially expanded working state within a range including a smallest radially expanded working state and a largest radially expanded working state. The frame in the smallest radially expanded working state can have a smallest expanded working diameter. The frame in the largest radially expanded working state can have a largest expanded working diameter. The annular skirt can be configured to be stretchable to a fully stretched state when the frame is radially expanded to the largest radially expanded working state.

[0059] In an example, a prosthetic heart valve can include a frame comprising a central longitudinal axis and a plurality of angled struts disposed at an end portion of the frame, a leaflet structure coupled to an inner surface of the frame, and an outer skirt coupled to an outer surface of the frame. Adjacent ones of the plurality of angled struts can be connected at their adjacent ends to form a corresponding one of a plurality of apex regions. The frame is in an initial fabricated state in which each one of the plurality of apex regions forms an angle that is less than a critical angle. The frame can be configured to be expandable to any one of a smallest radially expanded working state and a largest radially expanded working state, in which each one of the plurality of apex regions is configured to form an angle that is greater than the critical angle. The leaflet structure can include a plurality of leaflets that each include a cusp edge portion defining a circular arc having a diameter equal to a diameter of the frame in the initial fabricated state. The outer skirt can include a plurality of weft threads and a plurality of warp threads. The outer skirt can be in an initial, taut state. The plurality of weft threads and theplurality of warp threads of the outer skirt in the initial, taut state can be oriented at a 45-degree angle relative to the central longitudinal axis of the frame. The outer skirt can be configured to be expandable to a fully stretched state. The plurality of weft threads and the plurality of warp threads of the outer skirt in the fully stretched state can be configured to be oriented at a 90-degree angle relative to the central longitudinal axis of the frame.

[0060] In an example, a prosthetic heart valve can include an annular frame having a largest expanded working diameter and a valvular structure coupled to the annular frame. The annular frame can include a central longitudinal axis and a pair of struts oriented at an angle relative to the central longitudinal axis and can be coupled at their adjacent ends to form an apex region at an end of the annular frame. The he pair of struts can be in a flattened configuration in which the struts of the pair form a substantially 180 degree angle therebetween.

[0061] In an example, a prosthetic heart valve can include an annular frame having an expanded state and a leaflet structure coupled to the annular frame at the commissure window. The annular frame can include a central longitudinal axis, a pair of axial struts that are parallel to the central longitudinal axis, a pair of angled struts that are angled relative to the central longitudinal axis, and a window strut comprising a commissure window. Each angled strut can include a first end and a second end. The angled struts can be connected at their first ends to form an angle therebetween. The angle can be in a range from 130 degrees to 179 degrees. The second end of each angled strut can he connected at a junction to a corresponding one of the pair of axial struts. Each junction can be disposed further in an outflow direction of the annular frame from an outflow end of the commissure window.

[0062] In an example, a prosthetic heart valve can include an annular frame having a radially expanded state. The annular frame can include a first axial end portion, a second axial end portion, a first plurality of angled struts defining a first circumferentially extending row at the first axial end portion of the annular frame, and a second plurality of angled struts defining a second circumferentially extending row between the first axial end portion and the second axial end portion. At least one pair of the first plurality of angled struts can form a first angle therebetween. A corresponding pair of the second plurality of angled struts can form a second angle therebetween. The first angle can be substantially equal to the second angle.

[0063] In some examples, a method or device can include one or more of any of the features recited in Examples 1-73 below.

[0064] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0065] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0066] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0067] FIG. 2 is a side view of a frame of the prosthetic heart valve of FIG. 1 , wherein the frame is shown in a radially expanded (annular) state.

[0068] FIG. 3 is a side view of a portion of the frame of FIG. 2, wherein the portion of the frame is shown in a straightened (non-annular) state.

[0069] FIG. 4 is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site, according to an example.

[0070] FIG. 5 is a side view of a prosthetic heart valve, according to an example.

[0071] FIG. 6 is a side view of the prosthetic heart valve of FIG. 5, wherein the prosthetic heart valve is shown in a radially compressed state.

[0072] FIG. 7 is a side view of a frame and an inner skirt of the prosthetic heart valve of FIG. 5.

[0073] FIG. 8 is a side view of the frame, the inner skirt, and a valvular structure of the prosthetic heart valve of FIG. 5.

[0074] FIG. 9 is a perspective view of the frame of FIGS. 6-8, wherein the frame is shown in the radially expanded (annular) state.

[0075] FIG. 10 is a side view of the frame of FIGS. 6-9, wherein the frame is shown in the straightened (non-annular) state.

[0076] FIG. 11A is a side view of a portion of the frame of FIGS. 2-3 shown in a first radially expanded working state.

[0077] FIG. 1 IB is a side view of the portion of the frame of FIG. 11A shown in a second radially expanded working state.

[0078] FIG. 11C is a side view of the portion of the frame of FIGS. 11 A- 1 IB shown in a third radially expanded working state.

[0079] FIG. 1 ID is a side view of the portion of the frame of FIGS. 11A-11C shown in a fourth radially expanded working state.

[0080] FIG. 12A is a side view of a portion of a frame, according to an example, wherein the portion of the frame is shown in a first state.

[0081] FIG. 12B is a side view of the portion of the frame of FIG. 12 A, wherein the frame is shown in a second state.

[0082] FIG. 12C is a side view of the portion of the frame of FIGS. 12A-12B, wherein the frame is shown in a third state.

[0083] FIG. 13 A is a side view of an outer skirt of a prosthetic heart valve, according to an example, wherein the outer skirt is shown in a taut state.

[0084] FIG. 13B is a side view of the outer skirt of FIG. 13 A, wherein the outer skirt is in a stretched state.

[0085] FIG. 14 is a side view of a leaflet of a valvular structure of a prosthetic heart valve, according to an example.

[0086] FIG. 15 is a side view of a leaflet of a valvular structure of a prosthetic heart valve, according to an example.

[0087] FIG. 16A is a side view of a portion of a frame of a prosthetic heart valve, wherein the frame is in a first radially expanded working state, according to an example.

[0088] FIG. 16B is a side view of the portion of the frame of FIG. 16A in a second radially expanded working state.

[0089] FIG. 16C is a side view of the portion of the frame of FIG. 16A in a third radially expanded working state.

[0090] FIG. 16D is a side view of the portion of the frame of FIG. 16A in a fourth radially expanded working state.

[0091] FIG. 17 is a side view of a portion of a frame of a prosthetic heart valve, wherein the frame is shown in a radially expanded working state, according to an example.

[0092] FIG. 18 is a side view of a portion of a frame of a prosthetic heart valve, wherein the frame is shown in a radially expanded working state, according to an example.

[0093] FIG. 19 is a side view of a portion of a frame of a prosthetic heart valve in a radially compressed state, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0094] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0095] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0096] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term“includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0097] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0098] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0099] Described herein are examples of a prosthetic heart valve that can comprise a radially expandable and compressible annular frame, an outer skirt coupled to the frame, and valvular structure comprising a plurality of leaflets coupled to the frame. The various examples of the prosthetic heart valve disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded working state. Thus, the prosthetic heart valve in the radially compressed state can be crimped on or retained by an implant delivery apparatus while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic heart valve can be expanded to the radially expanded working state once the prosthetic heart valve reaches the implantation site. It is understood that the prosthetic heart valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0100] In some examples, the prosthetic heart valve can be expandable to any one of a plurality of radially expanded, functional states inside a patient. For example, the prosthetic heart valve can be expandable to any one of a first radially expanded working state and a second radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomicfeatures (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0101] Similar to the overall prosthetic heart valve, the frame of the prosthetic heart valve can be radially compressible and expandable between a radially compressed state and a radially expanded working state. For example, the frame can be configured to be compressible to the radially compressed state, in which the frame has a compressed diameter (which is also referred to herein as a “crimped diameter”). In some examples, the frame can be configured to be expandable to any one of a plurality of radially expanded working states in order to facilitate the variable expansion of the prosthetic heart valve to a desired working diameter in a range of working diameters. For example, the frame can be configured to be expandable to any one of a smallest radially expanded working state (which is also referred to herein as a “low-end state”) in which the frame has a diameter equal to a smallest expanded working diameter in a range of expanded working diameters and a largest radially expanded working state (which is also referred to herein as a “high-end state”) in which the frame has a diameter equal to a largest expanded working diameter in the range of expanded working diameters. Thus, the frame can be configured to be expandable across a range of expanded working diameters.

[0102] In some examples, the frame of the prosthetic heart valve can be formed from a tube, for example, by cutting the tube to form a plurality of struts and / or a plurality of open cells of the frame. The frame can have an initial fabricated state in which the frame has an initial fabricated diameter that is equal to the diameter of the tube. In some examples, the initial fabricated diameter can be greater than the smallest expanded working diameter in the range of expanded working diameters and smaller than the largest expanded working diameter in the range of expanded working diameters. In some examples, the initial fabricated diameter can be equal to the smallest expanded working diameter. As used herein, a “low end tube” is a tube from which the frame is cut to form a frame having an initial fabricated diameter equal to the smallest expanded working diameter of the frame. In some examples, the initial fabricated diameter can be less than the smallest expanded working diameter.

[0103] The frame can comprise the plurality of struts. Adjacent ones of the plurality of struts can form a corresponding one of a plurality of apex regions at an end portion of the frame. Each one of the plurality of apex regions can define an angle between the adjacent ones of the plurality of struts. The angle defined by each one of the plurality of apex regions can be below a threshold angle (which is also referred to herein as a “critical angle”, which is discussed below) when the frame is in the initial fabricated state. In some example, the threshold anglecan be in a range from 120 degrees to 140 degrees, such from 125 degrees to 135 degrees. In this way, the plurality of struts of the frame can be more easily pivoted or bent at the plurality of apex regions such that the frame and / or the prosthetic heart valve can be more easily crimped from the initial fabricated state to the radially compressed state.

[0104] Each one of the plurality of apex regions can define an angle that is above the threshold angle when the frame is in the largest radially expanded working state corresponding to the largest working diameter of the frame. In this way, when the angle of each one of the plurality of apex regions is greater than the threshold angle, the plurality of struts of the frame can be oriented in a relatively circumferential direction that allows the frame to better resist forces acting thereupon. In this way, configuring the frame to expand such that the angle of each one of the plurality of apex regions is greater than the threshold angle provides for more uniform expansion of the frame along an axial length of the frame.

[0105] In some examples, a skirt of the prosthetic heart valve (an inner skirt and / or an outer skirt) can include a plurality of weft threads or yams and a plurality of warp threads or yams. The skirt can be stretchable between an initial, taut state and a fully stretched state when coupled to the frame of the prosthetic heart valve. In some examples, the skirt can be configured to be in the initial, taut state when the frame is in the initial fabricated state (in other words, when the frame’s diameter is equal to the initial fabricated diameter and / or less than the largest expanded working diameter) and configured to be in the fully stretched state when the frame is in the largest radially expanded working state (in other words, when the frame’s diameter is equal to the largest expanded working diameter). In some examples, when the skirt is in the initial, taut state, the skirt can conform to an outer surface of the frame such that there is beneficially no or minimal slack in the skirt. In some examples, the threads or yams of the skirt are not stretched or tensioned when the skirt is in the initial, taut state and mounted on the frame in the initial fabricated state. In some examples, the threads or yarns of the skirt are slightly and / or less than fully stretched when the skirt is in the initial, taut state mounted on the frame in the initial fabricated state. In some examples, when the skirt is in the initial, taut state and mounted on the frame in the initial fabricated state, each one of a plurality of weft threads and a plurality of warp threads of the skirt can be oriented at an approximately 45 degree angle relative to a longitudinal axis of the prosthetic heart valve.

[0106] As the frame is expanded beyond the initial fabricated state toward the largest radially expanded working state and the skirt is stretched, the warp and weft threads / yarns pivot or move closer toward a plane that is perpendicular to the longitudinal axis of the prosthetic heartvalve (increasing the angles between the warp and weft threads / yarns and the longitudinal axis). In this way, the skirt can expand and contract with the frame in a way that beneficially further minimizes slack in the skirt. In some examples, when the prosthetic heart valve is in the largest radially expanded working state corresponding to the frame’s largest working diameter, each one of the plurality of weft threads or yams and the plurality of warp threads or yams of the skirt can be oriented at an approximately 90 degree angle relative to the longitudinal axis of the prosthetic heart valve, which can resist further expansion of the prosthetic heart valve under a predetermined inflation pressure of a catheter balloon that is used to deploy the prosthetic heart valve. In this manner, the skirt can serve as a stop or expansion limiter that prevents overexpansion of the prosthetic heart valve beyond the upper limit of its expansion range.

[0107] In some examples, the valvular structure can comprise a plurality of leaflets. Each one of the plurality of leaflets can comprise a portion of leaflet material that includes a cusp edge portion. The cusp edge portion can he defined by a circular arc having a diameter substantially equal to the initial fabricated diameter of the frame. In this way, the valvular structure can be “sized” to fit the frame. “Sizing” the valvular structure to fit the frame can beneficially eliminate the need to stretch the plurality of leaflets while coupling the plurality of leaflets to the frame in the initial fabricated state, thereby simplifying the prosthetic heart valve fabrication process. Additionally or alternatively, sizing the valvular structure to fit the frame can beneficially result in more consistent performance across the range of expanded working diameters of the frame.Examples of the Disclosed Technology

[0108] FIG. 1 shows a prosthetic heart valve 100 (which is also referred to herein as a “prosthetic valve”), according to an example. Any one of the prosthetic heart valves disclosed herein can be adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic heart valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a subject. The disclosed prosthetic heart valves also can be implanted within a previously implanted prosthetic heart valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0109] In some examples, the disclosed prosthetic heart valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In some examples, the disclosed prosthetic heart valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic heart valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in U.S. Publication No. 2022 / 0079749, which is incorporated by reference herein in its entirety. In some examples, the disclosed prosthetic heart valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated by reference herein in its entirety.

[0110] The prosthetic heart valve 100 and any prosthetic heart valve disclosed herein (for example, prosthetic heart valve 300) can be radially compressible and expandable between a radially compressed state and at least one radially expanded working state. For example, the prosthetic heart valve 100 can be expandable to any one of a plurality of radially expanded working states that includes a smallest radially expanded working state and a largest radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0111] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, an inner skirt 107, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 and the inner skirt 107 can be disposed on an interior of the frame 102 while the outer skirt 106 can be disposed around an outer surface of the frame 102.

[0112] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs 115) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs 115 disposed on opposite sides of the leaflet 112 and a cusp edge portion 113 (FIG. 8) extending between the opposing commissure tabs 115. The cusp edge portion 113 of the leaflets 112 can have anundulating, curved scalloped shape, and can be secured directly to the frame 102 (for example, by sutures). However, in some examples, the cusp edge portion 113 of the leaflets 112 can be secured to the inner skirt 107 which is then secured to the frame 102. In some examples, the leaflets 112 (and / or any leaflets described herein, such as leaflets 612 (FIG. 14) and / or leaflets 712 (FIG. 15)) can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein in its entirety.

[0113] In some examples, the outer skirt 106 and / or the inner skirt 107 can be annular skirts. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102.

[0114] The skirts 106, 107 and / or any one of the skirts disclosed herein (for example, inner skirt 307 (FIGS. 7-8) and / or outer skirt 506 (FIGS. 13A-13B)) can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 106, 107 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 106, 107 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 106, 107 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 106, 107 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 106, 107 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0115] The frame 102 can be radially compressible and expandable. The frame 102 can be configured to be readily compressible from an initial fabricated state to a radially compressed state (which is also referred to herein as a “radially compressed configuration,” a “radiallycollapsed state,” and / or a “radially collapsed configuration”). The frame 102 can be configured to be radially expandable from the initial fabricated state or the radially compressed state to at least one radially expanded working state (which is also referred to herein as a “radially expanded state,” a “radially expanded configuration,” a “working configuration,” a “working state,” an “annular configuration,” and / or an “annular state”). For example, the frame 102 can be configured to be expandable to any one of a plurality of radially expanded working states, including any one of a smallest radially expanded working state and a largest radially expanded working state. The frame 102 in an exemplary radially expanded (annular) state is shown in FIGS. 1-2. A portion of the frame 102 in an exemplary straightened (non-annular) state is shown in FIG. 3. As used herein, a “radially expanded working state” is a state or configuration in which the frame 102 allows the leaflets 112 coupled to the frame 102 to sufficiently open and close (coapt) to regulate the flow of blood through the frame 102 (in other words, a state that allows the valvular structure 104 coupled to the frame 102 to work or operate).

[0116] The frame 102 and / or any one of the frames disclosed herein (for example, frame 302 and / or frame 402) can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the prosthetic heart valve 100) can be crimped to a radially compressed (or crimped) state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the prosthetic heart valve 100) can be crimped to a radially compressed state and restrained in the radially compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic heart valve 100 can be advanced from the delivery sheath, which allows the prosthetic heart valve 100 to expand to its functional state (for example, any one of the plurality of radially expanded working states).

[0117] Suitable plastically-expandable materials that can be used to form the frame 102 and / or any one of the frames disclosed herein (for example, frame 302 and / or frame 402) include metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame can comprise stainless steel. In some examples, the frame can comprise cobalt-chromium. In some examples, the frame can comprise nickel-cobalt- chromium. In some examples, the frame comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035(covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0118] As shown in FIGS. 2-3, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the inflow end 108 and the outflow end 1 10 of the frame 102. In some examples, as shown in FIGS. 2-3, the frame 102 comprises three rows of cells 118 with a first (upper in the orientation shown in FIGS. 2-3) row 120 disposed at the outflow end 110. The first row 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row 120 can have a longer axial length 124 (FIG. 3) than cells 118 in the remaining rows of cells, which can include a second row 126 and a third row 128, the third row 128 being disposed at the inflow end 108 and the second row 126 being disposed between the first row 120 and the third row 128.

[0119] In some examples, such as the example shown in FIG. 2, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a “nine-cell frame.”

[0120] In some examples, the frame 102 can comprise more than three rows of cells (for example, four or five) and / or more or less than nine cells per row. In some examples, the cells 118 in the first row 120 may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (for example, the second row 126 and / or the third row 128).

[0121] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame 102, a second row of circumferentially extending, angled struts 132, a third row of circumferentially extending, angled struts 134, and a fourth row of circumferentially extending, angled struts 136 at the outflow end 110 of the frame 102. The fourth row of angled struts 136 can be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows 142 (which are also referred to herein as “windows” and / or “open windows”) that are spaced apart from one another around the frame102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs 115 of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114 shown in FIG. 1). In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 can be referred to herein as “commissure features” or “commissure supports,” wherein each commissure feature or support can be configured to receive and / or be secured to a pair of commissure tabs 115 of a pair of adjacent leaflets 112.

[0122] One or more (for example, two, as shown in FIGS. 2-3) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the window struts 138. Since the frame 102 can include fewer cells per row and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0123] Each axial strut 140 and each window strut 138 can extend from a location defined by the convergence of the lower ends (for example, ends arranged inward of and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an “upper strut junction” or “upper elongated strut junction”) to another location defined by the convergence of the upper ends (for example, ends arranged closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a “lower strut junction” or “lower elongate strut junction”). Each axial strut 140 and each window strut 138 can form an axial side of two adjacent cells of the first row 120.

[0124] Now referring back to FIG. 1, the commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114. In some examples, the commissure 114 of the prosthetic heart valve 100 can comprise two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 1 14 can be secured to the window struts 138 forming the commissure window 142. In some examples, rather than having window struts 138, the frame 102 can include commissure supports that support commissure tabs 115 of respective commissures 114 entirely inside the frame 102.

[0125] The cusp edge portion 113 (which is also referred to herein as a “scallop edge” and / or “scallop edge portion”) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, the cusp edge portion 1 13 of each leaflet112 can be secured directly to the struts of the frame 102 (for example, angled struts 130, 132, and 134). For example, the cusp edge portions 113 of the leaflets 112 can be sutured to certain ones of the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions 113 of the leaflets 112.

[0126] In some examples, the cusp edge portion 1 13 of the leaflets 112 can be secured to the inner skirt 107 and the inner skirt 107 can then be secured directly to the frame 102, such as shown in FIG. 8.

[0127] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication No. WO 2023 / 086548, which is incorporated by reference herein in its entirety.

[0128] Now referring back to FIGS. 2-3, the interconnected struts 116 can also comprise horizontal struts 182 that extend between adjacent cells 118 of a row of cells of the frame 102. The horizontal struts 182 can extend in a circumferential direction and can also be referred to as circumferentially extending struts 182. The horizontal struts 182 can connect angled struts (for example, struts 130, 132, 134) of two adjacent rows of angled struts of the frame 102 to one another. For example, each horizontal strut 182 can connect to two angled struts of one row of struts (for example, struts 134 shown in FIG. 3) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in FIG. 3). As a result, an angled strut 134 extending between an axially extending window strut 138 and the horizontal strut 182 and an angled strut 132 extending between the horizontal strut 182 and another horizontal strut 182 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets 112 (when the leaflets 112 are attached to the frame 102). Thus, the horizontal struts 182 can allow the angled struts 130, 132, 134 to follow a shape that more closely matches a shape of the scallop line of the leaflets 112 when the frame 102 is in the radially expanded working state (as shown in FIGS. 2-3). Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby beneficially reducing a risk of pinching the leaflets 112 between the struts when the prosthetic heart valve 100 is in the radially compressed state.

[0129] In some examples, the adjacent ones of angled struts 132 disposed below and connected to the horizontal strut 182 can define an angle 190 (which is also referred to herein as a “junction angle” and / or an “interior angle”). As shown, the adjacent ones of angled struts 134disposed above and connected to the horizontal strut 182 define the same angle 190. Although the angled struts 132 and 134 are presently shown to form the same angle 190, in some examples, the angled struts 132 and 134 can each form a different angle.

[0130] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 1 10, wherein each apex region 152 forms a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 can be spaced apart from one another in a circumferential direction at the inflow end 108 and the outflow end 110.

[0131] Each apex region 152 can comprise a corresponding apex 154 (the most outward extending point in an axial direction) and two thinned (or narrowed) strut portions 156. One thinned strut portion 156 can extend from either side of the apex 154 to a corresponding, wider, angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152 and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152. Each one of the apex regions 152 can form an angle 180 (which is also referred to herein as an “apex angle”) between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152.

[0132] As previously discussed, the frame 102 can be configured to be compressible from the initial fabricated state to the radially compressed state (on a delivery apparatus for delivery into patient) and can be configured to be expandable from the initial fabricated state or the radially compressed state to at least one radially expanded working state. For example, the frame 102 can be expandable to any one of a plurality of radially expanded working states defining a range of working diameters for the prosthetic valve, wherein the radially expanded working states include a smallest radially expanded working state corresponding to the smallest working diameter for the prosthetic valve and a largest radially expanded working state corresponding to the largest working diameter for the prosthetic valve.

[0133] The smallest and largest expanded working diameters of the frame 102 can define a range of expanded working diameters (which is also referred to herein as a “range of deployed diameters”) at which the leaflets 112 of the prosthetic heart valve 100 can adequately open and close (in other words, coapt) to regulate the flow of blood through the prosthetic heart valve100. As used herein, “the smallest radially expanded working state” corresponds to the state of the prosthetic heart valve 100 at the smallest working diameter for the prosthetic heart valve 100 and “the largest radially expanded working state” corresponds to the state of the prosthetic heart valve 100 at the largest working diameter for the prosthetic heart valve 100. In some examples, the difference between the smallest working diameter and the largest working diameter in this range can at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 4.5 mm, or at least 5 mm. In some examples, a prosthetic heart valve can have a range of expanded working diameters spanning from 21 to 24 mm, such as from 21.5 mm to 24 mm, from 22 mm to 24 mm, 22 m to 23.5 mm, or from 22 mm to 23 mm. In some examples, the prosthetic heart valve 100 can have a range of working diameters spanning from 25.5 mm to 30 mm, such as from 26 mm to 30 mm, from 26 mm to 29 mm, from 27 mm to 30 mm, from 28 mm to 30 mm, or from 29 mm to 30 mm. In this way, the frame 102 (and the prosthetic heart valve 100) can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0134] The frame 102 in the initial fabricated state (such as when laser cut from a tube) can have an initial fabricated diameter. The initial fabricated diameter can be less than the largest working diameter. In some examples, the initial fabricated diameter can be less than the largest working diameter and greater than the smallest working diameter. In some examples, the initial fabricated diameter can be substantially equal to (for example, within 10%) the smallest working diameter. In some examples, the initial fabricated diameter can be less than the smallest working diameter.

[0135] The frame 102 in the radially compressed, delivery state can have a diameter that is less than the initial fabricated diameter.

[0136] It has been discovered that designing the frame 102 such that the angle 180 formed by each one of the apex regions 152 is below a “threshold angle” (which is also referred to herein as a “critical angle”) when the frame 102 is in the initial fabricated state can beneficially provide for improved crimping of the frame 102 and / or the prosthetic heart valve 100. For example, when the frame 102 is in the initial fabricated state and the angle 180 is below the threshold angle, the plurality of struts 116 of the frame 102 can be more easily pivoted or bent at the plurality of apex regions 152, thereby allowing the frame 102 and / or the prosthetic heartvalve 100 to be more easily radially compressed from the initial fabricated state to the radially compressed state.

[0137] Furthermore, it has been discovered that designing the frame 102 such that the angle 180 formed by each one of the apex regions 152 is above the threshold angle when the frame 102 is in the largest radially expanded working state can beneficially increase the strength of the frame 102. For example, when the frame 102 is in the largest radially expanded working state and the angle 180 is above the threshold angle, the plurality of struts 116 of the frame 102 can be oriented in a relatively circumferential direction that allows the frame 102 to better resist radial forces acting thereupon. Furthermore, designing the frame 102 in this way provides for more uniform expansion along its axial length when the frame 102 is expanded to certain radially expanded working states (for example, the largest radially expanded working state). Thus, it has been discovered that the disclosed frame 102, which is configured have an initial fabricated state in which the angle 180 is less than the threshold angle and is further configured to be expandable to a largest radially expanded working state in which the angle 180 is greater than the threshold angle, provides for a frame that exhibits a desirable balance between strength and compressibility.

[0138] The threshold angle can be any angle in a range from 120 degrees to 140 degrees. In some examples, the threshold angle can be substantially equal to (for example, within 10%) any one of 120 degrees, 125 degrees, 130 degrees, 135 degrees, and 140 degrees, etc.

[0139] In some examples, the angle 180 can be in a range from 100 degrees to 130 degrees, such as from 110 degrees to 130 degrees, from 110 degrees to 120 degrees, from 115 degrees to 125 degrees, etc. when the frame is in the initial fabricated state.

[0140] In some examples, the angle 180 can be in a range from 130 degrees to 179 degrees, such as from 130 degrees to 150 degrees, from 130 degrees to 150 degrees, from 135 degrees to 145 degrees, from 140 degrees to 179 degrees, from 150 degrees to 179 degrees, from 140 degrees to 160 degrees, from 140 degrees to 150 degrees, from 145 degrees to 155 degrees, etc. when the frame is in the largest radially expanded working state.

[0141] FIGS. 11A-11D are side views of a portion of the frame 102 in various radially expanded working states, according to an example. The illustrated portion of the frame 102 is a column extending between the outflow end 110 and the inflow end 108 that includes two adjacent ones of the plurality of cells 118.

[0142] FIG. 11A shows the portion of the frame 102 in an exemplary first radially expanded working state. In some examples, the first radially expanded working state can also be the initial fabricated state and / or the smallest radially expanded working state.

[0143] In the first radially expanded working state, the frame 102 can have a working diameter of 21 mm. As shown, the apex region 152 at the inflow end 108 forms an angle 180a of 115 degrees between the two angled struts 130. As further shown, the apex region 152 at the outflow end 110 forms the same angle 180a. However, in any one of the exemplary radially expanded states illustrated in FIGS. 11A-1 ID, the angle formed by the apex region 152 at the inflow end 108 can be different than the angle formed by the apex region 152 at the outflow end 110.

[0144] In the first radially expanded working state, the frame 102 can form an angle 190a of 81 degrees between adjacent ones of the angled struts 132. As shown, the frame 102 can form the same angle 190a between adjacent ones of angled struts 134. However, in any one of the exemplary radially expanded states illustrated in FIGS. 11A-11D, the angle formed by angled struts 132 can be different than the angle formed by angled struts 134.

[0145] FIG. 1 IB shows the portion of the frame 102 in an exemplary second radially expanded working state. In some examples, the second radially expanded working state can also he the initial fabricated state and / or the smallest radially expanded working state. In the second radially expanded working state, the frame 102 can have a working diameter of 22 mm. As shown, the apex region 152 at the inflow end 108 forms an angle 180b of 125 degrees between the two angled struts 130; the apex region 152 at the outflow end 110 of the frame 102 forms the same angle 180b between the two angled struts 136. As further shown, the frame 102 forms angles 190b of 88 degrees between the two angled struts 132 and the two angled struts 134.

[0146] FIG. 11C shows the portion of the frame 102 in an exemplary third radially expanded working state. In some examples, the third radially expanded working state can also be the largest radially expanded working state. In the third radially expanded working state, the frame 102 can have a working diameter of 23.5 mm. As shown, the apex region 152 at the inflow end 108 forms an angle 180c of 143 degrees between the two angled struts 130; the apex region 152 at the outflow end 110 of the frame 102 forms the same angle 180c between the two angled struts 136. As further shown, the frame 102 forms angles 190c of 97 degrees between the two angled struts 132 and the two angled struts 134.

[0147] FIG. HD shows the portion of the frame 102 in an exemplary fourth state. In some examples, the fourth radially expanded working state can also be the largest radially expanded working state. In the fourth radially expanded working state, the frame 102 can have a working diameter of 24 mm. As shown, the apex region 152 at the inflow end 108 forms an angle 180d of 150 degrees between the two angled struts 130; the apex region 152 at the outflow end 110 of the frame 102 forms the same angle 180d between the two angled struts 136. As further shown, the frame 102 forms angles 190d of 100 degrees between the two angled struts 132 and the two angled struts 134.

[0148] As previously discussed, the angle 180 can be less than the threshold angle when the frame 102 is in the initial fabricated state and the angle 180 can be greater than the threshold angle when the frame 102 is in the largest radially expanded working state. Thus, in some examples where the threshold angle is greater than 115 degrees and less than 125 degrees, the first radially expanded working state can also be the initial fabricated state and any one of the second, third, and fourth radially expanded working states can also be the largest radially expanded working state. In some examples where the threshold angle is greater than 125 degrees and less than 143 degrees, any one of the first radially expanded state and the second radially expanded working state can also be the initial fabricated state and any one of the third and fourth radially expanded working states can also be the largest radially expanded working state. In this way, the frame 102 can be configured to exhibit a desirable balance between strength and compressibility.

[0149] FIGS. 12A-12C are side views of the portion of a frame 402 in various radially expanded working states, according to an example. The portion of the frame 402 illustrated in FIGS. 12A-12C has the same general shape as the portion of the frame 102 illustrated in FIGS. 11 A- HD. The illustrated portions of the frames 102, 402 can share certain similar features, which are referred to using similar reference numbers (offset in increments of hundreds). One exemplary difference between the frame 402 and the frame 102 is that certain relative dimensions (for example, angles 480 and 490) may be different than their corresponding relative dimensions (for example, angles 180 and 190) illustrated in FIGS. HA- HD.

[0150] FIG. 12A shows the portion of the frame 402 in an exemplary first radially expanded working state. In some examples, the first radially expanded working state can also be the initial fabricated state and / or the smallest radially expanded working state of the frame 402.

[0151] In the first radially expanded working state, the frame 402 can have a working diameter of 20 mm. As shown, the apex region 452 at the inflow end 408 forms an angle 480a of 103 degrees between the two angled struts 430. As further shown, the apex region 452 at the outflow end 410 forms the same angle 480a. However, in any one of the exemplary radially expanded states illustrated in FIGS. 12A-12C, the angle formed by the apex region 452 at the inflow end 408 can be different than the angle formed by the apex region 452 at the outflow end 410.

[0152] In the first radially expanded working state, the frame 402 can form an angle 490a of 73 degrees between adjacent ones of the angled struts 432. As shown, the frame 402 can form the same angle 490a between adjacent ones of angled stmts 434. However, in any one of the exemplary radially expanded states illustrated in FIGS. 12A-12C, the angle formed by angled struts 432 can be different than the angle formed by angled struts 434.

[0153] FIG. 12B shows the portion of the frame 402 in an exemplary second radially expanded working state. In some examples, the second radially expanded working state can also be the initial fabricated state, the smallest radially expanded working state, or the largest radially expanded working state. In the second radially expanded working state, the frame 402 can have a working diameter of 21 mm. As shown, the apex region 452 at the inflow end 408 forms an angle 480b of 110 degrees between the two angled struts 430; the apex region 452 at the outflow end 410 of the frame 102 forms the same angle 480b between the two angled stmts 436. As further shown, the frame 402 forms angles 190b of 78 degrees between the two angled stmts 132 and the two angled stmts 134.

[0154] FIG. 12C shows the portion of the frame 402 in an exemplary third radially expanded working state. In some examples, the third radially expanded working state can also be the largest radially expanded working state. In the third radially expanded working state, the frame 402 can have a working diameter of 22 mm. As shown, the apex region 452 at the inflow end 408 forms an angle 480c of 120 degrees between the two angled stmts 430; the apex region 452 at the outflow end 410 of the frame 102 forms the same angle 480c between the two angled stmts 436. As further shown, the frame 402 forms angles 190c of 84 degrees between the two angled struts 132 and the two angled stmts 134.

[0155] Similar to the angle 180 shown in FIGS. 11A-1 ID, the angle 480 shown in FIGS. 12A- 12C can be less than the threshold angle when the frame 402 is in the initial fabricated state and can be greater than the threshold angle when the frame 402 is in the largest radiallyexpanded working state. Thus, in some examples where the threshold angle is greater than 103 degrees and less than 110 degrees, the first radially expanded working state can also be the initial fabricated state and any one of the second and third radially expanded working states can also be the largest radially expanded working state. In some examples where the threshold angle is greater than 110 degrees and less than 120 degrees, any one of the first radially expanded state and the second radially expanded working state can also be the initial fabricated state and the third radially expanded working state can also be the largest radially expanded working state.

[0156] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO2022 / 226147, which is incorporated by reference herein in its entirety.

[0157] FIGS. 5-8 illustrate a prosthetic heart valve 300, according to an example, that can be radially expandable and compressible between a radially expanded working state (FIG. 5) and a radially compressed state (FIG. 6). As shown, the prosthetic heart valve 300 includes a frame 302, the valvular structure 104 disposed on an interior of the frame 302, an inner skirt 307, and the outer skirt 106 disposed around an outer surface of the frame 302. The prosthetic heart valve 300 and the other prosthetic heart valves described herein (for example, prosthetic heart valve 100) can share certain similar features, which are referred to using similar reference numbers (offset in increments of hundreds).

[0158] FIG. 7 is a side view of the prosthetic heart valve 300, wherein the valvular structure 104 and the outer skirt 106 have been removed for clarity. Thus, only the frame 302 and the inner skirt 307 disposed around an inner surface of the frame 302 are shown in FIG. 7. As shown, the inner skirt 307 is secured directly to the frame 302 (for example, an inner surface of the frame 302). The inner skirt 307 can be secured to selected struts of the frame 302 with one or more sutures forming a plurality of stitches that extend through the inner skirt and around selected struts. For example, an outflow end portion of the inner skirt 307 can he secured to struts 334 with stitches 350 (for example, whip stitches) and an inflow end portion of the inner skirt 307 can be secured to struts 330 with stitches 352 (for example, whip stitches). An intermediate portion of the inner skirt 307 between the inflow end portion and the outflow end portion can be secured to selected struts 332, 334 with stitches 354 (for example, whip stitches). However, it should be understood that some examples of the prosthetic heart valve 300 can lack the inner skirt 307. It should also be understood that any prosthetic heart valve disclosed herein (for example, prosthetic heart valve 100) can include the inner skirt 307.

[0159] FIG. 8 is a side view of the prosthetic heart valve 300, wherein the outer skirt 106 has been removed for clarity. Thus, only the frame 302, the valvular structure 104, and the inner skirt 307 are shown in FIG. 8. As shown, the cusp edge portions 113 of the leaflets 112 of the valvular structure 104 are secured (for example, sutured) directly to the inner skirt 307 with one or more sutures forming a stitch line 125 comprising a plurality of stitches (for example, in and out stitches extending through the cusp edge portions 113 and the inner skirt 307). In some examples, the stitch 125 can be referred to as a “scallop line” due to its scallop shape. However, in some examples, the valvular structure 104 can instead be secured (for example, sutured) directly to the frame 302.

[0160] FIGS. 9-10 are different views of the frame 302. For example, FIG. 9 is a perspective view of the frame 302, wherein the frame 302 is in an exemplary radially expanded (annular) state and FIG. 10 shows of the frame 302 in a straightened (non-annular) state.

[0161] Similar to the frame 102 shown in FIGS. 2-3, the frame 302 shown in FIGS. 9-10 can be radially compressible from an initial fabricated state to a radially compressed (or collapsed) state (best shown in FIG. 6) and can be radially expandable from any one of the initial fabricated state and the radially compressed state to at least one radially expanded working state (for example, any one of a smallest radially expanded working state and a largest radially expanded working state). The frame 302 in the initial fabricated state can have an initial fabricated diameter. The frame 302 in the radially compressed state can have a compressed diameter. The frame 302 can have a different working diameter in each one of the plurality of radially expanded working states. For example, the frame 302 can have a smallest working diameter in the smallest radially expanded working state and a largest working diameter in the largest radially expanded working state, where the smallest working diameter and the largest working diameter define a range of working diameters spanning therebetween. In some examples, the prosthetic heart valve 300 can have a range of expanded working diameters spanning from 21 to 24 mm, such as from 21.5 mm to 24 mm, from 22 mm to 24 mm, from 22 mm to 23.5 mm, or from 22 mm to 23 mm. In some examples, the prosthetic heart valve 300 can have a range of working diameters spanning from 25.5 mm to 30 mm, such as from 26 mm to 30 mm, from 26 mm to 29 mm, from 27 mm to 30 mm, from 28 mm to 30 mm, or from 29 mm to 30 mm.

[0162] The frame 302 and the frame 102 shown in FIGS. 1-3 can share certain similar features, which are referred to using similar reference numbers (offset in increments of hundreds). One exemplary difference between the frame 302 and the frame 102 shown in FIGS. 1-3 is that theframe 302 can comprise a greater number of cells (for example, twelve cells) in each row than the frame 102. Thus, in such examples, the frame 302 can be referred to as a “twelve-cell frame.”

[0163] The frame 302 can comprise a plurality of interconnected struts 316 that form open cells 318 disposed in multiple rows 320, 326, 327, and 328 that extend in a circumferential direction and are disposed between an inflow end 308 and an outflow end 310 of the frame 302. As shown, the frame 302 comprises four circumferentially extending rows of cells (for example, a first row 320, a second row 326, a third row 327, and a fourth row 328) with the first (upper in the orientation shown in FIGS. 9-10) row 320 disposed at the outflow end 310. In some examples, first row 320 can comprise cells 318a that are elongated in an axial direction (relative to a central longitudinal axis 322 of the frame 302), compared to cells 318b in the remaining rows 326, 327, and 328. In some examples, the cells 318a of the first row 320 may not be elongated relative to the other rows and / or the cells of the other rows (for example, the second, third, and / or fourth rows 326, 327, and / or 328) may be elongated relative to the remaining rows. As shown, the frame 302 includes twelve cells per row 320, 326, 327, and 328. In some examples, the frame 302 can include a greater or fewer number of cells in each row 320, 326, 327, and 328.

[0164] The interconnected struts 316 can include a plurality of angled struts 330, 332, 333, 334, and 336 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 302 between the outflow end 310 and the inflow end 308. For example, the frame 302 can comprise a first row of angled struts 330 arranged end-to-end and extending circumferentially at the inflow end 308 of the frame 302; a second row of circumferentially extending, angled struts 332; a third row of circumferentially extending, angled struts 333; a fourth row of circumferentially extending, angled struts 334; and a fifth row of circumferentially extending, angled struts 336 at the outflow end 310 of the frame 302. The fifth row of angled struts 336 can be connected to the fourth row of angled struts 334 by a plurality of axially extending window struts 338 and a plurality of axial struts 340. The axially extending window struts 338 can define commissure windows 342 that are spaced apart from one another around the frame 302, in a circumferential direction, and which are adapted to receive a pair of commissure tabs 115 of a pair of adjacent leaflets 112 arranged into a commissure. In some examples, rather than having window struts 338, the frame 302 can include commissure supports that support commissure tabs 115 of respective commissures 114 entirely inside the frame 302.

[0165] The frame 302 can further comprise a plurality of apex regions 352 formed at the inflow end 308 and the outflow end 310, wherein each one of the plurality of apex regions 352 forms a junction between two angled struts 330 at the inflow end 308 or two angled struts 336 at the outflow end 310. As such, the apex regions 352 can be spaced apart from one another, in a circumferential direction at the inflow end 308 and the outflow end 310.

[0166] Each apex region 352 can comprise a corresponding apex 354 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 356, one thinned strut portion 356 extending from either side of the apex 354 to a corresponding, wider, angled strut 336 (at the outflow end 310) or angled strut 330 (at the inflow end 308). In this way, each of the apex regions 352 at the outflow end 310 can form a narrowed transition region between and relative to the two angled struts 336 extending from the corresponding apex region 352 and each of the apex regions 352 at the inflow end 308 can form a narrowed transition region between and relative to the two angled struts 330 extending from the corresponding apex region 352. In some examples, each of the apex regions 352 can form an angle 380 between the two angled struts 330 or 336 extending from either side of the corresponding apex region 352 (FIG. 10).

[0167] Similar to the frame 102, the frame 302 can be configured such that the angle 380 formed by the apex regions 352 is less than the threshold angle when the frame 302 is in the initial fabricated state and the angle 380 is greater than the threshold angle when the frame 302 is in the largest radially expanded working state. In some examples, the threshold angle can be any angle in a range from 120 degrees to 140 degrees (for example, any one of 120 degrees, 125 degrees, 130 degrees, 135 degrees, and 140 degrees, etc.). In this way, the frame 302 can be configured to exhibit a desirable balance between strength and compressibility.

[0168] In some examples, the adjacent ones of angled struts 333 disposed below and connected to the horizontal strut 382 can define an angle 390. In some examples, the adjacent ones of angled struts 334 disposed above and connected to the horizontal strut 382 can define the same angle 390. Although the angled struts 333 and 334 are shown to form the same angle 390, in some examples, the angled struts 333 and 334 can form different angles. As shown, adjacent ones of the angled struts 332 disposed below the horizontal strut 382 can define the same angle 390. However, ins some examples, the angled struts 332 can form different angles than angled struts 333, 334.

[0169] Any one of the frames described herein (for example, any one of frames 102, 302, and 402) can be formed from a tube. The frame can be formed by removing material from the tube to form a plurality of struts and / or a plurality of open cells. In some examples, the frame can be cut (for example, laser cut) to remove the material in order to form the plurality of struts and / or the plurality of open cells.

[0170] The diameter of the tube can be equal to the initial fabricated diameter of the frame (and thus be less than the largest expanded diameter). Since the angles formed by the apex regions of the frame in the initial fabricated state are smaller than the angles formed by the apex regions of the frame in the largest radially expanded working state, forming the frame to have an initial fabricated diameter that is less than the largest expanded diameter can help reduce the amount of movement experienced by the plurality of struts during crimping and / or radial compression, thereby beneficially further reducing the risk of deformation during crimping and / or radial compression.

[0171] FIGS. 13A-13B are flattened views of an outer skirt 506 of a prosthetic heart valve, according to an example. The outer skirt 506 can be used in conjunction with any frame described herein and / or any valvular structure described herein to form any prosthetic heart valve described herein.

[0172] The outer skirt 506 can comprise at least one skirt portion connected to a frame (for example, any one of the frame 102, the frame 302, and the frame 402) to form an annular skirt. The skirt portion can define two edge portions 508 (which are also be referred to herein as “short edge portions” and / or “circumferential edge portions”) which each extend between an inflow edge portion 512 and an outflow edge portion 514 (which are also referred to herein as “long edge portions” and / or “axial edge portions”) of the outer skirt 506. In some examples, the edge portions 508 can be non-perpendicular to the inflow edge portion 512 and / or the outflow edge portion 514. For example, the edge portions 508 can extend at angles of approximately 45 degrees (for example, ± 5 degrees) relative to the inflow edge portion 512 and / or the outflow edge portion 514. Therefore, an overall general shape of the outer skirt 506, when flattened into a non-annular state, can be that of a rhomboid or parallelogram.

[0173] In some examples, each one of the edge portions 508 can include at least one aperture 510 extending therethrough. Thus, when the outer skirt 506 is mounted to a frame of a prosthetic heart valve (such as frame 102, frame 302, or frame 402), the edge portions 508 and their corresponding at least one aperture 510 can overlap one another. A suture can be used toform a plurality of stitches (for example, a plurality of in and out stitches) through the overlapping apertures 510, thereby securing the edge portions 508 together.

[0174] The outer skirt 506 can include at least one skirt portion woven from a plurality of weft threads or yarns 516 and a plurality of warp threads or yams 518. The plurality of weft and warp threads or yarns 516, 518 can be angled relative to a longitudinal axis 522 of the outer skirt 506. The longitudinal axis 522 can be parallel to the longitudinal axis of the frame and / or prosthetic heart valve when the outer skirt 506 is coupled to the frame. The plurality of weft and warp threads or yarns 516, 518 can be configured to pivot relative to each other.

[0175] In some examples, the skirt 506 can be assembled onto a frame (including any of the frames disclosed herein) when the frame is in an initial fabricated state that is equal to the smallest radially expanded working state of the frame. In such examples, the skirt 506 can assembled onto the frame in an initial, taut state, defined below. Assembling the skirt 506 onto a frame means placing the skirt 506 around the frame and securing the skirt 506 to the frame, such as by stitching the skirt 506 to struts of the frame. In some examples, assembling the skirt 506 onto the frame involves stitching the circumferential edge portions 508 together, sliding the skirt 506 onto the frame, and then stitching or otherwise securing the skirt 506 to the frame. In some examples, in the initial, taut state, the skirt 506 can be partially stretched or partially expanded. In some examples, in the initial, taut state, the skirt 506 fits snugly around the frame without any slack but is not necessarily stretched or expanded.

[0176] Assembling the skirt 506 on the frame when the frame is in the smallest radially expanded working state (rather than in a relatively larger state) can advantageously allow the skirt 506 to at least partially stretch and remain sufficiently taut around the frame at all diameters from the smallest radially expanded working state and the largest radially expanded working state. Conversely, if the skirt 506 is assembled onto the frame that is in a larger state (for example, the largest radially expanded working state), then the skirt 506 may be too loose if the prosthetic valve is implanted at a relatively smaller diameter. Moreover, it can be more difficult to slide a skirt over a frame at a relatively larger diameter.

[0177] Another advantage of assembling a partially stretched skirt onto the frame at the smallest radially expanded working state of the frame is that the skirt can promote even expansion of the frame. For example, if the prosthetic valve is under expanded (such as to a diameter that is slightly less than the smallest radially expanded working state), then the cells of the frame can expand unevenly such that some cells may be smaller than others. Thepartially stretched skirt can provide resistance against the expansion force applied to the frame (such as from a balloon), which can resist further expansion of the larger cells while allowing further expansion of the under expanded cells until all of the cells are more evenly expanded.

[0178] FIG. 13 A is a flattened view of the outer skirt 506, wherein the outer skirt 506 is shown in the initial, taut state. When assembled onto a frame, the initially taut skirt 506 can have an annular shape surrounding the frame. However, for purposes of illustration, FIG. 13A does not show a frame and shows the initially taut skirt 506 in a flattened shape rather than in an annular shape. The “initial, taut state” of the skirt 506 refers to the state of the skirt 506 when the skirt 506 is initially assembled onto a frame. In the initial, taut state, the skirt 506 does not have any slack in the circumferential direction and fits snugly around the outer surface of a frame in an initial fabricated state that is equal to a smallest radially expanded working state. Furthermore, when the skirt 506 is in the initial, taut state, each of the plurality of weft and warp threads 516, 518 of the skirt 506 can form an angle 520a relative to the longitudinal axis 522 that is approximately 45 degrees (for example, + 5 degrees). Thus, each one of the plurality of weft threads or yams 516 can be configured to be perpendicular to each one of the plurality of warp threads or yams 518 when the skirt 506 is in the initial, taut state. In this way, the initially taut skirt 506 can fit tautly or snugly around a frame in an initial fabricated state, yet be capable of further expansion or stretching (via the rotation of the weft and warp threads or yams 516, 518 from a perpendicular orientation to a parallel orientation, as further described with reference to FIG. 13B) when the frame is expanded to a larger radially expanded working state.

[0179] In some examples, the skirt 506 can be in the initial, taut state without any tensioning of the skirt 506 in the circumferential direction and / or without any tensioning or rotation of the weft and warp fibers or yarns 516, 518. In some examples, the skirt 506 can be slightly tensioned in the circumferential direction to bring the skirt 506 into the initial, taut state. In some examples, the warp and weft fibers or yarns 516, 518 of the skirt 506 can be slightly tensioned or rotated to bring the skirt 506 into the initial, taut state.

[0180] FIG. 13B is a flattened view of the skirt 506, representing a circumferentially stretched and expanded state of the skirt 506 after a prosthetic heart valve including the skirt 506 is expanded to the largest radially expanded working state. This can be referred to as the “fully stretched state,” a “fully expanded state,” and / or a “final state” of the skirt 506. In this state, each of the plurality of weft and warp threads or yarns 516, 518 can be configured to form an angle 520b relative to the longitudinal axis 522 that is approximately 90 degrees (for example,± 5 degrees). Thus, each one of the plurality of weft threads or yams 516 can form an obtuse angle with at least one corresponding one of the plurality of warp threads or yams 518 when the outer skirt 506 is in the fully stretched state. In this way, the plurality of weft and warp threads or yams 516, 518 can pivot relative to each other to accommodate the expansion and / or stretching of the skirt 506 when the skirt 506 is circumferentially expanded from the initial, taut state to the final, fully stretched state. As noted, the skirt 506, when in the initial, taut state, optionally can be stretched to some degree. In such cases, the final, fully stretched state of the skirt 506 can be a further stretched state. For example, in the fully stretched state, the plurality of weft threads or yarns 516 of the skirt 506 can form a substantially 180 degree angle with the plurality of warp threads or yams 518, such that the plurality of weft and warp threads or yams 516, 518 cannot continue to pivot to form a greater angle therebetween. In such examples, since the skirt 506 is less amenable to continued expansion and / or stretching after the plurality of weft and warp threads or yarns 516, 518 are perpendicular or substantially perpendicular to the longitudinal axis 522, the skirt 506 can beneficially provide added resistance to further expansion in order to help prevent over-expansion of the prosthetic heart valve and / or promote even expansion of the frame of the prosthetic heart valve.

[0181] In some examples, a difference of the diameter of the skirt 506 in the final, fully stretched state and the diameter of the outer skirt 506 in the initial, taut state is greater or equal to at least 5% of the diameter of the outer skirt 506 in the initial, taut state, such as 10%, 15%, etc.

[0182] FIG. 14 is a flattened view of a leaflet 612 of a valvular structure / assembly for a prosthetic heart valve, according to an example. A valvular structure can include a plurality of such leaflets 612. Similar to leaflets 112, the leaflets 612 can be secured to one another at their adjacent sides to form a resulting valvular stmcture. The leaflets 612 (and resulting valvular structure) can be used in conjunction with any frame and / or skirt described herein and / or can be used to form any prosthetic heart valve disclosed herein.

[0183] As shown, each leaflet 612 can comprise opposing lower commissure tabs 615 disposed on opposite sides of the leaflet 612, opposing upper commissure tabs 616 disposed on opposite sides of the leaflet 612 and disposed above a corresponding one of the lower commissure tabs 615, and a cusp edge portion 613 extending between the opposing lower and upper commissure tabs 615 and 616. As shown, each one of the lower commissure tabs 615 includes a circumferential edge 617 and each one of the upper commissure tabs 616 includes a circumferential edge 618. As shown, the circumferential edge 617 of the left lower commissuretab 615 is parallel to but offset in a circumferential direction from the circumferential edge 618 of the corresponding left upper commissure tab 616. Similarly, as shown, the circumferential edge 617 of the right lower commissure tab 615 is parallel to but offset in a circumferential direction from the circumferential edge 618 of the corresponding right upper commissure tab 616. As shown, the circumferential edges 617, 618 of the lower and upper commissure tabs 615, 616 are parallel to a longitudinal axis of the leaflet 612. As shown, each leaflet 612 also includes a free edge 619 that extends between opposing ones of the lower and upper commissure tabs 615 and 616 opposite the cusp edge portion 613.

[0184] In some examples, the leaflet 612 can be designed and / or fabricated in part by superimposing a circle 620 over a portion of leaflet material, such as a piece of tissue (pericardial tissue) or synthetic material. The circle 620 can have a diameter substantially equal (for example, within 10%) to the initial fabricated diameter of the frame to which the resulting valvular structure is coupled. The circle 620 can comprise three portions having substantially equal axial heights or lengths: an upper third 624, a middle third 626, and a lower third 628. A first line 625 can be drawn between the upper third 624 and the middle third 626 and a second line 627 can be drawn between the middle third 626 and the lower third 628.

[0185] As shown, the free edge 619 substantially conforms to (for example, within 0.5 mm) the first line 625, such that the free edge 619 is substantially flat, straight, and / or linear. As further shown, the first line 625 is disposed between the lower commissure tabs 615 and the upper commissure tabs 616 with the first line 625 extending through the opposing ends of the free edge 619. Thus, the free edge 619 can be formed by cutting the leaflet material substantially along the first line 625.

[0186] As shown, the cusp edge portion 613 substantially conforms to (for example, within 0.5 mm) the circular arc of the lower third 628, such that the cusp edge portion 613 is substantially arc-shaped. As further shown, the upper ends of the cusp edge portion 613 intersect the circle 620 at the same locations where the second line 627 intersects the circle 620. Thus, the cusp edge portion 613 can be formed by cutting the leaflet material substantially along the circular arc of the lower third 628 of the circle 620.

[0187] By designing the cusp edge portion 613 of the leaflet 612 to substantially conform to the circular arc having a diameter substantially equal to the initial fabricated diameter of the frame, the leaflet 612 and resulting valvular structure can be “sized” to fit the frame. A valvular structure that is sized to fit a frame beneficially requires minimal, if any, stretching in order toattach (for example, suture) the cusp edge portion 613 to the frame and / or an inner skirt attached to the frame, thereby simplifying the prosthetic heart valve fabrication process. Furthermore, a valvular structure that is sized to fit a frame having a range of working diameters can beneficially exhibit more consistent performance across the range of working diameters.

[0188] Tn some examples, the leaflets 612 are sized to the initial fabricated diameter of the frame that is equal to the smallest working diameter of the frame. In this way, the leaflets 612 can be assembled onto the frame with minimal or no stretching of the leaflets 612. If the prosthetic heart valve is expanded to a working diameter than is greater than the smallest working diameter, the leaflets 612 can stretch to some degree while still maintaining full coaptation within the working range of the prosthetic heart valve. In some examples, the leaflets 612 can stretch at least about 10% while maintaining full coaptation within the entire working range of the prosthetic heart valve. In one example, the leaflets 612 can be sized for a 26 mm frame of a prosthetic valve that has a working range from 26 mm to 29 mm and can maintain full coaptation within this working range; that is, for a prosthetic heart valve having a working range from 26 mm to 29 mm, the frame can be cut to have an initial diameter of 26 mm and the leaflets 612 can be cut to match the 26 mm frame (for example, a 26 mm circle 620 can be used to cut the leaflets 612).

[0189] In some examples, a prosthetic heart valve can be formed by cutting the leaflets 612 to match the smallest working diameter of the frame, but the frame can be cut from a tube having an initial fabricated diameter that is greater than the smallest working diameter (such as the largest working diameter), and then the cut frame can be radially compressed to the smallest working diameter. The leaflets can then be assembled on the compressed frame.

[0190] FIG. 15 is a flattened view of a leaflet 712 of a valvular structure for a prosthetic heart valve, according to an example. The leaflet 712 and the leaflet 612 shown in FIG. 14 can share certain similar features, which are referred to using similar reference numbers (offset in increments of hundreds). For example, the leaflet 712 can comprise a cusp edge portion 713, lower commissure tabs 715 disposed above the cusp edge portion 713, upper commissure tabs 716 disposed above the lower commissure tabs 715, and a free edge 719 extending between the lower commissure tabs 715. One exemplary difference between the leaflet 712 and the leaflet 612 is that the leaflet 712 comprises lower commissure tabs 715 and upper commissure tabs 716 whose circumferential edges 717, 718 are angled relative to a longitudinal direction of the leaflet 712. Any of the methods and techniques for sizing leaflets and assembling themto a frame described above can be used to form a prosthetic heart valve incorporating leaflets 712.

[0191] FIGS. 16A-16D are side views of a portion of a frame 802 of a prosthetic heart valve as the frame 802 is sequentially expanded from a first radially expanded working state to a fourth radially expanded working state, wherein the fourth radially expanded working state is the largest radially expanded working state of the frame 802. In some examples, the frame 802 is representative of the frames disclosed herein (for example, frames 102, 302, 402, etc.) and FIGS. 16A-16D show how any one of these frames can be expanded within a native heart valve or a previously implanted prosthetic heart valve in a valve-in-valve procedure. The frame 802 includes two angled struts 836 disposed at an outflow end 810 of the frame 802. The frame 802 further includes an apex region 852 disposed between the two angled struts 836. The apex regions 852 forms an angle 880 (which is also referred to herein as an “apex angle” and / or an “outflow angle”) between the two angled struts 836 extending from either side of the apex region 352. Since the angled stmts 836 are disposed at the outflow end 810 of the frame 802, the angled stmts 836 can also be referred to herein as “outflow stmts.” In some examples, the angled stmts 836 can be “inflow stmts” at an inflow end of the frame 802.

[0192] FIGS. 16A and 16B show the portion of the frame 802 expanded to first and second radially expanded working states, respectively, wherein the second radially expanded working state is larger than the first radially expanded working state. As shown, the angle 880 between the outflow stmts 836 is less than 180 degrees when the frame 802 is radially expanded to the first and second radially expanded working states.

[0193] FIGS. 16C and 16D show the portion of the frame 802 expanded to third and fourth radially expanded working states, respectively, wherein the fourth radially expanded working state is larger than each of the first, second, and third radially expanded working states. The fourth radially expanded working state can be the largest working state of the frame 802. In some examples, the fourth radially expanded state (FIG. 16D) can be an over-expanded state that is achieved by inflating the balloon (for example, balloon 218) of a delivery apparatus with sufficient pressure to cause the apex region 852 to plastically expand and lengthen in a circumferential direction, thereby increasing the diameter of the frame 802 from the third radially expanded state (FIG. 16C) to the fourth radially expanded state (FIG. 16D). As shown, the angle 880 between the outflow stmts 836 is a substantially 180 degree angle (for example, ±10%, ±5%) when the frame is expanded to the third and fourth radially expanded working states. Thus, the outflow stmts 836 are substantially parallel and form a flattened configurationwhen the frame 802 is in the third or fourth working states. In some examples, each pair of outflow struts 836 can form a flattened configuration when the frame 802 is in the third or fourth working states. In some examples, only a subset of the outflow struts 836 (for example, only one pair of outflow struts 836) can form a flattened configuration when the frame 802 is in the third or fourth working states.

[0194] The angled struts 836 define an upper boundary of an outflow end of a cell (which is also referred to herein as an “outflow cell” and / or an “upper cell”), which can have the same shape and configuration as the cell 118 shown in FIGS. 1 and 3. In some examples, it can be desirable to size the upper cell to allow the passage of a surgical tool (for example, a 6Fr. coronary catheter) therethrough if additional intervention (for example, a subsequent implant or repair procedure) is required after the implantation of the prosthetic heart valve. Thus, sizing the upper cell to allow for the passage of a surgical tool can improve the serviceability of the prosthetic heart valve.

[0195] The serviceability of the prosthetic heart valve can be further improved by enlarging a gap formed between the outflow end 810 of the frame 802 and the subject’s vasculature. For example, the gap can be formed between the outflow struts 836 and the subject’s vasculature at the sinotubular junction level. It has been discovered that configuring the frame 802 to form a substantially 180 degree angle (for example, ±10%, ±5%) at larger working states (for example, the third and fourth working states shown in FIGS. 16C and 16D) lowers the position of the outflow stmts 836 and increases the size of this gap, thereby allowing for the passage of larger catheters or other surgical tools through this gap. Thus, the gap between the outflow stmts 836 and the subject’s vasculature at the sinotubular junction level can provide an additional or alternative passageway for catheters and other surgical implements.

[0196] Thus, a method can include steering a coronary catheter towards the subject’s coronary ostia through the gap formed between the outflow stmts 836 and the subject’s vasculature at the sinotubular junction level, instead of passing the coronary catheter through an opening of the outflow cell).

[0197] In some examples, one or more pairs of inflow stmts can additionally or alternatively be configured to form a flattened configuration when the frame 802 is in the third or fourth working states.

[0198] FIG. 17 is a side view of a portion of a frame 902 of a prosthetic heart valve, wherein the frame 902 is in a radially expanded working state, according to an example. The frame 902includes a plurality of angled struts 936 (which are also referred to herein as “outflow struts”). Each angled strut 936 includes a first end coupled to an adjacent angled strut 936 and a second end coupled to an axial strut 940 or a commissure window strut 938. The prosthetic heart valve incorporating the frame 902 can incorporate any of the features disclosed herein for the prosthetic heart valves 100, 300 and / or can incorporate any of the skirts or leaflets disclosed in FIGS. 13A, 13B, 14, and / or 15. Additionally, the prosthetic heart valve incorporating the frame 902 can be made by any of the methods and techniques disclosed herein.

[0199] Adjacent ones of the angled struts 936 are joined at an apex region 952 that forms a junction between the two angled struts 936 at an outflow end 910 of the frame 902. The apex region 952 defines an angle 980 (which is also referred to herein as an “apex angle” or an “outflow angle”). The angle 980 can be equal to other angles previously disclosed herein (for example, any one of angles 180, 380, 480). In some examples, the angle 980 can be in a range from 100 degrees to 130 degrees, such as from 110 degrees to 130 degrees, from 110 degrees to 120 degrees, from 1 15 degrees to 125 degrees, etc. when the frame 902 is in the radially expanded working state. In some examples, the angle 980 can be in a range from 130 degrees to 179 degrees, such as from 130 degrees to 150 degrees, from 130 degrees to 150 degrees, from 135 degrees to 145 degrees, from 140 degrees to 179 degrees, from 150 degrees to 179 degrees, from 140 degrees to 160 degrees, from 140 degrees to 150 degrees, from 145 degrees to 155 degrees, etc. when the frame 902 is in the radially expanded working state.

[0200] Each commissure window strut 938 (similar to window struts 138) can include a commissure window 942 (similar to commissure windows 142). Half of the commissure window strut 938 and half of the commissure window 942 are shown in FIG. 17. Each commissure window 942 can have an outflow end 944. As shown, the commissure window strut 938 and the axial strut 940 are elongated above a level of the outflow ends of the commissure windows, wherein the level is indicated by a dashed line 943. In other words, outflow ends of the axial struts 940 can be disposed further towards the outflow end 910 of the frame 902 than the outflow ends 944 of the commissure windows 942.

[0201] Each axial strut 940 and commissure window strut 938 is connected to a corresponding angled strut 936 at a junction 941. The junctions 941 are spaced apart in the axial direction from the level of the outflow ends 944 of the commissure windows 942 (in other words, line 943) by a distance 946. In some examples, the free edges of the leaflets (for example, leaflets 112) attached to the frame 902 are at the same level as the outflow ends 944 of the commissure windows 938. In such examples, the junctions 941 are also spaced apart in the axial directionfrom the outflow edges of the leaflets by the distance 946. In some examples, the distance 946 can be at least approximately 0.3 millimeters (for example, ±10%), for example, at least approximately 0.33 millimeters for a 20-mm diameter frame, at least 1.6 millimeters for a 23- mm diameter frame, at least approximately 1.7 millimeters for a 29-mm diameter frame, or at least 2.3 millimeters for a 32-mm diameter frame. In some examples, the distance 946 can be in a range from approximately 0.3 millimeters to approximately 3 millimeters, such as a range from approximately 0.3 millimeters to approximately 2.8 millimeters.

[0202] The combination of the angle 980 (which can be greater than similar angles in conventional prosthetic heart valve frames) formed by the angled struts 936 and the increased length of the axial struts 940 (which can be longer than similar axial struts in conventional prosthetic heart valve frames) can provide several benefits. For example, elongating the axial struts 940 can result in the angled struts 936, the axial struts 940, and the free edges of the leaflets (which can be coincident with the level of the outflow ends 944 of the commissure windows 942) attached to the frame 902 forming a lateral, pentagonal opening above the leaflets. This lateral opening can provide an area through which a catheter or other surgical implement can be passed. Additionally, elongating the axial strut 940 above the level of the outflow ends 944 of the commissure windows 942 (indicated by line 943) further distances the leaflets and their commissures from the native anatomy (for example, from the sinotubular junction level). The increased distance can further reduce the risk of tissue ingrowth or Pannus development over the commissures.

[0203] FIG. 18 is a side view of a portion of a frame 1002 of a prosthetic heart valve, wherein the frame 1002 is in a radially expanded working state, according to an example. The prosthetic heart valve incorporating the frame 1002 can incorporate any of the features disclosed herein for the prosthetic heart valves 100, 300 and / or can incorporate any of the skirts or leaflets disclosed in FIGS. 13A, 13B, 14 and 15. Additionally, the prosthetic heart valve incorporating the frame 1002 can be made by any of the methods and techniques disclosed herein.

[0204] The frame 1002 can include a plurality of angled struts 1030, 1032, 1033, 1034, and 1036 arranged in a plurality of circumferentially extending rows arrayed between an inflow end 1008 and an outflow end 1010. For example, as shown, a first row of the angled struts 1030 is arranged end-to-end and extending circumferentially at the inflow end 1008, a second row of the angled struts 1032 is disposed adjacent the first row, a third row of the angled struts 1033 is disposed adjacent the second row, a fourth row of the angled struts 1034 is disposed adjacent the third row, and a fifth row of the angled struts 1036 is arranged end-to-end andextending circumferentially at the outflow end 1010. The angled struts 1034, the angled struts 1036, commissure window struts 1038 extending between the angled struts 1034, 1036, and axial struts 1040 extending between the angled struts 1034, 1036 can define a cell 1018 (which is also referred to herein as an “outflow cell”), with angled struts 1034 defining an inflow end of the outflow cell 1018 and angled struts 1036 defining an outflow end of the outflow cell 1018.

[0205] The frame 1002 can further comprise a plurality of inflow apex regions 1052i formed at the inflow end 1008 of the frame and a plurality of outflow apex regions 1052o the outflow end 1010 of the frame. Each inflow apex region 1052i forms a junction between two of the angled struts 1030 at the inflow end 1008 of the frame 1002 and defines an inflow apex angle 1080i between the two angled struts 1030. Similarly, each outflow apex region 1052o forms a junction between two of the two angled struts 1036 at the outflow end 1010 of the frame 1002 and defines an outflow apex angle 1080o between the two angled struts 1036. As shown, the inflow apex angle 1080i and the outflow apex angle 1080o can he substantially equal (for example, ±10%, ±5%). For example, the inflow apex angle 1080i can equal 116 degrees and the outflow apex angle 1080o can equal 115 degrees.

[0206] Adjacent ones of the angled struts 1034 can define an angle 1090o (which is also referred to herein as a “first angle,” a “junction angle,” a “first junction angle,” an “interior angle,” and / or a “first interior angle”). As shown, the angle 1090o is substantially equal (for example, ±10%, ±5%) to the outflow apex angle 1080o. For example, the outflow apex angle 1080o can equal 115 degrees and the angle 1090o can equal 116 degrees. In this way, the angle of the struts 1034 at the inflow end of the outflow cell 1018 can be substantially equal to the angle of the struts 1036 at the outflow end of the outflow cell 1018. Stated otherwise, the angles 1080o, 1090o between the struts 1034, 1036 forming the outflow and inflow ends of the outflow cell 1018 are equal or substantially equal to each other. It has been discovered that the frame 1002 expands in a more even manner when the angles 1080o, 1090o are substantially equal to each other. Thus, configuring the angles 1080o, 1090o to be substantially equal to each other when the frame 1002 is deployed to a radially expanded working state can help the frame expand in a more even, uniform manner.

[0207] The first angle 1090o is formed on an outflow side of a junction 1082. A second angle 1090i is formed on an inflow side of the junction 1082. As shown, the second angle 1090i is less than the first angle 1090o. For example, the first angle 1090o can be equal to 116 degrees and the second angle 1090i can be equal to 67 degrees.

[0208] The first row of struts 1030 and the second row of struts 1032 form a first, inflow row of cells 1060; the second row of struts 1032 and the third row of struts 1033 form a second row of cells 1062, and the third row of struts 1033 and the fourth row of struts 1034 form a third row of cells 1064. The outflow row of cells 1018 defines a fourth row of cells. To accommodate the relatively larger angles 1090o in the fourth row of struts 1034, the struts 1032 and 1033 can be longer than the struts 1030 and 1034, and the cells 1062 can be longer in the axial direction than the cells 1060 and 1064. In some examples, as shown in FIG. 18, each cell 1060, 1064 can have a kite or diamond shape having two sides that are longer than two other sides. For examples, the two struts 1032 that form two sides of the cell 1060 are longer than the two struts 1030 that form the two other sides of the cell 1060. In some examples, the cells 1060 are mirror images of the cells 1064 with respect to a circumferential axis 1066 intersecting junctions between the cells 1060, 1064.

[0209] FIG. 19 is a side view of a portion of a frame 1102 of a prosthetic heart valve, wherein the frame 1 102 is in a radially compressed state, according to an example. The prosthetic heart valve incorporating the frame 1102 can incorporate any of the features disclosed herein for the prosthetic heart valves 100, 300 and / or can incorporate any of the skirts or leaflets disclosed in FIGS. 13A, 13B, 14 and 15. Additionally, the prosthetic heart valve incorporating the frame 1102 can be made by any of the methods and techniques disclosed herein.

[0210] The illustrated portion of the frame 1102 includes two pairs of angled struts 1136 disposed at an outflow end 1 110 of the frame 1 102. Also illustrated are two apex regions 1152, wherein each apex region 1152 forms a junction between the two angled struts 1136 in each pair of angled struts 1136. As shown, each angled strut 1136 in the illustrated pair defines a positive angle 1184 with a central longitudinal axis 1122 of the frame 1102 and a positive angle 1186 between adjacent struts 1136 when the frame 1102 is in the radially compressed state. The positive angle 1184 can be in a range from 0.1 degrees to 20 degrees, for example, from 0.1 degrees to 15 degrees, from 0.1 degrees to 10 degrees, from 0.1 degrees to 5 degrees, from 0.1 degrees to 4 degrees, from 0.1 degrees to 3 degrees, from 0.1 degrees to 2 degrees, and / or from 0.1 degrees to 1 degree. The angle 1186 is twice the angle 1184. Thus, the angled struts 1136 are not parallel to each other when the frame 1102 is in the radially compressed state. In some examples, each angled strut 1136 of the frame 1102 can define a positive angle with the central longitudinal axis 1122. In some examples, only a subset of the angled struts 1136 can define positive angles 1180 with the central longitudinal axis 1122. In some examples, one or more of angled struts (for example, each angled strut) atan inflow end of the frame 1102 can additionally or alternatively define a positive angle with the central longitudinal axis 1122.

[0211] In some examples, configuring the angle 1184 to be positive and / or configuring the angled struts 1136 to be non-parallel when the frame 1102 is in the radially compressed state can help prevent the pairs of angled struts 1 1 6 from contacting each other when the frame 1102 is crimped to the radially compressed state. Furthermore, configuring the angle 1184 to be positive and / or configuring the angled struts 1136 to be non-parallel when the frame 1102 is in the radially compressed state can help prevent a commissure window of the frame 1102 from bending in the radially inwards facing direction during crimping. In this way, soft components (for example, leaflets) pushing against the frame 1102 during crimping will not be focused on one region that bends the commissure windows, but will rather push in a relatively uniform manner against the entire frame 1102, pushing it radially inwards as a one-piece component. It should be understood that any prosthetic valve disclosed herein can include a frame with one or more angled struts at the inflow or outflow end that defines a positive angle with a central longitudinal axis of the frame.Delivery Apparatus

[0212] FIG. 4 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0213] The delivery apparatus 200 in the illustrated example of FIG. 4 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0214] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0215] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can he configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0216] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0217] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0218] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0219] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 4), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4, a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0220] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0221] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion224, when the prosthetic valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 4) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0222] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0223] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0224] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0225] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site).Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0226] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0227] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0228] In view of the above-described implementations of the disclosed subject matter, this application discloses the 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.

[0229] Example 1. A method of fabricating a prosthetic heart valve can include fabricating a frame having an initial fabricated state in which the frame has an initial fabricated diameter, mounting a skirt in an initial, taut state to the frame in the initial fabricated state, and coupling a valvular structure to the frame in the initial fabricated state. The frame can be configured to radially expand to any one of a smallest radially expanded working state in which the frame is configured to have a smallest working diameter and a largest radially expanded working state in which the frame is configured to have a largest working diameter. The largest working diameter can be greater than the initial fabricated diameter. The skirt in the initial, taut state can include a plurality of weft yams and a plurality of warp yams oriented at a 45 degree angle relative to a longitudinal axis of the frame. The skirt can be configured to expand to a fully stretched state when the frame is expanded to the largest radially expanded working state. Theplurality of weft yarns and the plurality of warp yarns of the skirt in the fully stretched state can be configured to be oriented at a 90 degree angle relative to the longitudinal axis of the frame. The valvular structure can include a plurality of leaflets, each with a cusp edge portion substantially conforming to a circular arc having a diameter substantially equal to the initial fabricated diameter of the frame.

[0230] Example 2. The method of any example herein, particularly Example 1, wherein fabricating the frame can include forming a plurality of angled struts of the frame.

[0231] Example 3. The method of any example herein, particularly Example 2, wherein adjacent ones of the plurality of angled struts can be coupled to form a corresponding one of a plurality of apex regions located at an end portion of the frame, an angle formed between the adjacent ones of the plurality of angled struts at each one of the plurality of apex regions can be less than a threshold angle, and the adjacent ones of the plurality of angled struts at each one of the plurality of apex regions can be configured to pivot as the frame is expanded to the largest radially expanded working state such that the angle formed between the adjacent ones of the plurality of angled struts is greater than the threshold angle.

[0232] Example 4. The method of any example herein, particularly Example 3, wherein the threshold angle can be in a range from 120 degrees to 140 degrees.

[0233] Example 5. The method of any example herein, particularly any one of Examples 1-4, wherein fabricating the frame can include cutting a tube having the initial fabricated diameter.

[0234] Example 6. The method of any example herein, particularly any one of Examples 1-5, wherein mounting the skirt in the initial, taut state to the frame in the initial fabricated state can include suturing the skirt to the frame.

[0235] Example 7. The method of any example herein, particularly any one of Examples 1-6, wherein mounting the skirt in the initial, taut state to the frame in the initial fabricated state does not include tensioning the skirt.

[0236] Example 8. The method of any example herein, particularly any one of Examples 1-7, wherein coupling the valvular structure to the frame in the initial fabricated state does not include stretching the plurality of leaflets of the valvular structure.

[0237] Example 9. A method can include cutting a tube having a first diameter to form a frame having the first diameter, coupling a skirt to the frame, and coupling a plurality of leafletsto the frame. The frame can be compressible from the first diameter to a second diameter less than the first diameter for delivery into a patient via catheterization. The frame can be expandable from the second diameter to a third diameter that is greater than the second diameter. The third diameter can be one of a plurality of working diameters of the frame that includes a smallest working diameter and a largest working diameter, in which the largest working diameter is greater than the first diameter.

[0238] Example 10. The method of any example herein, particularly Example 9, wherein the tube can be formed from a plastically-expandable metal.

[0239] Example 11. The method of any example herein, particularly any one of Examples 9- 10, wherein cutting the tube to form the frame can include cutting the tube to form a plurality of struts of the frame, and the plurality of struts can be arranged in a circumferentially extending row at an end portion of the frame.

[0240] Example 12. The method of any example herein, particularly Example 11, wherein adjacent ones of the plurality of struts can define an angle therebetween.

[0241] Example 13. The method of any example herein, particularly Example 12, wherein the angle can be less than a critical angle, and the angle can be configured to be greater than the critical angle after the frame is expanded to the third diameter.

[0242] Example 14. The method of any example herein, particularly Example 13, wherein the critical angle can be in a range from 120 degrees to 140 degrees.

[0243] Example 15. The method of any example herein, particularly any one of Examples 9-14, wherein the skirt can be coupled to an outer surface of the frame.

[0244] Example 16. The method of any example herein, particularly any one of Examples 9-15, wherein the skirt is in an initial, taut state when coupled to the frame.

[0245] Example 17. The method of any example herein, particularly Example 16, wherein the skirt can include a plurality of warp threads and a plurality of weft threads, and wherein the plurality of warp threads and the plurality of weft threads of the skirt in the initial, taut state can be oriented at an approximately 45-degree angle relative to a central longitudinal axis of the frame.

[0246] Example 18. The method of any example herein, particularly Example 17, wherein the skirt can be stretchable from the initial, taut state to a fully stretched state, the skirt can be configured to stretch to the fully stretched state as the frame expands to the third diameter, andthe plurality of weft threads and the plurality of warp threads of the skirt in the fully stretched state can be configured to be oriented at an approximately 90-degree angle relative to the central longitudinal axis of the frame.

[0247] Example 19. The method of any example herein, particularly any one of Examples 9-18, wherein the method can further include, prior to coupling the plurality of leaflets to the frame, for each one of the plurality of leaflets, cutting a portion of leaflet material along a circular arc having a diameter equal to the first diameter of the frame to form a cusp edge portion.

[0248] Example 20. The method of any example herein, particularly any one of Examples 9-19, wherein the method can further include, prior to coupling the plurality of leaflets to the frame, for each one of the plurality of leaflets, forming at a plurality of commissure tabs, coupling adjacent ones of the plurality of leaflets at adjacent ones of the plurality of commissure tabs, and coupling the plurality of commissure tabs to the frame.

[0249] Example 21. The method of any example herein, particularly Example 20, wherein forming at least one commissure tab can include forming a pair of lower commissure tabs and forming a pair of upper commissure tabs.

[0250] Example 22. The method of any example herein, particularly any one of Examples 9- 21, wherein the plurality of working diameters can span from 22 millimeters to 24 millimeters.

[0251] Example 23. The method of any example herein, particularly any one of Examples 9- 21, wherein the plurality of working diameters can span from 26 millimeters to 29 millimeters.

[0252] Example 24. A method can include compressing a prosthetic heart valve comprising a frame, a skirt, and a valvular structure from an initial fabricated state to a crimped state, and expanding the prosthetic heart valve from the crimped state to any one of a plurality of working states including a smallest working state and a largest working state. The frame can include a plurality of apex regions and an angle defined by each apex region. The angle defined by each apex region of the prosthetic heart valve in the initially fabricated state can be less than a threshold angle. A diameter of the prosthetic heart valve in the largest working state can be greater than a diameter of the prosthetic heart valve in the initial fabricated state. The angle defined by each apex region of the frame of the prosthetic heart valve in the largest working state can be greater than the threshold angle.

[0253] Example 25. The method of any example herein, particularly Example 24, wherein the diameter of the prosthetic heart valve in the initial fabricated state can be substantially equal to a diameter of the prosthetic heart valve in the smallest working state.

[0254] Example 26. The method of any example herein, particularly any one of Examples 24-25, wherein the skirt can include a plurality of weft threads and a plurality of warp threads, each one of the plurality of weft threads can be substantially perpendicular to each one of the plurality of warp threads when the prosthetic heart valve is in the initial fabricated state, and each one of the plurality of weft threads can be substantially parallel to each one of the plurality of warp threads when the prosthetic heart valve is in the largest working state.

[0255] Example 27. The method of any example herein, particularly any one of Examples 24-26, wherein the valvular structure of the prosthetic heart valve in any one of the plurality of working states can be capable of full coaption.

[0256] Example 28. The method of any example herein, particularly any one of Examples 24-27, wherein the compressing the prosthetic heart valve from the initial fabricated state to the crimped state can include mounting the prosthetic heart valve around a catheter balloon.

[0257] Example 29. The method of any example herein, particularly Example 28, wherein expanding the prosthetic heart valve from the crimped state to any one of the plurality of working states can include inflating the catheter balloon.

[0258] Example 30. A prosthetic valve can include an annular frame with a plurality of struts and a valvular structure coupled to the annular frame. The annular frame can have an initial fabricated diameter. The annular frame can be configured to be compressed from the initial fabricated diameter to a compressed diameter for delivery into a patient via catheterization. The annular frame can be configured to be expanded from the compressed diameter to any expanded working diameter in a range of expanded working diameters that includes a smallest expanded working diameter and a largest expanded working diameter, wherein the initial fabricated diameter is less than the largest expanded working diameter in the range of expanded working diameters.

[0259] Example 31. The prosthetic valve of any example herein, particularly Example 30, wherein the initial fabricated diameter can be greater than the smallest expanded working diameter.

[0260] Example 32. The prosthetic valve of any example herein, particularly Example 30, wherein the initial fabricated diameter can be equal to the smallest expanded working diameter.

[0261] Example 33. The prosthetic valve of any example herein, particularly Example 30, wherein the initial fabricated diameter can be less than the smallest expanded working diameter.

[0262] Example 34. The prosthetic valve of any example herein, particularly any one of Examples 30-33, wherein the range of expanded working diameters can span from 22 millimeters to 24 millimeters.

[0263] Example 35. The prosthetic valve of any example herein, particularly any one of Examples 30-33, wherein the range of expanded working diameters can span from 26 millimeters to 29 millimeters.

[0264] Example 36. The prosthetic valve of any example herein, particularly any one of Examples 30-35, wherein a difference of the largest expanded working diameter and the smallest expanded working diameter can be greater than or equal to two millimeters.

[0265] Example 37. The prosthetic valve of any example herein, particularly any one of Examples 30-35, wherein a difference of the largest expanded working diameter and the smallest expanded working diameter can be greater than or equal to three millimeters.

[0266] Example 38. The prosthetic valve of any example herein, particularly any one of Examples 30-37, wherein adjacent ones of the plurality of struts can form a corresponding one of a plurality of apex regions, wherein each one of the plurality of apex regions can be disposed at an end portion of the annular frame.

[0267] Example 39. The prosthetic valve of any example herein, particularly Example 38, wherein each of the plurality of apex regions can define an angle less than a critical angle when the annular frame is at the initial fabricated diameter.

[0268] Example 40. The prosthetic valve of any example herein, particularly Example 39, wherein the annular frame can be configured such that each of the plurality of apex regions defines an angle that is greater than the critical angle when the annular frame is expanded to the largest expanded working diameter.

[0269] Example 41. The prosthetic valve of any example herein, particularly any one of Examples 30-40, wherein the valvular structure can include a plurality of leaflets, each one of the plurality of leaflets can include a cusp edge portion that defines a substantially circular arc, and the substantially circular arc can have a diameter equal to the initial fabricated diameter of the annular frame.

[0270] Example 42. The prosthetic valve of any example herein, particularly any one of Examples 30-41, wherein the prosthetic valve can further include a skirt coupled to the annular frame having the initial fabricated diameter, wherein the skirt can assume a initial, taut state.

[0271] Example 43. The prosthetic valve of any example herein, particularly Example 42, wherein the skirt can be configured to assume a fully stretched state when the annular frame is expanded to the largest expanded working diameter.

[0272] Example 44. A prosthetic heart valve can include a frame comprising a central longitudinal axis and a plurality of struts oriented at an angle relative to the central longitudinal axis, wherein adjacent ones of the plurality of struts are coupled to form a corresponding one of a plurality of apex regions located at an end portion of the frame, an outer skirt coupled to the frame; and a valvular structure coupled to the frame. The frame can have an initial fabricated diameter. The frame can be compressible from the initial fabricated diameter to a crimped diameter. The frame can be expandable from the crimped diameter to any one of a plurality of working diameters including a smallest working diameter and a largest working diameter. The initial fabricated diameter can be less than the largest working diameter. Each one of the plurality of apex regions can define a first angle. Each one of the plurality of apex regions can be configured to define a second angle greater than the first angle when the frame is expanded to the largest working diameter.

[0273] Example 45. The prosthetic heart valve of any example herein, particularly Example 44, wherein the plurality of apex regions can be disposed at an inflow end portion of the frame.

[0274] Example 46. The prosthetic heart valve of any example herein, particularly Example 44, wherein the plurality of apex regions can be disposed at an outflow end portion of the frame.

[0275] Example 47. The prosthetic heart valve of any example herein, particularly any one of Examples 44-46, wherein the outer skirt can have an initial, taut state when the frame is at the initial fabricated diameter.

[0276] Example 48. The prosthetic heart valve of any example herein, particularly Example47, wherein the outer skirt can include a plurality of warp threads and a plurality of weft threads, and the plurality of weft threads and the plurality of warp threads can be oriented at an approximately 45 degree angle relative to the central longitudinal axis of the frame when the outer skirt is coupled to the frame having the initial fabricated diameter.

[0277] Example 49. The prosthetic heart valve of any example herein, particularly Example48, wherein the plurality of weft threads and the plurality of warp threads can be configured torotate to be oriented at an approximately 90 degree angle relative to the central longitudinal axis of the frame when the frame is expanded to the largest working diameter.

[0278] Example 50. A prosthetic heart valve can include a frame, an outer skirt coupled to the frame; and a valvular structure coupled to the frame. The frame can have a first, initial fabricated diameter. The frame can be radially compressible to a second diameter less than the first diameter for delivery into a patient via catheterization. The frame can be radially expandable to any third, final working diameter in a range of working diameters, wherein the third diameter can be greater than the first diameter. The valvular structure can be sized to the first diameter of the frame.

[0279] Example 51. The prosthetic heart valve of any example herein, particularly Example50, wherein the valvular structure sized to the first diameter of the frame can include a plurality of leaflets, and each one of the plurality of leaflets can include a cusp edge portion that that defines a circular arc having a diameter equal to the first diameter of the frame.

[0280] Example 52. The prosthetic heart valve of any example herein, particularly Example51, wherein each one of the plurality of leaflets can include a substantially straight free edge.

[0281] Example 53. The prosthetic heart valve of any example herein, particularly any one of Examples 51-52, wherein each one of the plurality of leaflets can include a first commissure tab and a second commissure tab disposed on opposite sides of the leaflet, the first commissure tab can include a first circumferential edge, and the second commissure tab can include a second circumferential edge.

[0282] Example 54. The prosthetic heart valve of any example herein, particularly Example 53, wherein the first circumferential edge and the second circumferential edge can be parallel to a longitudinal axis of the leaflet.

[0283] Example 55. The prosthetic heart valve of any example herein, particularly Example 53, wherein the first circumferential edge and the second circumferential edge can be angled relative to a longitudinal axis of the leaflet.

[0284] Example 56. A prosthetic heart valve can include a radially compressible and expandable frame, a valvular structure coupled to an inner surface of the frame, and an annular skirt in an initial, taut state coupled to an outer surface of the frame. The frame can have an initial fabricated state in which the frame defines an initial fabricated diameter. The frame can be configured to be radially expandable to a radially expanded working state within a range including a smallest radially expanded working state and a largest radially expanded workingstate. The frame in the smallest radially expanded working state can have a smallest expanded working diameter. The frame in the largest radially expanded working state can have a largest expanded working diameter. The annular skirt can be configured to be stretchable to a fully stretched state when the frame is radially expanded to the largest radially expanded working state.

[0285] Example 57. The prosthetic heart valve of any example herein, particularly Example56, wherein the annular skirt can include a plurality of warp threads and a plurality of weft threads.

[0286] Example 58. The prosthetic heart valve of any example herein, particularly Example57, wherein the plurality of weft threads and the plurality of warp threads of the annular skirt in the initial, taut state can be oriented at approximately 45 degrees relative to a central longitudinal axis of the prosthetic heart valve.

[0287] Example 59. The prosthetic heart valve of any example herein, particularly Example58, wherein the plurality of weft threads and the plurality of warp threads of the annular skirt in the fully stretched state can be configured to be oriented at approximately 90 degrees relative to the central longitudinal axis of the prosthetic heart valve.

[0288] Example 60. A prosthetic heart valve can include a frame with a central longitudinal axis and a plurality of angled struts disposed at an end portion of the frame, a leaflet structure coupled to an inner surface of the frame, and an outer skirt coupled to an outer surface of the frame. Adjacent ones of the plurality of angled struts can be connected at their adjacent ends to form a corresponding one of a plurality of apex regions. The frame is in an initial fabricated state in which each one of the plurality of apex regions forms an angle that is less than a critical angle. The frame can be configured to be expandable to any one of a smallest radially expanded working state and a largest radially expanded working state, in which each one of the plurality of apex regions is configured to form an angle that is greater than the critical angle.

[0289] The leaflet structure can include a plurality of leaflets that each include a cusp edge portion defining a circular arc having a diameter equal to a diameter of the frame in the initial fabricated state. The outer skirt can include a plurality of weft threads and a plurality of warp threads. The outer skirt can be in an initial, taut state. The plurality of weft threads and the plurality of warp threads of the outer skirt in the initial, taut state can be oriented at a 45-degree angle relative to the central longitudinal axis of the frame. The outer skirt can be configured to be expandable to a fully stretched state. The plurality of weft threads and the plurality ofwarp threads of the outer skirt in the fully stretched state can be configured to be oriented at a 90-degree angle relative to the central longitudinal axis of the frame.

[0290] Example 61. A prosthetic heart valve can include an annular frame having a largest expanded working diameter. The annular frame can include a central longitudinal axis and a pair of struts oriented at an angle relative to the central longitudinal axis and coupled at their adjacent ends to form an apex region at an end of the annular frame. The pair of struts can be in a flattened configuration in which the struts of the pair form a substantially 180 degree angle therebetween. The prosthetic heart valve can further include a valvular structure coupled to the annular frame.

[0291] Example 62. The prosthetic heart valve of any example herein, particularly Example 61 , wherein the pair of struts can form an apex region at an outflow end of the annular frame.

[0292] Example 63. The prosthetic heart valve of any example herein, particularly any one of Examples 61-62, wherein the annular frame can include a plurality of pairs of struts that form a plurality of apex regions at the end of the annular frame, and wherein each one of the plurality of pairs of struts are in the flattened configuration.

[0293] Example 64. The prosthetic heart valve of any example herein, particularly any one of Examples 61-63, wherein the annular frame can be configured to be compressed to a radially compressed state, wherein at least one strut of the pair of struts can form a positive angle with the central longitudinal axis when the frame is in the radially compressed state, and wherein the positive angle can be in a range from 0.1 degrees to 5 degrees.

[0294] Example 65. A prosthetic heart valve can include an annular frame having an expanded state. The annular frame can include a central longitudinal axis, a pair of axial struts that are parallel to the central longitudinal axis, and a pair of angled struts that are angled relative to the central longitudinal axis. Each angled strut can include a first end and a second end. The angled struts can be connected at their first ends to form an angle therebetween. The angle can be in a range from 130 degrees to 179 degrees. The second end of each angled strut can be connected at a junction to a corresponding one of the pair of axial struts. The annular frame can further include a window strut comprising a commissure window, wherein each junction can be disposed further in an outflow direction of the annular frame from an outflow end of the commissure window. The prosthetic heart valve can further include a leaflet structure coupled to the annular frame at the commissure window.

[0295] Example 66. The prosthetic heart valve of any example herein, particularly Example 65, wherein the angle can be in a range from 140 degrees to 150 degrees.

[0296] Example 67. The prosthetic heart valve of any example herein, particularly any one of Examples 65-66, wherein the pair of axial struts, the pair of angled struts, and the leaflet structure can define a lateral opening of the prosthetic heart valve.

[0297] Example 68. The prosthetic heart valve of any example herein, particularly any one of Examples 65-67, wherein the annular frame can be configured to be crimped to a radially compressed state, wherein at least one strut of the pair of struts can form a positive angle with the central longitudinal axis of the annular frame in the radially compressed state, and wherein the positive angle can be in a range from 0. 1 degrees to 5 degrees.

[0298] Example 69. The prosthetic heart valve of any example herein, particularly any one of Examples 65-68, wherein the leaflet structure can include a plurality of leaflets having outflow edges, and wherein the outflow edges can be spaced apart in an axial direction from the junctions.

[0299] Example 70. The prosthetic heart valve of any example herein, particularly any one of Examples 65-69, wherein the junctions can be spaced from the outflow end of the commissure window in an axial direction by at least 1.5 mm.

[0300] Example 71. A prosthetic heart valve can include an annular frame having an expanded state. The annular frame can include a central longitudinal axis, an axial strut extending parallel to the central longitudinal axis, a commissure window strut extending parallel to the central longitudinal axis and including a commissure window; and a pair of angled struts with a first angled strut connected to a second angled strut. The first angled strut and the axial strut can be connected at a first junction, and the second angled strut and the commissure window strut can be connected at a second junction. The prosthetic heart valve can further include a leaflet structure coupled to the commissure window of the commissure window strut and including an outflow edge, wherein the outflow edge of the leaflet structure can be spaced apart in a direction of the central longitudinal axis from both the first junction and the second junction.

[0301] Example 72. The prosthetic heart valve of any example herein, particularly Example 71, wherein the axial strut, the commissure window strut, the pair of angled struts, and the outflow edge of the leaflet structure can define a lateral opening of the prosthetic heart valve.

[0302] Example 73. The prosthetic heart valve of any example herein, particularly Example 72, wherein the lateral opening can be pentagonal.

[0303] Example 74. The prosthetic heart valve of any example herein, particularly any one of Examples 71-73, wherein an axial distance between the outflow edge of the leaflet structure and the first junction or the second junction can be in a range from 1 .5 millimeters to 2 millimeters.

[0304] Example 75. A prosthetic heart valve can include an annular frame having a radially expanded state. The annular frame can include a first axial end portion, a second axial end portion, a first plurality of angled struts defining a first circumferentially extending row at the first axial end portion of the annular frame, and a second plurality of angled struts defining a second circumferentially extending row between the first axial end portion and the second axial end portion, wherein at least one pair of the first plurality of angled struts can form a first angle therebetween, a corresponding pair of the second plurality of angled struts can form a second angle therebetween, and the first angle can be substantially equal to the second angle.

[0305] Example 76. The prosthetic heart valve of any example herein, particularly Example 75, wherein the second circumferentially extending row can be axially adjacent the first circumferentially extending row.

[0306] Example 77. The prosthetic heart valve of any example herein, particularly any one of Examples 75-76, wherein the pair of the first plurality of angled struts can define an first end of a cell, and wherein the pair of the second plurality of angled struts can define a second end of the cell.

[0307] Example 78. The prosthetic heart valve of any example herein, particularly any one of Examples 75-77, wherein the first axial end portion of the annular frame can be an outflow end portion of the annular frame.

[0308] Example 79. The prosthetic heart valve of any example herein, particularly Example 78, wherein the second circumferentially extending row can be adjacent the first circumferentially extending row, the frame can include a third plurality of angled struts defining a third circumferentially extending row adjacent the second row, the frame can include a fourth plurality of angled struts defining a fourth circumferentially extending row adjacent the third row; and the frame can include a fifth plurality of angled struts defining a fifth circumferentially extending row adjacent the fourth row.

[0309] Example 80. The prosthetic heart valve of any example herein, particularly Example 79, wherein the fifth circumferentially extending row can be an inflow row of cells.

[0310] Example 81. The prosthetic heart valve of any example herein, particularly any one of Examples 79-80, wherein each one of the first plurality of struts can have a first length, each one of the second plurality of struts can have a second length, each one of the third plurality of struts can have a third length, each one of the fourth plurality of struts can have a fourth length, and each one of the fifth plurality of struts can have a fifth length.

[0311] Example 82. The prosthetic heart valve of any example herein, particularly Example 81, wherein the second length can be greater than the first length.

[0312] Example 83. The prosthetic heart valve of any example herein, particularly any one of Examples 81-82, wherein the second length can be greater than the fourth length.

[0313] Example 84. The prosthetic heart valve of any example herein, particularly any one of Examples 81-83, wherein the third length can be greater than the first length.

[0314] Example 85. The prosthetic heart valve of any example herein, particularly any one of Examples 81-84, wherein the third length can be greater than the fourth length.

[0315] Example 86. The prosthetic heart valve of any example herein, particularly any one of Examples 81-86, wherein the fourth length can be equal to the fifth length.

[0316] Example 87. The prosthetic heart valve of any example herein, particularly any one of Examples 79-86, wherein the first plurality of struts, the second plurality of struts, a plurality of axial struts of the frame, and a plurality of commissure window struts of the frame can define a first circumferentially extending row of cells, the second plurality of struts and the third plurality of struts can define a second circumferentially extending row of cells, the third plurality of struts and the fourth plurality of struts can define a third circumferentially extending row of cells, and the fourth plurality of struts and the fifth plurality of struts can define a fourth circumferentially extending row of cells.

[0317] Example 88. The prosthetic heart valve of any example herein, particularly Example 87, wherein each cell in the second circumferentially extending row of cells can be kiteshaped.

[0318] Example 89. The prosthetic heart valve of any example herein, particularly any one of Examples 87-88, wherein each cell in the third circumferentially extending row of cells can be symmetric about a circumferentially extending axis.

[0319] Example 90. The prosthetic heart valve of any example herein, particularly any one of Examples 87-89, wherein each cell in the fourth circumferentially extending row of cells can be kite-shaped.

[0320] Example 91. The prosthetic heart valve of any example herein, particularly any one of Examples 87-90, wherein each cell in the third circumferentially extending row of cells can have a longer axial length than each cell in the second circumferentially extending row of cells and the fourth circumferentially extending row of cells.

[0321] Example 92. The prosthetic heart valve of any example herein, particularly any one of Examples 87-91, wherein each cell in the first circumferentially extending row of cells can have a longer axial length than each cell in the second circumferentially extending row of cells and the fourth circumferentially extending row of cells.

[0322] Example 93. The prosthetic heart valve of any example herein, particularly any one of Examples 75-92, wherein the annular frame can be configured to be crimped to a radially compressed state, wherein at least one angled strut at least one of the first plurality of angled struts or the second plurality of angled struts forms a positive angle with a central longitudinal axis of the annular frame in the radially compressed state, and wherein the positive angle is in a range from 0.1 degrees to 5 degrees.

[0323] Example 94. A method can include advancing a prosthetic valve through a subject’s vasculature to a target implantation site, and implanting the prosthetic valve at the target implantation site such that a gap is formed between an outflow end of the implanted prosthetic valve and the subject’s vasculature at a sinotubular junction level.

[0324] Example 95. The method of any example herein, particularly Example 94, wherein the prosthetic valve can include a pair of angled struts disposed at the outflow end of the prosthetic valve, and wherein the gap can be formed between the pair of angled struts and the subject’s vasculature at a sinotubular junction level.

[0325] Example 96. The method of any example herein, particularly Example 95, wherein the pair of angled struts can include a first angled strut connected to a second angled strut, and wherein the first angled strut and the second angled strut can form a substantially 180 degree angle therebetween.

[0326] Example 97. The method of any example herein, particularly any one of Examples 94-96, further comprising steering a coronary catheter through the gap.

[0327] Example 98. The prosthetic heart valve of any example herein, wherein the prosthetic heart valve is sterilized.

[0328] The features described herein with regard to any example can be combined with other features described in any one or more examples, unless otherwise stated. For example, any one or more of the features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve. Additionally or alternatively, any one or more of the features of one method can be combined with any one or more features of another method.

[0329] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A method comprising: cutting a tube having a first diameter to form a frame having the first diameter, wherein: the frame is compressible from the first diameter to a second diameter less than the first diameter for delivery into a patient via catheterization, the frame is expandable from the second diameter to a third diameter that is greater than the second diameter, and the third diameter is one of a plurality of working diameters of the frame that includes a smallest working diameter and a largest working diameter, in which the largest working diameter is greater than the first diameter; coupling a skirt to the frame; and coupling a plurality of leaflets to the frame.

2. The method of claim 1, wherein: cutting the tube to form the frame comprises cutting the tube to form a plurality of struts of the frame, and the plurality of struts are arranged in a circumferentially extending row at an end portion of the frame.

3. The method of claim 2, wherein adjacent ones of the plurality of struts define an angle therebetween, wherein the angle is less than a critical angle, and wherein the angle is configured to be greater than the critical angle after the frame is expanded to the third diameter.

4. The method of claim 3, wherein the critical angle is in a range from 120 degrees to 140 degrees.

5. The method of any one of claims 1-4, wherein the skirt is in an initial, taut state when coupled to the frame.

6. The method of claim 5, wherein: the skirt comprises a plurality of warp threads and a plurality of weft threads, andthe plurality of warp threads and the plurality of weft threads of the skirt in the initial, taut state are oriented at an approximately 45-degree angle relative to a central longitudinal axis of the frame.

7. The method of any one of claims 1-6, further comprising, prior to coupling the plurality of leaflets to the frame: for each one of the plurality of leaflets, cutting a portion of leaflet material along a circular arc having a diameter equal to the first diameter of the frame to form a cusp edge portion.

8. A prosthetic heart valve comprising: an annular frame having a largest expanded working diameter, the annular frame comprising: a central longitudinal axis; and a pair of struts oriented at an angle relative to the central longitudinal axis and coupled at their adjacent ends to form an apex region at an end of the annular frame, wherein the pair of struts are in a flattened configuration in which the struts of the pair form a substantially 180 degree angle therebetween; and a valvular structure coupled to the annular frame.

9. The prosthetic heart valve of claim 8, wherein the pair of struts form an apex region at an outflow end of the annular frame.

10. The prosthetic heart valve of any one of claims 8-9, wherein the annular frame comprises a plurality of pairs of struts that form a plurality of apex regions at the end of the annular frame, and wherein each one of the plurality of pairs of struts are in the flattened configuration.

11. A prosthetic heart valve comprising: an annular frame having an expanded state, the annular frame comprising: a central longitudinal axis; a pair of axial struts that are parallel to the central longitudinal axis;a pair of angled struts that are angled relative to the central longitudinal axis, wherein: each angled strut comprises a first end and a second end, the angled struts are connected at their first ends to form an angle therebetween, the angle is in a range from 130 degrees to 179 degrees, and the second end of each angled strut is connected at a junction to a corresponding one of the pair of axial struts; and a window strut comprising a commissure window, wherein each junction is disposed further in an outflow direction of the annular frame from an outflow end of the commissure window; and a leaflet structure coupled to the annular frame at the commissure window.

12. The prosthetic heart valve of claim 11 , wherein the angle is in a range from 140 degrees to 150 degrees.

13. The prosthetic heart valve of any one of claims 11-12, wherein the pair of axial struts, the pair of angled struts, and the leaflet structure define a lateral opening of the prosthetic heart valve.

14. The prosthetic heart valve of any one of claims 11-13, wherein the leaflet structure comprises a plurality of leaflets having outflow edges, wherein the outflow edges are spaced apart in an axial direction from the junctions.

15. The prosthetic heart valve of any one of claims 11-14, wherein the junctions are spaced from the outflow end of the commissure window in an axial direction by at least 1.5 mm.

16. A prosthetic heart valve comprising: an annular frame having a radially expanded state, the annular frame comprising: a first axial end portion; a second axial end portion; a first plurality of angled struts defining a first circumferentially extending row at the first axial end portion of the annular frame; anda second plurality of angled struts defining a second circumferentially extending row between the first axial end portion and the second axial end portion, wherein: at least one pair of the first plurality of angled struts forms a first angle therebetween, a corresponding pair of the second plurality of angled struts forms a second angle therebetween, and the first angle is substantially equal to the second angle.

17. The prosthetic heart valve of claim 16, wherein the pair of the first plurality of angled struts defines an first end of a cell, and wherein the pair of the second plurality of angled struts defines a second end of the cell.

18. The prosthetic heart valve of any one of claims 16-17, wherein the first axial end portion of the annular frame is an outflow end portion of the annular frame.

19. The prosthetic heart valve of claim 18, wherein: the second circumferentially extending row is adjacent the first circumferentially extending row; the frame comprises a third plurality of angled struts defining a third circumferentially extending row adjacent the second row, the frame comprises a fourth plurality of angled struts defining a fourth circumferentially extending row adjacent the third row; and the frame comprises a fifth plurality of angled struts defining a fifth circumferentially extending row adjacent the fourth row.

20. The prosthetic heart valve of any one of claims 16-19, wherein the annular frame is configured to be crimped to a radially compressed state, wherein at least one angled strut at least one of the first plurality of angled struts or the second plurality of angled struts forms a positive angle with a central longitudinal axis of the annular frame in the radially compressed state, and wherein the positive angle is in a range from 0.1 degrees to 5 degrees.

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