Sealing skirt for prosthetic heart valves

Abstract

The prosthetic heart valve includes a radially expandable frame having inflow and outflow ends and a central longitudinal axis extending between the inflow and outflow ends, the frame defining a partial radially compressed diameter in a partial radially compressed state and a radially expanded diameter in a radially expanded state. A sealing skirt coupled to the frame includes inflow and outflow end portions, an inelastic skirt portion including weft and warp threads, and a tensioning element coupled to and extending circumferentially along the outflow end portion. When the sealing skirt is in a relaxed state, the distal outflow edge defines a skirt diameter equal to or greater than the partial radially compressed diameter and less than the radially expanded diameter, and the plurality of weft threads and the plurality of warp threads are configured to be oriented at an angle of approximately 45 degrees relative to the central longitudinal axis.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 480,678, filed January 19, 2023, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to prosthetic heart valves, and more particularly to a sealing skirt for a prosthetic heart valve and a method for attaching the sealing skirt to a frame of the prosthetic heart valve. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are numerous known repair devices (e.g., stents) and prosthetic valves, as well as numerous known methods for implanting these devices and valves into humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily 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 device and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, or by activating a mechanical actuator that applies an expansive force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device, allowing the prosthetic heart valve to self-expand to its functional size.

[0004] Most expandable prosthetic heart valves include a frame or stent and a valvular structure attached to the interior of the frame. The frame may include a plurality of struts forming a plurality of rows of cells. The prosthetic heart valve may also include a sealing skirt coupled to the frame. The sealing skirt may be configured to assist in forming a seal between the prosthetic heart valve and the native annulus of the native valve by blocking blood flow through the open cells of the frame. Summary of the Invention [Problem to be solved by the invention]

[0005] Described herein are prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves. The disclosed prosthetic heart valves, delivery devices, and methods can provide, for example, increased longevity and durability of the prosthetic heart valves. As such, the devices and methods disclosed herein can overcome, among other things, one or more drawbacks of typical prosthetic heart valves and their delivery devices. [Means for solving the problem]

[0006] The prosthetic heart valve may include a frame and a valvular structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more components disclosed herein.

[0007] In some examples, the frame can include an inflow end, an outflow end, a central longitudinal axis extending between the inflow and outflow ends of the frame, and a plurality of struts forming a plurality of cell rows disposed between the inflow and outflow ends. The frame can define a partial radially compressed diameter when the frame is in a partial radially compressed state and a radially expanded diameter when the frame is in a radially expanded state. The partial radially compressed diameter is smaller than the radially expanded diameter.

[0008] In some instances, the valve structure can include multiple leaflets coupled to the frame and / or the interior of the seal skirt.

[0009] In some examples, the prosthetic heart valve can optionally include a sealing skirt coupled to the interior of the frame and circumferentially disposed on the inner or outer surface of the frame.

[0010] In some examples, a sealing skirt (which may also be referred to as a "sealing member") may be coupled to the frame and / or valvular structure and may be configured to reduce or prevent paravalvular leakage through and / or around the prosthetic heart valve.

[0011] In some examples, the seal skirt may include an inlet flow end portion, an outlet flow end portion, and a skirt portion extending between the inlet flow end portion and the outlet flow end portion.

[0012] In some examples, the skirt portion can include a plurality of weft yarns and a plurality of warp yarns configured to be oriented at an angle of approximately 45 degrees relative to a central longitudinal axis of the frame when the seal skirt is coupled to the frame and when the seal skirt is in a relaxed or untensioned state.

[0013] In some examples, the outflow end portion can terminate at a terminal outflow edge that can define a skirt diameter when the seal skirt is in a relaxed state. The skirt diameter can optionally be greater than or equal to the partial radially compressed diameter and less than the radially expanded diameter.

[0014] In some examples, the seal skirt may optionally include a tensioning element coupled to the seal skirt and extending circumferentially along the outflow end portion.

[0015] In some examples, the prosthetic heart valve can include a frame, the frame including an inflow end, an outflow end, and a central longitudinal axis extending between the inflow and outflow ends, and defining a radially expanded diameter when the frame is in a radially expanded state. The prosthetic heart valve can further include a valvular structure including a plurality of leaflets disposed within the frame, and a sealing skirt coupled to an inner surface of the frame. The sealing skirt can include an inflow end portion disposed toward the inflow end of the frame and an outflow end portion disposed toward the outflow end of the frame, the outflow end portion terminating in a distal outflow edge, the distal outflow edge defining a skirt diameter when the sealing skirt is in a relaxed state, the skirt diameter being smaller than the radially expanded diameter of the frame. The sealing skirt can further include a skirt portion extending between the inflow and outflow end portions, the skirt portion including a plurality of warp yarns and a plurality of weft yarns oriented at an angle of approximately 45 degrees relative to the central longitudinal axis when the sealing skirt is in a relaxed state, the plurality of warp yarns and the plurality of weft yarns being formed from a non-elastic polymeric material. The seal skirt may further include a tensioning element sewn circumferentially through the skirt portion along the outflow end portion.

[0016] In some examples, the prosthetic heart valve can include a frame, the frame including an inflow end, an outflow end, and a central longitudinal axis extending between the inflow and outflow ends. The prosthetic heart valve can further include a sealing skirt secured to an inner surface of the frame, the sealing skirt including an inflow end portion disposed toward the inflow end of the frame, an outflow end portion disposed toward the outflow end of the frame and terminating at a distal outflow edge, a skirt portion extending between the inflow and outflow end portions, the skirt portion being formed from a non-elastic polymeric material, and a tensioning element coupled to and extending circumferentially along the outflow end portion.

[0017] In some examples, the prosthetic heart valve can include a frame including an inflow end and an outflow end, the frame defining a partial radially compressed diameter when the frame is in a partial radially compressed state and a radially expanded diameter when the frame is in a radially expanded state. The prosthetic heart valve can further include a sealing skirt coupled to an inner surface of the frame, the sealing skirt including an inflow end portion disposed toward the inflow end of the frame and an outflow end portion disposed toward the outflow end of the frame and terminating at a distal outflow edge, the distal outflow edge defining a skirt diameter when the sealing skirt is in a relaxed state, the skirt diameter being equal to or greater than the partial radially compressed diameter and less than the radially expanded diameter of the frame, and the sealing skirt formed from a non-elastic polymeric material.

[0018] In some examples, a method for manufacturing a prosthetic heart valve can include selecting a frame including an inflow end and an outflow end, the frame defining a partial radially compressed diameter in a partial radially compressed state and a radially expanded diameter in a radially expanded state; selecting a sealing skirt including a distal outflow edge disposed toward the outflow end of the sealing skirt, the distal outflow edge defining a skirt diameter when the sealing skirt is in a relaxed state, the skirt diameter being greater than or equal to the partial radially compressed diameter and less than the radially expanded diameter; and bonding the sealing skirt to the frame.

[0019] In some examples, a method for manufacturing a prosthetic heart valve can include applying tension to a sealing skirt, the sealing skirt including an outflow end portion disposed toward an outflow end of the prosthetic heart valve, coupling a tensioning element to the outflow end portion of the sealing skirt, and coupling the sealing skirt to a frame of the prosthetic heart valve.

[0020] In some examples, the prosthetic heart valve includes one or more components described in Examples 1-26 below.

[0021] The various innovations of the present disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts 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. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a side view of a prosthetic heart valve, according to one example. [Figure 2] 2 is a side view of the frame of the prosthetic heart valve of FIG. 1. FIG. [Figure 3] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straightened (non-circular) state. [Figure 4A] FIG. 4A is a cross-sectional view of a conventional artificial heart valve, showing the valve structure of the conventional artificial heart valve in an occluded state. [Figure 4B] FIG. 4B is a cross-sectional view of the conventional prosthetic heart valve of FIG. 4A, showing the valve structure of the conventional prosthetic heart valve in an open state. [Figure 5A] FIG. 5A is a cross-sectional view of the prosthetic heart valve of FIG. 1, showing the valve structure of the prosthetic heart valve in an occluded state. [Figure 5B] FIG. 5B is a cross-sectional view of the prosthetic heart valve of FIG. 1, showing the valve structure of the prosthetic heart valve in an open state. [Figure 6A] FIG. 6A is a side view of the exterior surface of a sealing skirt for a prosthetic heart valve, according to one example, where the sealing skirt is shown in a flattened configuration. [Figure 6B] FIG. 6B is a side view of the inner surface of the sealing skirt of FIG. 6A, with the sealing skirt shown in a flattened configuration. [Figure 7A] FIG. 7A is a side view of the exterior surface of a sealing skirt for a prosthetic heart valve according to a second embodiment, the sealing skirt being in a flattened configuration. [Figure 7B] FIG. 7B is a side view of the inner surface of the sealing skirt of FIG. 7A, with the sealing skirt shown in a flattened configuration. [Figure 8] FIG. 8 is a side view of the exterior of a sealing skirt for a prosthetic heart valve according to a third embodiment, the sealing skirt being in a flattened configuration. [Figure 9] FIG. 9 is a side view of the exterior of a sealing skirt for a prosthetic heart valve according to a fourth embodiment, the sealing skirt being in a flattened configuration. [Figure 10A] FIG. 10A illustrates a process for bonding a sealing skirt to a prosthetic heart valve, according to one example. [Figure 10B] FIG. 10B illustrates a process for bonding a sealing skirt to a prosthetic heart valve, according to one example. [Figure 10C] FIG. 10C illustrates a process for coupling a sealing skirt to a prosthetic heart valve, according to one example. [Figure 10D] FIG. 10D illustrates a process for bonding a sealing skirt to a prosthetic heart valve, according to one example. [Figure 11] FIG. 11 is a side view of the prosthetic heart valve of FIG. 1, which additionally includes an outer sealing skirt. [Figure 12] FIG. 12 is a side view of a second example of a prosthetic heart valve. [Figure 13] FIG. 13 is a side view of an exemplary delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site, according to one example. DETAILED DESCRIPTION OF THE INVENTION

[0023] Basic premise

[0024] For purposes of description, certain aspects, advantages, and novel features of the disclosed examples are described in this disclosure. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed examples require the presence of any one or more particular advantages or problems to be solved.

[0025] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0026] As used in this application and 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." Furthermore, the term "couple" generally means to physically, mechanically, chemically, magnetically, and / or electrically join or connect, and does not exclude the presence of intermediate elements between joined or associated members, unless specific language to the contrary exists.

[0027] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in a proximal-distal direction.

[0028] As used herein, the term "elastic" refers to the ability of a material to plastically deform and return to its original shape or configuration when the force causing the deformation is removed. Thus, "elastic materials" disclosed herein, which may include thermoplastic polyurethane (TPU), polyethylene terephthalate (PET), polyethylene (PE), ultra-high weight polyethylene (UHMWPE), ultra-high weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), etc., can have a modulus of elasticity of 0.05 GPa to 0.6 GPa, less than 1 GPa, less than 0.5 GPa, or less than 0.3 GPa. Conversely, "non-elastic materials" such as PET, PE, UHMWPE, etc. can have a modulus of elasticity of at least 0.3 GPa, at least 0.5 GPa, at least 1 GPa, or in the range of 0.3 GPa to 3.5 GPa. However, it will be understood that the terms "non-elastic" and "elastic" are relative terms and refer to the relative elasticity between two materials within a set of materials. Thus, in any pairing or combination of elastic and non-elastic materials referred to throughout this application and claims, the elastic material has a lower modulus of elasticity than the non-elastic material.

[0029] As used herein, the terms "free state," "relaxed state," and "non-tensioned state" refer to the state of a material or component, such as the state of a sealing skirt of a prosthetic heart valve, when no external forces are acting on the material or component. That is, in the free, relaxed, and non-tensioned states, the material or component is not subjected to any external compressive or tensile forces.

[0030] As used herein, the terms "radially expanded state" and "functional state" refer to the configuration of a prosthetic heart valve or the configuration of a prosthetic heart valve frame in a functional configuration. In the radially expanded state, the leaflets of the prosthetic heart valve are configured to coapt with adjacent leaflets, thereby allowing blood to flow through the prosthetic heart valve from the inflow end to the outflow end, or preventing blood from flowing through the prosthetic heart valve from the outflow end to the inflow end. Thus, the terms "radially expanded diameter," "functional diameter," or "functional size" refer to the nominal diameter of a prosthetic heart valve when the prosthetic heart valve is in the radially expanded state.

[0031] As used herein, the term "radially compressed state" refers to the configuration of a prosthetic heart valve or a frame of a prosthetic heart valve as it is housed within a delivery sheath of a delivery device and / or inserted into a patient's vasculature on a delivery device. In some instances where a prosthetic heart valve is crimped onto a delivery device, the radially compressed state may additionally or alternatively be referred to as the "crimped state." Thus, the terms "radially compressed diameter" and "crimped diameter" refer to the nominal diameter of a prosthetic heart valve when it is in the radially compressed state. The radially compressed diameter is smaller than the expanded diameter.

[0032] As used herein, the term "partially radially compressed state" refers to the configuration of the frame of a prosthetic heart valve between the radially compressed state and the radially expanded state. Thus, the term "partially radially compressed diameter" refers to the nominal diameter of the prosthetic heart valve when the prosthetic heart valve is in the partially radially compressed state. The partially radially compressed diameter is less than the radially expanded diameter and greater than or equal to the radially compressed diameter.

[0033] Overview of the technology to be disclosed

[0034] As introduced above, a prosthetic heart valve may include a frame including a plurality of interconnected struts, a valve leaflet structure including a plurality of leaflets attached to the interior of the frame, and a sealing skirt circumferentially coupled to the frame and disposed between the valve leaflet structure and the inner surface of the frame. In some examples, an outflow end portion of the sealing skirt, terminating in a distal outflow edge, may be disposed across the inner surface of the frame at the level of the leaflets. In this manner, the outflow end portion and / or the distal outflow edge may contact the leaflets during operation of the prosthetic heart valve. However, it has been discovered that reducing contact between the leaflets and other components of the prosthetic heart valve, such as the outflow end portion and the distal outflow edge of the sealing skirt, may better increase the durability and lifespan of the prosthetic heart valve.

[0035] Described herein are various inner skirts and methods for coupling the inner skirts to prosthetic heart valves that help reduce contact between the inner skirts and the leaflets of the prosthetic heart valve, thereby potentially increasing the durability and longevity of the prosthetic heart valve.

[0036] Examples of technologies to be disclosed

[0037] FIG. 1 illustrates a prosthetic heart valve 100 (prosthetic valve), according to one example. While any prosthetic valve disclosed herein is configured for implantation within the native aortic valve annulus, in other examples, it can be configured for implantation within other native valve annulus of the heart (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed prosthetic valves can also be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0038] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device implanted within a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, such as that disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at a native mitral valve, such as that disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, such as that disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0039] The prosthetic heart valve 100 may include a stent or frame 102, a valvular structure 104, and a sealing skirt 106. The prosthetic heart valve 100 (and frame 102) may have an inflow end 108 and an outflow end 110. The valvular structure 104 may be disposed on the interior of the frame 102 and / or may be bonded to the inner surface of the frame 102.

[0040] 1 , the seal skirt 106 may be disposed on the interior of the frame 102 and / or may be coupled to an inner surface of the frame 102. Thus, in these examples, the seal skirt 106 may alternatively be referred to as an "internal skirt" or "internal seal skirt." As described below, in some examples, the valvular structure 104 may be coupled to the seal skirt 106, which may be coupled to an inner surface of the frame 102.

[0041] 1 illustrates the sealing skirt 106 as being disposed on the interior of the frame 102, other examples of the sealing skirt may be disposed on the exterior of the frame 102 or may be coupled to the outer surface of the frame 102. Thus, in these other examples, the sealing skirt 106 may alternatively be referred to as an "outer skirt" or an "outer sealing skirt."

[0042] The valvular structure 104 can include a plurality of leaflets 112 (e.g., three leaflets, as shown in FIG. 1 ) that collectively form a leaflet structure that can be configured to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (e.g., commissure tabs), thereby forming commissures 114 of the valvular structure 104. For example, each leaflet 112 can include opposing commissure tabs 115 located on opposing sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs 115. The cusp edge portions of the leaflets 112 can have an undulating, curved, scalloped shape.

[0043] In some examples, the leaflets 112 can be formed from pericardial tissue (e.g., bovine pericardial tissue), from a biocompatible synthetic material, or from a variety of other suitable natural or synthetic materials as known in the art and as described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0044] Frame 102 may be radially compressible and expandable between a radially compressed, crimped, or collapsed state and a radially expanded state (the expanded state is shown in Figure 1). Frame 102 is shown alone in Figure 2, and a portion of frame 102 is shown in a straightened (non-circular) configuration in Figure 3.

[0045] The frame 102 can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi) such as Nitinol). When constructed from a plastically expandable material, the frame 102 (and thus the valve 100) can be crimped onto a delivery catheter into a radially compressed state and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state and restrained in that compressed state by insertion into a sheath of a delivery catheter or equivalent mechanism. Once in the body, the valve can be advanced from a delivery sheath, allowing the valve to expand to its functional size.

[0046] Suitable plastically expandable materials that can be used to form the frame 102 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular example, the frame 102 can be made from a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N® alloy / UNS R30035 contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0047] As shown in Figures 2 and 3, the frame 102 can include a plurality of interconnected struts 116 that form a plurality of cell rows 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in Figures 2 and 3, the frame 102 can include three cell rows 118, with the cell rows 118 having a first (upper, in the orientation shown in Figures 2 and 3) cell row 120 disposed at the outflow end 110. The first cell row 120 includes cells 118 that are axially elongated (relative to a central longitudinal axis 122 of the frame 102) compared to the remaining cell rows 118. For example, the cells 118 of the first cell row 120 can have a longer axial length 124 compared to the cells 118 in the remaining cell rows (FIG. 3), where the remaining cell rows can include a second cell row 126 and a third cell row 128, with the third cell row 128 located at the inlet end 108 and the second cell row 126 located between the first cell row 120 and the third cell row 128.

[0048] In some examples, as shown in Figure 2, each cell column includes nine cells 118. Thus, in such examples, frame 102 may be referred to as a nine-cell frame.

[0049] In alternative examples, frame 102 may include more than three rows of cells (e.g., four or five) and / or may include more or fewer than nine cells per row. In some examples, cells 118 in first row 120 may not be as elongated as cells 118 in the remaining rows of cells of frame 102 (second row 126 and third row 128).

[0050] The interconnecting struts 116 may include a plurality of diagonal struts 130, 132, 134, 136 arranged as multiple circumferentially extending rows of diagonal struts, with the rows arranged along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 may be arranged end-to-end and include a first row of circumferentially extending diagonal struts 130 at the inflow end 108 of the frame, a second row of circumferentially extending diagonal struts 132, a third row of circumferentially extending diagonal struts 134, and a fourth row of circumferentially extending diagonal struts 136 at the outflow end 110 of the frame 102. The fourth row of diagonal struts 136 may be connected to the third row of diagonal struts 134 by a plurality of axially extending window struts (or window strut portions) 138 and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which may also be referred to as axial struts including commissural windows) define commissural windows (e.g., open windows) 142 circumferentially spaced apart about the frame 102, and the commissural windows 142 are configured to receive a pair of commissural tabs of a pair of adjacent leaflets 112 disposed at a commissure (e.g., the commissure 114 shown in FIG. 1 ). In some examples, the commissural windows 142 and / or the axially extending window struts 138 defining the commissural windows 142 may be referred to herein as commissural features or commissural supports, each configured to receive and / or secure a pair of commissural tabs of an adjacent pair of leaflets.

[0051] One or more (e.g., two, as shown in FIGS. 2 and 3 ) axial struts 140 can be circumferentially positioned between two commissure windows 142 formed by the window struts 138. Because the frame 102 can include fewer cells per row (e.g., nine) and fewer axial struts 140 between each commissure window 142 compared to some more conventional prosthetic heart valves, each cell 118 can have an increased width (circumferentially), which can provide a larger opening for blood flow and / or coronary access.

[0052] Each axial strut 140 and each window strut 138 extends from a location (which may also be referred to as an upper strut junction or an upper long strut junction) defined by the convergence of the lower ends of two diagonal struts 136 (e.g., the ends located inboard of and furthest from the outflow end 110) to another location (which may also be referred to as a lower strut junction or a lower long strut junction) defined by the convergence of the upper ends (e.g., the ends located closer to the outflow end 110) of two diagonal struts 134. Each axial strut 140 and each window strut 138 forms the axial sides of two adjacent cells in the first cell row 120.

[0053] In some examples, as shown in FIG. 3, each axial strut 140 can have a width 144 (FIG. 3) that is greater than the width of the diagonal struts 130, 132, 134, 136. As used herein, the "width" of a strut is measured between locations on opposite surfaces of the strut extending between diametrically opposed inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between locations on diametrically opposed inner and outer surfaces of the strut and is perpendicular to the strut width. In some examples, the width 144 of an axial strut 140 is greater than the width of the diagonal struts of the frame 102 by 50% to 200%, by 75 to 150%, or by at least 100% (e.g., twice as large).

[0054] By providing the axial struts 140 with a width 144 that is greater than the width of the other angled struts of the frame 102, a larger contact area is provided when the leaflets 112 contact the wide axial struts 140 during systole, thereby distributing stress and reducing the extent to which the leaflets 112 may fold radially outward through the cells 118 onto the axial struts 140. As a result, the long-term durability of the leaflets 112 may be increased.

[0055] Because the cells 118 of the frame 102 can have a larger width compared to alternative prosthetic valves that have more than nine cells per row (as introduced above), wider axial struts 140 can be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary access.

[0056] The commissure tabs 115 of adjacent leaflets 112 can be secured together to form a commissure 114 ( FIG. 1 ). Each commissure 114 of the prosthetic heart valve 100 includes two pairs of commissure tabs 115, one from each of two adjacent leaflets 112, extending through commissure windows 142 in the frame 102. Each commissure 114 can be secured to a window strut 138 that forms the commissure window 142.

[0057] The cusp edge portion (e.g., a scalloped edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (e.g., sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to a strut (e.g., an angled strut 130, 132, 134) of the frame 102. For example, the cusp edge portion of the leaflet 112 can be sewn to the angled strut 130, 132, 134, which generally follows the contour of the cusp edge portion of the leaflet 112. Additional methods for securing the leaflets 112 to the frame 102 are disclosed in U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, and U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, both of which are incorporated herein by reference.

[0058] In other examples, the cusp edge portions of the leaflets 112 can be secured to the seal skirt 106, which can be secured to the frame 102. For example, as shown in FIG. 1 , the cusp edge portions of the leaflets 112 can be sewn to the seal skirt 106 along suture lines 113, where the seal skirt 106 is attached to the frame 102. The leaflets 112 can be secured to the seal skirt 106 using methods known in the art and disclosed in U.S. Patent No. 9,393,110, which is incorporated herein by reference.

[0059] 2 and 3 , in some examples, one or more, or each, of the axial struts 140 can include an inflow end portion 146 (e.g., the end portion closest to the inflow end 108) and an outflow end portion 148 that are expanded relative to an intermediate portion 150 (which can be defined by a width 144) of the axial strut 140. In some instances, the inflow end portion 146 of the axial strut 140 can include an opening 147. The opening 147 can be configured to receive a fastener (e.g., a suture) for attaching the soft component of the prosthetic heart valve 100 to the frame 102.

[0060] The interconnected struts 116 may also include horizontal struts 182 extending between adjacent cells 118 in a row of cells of the frame 102 (FIGS. 2 and 3). The horizontal struts 182 may extend circumferentially and may also be referred to as circumferentially extending struts 182. The horizontal struts 182 may connect the diagonal struts in two adjacent diagonal strut rows of the frame 102. For example, each horizontal strut 182 may connect to two diagonal struts in one strut row (e.g., strut 134 shown in FIG. 3) and to two diagonal struts in another adjacent strut row (e.g., strut 132 shown in FIG. 3). As a result, the angled struts 183 extending between the axially extending window struts 138 and the horizontal strut 182, and the angled struts 185 extending between the horizontal strut 182 and another horizontal strut 182 positioned adjacent to the inflow end 108 of the frame 102, can be aligned along angled lines that can conform to the scallop lines of the valve leaflets (when the leaflets are attached to the frame 102). Thus, when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2 and 3), the horizontal struts 182 allow the angled struts to conform more closely to the shape of the scallop lines of the valve leaflets. Additionally, the horizontal struts 182 can function as spacers that can maintain a predetermined gap between the angled struts when the frame 102 is configured in the radial state, thereby reducing the risk of pinching the valve leaflets between the struts configured in the radial state.

[0061] The frame 102 may further include a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, with each apex region 152 extending to form a junction between two inclined struts 130 at the inflow end 108 or a junction between two inclined struts 136 at the outflow end 110. As such, the apex regions 152 are circumferentially spaced apart from one another at the inflow end 108 and the outflow end 110.

[0062] Each apex region 152 can include an apex 154 (the highest or most outwardly extending point in the axial direction) and two thinned (or narrow) strut portions 156, one extending from one side of the apex 154 to a corresponding wider oblique strut 136 (at the outflow end 110) or oblique strut 130 (at the inflow end 108) ( FIG. 3 ). In this manner, each apex region 152 at the outflow end 110 can form a narrow transition region between the two oblique struts 136 extending from the corresponding apex region 152, and each apex region 152 at the inflow end 108 can form a narrow transition region between the two oblique struts 130 extending from the corresponding apex region 152.

[0063] The thinned strut portion 156 of the apex region 152 can have a width 158 that is smaller than the width 160 ( FIG. 3 ) of the angled struts 130, 136. In some examples, the width 158 can be a uniform width (e.g., along the entire length of the strut portion 156). In some examples, the width 158 of the thinned strut portion 156 can be reduced compared to the width 160 of the angled struts 130 and / or 136 by approximately 0.06 mm to 0.15 mm.

[0064] The thinned strut portion 156 of the apex region 152 can have a first length 162 (FIG. 3). In some examples, the first length 162 is in the range of 0.8 mm to 1.4 mm, in the range of 0.9 mm to 1.2 mm, in the range of 0.95 mm to 1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternative examples, the first length 162 is in the range of 0.3 mm to 0.7 mm, in the range of 0.4 mm to 0.6 mm, in the range of 0.45 mm to 0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0065] Thus, each outflow apex region 152 may include two thin-walled strut portions 156, each extending outward from the apex 154 relative to a central longitudinal axis 164 of the cell 118 and having a first length 162. Thus, the total length of the apex region 152 may be twice the first length 162.

[0066] Each apex region 152 and two corresponding inclined struts 136 at the outflow end 110 can form an outflow strut 166, and each apex region 152 and two corresponding inclined struts 130 at the inflow end 108 can form an inflow strut 168.

[0067] Each outflow strut 166 and each inflow strut 168 can have a length that includes the apex region 152 and the two diagonal struts 136, 130 (or strut portions) located on either side of the apex region 152. Half of the total length of each outflow strut 166 and each inflow strut 168 is shown in FIG. 3 as length 170, which extends from one end of one diagonal strut 136, 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and each inflow strut 168 is twice the length 170. In some examples, the length 170 for one half of each inflow strut 168 can be different from the length 170 for the other half of each outflow strut 166.

[0068] In some instances, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. Stated another way, the length of each apex region 152 (whose total length is twice the first length 162) can be at least 25% of the total length (twice the length 170) of the outflow strut 166 or inflow strut 168. In some instances, the length of each apex region 152 can be more than 25% of the total length of the corresponding outflow strut 166 or inflow strut 168, such as between 25% and 35%.

[0069] In some examples, each apex region 152 can include a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner recess 174 that forms the thinned strut portion 156. For example, the curved inner recess 174 can be recessed from the inner surface of the angled strut portion 156 toward the curved outer surface 172, thereby forming a narrower, thinned strut portion 156. Thus, the curved inner recess 174 can be formed on the cell side of the apex region 152 (e.g., facing outward from the apex region 152).

[0070] In some examples, the curved outer surface 172 of each apex region 152 can form a single continuous curve from one slanted strut portion 156 on a first side of the apex region 152 to another slanted strut portion 156 on an opposite second side of the apex region 152 (e.g., the curved outer surface 172 can have a constant curvature).

[0071] Each apex region 152 can have a radius of curvature 176 along its curved outer surface 172 (e.g., in some instances, along the entirety or length of the curved outer surface 172) (FIG. 3). In some instances, the radius of curvature 176 at the apex 154 of the apex region 152 and / or along the entirety of the curved outer surface 172 of the apex region 152 can be greater than 1 mm. In some instances, the radius of curvature 176 can range from 1 mm to 20 mm, 3 mm to 16 mm, or 8 mm to 14 mm. In some instances, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can depend on (and thus vary depending on) the width 158 (e.g., the amount of width reduction from the angled struts 130, 136) and the first length 162 of the thinned strut portion 156.

[0072] Furthermore, the height (axial height) 178 of the apex region 152 can be defined axially from the outer surfaces of the two angled struts 130, 136 to the curved outer surface 172 of the apex region 152 at the apex 154, and can be the width 158 ( FIG. 3 ) of the thin-walled strut portion 156. In this manner, the height 178 of the apex region 152 can be relatively small and does not add significantly to the overall axial height of the radial expansion frame 102. Thus, the leaflets 112 ( FIG. 1 ), which are fixed relative to the frame 102, can be positioned closer to the inflow end 108, thereby leaving more open space at the outflow end 110 of the frame 102 that is not obstructed by the leaflets 112.

[0073] In some examples, each of the apex regions 152 can form an angle 180 between two angled struts 130, 136 extending from either of the corresponding apex regions 152 (FIG. 3). In some instances, the angle 180 can be in the range of 120 degrees (excluding this boundary value) to 140 degrees (e.g., the angle 180 is intended to be greater than 120 degrees and less than or equal to 140 degrees).

[0074] Additional details and examples regarding frames for prosthetic heart valves, including apex regions, can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated herein by reference.

[0075] 4A-4B, a conventional prosthetic heart valve 200 can include a frame 102, a valvular structure 104, and a conventional sealing skirt 206. The valvular structure 104 can be coupled to the conventional sealing skirt 206 and can include a plurality of leaflets 112 disposed within the frame 102. The conventional sealing skirt 206 can be coupled to an inner surface of the frame 102 and can include a distal outflow edge 284 disposed at the outflow end of the sealing skirt 206.

[0076] As shown in FIG. 4A, the conventional sealing skirt 206 of the conventional prosthetic heart valve 200 does not contact the leaflets 112 of the valvular structure 104 when the valvular structure 104 is in an occluded state configured to reduce or prevent blood flow through the valvular structure 104.

[0077] 4B , the conventional seal skirt 206 of the conventional prosthetic heart valve 200 can contact the leaflets 112 of the valvular structure 104 when the valvular structure 104 is in an open state configured to allow blood to flow through the valvular structure 104. In the illustrated example, the distal outflow edge 284 of the conventional seal skirt 206 can contact the leaflets 112 when the conventional seal skirt 206 is collapsed inward toward the radial center of the conventional prosthetic heart valve 200. However, in other examples, other portions of the conventional seal skirt 206, such as an intermediate portion of the conventional seal skirt 206, can contact the leaflets 112, as indicated by the dashed line extending beyond the distal outflow edge 284.

[0078] A conventional seal skirt 206 is less likely to collapse radially inward if the conventional seal skirt 206 has excess slack or if the conventional seal skirt 206 is too large for the frame 102. However, achieving tension between the frame 102 and a conventional seal skirt 206 formed from an inelastic material can be difficult because inelastic materials cannot be tensioned to reduce slack. Furthermore, due to the small size of prosthetic heart valves and the tight tolerances required to manufacture seal skirts for prosthetic heart valves, it can be difficult to manufacture a conventional seal skirt 206 while minimizing excess slack.

[0079] 5A-5B, the prosthetic heart valve 100 previously shown in FIG. 1 can be configured to overcome shortcomings of the prior art, such as the conventional prosthetic heart valve 200 shown in FIG. 4A-4B. The prosthetic heart valve 100 can include a frame 102, a valvular structure 104 having a plurality of leaflets 112 disposed within the frame 102, and a sealing skirt 106 disposed between the valvular structure 104 and the inner surface of the frame 102.

[0080] Although not shown in FIGS. 5A-5B, in other examples, the sealing skirt 106 can be positioned on the exterior of the frame 102 instead of on the interior of the frame 102.

[0081] The sealing skirt 106 may include a distal outflow edge 184 and an outflow end portion 186. The outflow end portion 186 may be disposed toward the outflow end of the sealing skirt 106 and may terminate at the distal outflow edge 184. The distal outflow edge 184 may be configured to form an annular opening at the outflow end of the sealing skirt 106 when the sealing skirt 106 is coupled to the frame 102.

[0082] In some examples, the annular opening formed by the distal outflow edge 184 of the sealing skirt 106 can define a skirt diameter. When the sealing skirt 106 is in a free, relaxed, or untensioned state, the sealing skirt 106 can optionally be “undersized” in that the skirt diameter is equal to or greater than the radially compressed diameter of the frame 102 in the partial radially compressed state and less than the radially expanded diameter of the frame 102 in the radially expanded state. However, after the sealing skirt 106 is coupled to the frame 102 and the frame is deployed to the radially expanded state, the sealing skirt 106 can be tensioned such that the diameter of the tensioned sealing skirt 106 is equal to the radially expanded diameter of the frame 102.

[0083] The seal skirt 106 may be formed from one or more skirt sections configured to be joined together to form an annular seal skirt. Each of the skirt sections may be formed from a non-resilient polymeric material having desirable properties for a seal skirt, such as polyethylene terephthalate (PET), polyethylene (PE), ultra-high molecular weight polyethylene (UHMWPE), etc. Any seal skirt disclosed herein may be formed from one or more of these non-resilient polymeric materials.

[0084] In some examples, one or more of the skirt portions can optionally be woven from a plurality of weft yarns 191 and a plurality of warp yarns 193 to form a non-elastic woven fabric. Each of the plurality of weft yarns 191 and the plurality of warp yarns 193 can be formed from a non-elastic polymeric material, such as any of the non-elastic polymeric materials disclosed herein.

[0085] In some examples, a skirt portion woven from a plurality of weft yarns 191 and a plurality of warp yarns 193 can have a thread count or thread density of about 7 threads per millimeter (eg, ±1 thread per millimeter).

[0086] In some examples, the plurality of weft yarns 191 and the plurality of warp yarns 193 can be oriented at an angle (α) relative to the central longitudinal axis 122 of the frame 102 when the seal skirt 106 is in a free, relaxed, or untensioned state. In these examples, the angle (α) can be approximately 45 degrees (e.g., ±5 degrees), although it will be appreciated that orienting the plurality of weft yarns 191 and the plurality of warp yarns 193 at a 45-degree angle advantageously provides the greatest pivoting capability for the plurality of weft yarns 191 and the plurality of warp yarns 193, and therefore the greatest lengthening capability for the seal skirt 106.

[0087] However, as shown in Figure 5B, the angle (α) between the multiple weft and warp yarns and the central longitudinal axis 122 of the frame 102 can be increased to approximately 90 degrees when the seal skirt 106 is coupled to the frame 102 and the frame 102 is in a radially expanded state. In this situation, the multiple weft and warp yarns can be substantially aligned and approximately perpendicular to the central longitudinal axis 122.

[0088] As shown in Figures 5A-5B, when the sealing skirt 106 is coupled to the frame 102 and the frame 102 is deployed to a radially expanded state, the plurality of weft threads 191 and the plurality of warp threads 193 are configured to pivot at least slightly relative to one another such that the angle (α) increases to form a substantially perpendicular angle of about 90 degrees (e.g., ±5 degrees).

[0089] In some examples, the sealing skirt 106 can optionally include a tensioning element 188. The tensioning element 188 can be attached to a portion of the sealing skirt 106, such as to the outflow end portion 186 of the sealing skirt 106. While the tensioning element 188 is sewn through the sealing skirt 106 as shown in Figures 5A-5B, other examples feature alternative methods for attaching the tensioning element 188 to the sealing skirt 106, including, but not limited to, embroidery, fasteners, sutures, and adhesives.

[0090] In some examples, the tensioning element 188 can be formed from an elastic material such as thermoplastic polyurethane (TPU), PET, ultra-high molecular weight PET (UHMWPET), polytetrafluoroethylene (PTFE), polyethylene (PE), ultra-high molecular weight PE (UHMWPE), etc., where the elastic modulus is less than the elastic modulus of the non-elastic material forming the skirt portion of the seal skirt 106. Any of the tensioning elements 188 disclosed herein can be formed from any of these elastic materials.

[0091] In some examples, the tensioning element 188 can include 4-0 ("four-oh") or 5-0 ("five-oh") elastic suture. In some examples, the tensioning element 188 can include multifilament elastic suture. The use of multifilament elastic suture can be advantageous because multifilament elastic sutures are less abrasive than single filament elastic sutures. However, in other examples, the tensioning element 188 can include single filament elastic suture, which can be advantageous because single filament elastic sutures can be more elastic compared to multifilament elastic sutures.

[0092] As shown in FIG. 5A, when the valvular structure 104 is in an occluded state, the seal skirt 106 does not contact the frame 102.

[0093] As shown in Figure 5B, the sealing skirt 106 of the prosthetic heart valve 100, unlike the sealing skirt 206 of the conventional prosthetic heart valve 200 shown in Figure 4B, is configured to minimize contact with the valve leaflets 112 when the valvular structure 104 is in the open state. As such, the sealing skirt 106 is shown in Figure 5B as not contacting the valve leaflets 112. Thus, the sealing skirt 106 can help reduce contact between the sealing skirt 106 and the valve leaflets 112 by reducing excess slack within the sealing skirt 106. Such a sealing skirt 106 is advantageous because, as discussed above, reducing contact between the sealing skirt 106 and the valve leaflets 112 can advantageously increase the lifespan and durability of the prosthetic heart valve 100.

[0094] The inventors have discovered a method for coupling an "undersized" sealing skirt to a prosthetic heart valve frame, where the skirt diameter of the sealing skirt in a relaxed state is equal to or greater than the radially compressed diameter of the frame and equal to or less than the radially expanded diameter of the frame in a radially expanded state. This method for coupling the sealing skirt to a prosthetic heart valve frame with less excess skirt material can advantageously reduce slack in the sealing skirt, thereby reducing undesirable contact between the sealing skirt and the valve leaflets.

[0095] Additionally, the inventors have also discovered that it is advantageous to orient the seal skirt so that the weft and warp yarns are at an angle of approximately 45 degrees relative to the central longitudinal axis of the frame. Orienting the weft and warp yarns at such an angle allows the inelastic fabric, which is made of an inelastic polymer material, to pivot at least slightly relative to one another, causing the weft and warp yarns to become increasingly perpendicular to the central longitudinal axis. In this manner, the inelastic skirt can lengthen as the frame moves from a radially expanded, axially compressed state to a radially compressed, axially elongated state, even though the individual fibers do not elastically deform. This feature advantageously allows a smaller seal skirt with less excess skirt material to be bonded to the frame of the prosthetic heart valve, thereby reducing slack in the seal skirt and reducing contact between the seal skirt and the valve leaflets.

[0096] Additionally, the inventors have discovered that it is desirable to provide a tensioning element along a portion (e.g., the outflow end) of the inelastic seal skirt that tensions the seal skirt so that the distal outflow edge of the seal skirt is spaced away from the valve leaflets (i.e., does not contact the leaflets during valve operation). This feature advantageously reduces slack in a seal skirt made from an inelastic material, thereby reducing contact between the seal skirt and the valve leaflets. In this manner, a seal skirt formed from an inelastic polymeric material and including one or more tensioning elements provides the benefits of a seal skirt made from an inelastic material (e.g., frictional engagement with natural tissue and / or tissue ingrowth) while increasing the longevity of the prosthetic valve leaflets.

[0097] The sealing skirts and methods for coupling the sealing skirts to the frame of a prosthetic heart valve as described herein may be applied to a variety of other skirts, frames, prosthetic heart valves, or alternative implantable medical devices (such as stents). Additionally, the features and methods described herein may be applied to a variety of other skirts and skirt edge portions, for example, other portions configured to attach to various locations on the frame (e.g., the outflow end, the inflow end, or a frame portion located between the inflow and outflow ends).

[0098] The features of the skirt and methods for coupling the skirt to the frame of the prosthetic heart valve as described herein can be similarly applied to the outer seal skirt. For example, the outer seal skirt can be crushed radially inward between adjacent struts of the frame or through one or more cells of the frame to contact the leaflets. The features and methods disclosed herein with respect to the seal skirt can additionally or alternatively be applied to the outer seal skirt to similarly increase the lifespan and durability of the prosthetic heart valve.

[0099] Furthermore, each of the features shown and described herein, including the method for joining the "undersized" seal skirt to the frame, and including forming the seal skirt from angled weft yarns, warp yarns, and tensioning elements for the seal skirt, can be implemented independently of one another and in various combinations and subcombinations with one another. Although some of these features are shown or described together in the same series of drawings or written descriptions for convenience and brevity, such grouping does not exclude the possibility that these features may be implemented independently of one another in various other examples of seal skirts for prosthetic heart valves.

[0100] 6A illustrates a side view of the exterior of a sealing skirt 106 for a prosthetic heart valve 100, according to one example, where the sealing skirt 106 is shown in a flattened configuration. The sealing skirt 106 can include one or more skirt sections that are connected together and / or individually to the frame 102 shown in FIG. 1 to form an annular skirt.

[0101] The skirt portion may define opposed first and second edge portions 302, 304 (which may also be referred to as short edges or short edge portions), each extending between the outflow end portion 186 and the inflow end portion 308 (which may also be referred to as long edges or long edge portions) of the seal skirt 106.

[0102] In some examples, the first edge portion 302 and the second edge portion 304 can be non-perpendicular to the inflow end portion 308. For example, the first edge portion 302 and the second edge portion 304 can extend at an angle of about 45 degrees (e.g., ±5 degrees) relative to the inflow end portion 308. Thus, in the flattened configuration, the overall overall shape of the seal skirt 106 can be that of a diamond or a parallelogram.

[0103] In some examples, each of the first edge portion 302 and the second edge portion 304 can include a plurality of apertures 310 extending therethrough. Thus, when the sealing skirt 106 is converted into an annular configuration (e.g., when attached to the prosthetic heart valve 100 as shown in FIG. 1 ), the first edge portion 302 and the second edge portion 304 can overlap one another, with the corresponding apertures 310 also overlapping. Sutures can then be used to form a plurality of stitches in an in-out pattern through the overlapping apertures 310, thereby securing the first edge portion 302 and the second edge portion 304 together and forming the annular configuration of the sealing skirt 106.

[0104] The outflow end portion 186 is the end of the sealing skirt 106 that is positioned closer to the outflow end of the prosthetic heart valve 100 (e.g., the outflow end 110 shown in FIG. 1 ) than the inflow end portion 308 when the sealing skirt 106 is coupled to the prosthetic heart valve 100. The outflow end portion 186 can terminate in a distal outflow edge 184 configured to form an annular outflow opening when the sealing skirt 106 is coupled to the frame 102. In some examples, the distal outflow edge 184 can include a rough, abrasive, or "fused" edge to prevent the sealing skirt 106 from fraying or unraveling.

[0105] In some examples, the outflow end portion 186 can optionally include a tensioning element 188 coupled to the seal skirt 106. The tensioning element 188 can be configured to apply tension to a portion of the seal skirt 106, such as the distal outflow edge 184 and / or the outflow end portion 186, between adjacent axial struts (e.g., axial struts 140 shown in FIGS. 2-3 ) or between adjacent diagonal struts (e.g., diagonal struts 134 shown in FIGS. 2-3 ) when the seal skirt 106 is coupled to the frame 102. The tension applied by the tensioning element 188 helps prevent the distal outflow edge 184 from collapsing radially inward when the seal skirt 106 is coupled to the frame 102, thereby advantageously reducing potential contact between the seal skirt 106 and the leaflets 112 of the prosthetic heart valve 100.

[0106] 6B illustrates a side view of the interior surface of the sealing skirt 106, with the sealing skirt 106 shown in a flattened configuration. The tensioning element 188 may include an elastic suture sewn through the skirt portion of the sealing skirt 106 and along the outflow end portion 186. In the illustrated example, the tensioning element 188 is sewn through the sealing skirt 106 to form a plurality of whip stitches 316 in a whip stitch pattern. Each whip stitch 316 may be formed by (1) passing the needle and tensioning element 188 through the exterior surface of the seal skirt 106, (2) moving the needle and tensioning element 188 along the interior surface of the seal skirt 106 in a direction opposite to the whip stitch pattern, (3) passing the needle and tensioning element 188 through the interior surface of the seal skirt 106 to form a loop or bend, and (4) moving the needle and elastic tensioning element 188 along the exterior surface of the seal skirt 106 to the next whip stitch 316. Each whip stitch 316 may define a whip stitch length (L1) 318 of approximately 1.5 millimeters (e.g., ±0.5 millimeters). In the illustrated example, the whip stitch length 318 may be the diameter of the loop or bend formed by the whip stitch 316. The pattern of whipstitches 316 may have an oc spacing or whipstitch pitch (L2) 320 of approximately 2 millimeters (e.g., ±0.5 millimeters), meaning that the whipstitches 316 are spaced apart at intervals of approximately 2 millimeters as measured from the geometric center of adjacent whipstitches 316. However, in other examples, the method for forming the whipstitches 316 may be mirrored such that the whipstitches 316 are formed on the outer surface of the sealing skirt 106.

[0107] In some examples, the whip stitch length (L1) 318 and the whip stitch pitch (L2) 320 of the whip stitch 316 can define a ratio (i.e., a ratio of L1:L2). In some examples, this ratio is less than one-half, meaning that a greater portion or length of the tensioning element 188 extends along the outer surface of the seal skirt 106 (i.e., the surface illustrated in FIG. 6A ) compared to the portion or length of the tensioning element 188 extending along the inner surface of the seal skirt 106 (i.e., the surface illustrated in FIG. 6B ). A smaller ratio can desirably reduce the amount of tensioning element 188 disposed on the inner surface of the seal skirt 106 facing the leaflets 112, which can further reduce contact between the tensioning element 188 and the leaflets 112 of the prosthetic heart valve 100. Thus, a smaller ratio can advantageously increase the lifespan and durability of the prosthetic heart valve 100, as it means less contact between the leaflets 112 and other components of the prosthetic heart valve 100. In some of these examples, the ratio can be in the range of 0.2 to 0.5. In still other examples, the ratio can be in the range of 0.3 to 0.38.

[0108] In some examples, the distance in the axial direction between the terminal outflow edge 184 and the tensioning element can define an axial distance (L3) 322. The axial distance (L3) 322 can be defined such that the tensioning element 188 is positioned sufficiently far from the terminal outflow edge 184 to prevent fraying or unraveling of the outflow end portion 186. For example, in some instances, the axial distance 322 can be approximately 2 mm (e.g., ±0.5 mm).

[0109] In some instances, it may be preferable to sew the tensioning element 188 through the skirt portion of the seal skirt 106 using a whip stitch 316 because the whip stitch 316 is easier to manufacture than other types of stitches. Furthermore, the process for manufacturing the whip stitch 316 may be more easily automated compared to processes for manufacturing other types of stitches. However, other stitch patterns, including those disclosed elsewhere in this application and known to those skilled in the art, have other desirable characteristics and may be used in place of the whip stitch pattern illustrated in Figures 6A-6B.

[0110] Although the sealing skirt 106 is not shown as coupled to the frame 102 in Figures 6A-6B, it will be understood that the central longitudinal axis 122 of the frame 102 may be shown for reference throughout the drawings (e.g., Figures 6A-6B, 7A-7B, 8, 9, and 10A-10B) to more clearly illustrate the angular orientation of the plurality of weft yarns 191 and the plurality of warp yarns 193.

[0111] 7A illustrates a side view of the exterior of a sealing skirt 406 for a second example prosthetic heart valve, where the sealing skirt 406 is in a flattened configuration. The sealing skirt 406 illustrated in FIGS. 7A-7B can have various similarities and differences compared to the sealing skirt 106 illustrated in FIGS. 1, 5A-5B, and 6A-6B.

[0112] One difference between the sealing skirt 406 and the sealing skirt 106 is that the tensioning element 188 may be sewn through the skirt portion of the sealing skirt 406 using a backstitch pattern that includes a plurality of backstitches 416. Each backstitch 416 is created by (1) passing the needle and tensioning element 188 through the exterior surface of the sealing skirt 406, (2) moving the needle and tensioning element 188 along the interior surface of the sealing skirt 406 in the direction of the backstitch pattern, (3) passing the needle and tensioning element 188 through the interior surface of the sealing skirt 406 to form a front portion 417 of the backstitch 416, and (4) extending the needle and tensioning element 188 along the exterior surface of the sealing skirt 406 in the direction opposite to the backstitch pattern. (5) by passing the needle and tensioning element 188 through the outer surface of the sealing skirt 406; (6) by moving the needle and tensioning element 188 along the inner surface of the sealing skirt 406 in a direction opposite to the backstitch pattern; (7) by passing the needle and tensioning element 188 through the inner surface of the sealing skirt 406 to form the rear portion 419 of the backstitch 416; and (8) by extending the needle and tensioning element 188 along the outer surface of the sealing skirt 406 to the next backstitch 416.

[0113] In some examples, each backstitch 416 can define a backstitch length (L1) 418 of about 1.5 millimeters (e.g., ±0.5 millimeters). The pattern of backstitches 416 can have an oc spacing or backstitch pitch (L2) 420 of about 2 millimeters (e.g., ±0.5 millimeters), meaning that adjacent backstitches 416 are spaced apart at intervals of about 2 millimeters as measured from the geometric center of the adjacent backstitch 416.

[0114] In some examples, the distance in the axial direction between the distal outflow edge 184 and the tensioning element can define an axial distance (L3) 422. The axial distance (L3) 422 can be defined such that the tensioning element 188 is positioned sufficiently far from the distal outflow edge 184 to prevent fraying or unraveling of the seal skirt 106. For example, in some examples, the axial distance 622 can be approximately 2 mm (e.g., ±0.1 mm). In some examples, the axial distance 422 can be equal to the axial distance 322 illustrated in FIGS. 6A-6B.

[0115] In some examples, the front portion 417 of the backstitch 416 can define a front portion length (L4) 421 of about X millimeters (e.g., ±0.5 millimeters). The back portion 419 of the backstitch 416 can define a back portion length (L5) 423 of about 2 millimeters (e.g., ±0.5 millimeters).

[0116] In some examples, the sum of the anterior portion length (L4) 421 and the posterior portion length (L5) 423 and the backstitch pitch (L2) 418 define a ratio, such as (L4 + L5):L2. In some examples, this ratio is less than half, meaning that a greater portion or length of the tensioning element 188 extends along the outer surface of the seal skirt 406 (i.e., the surface illustrated in FIG. 7A ) compared to the portion or length of the tensioning element 188 extending along the inner surface of the seal skirt 406 (i.e., the surface illustrated in FIG. 7B ). A smaller ratio can desirably reduce the amount of tensioning element 188 disposed on the inner surface of the seal skirt 406 facing the leaflets 112, thereby further reducing contact between the tensioning element 188 and the leaflets 112 of the prosthetic heart valve 100. Thus, a smaller ratio can advantageously increase the lifespan and durability of the prosthetic heart valve 100. In some of these examples, the ratio may range from 0.2 to 0.5. In still other of these examples, the ratio may range from 0.3 to 0.38.

[0117] 8 illustrates a side view of the exterior of a sealing skirt 506 for a prosthetic heart valve according to a third example, where the sealing skirt 506 is in a flattened configuration. One difference between the sealing skirt 506 and the sealing skirts 106, 406 described above is that the tensioning element 188 may be bonded only to the exterior surface of the skirt portion. Bonding the tensioning element 188 only to the exterior surface of the sealing skirt 506 advantageously prevents any portion of the tensioning element 188 from contacting the valve leaflets 112. The tensioning element 188 may be bonded to the exterior surface of the sealing skirt 506 using methods including, but not limited to, embroidery, adhesives, and fasteners.

[0118] 9 illustrates a side view of the exterior of a sealing skirt 606 for a prosthetic heart valve according to a fourth example, where the sealing skirt 606 is in a flattened configuration. One difference between the sealing skirt 606 and the sealing skirts 106, 406, and 506 described above is that the sealing skirt 606 may include multiple tensioning elements 188a, 188b, and 188c coupled to a skirt portion of the sealing skirt 606. The multiple tensioning elements 188a, 188b, and 188c may be positioned between the outflow end portion 186 and the inflow end portion 308. Although three tensioning elements are shown in the illustrated example, the sealing skirt 606 may have two, four, five, six, or any suitable number of tensioning elements.

[0119] In some examples, the multiple tensioning elements 188a, 188b, 188c can be equally spaced between the outflow end portion 186 and the inflow end portion 308 at an axial spacing or axial pitch (L6) 624 of about 2 millimeters (e.g., ±0.5 millimeters).

[0120] Although Figure 9 illustrates the plurality of tensioning elements 188a, 188b, 188c sewn to the seal skirt 606 using the whip stitch pattern illustrated in Figures 6A-6B, it will be understood that other stitch patterns, including those disclosed elsewhere in this application and known to those skilled in the art, may be substituted for the whip stitch pattern illustrated in Figure 9. Furthermore, it will be understood that other methods of attaching tensioning elements to the seal skirt may be used to attach the plurality of tensioning elements 188a, 188b, 188c to the seal skirt 606, such as embroidery, mechanical fasteners, and adhesives.

[0121] 10A-10D illustrate an exemplary method for coupling a sealing skirt 106 to a frame 102 of a prosthetic heart valve 100, according to one example. In other examples of this method, the prosthetic heart valve 100 can be replaced by any other of the prosthetic heart valves disclosed herein. Additionally, in other examples of this method, the sealing skirt 106 illustrated in this method can be replaced by any other of the sealing skirts disclosed herein.

[0122] 10A illustrates the optional step of coupling a tensioning element 188 to the skirt portion of the seal skirt 106. As mentioned above, this step is optional because some examples of the seal skirt 106 do not include a tensioning element 188. The seal skirt 106 can be loaded into a fixture or fixture 702 configured to apply tension to the seal skirt 106. Although the fixture 702 is illustrated as a set of two vise grips, it will be understood that any fixture suitable for applying tension to the seal skirt 106 can be used.

[0123] In an example where the seal skirt 106 includes a skirt portion woven from a plurality of weft yarns 191 and a plurality of warp yarns 193, applying tension to the seal skirt 106 can cause the plurality of weft yarns 191 and the plurality of warp yarns 193 to pivot relative to one another, such that the plurality of weft yarns 191 and the plurality of warp yarns 193 form an angle of at least 45 degrees with respect to an axis extending between the outflow end portion 110 and the inflow end portion 308, i.e., with respect to the central longitudinal axis 122. In other words, the maximum angle between the plurality of weft yarns 191 and the plurality of warp yarns 193 can be an obtuse angle greater than 90 degrees.

[0124] After the seal skirt 106 is tensioned within the securing member 702, the tensioning element 188 may be coupled to a skirt portion of the seal skirt 106, such as at the outflow end portion 186. In the illustrated example, the tensioning element 188 may be coupled to the seal skirt 106 by sewing the tensioning element 188 through a skirt portion constructed from a non-elastic polymeric material. The tensioning element 188 may be in a tensioned state when coupled to the seal skirt 106. Although the illustrated example shows the tensioning element 188 being sewn through the skirt portion of the seal skirt 106 using a suture needle 704, it will be understood that any suturing device or method known in the art may be used to sew the tensioning element 188 through the skirt portion of the seal skirt 106.

[0125] 10B illustrates the sealing skirt 106 after it has been removed from the retaining member 702. When the sealing skirt 106 is removed from the retaining member 702, the sealing skirt 106 can be in a free, relaxed, or untensioned state with no external force acting on it. The tensioning element 188, which is now untensioned, can contract, causing the skirt portion of the sealing skirt 106 to bunch or ruffle at the outflow end portion 186 of the sealing skirt 106.

[0126] When the sealing skirt 106 is in an annular configuration and in a free, relaxed, or untensioned state, the distal outflow edge 184 of the sealing skirt 106 may form an annular opening that defines a skirt diameter 706. Although the sealing skirt 106 is shown in an annular configuration before being bonded to the frame 102 to more clearly illustrate the skirt diameter 706, in some instances, the sealing skirt 106 is not in an annular configuration until it is bonded to the frame 102.

[0127] In examples where the seal skirt 106 includes a skirt portion woven from a plurality of weft yarns 191 and a plurality of warp yarns 193, the plurality of weft yarns 191 and the plurality of warp yarns 193 can pivot relative to one another in a free, relaxed, or untensioned state, such that the plurality of weft yarns 191 and the plurality of warp yarns 193 form an angle of approximately 45 degrees relative to an axis extending between the outflow end portion 186 and the inflow end portion 308, e.g., relative to the central longitudinal axis 122. In other words, the plurality of weft yarns 191 and the plurality of warp yarns 193 can form an angle of approximately 90 degrees relative to one another.

[0128] 10C illustrates the seal skirt 106 coupled to the frame 102, where the frame 102 may be in a partial radial compression state. The partial radial compression state may be between the radial compression state and the radial expansion state. In the partial radial compression state, the frame 102 defines a partial radial compression diameter 708, which is the nominal diameter of the frame 102 in the partial radial compression state. The partial radial compression diameter 708 may be equal to or less than the skirt diameter 706.

[0129] The sealing skirt 106 can be coupled to the frame 102 using sutures, fasteners, or other known methods for coupling a sealing skirt to a frame. In some examples, such as the example illustrated in FIG. 10C , the sealing skirt 106 can be secured to the diagonal struts 134 of the frame 102 using a first set of sutures 187. Additionally or alternatively, the sealing skirt 106 can be secured to the axial struts 140. Additionally or alternatively, the sealing skirt 106 can be secured to the frame 102 at the inflow end 108 by sewing the sealing skirt 106 to the first row of diagonal struts 130 using a second set of sutures 189. Additional methods for coupling the skirt to a frame are disclosed in U.S. Pat. No. 9,393,110.

[0130] 10D shows the prosthetic heart valve 100, including the frame 102 and the sealing skirt 106, deployed to a radially expanded state, which may also be referred to as a "functional state." In some examples, the prosthetic heart valve 100 may be deployed to the radially expanded state during surgery, i.e., the prosthetic heart valve 100 may be compressed or crimped onto a delivery device, delivered through the patient's vasculature, and positioned within the native valve annulus before being deployed to the radially expanded state. When in the radially expanded state, the leaflets 112 of the prosthetic heart valve 100 are configured to coapt with adjacent leaflets 112 to permit blood flow through the prosthetic heart valve 100 from the inflow end 108 to the outflow end 110 of the prosthetic heart valve 100 and to prevent blood flow through the prosthetic heart valve 100 from the outflow end 110 to the inflow end 108.

[0131] Although the prosthetic heart valve 100 may include additional components, such as the valvular structure 104, these additional components are omitted from FIG. 10D to more clearly show the sealing skirt 106.

[0132] When the frame 102 is in the radially expanded state, the frame 102 defines a radially expanded diameter 710. The radially expanded diameter 710, which may alternatively be referred to as an expanded working diameter, functional diameter, or functional size, may be the nominal diameter of the frame 102 and / or the prosthetic heart valve 100 in the radially expanded state. The radially expanded diameter 710 may range from 20 millimeters to 29 millimeters. In some examples, the radially expanded diameter 710 is one of 20 millimeters, 23 millimeters, 26 millimeters, and 29 millimeters.

[0133] Radially expanded diameter 710 can be larger than skirt diameter 706 and larger than partially radially compressed diameter 708. Furthermore, radially expanded diameter 710 can be larger than the radially compressed diameter of frame 102 in a radially compressed state. In some examples, skirt diameter 706 can be defined as a percentage of radially expanded diameter 710. In some of these examples, skirt diameter 706 is between 70.9% and 93.5% of radially expanded diameter 710. In other examples, skirt diameter 706 can be smaller than radially expanded diameter 710 by a particular amount, such as 1.5 millimeters smaller than radially expanded diameter 710.

[0134] In an example where the sealing skirt 106 includes a skirt portion woven from a plurality of weft threads 191 and a plurality of warp threads 193, deploying the prosthetic heart valve 100 to the radially expanded state allows the plurality of weft threads 191 and the plurality of warp threads 193 to pivot relative to one another, such that the plurality of weft threads 191 and the plurality of warp threads 193 are substantially perpendicular to the central longitudinal axis 122. In other words, the plurality of weft threads 191 and the plurality of warp threads 193 can be substantially aligned in a direction perpendicular to the central longitudinal axis 122.

[0135] FIG. 11 illustrates the prosthetic heart valve 100 of FIG. 1 having an outer seal skirt 107 disposed around the outer surface of the frame 102. In some examples, the outer skirt 107 can be an annular skirt configured to reduce paravalvular leakage (PVL). In some examples, the outer seal skirt 107 can include one or more skirt sections connected together and / or individually to the frame 102. The outer seal skirt 107 can include a woven or polymeric material, such as expanded polytetrafluoroethylene (ePTFE), PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG. 11 , the outer seal skirt 107 can have a contoured upper edge portion that extends along and is fixed to the diagonal struts 134. Examples of such outer seal skirts, as well as various other outer seal skirts that may be used with the frame 102, can be found in U.S. Provisional Patent Application No. 63 / 366,599, filed June 17, 2022, which is incorporated herein by reference.

[0136] 11, the seal skirt 106 is hidden from view by the outer seal skirt 107. However, the tensioning element 188 disposed on the seal skirt 106 and located behind the outer seal skirt 107 is shown in dashed lines. Other illustrations in this application, such as FIG. 1, more clearly show the tensioning element 188 disposed on the seal skirt 106.

[0137] 12 shows an exemplary prosthetic heart valve 800 according to another example. The prosthetic heart valve 800 includes four main components: a stent or frame 802, a valvular structure 804, a sealing skirt 806, and a perivalvular outer sealing member or outer seal skirt 807. The prosthetic heart valve 800 may include an inflow end portion 808, an outflow end portion 810, and a central longitudinal axis 822 formed between the inflow end portion 808 and the outflow end portion 810. The sealing skirt 806 may be disposed on and / or coupled to the inner surface of the frame 802, while the outer seal skirt 807 may be disposed on and / or coupled to the outer surface of the frame 802.

[0138] The frame 802 may be radially compressible (collapseable) and expandable and may include a plurality of interconnected struts 816. A plurality of circumferentially spaced apices 817 are formed at the inflow end portion 808 and the outflow end portion 810 of the frame 802 (only the apices 817 at the outflow end portion 810 are visible in FIG. 11 ). Each apice 817 is formed at a junction between two angled struts 816 in either the inflow end portion 808 or the outflow end portion 810. FIG. 1 illustrates the apices 817 forming a U-shaped bend between two angled struts 816.

[0139] The sealing skirt 806 can include one or more skirt portions arranged in an annular configuration. In some examples, the skirt portion can be woven from a plurality of inelastic weft yarns 891 and a plurality of warp yarns 893 that are configured to be oriented at an angle (α) of approximately 45 degrees relative to the central longitudinal axis 822 when the sealing skirt 806 is coupled to the frame and when the sealing skirt 806 is in a free, relaxed state. The angle (α) is configured to increase, for example, to an angle of approximately 90 degrees, when the prosthetic heart valve 800 is deployed to a radially expanded state.

[0140] The seal skirt 806 may further include a tensioning element 888 that extends circumferentially along the outflow end portion 886 adjacent a circumferential free edge 884 disposed at the outflow end of the seal skirt 806. The tensioning element 888 may be formed from an elastic material having a modulus of elasticity that is less than the modulus of elasticity of the non-elastic polymeric material forming the skirt portion of the seal skirt 806.

[0141] delivery device 13 illustrates a delivery device 900, according to one example, that may be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG. 1 and / or any other prosthetic heart valve described herein). In some examples, the delivery device 900 is specifically configured for use in introducing the prosthetic valve into the heart.

[0142] 13 is a balloon catheter and includes a handle 902 and a steerable outer shaft 904 extending distally from the handle 902. The delivery device 900 can further include an intermediate shaft 906 (which can also be referred to as a balloon shaft) extending proximally and distally from the handle 902, the portion extending distally from the handle 902 also extending coaxially through the outer shaft 904. Additionally, the delivery device 900 can further include an inner shaft 908 extending distally from the handle 902 coaxially through the intermediate shaft 906 and the outer shaft 904 and coaxially through the intermediate shaft 906.

[0143] The outer shaft 904 and the intermediate shaft 906 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 920 of the delivery device 900 to facilitate delivery and positioning of the prosthetic valve to an implantation site within a patient's body.

[0144] The midshaft 906 can include a proximal end portion 910 that extends proximally from the proximal end of the handle 902 to an adapter 912. A rotatable knob 914 can be mounted on the proximal end portion 910 and configured to rotate the midshaft 906 relative to the outer shaft 904 about a central longitudinal axis 920.

[0145] The adapter 912 can include a first port 938 configured to receive a guidewire therethrough and a second port 940 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 940 can be fluidly coupled to the lumen of the midshaft 906.

[0146] The mid-shaft 906 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 904 when the distal end of the outer shaft 904 is positioned away from the inflatable balloon 918 of the delivery device 900. The distal end portion of the inner shaft 908 can extend distally beyond the distal end portion of the mid-shaft 906.

[0147] The balloon 918 can be coupled to the distal end portion of the midshaft 906 .

[0148] In some examples, the distal end of the balloon 918 can be coupled to the distal end of the delivery device 900, such as a nosecone 922 (as shown in FIG. 13 ), or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 900. An intermediate portion of the balloon 918 can cover a valve mounting portion 924 at the distal end portion of the delivery device 900, and the distal end portion of the balloon 918 can cover a distal shoulder 926 of the delivery device 900. The valve mounting portion 924 and the intermediate portion of the balloon 918 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 13 , a prosthetic heart valve 950 (which can be one of the prosthetic valves described herein) can be attached to the periphery of the balloon 918 at the valve mounting portion 924 of the delivery device 900.

[0149] The balloon shoulder assembly, including the distal shoulder 926, is configured to maintain the prosthetic heart valve 950 (or other medical device) in a fixed position on the balloon 918 during delivery through the patient's vasculature.

[0150] The outer shaft 904 can include a distal tip portion 928 mounted on its distal end. The outer shaft 904 and the intermediate shaft 906 can be axially translated relative to one another to position the distal tip portion 928 adjacent the proximal end of the valve mounting portion 924 when the prosthetic valve 950 is mounted in radial compression on the valve mounting portion 924 (as shown in FIG. 13 ) and during delivery of the prosthetic valve to the target implantation site. In this manner, the distal tip portion 928 can be configured to resist proximal axial movement of the prosthetic valve 950 relative to the balloon 918 when the distal tip portion 928 is positioned proximally adjacent the valve mounting portion 924.

[0151] An annular space can be defined between the outer surface of the inner shaft 908 and the inner surface of the midshaft 906, and the annular space can be configured to receive fluid from a fluid source via the second port 940 of the adapter 912. 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 908 and the inner surface of the balloon 918. In this manner, fluid from the fluid source can flow from the annular space to the fluid passageway, thereby inflating the balloon 918 and radially expanding and deploying the prosthetic valve 950.

[0152] The lumen of the inner shaft can be configured to receive a guidewire therethrough for steering the distal end portion of the delivery device 900 to the target implantation site.

[0153] The handle 902 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 900. In the illustrated example, for example, the handle 902 includes an adjustment member, such as the illustrated rotatable knob 960, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 902 through the outer shaft 904 and have a distal end portion fixed relative to the outer shaft 904 at or near its distal end. By rotating the knob 960, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 900. Further details regarding steering or bending mechanisms for delivery devices can be found in U.S. Pat. No. 9,339,384, incorporated herein by reference.

[0154] The handle 902 can further include an adjustment mechanism 961 that includes an adjustment member, such as the illustrated rotatable knob 962, and an associated locking mechanism that includes another adjustment member configured as a rotatable knob 978. The adjustment mechanism 961 is configured to adjust the axial position of the intermediate shaft 906 relative to the outer shaft 904 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 900 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0155] delivery technology To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath and allowing it to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0156] To implant a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and then advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum) into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0157] To implant the prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and then advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0158] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as through a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0159] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0160] Therapeutic techniques, methods, steps, etc., as described or suggested herein or in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, tissue, etc. is simulated), etc.

[0161] Any system, device, apparatus, etc. herein can be sterilized (e.g., using heat, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method herein can include sterilizing the associated system, device, apparatus, etc. as one of the method steps. Examples of heat / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be achieved, for example, using hydrogen peroxide plasma.

[0162] Additional Examples of the Disclosed Technology

[0163] In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional examples: It should be noted that any single feature in an example individually, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also additional examples falling within the disclosure of the present application. [Example]

[0164] Example 1 1. A prosthetic heart valve comprising: a frame including an inflow end, an outflow end, and a central longitudinal axis extending between the inflow and outflow ends, the frame defining a radially expanded diameter when the frame is in a radially expanded state; a valvular structure including a plurality of leaflets disposed within the frame; and a sealing skirt coupled to an inner surface of the frame, the sealing skirt having an inflow end portion disposed toward the inflow end of the frame and an outflow end portion disposed toward the outflow end of the frame, the outflow end portion terminating in a distal outflow edge, the distal outflow edge extending beyond the distal end of the sealing skirt when the sealing skirt is relaxed. 1. A prosthetic heart valve comprising: a sealing skirt including: an outflow end portion defining a skirt diameter when in a relaxed state, the skirt diameter being smaller than a radially expanded diameter of the frame; a skirt portion extending between the inflow end portion and the outflow end portion, the skirt portion including a plurality of warp yarns and a plurality of weft yarns oriented at an angle of approximately 45 degrees relative to a central longitudinal axis when the sealing skirt is in a relaxed state, the plurality of warp yarns and the plurality of weft yarns being formed from a non-elastic polymeric material; and a tensioning element sewn circumferentially through the skirt portion along the outflow end portion.

[0165] Example 2. 1. A prosthetic heart valve comprising: a frame including an inflow end, an outflow end, and a central longitudinal axis extending between the inflow and outflow ends; a sealing skirt secured to an inner surface of the frame, the sealing skirt including: an inflow end portion disposed toward the inflow end of the frame; an outflow end portion disposed toward the outflow end of the frame and terminating in a distal outflow edge; a skirt portion extending between the inflow and outflow end portions, the skirt portion being formed from a non-elastic polymeric material; and a tensioning element coupled to the outflow end portion and extending circumferentially along the outflow end portion.

[0166] Example 3 The prosthetic heart valve as described in any example herein, particularly as described in Example 2, wherein the tensioning element comprises an elastic suture configured to be sewn through the skirt portion.

[0167] Example 4. The prosthetic heart valve as described in any example herein, particularly as described in Example 3, wherein the tensioning element is an elastic suture formed from one of TPU, PET, ultra-high weight PET, and PTFE.

[0168] Example 5. The prosthetic heart valve as described in any example herein, particularly as described in Example 3, wherein the tensioning element comprises one of a 4-0 ("four-O") elastic suture and a 5-0 ("five-O") elastic suture.

[0169] Example 6 10. The prosthetic heart valve as described in any example herein, particularly as described in Example 3, wherein the tensioning element comprises a multifilament elastic suture.

[0170] Example 7 The prosthetic heart valve as described in any example herein, particularly as described in Example 3, wherein the tensioning element defines a plurality of whip stitches within the skirt portion, the plurality of whip stitches being circumferentially arranged along the outflow end portion.

[0171] Example 8 The prosthetic heart valve according to any of the examples herein, particularly Example 7, wherein the pitch between adjacent whip stitches of the plurality of whip stitches is in the range of 2 millimeters to 2.5 millimeters.

[0172] Example 9. The prosthetic heart valve as described in any example herein, particularly as described in Example 7, wherein each of the plurality of whip stitches has a length ranging from 1 millimeter to 2 millimeters.

[0173] Example 10. The prosthetic heart valve as described in any example herein, particularly as described in example 3, wherein the tensioning element defines a plurality of backstitches within the skirt portion.

[0174] Example 11 The prosthetic heart valve as described in any example herein, particularly as described in Example 2, wherein the skirt portion is formed from one of PET, PE, and UHMWPE.

[0175] Example 12 1. The prosthetic heart valve of any example herein, particularly Example 2, wherein the skirt portion comprises a woven fabric including a plurality of weft yarns and a plurality of warp yarns formed from a non-elastic polymeric material, and the skirt portion has a thread count of about 7 yarns per millimeter.

[0176] Example 13 A prosthetic heart valve as described in any embodiment herein, particularly as described in embodiment 2, wherein the skirt portion includes a plurality of weft threads and a plurality of warp threads, the plurality of weft threads and the plurality of warp threads being formed from a non-elastic material and configured to form an angle of approximately 45 degrees with respect to the central longitudinal axis of the frame when the sealing skirt is in a relaxed state.

[0177] Example 14. 10. The prosthetic heart valve of any embodiment herein, particularly embodiment 2, wherein a first length of tensioning element is disposed on an inner surface of the skirt portion and a second length of tensioning element is disposed on an outer surface of the skirt portion.

[0178] Example 15. The prosthetic heart valve of any example herein, particularly example 14, wherein the second length of the tensioning element disposed on the outer surface of the skirt portion is longer than the first length of the tensioning element disposed on the inner surface of the skirt portion.

[0179] Example 16. The prosthetic heart valve according to any example herein, particularly example 15, wherein the ratio of the first length to the second length is in the range of 0.6 to 0.75.

[0180] Example 17. 1. A prosthetic heart valve comprising: a frame including an inflow end and an outflow end, the frame defining a partial radially compressed diameter when the frame is in a partially radially compressed state and a radially expanded diameter when the frame is in a radially expanded state; and a sealing skirt coupled to an inner surface of the frame, the sealing skirt including an inflow end portion disposed toward the inflow end of the frame and an outflow end portion disposed toward the outflow end of the frame and terminating at a distal outflow edge, the distal outflow edge defining a skirt diameter when the sealing skirt is in a relaxed state, the skirt diameter being equal to or greater than the partial radially compressed diameter of the frame and less than the radially expanded diameter, the sealing skirt being formed from a non-elastic polymeric material.

[0181] Example 18. The prosthetic heart valve as described in any embodiment herein, particularly embodiment 17, wherein the sealing skirt is formed from a plurality of inelastic warp yarns and a plurality of inelastic weft yarns.

[0182] Example 19. A prosthetic heart valve as described in any example herein, particularly as described in Example 18, wherein the frame defines a central longitudinal axis extending between the inflow end and the outflow end of the frame, and each of the plurality of inelastic warp yarns and each of the plurality of inelastic weft yarns are oriented at an angle of approximately 45 degrees relative to the central longitudinal axis when the sealing skirt is in a relaxed state.

[0183] Example 20. The prosthetic heart valve according to any example herein, particularly example 19, wherein the skirt diameter is between 70.9% and 93.5% of the radially expanded diameter.

[0184] Example 21. 1. A method for manufacturing a prosthetic heart valve, the method comprising: selecting a frame including an inflow end and an outflow end, the frame defining a partial radially compressed diameter in a partial radially compressed state and a radially expanded diameter in a radially expanded state; selecting a sealing skirt including a distal outflow edge disposed toward the outflow end of the sealing skirt, the distal outflow edge defining a skirt diameter when the sealing skirt is in a relaxed state, the skirt diameter being greater than or equal to the partial radially compressed diameter and less than the radially expanded diameter; and bonding the sealing skirt to the frame.

[0185] Example 22. The method of any embodiment herein, particularly embodiment 21, further comprising coupling a tensioning element to the seal skirt prior to coupling the seal skirt to the frame.

[0186] Example 23. A method for manufacturing a prosthetic heart valve, the method comprising: applying tension to a sealing skirt, the sealing skirt including an outflow end portion disposed toward the outflow end of the prosthetic heart valve; coupling a tensioning element to the outflow end portion of the sealing skirt; and coupling the sealing skirt to a frame of the prosthetic heart valve.

[0187] Example 24. The method of any embodiment herein, particularly embodiment 23, wherein tension is applied to the seal skirt by attaching the seal skirt to a fixing member.

[0188] Example 25. The method of any example herein, particularly example 23, wherein the tensioning element is attached to the sealing skirt by sewing the tensioning element through the sealing skirt along the outflow end portion.

[0189] Example 26. 10. The prosthetic heart valve according to any of the examples herein, in particular any one of Examples 1 to 25, wherein the prosthetic heart valve is sterile.

[0190] Each feature described herein with respect to any example may be combined with other features described in any one or more other examples, unless otherwise stated. For example, any one or more features of one skirt may be combined with any one or more features of another skirt. As another example, any one or more features of one prosthetic heart valve or device may be combined with any one or more features of another prosthetic heart valve or device.

[0191] In view of the many possible ways in which the principles of the present disclosure may be applied, it will be appreciated that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A prosthetic heart valve, comprising: A frame, an inlet end; The outflow end and a central longitudinal axis extending between the inlet end and the outlet end; a frame defining a radially expanded diameter when the frame is in a radially expanded state; a valve structure including a plurality of leaflets disposed within the frame; a seal skirt coupled to an inner surface of the frame, an inflow end portion disposed toward the inflow end of the frame; an outflow end portion disposed toward the outflow end of the frame, the outflow end portion terminates in a distal outflow edge; the distal outflow edge defines a skirt diameter when the seal skirt is in a relaxed state; an outflow end portion, the skirt diameter being smaller than the radially expanded diameter of the frame; a skirt portion extending between the inlet and outlet end portions, the skirt portion including a plurality of warp yarns and a plurality of weft yarns oriented at an angle of approximately 45 degrees relative to the central longitudinal axis when the seal skirt is in the relaxed state, the plurality of warp yarns and the plurality of weft yarns being formed from a non-elastic polymeric material; a tensioning element sewn circumferentially along the outflow end portion and through the skirt portion; and a sealing skirt including:

2. 1. A prosthetic heart valve, comprising: A frame, an inlet end; The outflow end and a frame including a central longitudinal axis extending between the inlet end and the outlet end; a sealing skirt secured against an inner surface of the frame, an inflow end portion disposed toward the inflow end of the frame; an outflow end portion disposed toward the outflow end of the frame and terminating at a distal outflow edge; a skirt portion extending between the inlet end portion and the outlet end portion, the skirt portion being formed from a non-elastic polymeric material; a tensioning element coupled to the outflow end portion and extending circumferentially along the outflow end portion; and a sealing skirt including:

3. The prosthetic heart valve of claim 2 , wherein the tensioning element comprises an elastic suture configured to be sewn through the skirt portion.

4. 4. The prosthetic heart valve of claim 3, wherein the tensioning element is an elastic suture formed from one of TPU, PET, ultra-high weight PET, and PTFE.

5. 4. The prosthetic heart valve of claim 3, wherein the tensioning element comprises one of a 4-0 ("four-o") elastic suture and a 5-0 ("five-o") elastic suture.

6. The prosthetic heart valve of claim 3 , wherein the tensioning element comprises a multifilament elastic suture.

7. 4. The prosthetic heart valve of claim 3, wherein the tensioning element defines a plurality of whip stitches in the skirt portion, the plurality of whip stitches being circumferentially disposed along the outflow end portion.

8. 8. The prosthetic heart valve of claim 7, wherein the pitch between adjacent whip stitches of the plurality of whip stitches ranges from 2 millimeters to 2.5 millimeters.

9. The prosthetic heart valve of claim 7, wherein the length of each of the plurality of whip stitches ranges from 1 millimeter to 2 millimeters.

10. The prosthetic heart valve of claim 3 , wherein the tensioning element defines a plurality of backstitches within the skirt portion.

11. 3. The prosthetic heart valve of claim 2, wherein the skirt portion is formed from one of PET, PE, and UHMWPE.

12. 3. The prosthetic heart valve of claim 2, wherein the skirt portion comprises a woven fabric including a plurality of weft yarns and a plurality of warp yarns formed from an inelastic polymeric material, the skirt portion having a thread count of approximately 7 yarns per millimeter.

13. 3. The prosthetic heart valve of claim 2, wherein the skirt portion includes a plurality of weft threads and a plurality of warp threads, the plurality of weft threads and the plurality of warp threads being formed from an inelastic material and configured to form an angle of approximately 45 degrees with respect to the central longitudinal axis of the frame when the sealing skirt is in a relaxed state.

14. 3. The prosthetic heart valve of claim 2, wherein a first length of the tensioning element is disposed on an inner surface of the skirt portion and a second length of the tensioning element is disposed on an outer surface of the skirt portion.

15. 15. The prosthetic heart valve of claim 14, wherein the second length of the tensioning elements disposed on the outer surface of the skirt portion is greater than the first length of the tensioning elements disposed on the inner surface of the skirt portion.

16. 16. The prosthetic heart valve of claim 15, wherein the ratio of the first length to the second length is in the range of 0.6 to 0.

75.

17. 1. A prosthetic heart valve, comprising: a frame including an inlet end and an outlet end, the frame defining a partially radially compressed diameter when the frame is in a partially radially compressed state and a radially expanded diameter when the frame is in a radially expanded state; a seal skirt coupled to an inner surface of the frame, an inflow end portion disposed toward the inflow end of the frame; an outflow end portion disposed toward the outflow end of the frame, the outflow end portion terminating at a distal outflow edge; the distal outflow edge defines a skirt diameter when the seal skirt is in a relaxed state; the skirt diameter is equal to or greater than the partially radially compressed diameter of the frame and less than the radially expanded diameter; a sealing skirt, wherein the sealing skirt is formed from a non-elastic polymeric material.

18. 18. The prosthetic heart valve of claim 17, wherein the sealing skirt is formed from a plurality of inelastic warp yarns and a plurality of inelastic weft yarns.

19. 19. The prosthetic heart valve of claim 18, wherein the frame defines a central longitudinal axis extending between the inflow end and the outflow end of the frame, and wherein each of the plurality of inelastic warp yarns and each of the plurality of inelastic weft yarns are oriented at an angle of approximately 45 degrees relative to the central longitudinal axis when the sealing skirt is in the relaxed state.

20. 20. The prosthetic heart valve of claim 19, wherein the skirt diameter is between 70.9% and 93.5% of the radially expanded diameter.

21. 1. A method for manufacturing a prosthetic heart valve, comprising: selecting a frame, said frame comprising: an inlet end; an outflow end, selecting, wherein the frame defines a partially radially compressed diameter in a partially radially compressed state and a radially expanded diameter in a radially expanded state; selecting a seal skirt, the seal skirt comprising: a distal outflow edge disposed toward the outflow end of the sealing skirt; the distal outflow edge defines a skirt diameter when the seal skirt is in a relaxed state; selecting the skirt diameter to be equal to or greater than the partially radially compressed diameter and less than the radially expanded diameter; and coupling the seal skirt to the frame.

22. The method of claim 21 , further comprising coupling a tensioning element to the seal skirt prior to coupling the seal skirt to the frame.

23. 1. A method for manufacturing a prosthetic heart valve, comprising: applying tension to a sealing skirt, the sealing skirt including an outflow end portion disposed toward the outflow end of the prosthetic heart valve; coupling a tensioning element to the outlet end portion of the seal skirt; and coupling the sealing skirt to a frame of the prosthetic heart valve.

24. 24. The method of claim 23, further comprising applying tension to the seal skirt by attaching the seal skirt to a stationary member.

25. 24. The method of claim 23, wherein the tensioning element is attached to the seal skirt by stitching the tensioning element through the seal skirt along the outflow end portion.

Images