Prosthetic heart valve having elongated sealing member - Patents.com

Abstract

The present disclosure is directed to a prosthetic heart valve having an elongated sealing member. In one example, the prosthetic heart valve includes an annular frame, a leaflet assembly including multiple leaflets, and a skirt assembly including an inner skirt, an outer skirt, and / or a third skirt. The frame is radially compressible and expandable between a radially compressed state and a radially expanded state and includes multiple leaflets at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates extra space between the inflow end of the frame and the skirt assembly when the frame is in the radially expanded state. The pocket allows the leaflets at the inflow end of the frame to move toward the inflow end of the pocket when the frame is radially compressed to the radially compressed state without protruding through the skirt assembly.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 164,663, filed March 23, 2021, which is incorporated herein by reference.

[0002] The present disclosure relates to a collapsible and expandable prosthetic heart valve having an elongated sealing member. [Background technology]

[0003] Physicians have attempted to repair and / or replace defective heart valves through open-heart surgery for many years. However, due to the risks and complications of open-heart surgery, foldable prosthetic heart valves have been developed that can be crimped to a thin enough profile (e.g., less than 8 mm in diameter) to be advanced through the patient's vasculature (e.g., veins and / or arteries) on a delivery catheter. Specifically, a physician can make a small incision near a blood vessel (e.g., a surgeon can make an incision in the patient's groin to access the femoral vein or artery), and then advance the foldable prosthetic heart valve in a crimped state through the patient's vasculature using a delivery catheter until the prosthetic heart valve reaches the defective native heart valve. Once the prosthetic heart valve reaches the defective native valve, the prosthetic heart valve can expand to its functional size via an inflatable balloon, mechanical actuator, shape memory material, etc. In this way, a physician can access the heart indirectly (e.g., through a small incision in the patient's groin) without having to open the patient's chest cavity. Such transcatheter approaches are much less invasive than open-heart surgery and can reduce and / or avoid the risks and complications associated with open-heart surgery.

[0004] A transcatheter prosthetic heart valve typically comprises a radially compressible and expandable annular metal frame supporting two or more prosthetic valve leaflets (often made from pericardial tissue of an animal (e.g., bovine)) that open and close to regulate blood flow through the valve. A transcatheter prosthetic heart valve may also comprise an outer fabric skirt (e.g., made from polyethylene terephthalate (abbreviated PET)) that cushions and seals the rigid frame against the surrounding native heart tissue. A transcatheter prosthetic heart valve may also comprise an inner fabric skirt, which can be used to attach the prosthetic valve leaflets to the frame and / or seal the openings within the frame.

[0005] The frames of some transcatheter prosthetic heart valves can lengthen or stretch axially when radially compressed (such as when crimped onto the balloon of a delivery device). In some cases, stretching of the frame during crimping can cause the cusps of the frame to protrude or extend through one end of the skirt of the prosthetic valve. The exposed cusps can contact the inner surface of the introducer sheath used to introduce the prosthetic valve and delivery device into the patient's vasculature. This can increase the pushing force required to push the prosthetic valve through the introducer sheath, potentially deforming the exposed cusps and damaging the valve.

[0006] Therefore, an assembly, device, and / or method for a sealing member (eg, a fabric skirt) that can protect the cusps of a prosthetic heart valve frame during an implantation procedure is desirable. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 10,195,025 [Patent Document 2] US Patent Application Publication No. 2012 / 0123529 [Patent Document 3] US Patent Application Publication No. 2019 / 0365530 Summary of the Invention

[0008] The present disclosure relates to examples of sealing members (e.g., fabric skirts) of prosthetic heart valves configured to protect the cusps of the frame from damage caused by contact with components of the delivery system. Specifically, the present disclosure is directed to elongated sealing members of prosthetic heart valves in which the valve extends beyond one end of the frame of the prosthetic heart valve when the valve is uncrimped (i.e., the valve is radially expanded) to accommodate the axial elongation of the frame during crimping. The elongated sealing member may form a pocket at one end of the frame to prevent the frame from protruding through the sealing member when the valve is crimped. Keeping the frame fully contained within the sealing member, even in its crimped state, can prevent damage to the frame and / or the remainder of the valve and / or reduce the force required to push the valve through the introducer sheath of the delivery assembly.

[0009] In one representative example, the prosthetic heart valve includes an annular frame, a leaflet assembly, and a skirt assembly. The annular frame includes an inflow end and an outflow end and is radially compressible and expandable between a radially compressed state and a radially expanded state. Additionally, the frame includes a plurality of leaflets at the inflow end. The leaflet assembly is positioned within the frame and includes a plurality of leaflets coupled to the frame and positioned entirely within the frame. The skirt assembly includes an inner skirt and an outer skirt. The inner skirt extends circumferentially around the inside of the frame and the outer skirt extends circumferentially around the outside of the frame. Both the inner skirt and the outer skirt have respective inflow and outflow edge portions, and the inflow edge portions of the inner skirt and the outer skirt are sewn together such that the inflow edge portion of the inner skirt and / or the inflow edge portion of the outer skirt form a pocket at the inflow end of the frame. The leaflets at the inflow end of the frame are disposed within the pocket and are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state. The apex moves closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state, but does not extend and / or protrude through the skirt assembly when the frame is in the radially compressed state.

[0010] In another representative embodiment, a prosthetic heart valve includes an annular frame, a leaflet assembly, an inner skirt, and an outer skirt. The annular frame has an inflow end and an outflow end and is radially compressible and expandable between a radially compressed state and a radially expanded state. The frame further includes a plurality of leaflets at the inflow end. The leaflet assembly includes a plurality of leaflets positioned within and coupled to the frame. The outer skirt extends circumferentially around an outside of the frame and has an inflow edge portion and an outflow edge portion. The inner skirt extends circumferentially around an inside of the frame and also has an inflow edge portion and an outflow edge portion. The inner skirt folds upon itself to form a pocket at the inflow end of the frame. A leaflet at the inflow end of the frame is disposed within the pocket. The pocket has an inflow end, and the leaflet is spaced from the inflow end of the pocket when the frame is in the radially expanded state. When the frame is radially compressed from a radially expanded state to a radially compressed state, the apex moves closer to the inflow end of the pocket but does not extend and / or protrude through the inflow end of the pocket.

[0011] In yet another representative embodiment, a prosthetic heart valve includes an annular frame, a leaflet assembly, an inner skirt, and an outer skirt. The annular frame includes an inflow end and an outflow end, the frame being radially compressible and expandable between a radially compressed state and a radially expanded state. Additionally, the frame includes a plurality of leaflets at the inflow end. The leaflet assembly includes a plurality of leaflets positioned within and coupled to the frame. The inner skirt extends circumferentially around an inside of the frame and has an inflow edge portion and an outflow edge portion. The outer skirt extends circumferentially around an outside of the frame and also has an inflow edge portion and an outflow edge portion. The outer skirt folds upon itself to form a pocket at the inflow end of the frame. A leaflet at the inflow end of the frame is disposed within the pocket. The pocket has an inflow end, and the leaflet is spaced from the inflow end of the pocket when the frame is in the radially expanded state. When the frame is radially compressed from a radially expanded state to a radially compressed state, the apex moves closer to the inflow end of the pocket but does not extend and / or protrude through the inflow end of the pocket.

[0012] In yet another representative example, a method of assembling a prosthetic heart valve includes the steps of attaching an inner skirt on an inside of a radially compressible and expandable frame having an inflow end, an outflow end, and a plurality of cusps at the inflow end; attaching an outer skirt on an outside of the frame; attaching a leaflet assembly including the plurality of cusps to the frame such that the leaflet assembly is fully positioned within the frame between the inflow and outflow ends of the frame; and sewing the inner and outer skirts together such that the inner and / or outer skirts form a pocket at the inflow end of the frame, or sewing a third skirt to the inner and outer skirts such that the third skirt extends beyond the inflow end of the frame and forms a pocket, the plurality of cusps being disposed within the pocket, the pocket having an inflow end that is separated from the plurality of cusps of the frame when the frame is in a radially expanded state.

[0013] In yet another representative example, a prosthetic heart valve includes an annular frame, a leaflet assembly, and a skirt assembly. The annular frame includes an inflow end and an outflow end and is radially compressible and expandable between a radially compressed state and a radially expanded state. The annular frame also includes a plurality of leaflets at the inflow end. The leaflet assembly is positioned within the frame and includes a plurality of leaflets coupled to the frame and positioned entirely within the frame. The skirt assembly includes an inner skirt and an outer skirt. The inner skirt extends circumferentially around an inner side of the frame and has an inflow edge portion and an outflow edge portion. The outer skirt, separate from the inner skirt, extends circumferentially around an outer side of the frame and has an inflow edge portion and an outflow edge portion. The inflow edge portions of the inner skirt and the outer skirt are coupled to one another to form a pocket adjacent the inflow end of the frame, the leaflets are disposed within the pocket, and the pocket has an inflow end. When the frame is in a radially expanded state, the apex is spaced from the inflow end of the pocket, and when the frame is radially compressed from the radially expanded state to the radially compressed state, the apex moves closer to the inflow end of the pocket.

[0014] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 illustrates a side view of a prosthetic heart valve, according to an embodiment. [Diagram 2] FIG. 2 shows a top perspective view of the prosthetic heart valve shown in FIG. 1 crimped onto a delivery device in a radially compressed state. [Diagram 3] FIG. 3 shows a top perspective view of the prosthetic heart valve shown in FIGS. 1-2 in a radially expanded state. [Figure 4] FIG. 4 shows a perspective view of a frame of the prosthetic heart valve shown in FIGS. 1-3, according to an embodiment. [Diagram 5]FIG. 5 shows a side view of the frame shown in FIG. 4 in an unfolded, flat configuration. [Figure 6] FIG. 6 shows an enlarged view of a first portion of the frame shown in FIGS. [Figure 7] FIG. 7 shows an enlarged view of a second portion of the frame shown in FIGS. [Figure 8] FIG. 8 shows an enlarged view of a third portion of the frame shown in FIGS. [Figure 9] FIG. 9 shows an enlarged view of a fourth portion of the frame shown in FIGS. [Figure 10] FIG. 10 shows an enlarged view of a fifth portion of the frame shown in FIGS. [Figure 11] FIG. 11 illustrates a side view of the inner side of the inner skirt of the prosthetic heart valve shown in FIGS. 1-3, according to an embodiment. [Figure 12] FIG. 12 shows an exterior side view of the inner skirt shown in FIG. [Figure 13] FIG. 13 shows an enlarged view of a portion of the inner skirt shown in FIGS. [Figure 14] FIG. 14 shows an enlarged view of a portion of the inner skirt shown in FIGS. [Figure 15] FIG. 15 illustrates a side view of the inner skirt shown in FIGS. 11-14 coupled to the frame shown in FIGS. 4-10, according to an embodiment. [Figure 16] FIG. 16 illustrates a top view of adjacent leaflets of the leaflet assembly of the prosthetic heart valve shown in FIGS. 1-3 coupled together via a connector, according to an embodiment. [Figure 17] FIG. 17 shows a top view of the leaflet assembly shown in FIG. [Figure 18] FIG. 18 illustrates a top perspective view of the commissures of the leaflet assembly shown in FIGS. 16-17 coupled to the frame shown in FIGS. 4-10, according to an embodiment. [Figure 19] FIG. 19 illustrates a side view of a portion of a leaflet of the leaflet assembly shown in FIGS. 16-18 coupled to the inner skirt shown in FIGS. 11-15, according to an embodiment. [Figure 20]FIG. 20 illustrates a side view of the leaflet assembly shown in FIGS. 16-19 coupled to the inner skirt shown in FIGS. 11-15 and the frame shown in FIGS. 4-10, according to an embodiment. [Figure 21] FIG. 21 illustrates a side view of the outer skirt of the prosthetic heart valve shown in FIGS. 1-3, according to an embodiment. [Figure 22] FIG. 22 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Figure 23] FIG. 23 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Figure 24] FIG. 24 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Diagram 25] FIG. 25 shows an enlarged side view of a portion of the frame shown in FIGS. 4-10 to which the outflow edge portion of the inner skirt shown in FIGS. 11-15 can be attached. [Figure 26A] FIG. 26A shows an exterior side perspective view of the outflow edge portion of the inner skirt of FIGS. 11-15 and 20 aligned on the frame shown in FIGS. 4-10 and 20 of the prosthetic heart valve shown in FIGS. 1-3. [Figure 26B] FIG. 26B shows an enlarged view of the outflow edge portion of the inner skirt shown in FIG. 26A. [Figure 27A] FIG. 27A shows an exterior perspective view of the inflow edge portions of the inner and outer skirts shown in FIGS. 11-15 and 20-21. [Figure 27B] FIG. 27B shows an interior perspective view of the inflow edge portion of the skirt shown in FIG. 27A. [Figure 28] FIG. 28 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Figure 29] FIG. 29 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Diagram 30]FIG. 30 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. [Diagram 31] FIG. 31 illustrates a cross-sectional view of the inflow edge portion of the prosthetic heart valve shown in FIGS. 1-3 in the radially expanded state shown in FIG. 3, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The described methods, systems, and devices 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 embodiments, both alone and in various combinations and subcombinations with one another. The disclosed methods, systems, and devices are not limited to any specific aspects, features, or combinations thereof, nor do the disclosed methods, systems, and devices require that any one or more specific advantages exist or problems be solved.

[0017] It is understood that any feature, integer, property, compound, chemical moiety, or group described in conjunction with a particular aspect, embodiment, or example of the present disclosure is applicable to any other aspect, embodiment, or example described herein, unless incompatible therewith. All of the features disclosed herein (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The present disclosure is not limited to the details of any of the foregoing examples. The present disclosure extends to any novel or any novel combination of features disclosed herein (including any accompanying claims, abstract, and drawings), or to any novel or any novel combination of steps of any method or process so disclosed.

[0018] Although some operations of the disclosed methods are described in a particular order for convenient presentation, it should be understood that this manner of description encompasses rearrangements, unless a particular order is required by specific terminology described below. For example, operations described sequentially may in some cases be rearranged or performed simultaneously. Moreover, for the sake of simplicity, the accompanying figures may not show the various ways in which the disclosed methods, systems, and devices can be used in conjunction with other systems, methods, and devices.

[0019] As used herein, the terms "a," "an," and "at least one" include one or more of the particular elements. That is, if two of the particular elements are present, then one of these elements is also present, and thus there is "an" element. The terms "multiple" and "plurality" refer to two or more of the particular elements.

[0020] As used herein, the term "and / or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0021] As used herein, the term "coupled" generally means physically connected or joined and does not exclude the presence of intermediate elements between the coupled items, unless specifically termed to the contrary.

[0022] Directions and other relative references (e.g., inside, outside, upper, lower, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, specific terms such as "inside," "outside," "top," "down," "interior," and "exterior" may be used. Such terms are used to provide a degree of clarity of description, where applicable, particularly when dealing with relative relationships with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part may become a "lower" part by simply flipping the object. It is still the same part, and the object remains the same. As used herein, "and / or" means "and" or "or," as well as "and" and "or."

[0023] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of a valve is its inflow end and the upper end of a valve is its outflow end.

[0024] With reference to prosthetic medical devices (e.g., heart valves), capsules, and delivery devices, "proximal" as used herein refers to a location, direction, or portion of a component that is closer to the handle of the delivery device that is external to the user and / or patient, while "distal" refers to a location, direction, or portion of a component that is further away from the user and / or handle of the delivery device and closer to the implantation site. The terms "longitudinal" and "axial" refer to an axis that extends in the proximal and distal directions, unless expressly defined otherwise. Additionally, the term "radial" refers to a direction that is disposed perpendicular to an axis and points along a radius from the center of the object (where an axis, such as the longitudinal axis of a prosthetic valve, is centrally located).

[0025] Disclosed Technology and Examples A collapsible transcatheter prosthetic heart valve may be crimped into a slim profile (e.g., radially compressed) on a delivery device so that it can be advanced through the patient's vasculature with minimal complications. However, as the frame lengthens as it is crimped, the cusps of the frame may protrude through the skirt assembly and contact the inner surface of the introducer sheath used to introduce the prosthetic valve and delivery device into the patient's vasculature. This increases the pushing force required to push the prosthetic valve through the introducer sheath, potentially deforming the exposed cusps and damaging the valve.

[0026] Disclosed herein is a foldable prosthetic heart valve having a sealing assembly configured to completely cover the apexes of at least one end of the frame when the prosthetic valve is in a radially compressed delivery configuration. Specifically, the prosthetic heart valve disclosed herein includes one or more elongated sealing members (also referred to herein as "skirts") that extend beyond one end of the frame and form a gap or pocket (e.g., hollow space) between the sealing members and the apexes of the frame at that end of the frame. The extra space provided by this pocket allows the frame to be lengthened during crimping without perforating the sealing members or without the apexes extending beyond the end of the skirt. Thus, the foldable prosthetic heart valve disclosed herein can protect the apexes of the frame from contact with components of the delivery system, particularly the inner surface of the introducer sheath, during the implantation procedure.

[0027] As discussed in more detail below, the pocket may be formed by an inner skirt and / or an outer skirt attached to the inside and outside of the frame, respectively. In some embodiments (FIG. 23), the pocket may be formed in both skirts. For example, in some such embodiments, both the inner skirt and the outer skirt may extend beyond the inflow end of the frame and may be sewn together at the pocket (below the inflow end of the frame). In other embodiments (FIG. 22), the pocket may be formed by an inner skirt. For example, in some such embodiments, the inner skirt may be wrapped around the inflow end of the frame, may extend over the outer skirt on the outside of the frame, and may be sewn to the outer skirt on the outside of the frame. In still further embodiments (FIG. 24), the pocket may be formed by an outer skirt. For example, in some such embodiments, the skirt on the outside of the frame may be wrapped around the inflow end of the frame, may extend over the inner skirt on the inside of the frame, and may be sewn to the inner skirt on the inside of the frame. In yet a further embodiment (FIGS. 28 and 30-31), the pocket may be at least partially formed by the inner skirt, the outer skirt, and / or a separate third skirt attached to the frame.

[0028] Further information and examples are provided below with reference to the accompanying drawings.

[0029] Figures 1-31 show various embodiments of a prosthetic heart valve according to the present disclosure. Specifically, Figures 1-3 show an exemplary prosthetic heart valve (Figures 1 and 3 show the valve in a radially expanded state and Figure 2 shows the valve in a radially compressed (i.e., crimped) state), and Figures 4-20 and 29 show various components of an exemplary prosthetic heart valve. Specifically, Figure 29 shows how the inner and outer skirts can be attached to the frame at both their inflow and outflow edge portions. Figures 22-24, 28, and 30-31 show four different embodiments of pockets of an exemplary prosthetic heart valve. Specifically, Figure 22 illustrates an example where an inner skirt is wrapped around the inflow edge of the frame to form a pocket, Figure 24 illustrates an example where an outer skirt is wrapped around the inflow edge of the frame to form a pocket, Figure 23 illustrates an example where both the inner and outer skirts extend beyond the inflow edge of the frame and are sewn together below the inflow edge of the frame to form a pocket, and Figures 28 and 30-31 illustrate an example where a separate third skirt is attached to the inflow edge portion of the inner skirt, the inflow edge portion of the outer skirt, and / or the inflow edge of the frame to form at least a portion of the pocket. Figure 25 illustrates how the inner skirt may be aligned with the frame to ensure proper pocket length in an example where the inner skirt forms the pocket, and Figures 26A-27B illustrate how the inner and outer skirts may be sewn together in a similar example where the inner skirt forms the pocket.

[0030] As shown in Figures 1-3, prosthetic heart valve 10 (herein referred to as "transcatheter prosthetic heart valve 10", "prosthetic valve 10", "radially compressible and expandable prosthetic heart valve 10") includes an annular frame 12 that can move between a radially expanded, axially contracted state (Figures 1 and 3) and a radially compressed, axially elongated (i.e., crimped) state (Figure 2), a leaflet assembly 14 including a plurality of leaflets 15 positioned within frame 12, and a skirt assembly 16 (which may be referred to herein as a "seal member assembly 16").

[0031] The skirt assembly 16 includes an inner skirt 17 (which may also be referred to herein as “inner seal member 17”) and an outer skirt 18 (which may also be referred to herein as “outer seal member 18”) attached to the opposite side of the frame 12. As mentioned above, the inner skirt 17 and / or the outer skirt 18 may form a pocket 20 ( FIG. 3 ) configured to receive an apex of the frame 12 between an inflow end 22 of the frame 12 and the skirt assembly 16 at the inflow end 22 of the frame 12 when the frame is crimped (i.e., radially compressed and axially elongated), such as into the radially compressed state shown in FIG.

[0032] Frame 12 also includes an outflow end 24 opposite the inflow end 22. Blood is generally configured to flow in only one direction (i.e., unidirectional) through valve 10, from the inflow end 22 of frame 12 to the outflow end 24 of frame 12. Thus, blood may be configured to enter valve 10 at inflow end 22 of frame 12, flow from inflow end 22 of frame 12 to outflow end 24 of frame 12, and then exit frame 12 at outflow end 24 of frame 12.

[0033] As shown in FIGS. 4-5, the frame 12 includes a plurality of struts 26 that form and / or otherwise define a plurality of open cells 28 (which may be referred to herein as “openings 28”). More specifically, the plurality of struts 26 may comprise a plurality of angled struts 30 arranged in rows. Adjacent angled struts 30 in each row of angled struts may be directly connected to one another (i.e., without any intervening components) at joints 32. Additionally, adjacent rows of angled struts 30 may be connected to one another at joints 32. In some embodiments, the joints 32 of two or more adjacent rows of angled struts 30 may be directly connected to one another. In some embodiments, the joints 32 of two or more adjacent rows of angled struts 30 may be connected to one another via one or more intermediate strut structures, such as one or more vertical struts (which may be referred to herein as “axially extending struts”) 34, to interconnect adjacent rows of angled struts 30.

[0034] 4-5, the rows of angled struts 30 include five rows of angled struts 30, namely, a first row of angled struts 36, a second row of angled struts 38, a third row of angled struts 40, a fourth row of angled struts 42, and a fifth row of angled struts 44. The first row of angled struts 36 (located closest to the inflow end 22 of the frame 12) may be connected to the second row of angled struts 38 via a first row of vertical struts 46, while the junctions 32 of the second row of angled struts 38 and the third row of angled struts 40 may be connected to each other. Similarly, the junctions 32 of the third row 40 of angled struts and the junctions 32 of the fourth row 42 of angled struts may be directly connected to each other, while the junctions 32 of the fourth row 42 of angled struts and the junctions 32 of the fifth row 44 of angled struts (positioned closest to the outflow end 24 of the frame 12) may be connected to each other via the second row 48 of vertical struts and a plurality of axially extending window frame struts 50 (defining commissure windows 52).

[0035] In this manner, the plurality of struts 26 may define and / or otherwise form four rows of open cells 28. The first 36 and second 38 rows of angled struts may define and / or otherwise form a first row 54 of open cells, the second 38, third 40 and fourth 42 rows of angled struts may form and / or otherwise define two intermediate rows 56 of open cells, and the fourth 42 and fifth 44 rows of angled struts may form and / or otherwise define a fourth row 58 of open cells.

[0036] 4-5, due to the inclusion of the vertical strut 46 between the first and second rows 36 and 38 of angled struts, and the inclusion of the struts 48, 50 between the fourth and fifth rows 42 and 44 of angled struts, the first row 54 of open cells and the fourth row 58 of open cells may be larger than the cells of the two intermediate rows 56 of open cells. Additionally, the struts 48, 50 may be longer than the vertical struts 46, and therefore the cells of the fourth row 58 of open cells may be larger than the cells of the first row 54 of open cells. The relatively large size of the cells of the fourth row 58 of open cells may allow portions of the leaflet assembly 14 to protrude or bulge into or through the frame 12 when the frame 12 is crimped to minimize the crimp profile. Generally, when the frame 12 is in a radially compressed state (FIG. 2) and portions of the leaflets 15 are allowed to protrude or bulge outwardly through the frame 12, the shape of the struts 26 and coaptations 32 help to provide sufficient open cells 28 so that the valve 10 can be crimped to a relatively smaller diameter than if all of the leaflet material were constrained within the crimped frame.

[0037] Additionally, the relatively large size of the first row of open cells 54 allows the frame, when crimped (FIG. 2), to assume an overall tapered shape that tapers from a maximum diameter at the outflow end 24 of the frame 12 to a minimum diameter at the inflow end 22. When crimped, the frame 12 has a reduced diameter region extending along a portion of the frame adjacent the inflow end 22 of the frame that generally corresponds to the area of ​​the frame 12 that is covered by the outer skirt 18. In some embodiments, the reduced diameter region is reduced relative to the diameter of an upper portion of the frame 12 (not covered by the outer skirt 18) such that the outer skirt 18 does not increase the overall crimped profile of the valve 10. When the valve 10 is deployed, the frame 12 can expand from a radially compressed state (FIG. 2) to a radially expanded state (FIGS. 1, 3, 4, 15, 20) in which the frame 12 is generally cylindrical and annular. In one example, the frame 12 of a 26 mm prosthetic valve, when crimped, has a first diameter of 14 French at the outflow end 24 of the frame 12 and a second diameter of 12 French at the inflow end 22 of the frame 12 .

[0038] 7, struts 46, 48, and / or 50 may have a thickness S1 that is less than a thickness S2 of joints 32. Joints 32 may help prevent complete closure of open cells 28.

[0039] The frame 12 is configured to reduce, prevent, or minimize overexpansion of the prosthetic valve at a given balloon pressure, particularly at the outflow end of the frame that supports the leaflet assembly 14. In one embodiment, the frame 12 is configured to have relatively large angles 60a, 60b, 60c, 60d, 60e between the angled struts 30, as shown in FIG. 5. The larger the angle, the more force required to open (expand) the frame. Thus, the angles between the angled struts 30 of the frame 12 can be selected to limit the radial expansion of the frame 12 at a given opening pressure (e.g., balloon inflation pressure). In a specific example, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and more specifically, these angles are up to about 120 degrees when the frame is expanded to its functional size.

[0040] The frame 12 may also include a plurality of apexes 62 at the inflow end 22 and / or the outflow end 24. The apexes 62 may be formed by the angled struts 30 at the inflow end 22 and / or the outflow end 24. Specifically, the first row of angled struts 36 and the fifth row of angled struts 44 may form a plurality of apexes 62 at the inflow end 22 and the outflow end 24, respectively, of the frame 12. The apexes 62 may be formed on the angled struts 30 and / or where adjacent angled struts 30 connect.

[0041] In the drawings, the frame 12 is shown as including five rows of angled struts 30 and four rows of open cells 28, although it will be appreciated that in other examples, the frame 12 may include more or less than five rows of angled struts 30 and / or four rows of open cells 28.

[0042] The frame 12 also includes window frame struts 50 that form and / or otherwise define commissure windows 52 (three in the illustrated example) that are adapted to attach the commissures of the leaflet assembly 14 to the frame 12, as described in more detail below. Each pair of window frame struts 50 is configured to attach a respective commissure of the leaflet assembly 14. As can be seen in Figures 4-5, each window frame strut 50 is secured at its upper and lower ends to adjacent rows of angled struts 30, providing a robust configuration that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to known cantilever struts for supporting the commissures of the leaflet assembly. This configuration allows for a reduction in frame wall thickness, achieving a smaller crimp diameter of the prosthetic valve. In a specific example, the thickness T of the frame 12 (Figure 4), measured between the inner and outer diameters, is about 0.48 mm or less. 6, 7, 8, 9, and 10 are enlarged views of portions of frame 12 identified by the letters A, B, C, D, and E, respectively, in FIG.

[0043] The frame 12 may 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) known in the art. When constructed of a plastically expandable material, the frame 12 (and thus the prosthetic heart valve 10) may be crimped to a radially compressed state on a delivery catheter and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic heart valve 10) may be crimped to a radially compressed state and restrained in the radially compressed state by insertion into a sheath or equivalent mechanism of the delivery catheter. Once inside the body, the valve 10 may be advanced from the delivery sheath, which allows the valve 10 to expand to its radially expanded state.

[0044] Suitable plastically expandable materials that may be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular embodiment, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (coated by ASTM F562-02). MP35N® alloy / UNS R30035 alloy includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using MP35N to form the frame 12 provides better structural results than stainless steel. In particular, when MP35N® is used as the frame material, less material is required to achieve the same or better performance in radial crush force resistance, fatigue resistance, and corrosion resistance. Additionally, because less material is required, the crimp profile of the frame may be reduced, thereby providing a smaller profile prosthetic valve assembly for percutaneous delivery to a treatment site within the body.

[0045] In some embodiments, frame 12 may be formed from a single material. In some such embodiments, open cells 28 are formed by removing material from the single material (e.g., via machining, milling, laser cutting, etc.). In other such embodiments, however, frame 12 and open cells 28 may be formed via a molding process (e.g., die casting, injection molding). In further embodiments, frame 12 may be formed from two or more materials that are formed separately and then connected together via any suitable connection means (e.g., welding, adhesives, fasteners).

[0046] As shown in Figures 1, 3, 15, 20, the inner skirt 17 may be mounted on the inner side 63 of the frame and coupled and / or otherwise secured to the frame 12, for example, via sutures. The inner skirt 17 includes an inner side 64 (Figure 11) opposite an outer side 65 (Figure 12), the inner side 64 facing radially inward (towards the lumen of the valve 10) and the outer side 65 facing radially outward and directly contacting the inner side 63 of the frame 12. In the example shown in Figures 1, 3, 15, 20, the inner skirt 17 may be sewn to the fourth row of angled struts 42. Specifically, the inner skirt 17 may include an inflow edge portion 66 opposite an outflow edge portion 68, which may be coupled to the fourth row of angled struts 42 via sutures 70. In some such embodiments, a plurality of protrusions 96 may be formed on the outflow edge portion 68 of the inner skirt 17, which may be wrapped over the fourth row of angled struts 42 and secured to the fourth row of angled struts via stitching 70. As discussed in more detail below, during alignment and attachment of the outflow edge portion 68 of the inner skirt 17 to the fourth row of angled struts 42, a user may ensure that the outflow edge portion 68 of the inner skirt 17 does not extend beyond the junction 32 of the fourth row of angled struts 42 by more than a threshold amount X ( FIG. 25 ) to maintain a sufficient length of the pocket 20 at the inflow end 22 of the frame 12.

[0047] The main function of the inner skirt 17 is to help form a good seal between the prosthetic valve 10 and the native annulus by securing the leaflet assembly 14 to the frame 12 and blocking blood flow through the open cells 28 of the frame 12 below the lower edge of the leaflets 15. The inner skirt 17 preferably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), although a variety of other synthetic or natural materials (e.g., pericardial tissue) can be used. The thickness of the skirt is preferably less than about 0.15 mm (about 6 mils), preferably less than about 0.1 mm (about 4 mils), and more preferably about 0.05 mm (about 2 mils). In some embodiments, the skirt 17 can have a variable thickness, for example, the skirt can be thicker at at least one of its edges than at its center. In one implementation, the skirt 17 can comprise a PET skirt having a thickness of about 0.07 mm at its edges and about 0.06 mm at its center. A thinner skirt can provide better crimping performance while still providing a good perivalvular seal.

[0048] The leaflet assembly 14 may be attached to the skirt via one or more reinforcing strips 72 (which together can form a sleeve), such as the thin PET reinforcing strips discussed below, which allow for secure suturing and protect the pericardial tissue of the leaflet assembly from laceration. The leaflet assembly 14 may be sandwiched between the skirt 17 and the thin PET strips 72, as shown in FIG. 19. The sutures 74 that secure the PET strips and skirt 17 to the leaflet assembly 14 may be any suitable suture, such as Ethibond Excel® PET suture (Johnson & Johnson, Brunswick, NJ). As described in more detail below, the sutures 74 desirably follow the curvature of the bottom edge of the leaflet assembly 14.

[0049] 12, in contrast to known fabric skirts, the skirt 17 is desirably woven from a first set of fibers, or threads or strands 78 and a second set of fibers, or threads or strands 80, both of which are not perpendicular to the outflow end 82 and the inflow end 84 of the skirt. In a specific embodiment, the first set of fibers 78 and the second set of fibers 80 extend at an angle of about 45 degrees (e.g., 15 degrees to 75 degrees or 30 degrees to 60 degrees) relative to the outflow end 82 and the inflow end 84. For example, the skirt 17 can be formed by weaving the fibers at a 45 degree angle relative to the outflow and inflow ends of the fabric. Alternatively, the skirt 17 can be cut diagonally (cut along the bias) from a vertically woven fabric (with the fibers extending perpendicular to the edges of the material) so that the fibers extend at a 45 degree angle relative to the cut outflow and inflow ends of the skirt. 12, the opposing short edges 86, 88 of the skirt 17 are desirably not perpendicular to the outflow and inflow ends 82, 84. For example, the short edges 86, 88 desirably extend at an angle of about 45 degrees relative to the outflow and inflow ends so as to be aligned with the first set of fibers 78. Thus, the overall general shape of the skirt 17 is a diamond or parallelogram.

[0050] 13 and 14 show the inner skirt 17 after the opposing short edge portions 90, 92 have been sewn together to form the annular shape of the skirt. As shown, the edge portion 90 may be placed in overlapping relation to the opposite edge portion 92, and the two edge portions may be sewn together by a diagonally extending stitching line 94 parallel to the short edges 86, 88. The inflow edge portion 66 of the inner skirt 17 may be formed with a plurality of projections 96 that define an undulating shape that generally follows the shape or profile of the fourth row 42 of angled struts immediately adjacent the lower end of the vertical strut 48. In this manner, the outflow end 82 of the inner skirt 17 may be securely secured to the fourth row 42 of angled struts with the stitching 70, as best shown in FIG. 15. The inner skirt 17 may also be formed with slits 98 to facilitate attachment of the skirt 17 to the frame 12. The slits 98 are sized to allow the outflow edge portion 68 of the inner skirt 17 to be wrapped partially around the fourth row 42 of angled struts to reduce stress on the skirt during the attachment procedure. For example, in the illustrated example, the inner skirt 17 is placed on the inner side 63 of the frame 12 and the outflow edge portion 68 of the skirt 17 is wrapped around the top surface of the fourth row 42 of angled struts and secured with sutures 70. Wrapping the outflow edge portion 68 of the inner skirt 17 around the fourth row 42 of angled struts in this manner provides a stronger and more durable attachment of the skirt 17 to the frame 12. The inner skirt 17 may additionally or alternatively be secured to the first row 36, second row 38, and / or third row 40 of angled struts with sutures 70, respectively.

[0051] As shown in FIG. 25 , the slits 98 may be circumferentially aligned with the junctions 32 between adjacent angled struts. In some embodiments, the slits 98 may not be axially spaced away from the junctions 32 by more than a threshold amount X to ensure that the pocket 20 is formed at the inflow end 22 of the frame 12 and / or to prevent overlap of the inner skirt 17. For example, the slits 98 may be axially spaced away from the junctions (towards the outflow end 24 of the frame) by 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, and / or up to 1.0 mm from the junctions 32 of the fourth row 42 of angled struts (i.e., the threshold amount X may be less than or equal to). Thus, in some embodiments, the inflow end 84 of the inner skirt 17 may extend beyond (i.e., below) the apex 62 at the inflow end 22 of the frame 12. However, in other embodiments, the inflow end 84 of the inner skirt 17 may extend to, but not beyond, the apex 62 at the inflow end of the frame 12. In still further embodiments, the inflow end 84 of the inner skirt 17 may not extend to, but may stop short of, the apex 62 at the inflow end 22 of the frame 12.

[0052] Due to the oblique orientation of the fibers relative to the inflow and outflow ends of the skirt 17, the skirt 17 can undergo greater elongation in the axial direction (i.e., in the direction from the outflow end 82 to the inflow end 84). Thus, when the frame 12 is crimped, the inner skirt 17 can elongate axially along the frame, thus providing a more uniform and predictable crimp profile. Each cell of the metal frame in the illustrated embodiment includes at least four angled struts that rotate toward the axial direction upon crimping (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each cell act as a mechanism to rotate the fibers of the skirt in the same direction as the struts, allowing the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.

[0053] Additionally, the spacing between the woven fibers or yarns can be increased to facilitate axial skirt elongation. For example, for a PET inner skirt 17 formed from 20 denier yarns, the yarn density can be about 15% to about 30% lower than a typical PET skirt. In some embodiments, the yarn spacing of the inner skirt 17 can be about 60 yarns per cm (about 155 yarns per inch) to about 70 yarns per cm (about 180 yarns per inch), such as about 63 yarns per cm (about 128 yarns per inch), while the yarn spacing in a typical PET skirt can be about 85 yarns per cm (about 217 yarns per inch) to about 97 yarns per cm (about 247 yarns per inch). The short edges 86, 88 promote uniform and even distribution of the fabric material along the inner circumference of the frame during crimping to reduce or minimize bunching of the fabric and facilitate uniform crimping to a minimum diameter. Additionally, cutting the diagonal stitching perpendicularly can leave loose fringes along the cut edges. The short edges 86, 88 help minimize this occurrence. Compared to a typical skirt construction (fibers running perpendicular to the outflow and inflow ends of the skirt), the construction of the inner skirt 17 avoids undesirable deformation of the frame struts and provides a more uniform crimping of the frame.

[0054] In alternative embodiments, the skirt 17 may be formed from woven elastic fibers that can stretch axially during crimping of the prosthetic valve 10. The longitudinal and transverse fibers may extend perpendicular and parallel to the inflow and outflow ends of the skirt 17, or alternatively, at angles between 0 degrees and 90 degrees relative to the inflow and outflow ends of the skirt 17, as described above.

[0055] The inner skirt 17 may be sewn to the frame 12 at a location away from the sutures 74 so that the skirt may be more flexible in that region. This configuration may avoid stress concentrations at the sutures 74, which attach the lower edge of the leaflet to the inner skirt 17.

[0056] As mentioned above, the leaflet assembly 14 in the illustrated example includes three flexible leaflets 15 (although a greater or lesser number of leaflets can be used). Additional information regarding leaflets as well as skirt materials can be found, for example, in U.S. Patent Application Publication No. 2019 / 0133999, issued Feb. 5, 2019, and incorporated herein by reference.

[0057] The leaflets 15 may be secured to each other on their adjacent sides to form commissures 114 of the leaflet assembly (FIG. 20). A number of flexible connectors 116 (one of which is shown in FIG. 16) may be used to interconnect pairs of adjacent sides of the leaflets and attach the leaflets to the window frame struts 50 (FIG. 5). FIG. 16 shows adjacent sides of two leaflets 15 interconnected by flexible connectors 116. Three flexible connectors 116 may be used to secure the leaflets 15 next to each other (FIG. 17). Additional information regarding connecting the leaflets to each other and assembling the leaflets and skirt into a frame may be found, for example, in U.S. Pat. Nos. 5,399,993 and 5,399,993, which are incorporated herein by reference.

[0058] To protect the leaflet assembly 14 from over-expansion, the leaflet assembly 14 is desirably secured to the frame 12 below the fifth row of angled struts 44, as best seen in FIG. 1. Specifically, the inflow and outflow ends 22, 24 of the frame 12 may generally be more prone to over-expansion than the central portion of the frame 12 due to the "dog-boning" effect of the balloon used to expand the prosthetic valve 10. Thus, if the outflow end 24 of the frame 12 over-expands, the leaflet assembly 14 will be positioned at a level below where over-expansion is likely to occur, thereby protecting the leaflet assembly 14 from over-expansion.

[0059] Another advantage of mounting the leaflets 15 away from the outflow end 24 of the frame 12 is that when the prosthetic valve 10 is crimped onto a delivery catheter, the outflow end 24 of the frame 12, rather than the leaflets 15, is the most proximal component of the prosthetic valve 10. In this manner, if the delivery catheter includes a pusher mechanism or stop member that pushes or abuts the outflow end 24 of the prosthetic valve 10, the pusher mechanism or stop member will contact the outflow end 24 of the frame 12, rather than the leaflets 15, to avoid damage to the leaflets 15.

[0060] As mentioned above, the inner skirt 17 may be used to aid in suturing the leaflet assembly 14 to the frame 12. The inner skirt 17 may have contoured temporary marking sutures to guide the attachment of the lower edge of each leaflet 15. The inner skirt 17 itself may be sewn to the struts of the frame 12 using sutures 70, as described above, prior to securing the leaflet assembly 14 to the skirt 17. The struts that cross the marking sutures are preferably not attached to the inner skirt 17. This allows the inner skirt 17 to be more flexible in the areas not secured to the frame, minimizing stress concentrations along the suture lines securing the lower edges of the leaflets to the skirt. As described above, when the skirt is secured to the frame, the fibers 78, 80 (see FIG. 12) of the skirt align with the angled struts of the frame, promoting uniform crimping and expansion of the frame.

[0061] FIG. 18 illustrates one specific approach for securing the commissures 114 of the leaflet assembly 14 to the commissure window frame struts 50 of the frame 12. The flexible connectors 116 (FIG. 17) securing the two adjacent sides of the two leaflets 15 are folded widthwise and the top tab portions 112 are folded downwardly against the flexible connectors. Each top tab portion 112 is folded lengthwise (vertically) to assume an L-shape with an inner portion 118 folded against the inner surface of the leaflet 15 and an outer portion 122 folded against the connector 116. The outer portions 122 can then be sutured to the connector 116 along suture lines 124. The commissure tab assemblies are then inserted through the commissure windows 52 of the corresponding pair of window frame struts 50 and the outer folds of the window frame struts 50 can be sutured to the portions 122.

[0062] FIG. 18 also illustrates that the folded top tab portion 112 may form two layers of leaflet material at the commissure. The inner portion 118 of the top tab portion 112 lies flat against the layers of the two leaflets 15 that form the commissure, such that each commissure includes four layers of leaflet material immediately inward of the window frame struts 50. This four-layer portion of the commissure may be more resistant to bending or articulating than the portion of the leaflet 15 radially inward from the relatively more rigid four-layer portion. This allows the leaflets 15 to articulate primarily at the inner edge 120 of the folded inner portion 118 in response to blood flowing through the prosthetic valve during operation in vivo, rather than articulating around or proximally to the axial struts of the window frame struts 50. Because the leaflets articulate at a location spaced radially inward from the window frame struts 50, the leaflets 15 may avoid contact with and damage from the frame 12. However, under higher forces, the four-layered portions of the commissures can spread apart about the longitudinal axis adjacent the window frame struts 50, with each inner portion 118 unfolding relative to its respective outer portion 122. This may occur, for example, when the prosthetic valve 10 is compressed to mount onto the delivery shaft, allowing for a smaller crimped diameter. The four-layered portions of the commissures can also spread apart about the longitudinal axis when the balloon catheter is inflated during inflation of the prosthetic valve, which can relieve some of the pressure on the commissures caused by the balloon and reduce potential damage to the commissures during expansion.

[0063] After all three commissure tab assemblies are secured to their respective window frame struts 50, the lower edge of the leaflets 15 between the commissure tab assemblies may be sutured to the inner skirt 17. For example, as shown in FIG. 19, each leaflet 15 may be sutured to the inner skirt 17 via sutures 74, for example, using Ethibond Excel™ PET thread. The sutures 74 may be in-and-out sutures that extend through each leaflet 15, the inner skirt 17, and each of the reinforcing strips 72. Each leaflet 15 and each of the reinforcing strips 72 may be separately sewn to the inner skirt 17. In this manner, the lower edge of the leaflets 15 is secured to the frame 12 via the inner skirt 17. As shown in FIG. 19, the leaflets may be further secured to the skirt with a continuous intertwining suture 126 that loops around the reinforcing strips 72 and the edge of the leaflets 15 while also extending through each of the reinforcing strips 72, leaflets 15, and inner skirt 17. The continuous interlocking sutures 126 may be formed from PTFE suture material. Figure 20 shows a side view of the frame 12, the leaflet assembly 14 and the inner skirt 17 after the leaflet assembly 14 and the inner skirt 17 have been secured to the frame 12 and the leaflet assembly 14 to the inner skirt 17.

[0064] In some embodiments (e.g., FIGS. 3 and 20 ), the leaflet assembly 14, including the leaflets 15, is positioned entirely within the frame 12 (between the inflow end 22 and the outflow end 24 of the frame 12) and does not extend beyond the inflow end 22 of the frame 12. In some such embodiments, the leaflets 15 do not extend to the inflow end 22 of the frame 12, but instead stop short of the inflow end 22 of the frame 12. For example, as shown in FIG. 3 , the leaflets 15 do not extend to the cusp 62 at the inflow end 22 of the frame 12. Thus, the leaflet assembly 14 may be shorter than the frame 12 and may be positioned entirely within the frame 12 such that the leaflets 15 do not extend beyond the inflow end 22 and the outflow end 24 of the frame 12.

[0065] FIG. 21 is a flat view of the outer skirt 18 prior to its attachment to the frame 12. The outer skirt 18 may be laser cut or otherwise formed from a strong and durable material, such as PET or a variety of other suitable synthetic or natural materials, configured to restrict and / or prevent blood flow therethrough. The outer skirt 18 may include a substantially straight lower (inflow or upstream) edge portion 128 and an upper (outflow or downstream) edge portion 130 that defines a plurality of alternating protrusions 132 and notches 134, or castellations, that generally follow the shape of the strut rows of the frame 12. The inflow and outflow edge portions 128, 130 may have other shapes in alternative examples. For example, in one implementation, the inflow edge portion 128 may be formed by a plurality of protrusions that generally match the shape of the strut rows of the frame 12, while the outflow edge portion 130 may be straight.

[0066] The outer skirt 18 may comprise an inner side 136 (e.g., FIGS. 22-24) opposite an outer side 138 (e.g., FIGS. 21-24), the inner side 136 being configured to face radially inward (toward the lumen of the valve 10), while the outer side 138 is configured to face radially outward (toward the exterior of the valve and surrounding autologous tissue). Specifically, the outer skirt 18 may be mounted on the outer side 140 of the frame 12 such that the inner side 136 of the outer skirt 18 faces and directly contacts the outer side 140 of the frame 12. In specific embodiments, the outer side 138 may comprise a soft and plush material that cushions and seals against the autologous tissue surrounding the prosthetic valve 10. In certain embodiments, the outer skirt 18 may be made from any of a variety of fabrics, knits, or crochet fabrics, with the outer surface of the outer side 138 being a plush nap or pile of fabric. Exemplary fibers having pile include velour, velvet, plush, corduroy, terry cloth, fleece, and the like.

[0067] In another embodiment, the outer skirt 18 may be made from a nonwoven material such as felt, or a fiber such as nonwoven cotton fiber. The outer skirt 18 may also be formed from a porous or spongy material such as, for example, any of a variety of suitable polymeric foam materials, or a woven material such as woven PET.

[0068] As shown in FIG. 1 , the outflow edge portion 130 (e.g., protrusion 132) of the outer skirt 18 may be attached and / or otherwise secured to the third row 40 of angled struts of the frame 12 ( FIG. 5 ). The protrusion 132 may, for example, be wrapped over a strut of the third row 40 of angled struts and secured with sutures 146. Thus, in such an example, the outflow end 142 of the outer skirt 18 may be positioned more proximal to the inflow end 22 of the frame 12 than the outflow end 82 of the inner skirt 17. However, in other embodiments, such as shown in FIG. 29 , the outflow edge portion 130 of the outer skirt 18 and the outflow edge portion 68 of the inner skirt 17 may be secured to the frame 12 at the same axial location on the frame 12 with a single set of sutures that extend entirely through the frame 12 and the skirts 17, 18. For example, as shown in FIG. 29 , the suture 70 may be omitted and the suture 146 may instead extend entirely through both the frame 12 and the skirts 17, 18 and secure the outflow edge portions 68, 130 of the inner and outer skirts 17, 18, respectively, to the frame 12 at the same axial location on the frame 12, such as the third row of angled struts 40.

[0069] The outer skirt 18 may additionally or alternatively be secured to the frame at the first row of angled struts 36 and / or the second row of angled struts 38. In some embodiments, the inflow end 144 of the outer skirt 18 may extend to, but not beyond, the apex 62 at the inflow end 22 of the frame 12. However, in other embodiments, the inflow end 144 of the outer skirt 18 may extend beyond the apex 62 at the inflow end 22 of the frame 12. In still further embodiments, the inflow end 144 of the outer skirt 18 may not extend to the apex 62 at the inflow end 22 of the frame 12, but may stop short of the apex 62 at the inflow end of the frame 12. For example, the outer skirt 18 need not extend to the inflow end 22 of the frame 12, but instead, the inflow end 144 of the outer skirt 18 may be secured to another location on the frame 12, such as the second row of angled struts 38.

[0070] The height of the outer skirt 18 (measured from the inflow end 144 to the outflow end 142) may vary in other examples. For example, in some embodiments, the outer skirt 18 may cover the entire outer surface of the frame 12, with the inflow edge portion 128 secured to the inflow end 22 of the frame 12 and the outflow edge portion 130 secured to the outflow end 24 of the frame 12. In other embodiments, the outer skirt 18 may extend from the inflow end 22 of the frame 12 to the second row of angled struts 38, or the fourth row of angled struts 42, or to a location along the frame 12 between two rows of struts.

[0071] The outer skirt 18 is desirably sized and shaped relative to the frame 12 such that when the prosthetic valve 10 is in its radially expanded state (FIGS. 1 and 3), the outer skirt 18 fits snugly against the outside 140 of the frame 12. When the prosthetic valve 10 is crimped into a radially compressed state (FIG. 2) for delivery, the portion of the frame to which the outer skirt is attached may elongate axially. The outer skirt 18 desirably has sufficient elasticity to stretch axially upon radial compression of the frame so as not to prevent complete radial compression of the frame or deform the struts during the crimping process.

[0072] In some embodiments, the inner skirt 17 and / or the outer skirt 18 (e.g., the inflow edge portion 66 of the inner skirt 17 and / or the inflow edge portion 128 of the outer skirt 18) may be additionally stitched to the frame 12 at or near the inflow end 22 of the frame, such as at the first row of angled struts 36. For example, as shown in FIG. 29, the inflow edge portions 66, 128 of both the inner skirt 17 and the outer skirt 18 may each be connected to the frame 12 at or near the inflow end 22 of the frame 12 (e.g., to the first row of angled struts 36) via stitches 320. The stitches 320 may extend entirely through the frame 12 and the skirts 17, 18 to secure the inflow edge portions 66, 128 of the skirts 17, 18, respectively, to the frame 12, as shown in FIG. 29. However, in other embodiments, the stitching 320 may extend through only one of the frame 12 and the skirt 17, such as only the inner skirt 17, and secure only the leading edge portion 66 of the inner skirt 17 to the frame 12. Alternatively, the stitching 320 may extend through only the frame 12 and the outer skirt 18, and secure only the leading edge portion 128 of the outer skirt 18 to the frame 12.

[0073] In some embodiments, as shown in FIG. 29 , the outer skirt 18 may be oversized relative to the frame 12 to accommodate axial expansion of the frame 12 during crimping or other radial compression. Specifically, the portion of the outer skirt 18 included between the sutures 146 and 320 may be longer than the corresponding region of the frame 12 (i.e., the portion of the frame included between the sutures 146 and 320) when the frame 12 is in a radially expanded state. The slack created by the larger sized outer skirt 18 helps the outer skirt 18 to accommodate the extra axial expansion of the frame 12 during radial compression of the frame 12. In some embodiments, because the outer skirt 18 is longer than the frame 12 in this region of the frame 12 (when the frame is in a radially expanded state), the outer skirt 18 may include bunched or pleated portions 330 when the frame 12 is in a radially expanded state. The bunched portion 330 is spread and flattened to allow the frame 12 to be radially compressed and the outer skirt 18 to be in a flatter position relative to the frame 12 in a radially expanded state. Thus, both the bunched portion 330 of the outer skirt 18 and the frame 12 can lengthen axially when the frame 12 is radially compressed, such as during crimping. In some embodiments, the bunched portion 330 can be formed by folding the outer skirt 18, such as in a zigzag pattern having multiple circumferentially extending creases. In some embodiments, the inner skirt 17 can additionally or alternatively include a similar bunched portion to facilitate radial compression and axial elongation of the frame 12. Additionally, the bunched portion can be formed in the outer skirt and / or the inner skirt in any of the embodiments shown in FIGS. 22-24.

[0074] However, in other embodiments, the inner skirt 17 and / or outer skirt 18 may be sewn only to the frame 12 at their outflow edge portions 68, 130, respectively, and may hang loosely at their inflow edge portions 66, 128 to facilitate movement (e.g., axial extension) of the apex 62 at the inflow end 22 of the frame 22 relative to the skirt assembly 16.

[0075] The inflow edge portions 66, 128 of the inner skirt 17 and the outer skirt 18, respectively, may be sewn together proximal to the inflow end 22 of the frame 12 via a suture or stitch 150 to form a pocket 20 at the inflow end 22 of the frame 12. In the embodiment shown in FIGS. 22-24, the suture 150 may extend only through each of the skirts 17, 18. In some such embodiments, another suture located proximate to the suture 150 (e.g., suture 320 shown in FIG. 29) may extend through one or both of the frame 12 and the skirts 17, 18 to secure the skirts 17, 18 to the inflow end 22 of the frame 12. For example, as shown in FIG. 29, the inflow edge portions 66 and / or 128 of the inner skirt 17 and / or the outer skirt 18, respectively, may be first sewn to the frame 12 via a suture 320. The inflow edge portions 66, 128 of the skirts 17, 18 may then be sewn together via a separate set of stitches such as stitches 150 (Figures 22-24), or a separate skirt (e.g., skirt 302 shown in Figure 28) may be sewn to the inflow edge portions 66, 128 of the inner skirt 17 and outer skirt 18, respectively.

[0076] 29 , the inflow edge portion 66 and / or 128 of the inner skirt 17 and / or outer skirt 18, respectively, may be sewn to the frame 12 via stitching 320 such that a portion of the inner skirt 17 extends beyond the inflow end 22 of the frame 12. This extended or depending portion of the inner skirt 17 may be of sufficient length to form the pocket 20, and may be wrapped around the inflow end 22 of the frame 12 and sewn with stitching 150 to the inflow edge portion 128 of the outer skirt 18 (at or near stitching 320) to form the pocket 20.

[0077] 22-24, the inner skirt 17 and / or the outer skirt 18 may extend beyond the apex 62 at the inflow end 22 of the frame 12 such that the pocket 20 creates a space between (and separates) the inflow end 22 of the frame 12 (including the apex 62) and the skirt assembly 16 when the frame 12 is in the radially expanded state. Thus, the apex 62 may be positioned within the pocket 20 and spaced apart from the skirt assembly 16 when the frame 12 is in the radially expanded state. The pocket 20 may also extend circumferentially around the inflow end 22 of the frame 12 such that all of the apexes 62 of the inflow end 22 of the frame 12 are positioned within the pocket 20.

[0078] The pocket 20 has an inflow end 154 (i.e., the section / portion of the pocket 20 axially furthest from the inflow end 22 of the frame 12) that may extend circumferentially around the inflow end 22 of the frame 12. The pocket 20 thus extends axially a distance Y between the apex 62 of the inflow end 22 of the frame 12 and the skirt assembly 16 when the frame 12 is in a radially expanded state. That is, the pocket 20 may separate the apex 62 of the inflow end 22 of the frame 12 from the skirt assembly 16 by the distance Y. Thus, the inflow end 22 of the frame 12 (including the apex 62) may be axially spaced away from the skirt assembly 16 at the inflow end 154 of the pocket 20 when the frame 12 is in a radially expanded state. In particular embodiments, when the frame is in a radially expanded state, the axial length of the pocket 20 (i.e., the distance Y between the apex 62 at the inflow end of the frame 12 and the inflow end 154 of the pocket 20) may be at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, at least 0.9 mm, at least 1.0 mm, at least 1.2 mm, at least 1.5 mm, at least 2.0 mm, at most 5.0 mm, at most 4.0 mm, at most 3.0 mm, at most 2.5 mm, at most 2.0 mm, at most 1.5 mm, and / or at most 1.0 mm.

[0079] As frame 12 is radially compressed, both the entire skirt assembly 16 (overall skirts 17, 18, and / or 302) and frame 12 may lengthen axially, although frame 12 may be axially longer than skirt assembly 16. However, pockets 20 can offset the additional elongation of the frame and prevent leaflets 62 from protruding through the skirt assembly when the prosthetic valve is radially compressed to the radially compressed state.

[0080] In some embodiments, when the frame 12 is in a radially compressed state, the length Y of the pocket 20 can be zero (i.e., the pocket 20 can disappear completely when the frame 12 is in a radially compressed state), so that the tines 62 of the frame 12 directly contact the skirt assembly 16. However, even in embodiments where the tines 62 directly contact the skirt assembly 16, they still do not protrude through the skirt assembly 16. In some embodiments, the skirt assembly 16 can be elastic and can stretch when the tines 62 contact and push against the skirt assembly 16. This stretching ability allows the skirt assembly 16 to accommodate more axial extension of the frame 12 when the tines 62 directly contact the skirt assembly 16. In some embodiments, one or more tines 62 can slightly protrude through the skirt assembly 16 at the pocket, but the majority of the tines 62 are still completely covered by the skirt assembly within the pocket.

[0081] In other embodiments, pocket 20 may still be present even when frame 12 is in a radially compressed state, and apex 62 of frame 12 may be physically separated from inflow end 154 of pocket 20 (i.e., apex 62 does not directly contact skirt assembly 16 even when in a radially compressed state, and distance Y is greater than zero). If present, pocket 20 itself may be hollow and / or contain only air.

[0082] In one example (FIGS. 22 and 26A-27B), the inner skirt 17 may form a pocket 20. In such an embodiment, the outer skirt 18 does not extend beyond the inflow end 22 of the frame 12 (i.e., the outer skirt 18 may extend to or stop short of the inflow end 22 of the frame 12); instead, the inner skirt 17 may extend beyond the inflow end 22 of the frame 12 and wrap around an apex 62 of the inflow end 22 of the frame 12 to form the pocket 20. Specifically, the inner skirt 17 may extend beyond the inflow end 22 of the frame 12 and be folded back on itself at the inflow end 154 of the pocket 20, and may stop at the inflow edge portion 128 of the outer skirt 18, such that a crease and / or fold line (i.e., apex) of the inner skirt 17 (i.e., the point where the inner skirt 17 is folded back on itself) forms and / or defines the inflow end 154 of the pocket 20. In some embodiments, such as shown in FIG. 22, the inflow edge portion 66 of the inner skirt 17 may overlap the inflow edge portion 128 of the outer skirt 18 such that the inflow edge portion 66 of the inner skirt 17 directly contacts and / or covers the outer side 138 of the outer skirt 18. In other embodiments, the inner skirt 17 and the outer skirt 18 may not overlap each other, and instead, the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18, respectively, may directly abut and / or be positioned adjacent to each other. Also, in other embodiments, the outer skirt 18 may extend beyond the apex 62 at the inflow end of the frame, but shorter than the inner skirt 17, which forms the majority of the pocket 20. For example, the outer skirt 18 may extend beyond the apex 62 at the inflow end of the frame to a position between the apex 62 and the inflow end 154 of the pocket 20.

[0083] In some such embodiments, the inflow edge portion 66 of the inner skirt 17 may extend over and / or cover the outer side 140 of the frame 12. Specifically, the outer skirt 18 may be positioned on the outer side 140 of the frame 12 such that the inner side 136 of the outer skirt 18 is in direct contact with the outer side 140 of the frame 12, and the inflow edge portion 66 of the inner skirt 17 may extend over and / or directly contact the outer side 138 of the outer skirt 18 such that the inflow edge portion 128 of the outer skirt 18 is positioned between the frame 12 and the inflow edge portion 66 of the inner skirt 17. However, in other embodiments, the inflow edge portion 66 of the inner skirt 17 may extend from the inflow end 154 of the pocket 20 toward and / or to the apex 62, but may not extend beyond the apex 62 on the outside of the frame, and therefore may not cover the outer side 140 of the frame 12. In such an embodiment, the inner skirt 17 may still form the entire pocket 20, but the inflow end 84 of the inner skirt 17 and the inflow end 144 of the outer skirt 18 may abut each other at the inflow end 22 of the frame 12 (without the inner skirt overlapping the outer skirt) such that the inner skirt 17 does not extend over the outside 140 of the frame 12.

[0084] 26A-26B show how the inner and outer skirts are assembled together on the frame 22 to form the pocket 20 configuration of FIG. 22. The inner and outer skirts 17, 18 may be sewn together at the inflow end of the frame 12, somewhat above the apex 62, with a plurality of in-and-out stitches 152 along stitch lines spaced from the edges of the skirts 17, 18. As shown in FIGS. 26A-26B, to form the pocket 20, an assembler may pierce the outer skirt 18 with a threading needle 210 from the outside 138 to the inside 136 of the outer skirt 18, just below the stitches 152 (with the valve inverted), and then pierce the inner skirt 17 from the outside 65 to the inside 64 of the inner skirt 17. The assembler may then wrap thread 212 over the inflow end 84 of the inner skirt 17, pull and fold the inflow end portion 66 of the inner skirt 17 over the inflow edge portion 128 of the outer skirt 18, and press the outer side 65 of the inner skirt 17 against the outer side 138 of the outer skirt 18. The assembler may then again puncture the outer skirt 18 at a location circumferentially spaced from the previous insertion point to complete a whipstitch 150 and begin another whipstitch 150.

[0085] To ensure that the proper pocket length (e.g., distance Y) is maintained when sewing the inner skirt 17 and the outer skirt 18 together, the user may sew the inner skirt 17 at least a threshold distance Z (FIG. 26A) from the inflow end 84 of the inner skirt 17. That is, when the passing needle 210 pierces the inner skirt 17 to form the stitch 150 with the thread 212, the user may maintain the threshold distance Z (FIG. 26A) between the passing needle 210 and the inflow end 84 of the inner skirt 17. The threshold distance Z may be at least 0.1 mm, at least 0.2 mm, at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, and / or at least 0.7 mm.

[0086] 27A-27B show the fully formed and completed pocket 20 after the inner skirt 17 and outer skirt 18 have been sewn together (FIG. 27A shows the outside of the valve 10, and FIG. 27B shows the inside of the valve 10). As shown in FIGS. 27A-27B, the skirt assembly 16 extends under the apex 62 at the inflow end 22 of the frame 12 to form the pocket 20. In the exemplary embodiment shown in FIGS. 27A-27B, the inner skirt 17 forms the pocket 20. The inner skirt 17 wraps over the outer skirt 18, around the apex 62, and is sewn to the outer skirt 18 at the inflow edge portion 128 of the outer skirt 18. Specifically, the inner skirt 17 extends under the apexes 62 at the inflow end 22 of the frame 12, folds over itself at the inflow end 154 of the pocket 20, extends over the outer skirt 18 on the outside 140 of the frame 12, and is sewn to the outer skirt 18 by stitches 150 to form the pocket 20. The pocket 20 may extend circumferentially around the entire inflow end 22 of the frame 12 such that all of the apexes 62 are completely covered by the skirt assembly 16 in both the radially expanded and radially compressed (i.e., crimped) states.

[0087] The pocket 20 provides extra room / space between the cusps 62 and the skirt assembly 16 so that the cusps 62 do not protrude through the skirt assembly 16 when the frame 12 is crimped. That is, the pocket 20 allows the frame 12 to lengthen axially when radially compressed, and ensures that the cusps 62 are still fully covered by the skirt assembly 16 when the frame 12 is in a radially compressed (i.e., crimped) state. Preventing the cusps 62 from protruding through the skirt assembly during crimping and keeping the cusps covered by the skirt assembly 16 even in the crimped state provides several advantages. First, it prevents the cusps 62 from contacting the introducer sheath, thereby reducing the pushing force required to push the prosthetic valve 10 through the introducer sheath and protecting against damage to the cusps. Second, it can protect the cusps from contacting surrounding tissue and causing trauma as the prosthetic valve advances through the patient's vasculature (while crimped on the delivery device).

[0088] In another embodiment (FIG. 24), the outer skirt 18 may form a pocket 20. In such an embodiment, the inner skirt 17 does not extend beyond the inflow end 22 of the frame 12 (i.e., the inner skirt 17 may extend to or stop short of the inflow end 22 of the frame 12), but instead the outer skirt 18 may extend beyond the inflow end 22 of the frame 12 and wrap around an apex 62 of the inflow end 22 of the frame 12 to form the pocket 20. Specifically, the outer skirt 18 may extend beyond the inflow end 22 of the frame 12 and be folded back on itself at the inflow end 154 of the pocket 20, and may stop at the inflow edge portion 66 of the inner skirt 17, such that a fold and / or crease line (i.e., apex) of the outer skirt 18 (i.e., the point where the outer skirt 18 is folded back on itself) forms and / or defines the inflow end 154 of the pocket 20. In some embodiments, such as shown in FIG. 24 , the inflow edge portion 128 of the outer skirt 18 may overlap the inflow edge portion 66 of the inner skirt 17 such that the inflow edge portion 128 of the outer skirt 18 directly contacts and / or covers the inner side 64 of the inner skirt 17. In other embodiments, the inner skirt 17 and the outer skirt 18 may not overlap each other, and instead, the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18, respectively, may directly abut and / or be positioned adjacent to each other. Also, in other embodiments, the inner skirt 17 may extend beyond the apex 62 at the inflow end of the frame, but shorter than the outer skirt 18, which forms the majority of the pocket 20. For example, the inner skirt 17 may extend beyond the apex 62 at the inflow end of the frame to a position between the apex 62 and the inflow end 154 of the pocket 20.

[0089] In some such embodiments, the inflow edge portion 128 of the outer skirt 18 may extend over and / or cover the inner side 63 of the frame 12. Specifically, the inner skirt 17 may be positioned on the inner side 63 of the frame 12 such that the outer side 65 of the inner skirt 17 is in direct contact with the inner side 63 of the frame 12, and the inflow edge portion 128 of the outer skirt 18 may extend over and / or directly contact the outer side 64 of the inner skirt 17 such that the inflow edge portion 66 of the inner skirt 17 is positioned between the frame 12 and the inflow edge portion 128 of the outer skirt 18. However, in other embodiments, the inflow edge portion 128 of the outer skirt 18 may extend from the inflow end 154 of the pocket 20 toward and / or to the apex 62, but not beyond the apex 62, and therefore may not cover the inner side 63 of the frame 12. In such an embodiment, the outer skirt 18 still forms the entire pocket 20, but the inner skirt 17 and the outer skirt 18 may abut one another at the inflow end 22 of the frame 12 such that the outer skirt 18 does not extend above the inside 63 of the frame 12.

[0090] In yet another embodiment, both the inner skirt 17 and the outer skirt 18 may form the pocket 20. In such an embodiment, the inner skirt 17 and the outer skirt 18 may extend beyond the inflow end 22 of the frame 12 and may be sewn together at a location below the inflow end 22 of the frame 12 (e.g., below the apex 62 at the inflow end 22 of the frame 12). In some such embodiments (FIG. 23), the inner skirt 17 and the outer skirt 18 may be sewn together at the inflow end 154 of the pocket 20 such that the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18, respectively, form the inflow end 154 of the pocket 20. In such an embodiment, the inner skirt 17 and the outer skirt 18 may extend below the inflow end 22 of the frame 12 by approximately the same amount (e.g., distance Y). In some embodiments (FIG. 23), the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18, respectively, may directly abut one another and may not overlap one another. However, in other embodiments, the skirts 17, 18 may overlap each other at the pocket 20.

[0091] 28 and 30-31 , the skirt assembly 16 may include a third skirt 302 (which may also be referred to herein as a “pocket skirt 302”) that may be coupled to the inner skirt 17, the outer skirt 18, and / or the frame 12 to form at least a portion of the pocket 20 when the frame 12 is in a radially expanded state. For example, in the example shown in FIG. 28 , a first end portion 304 of the third skirt 302 may overlap and be coupled (e.g., sewn) to the inflow end portion 66 of the inner skirt 17, such as via stitching 306, and an opposing second end portion 308 of the third skirt 302 may overlap and be coupled (e.g., sewn) to the inflow edge portion 128 of the outer skirt 18, such as via stitching 310. The third skirt 302 may be significantly longer than the width of the frame 12 and the skirts 17, 18, so that the third skirt 302 extends beyond the inflow end of the frame 12 (away from the inner skirt 17 and the outer skirt 18) when the frame 12 is in a radially expanded state, thereby forming the pocket 20.

[0092] As another example, instead of overlapping and being connected (e.g., sewn) to the inner skirt 17 and the outer skirt 18 as shown in FIG. 30 , the third skirt 302 may instead be sewn to itself and / or to the frame 12 and may abut the inner skirt 17 and the outer skirt 18 at or near the inflow end 22 of the frame 12. Specifically, the first end portion 304 of the third skirt 302 may abut the inflow end 84 of the inner skirt 17 and / or the second end portion 308 of the third skirt 302 may abut the inflow end 144 of the outer skirt 18. Further, the first end portion 302 and the second end portion 308 of the third skirt 302 may be connected (e.g., sewn) together, such as via a stitch 322, which may extend circumferentially around the frame 12. In some such examples, the stitch 322 may extend through an opening in the frame 12, such as through the first row of open cells 54 ( FIG. 5 ). In other embodiments, the first end portion 302 and the second end portion 308 of the third skirt 302 may be sewn directly to the frame 12, such as directly to the first row of angled struts 36 (FIG. 5). In any of the above embodiments, the third skirt 302 may effectively depend from the first row of angled struts 36 and / or the apex 62 of the frame 12 at the inflow end 22 of the frame 12 and may extend beyond the inflow end 22 of the frame 12 to form the pocket 20.

[0093] In any of the embodiments in which the third skirt 302 is connected (e.g., stitched) to the skirts 17, 18 to form at least a portion of the pocket 20, one or both of the skirts 17, 18 can also form at least a portion of the pocket 20. That is, one or both of the skirts 17, 18 need not stop at or short of the inflow end 22 of the frame 12 shown in Figures 28 and 30, but instead one or both of the skirts 17, 18 can extend beyond the inflow end 22 of the frame 12 to form at least a portion of the pocket 20. However, in other embodiments, both of the skirts 17, 18 can stop at or short of the inflow end 22 of the frame 12 (such that the skirts 17, 18 do not extend beyond the inflow end of the frame 12) and only the third skirt 302 can form the entire pocket 20.

[0094] As yet another example, one or both of the skirts 17, 18 can be wrapped around the outside of the third skirt 302. For example, as shown in FIG. 31 , the inner skirt 17 can be wrapped completely around the third skirt 302 on the outside 138 of the outer skirt 18 (such that the inner skirt drapes over and / or otherwise contacts the outside of the third skirt 302) and can be connected (e.g., sewn to) the outer skirt 18, such as via stitching 150. In another example, the outer skirt 18 can instead be wrapped completely around the third skirt 302 on the inside 64 of the inner skirt 17 (such that the outer skirt drapes over and / or otherwise contacts the outside of the third skirt 302) and can be connected (e.g., sewn to) the inner skirt 17, such as via stitching 150. In yet further embodiments, both skirts 17, 18 may extend around the third skirt 302 and may be connected (e.g., sewn) together at a location where the skirts 17, 18 overlap the third skirt 302, such as at a location below the inflow end 22 of the frame 12.

[0095] Although the inner skirt 17 and the outer skirt 18 are shown and described as being secured to each other at the inflow edge portions 66, 128, respectively, via stitches 150, it will be appreciated that the inflow edge portions 66, 128 may be attached to each other using additional and / or alternative joining means, such as ultrasonic welding, adhesives, mechanical fasteners, etc.

[0096] Additionally, while the pocket 20 is shown and described as being formed / included at the inflow end 22 of the frame 12, it will be appreciated that the pocket 20 may additionally or alternatively be included / formed at the outflow end 24 of the frame 12. Specifically, the inner skirt 17 and / or the outer skirt 18 may extend to the outflow end 24 of the frame 12 and may be sewn together at or near the outflow end 24 of the frame 12 in a manner similar to that described above for the inflow end 22 of the frame 12 to form a pocket 20 (e.g., as shown in FIGS. 22-24 ) at the outflow end 24 of the frame 12. In some such embodiments, the pocket 20 may be formed at both the inflow end 22 and the outflow end 24 of the frame 12 such that the valve 10 includes two pockets 20, one at each end of the frame 12. In other such embodiments, the pocket 20 may be formed at only the outflow end 24 of the frame 12 instead of at the inflow end 22 of the frame 12.

[0097] Additional Examples of the Disclosed Technique In view of the above-described implementations of the disclosed subject matter, the present application discloses additional embodiments, which are listed below. It should be noted that any feature of an embodiment alone, or two or more features of an embodiment taken in combination, and optionally in combination with one or more features of one or more additional embodiments, are additional embodiments that are also included within the disclosure of the present application.

[0098] [Example 1] 1. A prosthetic heart valve comprising: an annular frame including an inflow end and an outflow end, the frame being radially compressible and expandable between a radially compressed state and a radially expanded state, the frame including a plurality of cusps at the inflow end; a leaflet assembly positioned within and coupled to the frame, the leaflet assembly comprising a plurality of leaflets positioned entirely within the frame; 1. A skirt assembly comprising: an inner skirt extending circumferentially around an inside of the frame and having an inlet edge portion and an outlet edge portion; a skirt assembly comprising: an outer skirt extending circumferentially around an outside of the frame, the outer skirt having an inflow edge portion and an outflow edge portion, the inflow edge portion of the outer skirt being stitched to the inflow edge portion of the inner skirt; the leading edge portion of the inner skirt and / or the leading edge portion of the outer skirt define a pocket, the apex is disposed within the pocket, the pocket having an inlet end; A prosthetic heart valve wherein when the frame is in a radially expanded state, the cusps are spaced from the inflow end of the pocket, and when the frame is radially compressed from the radially expanded state to the radially compressed state, the cusps move closer to the inflow end of the pocket.

[0099] [Example 2] The prosthetic heart valve of any of the embodiments herein, particularly embodiment 1, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the pocket.

[0100] [Example 3] The prosthetic heart valve of any of the embodiments herein, particularly embodiment 2, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the inflow end of the pocket.

[0101] [Example 4] The prosthetic heart valve according to any of the embodiments herein, particularly any one of embodiments 1-3, wherein the inflow edge portions of the inner and outer skirts extend axially beyond the inflow end of the frame.

[0102] [Example 5] The prosthetic heart valve of any embodiment herein, particularly embodiment 4, wherein the inflow edge portions of the inner skirt and the outer skirt extend axially beyond the inflow end of the frame by approximately the same amount.

[0103] [Example 6] The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 1-5, wherein the cusps are spaced at least 0.5 mm from the inflow end of the pocket when the frame is in a radially expanded state.

[0104] [Example 7] The prosthetic heart valve according to any of the embodiments herein, particularly any one of embodiments 1-6, wherein the pocket extends circumferentially around the inflow end of the frame.

[0105] [Example 8] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 1-7, wherein the outflow edge portion of the inner skirt is sewn to the frame between the inflow and outflow ends of the frame, and the outflow edge portion of the outer skirt is sewn to the frame closer to the inflow end of the frame than the outflow edge portion of the inner skirt.

[0106] [Example 9] A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 1-8, wherein the outflow edge portion of the inner skirt is provided with a plurality of slits, the plurality of slits being spaced axially at most 0.5 mm from the junction of the two struts of the frame.

[0107] [Example 10] The prosthetic heart valve according to any embodiment herein, particularly any one of embodiments 1-9, wherein the inner skirt contacts the inside of the frame and the outer skirt contacts the outside of the frame.

[0108] [Example 11] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 1-10, wherein the leaflets do not extend beyond the inflow end of the frame, but are positioned entirely between the inflow and outflow ends of the frame.

[0109] [Example 12] The prosthetic heart valve according to any of the embodiments herein, in particular any one of embodiments 1 to 11, wherein the pocket is hollow.

[0110] [Example 13] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 1 and 6-12, wherein an inner skirt is wrapped around the apex at the inflow end of the frame and extends over an outer skirt on the outside of the frame, forming a pocket.

[0111] [Example 14] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 1 and 6-12, wherein an outer skirt is wrapped around the apex at the inflow end of the frame and extends over the inner skirt on the inside of the frame, forming a pocket.

[0112] [Example 15] 1. A prosthetic heart valve comprising: an annular frame including an inflow end and an outflow end, the frame being radially compressible and expandable between a radially compressed state and a radially expanded state, the frame including a plurality of cusps at the inflow end; a leaflet assembly including a plurality of leaflets, the leaflet assembly being positioned within and coupled to the frame; an outer skirt extending circumferentially around the outside of the frame and having an inlet edge portion and an outlet edge portion; an inner skirt extending circumferentially around an inside of the frame, the inner skirt having an inflow edge portion and an outflow edge portion, the inner skirt folding upon itself to form a pocket at the inflow end of the frame, cusps at the inflow end of the frame being disposed within the pocket, the pocket having an inflow end, the cusps being spaced from the inflow end of the pocket when the frame is in a radially expanded state, and the cusps moving closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to a radially compressed state.

[0113] [Example 16] The prosthetic heart valve of any embodiment herein, particularly embodiment 15, wherein the inflow edge portion of the inner skirt is sewn together with the inflow edge portion of the outer skirt.

[0114] [Example 17] The prosthetic heart valve of any one of the embodiments herein, particularly any one of embodiments 15 or 16, wherein an inner skirt is wrapped around the cusps at the inflow end of the frame and covers the outside of the frame.

[0115] [Example 18] The prosthetic heart valve of any embodiment herein, particularly embodiment 17, wherein the inflow edge portion of the inner skirt extends circumferentially around the outside of the frame.

[0116] [Example 19] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 15-18, wherein the outer skirt has an inner side opposite the outer side, the inner side of the outer skirt contacting the outer side of the frame, and an inflow edge portion of the inner skirt extends around the inflow end of the frame over the outer side of the frame and contacts the outer side of the outer skirt.

[0117] [Example 20] The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 15-19, wherein the outer skirt does not extend beyond the inflow end of the frame.

[0118] [Example 21] The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 15-20, wherein the cusps are spaced at least 0.5 mm from the inflow end of the pocket when the frame is in a radially expanded state.

[0119] [Example 22] The prosthetic heart valve according to any of the embodiments herein, in particular any one of embodiments 15 to 21, wherein the pocket is hollow.

[0120] [Example 23] A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 15-22, wherein the outflow edge portion of the inner skirt is provided with a plurality of slits, the plurality of slits being spaced axially apart from the junction of the two struts of the frame by a maximum of 0.5 mm.

[0121] [Example 24] A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 15-23, wherein the plurality of valve leaflets do not extend beyond the inflow end of the frame, but are positioned entirely between the inflow end and the outflow end of the frame.

[0122] [Example 25] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 15-24, further comprising stitching connecting the inflow edge portion of the inner skirt to the inflow edge portion of the outer skirt, the stitching being spaced approximately 0.5 mm from the inflow edge of the inner skirt.

[0123] [Example 26] 1. A prosthetic heart valve comprising: an annular frame including an inflow end and an outflow end, the frame being radially compressible and expandable between a radially compressed state and a radially expanded state, the frame including a plurality of cusps at the inflow end; a leaflet assembly including a plurality of leaflets, the leaflet assembly being positioned within and coupled to the frame; an inner skirt extending circumferentially around an inside of the frame and having an inlet edge portion and an outlet edge portion; an outer skirt extending circumferentially around the outside of the frame, the outer skirt having an inflow edge portion and an outflow edge portion, the outer skirt folding upon itself to form a pocket at the inflow end of the frame, cusps at the inflow end of the frame being disposed in the pocket, the pocket having an inflow end, the cusps being spaced from the inflow end of the pocket when the frame is in a radially expanded state, and the cusps moving closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to a radially compressed state.

[0124] [Example 27] The prosthetic heart valve of any embodiment herein, particularly embodiment 26, wherein the inflow edge portion of the outer skirt is sewn together with the inflow edge portion of the inner skirt.

[0125] [Example 28] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 26 or 27, wherein an outer skirt is wrapped around the cusps at the inflow end of the frame and covers the inside of the frame.

[0126] [Example 29] The prosthetic heart valve of any embodiment herein, particularly embodiment 28, wherein the inflow edge portion of the outer skirt extends circumferentially around the inside of the frame.

[0127] [Example 30] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 26-29, wherein the inner skirt has an inner side opposite an outer side, the outer side of the inner skirt contacting the inner side of the frame, and an inflow edge portion of the outer skirt extends around the inflow end of the frame over the inner side of the frame and contacts the inner side of the inner skirt.

[0128] [Example 31] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 26-30, wherein the inner skirt does not extend beyond the inflow end of the frame.

[0129] [Example 32] The prosthetic heart valve of any embodiment herein, particularly any one of embodiments 26-31, wherein the cusps are spaced at least 0.5 mm from the inflow end of the pocket when the frame is in a radially expanded state.

[0130] [Example 33] The prosthetic heart valve according to any of the embodiments herein, in particular any one of embodiments 26 to 32, wherein the pocket is hollow.

[0131] [Example 34] A prosthetic heart valve as described in any of the embodiments herein, particularly any one of embodiments 26-33, wherein the plurality of valve leaflets do not extend beyond the inflow end of the frame and are positioned entirely between the inflow end and the outflow end of the frame.

[0132] [Example 35] The prosthetic heart valve of any of the embodiments herein, particularly any one of embodiments 26-34, further comprising stitching connecting the inflow edge portion of the outer skirt to the inflow edge portion of the inner skirt, the stitching being spaced approximately 0.5 mm from the inflow edge of the outer skirt.

[0133] [Example 36] 1. A method of assembling a prosthetic heart valve, comprising: mounting an inner skirt on an inside of a radially compressible and expandable frame, the frame having an inflow end, an outflow end, and a plurality of apexes at the inflow end; attaching an outer skirt onto the exterior of the frame; mounting a leaflet assembly including a plurality of leaflets such that the leaflet assembly is positioned entirely within the frame between an inflow end and an outflow end of the frame; a step of sewing the inner skirt and the outer skirt together such that the inner skirt and / or the outer skirt form a pocket at the inflow end of the frame, or a step of sewing a third skirt to the inner skirt and the outer skirt such that the third skirt extends beyond the inflow end of the frame and forms a pocket, wherein a plurality of apexes are disposed within the pocket, the pocket having an inflow end that is separated from the plurality of apexes of the frame when the frame is in a radially expanded state.

[0134] [Example 37] The method of any of the embodiments herein, particularly embodiment 36, wherein the step of sewing the inner skirt and the outer skirt together includes the step of sewing the inner skirt and the outer skirt together at a pocket, such that both the inner skirt and the outer skirt form a pocket.

[0135] [Example 38] The method of any one of the embodiments herein, particularly any one of embodiments 36 or 37, wherein sewing the inner skirt and the outer skirt together comprises sewing the inner skirt and the outer skirt together at an inflow end of the pocket.

[0136] [Example 39] The method of any embodiment herein, particularly embodiment 36, further comprising wrapping the inner skirt around the inflow end of the frame over the outside of the frame so that the inner skirt forms a pocket, and wherein sewing the inner skirt and outer skirt together comprises sewing the inner skirt to the outer skirt over the outside of the frame.

[0137] [Example 40] The method of any embodiment herein, particularly embodiment 39, wherein the step of mounting the inner skirt on the frame includes the step of coupling the inner skirt to the frame such that the inner skirt extends axially beyond the inflow end of the frame by at least 1.5 mm prior to wrapping the inner skirt around the inflow end of the frame.

[0138] [Example 41] The method of any one of the embodiments herein, particularly any one of embodiments 39 or 40, wherein the step of sewing the inner skirt and the outer skirt together includes the step of maintaining a distance of approximately 0.5 mm between the inflow edge of the inner skirt and the stitching.

[0139] [Example 42] The method of any embodiment herein, particularly embodiment 36, further comprising wrapping the outer skirt around the inflow end of the frame over the inside of the frame so that the outer skirt forms a pocket, and wherein sewing the inner skirt and the outer skirt together comprises sewing the outer skirt to the inner skirt over the inside of the frame.

[0140] [Example 43] The method of any embodiment herein, particularly embodiment 42, wherein the step of mounting the outer skirt on the frame comprises the step of coupling the outer skirt to the frame such that the outer skirt extends axially beyond the inflow end of the frame by at least 1.5 mm prior to wrapping the outer skirt around the inflow end of the frame.

[0141] [Example 44] The method of any one of the embodiments herein, particularly any one of embodiments 42 or 43, wherein the step of sewing the inner skirt and the outer skirt together includes the step of maintaining a distance of approximately 0.5 mm between the inflow edge of the outer skirt and the stitching.

[0142] [Example 45] A method as described in any of the embodiments herein, particularly any one of embodiments 36-44, wherein the step of attaching the inner skirt onto the inside of the frame includes sewing the inner skirt to a first row of struts on the frame, and the step of attaching the outer skirt onto the outside of the frame includes sewing the outer skirt to a second row of struts positioned closer to the inflow end of the frame than the first row of struts on the frame.

[0143] [Example 46] The method of any embodiment herein, particularly embodiment 45, wherein the step of attaching the inner skirt onto the inside of the frame further comprises the step of aligning the outflow edge portion of the inner skirt with the first row of struts prior to sewing the inner skirt to the first row of struts such that a plurality of slits in the outflow edge portion of the inner skirt are positioned at most 0.5 mm from the joints between adjacent struts in the first row of struts.

[0144] [Example 47] The method of any embodiment herein, particularly embodiment 36, wherein the step of sewing the third skirt to the inner skirt and the outer skirt includes the steps of sewing a first end portion of the third skirt to the inflow edge portion of the inner skirt and sewing a second end portion of the third skirt to the inflow edge portion of the outer skirt.

[0145] [Example 48] The method of any of the embodiments herein, particularly any one of embodiments 36-47, wherein the inflow end of the pocket is spaced at least 0.5 mm from the apexes of the frame when the frame is in a radially expanded state.

[0146] [Example 49] The method according to any of the embodiments herein, particularly any one of embodiments 36 to 48, wherein the pocket is hollow.

[0147] [Example 50] The method of any of the embodiments herein, particularly any one of embodiments 36-49, wherein the pocket extends circumferentially around the inflow end of the frame.

[0148] [Example 51] 1. A prosthetic heart valve comprising: an annular frame including an inflow end and an outflow end, the frame being radially compressible and expandable between a radially compressed state and a radially expanded state, the frame including a plurality of cusps at the inflow end; a leaflet assembly positioned within and coupled to the frame, the leaflet assembly comprising a plurality of leaflets positioned entirely within the frame; 1. A skirt assembly comprising: an inner skirt extending circumferentially around an inside of the frame and having an inlet edge portion and an outlet edge portion; an outer skirt separated from an inner skirt extending circumferentially around an outside of the frame and having an inlet edge portion and an outlet edge portion; an inflow edge portion of the inner skirt and an outer skirt are joined together to form a pocket adjacent the inflow end of the frame, the apex is disposed within the pocket, the pocket having an inflow end; A prosthetic heart valve wherein when the frame is in a radially expanded state, the cusps are spaced from the inflow end of the pocket, and when the frame is radially compressed from the radially expanded state to the radially compressed state, the cusps move closer to the inflow end of the pocket.

[0149] [Example 52] A prosthetic heart valve as described in any embodiment herein, particularly embodiment 51, wherein the inflow edge portions of the inner skirt and outer skirt extend axially beyond the inflow end of the frame and are sewn together at a location upstream of the inflow end of the frame to form a pocket.

[0150] [Example 53] The prosthetic heart valve of any embodiment herein, particularly embodiment 51, wherein the inflow edge portion of the inner skirt extends axially beyond the inflow end of the frame, wraps around the cusp, and is sewn to the outer skirt on the outside of the frame to form a pocket.

[0151] [Example 54] The prosthetic heart valve of any embodiment herein, particularly embodiment 51, wherein the inflow edge portion of the outer skirt extends axially beyond the inflow end of the frame, wraps around the cusp, and is sewn to the inner skirt on the inside of the frame to form a pocket.

[0152] [Example 55] The prosthetic heart valve described in any embodiment herein, particularly embodiment 51, wherein the skirt assembly comprises a third skirt separate from the inner skirt and the outer skirt, extending beyond the inflow end of the frame and forming at least a portion of the pocket.

[0153] [Example 56] The prosthetic heart valve as described in any embodiment herein, particularly embodiment 55, wherein the third skirt is sewn to the inflow edge portions of the inner skirt and the outer skirt.

[0154] [Example 57] A prosthetic heart valve as described in any embodiment herein, particularly embodiment 55 or 56, wherein the inner skirt and / or outer skirt extend beyond the inflow end of the frame and form at least a portion of the pocket, such that the third skirt and the inner skirt and / or outer skirt form the pocket.

[0155] [Example 58] The prosthetic heart valve of any embodiment herein, particularly embodiment 55, wherein the third skirt is sewn to itself at the open cells of the first row of the frame.

[0156] [Example 59] The prosthetic heart valve according to any embodiment herein, in particular embodiment 55 or 58, wherein the third skirt alone forms the pocket.

[0157] [Example 60] The prosthetic heart valve according to any embodiment herein, particularly any one of embodiments 51-59, wherein the inner skirt and / or the outer skirt extends around the third skirt.

[0158] [Example 61] A prosthetic valve according to any of the embodiments herein, in particular any one of embodiments 51 to 60, or any one of claims 51 to 55, wherein the inner skirt is sutured to the frame at or near the inflow edge and at or near the outflow edge.

[0159] [Example 62] An artificial valve as described in any of the embodiments herein, particularly any one of embodiments 51 to 61, wherein the outer skirt is sutured to the frame at or near the inflow edge and at or near the outflow edge.

[0160] [Example 63] An artificial valve as described in any of the embodiments herein, particularly any one of embodiments 51-62, wherein both the inner skirt and the outer skirt are sewn to a first row of struts of the frame via a first set of sutures and both are sewn to a second row of struts of the frame via a second set of sutures, the first row of struts being positioned closer to the inflow end of the frame than the second row of struts.

[0161] [Example 64] The prosthetic valve described in any of the embodiments herein, particularly any one of embodiments 62 or 63, wherein the outer skirt comprises a bundled portion between the inflow edge portion and the outflow edge portion.

[0162] [Example 65] The prosthetic valve of any embodiment herein, particularly embodiment 64, wherein the outer skirt is folded in a zigzag pattern at the bundled portion.

[0163] [Example 66] An artificial valve described in any embodiment herein, particularly any one of embodiments 59 or 60, wherein the bundled portion of the outer skirt expands and lengthens axially when the frame is radially compressed.

[0164] [Example 67] The prosthetic valve of any of the embodiments herein, particularly any one of embodiments 51-66, further comprising the subject matter of any one of embodiments 1-35.

[0165] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred embodiments of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all inventions that come within the scope and spirit of these claims. [Explanation of symbols]

[0166] 10 prosthetic heart valve, 12 frame, 14 leaflet assembly, 15 leaflet, 16 skirt assembly, 17 inner skirt, 18 outer skirt, 20 pocket, 22 inflow end, 24 outflow end, 26 strut, 32 joint, 62 leaflet, 66, 128 inflow edge portion, 68, 130 outflow edge portion, 98 slit, 302 third skirt

Claims

1. A prosthetic heart valve (10), comprising: an annular frame (12) including an inflow end (22) and an outflow end (24), said annular frame (12) being radially compressible and expandable between a radially compressed state and a radially expanded state, said annular frame (12) including a plurality of cusps (62) at said inflow end (22); a leaflet assembly (14) positioned within and coupled to the annular frame (12), the leaflet assembly (14) comprising a plurality of leaflets (15) positioned entirely within the annular frame (12); A skirt assembly (16), an inner skirt (17) extending circumferentially around an inner side (63) of the annular frame (12) and having an inlet edge portion (66) and an outlet edge portion (68); an outer skirt (18) extending circumferentially around an outside (140) of the annular frame (12), the outer skirt (18) having an inflow edge portion (144) and a straight outflow edge portion (130), the inflow edge portion (144) of the outer skirt (18) being stitched to the inflow edge portion (66) of the inner skirt (17); the inlet edge portion (66) of the inner skirt (17) and / or the inlet edge portion (144) of the outer skirt (18) form a pocket (20), the apex (62) is disposed within the pocket (20), the pocket (20) having an inlet end (154); The prosthetic heart valve (10) has cusps (62) spaced from the inflow end (154) of the pocket (20) when the annular frame (12) is in the radially expanded state, and the cusps (62) move closer to the inflow end (154) of the pocket (20) when the annular frame (12) is radially compressed from the radially expanded state to the radially compressed state.

2. 2. The prosthetic heart valve (10) of claim 1, wherein the inflow edge portions (66, 144) of the inner skirt (17) and the outer skirt (18) are sewn together at the pocket (20).

3. 3. The prosthetic heart valve (10) of claim 2, wherein the inflow edge portions (66, 144) of the inner skirt (17) and the outer skirt (18) are sewn together at the inflow end (154) of the pocket (20).

4. The prosthetic heart valve (10) of any one of claims 1 to 3, wherein the inflow edge portions (66, 144) of the inner skirt (17) and the outer skirt (18) extend axially beyond the inflow end (22) of the annular frame (12), and preferably the inflow edge portions (66, 144) of the inner skirt (17) and the outer skirt (18) extend axially beyond the inflow end (22) of the annular frame (12) by approximately the same amount.

5. An artificial heart valve (10) as described in any one of claims 1 to 4, wherein the outer skirt (18) fits snugly against the outside (140) of the annular frame (12).

6. 6. The prosthetic heart valve (10) of claim 1, wherein the cusps (62) are spaced at least 0.5 mm from the inflow end (154) of the pocket (20) when the annular frame (12) is in the radially expanded state.

7. The prosthetic heart valve (10) of any one of claims 1 to 6, wherein the pocket (20) extends circumferentially around the inflow end (22) of the annular frame (12).

8. 8. The prosthetic heart valve (10) according to any one of claims 1 to 7, wherein the outflow edge portion (68) of the inner skirt (17) is sewn to the annular frame (12) between the inflow end (22) and the outflow end (24) of the annular frame (12), and the outflow edge portion (130) of the outer skirt (18) is sewn to the annular frame (12) closer to the inflow end (22) of the annular frame (12) than the outflow edge portion (68) of the inner skirt (17).

9. 9. The prosthetic heart valve (10) according to any one of claims 1 to 8, wherein the outflow edge portion (68) of the inner skirt (17) comprises a plurality of slits (98), the plurality of slits (98) being spaced axially at a maximum distance of 0.5 mm from a junction of two struts (42) of the annular frame.

10. The prosthetic heart valve (10) of any one of claims 1 to 9, wherein the inner skirt (17) contacts the inner side (63) of the annular frame (12) and the outer skirt (18) contacts the outer side (140) of the annular frame (12).

11. 11. The prosthetic heart valve (10) of claim 1, wherein the plurality of valve leaflets (15) do not extend beyond the inflow end (22) of the annular frame (12) and are positioned entirely between the inflow end (22) and the outflow end (24) of the annular frame (12).

12. The prosthetic heart valve (10) according to any one of the preceding claims, wherein the pocket (20) is hollow.

13. 13. The prosthetic heart valve (10) of any one of claims 1 and 6 to 12, wherein the inner skirt (17) is wrapped around the cusp (62) at the inflow end (22) of the annular frame (12) and extends over the outer skirt (18) on the outside (140) of the annular frame (12) to form the pocket (20).

14. 13. The prosthetic heart valve (10) of any one of claims 1 and 6 to 12, wherein the outer skirt (18) is wrapped around the cusp (62) at the inflow end (22) of the annular frame (12) and extends over the inner skirt (17) on the inside (63) of the annular frame (12) to form the pocket (20).

15. A method of assembling a prosthetic heart valve (10), comprising the steps of: mounting an inner skirt (17) on an inner side (63) of a radially compressible and expandable frame (12), said frame having an inflow end (22), an outflow end (24), and a plurality of apexes (62) at said inflow end (22); attaching an outer skirt (18) onto an outer side (140) of the frame (12); attaching the leaflet assembly (14) comprising a plurality of leaflets (15) to the frame (12) such that the leaflet assembly (14) is positioned entirely within the frame (12) between the inflow end (22) and the outflow end (24) of the frame (12); or sewing the inner skirt (17) and the outer skirt (18) together such that the inner skirt (17) and / or the outer skirt (18) form a pocket (20) at the inflow end (22) of the frame (12); or sewing the third skirt (302) to the inner skirt (17) and the outer skirt (18) such that a third skirt (302) extends beyond the inflow end (22) of the frame (12) to form the pocket (20), wherein the plurality of apexes (62) are disposed within the pocket (20), the pocket (20) having an inflow end (22) that is separated from the plurality of apexes (62) of the frame (12) when the frame (12) is in a radially expanded state.

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