Prosthetic heart valve with elongate sealing member

Abstract

The present disclosure relates to prosthetic heart valves having elongated sealing members. As one example, a prosthetic heart valve includes an annular frame, a leaflet assembly including a plurality of 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 a plurality of apices at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates additional 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 apices at the inflow end of the frame to move toward the inflow end of the pocket without protruding through the skirt assembly when the frame is radially compressed to the radially compressed state.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 164,663, filed March 23, 2021, which is incorporated herein by reference. Technical Field

[0003] This invention relates to collapsible and expandable prosthetic heart valves with elongated sealing members. Background Technology

[0004] For years, physicians have attempted to repair and / or replace defective heart valves through open-heart surgery. However, due to the risks and complications of open-heart surgery, collapsible prosthetic heart valves have been developed that can be rolled into a sufficiently thin profile (e.g., less than 8 mm in diameter) to be advanced over a delivery catheter through the patient's vascular system (e.g., veins and / or arteries). Specifically, a physician can make a small incision near the blood vessel (e.g., a surgeon can make an incision in the patient's groin to access the femoral vein or artery), and then use a delivery catheter to advance the rolled-up, collapsible prosthetic heart valve through the patient's vascular system until the prosthetic heart valve reaches the defective natural heart valve. Once at the defective natural valve, the prosthetic heart valve can be expanded to its functional size using an inflatable balloon, mechanical actuator, shape memory material, etc. In this way, physicians 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. This transcatheter approach is much less invasive than open-heart surgery and can reduce and / or avoid the risks and complications associated with open-heart surgery.

[0005] Transcatheter prosthetic heart valves typically comprise a radially compressible and expandable annular metal frame that supports two or more prosthetic leaflets (usually made from animal (e.g., bovine) pericardial tissue) that open and close to regulate blood flow through the valve. Transcatheter prosthetic heart valves may also include an outer fabric skirt (e.g., made of polyethylene terephthalate, or PET for short) that cushions and seals the rigid frame against the surrounding natural heart tissue. Transcatheter prosthetic heart valves may also include an inner fabric skirt that can be used to mount the prosthetic leaflets to the frame and / or to seal openings in the frame.

[0006] When radially compressed, such as when crimped onto a balloon of a delivery device, some frames of transcatheter prosthetic heart valves can elongate or stretch in an axial direction. In some cases, the elongation of the frame during crimping can cause the apices of the frame to protrude through or extend beyond one end of a skirt of the prosthetic valve. The exposed apices can contact the inner surface of an introducer sheath used to introduce the prosthetic valve and delivery device into the vasculature of a patient. This can increase the force needed to push the prosthetic valve through the introducer sheath and can deform the exposed apices, potentially damaging the valve.

[0007] Accordingly, there is a need for assemblies, devices, and / or methods for a sealing member (e.g., a fabric skirt) that can protect the apices of a frame of a prosthetic heart valve during an implantation procedure. SUMMARY

[0008] The present disclosure relates to examples of a sealing member (e.g., a fabric skirt) for a prosthetic heart valve configured to protect the apices of a frame from damage due to contact with components of a delivery system. In particular, the present disclosure relates to an elongate sealing member for a prosthetic heart valve that extends beyond one end of a frame of the prosthetic heart valve when the valve is not crimped (i.e., when the valve is radially expanded) to accommodate axial elongation of the frame during crimping. The elongate sealing member can form a pocket at one end of the frame that prevents the frame from protruding through the sealing member when the valve is crimped. Keeping the frame entirely 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 needed to push the valve through an introducer sheath of a delivery assembly.

[0009] In one 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. Further, the frame includes a plurality of apices at the inflow end. The leaflet assembly is positioned within and coupled to the frame and includes a plurality of leaflets 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 the outer skirt extends circumferentially around an outer side of the frame. Both the inner skirt and the outer skirt have respective inflow edge portions and outflow edge portions, wherein 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 forms a pocket at the inflow end of the frame. The apices at the inflow end of the frame are disposed within the pocket and spaced apart from the inflow end of the pocket when the frame is in the radially expanded state. The apices move 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 the apices do not extend through and / or protrude through the skirt assembly when the frame is in the radially compressed state.

[0010] In another representative example, 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, and is radially compressible and expandable between a radially compressed state and a radially expanded state. Further, the frame includes a plurality of cusps 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 outer side of the frame and has an inflow edge portion and an outflow edge portion. The inner skirt extends circumferentially around an inner side of the frame and also has an inflow edge portion and an outflow edge portion. The inner skirt is folded over on itself and forms a pocket at the inflow end of the frame. The cusps at the inflow end of the frame are disposed within the pocket. The pocket has an inflow end, and the cusps are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state. 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, but do not extend through and / or protrude through the inflow end of the pocket.

[0011] In another representative example, 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, and the frame is radially compressible and expandable between a radially compressed state and a radially expanded state. Further, the frame includes a plurality of cusps 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 inner side of the frame and has an inflow edge portion and an outflow edge portion. The outer skirt extends circumferentially around an outer side of the frame and also has an inflow edge portion and an outflow edge portion. The outer skirt is folded over on itself and forms a pocket at the inflow end of the frame. The cusps at the inflow end of the frame are disposed within the pocket. The pocket has an inflow end, and the cusps are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state. 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, but do not extend through and / or protrude through the inflow end of the pocket.

[0012] In yet another representative example, a method for assembling a prosthetic heart valve includes mounting an inner skirt on an inner side of a radially compressible and expandable frame, the frame having an inflow end and an outflow end and a plurality of cusps at the inflow end; mounting an outer skirt on an outer side of the frame; mounting a leaflet assembly including a plurality of leaflets to the frame such that the leaflet assembly is positioned entirely within the frame between the inflow end and the outflow end of the frame; sewing the inner skirt and the outer skirt together such that the inner skirt and / or the outer skirt forms a pocket at the inflow end of the frame, or 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 the pocket, wherein the plurality of cusps are disposed in the pocket, and wherein the pocket has an inflow end that is spaced apart 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 cusps at the inflow end. The leaflet assembly is positioned within and coupled to the frame and includes a plurality of leaflets 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 each other so as to form a pocket adjacent the inflow end of the frame, wherein the cusps are disposed in the pocket, and wherein the pocket has an inflow end. The cusps are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and the cusps move closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.

[0014] The above and other objects, features and advantages of the disclosed technology will become more apparent from the following detailed description, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 illustrates a side view of a prosthetic heart valve according to one example.

[0016] Figure 2 illustrates a prosthetic heart valve crimped in a radially compressed state on a delivery apparatus according to one example. Figure 1 illustrates a perspective view of the prosthetic heart valve shown.

[0017] Figure 3 illustrates the prosthetic heart valve shown in a radially expanded state. Figures 1-2 illustrates a perspective view of the prosthetic heart valve shown.

[0018] Figure 4illustrates a prosthetic heart valve according to one example. Figures 1-3 illustrated is a perspective view of a frame of a prosthetic heart valve.

[0019] Figure 5 illustrates a prosthetic heart valve according to one example. Figure 4 illustrated is a side view of the frame.

[0020] Figure 6 illustrates a prosthetic heart valve according to one example. Figures 4-5 illustrated is a magnified view of a first portion of the frame.

[0021] Figure 7 illustrates a prosthetic heart valve according to one example. Figures 4-6 illustrated is a magnified view of a second portion of the frame.

[0022] Figure 8 illustrates a prosthetic heart valve according to one example. Figures 4-7 illustrated is a magnified view of a third portion of the frame.

[0023] Figure 9 illustrates a prosthetic heart valve according to one example. Figures 4-8 illustrated is a magnified view of a fourth portion of the frame.

[0024] Figure 10 illustrates a prosthetic heart valve according to one example. Figures 4-9 illustrated is a magnified view of a fifth portion of the frame.

[0025] Figure 11 illustrates a prosthetic heart valve according to one example. Figures 1-3 illustrated is a side view of an inner side of an inner skirt of a prosthetic heart valve.

[0026] Figure 12 illustrates a prosthetic heart valve according to one example. Figure 11 illustrated is a side view of an outer side of the inner skirt.

[0027] Figure 13 illustrates a prosthetic heart valve according to one example. Figures 11-12 illustrated is a magnified view of a portion of the inner skirt.

[0028] Figure 14 illustrates a prosthetic heart valve according to one example. Figures 11-13 illustrated is a magnified view of a portion of the inner skirt.

[0029] Figure 15 illustrates a prosthetic heart valve according to one example. Figures 4-10 illustrated is a side view of the frame. Figures 11-14 illustrated is a side view of the inner skirt.

[0030] Figure 16 illustrates a prosthetic heart valve according to one example. Figures 1-3 illustrated is a top view of adjacent leaflets of a leaflet assembly of a prosthetic heart valve.

[0031] Figure 17 illustratesFigure 16 The top view of the leaf component shown.

[0032] Figure 18 The diagram illustrates the coupling according to the example. Figures 4-10 The frame shown Figures 16-17 A perspective view of the connecting part of the leaflet assembly.

[0033] Figure 19 The diagram illustrates the coupling according to the example. Figures 11-15 The inner skirt shown Figures 16-18 The side view of a portion of the leaflet component shown.

[0034] Figure 20 The diagram illustrates the coupling according to the example. Figures 4-10 The frame shown Figures 11-15 The inner skirt shown and Figures 16-19 The side view of the leaf component shown.

[0035] Figure 21 The illustration shows the example. Figures 1-3 The side view of the outer skirt of the prosthetic heart valve is shown.

[0036] Figure 22 The illustration shows the state according to the example. Figure 3 The radial expansion state shown Figures 1-3 A cross-sectional view of the inflow edge portion of the prosthetic heart valve shown.

[0037] Figure 23 The illustration shows the state according to the example. Figure 3 The radial expansion state shown Figures 1-3 A cross-sectional view of the inflow edge portion of the prosthetic heart valve shown.

[0038] Figure 24 The illustration shows the state according to the example. Figure 3 The radial expansion state shown Figures 1-3 A cross-sectional view of the inflow edge portion of the prosthetic heart valve shown.

[0039] Figure 25 The diagram shows Figures 4-10 An enlarged side view of a portion of the frame shown, in which Figures 11-15 The exposed edge of the inner skirt shown can be attached to the frame.

[0040] Figure 26A The diagram shows Figures 11-15 and Figure 20 An outer perspective view of the outer edge of the inner skirt, where the outer edge is... Figures 1-3 The prosthetic heart valve shown Figures 4-10 and Figure 20 Align with the frame shown.

[0041] Figure 26B An enlarged view of an outflow edge portion of the inner skirt is illustrated. Figure 26A An enlarged view of an outflow edge portion of the inner skirt is illustrated.

[0042] Figure 27A An enlarged view of an outflow edge portion of the inner skirt is illustrated. Figures 11-15 An enlarged view of an outflow edge portion of the inner skirt is illustrated. Figures 20-21 An enlarged view of an outflow edge portion of the inner skirt is illustrated.

[0043] Figure 27B An enlarged view of an outflow edge portion of the inner skirt is illustrated. Figure 27A An enlarged view of an outflow edge portion of the inner skirt is illustrated.

[0044] Figure 28 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figure 3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figures 1-3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated.

[0045] Figure 29 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figure 3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figures 1-3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated.

[0046] Figure 30 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figure 3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figures 1-3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated.

[0047] Figure 31 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figure 3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. Figures 1-3 A cross-sectional view of an inflow edge portion of the prosthetic heart valve is illustrated. DETAILED DESCRIPTION

[0048] In general consideration

[0049] For purposes of the present description, certain aspects, advantages, and novel features of the examples of the present disclosure are described herein. The methods, systems, and devices should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, systems, and devices of the present disclosure are not limited to any particular aspect, feature, or combination thereof, nor do the methods, systems, and devices require that any one or more of the advantages described be present or problems be solved.

[0050] Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect or example of the disclosure are to be understood to be applicable to any other aspect or example described herein for which they do not prohibit. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings) can be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The disclosure is not restricted to the details of any foregoing examples. The disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0051] While, for convenience, the operations of some of the methods of this disclosure have been described in a particular, serial order, it is to be understood that such descriptions are meant to be illustrative only. For example, described serially, operations can in some cases be reordered or performed concurrently. Furthermore, for brevity, the drawings can not show various ways in which methods, systems, and devices of the present disclosure can be used in conjunction with other systems, methods, and devices.

[0052] As used herein, the terms "one," "a," and "at least one" include one or more of the specified element. That is, if there are two of the specified elements, then "one" or "at least one" of the elements exists, and there are, therefore, two of the elements. The terms "plurality" and "a plurality" mean two or more of the specified elements.

[0053] As used herein, the term "and / or," when used between the last two items in 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."

[0054] As used herein, the term "coupled" generally means physically coupled or linked, and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

[0055] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) can be used to facilitate the discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms such as “inboard,” “outboard,” “top,” “down,” “interior,” “exterior,” and the like can be used. Such terms, when applicable, are used to provide some clarity of description when dealing with relative relationships, especially with respect to the illustrated examples. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, for an object, “upper” can become “lower” simply by turning the object over. However, it is still the same part, and the object is still the same. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0056] In the context of the present application, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, a lower end of a valve is its inflow end, and an upper end of a valve is its outflow end.

[0057] As used herein with reference to a prosthetic medical device (e.g., a prosthetic heart valve), a capsule, and a delivery apparatus, “proximal” refers to the location, orientation, or portion of a component of the delivery apparatus that is closer to the user and / or outside of the patient, while “distal” refers to the location, orientation, or portion of a component that is further from the user and / or the handle of the delivery apparatus and closer to the implantation site. The terms “longitudinal” and “axial” refer to an axis that extends in the proximal and distal directions, unless explicitly defined otherwise. Additionally, the term “radial” refers to a direction that is arranged perpendicular to an axis and along a radius from a center of a point of an object (where the axis is positioned at the center, such as the longitudinal axis of a prosthetic valve).

[0058] Disclosed technology and embodiments

[0059] Collapsible transcatheter prosthetic heart valves can be crimped into an elongated profile (e.g., a radially compressed state) on a delivery device such that they can be advanced through a patient’s vasculature with minimal complications. However, because the frames lengthen as they are crimped, the apices of the frames can protrude through the skirt assembly and contact the inner surface of an introducer sheath used to introduce the prosthetic valve and delivery device into the patient’s vasculature. This can increase the push force required to push the prosthetic valve through the introducer sheath and can deform the exposed apices, potentially damaging the valve.

[0060] Disclosed herein are collapsible prosthetic heart valves having a sealing assembly configured to completely cover the apex of at least one end of the frame when the prosthetic valve is in a radially compressed delivery configuration. In particular, the prosthetic heart valves disclosed herein include one or more elongate sealing members (also referred to herein as "skirts") that extend beyond one end of the frame and form a gap or pocket (e.g., a hollow space) between the sealing member and the apex of the frame at that end of the frame. The additional space provided by the pocket allows the frame to elongate during crimping without puncturing the sealing member or allowing the apex to extend beyond the end of the skirt. Thus, the collapsible prosthetic heart valves disclosed herein can protect the apex of the frame from contacting components of the delivery system, particularly the inner surface of an introducer sheath, during an implantation procedure.

[0061] As discussed in greater detail below, the pocket can be formed by an inner skirt and / or an outer skirt mounted on the inner side and the outer side of the frame, respectively. In some examples Figure 23 ) in which two skirts form the pocket. For example, in some such examples, both the inner skirt and the outer skirt can extend beyond the inflow end of the frame and can be sewn together at the pocket (under the inflow end of the frame). In other examples Figure 22 ) in which the pocket is formed by the inner skirt. For example, in some such examples, the inner skirt can wrap around the inflow end of the frame, can extend over the outer skirt on the outer side of the frame, and can be sewn to the outer skirt on the outer side of the frame. In further examples Figure 24 ) in which the pocket is formed by the outer skirt. For example, in some such examples, the skirt on the outer side of the frame can wrap around the inflow end of the frame, can extend over the inner skirt on the inner side of the frame, and can be sewn to the inner skirt on the inner side of the frame. In further examples Figure 28 and Figures 30-31 ) in which the pocket is at least partially formed by a separate third skirt attached to the inner skirt, the outer skirt, and / or the frame.

[0062] Further information and examples are provided below with reference to the accompanying drawings.

[0063] Figures 1-31 Various examples of prosthetic heart valves according to the present application are depicted. In particular, Figure 1 u- Figure 3 Example prosthetic heart valves are shown Figure 1 and Figure 3 illustrate the valve in a radially expanded state, while Figure 2 illustrate the valve in a radially compressed (i.e., crimped) state), while Figures 4-20 and Figure 29 Various components of example prosthetic heart valves are depicted. In particular, Figure 29Figures depicting how the inner skirt and the outer skirt can be attached to the frame at both the inflow edge portion and the outflow edge portion of the frame. Figures 22-24 , Figure 28 and Figures 30-31 Figures depicting four different examples of a pocket of an example prosthetic heart valve. Specifically, Figure 22 Figures depicting an example of an inner skirt wrapped around an inflow end of a frame to form a pocket, Figure 24 Figures depicting an example of an outer skirt wrapped around an inflow end of a frame to form a pocket, and Figure 23 Figures depicting an example of both an inner skirt and an outer skirt extending beyond an inflow end of a frame and being sewn together under the inflow end of the frame to form a pocket, and Figure 28 and Figures 30-31 Figures depicting an example of a separate third skirt attached to an inflow edge portion of the inner skirt, an inflow edge portion of the outer skirt, and / or an inflow end of the frame to form at least a portion of a pocket. Figure 25 Figures depicting how an inner skirt can be aligned with a frame in an example of the inner skirt forming a pocket to ensure proper pocket length, and Figures 26A-27B Figures depicting how an inner skirt and an outer skirt can be sewn together in a similar such example of the inner skirt forming a pocket.

[0064] As shown in Figures Figures 1-3 , a prosthetic heart valve 10 (which can also be referred to herein as a “transcatheter prosthetic heart valve 10,” a “prosthetic valve 10,” and / or a “radially compressible and expandable prosthetic heart valve 10”) includes an annular frame 12 that can move between a radially expanded and axially shortened state (Figures Figure 1 and Figure 3 ) and a radially compressed and axially elongated (i.e., crimped) state (Figures Figure 2 ), a leaflet assembly 14 including a plurality of leaflets 15 positioned within the frame 12, and a skirt assembly 16 (which can also be referred to herein as a “sealing member assembly 16”).

[0065] The skirt assembly 16 includes an inner skirt 17 (which can also be referred to herein as an “inner sealing member 17”) and an outer skirt 18 (which can also be referred to herein as an “outer sealing member 18”) mounted on opposite sides of the frame 12. As noted above, the inner skirt 17 and / or the outer skirt 18 can form a pocket 20 (Figures Figure 3 ) between an inflow end 22 of the frame 12 and the skirt assembly 16 at the inflow end 22 of the frame 12, which pocket 20 is configured to receive an apex of the frame 12 when the frame is crimped (i.e., radially compressed and axially elongated) to a radially compressed state such as shown in Figures Figure 2 .

[0066] The frame 12 also includes an outflow end 24 opposite to the inflow end 22. Blood is typically configured to flow through the valve 10 in only one direction (i.e., unidirectionally), from the inflow end 22 of the frame 12 to the outflow end 24 of the frame 12. Thus, blood can be configured to enter the valve 10 at the inflow end 22 of the frame 12, flow from the inflow end 22 of the frame 12 to the outflow end 24 of the frame 12, and then exit the frame 12 at the outflow end 24 of the frame 12.

[0067] like Figures 4-5 As shown, frame 12 includes a plurality of pillars 26 that form and / or otherwise define a plurality of open cells 28 (which may also be referred to herein as “openings 28”). More specifically, the plurality of pillars 26 may include a plurality of angled pillars 30 arranged in rows. Adjacent angled pillars 30 in each row of angled pillars may be directly connected to each other at joints 32 (i.e., without any intermediate components). Furthermore, adjacent rows of angled pillars 30 may be connected to each other at joints 32. In some examples, the joints 32 of two or more adjacent rows of angled pillars 30 may be directly connected to each other. In some examples, the joints 32 of two or more adjacent rows of angled pillars 30 may be connected to each other via one or more intermediate structures, such as one or more vertical pillars (which may also be referred to herein as “axially extending pillars”) 34, to interconnect adjacent rows of angled pillars 30.

[0068] exist Figures 4-5 In the example shown, the multi-row angled pillars 30 include five rows of angled pillars 30: a first row of angled pillars 36, a second row of angled pillars 38, a third row of angled pillars 40, a fourth row of angled pillars 42, and a fifth row of angled pillars 44. The first row of angled pillars 36 (located closest to the inflow end 22 of the frame 12) can be connected to the second row of angled pillars 38 via the first row of vertical pillars 46, and the joints 32 of the second row of angled pillars 38 and the joints 32 of the third row of angled pillars 40 can be directly connected to each other. Similarly, the joints 32 of the third row of angled pillars 40 and the joints 32 of the fourth row of angled pillars 42 can be directly connected to each other, and the joints 32 of the fourth row of angled pillars 42 and the joints 32 of the fifth row of angled pillars 44 (located closest to the outflow end 24 of the frame 12) can be connected to each other via the second row of vertical pillars 48 and a plurality of axially extending window frame pillars 50 (which define the connecting window 52).

[0069] In this manner, the plurality of struts 26 can define and / or otherwise form four rows of open cells 28. The first and second rows of angled struts 36, 38 can define and / or otherwise form a first row of open cells 54, the second, third, and fourth rows of angled struts 38, 40, 42 can form and / or otherwise define two intermediate rows of open cells 56, and the fourth and fifth rows of angled struts 42, 44 can form and / or otherwise define a fourth row of open cells 58.

[0070] As shown in FIG. 1, the first and second rows of angled struts 36, 38 can define and / or otherwise form a first row of open cells 54, the second, third, and fourth rows of angled struts 38, 40, 42 can form and / or otherwise define two intermediate rows of open cells 56, and the fourth and fifth rows of angled struts 42, 44 can form and / or otherwise define a fourth row of open cells 58. Figures 4-5 As shown, due to the inclusion of vertical struts 46 between the first and second rows of angled struts 36, 38 and struts 48, 50 between the fourth and fifth rows of angled struts 42, 44, the cells of the first row of open cells 54 and the fourth row of open cells 58 can be larger than the cells of the two intermediate rows of open cells 56. Further, the struts 48, 50 can be longer than the vertical struts 46, and thus, the cells of the fourth row of open cells 58 can be larger than the cells of the first row of open cells 54. The relatively large size of the cells of the fourth row of open cells 58 can allow portions of the leaflet assembly 14 to protrude or bulge into and / or through the frame 12 in order to minimize the crimped profile when the frame 12 is crimped. Generally, the geometry of the struts 26 and the junctions 32 facilitate the open cells 28 being large enough to allow portions of the leaflets 15 to protrude or bulge outwardly through the frame 12 when the frame 12 is in a radially compressed state Figure 2 ). This allows the valve 10 to be crimped to a relatively smaller diameter than if all of the leaflet material were constrained within the crimped frame.

[0071] Further, the relatively large size of the first row of open cells 54 allows the frame to assume a generally tapered shape when crimped Figure 2 ), tapering 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 region of decreasing diameter extending along a portion of the frame adjacent the inflow end 22 of the frame, which generally corresponds to the region of the frame 12 covered by the outer skirt 18. In some examples, the region of decreasing diameter decreases in diameter compared to the upper portion of the frame 12 (which is 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 Figure 2 to a radially expanded state Figure 1 , Figure 3 , Figure 4 , Figure 15 and Figure 20The frame 12 is generally cylindrical and annular in shape. In one example, when rolled up, the frame 12 of the 26mm prosthetic valve 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.

[0072] like Figure 7 Ideally, the supports 46, 48, and / or 50 may have a thickness S1 that is less than the thickness S2 of the joint 32. The joint 32 may help prevent the open unit 28 from being completely closed.

[0073] Frame 12 is configured to reduce, prevent, or minimize possible excessive expansion of the prosthetic valve under predetermined balloon pressure, particularly at the outflow portion of the frame supporting the leaflet assembly 14. On one hand, frame 12 is configured to have relatively larger angles 60a, 60b, 60c, 60d, and 60e between the angled struts 30, such as... Figure 5 As shown. The larger the angle, the greater the force required to open (expand) the frame. Therefore, the angle between the angled struts 30 of frame 12 can be selected to limit the radial expansion of frame 12 under a given opening pressure (e.g., the inflation pressure of a balloon). In a specific example, these angles are at least 110 degrees or greater when the frame expands to its functional size, and more specifically, these angles are up to approximately 120 degrees when the frame expands to its functional size.

[0074] The frame 12 may also include a plurality of vertices 62 at the inflow end 22 and / or the outflow end 24. Vertices 62 may be formed at the inflow end 22 and / or the outflow end 24 by angled supports 30. Specifically, the first row of angled supports 36 and the fifth row of angled supports 44 may form a plurality of vertices 62 at the inflow end 22 and the outflow end 24 of the frame 12, respectively. Vertices 62 may be formed at the junctions and / or within adjacent angled supports 30.

[0075] Although frame 12 is shown in the figures as comprising five rows of angled pillars 30 and four rows of open units 28, it should be understood that in other examples, frame 12 may include more or fewer than five rows of angled pillars 30 and / or four rows of open units 28.

[0076] Frame 12 also includes window frame supports 50 that form and / or otherwise define joint windows 52 (three in the illustrated example), the joint windows 52 being adapted to mount the joints of leaflet assemblies 14 onto frame 12, as described in more detail below. Each pair of window frame supports 50 is configured to mount a corresponding joint of the leaflet assembly 14. Figures 4-5As can be seen, each window frame strut 50 is fixed at its upper and lower ends to adjacent rows of angled struts 30 to provide a robust construction that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to known cantilever struts for supporting the commissures of a leaflet assembly. This construction enables the frame wall thickness to be reduced to achieve a smaller crimped diameter of the prosthetic valve. In a specific example, the thickness T of the frame 12 Figure 4 ) measured between the inner diameter and the outer diameter is about 0.48 mm or less. Figure 6 、 Figure 7 、 Figure 8 、 Figure 9 and Figure 10 are enlarged views of portions of the frame 12 identified by letters A, B, C, D, and E in Figure 5

[0077] The frame 12 can be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium (NiTi), such as Nitinol) known in the art. When composed of a plastically expandable material, the frame 12 (and thus the prosthetic heart valve 10) can be crimped to a radially compressed state on a delivery catheter and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. When composed of a self-expanding material, the frame 12 (and thus the prosthetic heart valve 10) can be crimped to a radially compressed state and restrained in the radially compressed state by a sheath tube or equivalent mechanism inserted into a delivery catheter. Once inside the body, the valve 10 can be advanced from the delivery sheath tube, which allows the valve 10 to expand to its radially expanded state.

[0078] Suitable plastically expandable materials that can be used to form the frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chrome or nickel-cobalt-chrome alloys), polymers, or combinations thereof. In a specific example, the frame 12 is made of a nickel-cobalt-chrome-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to the UNS R30035 alloy (covered by ASTM F562-02). The MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using the MP35N® alloy to form the frame 12 provides structural benefits over stainless steel. In particular, less material is needed to achieve the same or superior performance in radial and crush force resistance, fatigue resistance, and corrosion resistance when the MP35N® alloy is used as the frame material. Moreover, because less material is needed, the crimped profile of the frame can be reduced, thereby providing a prosthetic valve assembly that is less profiled for percutaneous delivery to a treatment site within the body. The MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using the MP35N® alloy to form the frame 12 provides structural benefits over stainless steel. In particular, less material is needed to achieve the same or superior performance in radial and crush force resistance, fatigue resistance, and corrosion resistance when the MP35N® alloy is used as the frame material. Moreover, because less material is needed, the crimped profile of the frame can be reduced, thereby providing a prosthetic valve assembly that is less profiled for percutaneous delivery to a treatment site within the body. ​​

[0079] In some examples, the frame 12 can be formed from a single piece of material. In some such examples, the open cells 28 can be formed by removing material from the single piece of material (e.g., via machining, milling, laser cutting, etc.). However, in other such examples, the frame 12 and the open cells 28 can be formed via a molding process (e.g., die casting, injection molding, etc.). In further examples, the frame 12 can be formed from two or more pieces that are formed separately and then coupled together via any suitable coupling means (e.g., welding, adhesive, fasteners, etc.).

[0080] As shown in FIGS. 1 1 and 12, the inner skirt 17 is mounted on the inner side 63 of the frame and can be coupled and / or otherwise secured to the frame 12 such as via sutures. The inner skirt 17 can include an inner side 64 opposite an outer side 65 of the frame 12. The inner side 64 faces radially inward (toward the lumen of the valve 10), and the outer side 65 faces radially outward and directly contacts the inner side 63 of the frame 12. In the example shown in FIGS. 1 1 and 12, the inner skirt 17 can be sutured to the fourth row of angled struts 42. Specifically, the inner skirt 17 can include an inflow edge portion 66 opposite an outflow edge portion 68, and the outflow edge portion 68 of the inner skirt 17 can be coupled to the fourth row of angled struts 42 via sutures 70. In some such examples, a plurality of tabs 96 formed on the outflow edge portion 68 of the inner skirt 17 can be wrapped around the fourth row of angled struts 42 and secured thereto via the sutures 70. As discussed in greater 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, the user can ensure that the outflow edge portion 68 of the inner skirt 17 does not extend more than a threshold amount X beyond the junctions 32 of the fourth row of angled struts 42 in order to maintain sufficient length for the pocket 20 at the inflow end 22 of the frame 12. Figure 1 Figure 3 Figure 15 Figure 20 As shown in FIGS. 1 1 and 12, the inner skirt 17 is mounted on the inner side 63 of the frame and can be coupled and / or otherwise secured to the frame 12 such as via sutures. The inner skirt 17 can include an inner side 64 opposite an outer side 65 of the frame 12. The inner side 64 faces radially inward (toward the lumen of the valve 10), and the outer side 65 faces radially outward and directly contacts the inner side 63 of the frame 12. In the example shown in FIGS. 1 1 and 12, the inner skirt 17 can be sutured to the fourth row of angled struts 42. Specifically, the inner skirt 17 can include an inflow edge portion 66 opposite an outflow edge portion 68, and the outflow edge portion 68 of the inner skirt 17 can be coupled to the fourth row of angled struts 42 via sutures 70. In some such examples, a plurality of tabs 96 formed on the outflow edge portion 68 of the inner skirt 17 can be wrapped around the fourth row of angled struts 42 and secured thereto via the sutures 70. As discussed in greater 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, the user can ensure that the outflow edge portion 68 of the inner skirt 17 does not extend more than a threshold amount X beyond the junctions 32 of the fourth row of angled struts 42 in order to maintain sufficient length for the pocket 20 at the inflow end 22 of the frame 12. Figure 12 Figure 11 Figure 1 Figure 3 Figure 15 Figure 20 Figure 25

[0081] ​​​​​​​​​​The primary function of the inner skirt 17 is to assist in securing the leaflet assembly 14 to the frame 12 and to help create a good seal between the prosthetic valve 10 and the native valve annulus by blocking blood flow through the open cells 28 of the frame 12 below the lower edge of the leaflets 15. The inner skirt 17 desirably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), although various other synthetic or natural materials (e.g., pericardial tissue) can be used. The thickness of the skirt is desirably less than about 0.15 mm (about 6 mils), and desirably less than about 0.1 mm (about 4 mils), and even more desirably about 0.05 mm (about 2 mils). In particular examples, the inner skirt 17 can have a variable thickness, e.g., the skirt can be thicker at its at least one edge than at its center. In one embodiment, the skirt 17 can comprise a PET skirt that is about 0.07 mm thick at its edge and about 0.06 mm thick at its center. A thinner skirt can provide better crimping performance while still providing a good paravalvular seal.

[0082] The leaflet assembly 14 can be attached to the skirt by one or more reinforcing strips 72 (which collectively can form a sleeve), e.g., thin PET reinforcing strips that enable secure suturing and prevent pericardial tissue tearing of the leaflet assembly. The leaflet assembly 14 can be sandwiched between the skirt 17 and the thin PET strips 72, as shown. Figure 19 The sutures 74 that secure the PET strips and the leaflet assembly 14 to the skirt 17 can be any suitable sutures, such as Ethibond PET sutures (Johnson & Johnson, New Brunswick, New Jersey). The sutures 74 desirably follow the curvature of the lower edge of the leaflet assembly 14, as described in more detail below.

[0083] Referring to Figure 12 In contrast to known fabric skirts, the skirt 17 is desirably woven from a first set of fibers or yarns or strands 78 and a second set of fibers or yarns or strands 80, neither of which is perpendicular to the outflow end 82 and the inflow end 84 of the skirt. In particular examples, the first set of fibers 78 and the second set of fibers 80 extend at an angle of about 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the outflow end 82 and the inflow end 84. For example, the skirt 17 can be formed by weaving fibers at a 45 degree angle relative to the outflow end and the inflow end of the fabric. Alternatively, the skirt 17 can be cut diagonally (on an angle) from a vertically woven fabric in which the fibers extend perpendicular to the edges of the material, such that the fibers extend at a 45 degree angle relative to the cut outflow end and the inflow end of the skirt. As Figure 12As further shown, the opposing short edges 86, 88 of the skirt 17 desirably are not perpendicular to the outflow end 82 and the inflow end 84. For example, the short edges 86, 88 desirably extend at an angle of about 45 degrees relative to the outflow end and the inflow end, and thus are aligned with the first set of fibers 78. Thus, the overall general shape of the skirt 17 is a diamond or parallelogram shape.

[0084] Figure 13 and Figure 14 The inner skirt 17 is shown 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 can be placed in overlapping relation relative to the opposing edge portion 92, and the two edge portions can be sewn together by a stitching line 94 that extends parallel to the diagonal of the short edges 86, 88. The inflow edge portion 66 of the inner skirt 17 can be formed with a plurality of protrusions 96 that define a wavy shape that generally follows the shape or contour of the fourth row of angled struts 42 immediately adjacent the lower end of the vertical strut 48. In this manner, as Figure 15 As best shown in FIG. 6, the outflow end 82 of the inner skirt 17 can be secured tightly to the fourth row of angled struts 42 via the stitching line 70. The inner skirt 17 can also be formed with a slit 98 to facilitate attachment of the skirt 17 to the frame 12. The slit 98 is sized so as to allow the outflow edge portion 68 of the inner skirt 17 to partially wrap around the fourth row of angled struts 42 and reduce stress in 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 upper surface of the fourth row of angled struts 42 and secured in place with the stitching line 70. Wrapping the outflow edge portion 68 of the inner skirt 17 around the fourth row of angled struts 42 in this manner provides a stronger and more durable attachment of the skirt 17 to the frame 12. The inner skirt 17 can additionally or alternatively be secured to the first, second, and / or third rows of angled struts 36, 38, 40, respectively, with the stitching line 70.

[0085] As Figure 25As shown, the slits 98 can be circumferentially aligned with the junctions 32 between adjacent angled struts. In some examples, the slits 98 can not be axially spaced apart 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 over-wrapping of the inner skirt 17. For example, the slits 98 can be axially spaced apart (i.e., the threshold amount X can be) at most 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, and / or at most 1.0 mm from the junctions 32 of the fourth row of angled struts 42 (towards the outflow end 24 of the frame). Thus, in some examples, the inflow end 84 of the inner skirt 17 can extend beyond (i.e., below) the apex 62 at the inflow end 22 of the frame 12. However, in other examples, the inflow end 84 of the inner skirt 17 can extend to but not beyond the apex 62 at the inflow end of the frame 12. In further examples, the inflow end 84 of the inner skirt 17 can not extend to the apex 62 at the inflow end 22 of the frame 12 and can fall short of the apex 62 at the inflow end of the frame 12.

[0086] Due to the angled orientation of the fibers relative to the inflow and outflow ends of the skirt 17, the skirt 17 can experience more 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 in the axial direction with the frame and thus provide a more uniform and predictable crimp profile. In the illustrated example, each cell of the metal frame includes at least four angled struts that rotate towards the axial direction when crimped (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 and allow the skirt to elongate along the length of the struts. This allows for more elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.

[0087] Additionally, the spacing between the woven fibers or yarns can be increased to promote elongation of the skirt in the axial direction. 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 examples, the yarn spacing of the inner skirt 17 can be about 60 yarns per centimeter (about 155 yarns per inch) to about 70 yarns per centimeter (about 180 yarns per inch), such as about 63 yarns per centimeter (about 128 yarns per inch), while in a typical PET skirt the yarn spacing can be about 85 yarns per centimeter (about 217 yarns per inch) to about 97 yarns per centimeter (about 247 yarns per inch). The short edges 86, 88 promote uniform and even distribution of the fabric material along the inner perimeter of the frame during crimping in order to reduce or minimize bunching of the fabric, thereby promoting uniform crimping to a minimum possible diameter. Furthermore, cutting the diagonal seams in a vertical manner can leave loose fringes along the cut edges. The short edges 86, 88 help to minimize this occurrence. The construction of the inner skirt 17 avoids undesirable deformation of the frame struts and provides for more uniform crimping of the frame as compared to the construction of a conventional skirt in which the fibers extend perpendicular to the outflow and inflow ends of the skirt.

[0088] In alternative examples, the skirt 17 can be formed from woven elastic fibers that can stretch in the axial direction during crimping of the prosthetic valve 10. The warp fibers and weft fibers can extend perpendicular and parallel to the outflow and inflow ends of the skirt 17, or alternatively, they can extend at an angle between 0 degrees and 90 degrees relative to the outflow and inflow ends of the skirt 17, as described above.

[0089] The inner skirt 17 can be sewn to the frame 12 at a location distal from the sutures 74 so that the skirt can be more pliable in this region. This construction can avoid stress concentrations at the sutures 74 that attach the lower edges of the leaflets to the inner skirt 17.

[0090] As described above, in the illustrated example, the leaflet assembly 14 includes three flexible leaflets 15 (although a greater or fewer number of leaflets can be used). Additional information regarding the leaflets and additional information regarding the skirt material can be found, for example, in U.S. Patent No. 10,195,025, issued February 5, 2019, which is incorporated by reference herein.

[0091] The leaflets 15 can be secured to one another at their adjacent sides to form a commissure 114 of the leaflet assembly. Figure 20 A plurality of flexible connectors 116 (one of which is shown in Figure 16 ) can be used to interconnect the pairs of adjacent sides of the leaflets and to mount the leaflets to the window frame struts 50 Figure 5 ).Figure 16 Adjacent sides of two leaflets 15 interconnected by a flexible connector 116 are shown. As Figure 17 shown, three flexible connectors 116 can be used to secure three leaflets 15 side-to-side to one another. Additional information regarding connecting leaflets to one another and assembling leaflets and skirts to frames can be found, for example, in U.S. Patent Application Publication Nos. 2012 / 0123529 and 2019 / 0365530, which are incorporated herein by reference.

[0092] To prevent overexpansion of the leaflet assembly 14, the leaflet assembly 14 is desirably secured to the frame 12 below the fifth row of angled struts 44, as Figure 1 best shown. In particular, due to the“dog bone” effect of the balloon used to expand the prosthetic valve 10, the inflow end 22 and the outflow end 24 of the frame 12 can often tend to overexpand more than the middle portion of the frame 12. Thus, in the event of overexpansion of the outflow end 24 of the frame 12, the leaflet assembly 14 is positioned at a level below which overexpansion can occur, thereby protecting the leaflet assembly 14 from overexpansion.

[0093] Another benefit of mounting the leaflets 15 at a location spaced apart 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. Thus, if the delivery catheter includes a push mechanism or stop member that pushes against or abuts the outflow end 24 of the prosthetic valve 10, the push mechanism or stop member contacts the outflow end 24 of the frame 12 rather than the leaflets 15 in order to avoid damage to the leaflets 15.

[0094] As noted above, the inner skirt 17 can be used to help suture the leaflet assembly 14 to the frame 12. The inner skirt 17 can have wavy temporary marker sutures to guide attachment of the lower edge of each leaflet 15. As noted above, prior to securing the leaflet assembly 14 to the skirt 17, the inner skirt 17 itself can be sutured to the struts of the frame 12 using sutures 70. The struts that intersect the marker sutures are desirably not attached to the inner skirt 17. This allows the inner skirt 17 to be more pliable in areas that are not secured to the frame and minimizes stress concentration along the sutures that secure the lower edge of the leaflets to the skirt. As noted above, when the skirt is secured to the frame, the fibers 78, 80 (see Figure 12 ) of the skirt are generally aligned with the angled struts of the frame to facilitate uniform crimping and expansion of the frame.

[0095] Figure 18 One particular method for securing the commissures 114 of the leaflet assembly 14 to the commissure window frame struts 50 of the frame 12 is shown. Flexible connectors 116 Figure 17) are folded down against the flexible connectors. Each upper tab portion 112 is folded longitudinally (vertically) to assume an L-shape having 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 portion 122 can then be sewn to the connector 116 along a stitch line 124. Next, the commissure tab assemblies are inserted through the commissure windows 52 of a corresponding pair of window frame struts 50, and the folded portions outside the window frame struts 50 can be sewn to the portions 122.

[0096] Figure 18 It is also shown that the folded down upper tab portions 112 can form a double layer of leaflet material at the commissure. The inner portions 118 of the upper tab portions 112 are positioned flat against the layers of the two leaflets 15 forming the commissure, such that each commissure includes four layers of leaflet material just inside the window frame strut 50. This four-layered portion of the commissure can be more resistant to bending or articulating / arthromoting than portions of the leaflets 15 radially inward from the relatively more rigid four-layered portion. This causes the leaflets 15 to articulate primarily at the inner edges 120 of the folded down inner portions 118 in response to blood flowing through the prosthetic valve during operation within the body, rather than articulating around or near the axial struts of the window frame strut 50. Because the leaflets articulate at a location spaced radially inward from the window frame strut 50, the leaflets 15 can avoid contact with and damage from the frame 12. However, under high forces, the four-layered portion of the commissure can splay open around the longitudinal axis adjacent the window frame strut 50, with each inner portion 118 folded outward against a corresponding outer portion 122. This can occur, for example, when the prosthetic valve 10 is compressed and mounted onto a delivery shaft, allowing for a smaller crimped diameter. The four-layered portion of the commissure can also splay open around the longitudinal axis when a balloon catheter is inflated during expansion of the prosthetic valve, which can relieve some of the pressure on the commissure caused by the balloon, reducing potential damage to the commissure during expansion.

[0097] After all three commissure tab assemblies are secured to the corresponding window frame struts 50, the lower edges of the leaflets 15 between the commissure tab assemblies can be sewn to the inner skirt 17. For example, as shown in FIG. 6, each leaflet 15 can be sewn to the inner skirt 17 via a stitch line 74, for example, using Ethibond® PET suture. The stitch line 74 can be an in-and-out stitch line extending through each leaflet 15, the inner skirt 17, and each reinforcing strip 72. Each leaflet 15 and corresponding reinforcing strip 72 can be sewn individually to the inner skirt 17. In this way, the lower edges of the leaflets 15 are secured to the frame 12 by the inner skirt 17. As shown in FIG. 6, the inner skirt 17 can be sewn to the reinforcing strips 72 via a stitch line 76, for example, using Ethibond® PET suture. The stitch line 76 can be an in-and-out stitch line extending through the inner skirt 17 and each reinforcing strip 72. The inner skirt 17 and corresponding reinforcing strip 72 can be sewn individually to each other. In this way, the inner skirt 17 is secured to the frame 12 by the reinforcing strips 72. Figure 19 PET suture. The stitch line 74 can be an in-and-out stitch line extending through each leaflet 15, the inner skirt 17, and each reinforcing strip 72. Each leaflet 15 and corresponding reinforcing strip 72 can be sewn individually to the inner skirt 17. In this way, the lower edges of the leaflets 15 are secured to the frame 12 by the inner skirt 17. As shown in FIG. 6, the inner skirt 17 can be sewn to the reinforcing strips 72 via a stitch line 76, for example, using Ethibond® PET suture. The stitch line 76 can be an in-and-out stitch line extending through the inner skirt 17 and each reinforcing strip 72. The inner skirt 17 and corresponding reinforcing strip 72 can be sewn individually to each other. In this way, the inner skirt 17 is secured to the frame 12 by the reinforcing strips 72. Figure 19 ​As shown, the leaflets can be further secured to the skirt by blanket sutures 126, which extend through each reinforcing strip 72, leaflet 15, and inner skirt 17, while surrounding the edges of the reinforcing strips 72 and leaflets 15. The blanket sutures 126 can be formed of PTFE suture material. Figure 20 A side view of the frame 12, leaflet assembly 14, and inner skirt 17 is shown after the leaflet assembly 14 and inner skirt 17 have been secured to the frame 12 and the leaflet assembly 14 has been secured to the inner skirt 17.

[0098] In some embodiments (e.g., Figure 3 and Figure 20 In this configuration, the leaflet component 14, including leaflet 15, is entirely positioned 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 examples, the leaflet 15 does not extend to the inflow end 22 of the frame 12, but rather almost reaches it. For example, as... Figure 3 As shown, leaflet 15 does not extend to vertex 62 at the inflow end 22 of frame 12. Therefore, leaflet assembly 14 can be shorter than frame 12 and can be positioned entirely within frame 12 such that leaflet 15 does not extend beyond the inflow end 22 and outflow end 24 of frame 12.

[0099] Figure 21 This is a plan view of the outer skirt 18 before it is attached to the frame 12. The outer skirt 18 may be laser-cut or otherwise formed of a robust and durable material (such as PET or various other suitable synthetic or natural materials) configured to restrict and / or prevent blood flow through it. The outer skirt 18 may include a generally straight lower (inflow or upstream) edge portion 128 and an upper (outflow or downstream) edge portion 130, which define a plurality of alternating protrusions 132 and notches 134 or serrations that generally conform to the shape of a row of pillars of the frame 12. In alternative examples, the inflow edge portion 128 and the outflow edge portion 130 may have other shapes. For example, in one embodiment, the inflow edge portion 128 may be formed with a plurality of protrusions that generally conform to the shape of a row of pillars of the frame 12, while the outflow edge portion 130 may be straight.

[0100] The outer skirt 18 may include the outer side 138 (e.g., Figures 21-24 ) Relative inner side 136 (e.g., Figures 22-24The inner side 136 is configured to face radially inward (towards the lumen of valve 10), while the outer side 138 faces radially outward (towards the exterior of the valve and surrounding natural tissue). Specifically, the outer skirt 18 may be mounted on the outer side 140 of frame 12 such that the inner side 136 of the outer skirt 18 faces and directly contacts the outer side 140 of frame 12. In a specific example, the outer side 138 may comprise a soft, plush material to cushion and seal the natural tissue surrounding the prosthetic valve 10. In some examples, the outer skirt 18 may be made of any of a variety of woven, knitted, or crocheted fabrics, wherein the surface of the outer side 138 is a nap or pile of the fabric. Exemplary fabrics with nap include velvet, velvet, corduroy, terry cloth, wool, etc.

[0101] In alternative examples, the outer skirt 18 is made of a nonwoven fabric such as felt or a fiber such as nonwoven cotton fiber. The outer skirt 18 may also be made of porous or sponge materials (such as any of a variety of compliant polymer foam materials) or woven fabrics (such as woven PET).

[0102] like Figure 1 As shown, the outward edge portion 130 (e.g., protrusion 132) of the outer skirt 18 may be attached and / or otherwise secured to the third row of angled pillars 40 of the frame 12. Figure 5 The protrusion 132 can, for example, be wrapped around the pillar of the third row of angled pillars 40 and secured with stitching 146. Thus, in such an example, the outflow end 142 of the outer skirt 18 can be positioned closer to the inflow end 22 of the frame 12 than the outflow end 82 of the inner skirt 17. However, in other examples, such as... Figure 29 As shown, the outward edge portion 130 of the outer skirt 18 and the outward edge portion 68 of the inner skirt 17 can be secured to the frame 12 at the same axial position on the frame 12 using a single set of seams extending through the frame 12 and the skirts 17 and 18. For example, as Figure 29 As shown, the suture 70 can be omitted, and the suture 146 can instead extend through the frame 12 and the two skirts 17, 18 to secure the outflow edge portions 68, 130 of the inner skirt 17 and the outer skirt 18 to the frame 12 at the same axial position on the frame 12, such as to the third row of angled pillars 40.

[0103] The outer skirt 18 can additionally or alternatively be fixed to the frame at the first row of angled struts 36 and / or the second row of angled struts 38. In some examples, the inflow end 144 of the outer skirt 18 can extend to but not beyond the apex 62 at the inflow end 22 of the frame 12. However, in other examples, the inflow end 144 of the outer skirt 18 can extend beyond the apex 62 at the inflow end of the frame 12. In further examples, the inflow end 144 of the outer skirt 18 can not extend to the apex 62 at the inflow end 22 of the frame 12 and can fall short of the apex 62 at the inflow end of the frame 12. For example, the outer skirt 18 need not extend all the way to the inflow end 22 of the frame 12, but rather the inflow end 144 of the outer skirt 18 can be fixed to another location on the frame 12, such as to the second row of angled struts 38.

[0104] In alternative examples, the height of the outer skirt 18 (measured from the inflow end 144 to the outflow end 142) can vary. For example, in some examples, the outer skirt 18 can cover the entire outer surface of the frame 12, with the inflow edge portion 128 fixed to the inflow end 22 of the frame 12 and the outflow edge portion 130 fixed to the outflow end 24 of the frame 12. In another example, the outer skirt 18 can extend from the inflow end 22 of the frame 12 to the second row of angled struts 38, or to the fourth row of angled struts 42, or to a location along the frame 12 between the two rows of struts.

[0105] The outer skirt 18 is ideally sized and shaped relative to the frame 12 such that the outer skirt 18 fits snugly (in a close-fitting manner) over the outside 140 of the frame 12 when the prosthetic valve 10 is in its radially expanded state (e.g., Figure 1 and Figure 3 ). When the prosthetic valve 10 is crimped to a radially compressed state (e.g., Figure 2 ) for delivery, the portion of the frame to which the outer skirt is mounted can elongate axially. The outer skirt 18 is ideally resilient enough to stretch in the axial direction when the frame is radially compressed so that it does not prevent full radial compression of the frame or deform the struts during the crimping process.

[0106] In some examples, 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) can additionally be sewn to the frame 12 at or near the inflow end 22 of the frame, such as to the first row of angled struts 36. For example, as shown in FIG. 1, the inflow edge portion 66 of the inner skirt 17 can be sewn to the first row of angled struts 36 at the inflow end 22 of the frame 12. Figure 29As shown, the inflow edge portions 66 and 128 of both the inner skirt portion 17 and the outer skirt portion 18 can be coupled to the frame 12 via a stitch 320 at or near the inflow end 22 of the frame 12 (e.g., coupled to the first row of angled pillars 36). The stitch 320 can extend through the frame 12 and the skirt portions 17 and 18 to secure the inflow edge portions 66 and 128 of the skirt portions 17 and 18 to the frame 12, as shown. Figure 29 As shown. However, in other examples, the stitch 320 may extend through only one of the frame 12 and the skirt 17 (such as only the inner skirt 17) to secure only the inflow edge portion 66 of the inner skirt 17 to the frame 12. Alternatively, the stitch 320 may extend through the frame 12 and only the outer skirt 18 to secure only the inflow edge portion 128 of the outer skirt 18 to the frame 12.

[0107] In some embodiments, such as Figure 29 As shown, the outer skirt 18 may be oversized relative to the frame 12 to accommodate the axial elongation of the frame 12 during curling or other radial compression. Specifically, when the frame 12 is in a radially extended state, the portion of the outer skirt 18 included between seam 146 and seam 320 may be longer than the corresponding region of the frame 12 (i.e., the portion of the frame included between seam 146 and seam 320). The slack created by the oversized outer skirt 18 helps the outer skirt 18 accommodate the additional axial elongation of the frame 12 during radial compression. In some examples, because the outer skirt 18 is longer than the frame 12 in this region (when the frame is in a radially extended state), the outer skirt 18 may include a gathering or pleated portion 330 when the frame 12 is in a radially extended state. When the frame 12 is radially compressed, the gathering portion 330 unfolds and flattens, allowing the outer skirt 18 to rest more flat against the frame 12 in the radially extended state. Therefore, when the frame 12 is radially compressed, such as during curling, both the bundled portion 330 of the outer skirt 18 and the frame 12 can elongate axially. In some examples, the bundled portion 330 can be formed by folding the outer skirt 18 in a zigzag pattern, such as with multiple circumferentially extending folds. In some examples, the inner skirt 17 may additionally or alternatively include a similar bundled portion to facilitate radial compression and axial elongation of the frame 12. Additionally, in Figures 22-24 In any of the examples shown, the bundled portion may be formed in the outer skirt and / or the inner skirt.

[0108] However, in other examples, the inner skirt 17 and / or the outer skirt 18 may be sewn to the frame 12 only at their outflow edge portions 68 and 130, respectively, and may be loosely suspended at their inflow edge portions 66 and 128, respectively, to allow for movement (e.g., axial elongation) of the apex 62 at the inflow end 22 of the frame 22 relative to the skirt assembly 16.

[0109] Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Figures 22-24 In the illustrated example, line of stitching 150 can extend through each of skirts 17, 18 only. In some such examples, another line of stitching (e.g., line of stitching 320 illustrated) proximate line of stitching 150 can extend through one or both of frame 12 and skirts 17, 18 to secure skirts 17, 18 to inflow end 22 of frame 12. For example, as illustrated, inflow edge portions 66 and / or 128 of inner skirt 17 and / or outer skirt 18, respectively, can be first stitched to frame 12 via line of stitching 320. Then, inflow edge portions 66, 128 of skirts 17, 18, respectively, can be stitched together via a separate set of stitches (such as line of stitches 150 (illustrated)) or separate skirts (e.g., skirts 302 illustrated) can be stitched to inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively. Figure 29 Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Figure 29 Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Figures 22-24 Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Figure 28 Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12.

[0110] In another example, and as illustrated, inflow edge portions 66 and / or 128 of inner skirt 17 and / or outer skirt 18, respectively, can be stitched to frame 12 via line of stitching 320 such that a portion of inner skirt 17 extends beyond inflow end 22 of frame 12. This extended or overhanging portion of inner skirt 17 can have a length that is long enough to form pocket 20 and can wrap around inflow end 22 of frame 12 and be stitched to inflow edge portion 128 of outer skirt 18 with line of stitches 150 at or proximate line of stitching 320 to form pocket 20. Figure 29 Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12. Inflow edge portions 66, 128 of inner skirt 17 and outer skirt 18, respectively, can be sewn together via a line of stitching or stitches 150 proximate inflow end 22 of frame 12 to form pocket 20 at inflow end 22 of frame 12.

[0111] In the illustrated example, when frame 12 is in the radially expanded state, inner skirt 17 and / or outer skirt 18 can extend beyond apex 62 at inflow end 22 of frame 12 such that pocket 20 creates a space between (and separates) inflow end 22 of frame 12 (including apex 62) and skirt assembly 16. Thus, apex 62 is positioned within pocket 20 and can be spaced apart from skirt assembly 16 when frame 12 is in the radially expanded state. Pocket 20 can also extend circumferentially around inflow end 22 of frame 12 such that all of apexes 62 at inflow end 22 of frame 12 are positioned within pocket 20. Figures 22-24 In the illustrated example, when frame 12 is in the radially expanded state, inner skirt 17 and / or outer skirt 18 can extend beyond apex 62 at inflow end 22 of frame 12 such that pocket 20 creates a space between (and separates) inflow end 22 of frame 12 (including apex 62) and skirt assembly 16. Thus, apex 62 is positioned within pocket 20 and can be spaced apart from skirt assembly 16 when frame 12 is in the radially expanded state. Pocket 20 can also extend circumferentially around inflow end 22 of frame 12 such that all of apexes 62 at inflow end 22 of frame 12 are positioned within pocket 20.

[0112] The pocket 20 has an inflow end 154 that can extend circumferentially around the inflow end 22 of the frame 12 (i.e., the section / part of the pocket 20 that is axially farthest from the inflow end 22 of the frame 12). Thus, when the frame 12 is in the radially expanded state, the apex 62 at the inflow end 22 of the frame 12 extends axially a distance Y between the pocket 20 and the skirt assembly 16. That is, the pocket 20 can separate the apex 62 at the inflow end 22 of the frame 12 from the skirt assembly 16 by a distance Y. Thus, when the frame 12 is in the radially expanded state, the inflow end 22 of the frame 12 (including the apex 62) can be axially spaced apart from the skirt assembly 16 by a distance Y at the inflow end 154 of the pocket 20. In particular examples, 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) can 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, at most 2.0, at most 1.5, and / or at most 1.0 mm when the frame is in the radially expanded state.

[0113] When the frame 12 is radially compressed, both the entire skirt assembly 16 (all of the skirts 17, 18, and / or 302) and the frame 12 can axially elongate, but the frame 12 can axially elongate more than the skirt assembly 16. However, when the prosthetic valve is radially compressed to the radially compressed state, the pocket 20 compensates for the additional elongation of the frame and can prevent the apex 62 from protruding through the skirt assembly.

[0114] In some examples, the length Y of the pocket 20 can be zero when the frame 12 is in the radially compressed state (i.e., the pocket 20 can completely disappear when the frame 12 is in the radially compressed state) such that the apex 62 of the frame 12 directly contacts the skirt assembly 16. However, even in examples where the apex 62 directly contacts the skirt assembly 16, they still do not protrude through the skirt assembly 16. In some examples, the skirt assembly 16 can be elastic and can stretch as the apex 62 contacts and pushes against the skirt assembly 16. This ability to stretch allows the skirt assembly 16 to accommodate even more axial elongation of the frame 12 when the apex 62 directly contacts the skirt assembly 16. In some examples, one or more apexes 62 can protrude slightly through the skirt assembly 16 at the pocket, but most of the apexes 62 are still completely covered by the skirt assembly within the pocket.

[0115] In other examples, the pouch 20 may still exist even when the frame 12 is in a radially compressed state, and the apex 62 of the frame 12 may still be physically separated from the inflow end 154 of the pouch 20 (i.e., even in a radially compressed state, the apex 62 may not directly contact the skirt assembly 16, and the distance Y may be greater than zero). When present, the pouch 20 itself may be hollow and / or may contain only air.

[0116] In one example ( Figure 22 and Figures 26A-27B In this configuration, the inner skirt 17 can form a pouch-like portion 20. In such an example, the outer skirt 18 may not extend beyond the inlet end 22 of the frame 12 (i.e., the outer skirt 18 may extend to or almost reach the inlet end 22 of the frame 12), but the inner skirt 17 may extend beyond the inlet end 22 of the frame 12, wrapping around the vertex 62 at the inlet end 22 of the frame 12 and forming the pouch-like portion 20. Specifically, the inner skirt 17 may extend beyond the inlet end 22 of the frame 12, folding back on itself at the inlet end 154 of the pouch-like portion 20, such that the crease and / or fold line (i.e., vertex) (the point where the inner skirt 17 folds back on itself) of the inner skirt 17 forms and / or defines the inlet end 154 of the pouch-like portion 20, and may terminate at the inlet edge portion 128 of the outer skirt 18. In some examples, such as Figure 22 As shown, the inflow edge portion 66 of the inner skirt 17 may overlap with 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 examples, the inner skirt 17 and the outer skirt 18 may not overlap each other, but rather the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18 may be directly adjacent to each other and / or positioned adjacent to each other, respectively. Additionally, in other examples, the outer skirt 18 may extend beyond the apex 62 at the inflow end of the frame, but is shorter than the inner skirt 17 forming most of the pocket portion 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 portion 20.

[0117] In some such examples, 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 over the outer side 140 of the frame 12 such that the inner side 136 of the outer skirt 18 directly contacts 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 examples, the inflow edge portion 66 of the inner skirt 17 may extend from the inflow end 154 of the pouch 20 toward the apex 62 and / or extend to the apex 62, but may not extend beyond the apex 62 on the outer side of the frame, and therefore may not cover the outer side 140 of the frame 12. In such an example, the inner skirt 17 can still fully form the bag-shaped portion 20, but the inflow end 84 of the inner skirt 17 and the inflow end 144 of the outer skirt 18 can be adjacent to each other at the inflow end 22 of the frame 12 (the inner skirt does not overlap with the outer skirt), so that the inner skirt 17 does not extend on the outer side 140 of the frame 12.

[0118] Figures 26A-26B This illustrates a method of assembling the inner skirt and outer skirt together on a frame to form Figure 22 The method of constructing the bag-shaped portion 20. The inner skirt portion 17 and the outer skirt portion 18 can be sewn together at or slightly above the vertex 62 at the inflow end of the frame 12 along multiple in-and-out stitches 152 spaced apart from the edges of the skirt portions 17 and 18. Figures 26A-26B As shown, to form the pouch 20, the assembler can use a threading needle 210 to pierce the outer skirt 18 from the outer side 138 to the inner side 136, just below the stitch 152 (where the valve is inverted), and then pierce the inner skirt 17 from the outer side 65 to the inner side 64. The assembler can then wrap the thread 212 around the inlet end 84 of the inner skirt 17, pull and fold the inlet end portion 66 of the inner skirt 17 onto the inlet 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 can then pierce the outer skirt 18 again at a location circumferentially spaced from the previous insertion point to complete the lockstitch 150 and begin another stitch 150.

[0119] To ensure that the appropriate bag-shaped portion length (e.g., distance Y) is maintained when the inner skirt 17 and the outer skirt 18 are sewn together, the user may sew the inner skirt 17 at at least a threshold distance Z from the inflow end 84 of the inner skirt 17. Figure 26A). That is, when the needle 210 is used to pierce the inner skirt 17 to form the stitches 150 with the thread 212, the user can maintain a threshold distance Z( Figure 26A ) between the needle 210 and the inflow end 84 of the inner skirt 17.

[0120] Figures 27A-27B A fully formed and complete pocket 20 is shown after the inner skirt 17 and the outer skirt 18 have been sewn together. Figure 27A The outflow side of the valve 10 is shown, and Figure 27B The inflow side of the valve 10 is shown. As Figures 27A-27B shown, the skirt assembly 16 extends below the apexes 62 at the inflow end 22 of the frame 12 to form the pocket 20. In Figures 27A-27B the particular example shown, the inner skirt 17 forms the pocket 20. The inner skirt 17 wraps around the outer skirt 18 around the apexes 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 below the apexes 62 at the inflow end 22 of the frame 12, folds over on itself at the inflow end 154 of the pocket 20, extends upward and over the outer skirt 18 on the outflow side 140 of the frame 12, and is sewn to the outer skirt 18 with the stitches 150 to create the pocket 20. The pocket 20 can 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.

[0121] The pocket 20 provides additional space / play between the apexes 62 and the skirt assembly 16 such that the apexes 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 axially lengthen when radially compressed and ensures that the apexes 62 are still completely covered by the skirt assembly 16 when the frame 12 is in the radially compressed (i.e., crimped) state. Preventing the apexes 62 from protruding through the skirt assembly during crimping and keeping them covered by the skirt assembly 16 even in the crimped state provides several advantages. First, it helps prevent the apexes 62 from contacting an introducer sheath, thereby reducing the push force needed to push the prosthetic valve 10 through the introducer sheath and preventing damage to the apexes. Second, it can prevent the apexes from contacting and causing trauma to surrounding tissue when the prosthetic valve (when crimped on a delivery device) is advanced through a patient’s vasculature.

[0122] In another example, Figure 24In this configuration, the outer skirt 18 can form a pouch-like portion 20. In such an example, the inner skirt 17 may not extend beyond the inflow end 22 of the frame 12 (i.e., the inner skirt 17 may extend to or not extend to the inflow end 22 of the frame 12), but the outer skirt 18 may extend beyond the inflow end 22 of the frame 12, wrapping around the vertex 62 at the inflow end 22 of the frame 12 and forming the pouch-like portion 20. Specifically, the outer skirt 18 may extend beyond the inflow end 22 of the frame 12, folding back on itself at the inflow end 154 of the pouch-like portion 20, such that the crease and / or fold line (i.e., vertex) (the point where the outer skirt 18 folds back on itself) of the outer skirt 18 forms and / or defines the inflow end 154 of the pouch-like portion 20, and may terminate at the inflow edge portion 66 of the inner skirt 17. In some examples, such as Figure 24 As shown, the inflow edge portion 128 of the outer skirt 18 can overlap with 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 examples, the inner skirt 17 and the outer skirt 18 may not overlap each other, but rather the inflow ends 84, 144 of the inner skirt 17 and the outer skirt 18 may be directly adjacent to each other and / or positioned adjacent to each other, respectively. Additionally, in other examples, the inner skirt 17 may extend beyond the apex 62 at the inflow end of the frame, but is shorter than the majority of the outer skirt 18 forming the pouch 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 pouch 20.

[0123] In some examples, 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 over the inner side 63 of the frame 12 such that the outer side 65 of the inner skirt 17 directly contacts 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 inner 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 examples, the inflow edge portion 128 of the outer skirt 18 may extend from the inflow end 154 of the pouch 20 toward the apex 62 and / or extend to the apex 62, but may not extend beyond the apex 62, and therefore may not cover the inner side 63 of the frame 12. In such an example, the outer skirt 18 can still fully form the bag-shaped portion 20, but the inner skirt 17 and the outer skirt 18 can be adjacent to each other at the inflow end 22 of the frame 12, so that the outer skirt 18 does not extend on the inner side 63 of the frame 12.

[0124] In yet another example, both the inner skirt 17 and the outer skirt 18 can form the pocket 20. In such examples, the inner skirt 17 and the outer skirt 18 can extend beyond the inflow end 22 of the frame 12 and can 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 examples Figure 23 ), the inner skirt 17 and the outer skirt 18 can 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 examples, the inner skirt 17 and the outer skirt 18 can extend approximately the same amount (e.g., distance Y) below the inflow end 22 of the frame 12. In some examples Figure 23 ), the inflow end 84 of the inner skirt 17 and the inflow end 144 of the outer skirt 18 can directly abut each other and can not overlap each other, respectively. However, in other examples, the skirts 17, 18 can overlap each other at the pocket 20.

[0125] In further examples, such as shown in Figure 28 and Figures 30-31 , the skirt assembly 16 can include a third skirt 302 (which can also be referred to herein as a “pocket skirt 302”) that can 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 the radially expanded state. For example, in the example shown in Figure 28 , a first end portion 304 of the third skirt 302 can overlap and be coupled (e.g., sewn) to the inflow end portion 66 of the inner skirt 17, such as via a stitch line 306, and an opposite second end portion 308 of the third skirt 302 can overlap and be coupled (e.g., sewn) to the inflow edge portion 128 of the outer skirt 18, such as via a stitch line 310. Because the third skirt 302 can be significantly longer than the width of the frame 12 and the skirts 17, 18, the third skirt 302 can extend 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 the radially expanded state, thereby forming the pocket 20.

[0126] As another example, as shown in Figure 30As shown, instead of overlapping and being joined (e.g., sewn) to the inner skirt 17 and the outer skirt 18, the third skirt 302 can instead be sewn to itself and / or the frame 12, and can abut the inner skirt 17 and the outer skirt 18 at or near the inflow end 22 of the frame 12. In particular, the first end portion 304 of the third skirt 302 can abut the inflow end 84 of the inner skirt 17, and / or the second end portion 308 of the third skirt 302 can 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 can be coupled (e.g., sewn) together, such as via a stitch line 322 that can extend circumferentially around the frame 12. In some such examples, the stitch line 322 can extend through an opening in the frame 12, such as through the first row of open cells 54 Figure 5 ). In other examples, the first end portion 302 and the second end portion 308 of the third skirt 302 can be sewn directly to the frame 12, such as directly to the first row of angled struts 36 Figure 5 ). In either of the above examples, the third skirt 302 can effectively hang 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 can extend beyond the inflow end 22 of the frame 12 to form the pocket 20.

[0127] In either of the above examples in which the third skirt 302 is coupled (e.g., sewn) 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 beyond the inflow end 22 of the frame 12, as Figure 28 and Figure 30 shown, but 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. In other examples, however, both of the skirts 17, 18 can stop at or beyond 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 the third skirt 302 can form the entire pocket 20 alone.

[0128] As yet another example, one or both of the skirts 17, 18 can wrap around an outer side of the third skirt 302. For example, as Figure 31As shown, the inner skirt 17 can wrap around the third skirt 302 on the outer side 138 of the outer skirt 18 (such that it abuts and / or otherwise contacts the outer side of the third skirt 302) and can be coupled (e.g., sewn) to the outer skirt 18, such as via the stitching line 150. In another example, the outer skirt 18 can instead wrap around the third skirt 302 on the inner side 64 of the inner skirt 17 (such that it abuts and / or otherwise contacts the outer side of the third skirt 302) and can be coupled (e.g., sewn) to the inner skirt 17, such as via the stitching line 150. In further examples, both skirts 17, 18 can extend around the third skirt 302 and can be coupled (e.g., sewn) together at a location where the skirts 17, 18 overlap the third skirt 302, such as a location below the inflow end 22 of the frame 12.

[0129] Although the inner skirt 17 and the outer skirt 18 are shown and described as being secured to one another at the inflow edge portions 66, 128 via the stitching 150, it should be appreciated that the inflow edge portions 66, 128 can be attached to one another using additional and / or alternative coupling means, such as ultrasonic welding, adhesive, mechanical fasteners, etc.

[0130] Furthermore, although the pocket 20 is shown and described as being formed / included at the inflow end 22 of the frame 12, it should be appreciated that the pocket 20 can additionally or alternatively be included / forming at the outflow end 24 of the frame 12. In particular, the inner skirt 17 and the outer skirt 18 can extend to and / or beyond the outflow end 24 of the frame 12 and can be sewn together at or near the outflow end 24 of the frame 12 in a similar manner as described above for the inflow end 22 of the frame 12 to form the pocket 20 at the outflow end 24 of the frame 12 (e.g., as shown in FIG. 1). In some such examples, the pocket 20 can 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 examples, the pocket 20 can be formed only at the outflow end 24 of the frame 12, and not the inflow end 22 of the frame 12. Figures 22-24

[0131] Further examples of the disclosed technology

[0132] In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional examples. It should be noted that one feature of an example, alone or in combination with one or more other features of an example, and optionally in combination with one or more features of one or more other examples, is also an example of more than one feature of an example falling within the disclosure of the present application.

[0133] Example 1. A prosthetic heart valve, comprising: ​

[0134] an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of cusps at the inflow end;

[0135] a leaflet assembly positioned within and coupled to the frame, wherein the leaflet assembly comprises a plurality of leaflets positioned entirely within the frame;

[0136] a skirt assembly comprising:

[0137] an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and

[0138] an outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the outer skirt is sewn to the inflow edge portion of the inner skirt;

[0139] wherein the inflow edge portion of the inner skirt and / or the inflow edge portion of the outer skirt forms a pocket, wherein the cusps are disposed in the pocket, and wherein the pocket has an inflow end; and

[0140] wherein the cusps are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and the cusps move closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.

[0141] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the pocket.

[0142] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the inflow end of the pocket.

[0143] Example 4. The prosthetic heart valve of any example herein, particularly any of examples 1-3, 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.

[0144] Example 5. The prosthetic heart valve of any example herein, particularly example 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.

[0145] Example 6. The prosthetic heart valve of any example herein, particularly any of examples 1-5, wherein the apex is spaced at least 0.5 mm from the inflow end of the pocket when the frame is in the radially expanded state.

[0146] Example 7. The prosthetic heart valve of any example herein, particularly any of examples 1-6, wherein the pocket extends circumferentially around the inflow end of the frame.

[0147] Example 8. The prosthetic heart valve of any example herein, particularly any of examples 1-7, wherein the outflow edge portion of the inner skirt is sewn to the frame between the inflow end and the outflow end of the frame, and wherein 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.

[0148] Example 9. The prosthetic heart valve of any example herein, particularly any of examples 1-8, wherein the outflow edge portion of the inner skirt includes a plurality of slits, and wherein the plurality of slits are axially spaced at most 0.5 mm from the junctions of two struts of the frame.

[0149] Example 10. The prosthetic heart valve of any example herein, particularly any of examples 1-9, wherein the inner skirt contacts the inner side of the frame, and wherein the outer skirt contacts the outer side of the frame.

[0150] Example 11. The prosthetic heart valve of any example herein, particularly any of examples 1-10, wherein the plurality of 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.

[0151] Example 12. The prosthetic heart valve of any example herein, particularly any of examples 1-11, wherein the pocket is hollow.

[0152] Example 13. The prosthetic heart valve of any example herein, particularly any of examples 1 and 6-12, wherein the inner skirt wraps around the apex at the inflow end of the frame, extends over the outer skirt on the outer side of the frame, and forms the pocket.

[0153] Example 14. The prosthetic heart valve of any example herein, particularly any of examples 1 and 6-12, wherein the outer skirt wraps around the apex at the inflow end of the frame, extends over the inner skirt on the inner side of the frame, and forms the pocket.

[0154] Example 15. A prosthetic heart valve, comprising:

[0155] an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of apexes at the inflow end;

[0156] a leaflet assembly comprising a plurality of leaflets, the leaflet assembly positioned within and coupled to the frame;

[0157] an outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion; and

[0158] an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion, wherein the inner skirt is folded over on itself and forms a pocket at the inflow end of the frame, wherein the apexes at the inflow end of the frame are disposed within the pocket, wherein the pocket has an inflow end, and wherein the apexes are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and the apexes move closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.

[0159] Example 16. The prosthetic heart valve of any example herein, particularly example 15, wherein the inflow edge portion of the inner skirt is sewn to the inflow edge portion of the outer skirt.

[0160] Example 17. The prosthetic heart valve of any example herein, particularly any of examples 15 or 16, wherein the inner skirt wraps around the plurality of apexes at the inflow end of the frame and covers the outer side of the frame.

[0161] Example 18. The prosthetic heart valve of any example herein, particularly example 17, wherein an inflow edge portion of the inner skirt extends circumferentially around the outer side of the frame.

[0162] Example 19. The prosthetic heart valve of any example herein, particularly any of examples 15-18, wherein the outer skirt has an inner side opposite an outer side, wherein the inner side of the outer skirt contacts the outer side of the frame, and wherein the inflow edge portion of the inner skirt extends over the outflow side of the frame and contacts the outer side of the outer skirt.

[0163] Example 20. The prosthetic heart valve of any example herein, particularly any of examples 15-19, wherein the outer skirt does not extend beyond the inflow end of the frame.

[0164] Example 21. The prosthetic heart valve of any example herein, particularly any of examples 15-20, wherein the apex is spaced at least 0.5 mm from the inflow end of the pocket when the frame is in the radially expanded state.

[0165] Example 22. The prosthetic heart valve of any example herein, particularly any of examples 15-21, wherein the pocket is hollow.

[0166] Example 23. The prosthetic heart valve of any example herein, particularly any of examples 15-22, wherein the outflow edge portion of the inner skirt includes a plurality of slits, and wherein the plurality of slits are axially spaced at most 0.5 mm from the junctions of two struts of the frame.

[0167] Example 24. The prosthetic heart valve of any example herein, particularly any of examples 15-23, wherein the plurality of 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.

[0168] Example 25. The prosthetic heart valve of any example herein, particularly any of examples 15-24, further comprising a stitch coupling the inflow edge portion of the inner skirt to the inflow edge portion of the outer skirt, wherein the stitch is spaced about 0.5 mm from an inflow end of the inner skirt.

[0169] Example 26. A prosthetic heart valve, comprising:

[0170] an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of apexes at the inflow end;

[0171] a leaflet assembly comprising a plurality of leaflets, the leaflet assembly positioned within and coupled to the frame;

[0172] an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and

[0173] an outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion, wherein the outer skirt is folded over on itself and forms a pocket at the inflow end of the frame, wherein the apex at the inflow end of the frame is disposed within the pocket, wherein the pocket has an inflow end, and wherein the apex is spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and 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.

[0174] Example 27. The prosthetic heart valve of any example herein, particularly example 26, wherein the inflow edge portion of the outer skirt is sewn to the inflow edge portion of the inner skirt.

[0175] Example 28. The prosthetic heart valve of any example herein, particularly any one of examples 26 or 27, wherein the outer skirt wraps around the plurality of apexes at the inflow end of the frame and covers the inner side of the frame.

[0176] Example 29. The prosthetic heart valve of any example herein, particularly example 28, wherein an inflow edge portion of the outer skirt extends circumferentially around an inner side of the frame.

[0177] Example 30. The prosthetic heart valve of any example herein, particularly any one of examples 26-29, wherein the inner skirt has an inner side opposite an outer side, wherein the outer side of the inner skirt contacts the inner side of the frame, and wherein the 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.

[0178] Example 31. The prosthetic heart valve of any example herein, particularly any one of examples 26-30, wherein the inner skirt does not extend beyond the inflow end of the frame.

[0179] Example 32. The prosthetic heart valve of any example herein, in particular any of examples 26-31, wherein the apexes are spaced at least 0.5 mm from the inflow end of the pocket when the frame is in the radially expanded state.

[0180] Example 33. The prosthetic heart valve of any example herein, in particular any of examples 26-32, wherein the pocket is hollow.

[0181] Example 34. The prosthetic heart valve of any example herein, in particular any of examples 26-33, wherein the plurality of 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.

[0182] Example 35. The prosthetic heart valve of any example herein, in particular any of examples 26-34, further comprising a stitch coupling an inflow edge portion of the outer skirt to the inflow edge portion of the inner skirt, wherein the stitch is spaced about 0.5 mm from an inflow end of the outer skirt.

[0183] Example 36. A method for assembling a prosthetic heart valve, comprising:

[0184] mounting an inner skirt on an inner side of a radially compressible and expandable frame, wherein the frame has an inflow end and an outflow end and a plurality of apexes at the inflow end;

[0185] mounting an outer skirt on an outer side of the frame;

[0186] mounting a leaflet assembly comprising a plurality of leaflets to the frame such that the leaflet assembly is positioned entirely within the frame between the inflow end and the outflow end of the frame;

[0187] stitching the inner skirt and the outer skirt together such that the inner skirt and / or the outer skirt forms a pocket at the inflow end of the frame, or stitching 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 the pocket, wherein the plurality of apexes are disposed in the pocket, and wherein the pocket has an inflow end that is spaced apart from the plurality of apexes of the frame when the frame is in a radially expanded state.

[0188] Example 37. The method of any example herein, in particular example 36, wherein stitching the inner skirt and the outer skirt together comprises stitching the inner skirt and the outer skirt together at the pocket such that both the inner skirt and the outer skirt form the pocket.

[0189] Example 38. The method of any example herein, in particular any one of examples 36 or 37, wherein sewing the inner skirt and the outer skirt together comprises sewing the inner skirt and the outer skirt together at the inflow end of the pocket.

[0190] Example 39. The method of any example herein, in particular example 36, further comprising wrapping the inner skirt around the inflow end of the frame on the outer side of the frame such that the inner skirt forms the pocket, and wherein sewing the inner skirt and the outer skirt together comprises sewing the inner skirt to the outer skirt on the outer side of the frame.

[0191] Example 40. The method of any example herein, in particular example 39, wherein mounting the inner skirt on the frame comprises 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 before wrapping the inner skirt around the inflow end of the frame.

[0192] Example 41. The method of any example herein, in particular any one of examples 39 or 40, wherein sewing the inner skirt and the outer skirt together comprises maintaining a distance of approximately 0.5 mm between the inflow end of the inner skirt and the stitch.

[0193] Example 42. The method of any example herein, in particular example 36, further comprising wrapping the outer skirt around the inflow end of the frame on the inner side of the frame such that the outer skirt forms the pocket, and wherein sewing the inner skirt and the outer skirt together comprises sewing the outer skirt to the inner skirt on the inner side of the frame.

[0194] Example 43. The method of any example herein, in particular example 42, wherein mounting the outer skirt on the frame comprises 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 before wrapping the outer skirt around the inflow end of the frame.

[0195] Example 44. The method of any example herein, in particular any one of examples 42 or 43, wherein sewing the inner skirt and the outer skirt together comprises maintaining a distance of approximately 0.5 mm between the inflow end of the outer skirt and the stitch.

[0196] Example 45. The method of any example herein, in particular any one of examples 36-44, wherein mounting the inner skirt on the inner side of the frame comprises sewing the inner skirt to a first row of struts on the frame, wherein mounting the outer skirt on the outer side of the frame comprises sewing the outer skirt to a second row of struts on the frame, the second row of struts positioned closer to the inflow end of the frame than the first row of struts.

[0197] Example 46. The method of any example herein, in particular example 45, wherein mounting the inner skirt on the inner side of the frame further comprises aligning an 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 included on the outflow edge portion of the inner skirt are positioned at most 0.5 mm from a joint between adjacent struts in the first row of struts.

[0198] Example 47. The method of any example herein, in particular example 36, wherein sewing the third skirt to the inner skirt and the outer skirt comprises sewing a first end portion of the third skirt to an inflow edge portion of the inner skirt and sewing a second end portion of the third skirt to an inflow edge portion of the outer skirt.

[0199] Example 48. The method of any example herein, in particular any one of examples 36-47, wherein the inflow end of the pocket is spaced apart from the plurality of apices of the frame by at least 0.5 mm when the frame is in the radially expanded state.

[0200] Example 49. The method of any example herein, in particular any one of examples 36-48, wherein the pocket is hollow.

[0201] Example 50. The method of any example herein, in particular any one of examples 36-49, wherein the pocket extends circumferentially around the inflow end of the frame.

[0202] Example 51. A prosthetic heart valve, comprising:

[0203] an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of apices at the inflow end;

[0204] a leaflet assembly positioned within and coupled to the frame, wherein the leaflet assembly comprises a plurality of leaflets positioned entirely within the frame;

[0205] a skirt assembly comprising:

[0206] an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and

[0207] an outer skirt separate from the inner skirt, the outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion;

[0208] wherein the inflow edge portions of the inner skirt and the outer skirt are coupled to each other so as to form a pocket adjacent the inflow end of the frame, wherein the apex is disposed in the pocket, and wherein the pocket has an inflow end; and

[0209] wherein the apex is spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and 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.

[0210] Example 52. The prosthetic heart valve of any example herein, particularly example 51, wherein the inflow edge portions of the inner skirt and the 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 the pocket.

[0211] Example 53. The prosthetic heart valve of any example herein, particularly example 51, wherein the inflow edge portion of the inner skirt extends axially beyond the inflow end of the frame, wraps around the apex, and is sewn to the outer skirt on the outer side of the frame to form the pocket.

[0212] Example 54. The prosthetic heart valve of any example herein, particularly example 51, wherein the inflow edge portion of the outer skirt extends axially beyond the inflow end of the frame, wraps around the apex, and is sewn to the inner skirt on the inner side of the frame to form the pocket.

[0213] Example 55. The prosthetic heart valve of any example herein, particularly example 51, wherein the skirt assembly includes a third skirt separate from the inner skirt and the outer skirt, the third skirt extending beyond the inflow end of the frame and forming at least a portion of the pocket.

[0214] Example 56. The prosthetic heart valve of any example herein, particularly example 55, wherein the third skirt is sewn to the inner skirt and the outer skirt at the inflow edge portion.

[0215] Example 57. The prosthetic heart valve of any example herein, particularly example 55 or 56, wherein the inner skirt and / or the outer skirt extends beyond the inflow end of the frame and also forms at least a portion of the pocket, such that the third skirt and the inner skirt and / or the outer skirt form the pocket.

[0216] Example 58. The prosthetic heart valve of any example herein, particularly example 55, wherein the third skirt is sewn to itself at the first row of open cells of the frame.

[0217] Example 59. The prosthetic heart valve of any example herein, particularly example 55 or 58, wherein the third skirt alone forms the pocket.

[0218] Example 60. The prosthetic heart valve of any example herein, particularly any of examples 51-59, wherein the inner skirt and / or the outer skirt extends around the third skirt.

[0219] Example 61. The prosthetic valve of any example herein, particularly any of examples 51-60, according to any of claims 51-55, wherein the inner skirt is sewn to the frame at or near the inflow edge portion and at or near the outflow edge portion.

[0220] Example 62. The prosthetic valve of any example herein, particularly any of examples 51-61, wherein the outer skirt is sewn to the frame at or near the inflow edge portion and at or near the outflow edge portion.

[0221] Example 63. The prosthetic valve of any example herein, particularly any of examples 51-62, wherein the inner skirt and the outer skirt are both sewn to a first row of struts of the frame via a first set of sutures and both sewn to a second row of struts of the frame via a second set of sutures, wherein the first row of struts is positioned closer to the inflow end of the frame than the second row of struts.

[0222] Example 64. The prosthetic valve of any example herein, particularly any of examples 62 or 63, wherein the outer skirt includes a bunching portion between the inflow edge portion and the outflow edge portion.

[0223] Example 65. The prosthetic valve of any example herein, particularly example 64, wherein the outer skirt is folded in the bunching portion in a zig-zag pattern.

[0224] Example 66. The prosthetic valve of any example herein, particularly either of examples 59 or 60, wherein the bunching portion of the outer skirt unfolds and axially elongates when the frame is radially compressed.

[0225] Example 67. The prosthetic valve of any example herein, particularly any of examples 51-66, further comprising the subject matter of any of examples 1-35.

[0226] In view of the many possible embodiments to which the principles of the disclosed application can be applied, it should be recognized that the illustrated embodiments are only preferred examples of the application and should not be considered to be limiting of the scope of the application. Rather, the scope of the application is defined by the following claims. We therefore claim all embodiments falling within the range and spirit of these claims.

Claims

1. A prosthetic heart valve, comprising: an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of cusps at the inflow end; a leaflet assembly positioned within and coupled to the frame, wherein the leaflet assembly comprises a plurality of leaflets positioned entirely within the frame; a skirt assembly comprising: an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and an outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and a straight outflow edge portion, wherein the inflow edge portion of the outer skirt is sewn to the inflow edge portion of the inner skirt; wherein the inflow edge portion of the inner skirt and / or the inflow edge portion of the outer skirt forms a pocket, wherein the cusps are disposed in the pocket, and wherein the pocket has an inflow end; and wherein the cusps are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state, and the cusps move closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.

2. The prosthetic heart valve of claim 1, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the pocket.

3. The prosthetic heart valve of claim 2, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the inflow end of the pocket.

4. The prosthetic heart valve of any one of claims 1-3, wherein the inflow edge portions of the inner skirt and the outer skirt extend axially beyond the inflow end of the frame.

5. The prosthetic heart valve of claim 4, wherein the inflow edge portions of the inner skirt and the outer skirt extend axially beyond the inflow end of the frame by the same amount.

6. The prosthetic heart valve of any one of claims 1-3, wherein the cusps are spaced apart from the inflow end of the pocket by at least 0.5 mm when the frame is in the radially expanded state.

7. The prosthetic heart valve of any one of claims 1-3, wherein the pocket extends circumferentially around the inflow end of the frame.

8. The prosthetic heart valve of any one of claims 1-3, wherein the outflow edge portion of the inner skirt is sewn to the frame between the inflow end and the outflow end of the frame, and wherein 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.

9. The prosthetic heart valve of any one of claims 1-3, wherein the outflow edge portion of the inner skirt comprises a plurality of slits, and wherein the plurality of slits are axially spaced apart from the junctions of two struts of the frame by at most 0.5 mm. ​ 10. The prosthetic heart valve of any of claims 1-3, wherein the inner skirt contacts an inner side of the frame, and wherein the outer skirt contacts an outer side of the frame.

11. The prosthetic heart valve of any of claims 1-3, wherein the plurality of leaflets does not extend beyond an inflow end of the frame and is positioned entirely between the inflow end and an outflow end of the frame.

12. The prosthetic heart valve of any of claims 1-3, wherein the pocket is hollow.

13. The prosthetic heart valve of claim 1, wherein the inner skirt wraps around the apex at the inflow end of the frame, extends over the outer skirt on an outer side of the frame, and forms the pocket.

14. The prosthetic heart valve of claim 1, wherein the outer skirt wraps around the apex at the inflow end of the frame, extends over the inner skirt on an inner side of the frame, and forms the pocket.

15. A prosthetic heart valve, comprising: a ring-shaped frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of apexes at the inflow end; a leaflet assembly comprising a plurality of leaflets, the leaflet assembly positioned within and coupled to the frame; an outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and a straight outflow edge portion; and an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion, wherein the inner skirt is folded over on itself and forms a pocket at the inflow end of the frame, wherein the apexes at the inflow end of the frame are disposed within the pocket, wherein the pocket has an inflow end, and wherein the apexes are spaced apart from the inflow end of the pocket when the frame is in the radially expanded state and the apexes move closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.

16. The prosthetic heart valve of claim 15, wherein the inflow edge portion of the inner skirt is sewn to the inflow edge portion of the outer skirt.

17. The prosthetic heart valve of claim 15 or 16, wherein the inner skirt wraps around the plurality of apexes at the inflow end of the frame and covers an outer side of the frame.

18. The prosthetic heart valve of claim 15 or 16, wherein the outer skirt has an inner side opposite the outer side, wherein the inner side of the outer skirt contacts an outer side of the frame, and wherein the inflow edge portion of the inner skirt extends around the inflow end of the frame on the outer side of the frame and contacts the outer side of the outer skirt.

19. The prosthetic heart valve of claim 15 or 16, wherein the outer skirt does not extend beyond the inflow end of the frame. ​ 20. The prosthetic heart valve of claim 15 or 16, wherein the apex is spaced at least 0.5 mm from an inflow end of the pocket when the frame is in the radially expanded state.

21. The prosthetic heart valve of claim 15 or 16, wherein the plurality of leaflets does not extend beyond an inflow end of the frame and is positioned entirely between the inflow end and an outflow end of the frame.

22. The prosthetic heart valve of claim 15 or 16, further comprising a stitch coupling an inflow edge portion of the inner skirt to an inflow edge portion of the outer skirt, wherein the stitch is spaced 0.5 mm from an inflow end of the inner skirt.

23. A method for assembling a prosthetic heart valve, comprising: mounting an inner skirt on an inner side of a radially compressible and expandable frame, wherein the frame has an inflow end and an outflow end and a plurality of apexes at the inflow end; mounting an outer skirt on an outer side of the frame; mounting a leaflet assembly comprising a plurality of leaflets to the frame such that the leaflet assembly is positioned entirely within the frame between the inflow end and the outflow end of the frame; stitching the inner skirt and the outer skirt together such that the inner skirt and / or the outer skirt forms a pocket at the inflow end of the frame, or stitching 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 the pocket, wherein the plurality of apexes are disposed in the pocket, and wherein the pocket has an inflow end that is separated from the plurality of apexes of the frame when the frame is in a radially expanded state.

24. The method of claim 23, wherein stitching the inner skirt and the outer skirt together comprises stitching the inner skirt and the outer skirt together at the pocket such that both the inner skirt and the outer skirt form the pocket.

25. The method of claim 23 or 24, wherein stitching the inner skirt and the outer skirt together comprises stitching the inner skirt and the outer skirt together at an inflow end of the pocket.

26. The method of claim 23, further comprising wrapping the inner skirt around the inflow end of the frame on an outer side of the frame such that the inner skirt forms the pocket, and wherein stitching the inner skirt and the outer skirt together comprises stitching the inner skirt to the outer skirt on the outer side of the frame.

27. The method of claim 26, wherein mounting the inner skirt on the frame comprises coupling the inner skirt to the frame such that the inner skirt extends axially at least 1.5 mm beyond the inflow end of the frame before wrapping the inner skirt around the inflow end of the frame.

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