Prosthetic heart valve with elongate sealing member

Abstract

The present disclosure relates to a prosthetic heart valve with an elongate sealing member. 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 vertices at an inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates an additional space between the inflow end of the frame and the skirt assembly when the frame is in a radially expanded state. The pocket allows the apex 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] This application is a divisional application of Chinese patent application 202210282138X entitled "Prosthetic Heart Valve with Elongated Sealing Member", filed on March 22, 2022.

[0002] Cross-references to related applications 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 rolled onto the balloon of the delivery device), some of the frames of a transcatheter prosthetic heart valve can elongate or stretch in the axial direction. In some cases, elongation of the frame during rollover can cause the apex of the frame to protrude through or extend beyond one end of the skirt of the prosthetic valve. The exposed apex can contact the inner surface of the introducer sheath used to introduce the prosthetic valve and delivery device into the patient's vascular system. This can increase the thrust required to push the prosthetic valve through the introducer sheath and can deform the exposed apex, potentially damaging the valve.

[0007] Therefore, there is a need for components, devices, and / or methods for sealing members (e.g., fabric skirts) that can protect the apex of the frame of the prosthetic heart valve during the implantation procedure. Summary of the Invention

[0008] This disclosure relates to examples of sealing members (e.g., fabric skirts) for prosthetic heart valves, the sealing members being configured to protect the apex of the frame from damage due to contact with components of the delivery system. Specifically, this disclosure relates to an elongated sealing member for a prosthetic heart valve that extends beyond one end of the frame of the prosthetic heart valve when the valve is not rolled up (i.e., when the valve is radially expanded) to accommodate axial elongation of the frame during roll-up. The elongated sealing member may form a pouch at one end of the frame, the pouch preventing the frame from protruding through the sealing member when the valve is rolled up. Keeping the frame completely contained within the sealing member even in its rolled-up state prevents damage to the frame and / or the remainder of the valve, and / or reduces the force required to push the valve through the introducer sheath of the delivery assembly.

[0009] In a representative example, a prosthetic heart valve includes an annular frame, a leaflet assembly, and a skirt assembly. The annular frame includes an inlet end and an outlet end, and is radially compressible and expandable between a radially compressed state and a radially expanded state. Furthermore, the frame includes multiple vertices at the inlet end. The leaflet assembly is positioned within and coupled to the frame, and includes multiple leaflets fully positioned within the frame. The skirt assembly includes an inner skirt and an outer skirt. The inner skirt extends circumferentially around the inner side of the frame, and the outer skirt extends circumferentially around the outer side of the frame. Both the inner and outer skirts have corresponding inlet edge portions and outlet edge portions, wherein the inlet edge portions of the inner and outer skirts are sewn together such that the inlet edge portions of the inner skirt and / or the inlet edge portions of the outer skirt form a pouch at the inlet end of the frame. The vertices at the inlet end of the frame are disposed within the pouch and are spaced apart from the inlet end of the pouch when the frame is in a radially expanded state. When the frame moves from a radially extended state to a radially compressed state, the apex moves closer to the inflow end of the bag-like portion; however, when the frame is in a radially compressed state, the apex does not extend through and / or protrude through the skirt assembly.

[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. Furthermore, the frame includes multiple vertices at the inflow end. The leaflet assembly includes multiple leaflets positioned within and coupled to the frame. The outer skirt extends circumferentially around the outer side of the frame and has an inflow edge portion and an outflow edge portion. The inner skirt extends circumferentially around the inner side of the frame and also has an inflow edge portion and an outflow edge portion. The inner skirt folds over itself and forms a pouch at the inflow end of the frame. The vertices at the inflow end of the frame are disposed within the pouch. The pouch has an inflow end, and when the frame is in a radially expanded state, the vertices are spaced apart from the inflow end of the pouch. When the frame is radially compressed from a radially expanded state to a radially compressed state, the vertices move closer to the inflow end of the pouch, but do not extend through and / or protrude through the inflow end of the pouch.

[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. Furthermore, the frame includes multiple vertices at the inflow end. The leaflet assembly includes multiple leaflets positioned within and coupled to the frame. The inner skirt extends circumferentially around the inner side of the frame and has an inflow edge portion and an outflow edge portion. The outer skirt extends circumferentially around the outer side of the frame and also has an inflow edge portion and an outflow edge portion. The outer skirt folds over itself and forms a pouch at the inflow end of the frame. The vertices at the inflow end of the frame are positioned within the pouch. The pouch has an inflow end, and when the frame is in a radially expanded state, the vertices are spaced apart from the inflow end of the pouch. When the frame is radially compressed from a radially expanded state to a radially compressed state, the vertices move closer to the inflow end of the pouch, but do not extend through and / or protrude through the inflow end of the pouch.

[0012] In another representative example, a method for assembling a prosthetic heart valve includes: mounting an inner skirt on the inside of a radially compressible and expandable frame having an inlet end and an outlet end and a plurality of vertices at the inlet end; mounting an outer skirt on the outside of the frame; mounting a leaflet assembly comprising a plurality of leaflets to the frame such that the leaflet assembly is fully positioned within the frame between the inlet and outlet ends; sewing the inner and outer skirts together such that the inner and / or outer skirts form a pouch at the inlet end of the frame, or sewing a third skirt to the inner and outer skirts such that the third skirt extends beyond the inlet end of the frame and forms a pouch, wherein the plurality of vertices are disposed in the pouch, and wherein the pouch has an inlet end that separates from the plurality of vertices of the frame when the frame is in a radially expanded state.

[0013] In 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 vertices at the inflow end. The leaflet assembly is positioned within and coupled to the frame, and includes a plurality of leaflets fully positioned within the frame. The skirt assembly includes an inner skirt and an outer skirt. The inner skirt extends circumferentially around the 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 the outer side of the frame and has an inflow edge portion and an outflow edge portion. The inflow edge portions of the inner and outer skirts are coupled to each other such that a pocket is formed adjacent to the inflow end of the frame, wherein vertices are disposed in the pocket, and wherein the pocket has an inflow end. When the frame is in a radially expanded state, the vertices are spaced apart from the inflow end of the pocket, and when the frame is radially compressed from a radially expanded state to a radially compressed state, the vertices move closer to the inflow end of the pocket.

[0014] The above and other objects, features and advantages of the disclosed technology will become clearer from the following detailed description, with reference to the accompanying drawings. Attached Figure Description

[0015] Figure 1 The illustration shows a side view of a prosthetic heart valve based on an example.

[0016] Figure 2 The illustration shows a coiled object in a radially compressed state on a delivery device. Figure 1 A three-dimensional view of the prosthetic heart valve shown.

[0017] Figure 3 The diagram illustrates a radially expanding state. Figure 1-2 A three-dimensional view of the prosthetic heart valve shown.

[0018] Figure 4The illustration shows an example. Figure 1-3 An upright perspective view of the frame of the prosthetic heart valve shown.

[0019] Figure 5 The illustration shows a structure that is unfolded and flattened. Figure 4 The side view of the frame shown.

[0020] Figure 6 The diagram shows... Figures 4-5 An enlarged view of the first part of the frame shown.

[0021] Figure 7 The diagram shows... Figures 4-6 An enlarged view of the second part of the frame shown.

[0022] Figure 8 The diagram shows... Figures 4-7 An enlarged view of the third part of the frame shown.

[0023] Figure 9 The diagram shows... Figures 4-8 An enlarged view of the fourth section of the frame shown.

[0024] Figure 10 The diagram shows... Figures 4-9 An enlarged view of the fifth section of the frame shown.

[0025] Figure 11 The illustration shows an example. Figures 1-3 A side view of the inner side of the inner skirt of the prosthetic heart valve.

[0026] Figure 12 The diagram shows... Figure 11 The side view of the outer side of the inner skirt shown.

[0027] Figure 13 The diagram shows... Figures 11-12 An enlarged view of a portion of the inner skirt shown.

[0028] Figure 14 The diagram shows... Figures 11-13 An enlarged view of a portion of the inner skirt shown.

[0029] Figure 15 The diagram illustrates the coupling to an example. Figures 4-10 The frame shown Figures 11-14 The side view of the inner skirt shown.

[0030] Figure 16 The illustration shows, according to an example, components coupled to each other via connectors. Figures 1-3 A top view of adjacent leaflets of the leaflet assembly of the prosthetic heart valve.

[0031] Figure 17 The diagram shows... Figure 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 A 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 The diagram shows... Figure 26A An enlarged view of the exposed edge of the inner skirt shown.

[0042] Figure 27A The diagram shows... Figures 11-15 and Figures 20-21 An external perspective view of the inflow edge portion of the inner skirt and outer skirt shown.

[0043] Figure 27B The diagram shows... Figure 27A An internal perspective view of the inflow edge portion of the skirt shown.

[0044] Figure 28 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.

[0045] Figure 29 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.

[0046] Figure 30 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.

[0047] Figure 31 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. Detailed Implementation

[0048] General considerations For the purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The methods, systems, and apparatuses described should not be construed as limiting in any way. Rather, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations. The methods, systems, and apparatuses of this disclosure are not limited to any particular aspect, feature, or combination thereof, nor do they require the existence of any one or more specific advantages or the solving of any one or more specific problems.

[0049] Features, integers, properties, compounds, chemical parts, or groups described in connection with specific aspects or examples of this disclosure shall be understood to be applicable to any other aspect or example described herein, unless incompatible with it. All features disclosed in this specification (including any appended claims, abstract, and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except for at least some mutually exclusive combinations of such features and / or steps. This disclosure is not limited to the details of any of the foregoing examples. This disclosure extends to any novel feature, or any novel combination of features, disclosed in this specification (including any appended claims, abstract, and drawings), or to any novel step, or any novel combination of steps, of any method or process so disclosed.

[0050] While some operations of the methods of this disclosure have been described in a specific sequential order for ease of illustration, it should be understood that this description includes rearrangement unless a specific order is specified by the following specific terms. For example, operations described sequentially may be rearranged or performed simultaneously in some cases. Furthermore, for the sake of brevity, the accompanying drawings may not show the various ways in which the methods, systems, and apparatus of this disclosure can be used in conjunction with other systems, methods, and apparatus.

[0051] As used herein, the terms “a,” “an,” and “at least one” include one or more specified elements. That is, if two specific elements exist, then one of those elements also exists, hence the term “a” element. The terms “multiple” and “plural” indicate two or more specified elements.

[0052] As used herein, the term “and / or” used between the last two elements in a list of elements refers to 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”.

[0053] As used in this article, the term “coupled” generally means physical coupling or linking, and does not preclude the existence of intermediate elements between coupled items in the absence of a specific opposite language.

[0054] Orientation and other relative references (e.g., inside, outside, up, down, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms such as “inside,” “outside,” “top,” “down,” “middle,” “exterior,” and the like may be used. Such terms are used, where applicable, to provide some clarity in the description when dealing with relative relationships, especially relative to the illustrated examples. However, such terms are not intended to imply absolute relationships, orientations, and / or directions. For example, with an object, simply flipping the object over can turn “up” into “down.” However, it remains the same part, and the object remains the same. As used herein, “and / or” means “and” or “or,” as well as “and” and “or.”

[0055] In the context of this application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow," respectively. Thus, for example, the lower end of the valve is its inflow end, and the upper end of the valve is its outflow end.

[0056] As used herein, with reference to prosthetic medical devices (e.g., prosthetic heart valves), capsules, and delivery devices, "proximal" refers to the location, orientation, or portion of a component closer to the user and / or the handle of the delivery device outside the patient, while "distal" refers to the location, orientation, or portion of a component further away from the user and / or the handle of the delivery device and closer to the implantation site. The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless otherwise explicitly defined. Additionally, the term "radial" refers to a direction arranged perpendicular to the axis and along a point radius from the center of the object (where the axis is positioned at the center, such as the longitudinal axis of a prosthetic valve).

[0057] The disclosed technologies and embodiments Collapsible transcatheter prosthetic heart valves can be rolled into an elongated profile (e.g., radially compressed state) on the delivery device, allowing them to be advanced through the patient's vascular system with minimal complications. However, because the frame elongates when rolled, the apex of the frame can protrude through the skirt assembly and contact the inner surface of the introducer sheath used to introduce the prosthetic valve and delivery device into the patient's vascular system. This can increase the thrust required to push the prosthetic valve through the introducer sheath and can deform the exposed apex, potentially damaging the valve.

[0058] This document discloses a collapsible prosthetic heart valve with a sealing assembly configured to completely cover the apex of at least one end of a frame when the prosthetic valve is in a radially compressed delivery configuration. Specifically, the disclosed prosthetic heart valve includes one or more elongated sealing members (also referred to herein as “skirts”) extending beyond one end of the frame and forming a gap or pouch (e.g., a hollow space) at that end of the frame between the sealing member and the apex of the frame. The additional space provided by this pouch allows the frame to elongate during rollover without puncturing the sealing member or allowing the apex to extend beyond the end of the skirt. Therefore, the disclosed collapsible prosthetic heart valve can protect the apex of the frame from contact with components of the delivery system, particularly the inner surface of the introducer sheath, during implantation procedures.

[0059] As discussed in more detail below, the pouch-like portion can be formed by an inner skirt and / or an outer skirt respectively mounted on the inner and outer sides of the frame. In some examples ( Figure 23 In this example, the two skirts can form a pocket-like portion. For instance, in some such examples, both the inner and outer skirts can extend beyond the inlet end of the frame and can be sewn together at the pocket-like portion (below the inlet end of the frame). In other examples ( Figure 22 In this example, the bag-like portion can be formed by an inner skirt. For instance, in some such examples, the inner skirt can wrap around the inlet end of the frame, extend onto the outer skirt on the outside of the frame, and be sewn to the outer skirt on the outside of the frame. In another example ( Figure 24 In this example, the bag-like portion can be formed by an outer skirt. For instance, in some such examples, the skirt on the outer side of the frame can wrap around the inlet end of the frame, can extend onto an 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 another example ( Figure 28 and Figures 30-31 In this structure, the bag-shaped portion may be formed at least partially by a separate third skirt attached to the inner skirt, outer skirt, and / or frame.

[0060] Further information and embodiments are provided below with reference to the accompanying drawings.

[0061] Figures 1-31 Various examples of prosthetic heart valves according to the present invention are depicted. Specifically, Figures 1-3 An exemplary prosthetic heart valve is shown. Figure 1 and Figure 3 The illustration shows a valve in a radially expanded state, while Figure 2 The illustration shows a valve in a radially compressed (i.e., curled) state. Figures 4-20 and Figure 29 Various components of an exemplary prosthetic heart valve are depicted. Specifically, Figure 29It depicts how the inner skirt and outer skirt can be attached to the frame at both their inflow and outflow edges. Figures 22-24 , Figure 28 and Figures 30-31 Four different examples of the pouch-like portion of an exemplary prosthetic heart valve are depicted. Specifically, Figure 22 An example is depicted where the inner skirt wraps around the inlet end of the frame to form a pouch-like portion. Figure 24 An example is depicted where the outer skirt wraps around the inflow end of the frame to form a pouch-like portion, and Figure 23 An example is depicted where the inner skirt and outer skirt extend beyond the inlet end of the frame and are sewn together below the inlet end of the frame to form a bag-like portion. Figure 28 and Figures 30-31 An example is depicted in which a separate third skirt is attached to the inflow edge portion of the inner skirt, the inflow edge portion of the outer skirt, and / or the inflow end of the frame to form at least a portion of the bag-shaped portion. Figure 25 An example depicting how the inner skirt can be aligned with the frame to ensure the appropriate length of the pouch-like portion is illustrated. Figures 26A-27B This illustrates how the inner and outer skirts can be sewn together, as in similar examples where a pouch-like section is formed in the inner skirt.

[0062] like Figures 1-3 As shown, the prosthetic heart valve 10 (also referred to herein as "transcatheter prosthetic heart valve 10", "prosthetic valve 10" and / or "radially compressible and expandable prosthetic heart valve 10") includes a configuration that can be radially expanded and axially shortened. Figure 1 and Figure 3 ) and radially compressed and axially elongated (i.e., curled) state ( Figure 2 The annular frame 12 that moves between the components, including a leaf assembly 14 comprising a plurality of leaflets 15 positioned within the frame 12, and a skirt assembly 16 (which may also be referred to herein as “sealing member assembly 16”).

[0063] The skirt assembly 16 includes an inner skirt 17 (which may also be referred to herein as "inner sealing member 17") and an outer skirt 18 (which may also be referred to herein as "outer sealing member 18") mounted on opposite sides of the frame 12. As described above, the inner skirt 17 and / or the outer skirt 18 may form a pouch-like portion 20 between the inlet end 22 of the frame 12 and the skirt assembly 16 at the inlet end 22 of the frame 12. Figure 3 The bag-shaped portion 20 is configured to be rolled up (i.e., radially compressed and axially elongated) into a shape such as Figure 2 The vertex of the receiving frame 12 is shown in the radial compression state.

[0064] 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.

[0065] 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.

[0066] 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).

[0067] In this way, multiple pillars 26 can define and / or otherwise form four rows of open units 28. Angled pillars 36 and 38 of the first and second rows can define and / or otherwise form a first row of open units 54, angled pillars 38, 40, and 42 of the second, third, and fourth rows can form and / or otherwise define two intermediate row open units 56, and angled pillars 42 and 44 of the fourth and fifth rows can form and / or otherwise define a fourth row of open units 58.

[0068] like Figures 4-5 As shown, since a vertical support 46 is included between the first and second row angled supports 36, 38, and supports 48, 50 are included between the fourth and fifth row angled supports 42, 44, the units of the first row open units 54 and the fourth row open units 58 can be larger than the units of the two intermediate row open units 56. Furthermore, supports 48, 50 can be longer than the vertical supports 46, and therefore, the units of the fourth row open units 58 can be larger than the units of the first row open units 54. When the frame 12 is curled, the relatively large size of the units of the fourth row open units 58 allows portions of the leaflet assembly 14 to protrude or bulge into and / or through the frame 12, thereby minimizing the curled profile. Typically, when the frame 12 is in a radially compressed state ( Figure 2 When the valve is in its open position, the geometry of the strut 26 and the joint 32 helps to make the open unit 28 large enough to allow portions of the leaflet 15 to protrude or bulge outward through the frame 12. This allows the valve 10 to curl to a relatively small diameter than would be with all the leaflet material confined within the curled frame.

[0069] Furthermore, the relatively large size of the first row of opening units 54 allows the frame to be rolled up ( Figure 2 The frame 12 exhibits an overall tapering shape, decreasing in diameter from its maximum diameter at the outflow end 24 to its minimum diameter at the inflow end 22. When coiled, the frame 12 has a diameter-reducing region extending along a portion of the frame adjacent to the inflow end 22, which roughly corresponds to the area of ​​the frame 12 covered by the outer skirt 18. In some examples, the diameter-reducing region is smaller than the diameter of 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 coiled profile of the valve 10. When the valve 10 is deployed, the frame 12 can be rotated from a radially compressed state ( Figure 2 ) extends to radial expansion 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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 an adjacent angled strut 30 to provide a robust construction with enhanced fatigue resistance under cyclic loading of the prosthetic valve compared to known cantilever struts used to support the lobule assembly. This construction allows for a reduction in frame wall thickness, resulting in a smaller curl diameter for the prosthetic valve. In a specific example, the frame 12 (measured between the inner and outer diameters) Figure 4 The thickness T is approximately 0.48 mm or less. Figure 6 , Figure 7 , Figure 8 , Figure 9 and Figure 10 They are respectively by Figure 5 An enlarged view of the portion of frame 12 identified by the letters A, B, C, D, and E.

[0075] The frame 12 can be made of any of a variety of suitable malleable expandable materials known in the art (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as nitinol). When made of a malleable expandable material, the frame 12 (and therefore the prosthetic heart valve 10) can be rolled into a radially compressed state on the delivery catheter and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. When made of a self-expanding material, the frame 12 (and therefore the prosthetic heart valve 10) can be rolled into a radially compressed state and restrained in a radially compressed state by a sheath or equivalent mechanism inserted into the delivery catheter. Once inside the body, the valve 10 can be advanced from the delivery sheath, which allows the valve 10 to expand to its radially expanded state.

[0076] Suitable malleable extension materials that can be used to form frame 12 include, without limitation, stainless steel, biocompatible high-strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific example, frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using MP35N® alloy to form frame 12 provides superior structural effects compared to stainless steel. Specifically, when the alloy is used as the frame material, less material is required to achieve the same or better performance in terms of radial and crushing force resistance, fatigue resistance, and corrosion resistance. Furthermore, due to the need for less material, the curl profile of the frame can be reduced, thereby providing a smaller profile prosthetic valve assembly for percutaneous delivery to the treatment site within the body.

[0077] In some examples, frame 12 may be formed from a single piece of material. In some such examples, open unit 28 may be formed by removing material from the single piece of material (e.g., via machining, milling, laser cutting, etc.). However, in other such examples, frame 12 and open unit 28 may be formed via a molding process (e.g., die casting, injection molding, etc.). In still other examples, frame 12 may be formed from two or more parts, which are formed separately and then coupled together via any suitable coupling means (e.g., welding, adhesives, fasteners, etc.).

[0078] like Figure 1 , Figure 3 , Figure 15 and Figure 20 As shown, 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 stitching. The inner skirt 17 may include an outer side 65 ( Figure 12 ) Relative inner side 64 ( Figure 11 The inner side 64 faces radially inward (towards the lumen of valve 10), and the outer side 65 faces radially outward and directly contacts the inner side 63 of frame 12. Figure 1 , Figure 3 , Figure 15 and Figure 20 In the example shown, the inner skirt 17 can be sewn to the fourth row of angled supports 42. Specifically, the inner skirt 17 may include an inflow edge portion 66 opposite to the outflow edge portion 68, and the outflow edge portion 68 of the inner skirt 17 can be coupled to the fourth row of angled supports 42 via a stitch 70. In some such examples, a plurality of protrusions 96 that may be formed on the outflow edge portion 68 of the inner skirt 17 can be wrapped around the fourth row of angled supports 42 and secured to the fourth row of angled supports via stitch 70. As discussed in more detail below, during the alignment and attachment of the outflow edge portion 68 of the inner skirt 17 to the fourth row of angled supports 42, the user can ensure that the outflow edge portion 68 of the inner skirt 17 does not extend beyond the joint 32 of the fourth row of angled supports 42 by more than a threshold amount X. Figure 25 ( ), so that the bag-shaped portion 20 can be maintained at a sufficient length at the inflow end 22 of the frame 12.

[0079] The primary function of the inner skirt 17 is to assist in securing the leaflet assembly 14 to the frame 12 and to help form a good seal between the prosthetic valve 10 and the natural valve annulus by preventing blood from flowing through the open unit 28 of the frame 12 below the lower edge of the leaflet 15. The inner skirt 17 preferably comprises a tough, tear-resistant material such as polyethylene terephthalate (PET), but various other synthetic or natural materials (e.g., pericardial tissue) can be used. The skirt thickness is ideally less than about 0.15 mm (about 6 mils), and ideally less than about 0.1 mm (about 4 mils), even more ideally about 0.05 mm (about 2 mils). In specific examples, the inner skirt 17 can have a variable thickness; for example, the skirt may be thicker at at least one edge than at its center. In one embodiment, the skirt 17 may comprise a PET skirt with a thickness of about 0.07 mm at its edge and about 0.06 mm at its center. A thinner skirt provides better curling performance while still offering good periplo seal.

[0080] The leaflet component 14 can be attached to the skirt via one or more reinforcing strips 72 (which together form a sleeve), such as thin PET reinforcing strips described below that enable strong suturing and prevent pericardial tissue tearing of the leaflet component. The leaflet component 14 can be sandwiched between the skirt 17 and the thin PET strips 72, as shown below. Figure 19 As shown. The stitch 74 that secures the PET strip and leaflet assembly 14 to the skirt 17 can be any suitable stitch, such as Ethibond Excel® PET stitch (Johnson & Johnson, New Brunswick, New Jersey). The stitch 74 ideally follows the curvature of the lower edge of the leaflet assembly 14, as described in more detail below.

[0081] refer to Figure 12 Compared to known fabric skirts, skirt 17 is ideally woven from a first set of fibers or yarns or plies 78 and a second set of fibers or yarns or plies 80, neither of which are perpendicular to the outflow end 82 and inflow end 84 of the skirt. In a specific example, the first set of fibers 78 and the second set of fibers 80 extend at an angle of approximately 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the outflow end 82 and inflow end 84. For example, skirt 17 can be formed by weaving fibers at a 45-degree angle relative to the outflow and inflow ends of the fabric. Alternatively, skirt 17 can be diagonally cut (oblique cut) from a vertically woven fabric (where fibers extend perpendicular to the edges of the material), such that the fibers extend at a 45-degree angle relative to the cut outflow and inflow ends of the skirt. Figure 12As further shown, the opposing short edges 86, 88 of the skirt 17 are ideally not perpendicular to the outlet end 82 and the inlet end 84. For example, the short edges 86, 88 ideally extend at an angle of approximately 45 degrees relative to the outlet end and the inlet end, and are thus aligned with the first set of fibers 78. Therefore, the overall shape of the skirt 17 is generally rhomboid or parallelogram-shaped.

[0082] Figure 13 and Figure 14 The inner skirt portion 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 portions 90 can be placed in an overlapping relationship relative to the opposing edge portions 92, and the two edge portions can be sewn together by a seam line 94 extending diagonally parallel to the short edges 86, 88. The inflow edge portion 66 of the inner skirt portion 17 can be formed with a plurality of protrusions 96, the plurality of protrusions 96 defining a wavy shape that generally follows the shape or profile of the fourth row of angled pillars 42 immediately adjacent to the lower end of the vertical pillars 48. In this way, as Figure 15 As best shown, the outflow end 82 of the inner skirt 17 can be securely attached to the fourth row of angled supports 42 via stitches 70. The inner skirt 17 may also be formed with slits 98 to facilitate attachment of the skirt 17 to the frame 12. The slits 98 are sized to allow the outflow edge portion 68 of the inner skirt 17 to partially wrap around the fourth row of angled supports 42, and to reduce stress in the skirt during the attachment process. For example, in the illustrated example, the inner skirt 17 is placed on the inside 63 of the frame 12, and the outflow edge portion 68 of the skirt 17 wraps around the upper surface of the fourth row of angled supports 42 and is secured in place using stitches 70. Wrapping the outflow edge portion 68 of the inner skirt 17 around the fourth row of angled supports 42 in this manner provides a stronger and more durable attachment of the skirt 17 to the frame 12. The inner skirt 17 can be additionally or alternatively secured to the angled supports 36, 38, and 40 of the first, second, and / or third rows respectively using stitching 70.

[0083] like Figure 25As shown, slit 98 can be circumferentially aligned with the joint 32 between adjacent angled supports. In some examples, slit 98 may not be axially spaced from the joint 32 by more than a threshold amount X to ensure that the pouch 20 is formed at the inlet end 22 of the frame 12 and / or to prevent over-winding of the inner skirt 17. For example, slit 98 may be axially spaced from the joint 32 of the fourth row of angled supports 42 (towards the outlet end 24 of the frame) by 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 (i.e., the threshold amount X may be). Therefore, in some examples, the inlet end 84 of the inner skirt 17 may extend beyond the apex 62 at the inlet end 22 of the frame 12 (i.e., below it). However, in other examples, the inlet end 84 of the inner skirt 17 may extend to but not exceed the apex 62 at the inlet end of the frame 12. In another example, the inflow end 84 of the inner skirt 17 may not extend to the vertex 62 at the inflow end 22 of the frame 12, but may almost reach the vertex 62 at the inflow end of the frame 12.

[0084] Because the fibers are angled relative to the inflow and outflow ends of the skirt 17, the skirt 17 can undergo greater elongation in the axial direction (i.e., in the direction from the outflow end 82 to the inflow end 84). Therefore, when the frame 12 is rolled up, the inner skirt 17 can elongate axially with the frame, thus providing a more uniform and predictable roll profile. In the illustrated example, each unit of the metal frame includes at least four angled struts that rotate in the axial direction during roll-up (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each unit act as a mechanism that rotates the fibers of the skirt in the same direction along the struts and allows the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt when the prosthetic valve is rolled up and avoids undesirable deformation of the struts.

[0085] 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 of 20 denier yarn, the yarn density can be about 15% to about 30% lower than that of 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 from about 85 yarns per centimeter (about 217 yarns per inch) to about 97 yarns per centimeter (about 247 yarns per inch). Short edges 86, 88 promote a uniform and even distribution of the fabric material along the perimeter within the frame during crimping, thereby reducing or minimizing fabric bundling and promoting uniform crimping to the smallest possible diameter. Furthermore, cutting the diagonal seam vertically leaves loose tassels along the cut edges. Short edges 86, 88 help minimize this. Compared to the construction of a conventional skirt (where fibers extend perpendicular to the outflow and inflow ends of the skirt), the construction of the inner skirt 17 avoids undesirable deformation of the frame supports and provides a more uniform curl of the frame.

[0086] In an alternative example, the skirt 17 may be formed of woven elastic fibers that can be stretched in the axial direction during the curling of the prosthetic valve 10. The warp and weft fibers may extend perpendicularly to and parallel to the outflow and inflow ends of the skirt 17, or alternatively, they may extend at an angle between 0 and 90 degrees relative to the outflow and inflow ends of the skirt 17, as described above.

[0087] The inner skirt 17 can be sewn to the frame 12 at a location away from the seam 74, allowing the skirt to be more flexible in that area. This construction avoids stress concentration at the seam 74, which attaches the lower edge of the leaflet to the inner skirt 17.

[0088] As described above, in the illustrated example, leaflet assembly 14 includes three flexible leaflets 15 (although more or fewer leaflets may be used). Further information regarding the leaflets and the skirt material can be found, for example, in U.S. Patent No. 10,195,025, issued February 5, 2019, which is incorporated herein by reference.

[0089] Leaflets 15 can be fixed to each other on their adjacent sides to form the connecting portion 114 of the leaflet assembly. Figure 20 Multiple flexible connectors 116 (in) Figure 16 One of them is shown in the figure. It can be used to interconnect pairs of adjacent sides of the leaflets and to mount the leaflets to the window frame pillar 50. Figure 5 ). Figure 16 The adjacent sides of two leaflets 15 interconnected by a flexible connector 116 are shown. Figure 17 As shown, three flexible connectors 116 can be used to secure the three leaflets 15 side-to-side with each other. Further information regarding the connection of the leaflets to each other and the assembly of the leaflets and skirt to the frame can be found, for example, in U.S. Patent Application Publications Nos. 2012 / 0123529 and 2019 / 0365530, which are incorporated herein by reference.

[0090] To prevent the leaflet assembly 14 from over-expanding, the leaflet assembly 14 is ideally fixed to the frame 12 below the fifth row of angled supports 44, as shown below. Figure 1 As best shown. Specifically, due to the "dog bone" effect of the balloon used to expand the prosthetic valve 10, the inlet end 22 and the outlet end 24 of the frame 12 may generally tend to over-expand more than the middle portion of the frame 12. Therefore, in the event of over-expansion of the outlet end 24 of the frame 12, the leaflet assembly 14 is positioned at a level below the level at which over-expansion may occur, thereby protecting the leaflet assembly 14 from over-expansion.

[0091] Another advantage of mounting the leaflet 15 at a location spaced apart from the outflow end 24 of the frame 12 is that, when the prosthetic valve 10 is coiled on the delivery catheter, the outflow end 24 of the frame 12, rather than the leaflet 15, is the closest component of the prosthetic valve 10. Therefore, if the delivery catheter includes an actuating mechanism or stop that pushes against or abuts the outflow end 24 of the prosthetic valve 10, the actuating mechanism or stop contacts the outflow end 24 of the frame 12 rather than the leaflet 15, in order to avoid damage to the leaflet 15.

[0092] As described above, the inner skirt 17 can be used to assist in sewing the leaflet assembly 14 to the frame 12. The inner skirt 17 may have wavy temporary marker sutures to guide the attachment of the lower edge of each leaflet 15. As described above, before securing the leaflet assembly 14 to the skirt 17, the inner skirt 17 itself can be sewn to the posts of the frame 12 using sutures 70. The posts intersecting the marker sutures are ideally not attached to the inner skirt 17. This allows the inner skirt 17 to be more flexible in areas not secured to the frame and minimizes stress concentration along the sutures securing the lower edge of the leaflet to the skirt. As described above, when the skirt is secured to the frame, the fibers 78, 80 of the skirt (see...) Figure 12 They are typically aligned with the angled struts of the frame to promote uniform curling and expansion of the frame.

[0093] Figure 18 A specific method is shown for securing the connecting portion 114 of the leaflet assembly 14 to the connecting portion window frame support 50 of the frame 12. Flexible connectors 116 secure two adjacent sides of the two leaflets 15. Figure 17The upper tab portion 112 is folded horizontally and folded downward against the flexible connector. Each upper tab portion 112 is longitudinally (vertically) folded to form an L-shape, which has 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 the seam line 124. Next, the connecting tab assembly is inserted into the connecting window 52 through the corresponding pair of window frame pillars 50, and the folds on the outside of the window frame pillars 50 can be sewn to portion 122.

[0094] Figure 18 It is also shown that the downward-folding upper tab portion 112 can form a double layer of leaflet material at the joint. The inner portion 118 of the upper tab portion 112 is positioned flat against the layers of the two leaflets 15 forming the joint, such that each joint includes four layers of leaflet material just inside the window frame strut 50. This four-layer portion of the joint can be more resistant to bending or hinge / joint movement than the portion of the leaflet 15 that is only radially inward from the relatively more rigid four-layer portion. This causes the leaflet 15 to hinge primarily at the inner edge 120 of the downward-folding inner portion 118 in response to blood flowing through the prosthetic valve during intra-body operation, rather than hinged around or near the axial strut of the window frame strut 50. Because the leaflets are hinged at a position 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 portions of the commissure can open around the longitudinal axis of the adjacent window frame strut 50, with each inner portion 118 folding outward against the corresponding outer portion 122. This can occur, for example, when the prosthetic valve 10 is compressed and mounted onto the delivery axis, allowing for a smaller coil diameter. The four layered portions of the commissure can also open around the longitudinal axis as the balloon catheter inflates during the expansion of the prosthetic valve, which can alleviate some of the pressure on the commissure caused by the balloon, thereby reducing potential damage to the commissure during expansion.

[0095] After all three connecting tab assemblies are secured to their respective window frame pillars 50, the lower edges of the leaflets 15 between the connecting tab assemblies can be sewn to the inner skirt 17. For example, as Figure 19 As shown, each leaflet 15 can be sewn to the inner skirt 17 via a seam 74, for example, using Ethibond Excel® PET thread. The seam 74 can be an in-and-out seam extending through each leaflet 15, the inner skirt 17, and each reinforcing strip 72. Each leaflet 15 and its corresponding reinforcing strip 72 can be individually sewn to the inner skirt 17. In this way, the lower edge of the leaflet 15 is secured to the frame 12 via the inner skirt 17. Figure 19As 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.

[0096] 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, 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.

[0097] 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 from 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.

[0098] 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 the surrounding natural tissue). Specifically, the outer skirt 18 may be mounted on the outer side 140 of the frame 12 such that the inner side 136 of the outer skirt 18 faces and directly contacts the outer side 140 of the frame 12. In 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.

[0099] In an alternative example, 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 a porous or sponge material (such as any of a variety of compliant polymer foam materials) or a woven fabric (such as woven PET).

[0100] like Figure 1 As shown, the outward edge portion 130 of the outer skirt 18 (e.g., protrusion 132) 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.

[0101] The outer skirt 18 may additionally or alternatively be secured to the frame at the first row of angled supports 36 and / or the second row of angled supports 38. In some examples, the inlet end 144 of the outer skirt 18 may extend to, but not beyond, the vertex 62 at the inlet end 22 of the frame 12. However, in other examples, the inlet end 144 of the outer skirt 18 may extend beyond the vertex 62 at the inlet end of the frame 12. In yet another example, the inlet end 144 of the outer skirt 18 may not extend to the vertex 62 at the inlet end 22 of the frame 12, and may just reach the vertex 62 at the inlet end of the frame 12. For example, the outer skirt 18 does not need to extend all the way to the inlet end 22 of the frame 12, but rather the inlet end 144 of the outer skirt 18 may be secured to another location on the frame 12, such as to the second row of angled supports 38.

[0102] In alternative examples, the height of the outer skirt 18 (measured from the inlet end 144 to the outlet end 142) can be varied. For example, in some examples, the outer skirt 18 can cover the entire outer surface of the frame 12, with the inlet edge portion 128 fixed to the inlet end 22 of the frame 12 and the outlet edge portion 130 fixed to the outlet end 24 of the frame 12. In another example, the outer skirt 18 can extend from the inlet end 22 of the frame 12 to the second row of angled pillars 38, or to the fourth row of angled pillars 42, or to a position along the frame 12 between two rows of pillars.

[0103] The outer skirt 18 is ideally sized and shaped relative to the frame 12 such that when the prosthetic valve 10 is in its radially expanded state (e.g., Figure 1 and Figure 3 When the outer skirt 18 is in close contact with the outer side 140 of the frame 12, the outer skirt 18 fits snugly (in a tight fit). When the prosthetic valve 10 is rolled into a radially compressed state... Figure 2 This allows the portion of the frame with the outer skirt to extend axially during delivery. The outer skirt 18 ideally has sufficient elasticity to stretch axially when the frame is radially compressed, so that it does not prevent full radial compression of the frame or deform the struts during the curling process.

[0104] 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) may additionally be sewn to the frame 12 at or near the inflow end 22 of the frame, such as sewing to the first row of angled pillars 36. For example, as 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.

[0105] 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.

[0106] 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.

[0107] The inflow edge portions 66 and 128 of the inner skirt portion 17 and the outer skirt portion 18 can be sewn together via a seam or stitch 150 near the inflow end 22 of the frame 12 to form a pouch-like portion 20 at the inflow end 22 of the frame 12. Figures 22-24 In the example shown, suture 150 may extend only through each of skirt sections 17, 18. In some such examples, another suture located near suture 150 (e.g., Figure 29 The stitching 320 shown may extend through one or both of the frame 12 and the skirts 17, 18 to secure the skirts 17, 18 to the inlet end 22 of the frame 12. For example, as Figure 29 As shown, the inflow edge portions 66 and / or 128 of the inner skirt 17 and / or outer skirt 18 can be first sewn to the frame 12 via stitch 320. Then, the inflow edge portions 66 and 128 of the skirts 17 and 18 can be sewn to the frame 12 via a separate set of stitches (such as stitch 150). Figures 22-24 ()) sewn together, or separate skirt parts (e.g., Figure 28 The skirt portion 302 shown can be sewn to the inflow edge portions 66 and 128 of the inner skirt portion 17 and the outer skirt portion 18, respectively.

[0108] In another example, and as Figure 29 As shown, the inflow edge portions 66 and / or 128 of the inner skirt portion 17 and / or the outer skirt portion 18 can be sewn to the frame 12 via stitch 320, such that a portion of the inner skirt portion 17 extends beyond the inflow end 22 of the frame 12. This extended or hanging portion of the inner skirt portion 17 can be long enough to form a pouch 20, and can be wrapped around the inflow end 22 of the frame 12 and sewn to the inflow edge portion 128 of the outer skirt portion 18 (at or near stitch 320) with stitch 150 to form the pouch 20.

[0109] exist Figures 22-24 In the example shown, when the frame 12 is in a radially extended state, the inner skirt 17 and / or the outer skirt 18 can extend beyond the apex 62 at the inflow end 22 of the frame 12, such that the pocket 20 creates (and separates) a space between (and separates) the inflow end 22 of the frame 12 (including the apex 62) and the skirt assembly 16. Therefore, the apex 62 is positioned within the pocket 20, and when the frame 12 is in a radially extended state, the apex 62 can be spaced apart from the skirt assembly 16. The pocket 20 can also extend circumferentially around the inflow end 22 of the frame 12, such that all apexes 62 at the inflow end 22 of the frame 12 are positioned within the pocket 20.

[0110] The bag-shaped portion 20 has an inlet end 154 that can extend circumferentially around the inlet end 22 of the frame 12 (i.e., the section / part of the bag-shaped portion 20 that is axially furthest from the inlet end 22 of the frame 12). Therefore, when the frame 12 is in a radially extended state, the bag-shaped portion 20 extends axially a distance Y between its apex 62 at the inlet end 22 of the frame 12 and the skirt assembly 16. In other words, the bag-shaped portion 20 can separate the apex 62 at the inlet end 22 of the frame 12 from the skirt assembly 16 by a distance Y. Therefore, when the frame 12 is in a radially extended state, the inlet end 22 of the frame 12 (including the apex 62) can be axially spaced a distance Y from the skirt assembly 16 at the inlet end 154 of the bag-shaped portion 20. In a specific example, when the frame is in a radially expanded state, the axial length of the bag-shaped portion 20 (i.e., the distance Y between the vertex 62 at the inflow end of the frame 12 and the inflow end 154 of the bag-shaped portion 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 mm, at most 2.0 mm, at most 1.5 mm, and / or at most 1.0 mm.

[0111] When frame 12 is radially compressed, both the entire skirt assembly 16 (all skirts 17, 18, and / or 302) and frame 12 can elongate axially, but frame 12 can elongate axially more than skirt assembly 16. However, when the prosthetic valve is radially compressed to the radially compressed state, the pouch 20 compensates for the additional elongation of the frame and prevents apex 62 from protruding through the skirt assembly.

[0112] In some examples, when frame 12 is in a radially compressed state, the length Y of the pouch 20 can be zero (i.e., the pouch 20 can completely disappear when frame 12 is in a radially compressed state), such that the vertices 62 of frame 12 directly contact the skirt assembly 16. However, even in examples where vertices 62 directly contact 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 when the vertices 62 contact and push against it. This stretching capability allows the skirt assembly 16 to accommodate even more axial elongation of frame 12 when the vertices 62 directly contact the skirt assembly 16. In some examples, one or more vertices 62 may slightly protrude through the skirt assembly 16 at the pouch, but most vertices 62 are still completely covered within the pouch by the skirt assembly.

[0113] 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.

[0114] 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., the 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.

[0115] 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.

[0116] 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 a stitch line spaced apart from the edges of the skirt portions 17 and 18 using multiple in-and-out stitches 152. 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.

[0117] To ensure that the appropriate bag 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 26AThat is, when the threading needle 210 pierces the inner skirt 17 to form a stitch 150 with the thread 212, the user can maintain a threshold distance Z between the threading needle 210 and the inlet end 84 of the inner skirt 17. Figure 26A The threshold distance Z 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 and / or at least 0.7 mm.

[0118] Figures 27A-27B This shows the fully formed and complete bag-shaped portion 20 after the inner skirt portion 17 and the outer skirt portion 18 have been sewn together. Figure 27A The outer side of valve 10 is shown, and Figure 27B The inner side of valve 10 is shown. Figures 27A-27B As shown, the skirt assembly 16 extends below the apex 62 at the inflow end 22 of the frame 12 to form a pouch-like portion 20. Figures 27A-27B In the specific example shown, the inner skirt 17 forms a pouch 20. The inner skirt 17 wraps around the outer skirt 18 around the apex 62 and is sewn to the outer skirt 18 at the inflow edge portion 128. Specifically, the inner skirt 17 extends below the apex 62 at the inflow end 22 of the frame 12, folds itself over the inflow end 154 of the pouch 20, extends upward and over the outer skirt 18 on the outer side 140 of the frame 12, and is sewn to the outer skirt 18 with stitch 150 to create the pouch 20. The pouch 20 can extend circumferentially around the entire inflow end 22 of the frame 12 such that all apex 62 are completely covered by the skirt assembly 16 in both radial expansion and radial compression (i.e., curling) states.

[0119] The pouch 20 provides additional space / room between the apex 62 and the skirt assembly 16, ensuring that the apex 62 does not protrude through the skirt assembly 16 when the frame 12 is rolled up. In other words, the pouch 20 allows the frame 12 to elongate axially during radial compression and ensures that the apex 62 remains fully covered by the skirt assembly 16 even when the frame 12 is in a radially compressed (i.e., rolled-up) state. Preventing the apex 62 from protruding through the skirt assembly during rolling and maintaining their coverage by the skirt assembly 16 even in the rolled-up state offers several advantages. First, it helps prevent the apex 62 from contacting the introducer sheath, thereby reducing the thrust required to push the prosthetic valve 10 through the introducer sheath and preventing damage to the apex. Second, it prevents the apex from contacting and traumatizing surrounding tissues as the prosthetic valve (when rolled up on the delivery device) is advanced through the patient's vascular system.

[0120] 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.

[0121] 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.

[0122] In yet another example, both the inner skirt 17 and the outer skirt 18 can form a pouch-like portion 20. In such an example, the inner skirt 17 and the outer skirt 18 can extend beyond the inlet end 22 of the frame 12 and can be sewn together at a position below the inlet end 22 of the frame 12 (e.g., below vertex 62 at the inlet end 22 of the frame 12). In some such examples ( Figure 23 In this example, the inner skirt 17 and the outer skirt 18 can be sewn together at the inlet end 154 of the bag-shaped portion 20, such that the inlet ends 84 and 144 of the inner skirt 17 and the outer skirt 18 respectively form the inlet end 154 of the bag-shaped portion 20. In such an example, the inner skirt 17 and the outer skirt 18 can extend approximately the same amount (e.g., distance Y) below the inlet end 22 of the frame 12. In some examples ( Figure 23 In this example, the inflow end 84 of the inner skirt 17 and the inflow end 144 of the outer skirt 18 can be directly adjacent to each other and can not overlap each other. However, in other examples, the skirts 17 and 18 can overlap each other at the pouch 20.

[0123] In other examples, such as Figure 28 and Figures 30-31 As shown, the skirt assembly 16 may include a third skirt 302 (which may also be referred to herein as "pocket-shaped skirt 302"), which may be coupled to the inner skirt 17, the outer skirt 18, and / or the frame 12 to form at least a portion of the pocket-shaped portion 20 when the frame 12 is in a radially extended state. For example, in Figure 28 In the example shown, the first end portion 304 of the third skirt 302 may overlap and couple (e.g., sew) to the inflow end portion 66 of the inner skirt 17, such as via a seam 306, and the opposite second end portion 308 of the third skirt 302 may overlap and couple (e.g., sew) to the inflow edge portion 128 of the outer skirt 18, such as via a seam 310. Because the third skirt 302 may be significantly longer than the width of the frame 12 and the skirts 17, 18, when the frame 12 is in a radially extended state, the third skirt 302 may extend beyond the inflow end of the frame 12 (away from the inner skirt 17 and the outer skirt 18), thereby forming a pouch-like portion 20.

[0124] As another example, such as Figure 30As shown, instead of overlapping and connecting (e.g., sewn) to the inner skirt 17 and outer skirt 18, the third skirt 302 may alternatively be sewn to itself and / or the frame 12, and may abut the inner skirt 17 and outer skirt 18 at or near the inflow end 22 of the frame 12. Specifically, the first end portion 304 of the third skirt 302 may abut the inflow end 84 of the inner skirt 17, and / or the second end portion 308 of the third skirt 302 may abut the inflow end 144 of the outer skirt 18. Furthermore, the first end portion 302 and the second end portion 308 of the third skirt 302 may be coupled (e.g., sewn) together, such as via a seam 322 that may extend circumferentially around the frame 12. In some such examples, the seam 322 may extend through an opening in the frame 12, such as extending through the first row of open units 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 angled support 36. Figure 5 In any of the above examples, the third skirt 302 can be effectively suspended at the inlet end 22 of the frame 12 from the first row of angled pillars 36 and / or apex 62 of the frame 12, and can extend beyond the inlet end 22 of the frame 12 to form a bag-shaped portion 20.

[0125] In any of the above examples where the third skirt 302 is coupled (e.g., sewn) to skirts 17, 18 to form at least a portion of the pouch-like portion 20, one or both of skirts 17, 18 may also form at least a portion of the pouch-like portion 20. That is, one or both of skirts 17, 18 do not need to stop at or outside the inflow end 22 of the frame 12, as... Figure 28 and Figure 30 As shown, one or both of the skirts 17 and 18 may extend beyond the inlet end 22 of the frame 12 to form at least a portion of the bag-shaped portion 20. However, in other examples, both skirts 17 and 18 may stop at or outside the inlet end 22 of the frame 12 (so that skirts 17 and 18 do not extend beyond the inlet end of the frame 12), and the third skirt 302 may form the entire bag-shaped portion 20 on its own.

[0126] As yet another example, one or both of the skirts 17 and 18 may wrap around the outside of the third skirt 302. For example, as Figure 31As shown, the inner skirt 17 may wrap around the third skirt 302 all the way around the outer side 138 of the outer skirt 18 (such that it comes into contact with and / or otherwise contacts the outer side of the third skirt 302), and may be coupled (e.g., sewn) to the outer skirt 18, such as via seam 150. In another example, the outer skirt 18 may alternatively wrap around the third skirt 302 all the way around the inner side 64 of the inner skirt 17 (such that it comes into contact with and / or otherwise contacts the outer side of the third skirt 302), and may be coupled (e.g., sewn) to the inner skirt 17, such as via seam 150. In yet another example, both skirts 17 and 18 may extend around the third skirt 302 and may be coupled (e.g., sewn) together at locations where skirts 17 and 18 overlap with the third skirt 302 (such as below the inlet end 22 of frame 12).

[0127] Although the inner skirt 17 and the outer skirt 18 are shown and described as being secured to each other at the inflow edge portions 66 and 128 via stitch 150 respectively, it should be understood that the inflow edge portions 66 and 128 may be attached to each other using other and / or alternative coupling means such as ultrasonic welding, adhesives, mechanical fasteners, etc.

[0128] Furthermore, although the pouch-like portion 20 is shown and described as being formed / included at the inlet end 22 of the frame 12, it should be understood that the pouch-like portion 20 may additionally or alternatively be included / formed at the outlet end 24 of the frame 12. Specifically, the inner skirt portion 17 and the outer skirt portion 18 may extend and / or exceed the outlet end 24 of the frame 12 and may be sewn together at or near the outlet end 24 of the frame 12 in a manner similar to that described above for the inlet end 22 of the frame 12, to form the pouch-like portion 20 at the outlet end 24 of the frame 12 (e.g., as shown in the image). Figures 22-24 (As shown). In some such examples, the pouch 20 may be formed at both the inlet end 22 and the outlet end 24 of the frame 12, such that the valve 10 includes two pouches 20, one at each end of the frame 12. In other such examples, the pouch 20 may be formed only at the outlet end 24 of the frame 12, instead of the inlet end 22 of the frame 12.

[0129] Other examples of the disclosed technology In view of the embodiments described above for the disclosed subject matter, this application discloses further examples listed below. It should be noted that examples with more than one feature, obtained by combining one or more features of one or more other examples individually or in combination, are also other examples falling within the scope of the disclosure of this application.

[0130] Example 1. A prosthetic heart valve, comprising: An annular frame, the annular frame including an inflow end and an outflow end, wherein the frame is radially compressed and expanded between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of vertices at the inflow end; Leaflet assembly, the leaflet assembly being positioned within and coupled to the frame, wherein the leaflet assembly includes a plurality of leaflets completely positioned within the frame; Skirt assembly, the skirt assembly comprising: An inner skirt extending circumferentially around the inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and An outer skirt portion that extends circumferentially around the outer side of the frame, wherein the outer skirt portion has an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the outer skirt portion is sewn to the inflow edge portion of the inner skirt portion; The inflow edge portion of the inner skirt and / or the inflow edge portion of the outer skirt form a pouch-like portion, wherein the apex is disposed in the pouch-like portion, and wherein the pouch-like portion has an inflow end; and When the frame is in the radially extended state, the vertex is spaced apart from the inflow end of the bag-shaped portion, and when the frame is radially compressed from the radially extended state to the radially compressed state, the vertex moves closer to the inflow end of the bag-shaped portion.

[0131] Example 2. A prosthetic heart valve according to any of the examples in this document (particularly Example 1), wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the pouch-like portion.

[0132] Example 3. A prosthetic heart valve according to any of the examples in this document (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 pouch.

[0133] Example 4. A prosthetic heart valve according to any of the examples herein (in particular any one 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.

[0134] Example 5. A prosthetic heart valve according to any of the examples in this document (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.

[0135] Example 6. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 1-5), wherein when the frame is in the radially expanded state, the apex is spaced at least 0.5 mm from the inflow end of the pouch.

[0136] Example 7. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 1-6), wherein the pouch extends circumferentially around the inlet end of the frame.

[0137] Example 8. A prosthetic heart valve according to any of the examples herein (particularly any one 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.

[0138] Example 9. A prosthetic heart valve according to any of the examples herein (particularly any one 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 from the junction of the two struts of the frame by up to 0.5 mm.

[0139] Example 10. A prosthetic heart valve according to any of the examples herein (in particular any one 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.

[0140] Example 11. A prosthetic heart valve according to any of the examples herein (in particular any one of Examples 1-10), wherein the plurality of leaflets do not extend beyond the inflow end of the frame and are completely positioned between the inflow end and the outflow end of the frame.

[0141] Example 12. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 1-11), wherein the pouch portion is hollow.

[0142] Example 13. A prosthetic heart valve according to any of the examples herein (particularly any one 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 pouch.

[0143] Example 14. A prosthetic heart valve according to any of the examples herein (particularly any one 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 pouch.

[0144] Example 15. A prosthetic heart valve, comprising: An annular frame, the annular frame including an inflow end and an outflow end, wherein the frame is radially compressed and expanded between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of vertices at the inflow end; Leaflet assembly, the leaflet assembly comprising a plurality of leaflets, the leaflet assembly being positioned within the frame and coupled to the frame; An outer skirt extending circumferentially around the outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion; and An inner skirt extends circumferentially around the inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion, wherein the inner skirt folds over itself and forms a pouch at the inflow end of the frame, wherein the vertex at the inflow end of the frame is disposed within the pouch, wherein the pouch has an inflow end, and wherein when the frame is in the radially extended state, the vertex is spaced apart from the inflow end of the pouch, and when the frame is radially compressed from the radially extended state to the radially compressed state, the vertex moves closer to the inflow end of the pouch.

[0145] Example 16. A prosthetic heart valve according to any example in this document (particularly Example 15), wherein the inflow edge portion of the inner skirt is sewn to the inflow edge portion of the outer skirt.

[0146] Example 17. A prosthetic heart valve according to any example in this document (in particular any one of Examples 15 or 16), wherein the inner skirt wraps around the plurality of vertices at the inflow end of the frame and covers the outer side of the frame.

[0147] Example 18. A prosthetic heart valve according to any of the examples in this document (particularly Example 17), wherein the inflow edge portion of the inner skirt extends circumferentially around the outer side of the frame.

[0148] Example 19. A prosthetic heart valve according to any of the examples herein (particularly any one of Examples 15-18), wherein the outer skirt has an inner side opposite to the 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 around the inflow end of the frame, on the outer side of the frame, and contacts the outer side of the outer skirt.

[0149] Example 20. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 15-19), wherein the outer skirt does not extend beyond the inlet end of the frame.

[0150] Example 21. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 15-20), wherein when the frame is in the radially expanded state, the apex is spaced at least 0.5 mm from the inflow end of the pouch.

[0151] Example 22. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 15-21), wherein the pouch portion is hollow.

[0152] Example 23. A prosthetic heart valve according to any of the examples herein (particularly any one 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 from the junction of the two struts of the frame by up to 0.5 mm.

[0153] Example 24. A prosthetic heart valve according to any of the examples herein (in particular any one 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.

[0154] Example 25. The prosthetic heart valve according to any of the examples herein (in particular any one of Examples 15-24) further includes 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 approximately 0.5 mm from the inflow end of the inner skirt.

[0155] Example 26. A prosthetic heart valve, comprising: An annular frame, the annular frame including an inflow end and an outflow end, wherein the frame is radially compressed and expanded between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of vertices at the inflow end; Leaflet assembly, the leaflet assembly comprising a plurality of leaflets, the leaflet assembly being positioned within the frame and coupled to the frame; An inner skirt extending circumferentially around the inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and An outer skirt extends circumferentially around the outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion, wherein the outer skirt folds over itself and forms a pouch at the inflow end of the frame, wherein the vertex at the inflow end of the frame is disposed within the pouch, wherein the pouch has an inflow end, and wherein when the frame is in the radially extended state, the vertex is spaced apart from the inflow end of the pouch, and when the frame is radially compressed from the radially extended state to the radially compressed state, the vertex moves closer to the inflow end of the pouch.

[0156] Example 27. A prosthetic heart valve according to any of the examples in this document (particularly Example 26), wherein the inflow edge portion of the outer skirt is sewn to the inflow edge portion of the inner skirt.

[0157] Example 28. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 26 or 27), wherein the outer skirt wraps around the plurality of vertices at the inlet end of the frame and covers the inner side of the frame.

[0158] Example 29. A prosthetic heart valve according to any of the examples in this document (particularly Example 28), wherein the inflow edge portion of the outer skirt extends circumferentially around the inner side of the frame.

[0159] Example 30. A prosthetic heart valve according to any of the examples herein (particularly any one of Examples 26-29), wherein the inner skirt has an inner side opposite to the 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, on the inner side of the frame, and contacts the inner side of the inner skirt.

[0160] Example 31. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 26-30), wherein the inner skirt does not extend beyond the inlet end of the frame.

[0161] Example 32. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 26-31), wherein when the frame is in the radially expanded state, the apex is spaced at least 0.5 mm from the inflow end of the pouch.

[0162] Example 33. A prosthetic heart valve according to any of the examples in this document (in particular any one of Examples 26-32), wherein the pouch portion is hollow.

[0163] Example 34. A prosthetic heart valve according to any of the examples herein (in particular any one of Examples 26-33), wherein the plurality of leaflets do not extend beyond the inflow end of the frame and are completely positioned between the inflow end and the outflow end of the frame.

[0164] Example 35. The prosthetic heart valve according to any of the examples herein (particularly any one of Examples 26-34) further includes a stitch coupling the inflow edge portion of the outer skirt to the inflow edge portion of the inner skirt, wherein the stitch is spaced approximately 0.5 mm from the inflow end of the outer skirt.

[0165] Example 36. A method for assembling a prosthetic heart valve, comprising: The inner skirt is mounted on the inside of a radially compressible and expandable frame, wherein the frame has an inlet end and an outlet end, as well as multiple vertices at the inlet end; The outer skirt is installed on the outside of the frame; A leaflet assembly comprising multiple leaflets is installed into the frame such that the leaflet assembly is completely positioned within the frame between the inflow end and the outflow end of the frame. The inner skirt and the outer skirt are sewn together such that the inner skirt and / or the outer skirt form a pouch at the inflow end of the frame, or a third skirt is sewn to the inner skirt and the outer skirt such that the third skirt extends beyond the inflow end of the frame and forms the pouch, wherein the plurality of vertices are disposed in the pouch, and wherein the pouch has an inflow end that is separated from the plurality of vertices of the frame when the frame is in a radially expanded state.

[0166] Example 37. The method according to any example in this document (particularly Example 36), wherein sewing the inner skirt and the outer skirt together includes sewing the inner skirt and the outer skirt together at the pocket-shaped portion, such that both the inner skirt and the outer skirt form the pocket-shaped portion.

[0167] Example 38. The method according to any example in this document (in particular any one of Examples 36 or 37), wherein sewing the inner skirt and the outer skirt together includes sewing the inner skirt and the outer skirt together at the inlet end of the bag-shaped portion.

[0168] Example 39. The method according to any example herein (particularly Example 36) further includes 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 bag-like portion, and wherein sewing the inner skirt and the outer skirt together includes sewing the inner skirt to the outer skirt on the outer side of the frame.

[0169] Example 40. The method according to any example in this document (especially Example 39), wherein mounting the inner skirt on the frame includes 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 the inner skirt is wrapped around the inflow end of the frame.

[0170] Example 41. The method according to any example in this document (in particular any one of Examples 39 or 40), wherein sewing the inner skirt and the outer skirt together includes maintaining a distance of about 0.5 mm between the inlet end of the inner skirt and the stitch.

[0171] Example 42. The method according to any example herein (particularly Example 36) further includes wrapping the outer skirt around the inflow end of the frame on the inside of the frame such that the outer skirt forms the bag-like portion, and wherein sewing the inner skirt and the outer skirt together includes sewing the outer skirt to the inner skirt on the inside of the frame.

[0172] Example 43. The method according to any example in this document (especially Example 42), wherein mounting the outer skirt to the frame includes 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 the outer skirt is wrapped around the inflow end of the frame.

[0173] Example 44. The method according to any example in this document (in particular any one of Examples 42 or 43), wherein sewing the inner skirt and the outer skirt together includes maintaining a distance of approximately 0.5 mm between the inlet end of the outer skirt and the stitch.

[0174] Example 45. The method according to any of the examples herein (particularly any one of Examples 36-44), wherein mounting the inner skirt on the inner side of the frame includes sewing the inner skirt to the frame with a first row of posts, wherein mounting the outer skirt on the outer side of the frame includes sewing the outer skirt to the frame with a second row of posts, the second row of posts being positioned closer to the inflow end of the frame than the first row of posts.

[0175] Example 46. The method according to any example (particularly Example 45) herein, wherein mounting the inner skirt on the inside of the frame further comprises aligning the outgoing edge portion of the inner skirt with the first row of posts before sewing the inner skirt to the first row of posts, such that a plurality of slits included on the outgoing edge portion of the inner skirt are positioned at a distance of at most 0.5 mm from the joint between adjacent posts in the first row of posts.

[0176] Example 47. The method according to any example in this document (especially Example 36), wherein sewing the third skirt to the inner skirt and the outer skirt includes sewing a first end portion of the third skirt to the inflow edge portion of the inner skirt and sewing a second end portion of the third skirt to the inflow edge portion of the outer skirt.

[0177] Example 48. The method according to any of the examples in this document (in particular any one of Examples 36-47), wherein when the frame is in the radially extended state, the inflow end of the bag-shaped portion is spaced at least 0.5 mm from the plurality of vertices of the frame.

[0178] Example 49. The method according to any of the examples in this document (in particular any of Examples 36-48), wherein the bag-shaped portion is hollow.

[0179] Example 50. The method according to any of the examples in this document (in particular any of Examples 36-49), wherein the bag-shaped portion extends circumferentially around the inflow end of the frame.

[0180] Example 51. A prosthetic heart valve, comprising: An annular frame, the annular frame including an inflow end and an outflow end, wherein the frame is radially compressed and expanded between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of vertices at the inflow end; Leaflet assembly, the leaflet assembly being positioned within and coupled to the frame, wherein the leaflet assembly includes a plurality of leaflets completely positioned within the frame; Skirt assembly, the skirt assembly comprising: An inner skirt extending circumferentially around the inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; and An outer skirt portion, which is separate from the inner skirt portion, extends circumferentially around the outer side of the frame, wherein the outer skirt portion has an inflow edge portion and an outflow edge portion; The inner skirt and the outer skirt's inflow edge portions are coupled to each other to form a pouch-like portion adjacent to the inflow end of the frame, wherein the apex is disposed in the pouch-like portion, and wherein the pouch-like portion has an inflow end; and When the frame is in the radially extended state, the vertex is spaced apart from the inflow end of the bag-shaped portion, and when the frame is radially compressed from the radially extended state to the radially compressed state, the vertex moves closer to the inflow end of the bag-shaped portion.

[0181] Example 52. A prosthetic heart valve according to 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 pouch.

[0182] Example 53. A prosthetic heart valve according to any example in this document (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 outside of the frame to form the pouch.

[0183] Example 54. A prosthetic heart valve according to 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 pouch.

[0184] Example 55. A prosthetic heart valve according to any example herein (particularly Example 51), wherein the skirt assembly includes a third skirt that is separate from the inner skirt and the outer skirt, the third skirt extending beyond the inlet end of the frame and forming at least a portion of the pouch.

[0185] Example 56. A prosthetic heart valve according to any of the examples herein (particularly Example 55), wherein the third skirt is sewn to the inflow edge portion of the inner skirt and the outer skirt.

[0186] Example 57. A prosthetic heart valve according to any of the examples herein (particularly Example 55 or 56), wherein the inner skirt and / or the outer skirt extends beyond the inlet end of the frame and also forms at least a portion of the pouch, such that the third skirt and the inner skirt and / or the outer skirt form the pouch.

[0187] Example 58. A prosthetic heart valve according to any of the examples in this document (especially Example 55), wherein the third skirt is sewn to itself at the first row of open units of the frame.

[0188] Example 59. A prosthetic heart valve according to any of the examples in this document (particularly Example 55 or 58), wherein the third skirt portion forms the pouch portion separately.

[0189] Example 60. A prosthetic heart valve according to any of the examples herein (in particular any one of Examples 51-59), wherein the inner skirt and / or the outer skirt extends around the third skirt.

[0190] Example 61. A prosthetic valve according to any of the examples herein (particularly any one of Examples 51-60), a prosthetic heart valve according to any one of claims 51-55, wherein the inner skirt is sutured to the frame at or near the inflow edge portion and at or near the outflow edge portion.

[0191] Example 62. A prosthetic valve according to any of the examples herein (in particular any one of Examples 51-61), wherein the outer skirt is sutured to the frame at or near the inflow edge portion and at or near the outflow edge portion.

[0192] Example 63. A prosthetic valve according to any of the examples herein (particularly any one of Examples 51-62), wherein both the inner skirt and the outer skirt are sutured to a first row of struts of the frame via a first set of sutures and 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.

[0193] Example 64. A prosthetic valve according to any of the examples herein (in particular any one of Examples 62 or 63), wherein the outer skirt includes a bundle portion between the inflow edge portion and the outflow edge portion.

[0194] Example 65. A prosthetic valve according to any of the examples in this document (particularly Example 64), wherein the outer skirt is folded in the convergent portion in a zigzag pattern.

[0195] Example 66. A prosthetic valve according to any of the examples in this document (in particular any one of Examples 59 or 60), wherein when the frame is radially compressed, the bundled portion of the outer skirt unfolds and elongates axially.

[0196] Example 67. The prosthetic valve described according to any of the examples in this document (in particular any of Examples 51-66) also includes the subject matter of any of Examples 1-35.

[0197] Given the many possible examples in which the principles of the disclosed invention can be applied, it should be recognized that the illustrated examples are merely preferred examples of the invention and should not be considered as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. Therefore, we claim that our invention is within the scope and spirit of these claims.

Claims

1. A prosthetic heart valve, comprising: An annular frame, the annular frame including an inflow end and an outflow end, wherein the frame is capable of radially compressing and expanding between a radially compressed state and a radially expanded state, wherein the frame includes a plurality of vertices at the inflow end; Leaflet assembly, the leaflet assembly being positioned within and coupled to the frame, wherein the leaflet assembly includes a plurality of leaflets completely positioned within the frame; Skirt assembly, the skirt assembly comprising: An inner skirt that extends circumferentially around the inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion; as well as An outer skirt portion that extends circumferentially around the outer side of the frame, wherein the outer skirt portion has an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the outer skirt portion is sewn to the inflow edge portion of the inner skirt portion; The inflow edge portion of the inner skirt and / or the inflow edge portion of the outer skirt form a pouch-like portion, wherein the apex is disposed in the pouch-like portion, and wherein the pouch-like portion has an inflow end; and When the frame is in the radially extended state, the vertex is spaced apart from the inflow end of the bag-shaped portion, and when the frame is radially compressed from the radially extended state to the radially compressed state, the vertex moves closer to the inflow end of the bag-shaped portion.

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 pouch-like portion.

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 pouch-shaped portion.

4. The prosthetic heart valve according to 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 approximately the same amount.

6. The prosthetic heart valve according to any one of claims 1-5, wherein when the frame is in the radially expanded state, the apex is spaced at least 0.5 mm from the inflow end of the pouch.

7. The prosthetic heart valve according to any one of claims 1-6, wherein the pouch extends circumferentially around the inlet end of the frame.

8. The prosthetic heart valve according to any one of claims 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.

9. The prosthetic heart valve according to any one of claims 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 from the junction of the two struts of the frame by up to 0.5 mm.

10. The prosthetic heart valve according to any one of claims 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.

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