Outer covering with protruding sealing members for prosthetic heart valves - Patents.com

Abstract

A sealing member for an outer skirt of a prosthetic heart valve is disclosed. By way of example, the prosthetic heart valve may include an annular frame, a plurality of leaflets disposed within the frame, and an outer skirt disposed about an outer surface of the frame. The outer skirt may include at least one folded portion and stitches extending through the folded portion to form a radially projecting rib.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 267,382, filed January 31, 2022, which is incorporated by reference in its entirety herein.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to prosthetic heart valves, and more particularly to an outer covering or skirt having protruding sealing members for prosthetic heart valves. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can cause serious malfunctions of the heart, eventually requiring repair of the native valve or replacement of the native valve with an artificial valve. Numerous repair devices (e.g., stents) and artificial valves are known, as are numerous methods for implanting the devices and valves in humans. Percutaneous and minimally invasive surgical approaches can be used in a variety of procedures to deliver artificial medical devices to locations within a patient's body that are not easily accessible by surgery and where access without surgery is desirable. In one embodiment, an artificial heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon in which the prosthetic valve is mounted, or by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device and allowing the prosthetic valve to self-expand to its functional size.

[0004] Most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. These valves also include one or more coverings (or skirts) on the inner or outer surface of the frame that run around the frame. These coverings can be configured to seal closely with the native tissue when the prosthetic heart valve is placed at the implantation site (and thus may be referred to as sealing members). However, the native tissue (e.g., the native annulus or arterial wall surrounding the native valve) may have an irregular shape, while the frame of the prosthetic heart valve is generally cylindrical. As a result, even with a covering on the prosthetic heart valve, gaps may form between the prosthetic heart valve and the native heart valve when the prosthetic heart valve is implanted within the native heart valve. Summary of the Invention

[0005] Described herein are prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves. In particular, described herein are examples of coverings for prosthetic heart valves, and methods of making and using such coverings. The prosthetic heart valve can include a frame and a leaflet assembly disposed on an inner surface of the frame. The prosthetic heart valve can include a covering disposed around a periphery of the frame and on an outer surface of the frame. The covering can include one or more sealing members that protrude radially outward and away from the frame. In some embodiments, the one or more sealing members can extend circumferentially around the frame. The one or more sealing members can be configured to better conform to the shape of the surrounding autologous tissue when the prosthetic heart valve is implanted. Thus, the coverings and prosthetic heart valves disclosed herein can overcome, among other things, one or more deficiencies of typical prosthetic heart valves.

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

[0007] In some examples, the prosthetic heart valve can include a sealing member configured to reduce paravalvular leakage.

[0008] In some embodiments, the prosthetic heart valve can include a frame, a valvular structure disposed within the frame, and an outer skirt or sealing member disposed about an outer surface of the frame, the outer skirt including one or more sealing members projecting radially outward and away from the frame and extending circumferentially around the frame.

[0009] In some embodiments, the prosthetic heart valve comprises an annular frame, a plurality of leaflets disposed within the frame, and an outer skirt disposed about an outer surface of the frame, the outer skirt comprising at least one folded portion and stitches extending through the folded portion to form radially projecting ribs.

[0010] In some embodiments, the prosthetic heart valve includes an annular frame including a plurality of interconnected struts and an outer skirt disposed on and around an outer surface of the frame, the outer skirt comprising an inner surface disposed against the outer surface of the frame and an outer surface disposed opposite the inner surface, a first row of first openings extending circumferentially of the first openings and a second row of second openings extending circumferentially of the second openings, a plurality of stitches formed between the first row and the second row, each stitch of the plurality of stitches extending between a respective one of the first openings and a respective one of the second openings, and a folded portion of the outer skirt between the first and second rows of openings forming a rib that projects radially outward from the outer surface of the outer skirt and away from the frame.

[0011] In some embodiments, the prosthetic heart valve comprises an annular frame including a plurality of interconnected struts, a plurality of leaflets disposed within the frame, and an outer skirt disposed on and around an outer surface of the frame. The outer skirt comprises an inflow edge secured to an inflow end of the frame, an outflow edge secured to a first portion of the plurality of interconnected struts, opposing inner and outer surfaces, the inner surface facing and disposed against the outer surface of the frame, and a sealing member that spirals around a circumference of the outer skirt between and toward the inflow and outflow edges. The sealing member comprises a folded portion of the outer skirt that extends radially outward from the outer surface of the outer skirt and away from the frame.

[0012] In some embodiments, the prosthetic heart valve comprises a radially expandable and compressible annular frame, a plurality of valve leaflets disposed within the frame, and an outer skirt disposed about an outer surface of the frame with one or more folded portions forming one or more radially outwardly protruding ribs that maintain the folded state when the prosthetic heart valve is in a radially compressed state and a radially expanded state.

[0013] In some embodiments, the prosthetic heart valve includes one or more of the components listed in Examples 1-73 below.

[0014] In some embodiments, a method of assembling a prosthetic heart valve includes securing a fabric skirt around an outer surface of a frame of the prosthetic heart valve; extending sutures in an alternating pattern between a first opening of a first row of spaced apart first openings in the skirt and a second opening of a second row of spaced apart second openings in the skirt, where the first and second rows extend circumferentially along the skirt and are axially spaced from one another; and tightening the sutures to form a protruding rib between the first row and the second row, where the protruding rib includes a folded portion of the skirt that protrudes radially outward from a remainder of the skirt that is disposed against the frame.

[0015] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce in a simplified form a selection of various concepts that are further described in the Detailed Description below. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the Detailed Description below, from the claims, and from the accompanying drawings. [Brief description of the drawings]

[0016] [Figure 1A] FIG. 1A is a perspective view of an example of a prosthetic valve that includes a frame and multiple leaflets attached to the frame. [Figure 1B] FIG. 1B is a perspective view of the prosthetic valve of FIG. 1A, with an outer skirt disposed about the frame. [Diagram 2] FIG. 2 is a side view of a delivery device for a prosthesis, such as an artificial valve, according to one embodiment. [Figure 3A] FIG. 3A is a side view of an outer skirt for a prosthetic heart valve, according to one embodiment, showing the outer skirt in a flattened configuration. [Figure 3B] FIG. 3B is a side view of an outer skirt for a prosthetic heart valve according to another embodiment, the outer skirt shown in a flattened configuration and including a row of apertures. [Figure 4A] FIG. 4A is a perspective view of the outer skirt of FIG. 3B disposed around an exemplary frame of a prosthetic heart valve, the outer skirt including radially outwardly protruding sealing members configured as spiral ribs. [Figure 4B] FIG. 4B is another perspective view of an outer skirt disposed about the exemplary frame of FIG. 4A. [Figure 5A] FIG. 5A is a perspective view of the outer skirt of FIG. 3B secured around an exemplary frame of a prosthetic heart valve. [Figure 5B] FIG. 5B is a perspective view showing a portion of a method for forming the spiral ribs of FIGS. 4A-4B, including extending sutures through an outer skirt disposed about the exemplary frame of FIG. 5A and a row of adjacent openings in the outer skirt. [Figure 5C] FIG. 5C is a perspective view of an outer skirt disposed about the exemplary frame of FIG. 5A and having a spiral rib formed around the frame in two revolutions. [Figure 5D] FIG. 5D is another perspective view of the spiral ribs extending radially outward from the outer skirt of FIG. 5C. [Figure 5E] FIG. 5E is yet another perspective view of a spiral rib extending radially outward from the outer skirt of FIG. 5C. [Figure 6A] FIG. 6A is a perspective view of an outer skirt disposed around a frame of a prosthetic heart valve, the outer skirt including a radially outwardly projecting sealing member configured as a spiral rib that rotates around the outer skirt and frame. [Figure 6B] FIG. 6B is another perspective view of the outer skirt and full-turn spirally arranged ribs of FIG. 6A. [Figure 7A] FIG. 7A is a perspective view of an outer skirt disposed about the frame of a prosthetic heart valve having a single radially protruding circular rib formed on the outer skirt. [Figure 7B] FIG. 7B is another perspective view of the outer skirt and circular rib of FIG. 7A. [Figure 8A] FIG. 8A is a perspective view of an outer skirt disposed around a frame of a prosthetic heart valve, illustrating how multiple circular ribs are formed in the outer skirt by utilizing multiple sutures extending through a row of multiple openings in the outer skirt. [Figure 8B] FIG. 8B is a perspective view of the outer skirt of FIG. 8A with a plurality of circular ribs formed thereon. [Figure 8C]FIG. 8C is another perspective view of the outer skirt of FIG. 8A showing a plurality of circular ribs formed on the outer skirt that project radially outward from the outer skirt and frame. [Figure 9A] FIG. 9A is a detailed view of a portion of an outer skirt for a prosthetic heart valve illustrating a method for forming radially outwardly protruding ribs by extending sutures in an alternating pattern between openings in two adjacent circumferentially extending rows of openings. [Figure 9B] FIG. 9B is a detailed view of a portion of the outer skirt shown in FIG. 9A having radially outwardly projecting ribs formed thereon. [Figure 9C] FIG. 9C is another detailed view of a portion of the outer skirt shown in FIG. 9A having radially outwardly projecting ribs formed thereon. [Figure 10A] FIG. 10A is a detailed view of a portion of an outer skirt for a prosthetic heart valve illustrating a method for forming radially outwardly protruding ribs by extending sutures in an alternating pattern between openings in a row of three adjacent circumferentially extending openings. [Figure 10B] FIG. 10B is a detailed view of a portion of the outer skirt shown in FIG. 10A having radially outwardly projecting ribs formed thereon. [Figure 11A] FIG. 11A is a detailed view of a portion of an outer skirt for a prosthetic heart valve illustrating a method for forming radially outwardly protruding ribs by extending sutures through one layer of the folded portion of the outer skirt in an alternating pattern between openings of two adjacent circumferentially extending rows of openings. [Figure 11B] FIG. 11B is a detailed view of a portion of the outer skirt shown in FIG. 11A having radially outwardly projecting ribs formed thereon. [Figure 12A]FIG. 12A is a detailed view of a portion of an outer skirt for a prosthetic heart valve illustrating a method for forming radially outwardly protruding ribs by extending sutures through both layers of the folded portion of the outer skirt in an alternating pattern between openings of two adjacent circumferentially extending rows of openings. [Figure 12B] FIG. 12B is a detailed view of a portion of the outer skirt of FIG. 12A having radially outwardly projecting ribs formed thereon. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the examples of the disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, both alone and in various combinations and subcombinations. The methods, devices, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the methods, devices, and systems require that any one or more particular advantages be present or problems be solved.

[0018] Although operations in some disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that aspects of the description encompass reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may in some cases be reordered or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed methods may be used in combination with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0019] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically connect or couple, and does not exclude the presence of intermediate elements between connected or associated members, unless specifically stated to the contrary.

[0020] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site toward the user (e.g., outside the patient's body), while distal movement of a device is movement of the device away from the user toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending proximally and distally, unless expressly defined otherwise.

[0021] Overview of the disclosed technology The prosthetic valves disclosed herein can be radially collapsible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held by the implant delivery device in a radially compressed state while being driven forward through the patient's vasculature on the delivery device. The prosthetic valve can be expanded to a radially expanded state once the prosthetic valve reaches the implantation site. It will be appreciated that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which are described in more detail below.

[0022] As mentioned above, most expandable prosthetic heart valves include a cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. These valves may also include one or more coverings (or skirts) on the inner or outer surface of the frame that span the periphery of the frame. These coverings may be configured to establish a seal with the native tissue when the prosthetic heart valve is radially expanded at the implantation site (and thus may be referred to as sealing members). However, the native tissue may have an irregular shape, while the frame of the prosthetic heart valve is generally cylindrical. As a result, even with a covering on the prosthetic heart valve, gaps may form between the prosthetic heart valve and the native heart valve when the prosthetic heart valve is implanted within the native heart valve. Thus, there is a need for improved coverings for prosthetic heart valves that can better fill the gaps between the native tissue and the prosthetic heart valve.

[0023] Described herein is an outer skirt or sealing member having one or more sealing members projecting radially outward from a base surface of the outer skirt and frame and configured to improve sealing of the prosthetic heart valve against the native tissue at the implantation site, which can result in reduced paravalvular leakage.

[0024] 1A-1B show an exemplary prosthesis (e.g., a prosthetic heart valve) that can be advanced through a patient's vasculature, such as to a native heart valve, by a delivery device, such as the exemplary delivery device shown in FIG. 2. The prosthetic heart valve can include an outer covering or skirt disposed about an outer surface of a frame of the prosthetic heart valve. The outer skirt can include one or more sealing members that protrude radially outward from a base surface of the outer skirt and frame and are configured to improve sealing of the prosthetic heart valve against the native tissue at the implantation site. Various examples of protruding sealing members for the outer skirt, and methods of forming these protruding sealing members, are shown in FIGS. 4A-12B.

[0025] Examples of the disclosed technology 1A-1B show an exemplary prosthetic valve 100, according to one embodiment. While any of the prosthetic valves disclosed herein are configured to be implanted into the native aortic valve annulus, in other embodiments, they may be configured to be implanted into other native valve annuluses of the heart (pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves may also be implanted into blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of the patient. The disclosed prosthetic valves may also be implanted into a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0026] In some embodiments, the disclosed prosthetic valves can be implanted within a docking device or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in U.S. Patent Application Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within or within a native mitral valve, as disclosed, for example, in WO 2020 / 247907, which is incorporated herein by reference. In another embodiment, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed, for example, in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0027] 1A-1B show an example of a prosthetic valve 100 (sometimes referred to herein as a prosthetic heart valve 100) having a frame 102. Figures 1A-1B show the frame 102 having a valvular structure 150 (which may include valve leaflets 158, as described further below) mounted within and relative to the annular frame 102. Figure 1B further shows an optional skirt assembly comprising an outer skirt 103.

[0028] As shown in FIGS. 1A and 1B, the valve structure 150 is coupled to and supported within the frame 102. The valve structure 150 is configured to regulate blood flow through the prosthetic valve 100 from the inflow end 134 to the outflow end 136. The valve structure 150 may include a leaflet assembly including one or more leaflets 158 made, for example, of a flexible material. The leaflets 158 may be made, in whole or in part, from a biological material, from a biocompatible synthetic material, or from other such materials. Suitable biological materials may include, for example, bovine pericardium (or pericardium from other sources). The leaflets 158 may be secured to one another at their adjacent sides to form commissures 152, each of which may be secured to a respective commissure support structure 144 (also referred to herein as a "commissure support") and / or other portions of the frame 102, as described in more detail below.

[0029] 1A and 1B, the valvular structure 150 includes three leaflets 158 that can be configured to collapse in a tricuspid arrangement. Each leaflet 158 ​​may have an inflow edge 160 (which may also be referred to as a leaflet edge) (FIG. 1A). The inflow edges 160 of the leaflets 158 may define an undulating, curved, scallop-shaped edge that circumferentially follows or tracks portions of the struts 112 of the frame 102 when the frame 102 is in a radially expanded configuration. Thus, the inflow edges 160 of the leaflets 158 may also be referred to as a "scallop line."

[0030] The prosthetic valve 100 may include one or more skirts attached around the frame 102. For example, as shown in FIG. 1B, the prosthetic valve 100 may include an outer skirt 103 (which may also be referred to herein as a covering or sealing member) attached around the outer surface of the frame 102. The outer skirt 103 may function as a sealing member for the prosthetic valve 100 by sealing against the tissue of the native annulus, helping to reduce paravalvular leakage through the prosthetic valve 100. In some cases, an inner skirt (not shown) may be attached around the inner surface of the frame 102. The inner skirt may function as a sealing member to prevent or reduce paravalvular leakage, secure the leaflets 158 to the frame 102, and / or protect the leaflets 158 from damage caused by contact with the frame 102 during crimping and during the work cycle of the prosthetic valve 100. In some examples, the inflow edge 160 of the leaflets 158 may be sutured to the inner skirt, generally along the scallop line. The inner skirt may then be sewn to the adjacent struts 112 of the frame 102. In other embodiments, as shown in FIG 1A, the leaflets 158 may be sewn directly to the frame 102 or to the reinforcement member 125 (also referred to as a reinforcement skirt or connecting skirt) in the form of a strip of material (e.g., a piece of fabric) that is then sewn to the frame 102 along the scallop line via stitches (e.g., whip stitches) 133.

[0031] The inner and outer skirts, and the connecting skirt 125, may be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials, including textiles (e.g., woven polyethylene terephthalate textiles), or autologous tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Publication No. 2020 / 0352711, which is incorporated by reference herein in its entirety.

[0032] Further details regarding the assembly of the leaflet assembly and the assembly of the leaflets and skirt to the frame can be found, for example, in U.S. Provisional Patent Application No. 63 / 209,904, filed June 11, 2021, and No. 63 / 224,534, filed July 22, 2021, which are incorporated by reference herein. Further details of the structure and function of the frame 102 can be found in International Patent Application No. PCT / US2021 / 052745, filed September 30, 2021, which are incorporated by reference herein.

[0033] The frame 102 includes an inflow end 109, an outflow end 108, and a number of axially extending posts 104. The axial direction of the frame 102 is indicated by a longitudinal axis 105 extending from the inflow end 109 to the outflow end 108 (FIG. 1A). Some of the posts 104 may be disposed in axially aligned pairs of first and second struts or posts 122, 124 (FIG. 1A). An actuator 126 (such as a threaded rod or bolt as shown) may extend through one or more pairs of the posts 122, 124 to form an integrated expansion and locking mechanism or actuator mechanism 106 configured to radially expand and compress the frame 102, as described further below. One or more of the posts 104 may be configured as a support post 107.

[0034] The actuator mechanism 106 (which may be used to radially expand and / or radially compress the prosthetic valve 100) may be incorporated into the frame 102 of the prosthetic valve 100, thereby reducing the crimp profile and / or bulk of the prosthetic valve 100. Incorporating the actuator mechanism 106 (which may also be referred to herein as an "expansion and locking mechanism") into the frame 102 may simplify the design of the prosthetic valve 100, thereby reducing the cost and / or ease of manufacture of the prosthetic valve 100. In the illustrated embodiment, an actuator 126 extends through each pair of axially aligned posts 122, 124. In other embodiments, one or more of the pairs of posts 122, 124 may not have a corresponding actuator.

[0035] The posts 104 may be linked together by a plurality of circumferentially extending link members or struts 112. Each strut 112 extends circumferentially between adjacent struts 104 and connects all of the axially extending struts 104. As an example, the prosthetic valve 100 may include an equal number of support posts 107 and pairs of actuator posts 122, 124, as well as pairs of posts 122, 124, and the support posts 107 may be arranged in an alternating order such that each strut 112 is positioned between one of the pairs of posts 122, 124 and one of the support posts 107 (i.e., each strut 112 may be coupled at one end to one of the posts 122, 124 and at the other end to one of the support posts 107). However, the prosthetic valve 100 may include a different number of support posts 107 and paired posts 122, 124, and / or the paired posts 122, 124 and support posts 107 may be arranged in a non-alternating order in other embodiments.

[0036] The struts 112 can form and / or define a number of cells (i.e., openings) in the frame 102. For example, the struts 112 can at least partially form and / or define a number of first cells 117 and a number of second cells 118 that extend circumferentially around the frame 102. As shown in FIG. 1A, the second cells 118 can each be disposed within one of the first cells 117.

[0037] As shown in FIGS. 1A and 1B, the struts 112 of the frame 102 may have a curved shape. Each first cell 117 may have an axially extending hexagonal shape including a first and second apex 119 (e.g., an inflow apex 119a and an outflow apex 119b). In embodiments where a delivery device is removably connected to the outflow apex 119b (as described below), each inflow apex 119a may be referred to as a "distal apex" and each outflow apex 119b may be referred to as a "proximal apex." Each second cell 118 may have a diamond shape including a first and second apex 120 (e.g., a distal apex 120a and a proximal apex 120b) (FIG. 1A). In some embodiments, the frame 102 includes six first cells 117 extending circumferentially in a row, six second cells 118 extending circumferentially in a row within the six first cells 117, and twelve posts 104. However, in some embodiments, frame 102 may include a greater or lesser number of first cells 117 and a corresponding greater or lesser number of second cells 118 and posts 104 .

[0038] As mentioned above, some of the posts 104 may be arranged in pairs of first and second posts 122, 124. The posts 122, 124 are aligned with one another along the length of the frame 102 and axially separated from one another by a gap (the posts having actuators 126 may be referred to as actuator posts or actuator struts). Each first post 122 (i.e., the lower post shown in FIG. 1A) may extend axially from the inflow end 109 of the prosthetic valve 100 toward the second post 124, and each second post 124 (i.e., the upper post shown in FIGS. 1A and 1B) may extend axially from the outflow end 108 of the prosthetic valve 100 toward the first post 122. For example, each first post 122 may be connected to and extend from the inflow apex 119a, and each second post 124 may be connected to and extend from the outflow apex 119b. Each of the first post 122 and second post 124 may include an internal bore configured to receive a portion of an actuator member, such as in the form of a substantially straight threaded rod 126 (or bolt) as shown in the illustrated embodiment. The threaded rod 126 may also be referred to herein as the actuator 126, the actuator member 126, and / or the screw actuator 126. In embodiments in which the delivery device is removably connectable to the outflow end 108 of the frame 102, the first post 122 may be referred to as the distal post or distal axial strut, and the second post 124 may be referred to as the proximal post or proximal axial strut.

[0039] Each threaded rod 126 extends axially through a corresponding first post 122 and second post 124. Each threaded rod 126 also extends through a hole in a nut 127 that is captured in a slot or window formed in an end 128 of the first post 122 (FIG. 1A). The threaded rod 126 has external threads that engage with internal threads of the hole in the nut 127. The inner hole of the second post 124 (through which the threaded rod 126 extends) may have a smooth and / or unthreaded inner surface to allow the threaded rod 126 to slide freely within the hole. Rotation of the threaded rod 126 relative to the nut 127 causes the frame 102 to radially expand and compress, as described further below.

[0040] In some embodiments, the threaded rod 126 may pass through the nut 127 and extend into an inner bore of the first post 122 toward the inflow end 109 of the frame 102. The nut 127 may be held in a fixed position relative to the first post 122 such that the nut 127 does not rotate relative to the first post 122. In this way, whenever the threaded rod 126 is rotated (e.g., by a physician), the threaded rod 126 can rotate relative to both the nut 127 and the first post 122. The engagement of the outer threads of the threaded rod 126 with the inner threads of the nut 127 prevents the rod 126 from moving axially relative to the nut 127 and first post 122 unless the threaded rod 126 is rotated relative to the nut 127. Thus, the threaded rod 126 may be held or supported by the nut 127 and may only be moved relative to the nut 127 and / or first post 122 by rotating the threaded rod 126 relative to the nut 127 and / or first post 122. In other examples, instead of using a nut 127, at least a portion of an internal bore of the first post 122 may be threaded. For example, a bore along the end 128 of the first post 122 may be provided with internal threads that engage with the externally threaded rod 126 such that rotation of the threaded rod causes the threaded rod 126 to move axially relative to the first post 122.

[0041] When the threaded rod 126 extends through and / or is otherwise coupled to a pair of axially aligned posts 122, 124, the pair of axially aligned posts 122, 124 and the threaded rod 126 can function as one of the expansion and locking mechanisms 106. In some embodiments, the threaded rod 126 can extend through each pair of axially aligned posts 122, 124 such that all of the posts 122, 124 (with their corresponding rods 126) function as expansion and locking mechanisms 106. As an example, the prosthetic valve 100 can include six pairs of posts 122, 124, and each of the six pairs of posts 122, 124 with their corresponding rods 126 can be configured as one of the expansion and locking mechanisms 106, totaling six expansion and locking mechanisms 106. In other embodiments, not all pairs of posts 122, 124 need to be expansion and locking mechanisms (i.e., actuators). If the pair of posts 122, 124 is not used as an expansion and locking mechanism, the threaded rod 126 does not need to extend through the pair of posts 122, 124.

[0042] The threaded rod 126 can rotate relative to the nut 127, the first post 122, and the second post 124 to axially shorten and / or axially lengthen the frame 102, thereby radially expanding and / or radially compressing the frame 102 (and thus the prosthetic valve 100), respectively. Specifically, as the threaded rod 126 rotates relative to the nut 127, the first post 122, and the second post 124, the first and second posts 122, 124 can move axially relative to one another, thereby widening or narrowing the gap separating the posts 122, 124, and radially compressing or radially expanding the prosthetic valve 100, respectively. Thus, the gap between the first and second posts 122, 124 narrows as the frame 102 is radially expanded, and widens as the frame 102 is radially compressed.

[0043] The threaded rod 126 may extend proximally beyond the proximal end of the second post 124 and may include a head 131 at its proximal end that may serve at least two functions. First, the head 131 may removably or releasably couple the threaded rod 126 to a respective actuator assembly of a delivery device that may be used to radially expand and / or radially compress the prosthetic valve 100 (e.g., the delivery device 200 of FIG. 2, as described below). Second, the head 131 may prevent the second post 124 from moving proximally relative to the threaded rod 126 and may apply a distally directed force to the second post 124, such as when radially expanding the prosthetic valve 100. Specifically, the head 131 may be of a width greater than the diameter of the inner bore of the second post 124 to prevent the head 131 from moving into the inner bore of the second post 124. Thus, as the threaded rod 126 is further threaded into the nut 127, the head portion 131 of the threaded rod 126 is drawn closer to the nut 127 and the first post 122, thereby drawing the second post 124 toward the first post 122 and causing the artificial valve 100 to shorten axially and expand radially.

[0044] The threaded rod 126 may also include a stopper 132 (e.g., in the form of a nut, washer, or flange) disposed thereon (FIG. 1A). Additionally, the stopper 132 may be integrally formed on or fixedly coupled to the threaded rod 126 such that it does not move relative to the threaded rod 126. Thus, the stopper 132 may remain in a fixed axial position on the threaded rod 126 such that it moves in lockstep with the threaded rod 126.

[0045] Rotating the threaded rod 126 in a first direction (e.g., clockwise) can move the first and second posts 122, 124 in corresponding axial directions, thereby causing the frame 102 to expand radially, while rotating the threaded rod 126 in an opposite second direction can move the first and second posts 122, 124 away from one another in corresponding axial directions, thereby causing the frame to compress radially. As the threaded rod 126 rotates in the first direction, the head 131 of the rod 126 abuts an adjacent surface of the frame (e.g., the outflow apex 119b), while the nut 127 and first post 122 move proximally along the threaded rod 126 toward the second post 124, thereby causing the frame to expand radially. As the frame 102 moves from the radially compressed configuration to the radially expanded configuration, the gap between the first and second posts 122, 124 can be narrowed.

[0046] As the threaded rod 126 rotates in the second direction, the threaded rod 126 and stopper 132 move toward the outflow end 108 of the frame until the stopper 132 abuts the inflow end 170 of the second post 124 (FIG. 1A). As the rod 126 rotates further in the second direction, the stopper 132 can exert a proximally directed force on the second post 124, radially compressing the frame 102. Specifically, during crimping / radial compression of the prosthetic valve 100, the threaded rod 126 can rotate in the second direction (e.g., counterclockwise) to cause the stopper 132 to press against (i.e., provide a proximally directed force on) the inflow end 170 of the second post 124, thereby moving the second post 124 away from the first post 122 and causing the prosthetic valve 100 to elongate axially and compress radially.

[0047] Thus, each of the second posts 124 can slide axially relative to a corresponding one of the first posts 122, but can be axially held and / or restrained between the head 131 and stopper 132 of the threaded rod 126. That is, each second post 124 can be restrained at its proximal end by the head 131 of the threaded rod 126 and at its distal end by the stopper 132. In this manner, the head 131 can apply a distally directed force to the second post 124 to radially expand the prosthetic valve 100, while the stopper 132 can apply a proximally directed force to the second post 124 to radially compress the prosthetic valve 100. As described above, axially expanding the prosthetic valve 100 shortens the prosthetic valve 100, causing the inflow and outflow ends 134, 136 (Figures 1A and 1B) of the prosthetic valve 100 to move axially toward each other, while axially compressing the prosthetic valve 100 lengthens the prosthetic valve 100, causing the inflow and outflow ends 134, 136 to move axially away from each other.

[0048] In other embodiments, the threaded rod 126 can be fixed against axial movement relative to the second post 124 (and the stopper 132 can be omitted) such that rotation of the threaded rod 126 in a first direction moves the nut 127 proximally and causes the frame 102 to expand radially, and rotation of the threaded rod 126 in a second direction moves the nut 127 distally and causes the frame 102 to compress radially.

[0049] As introduced above, some of the posts 104 may be configured as support posts 107. As shown in FIG. 1A, the support posts 107 may extend axially between the inflow and outflow ends 108, 109 of the frame 102 and each may have an inflow end 138 and an outflow end 139. The outflow end 139 of one or more of the support posts 107 may include a commissure support structure or member 144. The commissure support structure 144 may include a strut portion defining a commissure opening therein.

[0050] The commissure openings (which may also be referred to herein as "commissure windows") may extend radially through the thickness of the support posts 107 and may be configured to receive a portion of the valvular structure 150 (e.g., the commissures 152) to couple the valvular structure 150 to the frame 102. For example, each commissure 152 may be attached to a respective commissure support structure 144, such as by inserting a pair of commissure tabs of adjacent leaflets 158 through the commissure openings and suturing the commissure tabs to each other and / or to the commissure support structure 144. In some examples, the commissure openings may be completely occluded by the support posts 107 such that a portion of the valvular structure 150 may be slid radially through the commissure openings from the interior to the exterior of the frame 102 during assembly.

[0051] Frame 102 may include any number of support posts 107, any number of which may be configured as commissure support structures 144. For example, frame 102 may include six support posts 107, three of which may be configured as commissure support structures 144. However, in other embodiments, frame 102 may include more or less than six support posts 107 and / or more or less than three commissure support structures 144.

[0052] The inflow end 138 of each support post 107 may include an extension 154 (shown as a cantilevered strut in FIG. 1A ) that extends toward the inflow end 109 of the frame 102. In some embodiments, the extension 154 may extend such that the inflow edge of the extension 154 is aligned or substantially aligned with the inflow end 109 of the frame 102. In use, the extension 154 may prevent or reduce a portion of the outer skirt 103 from extending radially inward, thereby preventing or reducing any obstruction to flow through the frame 102 by the outer skirt 103. The extension 154 may further function as a support that may connect portions of the inner and / or outer skirts and / or leaflets and / or connecting skirt 125. For example, sutures used to connect the inner and / or outer skirts and / or leaflets and / or connecting skirt 125 may be wrapped around the extension 154 and / or extend through openings in the extension 154.

[0053] Each extension 154 may have openings or other features for receiving sutures or other attachment material for connecting adjacent inflow edges 160 (FIG. 1A), outer skirt 103 (FIG. 1B), connecting skirt 125, and / or inner skirt of leaflets 158. In some embodiments, the inflow edges 160 of each leaflet 158 ​​may be connected to a corresponding extension via sutures 135 (FIG. 1A).

[0054] In some embodiments, the outer skirt 103 can be fitted around the outer surface of the frame 102 as shown in FIG. 1B, and the inflow edge (lower edge in FIG. 1B) of the outer skirt 103 can be attached to the inflow edge 160 of the leaflet 158 ​​already secured to the connecting skirt 125 and / or frame 102, as well as to the extension 154 of the frame by sutures 129. The outflow edge (upper edge in FIG. 1B) of the outer skirt 103 can be attached to selected struts by stitches 137. In implementations where the prosthetic valve includes an inner skirt, the inflow edge of the inner skirt can be secured to the inflow edge 160 prior to securing the leaflet edge to the frame, such that the inner skirt is between the leaflet and the inner surface of the frame. After the inner skirt and leaflets are secured in place, the outer skirt can be fitted around the frame as described above.

[0055] The frame 102 may be a unitary and / or fastener-less frame that may be constructed from a single material (e.g., Nitinol, stainless steel, or cobalt chrome alloy), such as in the form of a tube. Multiple cells may be formed by partially removing the single material (e.g., via laser cutting). The threaded rod 126 may be formed separately and then inserted through a hole in the second (proximal) post 124 and threaded into the threaded nut 127.

[0056] In some embodiments, the frame 102 may be formed from a plastically expandable material (e.g., stainless steel, etc.). If the frame is formed from a plastically expandable material, the prosthetic valve 100 may be placed in a radially compressed state along the distal end of a delivery device for insertion into the patient's body. When at the desired implantation site, the frame 102 (and thus the prosthetic valve 100) may be radially expanded from the radially compressed state to a radially expanded state via actuation of an actuation assembly of the delivery device (as described further below), which rotates the rod 126 to expand the frame 102. During delivery to the implantation site, the prosthetic valve 100 may be placed inside a delivery capsule (sheath) to protect the prosthetic valve from contacting the patient's vasculature, such as when the prosthetic valve is advanced through the femoral artery. The capsule may also hold the prosthetic valve in a compressed state having a slightly smaller diameter and crimped profile than would be possible without the capsule, by preventing any recoil (expansion) of the frame when crimped onto the delivery device.

[0057] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 102) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 102 can include stainless steel. In some embodiments, frame 102 can include cobalt chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include a nickel-cobalt-chromium alloy, such as MP35N™ (a trade name of SPS Technologies), which is equivalent to UNS R30035 (coated per ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0058] In other examples, the frame 102 can be formed from a self-expandable material (e.g., Nitinol). If the frame 102 is formed from a self-expandable material, the prosthetic valve can be radially compressed and placed into a capsule of the delivery device, and the prosthetic valve can be maintained in a radially compressed state during delivery to the implantation site. Once the desired implantation site is reached, the prosthetic valve is deployed or released from the capsule. In some examples, the frame (and thus the prosthetic valve) can partially self-expand from a radially compressed state to a partially radially expanded state. The frame 102 (and thus the prosthetic valve 100) can be further radially expanded from a partially expanded state to a further radially expanded state via actuation of an actuation assembly of the delivery device (as described further below), which rotates the rod 126 to expand the frame.

[0059] As mentioned above, the threaded rod 126 can removably couple the prosthetic valve 100 to an actuator assembly of the delivery device. Referring to FIG. 2, an exemplary delivery device 200 is shown for delivering a prosthesis or valve 202 (e.g., the prosthetic valve 100) to a desired implantation location. The prosthetic valve 202 can be removably coupled to the delivery device 200. It should be understood that the delivery device 200 and other delivery devices disclosed herein may be used to implant prostheses other than prosthetic valves, such as stents or grafts.

[0060] The delivery device 200 of the illustrated embodiment generally includes a handle 204, a first elongate shaft 206 (which in the illustrated embodiment comprises an outer shaft) extending distally from the handle 204, at least one actuator assembly 208 extending distally through the first shaft 206, a second elongate shaft 209 extending through the first shaft 206, and a nosecone 210 coupled to a distal end of the second shaft 209. The second shaft 209 and the nosecone 210 can define a guidewire lumen for advancing the delivery device over a guidewire through the patient's vasculature. The at least one actuator assembly 208 can be configured to radially expand and / or radially collapse the prosthetic valve 202 when actuated by one or more knobs 211, 212, 214, etc. included on the handle 204 of the delivery device 200.

[0061] While the illustrated embodiment shows two actuator assemblies 208 for illustrative purposes, it should be understood that one actuator assembly 208 may be provided for each actuator (e.g., actuator or threaded rod 126) on the prosthetic valve. For example, three actuator assemblies 208 may be provided for a prosthetic valve having three actuators. In other embodiments, there may be a greater or lesser number of actuator assemblies.

[0062] In some embodiments, the distal end 216 of the shaft 206 can be sized to accommodate the prosthetic valve in its radially compressed delivery state during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end 216 acts as a delivery sheath or capsule for the prosthetic valve during delivery.

[0063] The actuator assemblies 208 can be releasably coupled to the prosthetic valve 202. For example, in the illustrated embodiment, each actuator assembly 208 can be coupled to a respective actuator (e.g., threaded rod 126) of the prosthetic valve 202. Each actuator assembly 208 can include a support tube and an actuator member. In operation, the actuator assembly can transmit a pushing force and / or a pulling force to a portion of the prosthetic valve to radially expand and collapse the prosthetic valve, as described above. The actuator assembly 208 can be at least partially radially disposed within one or more lumens of the first shaft 206 and can extend axially through the one or more lumens. For example, the actuator assembly 208 can extend through a central lumen of the shaft 206 or through each separate lumen formed within the shaft 206.

[0064] The handle 204 of the delivery device 200 may include one or more control mechanisms (e.g., knobs or other actuation mechanisms) for controlling different components of the delivery device 200 to expand and / or deploy the prosthetic valve 202. For example, in the illustrated embodiment, the handle 204 includes first, second, and third knobs 211, 212, and 214.

[0065] The first knob 211 may be a rotatable knob configured to generate axial movement of the first shaft 206 in a distal and / or proximal direction relative to the prosthetic valve 202 to deploy the prosthetic valve from the delivery sheath 216 as the prosthetic valve is driven forward to or adjacent a desired implantation location within the patient's body. For example, rotation of the first knob 211 in a first direction (e.g., clockwise) can retract the sheath 216 proximally relative to the prosthetic valve 202, and rotation of the first knob 211 in a second direction (e.g., counterclockwise) can advance the sheath 216 distally. In other examples, the first knob 211 may be actuated by sliding or moving the knob 211 axially, such as by pulling and / or pushing the knob. In other embodiments, actuation of the first knob 211 (rotation or sliding movement of the knob 211) can generate axial movement of the actuator assembly 208 (and thus the prosthetic valve 202) relative to the delivery sheath 216 to advance the prosthetic valve distally from the sheath 216.

[0066] The second knob 212 may be a rotatable knob configured to radially expand and / or compress the prosthetic valve 202. For example, rotation of the second knob 212 may rotate a threaded rod of the prosthetic valve 202 via the actuator assembly 208. Rotation of the second knob 212 in a first direction (e.g., clockwise) may radially expand the prosthetic valve 202, and rotation of the second knob 212 in a second direction (e.g., counterclockwise) may radially collapse the prosthetic valve 202. In other examples, the second knob 212 may be actuated by sliding or moving the knob 212 axially, such as by pulling and / or pushing the knob.

[0067] For example, the third knob 214 may be operably connected to a proximal end of each actuator assembly 208. The third knob 214 can be configured to retract the outer sleeve or support tube of each actuator assembly 208 to disconnect the actuator assembly 208 from a proximal portion of the actuator of the prosthetic valve (e.g., a threaded rod). Once the actuator assembly 208 is decoupled from the prosthetic valve 202, the delivery device 200 can be removed from the patient, leaving only the prosthetic valve 202 within the patient.

[0068] Further details regarding actuator assemblies for mechanically expandable prostheses (e.g., valves) and delivery devices for mechanically expandable prostheses can be found in International Patent Application No. PCT / US2021 / 052745, which is incorporated herein by reference.

[0069] 3A shows an exemplary outer skirt 300 for a prosthesis such as the prosthetic valve 100 shown in FIG. 1A and FIG. 1B in a flat configuration. The outer skirt 300, as well as other outer skirts disclosed herein, can be used with mechanically expandable prosthetic valves (e.g., the valve 100 of FIG. 1A and FIG. 1B), balloon-expandable prosthetic valves, and / or self-expandable prosthetic valves. Further details regarding balloon-expandable prosthetic valves can be found in U.S. Patent No. 9,393,110, U.S. Provisional Patent Application No. 63 / 178,416, filed April 22, 2021, U.S. Provisional Patent Application No. 63 / 194,830, filed May 28, 2021, and U.S. Provisional Patent Application No. 63 / 279,096, filed November 13, 2021, all of which are incorporated herein by reference.

[0070] The outer skirt 300 can be wrapped around the outer surface of the prosthesis frame (the surface facing radially outward relative to the central longitudinal axis of the prosthesis) thereby transitioning to an annular configuration (e.g., as shown in FIG. 1B or FIG. 4A).

[0071] As shown in FIG. 3A, the outer skirt 300 can include opposing first and second edges 302, 304 (which can also be referred to as short edges or short edges), each of which extends between an outflow edge 306 and an inflow edge 308 of the outer skirt 300. The first and second edges 302, 304 can be non-perpendicular to the inflow edge 308. For example, the first and second edges 302, 304 can extend at an angle of about 45 degrees (or within a range of 40 degrees to 50 degrees) relative to the inflow edge 308. Thus, the overall general shape of the outer skirt 300 is a diamond or parallelogram.

[0072] The first and second edges 302, 304 can each include a number of openings 310 extending therethrough. Thus, when the outer skirt 300 is transformed into its annular configuration (e.g., when attached around a prosthesis as shown in FIG. 4A), the first and second edges 304, 302 can overlap one another with their respective openings 310 also overlapping. A suture can then be used to form multiple stitches in an in-and-out pattern through the overlapping openings 310 (e.g., stitches 340 shown in FIG. 4A) to secure the first and second edges 302, 304 together and form the annular configuration of the outer skirt 300. As shown in FIG. 4A, due to the angled shape of the overlapping first and second edges 302, 304, the stitches 340 form diagonally extending sutures 342.

[0073] The outflow edge 306 (e.g., disposed closer to the outflow end of the prosthesis than the inflow edge 308 when placed around the prosthesis as shown in FIG. 4A) can be formed with a plurality of protrusions 312 that define an undulating shape that generally follows the shape or contour of the frame post to which they are secured (e.g., the frame post 112 connected to the second post 124 shown in FIGS. 1A and 1B, or the post 344 shown in FIG. 4A).

[0074] In alternative embodiments, the outflow edges 306 may have a different shape than that shown in FIG. 3A, such as being straight (e.g., parallel to the inflow edges 308) or a different non-linear shape that does not follow the shape or contour of the columns of the frame to which they are secured.

[0075] In some embodiments, the outer skirt 300 may also be formed with slots 314 (or recesses) to facilitate attachment of the skirt to a frame. For example, each slot 314 may be located between two adjacent projections 312. In some embodiments, the slots 314 may be shaped and sized such that the slots 314 may fit and / or wrap or be secured around a support post of the frame (e.g., support post 107 shown in FIG. 1B).

[0076] If the outer skirt 300 is placed around the outer surface of the prosthesis frame (e.g., with outer skirt 103, shown in FIG. 1B), sutures can be used to secure the outflow edge 306 of the outer skirt 300 to the struts of the frame (e.g., stitches 137 shown in FIG. 1B). In some embodiments, additional sutures can be used to secure the inflow edge 308 of the outer skirt 300 to the prosthesis frame and / or leaflets (e.g., sutures 129 shown in FIG. 1B).

[0077] The outer skirt 300 and other skirts or coverings described herein may comprise a variety of synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric (PET fabric) or ultra-high molecular weight polyethylene (UHMWPE) fabric), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), hybrid materials including one or more fabrics or polymeric materials (e.g., PET coated on TPU), or autologous tissue (e.g., pericardial tissue). In some embodiments, the outer skirt 300 may be formed of a relatively flat fabric that allows for a relatively small crimp profile when the prosthesis is in a radially compressed configuration. However, such a configuration may not allow the outer skirt 300 to effectively match the autologous tissue and / or fill gaps between the autologous tissue and the implanted prosthesis to improve sealing of paravalvular leaks.

[0078] It may therefore be desirable to provide an outer skirt, such as outer skirt 300, with one or more sealing members projecting radially outward from a base portion of the outer skirt and from the prosthesis frame to further enhance sealing of paravalvular leaks at the implantation site. For example, the outer skirt may be provided with a row of apertures configured to receive one or more sutures (or other fibrous or polymeric tying members) therethrough, and one or more radially projecting ribs or steps may be formed in the outer skirt upon tightening of one or more sutures extending through the apertures. Various examples of creating such radially projecting ribs in the material of the outer skirt are described below with reference to Figures 3B-12B.

[0079] It should be noted that the radially projecting ribs described herein are described as being formed by a fastened suture extending through adjacent rows of openings in the outer skirt. However, in other embodiments, the radially projecting ribs described herein may be formed by a fastened suture extending through the outer skirt along adjacent circumferentially extending paths in the outer skirt. Thus, instead of extending through rows of pre-formed openings in the outer skirt, the suture stitches described below may extend through selected locations in the outer skirt forming adjacent circumferentially extending rows described below. In some embodiments, the selected locations of the suture stitches may be marked by a marker (such as ink), a suture guide plate that rests against the outer skirt, or the like. In still other embodiments, the stitches described below that form the radially projecting ribs upon fastening of the outer skirt may be threaded through the outer skirt freehand or with a free eye, thus forming the circumferentially extending stitches described below. In some examples, freehand stitches or stitches extending through a row of markers can form openings (e.g., formed by inserting a needle into the fabric of the outer skirt) at the locations of the openings shown in Figures 3B-12B.

[0080] Figure 3B illustrates another exemplary outer skirt 350 for a prosthesis in a flat configuration. The outer skirt 350 may be similar to the outer skirt 300 of Figure 3A, except that the outer skirt 350 includes a plurality of rows of apertures 352, 353 extending between the first and second edge portions 304, 302 across a length 354 of the outer skirt 350 (wherein the length 354 is the circumference of the outer skirt 350 when the outer skirt 350 is disposed around a prosthesis or valve, such as the prosthetic valve 380 illustrated in Figures 4A and 4B).

[0081] 3B, the outer skirt 350 includes a first row 356 of first or upper openings 352 and a second row 358 of second or lower openings 353, which are grouped into a first pair of opening rows 364. The outer skirt 350 further includes a third row 360 of first or upper openings 352 and a fourth row 362 of second or lower openings 353, which are grouped into a second pair of opening rows 366. Each of the first row 356, second row 358, third row 360, and fourth row 362 may include a plurality of openings 352 or 353 spaced apart from one another within the row and extending at an angle (e.g., a non-zero angle) across the length 354 of the outer skirt 300 relative to the inlet edge 308. As will be further described below with reference to Figures 4A and 4B, this angling of the rows of apertures can create ribs 372 that, when positioned around the outer surface of the frame 382 of the prosthetic valve 380, spiral around the circumference of the outer skirt 350 in its annular configuration.

[0082] In some embodiments, a first spacing 368 between a first pair of rows of apertures 364 and a second pair of rows of apertures 366 (the spacing between the second row of apertures 358 and the third row of apertures 360) may be greater than a second spacing 370 between rows of apertures in the same pair (e.g., the second spacing 370 between the first row 356 and the second row 358 and the second spacing 370 between the third row 360 and the fourth row 362). The first spacing 368 and the second spacing 370 may be selected based on a predetermined width of the resulting rib 372 and / or a predetermined number of turns of the rib 372 around the circumference of the outer skirt 350 (when disposed around a frame 382 of a prosthetic valve 380, as shown in FIGS. 4A and 4B ).

[0083] In some embodiments, the axial height 321 of the outer skirt 350 (before forming the sealing ribs) may be greater than the axial height of the portion of the frame to which the outer skirt 350 is coupled. For example, the axial height 321 may be greater than the axial height 316 of the outer skirt 300 that does not include openings for forming one or more sealing ribs. In this way, the axial height 321 can provide additional skirt material (axially) to accommodate the ribs 372 formed from the folded over portion of the outer skirt 350.

[0084] 4A-4B show outer skirt 350 disposed and secured around the outer surface of frame 382 of prosthetic valve 380 (with leaflets disposed inside frame 382), with ribs 372 already formed. Figures 5A-5E show outer skirt 350 secured to frame 382 (with no leaflets inside the frame) and a series of views showing how ribs 372 are formed in outer skirt 350 while outer skirt 350 is disposed around frame 382.

[0085] When the outer skirt 350 is wrapped around the outer surface of the frame 382, ​​the first and second edges 302, 304 are positioned such that they overlap one another, and then a suture can be threaded in an in-and-out pattern through the overlapping openings 310 to form a diagonally extending suture line 342 of stitches 340 from the inflow edge 308 to one of the slots 314 adjacent the outflow edge 306 (FIGS. 4A and 5A). As a result, the first and second edges 302, 304 are secured together around the frame 382.

[0086] The prosthetic valve 380 (and its frame 382) may be similar to the prosthetic valve 100 of FIGS. 1A and 1B in that the leaflets (e.g., leaflets 158) are secured to an inner surface of the frame 382. In this manner, the leaflets may be disposed inside the frame 382 while the outer skirt 350 is disposed outside the frame. As described above with reference to FIG. 1A, in some embodiments, an additional inner skirt may be disposed on the inner surface of the frame between the leaflets and the inner surface of the frame.

[0087] When the outer skirt 350 is in its annular configuration, the openings 352, 353 of the second pair of rows of openings 366 disposed adjacent the first edge 302 may be continuous with the openings 352, 353 of the first pair of rows of openings 364 disposed adjacent the second edge 304 (Figures 5A-5B).

[0088] 4A and 4B, the suture 376 can be threaded alternately in a zigzag pattern between the upper and lower openings 352, 353 of the first pair of rows of openings 364 along the entire length of the first pair of rows 364, and then between the upper and lower openings 352, 353 of the second pair of rows of openings 366 along the entire length of the second pair of rows 366, thereby forming a plurality of stitches 374 (FIG. 5B). In some embodiments, the stitches 374 can be angled (at a non-zero angle) relative to the inflow edge 308.

[0089] In some embodiments, the suture 376 can be threaded through either the first pair of rows of apertures 364 or the second pair of rows of apertures 366 when the outer skirt 350 is still in a flat configuration (FIG. 3B). However, in that case, the outer skirt 350 must be placed in its annular configuration (or cylindrical shape, e.g., by placing the outer skirt 350 around a frame 382) so that the same suture 376 can extend continuously through the remaining portions of the apertures 352, 353 in the other row of the first pair of rows of apertures 364 or the second pair of rows of apertures 366.

[0090] After the suture 376 has been threaded through all of the openings 352, 353, it is tightened (e.g., by pulling on its ends) to move the upper and lower openings 352, 353 through which it is threaded toward one another, thereby folding the material of the outer skirt 350 sandwiched between the upper and lower openings 352, 353 of each row pair 364, 366 (FIG. 5C). This folding of the skirt material creates radially outwardly projecting ribs 372 (sometimes referred to as "steps" or "projections") as shown in FIGS. 4A, 4B, and 5C-5E. The skirt material between the upper and lower openings 352, 353 of the first pair of rows 364 forms a first portion or section of the rib 372, and the skirt material between the upper and lower openings 352, 353 of the second pair of rows 366 forms a second portion or section of the rib 372.

[0091] As introduced above, due to the angled orientation of the rows of apertures 356, 358, 360, 362 (FIG. 3B), in the illustrated embodiment, the ribs 372 formed on the outer skirt 350 are continuous ribs that spiral continuously around the circumference of the outer skirt 350 from the inflow edge 308 to the outflow edge 306 (FIGS. 4A-5E). FIGS. 5C-5E show different views of the outer skirt 350 secured about a frame 382, ​​illustrating how the ribs 372 spiral continuously around the circumference of the frame 382.

[0092] In another embodiment, a plurality of discontinuous ribs can be created in the outer skirt 350 by creating gaps between rows of a plurality of pairs of openings in the outer skirt 350 and utilizing a plurality of sutures 376.

[0093] The two pairs of rows 364, 366 of apertures in the outer skirt 350 (FIG. 3B) are spiraled into a rib 372 that makes two turns around the frame 382, ​​as shown in FIGURES 4A, 4B, and 5C-5E. For example, as shown in FIGURE 5C, a first turn 386 of the rib 372 extends from the overlapping first and second edges 302, 304 adjacent the outflow edge 306, around the circumference of the outer skirt 350 to the overlapping first and second edges 302, 304 at a location 390 between the outflow edge 306 and the inflow edge 308. The second turn 388 of the rib 372 extends from the first and second edges 302, 304, which overlap at a location 390 between the outflow edge 306 and the inflow edge 308, around the circumference of the outer skirt 350 to the first and second edges 302, 304, which overlap adjacent the inflow edge 308.

[0094] In other embodiments, the rows of apertures in the outer skirt 350 can be configured such that the spiral rib 372 is formed over two or more revolutions (e.g., one revolution, one and a half revolutions, three revolutions, etc.). For example, as shown in FIGS. 6A and 6B, the outer skirt 400 can include a continuous radially outwardly projecting rib 402 that spirals around the outer skirt 400 between the inlet and outlet edges 404 and 406 of the outer skirt 400. The rib 402 spirals approximately one revolution 408 around the outer skirt 400. As used herein, a "revolution" can refer to a 360 degree path. As shown in FIG. 6B, the ends of the rib 402 can be axially spaced apart from one another along the height of the skirt 350.

[0095] The outer skirt 400 may be similar to the outer skirt 350 of Figure 3B. However, instead of having two pairs of openings 364, 366, the outer skirt 400 may include only one pair of rows of openings extending along the length of the outer skirt 400 at an angle relative to the inflow edge 404. In other words, the outer skirt 400 may include a first row of first or upper openings and a second row of second or lower openings, the first and second rows extending parallel to each other and at an angle along the length of the outer skirt 400 from the inflow edge 404 to a location proximate the outflow edge 406 (e.g., proximate one of the slots 314).

[0096] It should be noted that Figures 6A and 6B, as well as some of the additional examples herein (e.g., Figures 5A-5E, 7A-7B, 8A-8C), show the outer skirt disposed about the frame before the inflow edge of the outer skirt is secured to the frame. Thus, some of these figures show the inflow edge, or a portion thereof, distal or proximal to the inflow end of the frame. However, after the inflow edge of the skirt is secured to the inflow end of the frame, the inflow edge of the skirt can extend circumferentially along the inflow end of the frame (e.g., as shown in Figures 4A-4B and IB).

[0097] Returning to Figures 4A-5E, the two turns 386 and 388 of ribs 372 of outer skirt 350 can provide a larger radially protruding surface area for enhanced sealing with native anatomical structures (e.g., native valve annulus) compared to an outer skirt having only a single turn of ribs around the prosthetic valve.

[0098] As shown in Figures 4A, 4B, and 5C-5E, the formed ribs 372 extend radially outward from a base surface 378 of the outer skirt 350. The base surface 378 may be an outer surface of the outer skirt 350 that faces radially outward relative to a central longitudinal axis of the frame 382. An inner surface 384 (Figures 4B and 5E) opposite the base surface 378 of the outer skirt 350 may be disposed adjacent (e.g., flush with) the outer surface of the post of the frame 382. Thus, the ribs 372 project radially outward from the base surface 378 and the frame 382 and away from the frame (and thus may be referred to herein as projecting ribs or sealing members).

[0099] In some embodiments, the rib 372 may be at least partially twisted between adjacent stitches 374 due to tightening of the suture 376 (FIGS. 5C-5E). In some embodiments, a plurality of petals or rib portions 392 are formed along the rib 372, with each rib portion 392 defined between two adjacent stitches 374 (FIGS. 5D and 5E). Each rib portion 392 extends radially outward from the base surface 378 and away from the frame 382. In some embodiments, one or more rib portions 392 may be shaped slightly differently or extend radially outward a different amount than one or more other rib portions 392.

[0100] The multiple ribs 392 allow the ribs 372 to have a non-uniform shape, which can better seal against the native anatomy (e.g., the wall of the atrium or annulus) since the native anatomy may have a non-uniform surface with multiple non-uniform indentations. For example, each petal or rib 392 can be pressed into a respective indentation of the native anatomy in which the prosthetic valve will be implanted. In this way, each rib 392 can independently conform to a respective portion of the native anatomy, separate from the other ribs 392 of the ribs 372.

[0101] In general, the spiral shape of the ribs 372 (compared to circular ribs, as described further below) can better conform to the irregular shapes of the surrounding natural anatomy and can more easily expand axially, thereby reducing the crimp profile of the prosthetic valve when in a radially compressed configuration.

[0102] The ribs 372 and similar radially protruding sealing members described herein can be formed from a relatively flat or two-dimensional fabric (FIG. 3B) without the need to preform the fabric with any special 3D features or to subject it to thermosetting or other thermal operations. More specifically, the sealing members and ribs described herein can be formed from a relatively flat skirt having one or more sutures extending through preformed openings in the skirt. In this manner, the ribs or radially protruding sealing members can be simply and efficiently formed during assembly of the artificial heart valve (or similar prosthesis). Furthermore, the ribs 372 or other sealing members can be formed on the outer surface (outer or base surface 378) of the skirt, while the inner surface 384 remains relatively flat without protruding into the interior of the frame 382, ​​thereby reducing interaction between the leaflets and the outer skirt. Furthermore, by forming the ribs 372 or other sealing members described herein from the same material as the remainder of the outer skirt, the method of fabricating the skirt and assembling the prosthesis can be simplified.

[0103] In other embodiments, the rib or ribs formed on the outer skirt may be circular (forming a ring-like or closed circle) and may extend around the circumference of the outer skirt at a relatively fixed axial location without spiraling. For example, FIGS. 7A and 7B show an exemplary outer skirt 500 secured to the outside of and around a frame 382 for a prosthetic valve. The outer skirt 500 may be similar to the outer skirt 350, except that it includes a single radially projecting circular rib 502 (instead of a rib that spirals around the frame 382). The circular rib 502 extends around the circumference of the outer skirt 500 and the frame 382 at a relatively fixed axial location disposed between the inflow edge 504 and the outflow edge 506 of the outer skirt 500, thereby forming a ring around the outer skirt 500.

[0104] As shown in FIG. 7B, a circular rib 502 projects (or extends) radially outward from the outer skirt 500 and a base surface 508 of the frame 382 and away from the frame.

[0105] In some embodiments, the outer skirt 500 may comprise a plurality of circular ribs 502 spaced apart from one another axially (relative to the central longitudinal axis of the frame 382) along the height of the skirt. For example, Figures 8A-8C show another exemplary outer skirt 600 disposed about and attached to the outer surface of the frame 382 or prosthetic valve. The outer skirt 600 includes a plurality of circular ribs 602 (three are shown in Figures 8B and 8C, although more or less than three circular ribs are possible), each extending around the circumference of the outer skirt 600 (e.g., each may extend one complete revolution around the outer skirt 600 and frame 382).

[0106] The circular ribs 602 can be formed (without spiraling or angling) by threading a suture (in some embodiments, one suture for each rib 602) through multiple pairs, e.g., three pairs, of horizontally or circumferentially extending rows of apertures (FIG. 8A). For example, FIG. 8A shows a first pair of rows of apertures 604 including a first row 606 of first (or upper) apertures 610 and a second row 608 of second (or lower) apertures 612. The first row 606 and the second row 608 can be disposed adjacent to one another. In some examples, the first row 606 and the second row 608 are parallel to one another. Additionally, the first row 606 and the second row 608 can be axially spaced apart from one another by a first distance 614.

[0107] The first circular rib 602a (FIG. 8B) may be formed by extending the first suture 616 in an alternating U-shaped pattern through the second openings 612 of the second row 608 and the first openings 610 of the first row 606 such that stitches 618 are formed on the outer surface 620 of the outer skirt 600, with each stitch 618 extending between two adjacent first openings 610 or two adjacent second openings 612. The suture 616 may also form a plurality of axially extending stitches 622 on the inner surface of the outer skirt 600 (opposite the outer surface 620 and disposed against the frame 382) that extend between and interconnect adjacent stitches 618. The axially extending stitches 622 are shown in FIG. 8A with thin lines to represent their location behind the outer skirt 600 (on the inner surface of the outer skirt 600) as viewed in FIG. 8A. Tightening the first suture 616 pulls the skirt material closer together between the first and second rows 606, 608 forming the first rib 602a.

[0108] Similarly, the outer skirt 600 may further include a second pair of rows of apertures 624 including a third row 626 of first apertures 610 and a fourth row 628 of second apertures 612, as well as a third pair of rows of apertures 630 including a fifth row 632 of first apertures 610 and a sixth row 634 of second apertures 612. The second circular rib 602b (FIG. 8B) may be formed by extending a second suture 636 through the first apertures 610 and the second apertures 612 of the second pair of rows of apertures 624 in an alternating U-shaped pattern and tightening the suture 636. A third circular rib 602c (FIG. 8B) can be formed by extending a third suture 638 through the first opening 610 and the second opening 612 of the third pair of rows of openings 630 in an alternating U-shaped pattern (FIG. 8A) and tightening the suture 638.

[0109] In some embodiments, the spacing between adjacent rows of apertures in each pair 604, 624, and 630 may be the same.

[0110] In other embodiments, the spacing between adjacent rows of each pair of apertures 604, 624, and 630 may be different. For example, as shown in FIG. 8A, a second spacing 640 between the third row 626 and the fourth row 628 may be greater than the first spacing 614, and a third spacing 642 between the fifth row 632 and the sixth row 634 may be greater than the second spacing 640.

[0111] The first spacing 614, the second spacing 640, and the third spacing 642 may be selected based on the desired width (radially) or amount that the rib protrudes radially outward from the outer surface 620 of the outer skirt 600.

[0112] When the sutures 616, 636, and 638 are tightened, the first circular rib 602a, the second circular rib 602b, and the third circular rib 602c are formed axially adjacent to one another (FIGS. 8B and 8C). Such an arrangement can improve the PVL seal when a prosthetic valve including the outer skirt 600 is implanted in a native anatomy (e.g., a native heart valve annulus).

[0113] In some embodiments, as shown in Figures 8B and 8C, the circular ribs 602a, 602b, 602c are disposed generally parallel to the inflow edge 644 of the outer skirt 600.

[0114] 8B and 8C, the three circular ribs 602a, 602b, 602c are spaced axially slightly apart from one another. In some embodiments, the axial spacing between the rows of paired apertures can be increased so that the three circular ribs 602a, 602b, 602c are spaced axially further apart from one another.

[0115] Additionally, in other embodiments, the outer skirt 600 can include more or less than three circular ribs 602 (eg, two, four, five, etc.).

[0116] In some embodiments, the ribs (or skirt sealing members or folds) formed in the outer skirt described herein may extend axially (vertically) along the height of the outer skirt (e.g., between the inflow edge 308 and the outflow edge 306 of the outer skirt 350) rather than circumferentially around the outer skirt.

[0117] In other embodiments, the outer skirt may include ribs (or folds) that extend in both the axial and circumferential directions. For example, the outer skirt may include one or more of the circular or spiral ribs described above, as well as one or more axial ribs that extend axially along the height of the outer skirt. In some embodiments, the axial ribs or folds may overlap or intersect with one or more of the circular or spiral ribs or folds of the outer skirt.

[0118] 9A-12B show various stitching methods for creating the circular or spiral ribs (or sealing members) described herein.

[0119] 9A-9C first illustrate an exemplary method for rib formation in an exemplary skirt 700 configured to be positioned around and secured to an outer surface of a frame of a prosthetic valve, such as frame 382. Skirt 700 can be similar to other skirts described herein, such as outer skirt 350 shown in FIG.

[0120] 9A, the rib formation method may include threading the suture 702 in a zigzag pattern between a first (upper) opening 704 in a first circumferentially extending row of openings 706 and a second (lower) opening 708 in a second circumferentially extending row of openings 710. Threading the suture 702 in a zigzag pattern may include threading the suture 702 alternately from the second opening 708 to a first opening 704 on a first side 712 of the skirt 700 to form a first stitch 714 across the first side 712, and then threading the suture 702 from the first opening 704 to a subsequent second opening 708 along an opposite second side of the skirt 700 (the side disposed behind the first side 712 in the view of FIG. 9A) to form a second stitch 716 on the second side of the skirt 700. This can be repeated along the length of the skirt 700 until the suture 702 has passed through all of the apertures 704 , 708 in the first row 706 and the second row 710 .

[0121] When the sutures 702 are tightened, they can form radially protruding ribs 718 (FIGS. 9B and 9C). The ribs 718 can be the outer surface of the skirt 700 when the skirt 700 is secured around the outside of the frame and can protrude radially outward from a first side 712 (or surface) that faces radially outward and away from the prosthetic frame.

[0122] 10A and 10B show another exemplary method of forming ribs on an exemplary skirt 800 configured to be positioned and secured around an outer surface of a frame of a prosthetic valve, such as frame 382. Skirt 800 may be similar to other skirts described herein, such as outer skirt 350 shown in FIG.

[0123] 10A, the rib forming method can include threading a suture 802 between three adjacent rows of apertures in a zigzag pattern. The three rows of apertures can include a first row 804 of first (upper) apertures 806, a second (center) row 808 of second (center) apertures 810, and a third (lower) row 812 of third (lower) apertures 814. For example, the method can include threading the suture 802 from a first (lower) aperture 814a to a second (center) aperture 810a on a first side 816 of the skirt 800 to form a first stitch 818, and then threading the suture 802 from the second aperture 810a to a third (upper) aperture 806a on an opposite second side of the skirt 800 to form a second stitch 820 (FIG. 10A). The method may then include threading the suture 802 again from the third opening 806a through a subsequent second (middle) opening 810b on the first side 816 to form a third stitch 822, and then from the second opening 810b through a subsequent first (lower) opening 814b on the opposite second side to form a fourth stitch 824 (FIG. 10A). This may be repeated along the length of the skirt 800 until the suture 802 has passed through all of the openings 806, 810, 814 in the first row 804, second row 808 and third row 812.

[0124] When the sutures 802 are tightened, they can form radially protruding ribs 826 (FIG. 10B). The ribs 826 can be an outer surface of the skirt 800 when the skirt 800 is secured around the outside of the frame, and can protrude radially outward from a first side 816 (or surface) of the skirt 800 that faces radially outward and away from the prosthetic frame.

[0125] 10A and 10B may include a first rib portion 828 disposed above (or on a first side) the clamped suture 802 and a second rib portion 830 disposed below (or on an opposing second side) the clamped suture 802 such that the rib 826 may form an undulating (e.g., sinusoidal) pattern along its length with multiple peaks and valleys along the length of the rib. In some embodiments, this may result in a rib 826 having a more irregular shape that may improve the PVL sealing effect against the native anatomy after implantation of a prosthesis around which the skirt 800 is secured.

[0126] 11A-12B show an additional embodiment for forming a rib in which a portion of skirt 900 is folded over on itself along a first row 902 of apertures 904. In the example of FIG. 11A, stitches 916 can be created by threading suture 906 in a zigzag pattern through a single layer of folds 912 (e.g., the top layer shown in FIG. 11A) between apertures 904 in the first row 902 and adjacent apertures 908 in the second row 910. As a result, when suture 906 is tightened and skirt 900 is expanded, radially outwardly projecting ribs 914 are formed (FIG. 11B).

[0127] In another embodiment, ribs 920 can be formed in skirt 900 by threading suture 906 through both layers of fold 912 in a zigzag pattern between openings 904 and 908 (FIG. 12A), tightening suture 906, and then opening skirt 900 (FIG. 12B).

[0128] The ribs or sealing members described herein may be referred to as "non-deployable" due to their ability to remain in a folded configuration when the prosthetic valve is in both a radially compressed configuration and a radially expanded configuration. Thus, the ribs or sealing members described herein can remain in a folded state when the prosthetic valve is radially compressed.

[0129] In some embodiments, the ribs or sealing members described herein (e.g., the folded portions of the skirt) can be formed using attachment means other than sutures, such as adhesives, ultrasonic welding, or fasteners (e.g., sutures 376 shown in Figures 4A, 4B, and 5B-5E), to secure the folded portions of the skirt material together.

[0130] delivery technology To implant the prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral artery and driven forward into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned inside the native aortic valve and radially expanded (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted inside the native aortic valve in a transapical procedure, in which the prosthetic valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal end of a delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then driven forward through the ascending aorta toward the native aortic valve.

[0131] To implant the prosthetic valve inside the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein, advanced into the inferior vena cava and through the inferior aorta into the right atrium, across the atrial septum (through a puncture hole created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted inside the native mitral valve in a transapical procedure, where the prosthetic valve (on the distal end of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned inside the native mitral valve.

[0132] To implant the prosthetic valve inside the native tricuspid valve, the prosthetic valve is mounted in radial compression along the distal end of the delivery device. The prosthetic valve and the distal end of the delivery device are inserted into the femoral vein and driven forward into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the prosthetic valve inside the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / artery.

[0133] Another delivery approach is the transatrial approach, where the prosthetic valve (on the distal end of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed endovascularly, such as from the pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve or into the native pulmonary valve or into the pulmonary artery.

[0134] In all delivery approaches, the delivery device may be driven forward over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0135] Any of the systems, devices, apparatus, etc. herein can be sterilized (e.g., using heat / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / high temperature sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet light, and electron beam. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization may be performed, for example, using hydrogen peroxide plasma.

[0136] Additional Examples of the Disclosed Technique In view of the above implementations of the disclosed subject matter, the present application discloses additional embodiments, which are listed below. It should be noted that a feature in isolation from an embodiment or two or more features taken in combination, and optionally in combination with one or more features from one or more additional embodiments, are also further embodiments that fall within the disclosure of the present application.

[0137] Example 1. A prosthetic heart valve comprising an annular frame, a plurality of valve leaflets disposed within the frame, and an outer skirt disposed about an outer surface of the frame, the outer skirt comprising at least one folded portion and stitches extending through the folded portion to form radially projecting ribs.

[0138] Example 2. The prosthetic heart valve as described in any of the examples herein, particularly Example 1, wherein the inner surface of the outer skirt is positioned against the outer surface of the frame, the base surface of the outer skirt is a radially outward facing surface of the outer skirt disposed opposite the inner surface, and ribs extend radially outward from the base surface and the frame.

[0139] Example 3. The prosthetic heart valve of any embodiment described herein, particularly any embodiment described herein as in either Example 1 or Example 2, wherein the annular frame comprises a plurality of interconnected struts and the outer skirt is positioned flush with an outer surface of the plurality of interconnected struts.

[0140] Example 4. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1-3, wherein the ribs extend between the inflow and outflow edges of the outer skirt.

[0141] Example 5. Any of the examples described herein, particularly example 4, wherein the inflow edge of the outer skirt is secured to the inflow end of the frame and the outflow edge of the outer skirt is secured to the struts of the frame disposed between the inflow and outflow ends of the frame.

[0142] Example 6. The prosthetic heart valve of any of the embodiments described herein, particularly any one of Examples 1-5, wherein the ribs are circumferentially extending ribs that extend around the entire circumference of the outer skirt and frame.

[0143] Example 7. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1-6, wherein the rib is a spiral rib that spirals continuously around the outer skirt for one or more revolutions between the inflow and outflow edges of the outer skirt.

[0144] Example 8. The prosthetic heart valve of any of the embodiments described herein, particularly example 7, wherein the spiral rib spirals continuously around the outer skirt for two revolutions.

[0145] Example 9. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1-6, wherein the rib is a first rib and the outer skirt includes a second folded portion and stitching that extends through the second folded portion to form a radially protruding second rib, each of the first rib and the second rib extending around the entire circumference of the outer skirt and forming two radially protruding rings.

[0146] Example 10. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 1-9, wherein the outer skirt includes a first row of openings and a second row of openings that are parallel to each other and each extend around the circumference of the outer skirt, and ribs are formed between the first and second rows of openings by fastened sutures that extend in an alternating pattern between adjacent openings in the first row of openings and the second row of openings to form a plurality of spaced stitches extending around the circumference of the outer skirt.

[0147] Example 11. Any of the embodiments described herein, particularly example 10, wherein the rib comprises a plurality of radially outwardly protruding rib portions, each rib portion being defined between two adjacent stitches of the plurality of stitches.

[0148] Example 12. The prosthetic heart valve of any embodiment described herein, particularly example 10 or example 11, wherein the row of first openings and the row of second openings extend around the circumference of the outer skirt at a non-zero angle relative to the inflow edge of the outer skirt.

[0149] Example 13. A prosthetic heart valve according to any of the embodiments described herein, in particular any one of embodiments 10-12, wherein the outer skirt further comprises a third row of openings and a fourth row of openings parallel to each other, each extending around the circumference of the outer skirt and axially spaced from the first and second rows of openings, the third and fourth rows of openings being continuous with the first and second rows of openings, respectively, and ribs are formed between the first and second rows of openings and between the third and fourth rows of openings by fastened sutures extending in an alternating pattern between adjacent ones of the first and second rows of openings and adjacent ones of the third and fourth rows of openings.

[0150] Example 14. The prosthetic heart valve of any of the embodiments described herein, particularly example 13, wherein the rib is a single rib on the outer skirt that spirals twice around the circumference of the outer skirt.

[0151] Example 15. A prosthetic heart valve as described in any of the embodiments described herein, particularly any of Example 10 or Example 11, wherein the first row of openings and the second row of openings extend around the circumference of the outer skirt parallel to the inflow edge of the outer skirt.

[0152] Example 16. The prosthetic heart valve of any of the embodiments described herein, particularly example 15, wherein the outer skirt further comprises a third row of openings and a fourth row of openings parallel to each other, each extending around the circumference of the outer skirt and axially spaced from the first and second rows of openings, and the rib is a first rib formed between the first and second rows of openings by a first fastened suture extending in an alternating pattern between adjacent openings of the first row of openings and the second row of openings, and a second rib formed between the third and fourth rows of openings by a second fastened suture extending in an alternating pattern between adjacent openings of the third row of openings and the fourth row of openings.

[0153] Example 17. Any of the embodiments described herein, particularly example 16, wherein the first rib is axially spaced from the second rib, and the first and second ribs are each configured as annular ribs extending entirely around the circumference of the outer skirt.

[0154] Example 18. The prosthetic heart valve of any embodiment described herein, particularly any of Examples 1-17, wherein the outer skirt comprises fabric.

[0155] Example 19. A prosthetic heart valve as described in any of the embodiments described herein, particularly any one of embodiments 1-18, wherein the outer skirt comprises an inflow edge, an outflow edge, and opposing first and second angled edges extending between the inflow edge and the outflow edge, the first and second angled edges being angled at a non-zero angle relative to the inflow edge, the first and second angled edges overlapping one another, and the outer skirt being secured together to form an annular configuration around the outer surface of the frame.

[0156] Example 20. A prosthetic heart valve as described herein in any of the embodiments, particularly example 19, wherein the inflow edge is straight and the outflow edge has an undulating shape defined by a plurality of protrusions.

[0157] Example 21. A prosthetic heart valve comprising an annular frame including a plurality of interconnected struts and an outer skirt disposed about an outer surface of the frame, the outer skirt having an inner surface disposed in contact with the outer surface of the frame, an outer surface disposed opposite the inner surface, a first row of circumferentially extending first openings and a second row of circumferentially extending second openings, a plurality of stitches formed between the first and second rows, each stitch extending between a respective one of the first openings and a respective one of the second openings, and a folded portion of the outer skirt between the first and second rows of openings forming a rib projecting radially outward from the outer surface of the outer skirt and away from the frame.

[0158] Example 22. Any of the embodiments described herein, particularly example 21, wherein the first row of first openings and the second row of second openings are arranged parallel to one another and extend at a non-zero angle along the circumference of the outer skirt relative to an inflow edge of the outer skirt that is secured to the inflow end of the frame.

[0159] Example 23. A prosthetic heart valve of any embodiment described herein, particularly either example 21 or example 22, wherein the ribs spiral around the circumference of the outer skirt from the inflow edge of the outer skirt to the outflow edge of the outer skirt.

[0160] Example 24 The prosthetic heart valve of any embodiment described herein, particularly example 23, wherein the ribs spiral around the circumference of the outer skirt.

[0161] Example 25. The prosthetic heart valve of any of the embodiments described herein, particularly example 23, wherein the outer skirt further comprises a third row of circumferentially extending first openings and a fourth row of circumferentially extending second openings, the third and fourth rows being arranged parallel to one another and axially spaced from the first and second rows, a plurality of stitches being further formed between the third and fourth rows, a first turn of the rib being formed between the first and second rows, and a second turn of the rib being formed between the third and fourth rows.

[0162] Example 26. Any of the embodiments described herein, particularly example 21, wherein the first row of first openings and the second row of second openings extend around the circumference of the outer skirt parallel to the inflow edge of the outer skirt that is secured to the inflow end of the frame.

[0163] Example 27 The prosthetic heart valve of any embodiment described herein, particularly example 26, wherein the ribs form a ring around the entire circumference of the outer skirt.

[0164] Example 28. The prosthetic heart valve of any of the embodiments described herein, in particular any of the embodiments 26 or 27, wherein the outer skirt further comprises a third row of circumferentially extending first openings and a fourth row of circumferentially extending second openings, the third and fourth rows being arranged parallel to each other and axially spaced from the first and second rows, the rib formed between the first and second rows being a first rib, the second rib being formed between the third and fourth rows, the second rib protruding radially outward from the outer surface of the outer skirt and away from the frame, and including a folded portion of the outer skirt forming a ring around the entire circumference of the outer skirt, and the first and second ribs being axially spaced from each other.

[0165] Example 29. A prosthetic heart valve as described in any of the embodiments described herein, particularly any one of embodiments 21-28, wherein the plurality of stitches includes alternating first stitches and second stitches, each of the first stitches extending between a respective first opening and a respective second opening on the outer surface of the outer skirt, and each of the second stitches extending between a respective first opening and a respective second opening on the inner surface of the outer skirt.

[0166] Example 30. A prosthetic heart valve as described in any of the embodiments described herein, particularly any one of embodiments 21-28, wherein the outer skirt further comprises a third row of third openings extending circumferentially, and a plurality of stitches are formed between the first, second, and third rows, each stitch extending between a respective one of the third openings and a respective one of the first openings or the second openings.

[0167] Example 31. Any of the embodiments described herein, particularly the prosthetic heart valve described in example 30, wherein the plurality of stitches includes alternating first stitches and second stitches, each of the first stitches extending between a respective third opening on the outer surface of the outer skirt and a respective first or second opening, and each of the second stitches extending between a respective third opening on the inner surface of the outer skirt and a respective first or second opening.

[0168] Example 32. A prosthetic heart valve as described in any of the embodiments described herein, particularly any one of embodiments 21 to 31, wherein the outer skirt has an inflow edge fixed to the inflow end of the frame and an outflow edge fixed to a first portion of a plurality of interconnected struts connected to a plurality of axially extending posts of the frame, the plurality of axially extending posts being further connected to a second portion of the plurality of interconnected struts defining the outflow end of the frame.

[0169] Example 33. A prosthetic heart valve as described herein in any of the embodiments, particularly example 32, wherein the inflow edge is straight and the outflow edge has an undulating shape defined by a plurality of protrusions.

[0170] Example 34. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 21 to 33, wherein the inner surface of the outer skirt is disposed flush with the outer surface of the frame.

[0171] Example 35. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of Examples 21-34, further comprising a plurality of leaflets disposed within the frame, and a plurality of interconnected struts disposed between the plurality of leaflets and the outer skirt.

[0172] Example 36. A method of assembling a prosthetic heart valve comprising: securing a fabric skirt around an outer surface of a frame of the prosthetic heart valve; extending sutures in an alternating pattern between a first opening of a first row of spaced apart first openings in the skirt, a first opening of a first row of spaced apart first openings in the skirt, and a second opening of a second row of spaced apart second openings in the skirt, wherein the first and second rows extend circumferentially along the skirt and are axially spaced from one another; and tightening the sutures to form a protruding rib between the first row and the second row, wherein the protruding rib includes a folded portion of the skirt that protrudes radially outward from a remainder of the skirt that is disposed against the frame.

[0173] Example 37. The method of any of the examples described herein, particularly example 36, wherein extending the suture in an alternating pattern includes passing the suture in a zigzag pattern from a second opening of one of the second openings on a first side of the skirt to a first opening of one of the first openings, and then from the first opening to a subsequent second opening on an opposing second side of the skirt, such that a plurality of spaced stitches are formed around the circumference of the skirt.

[0174] Example 38. The method of any of the examples described herein, particularly example 37, wherein the protruding rib protrudes radially outward from a first side of the skirt and the second side of the skirt is disposed flush with the outer surface of the frame.

[0175] Example 39. Any of the examples described herein, particularly the method of any one of Examples 36-38, wherein securing the skirt around the outer surface of the frame includes wrapping the skirt around the outer surface of the frame, overlapping first and second edges of the skirt angled relative to the inflow edge of the skirt, and securing the overlapped first and second edges together with an angled stitch line extending between the inflow edge and the outflow edge of the skirt.

[0176] Example 40. The method of any of the embodiments described herein, particularly example 39, wherein securing the skirt around the outer surface of the frame further comprises securing the inflow edge to an inflow end of the frame, and securing the outflow edge to a plurality of angled struts extending around the periphery of the frame at locations axially disposed between the inflow and outflow ends of the frame.

[0177] Example 41. The method of any of the embodiments herein, particularly any one of embodiments 36-40, wherein the first row and the second row extend circumferentially along the skirt at a non-zero angle relative to an inflow edge of the skirt that is secured to the inflow end of the frame.

[0178] Example 42. The method of any of the embodiments described herein, especially example 41, wherein the protruding rib spirals one or more turns around the circumference of the skirt from the inflow edge of the skirt to the outflow edge of the skirt.

[0179] Example 43. The method of any of the examples described herein, particularly any one of Examples 36-40, wherein the first row and the second row extend circumferentially along the skirt, parallel to an inflow edge of the skirt that is secured to the inflow end of the frame.

[0180] Example 44 The method of any example described herein, especially example 43, wherein the protruding rib forms a ring around the entire circumference of the skirt.

[0181] Example 45. The method of any of the embodiments described herein, particularly any one of Examples 36-44, further comprising disposing a plurality of leaflets within the frame.

[0182] Example 46. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts; a plurality of valve leaflets disposed within the frame; an outer skirt disposed about an outer surface of the frame, the outer skirt having an inflow edge secured to an inflow end of the frame and an outflow edge secured to a first portion of the plurality of interconnected struts, and opposing inner and outer surfaces, the inner surface facing the outer surface of the frame and disposed in contact with the outer surface; and a sealing member spiraling around the circumference of the outer skirt between the inflow and outflow edges toward the outflow edge, the sealing member comprising a folded portion of the outer skirt extending radially outward from the outer surface of the outer skirt and away from the frame.

[0183] Example 47. Any of the embodiments described herein, particularly example 46, wherein a first portion of the plurality of interconnected struts is disposed adjacent to a second portion of the plurality of interconnected struts forming the outflow end of the frame.

[0184] Example 48. A prosthetic heart valve according to any of the embodiments described herein, particularly any of Example 46 or Example 47, wherein the sealing member is in the form of a spiral that makes two turns around the outer skirt.

[0185] Example 49. Any of the embodiments described herein, particularly example 48, wherein the outer skirt further comprises a plurality of protrusions forming an undulating shape of the outflow edge, and the sealing member is spiraled between the inflow edge and a slot formed between two adjacent protrusions of the plurality of protrusions.

[0186] Example 50. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of embodiments 46-49, wherein the folded portion of the outer skirt of the sealing member is formed by a plurality of fastened stitches extending in an alternating pattern around the circumference of the outer skirt between adjacent openings of the first row of openings and the second row of openings disposed in the outer skirt, wherein the first row of openings and the second row of openings are parallel to each other and spiral around the circumference of the outer skirt.

[0187] Example 51. A prosthetic heart valve as described in any of the embodiments described herein, particularly example 50, wherein the plurality of fastened stitches comprises a first portion of stitches disposed on the outer surface of the outer skirt and a second portion of stitches disposed on the inner surface of the outer skirt, the first portion of stitches and the second portion of stitches alternating with each other around the circumference of the outer skirt.

[0188] Example 52. A prosthetic heart valve of any of the embodiments described herein, particularly either Example 50 or Example 51, wherein the plurality of fastened stitches form a plurality of rib portions each extending circumferentially between two adjacent stitches of the plurality of stitches and radially outward from the outer surface of the outer skirt.

[0189] Example 53. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of embodiments 46-52, wherein the sealing member extends circumferentially around the outer skirt at an angle to the inflow edge of the outer skirt.

[0190] Example 54. A prosthetic heart valve comprising a radially expandable and compressible annular frame, a plurality of valve leaflets disposed within the frame, and an outer skirt disposed around an outer surface of the frame, the outer skirt including one or more folded portions forming one or more radially outwardly protruding ribs that maintain the folded state when the prosthetic heart valve is in a radially compressed state and a radially expanded state.

[0191] Example 55. Any of the embodiments described herein, particularly example 54, wherein the inner surface of the outer skirt is positioned in contact with the outer surface of the frame and one or more ribs protrude radially outward from the outer surface of the outer skirt disposed opposite the inner surface of the outer skirt.

[0192] Example 56. A prosthetic heart valve as described in any of the embodiments described herein, particularly any of Example 54 or Example 55, wherein the frame comprises a plurality of interconnected struts and the outer skirt is positioned flush with the outer surface of the plurality of interconnected struts.

[0193] Example 57. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of embodiments 54-56, wherein one or more ribs extend between the inflow and outflow edges of the outer skirt.

[0194] Example 58. A prosthetic heart valve as described in any of the embodiments described herein, particularly example 57, wherein the inflow edge of the outer skirt is fixed to the inflow end of the frame and the outflow edge of the outer skirt is fixed to a support post of the frame positioned between the inflow and outflow ends of the frame.

[0195] Example 59. A prosthetic heart valve as described in any embodiment described herein, particularly any one of embodiments 54 to 58, wherein each of the one or more ribs extends around the entire circumference of the outer skirt and frame.

[0196] Example 60. A prosthetic heart valve described in any embodiment herein, particularly any one of embodiments 54-59, wherein one or more ribs include a spiral rib that forms a continuous spiral around the outer skirt at least once between the inflow edge and the outflow edge of the outer skirt.

[0197] Example 61 A prosthetic heart valve as described in any of the embodiments described herein, particularly example 60, wherein the spiral rib spirals continuously around the outer skirt for two revolutions.

[0198] Example 62. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of embodiments 54-59, including one or more ribs each extending around the entire circumference of the outer skirt and forming one or more radially protruding rings.

[0199] Example 63. A prosthetic heart valve as described in any of the embodiments described herein, particularly any one of embodiments 54 to 62, wherein the outer skirt includes a first row of openings and a second row of openings that are parallel to each other and each extend circumferentially along the outer skirt, and one or more ribs are formed between the first and second rows of openings by fastened sutures that extend in an alternating pattern between adjacent openings in the first row of openings and the second row of openings, forming a plurality of spaced stitches extending circumferentially along the outer skirt.

[0200] Example 64. Any of the embodiments described herein, particularly example 63, wherein one or more ribs have a plurality of radially outwardly protruding rib portions, each rib portion being defined between two adjacent stitches of the plurality of stitches.

[0201] Example 65. A prosthetic heart valve as described in any of the examples described herein, particularly example 63 or example 64, wherein the first row of openings and the second row of openings extend circumferentially along the outer skirt at a non-zero angle relative to the inflow edge of the outer skirt.

[0202] Example 66. A prosthetic heart valve according to any of the embodiments described herein, particularly any one of embodiments 63 to 65, wherein the outer skirt further comprises a third row of openings and a fourth row of openings, each of which is parallel to one another, each of which extends circumferentially along the outer skirt and spaced axially from the first and second rows of openings, the third and fourth rows of openings being continuous with the first and second rows of openings, respectively, and one or more ribs are formed between the first and second rows of openings and the third and fourth rows of openings by fastened sutures extending in an alternating pattern between adjacent openings in the first row of openings and the second row of openings and adjacent openings in the third row of openings and the fourth row of openings.

[0203] Example 67. A prosthetic heart valve as described in any of the embodiments described herein, particularly example 66, wherein the one or more ribs comprise a single rib that spirals twice around the circumference of the outer skirt.

[0204] Example 68. A prosthetic heart valve as described in any of the embodiments described herein, particularly any of embodiment 63 or embodiment 64, wherein the first row of openings and the second row of openings extend circumferentially along the outer skirt, parallel to the inflow edge of the outer skirt.

[0205] Example 69. A prosthetic heart valve as described in any of the embodiments described herein, particularly example 68, wherein the outer skirt further comprises a third row of openings and a fourth row of openings, each parallel to each other and extending circumferentially along the outer skirt, and axially spaced from the first and second rows of openings, and wherein a first rib of the one or more ribs is formed between the first and second rows of openings by a first fastened suture extending in an alternating pattern between adjacent openings of the first row of openings and the second row of openings, and a second rib of the one or more ribs is formed between the third row of openings and the fourth row of openings by a second fastened suture extending in an alternating pattern between adjacent openings of the third row of openings and the fourth row of openings.

[0206] Example 70. Any of the embodiments described herein, particularly example 69, wherein the first rib is axially spaced from the second rib, and the first rib and the second rib are each configured as annular ribs extending entirely around the circumference of the outer skirt.

[0207] Example 71 The prosthetic heart valve of any embodiment described herein, particularly any one of embodiments 54-70, wherein the outer skirt comprises fabric.

[0208] Example 72. A prosthetic heart valve described in any of the embodiments described herein, particularly any one of embodiments 54 to 71, wherein the outer skirt has an inflow edge, an outflow edge, and opposing first and second angled edges extending between the inflow edge and the outflow edge, the first and second angled edges being angled at a non-zero angle relative to the inflow edge, the first and second angled edges overlapping each other, and the outer skirt being secured together to form an annular configuration around the outer surface of the frame.

[0209] Example 73. A prosthetic heart valve as described herein in any of the embodiments, particularly example 72, wherein the inflow edge is straight and the outflow edge has an undulating shape defined by a plurality of protrusions.

[0210] Example 74. A method comprising sterilizing the prosthetic heart valve, device, and / or assembly of any of the examples.

[0211] Example 75. The artificial heart valve of any one of Examples 1 to 73, wherein the artificial heart valve is sterilized.

[0212] Various features described herein with respect to any example may be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one skirt, covering, or sealing member may be combined with any one or more features of another skirt, covering, or sealing member. For example, any one or more features of one prosthesis may be combined with any one or more features of another prosthesis.

[0213] In view of the many possible manners in which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims, and equivalents thereof.

Claims

1. 1. A prosthetic heart valve comprising: An annular frame; a plurality of valve leaflets disposed within the frame; an outer skirt disposed about an outer surface of the frame, the outer skirt including at least one folded portion and stitching extending through the folded portion to form a radially projecting rib; An artificial heart valve comprising:

2. 2. The prosthetic heart valve of claim 1, wherein an inner surface of the outer skirt is positioned against the outer surface of the frame, a base surface of the outer skirt is a radially outwardly facing surface of the outer skirt disposed opposite the inner surface, and the ribs extend radially outward from the base surface and the frame.

3. 3. The prosthetic heart valve of claim 1, wherein the annular frame comprises a plurality of interconnected struts, and the outer skirt is positioned flush against an outer surface of the plurality of interconnected struts.

4. The prosthetic heart valve of any one of claims 1 to 3, wherein the ribs extend between the inflow and outflow edges of the outer skirt.

5. 5. The prosthetic heart valve of claim 4, wherein the inflow edge of the outer skirt is secured to the inflow end of the frame and the outflow edge of the outer skirt is secured to a post of the frame disposed between the inflow and outflow ends of the frame.

6. The prosthetic heart valve of any one of claims 1 to 5, wherein the ribs are circumferentially extending ribs that extend around the entire circumference of the outer skirt and the frame.

7. 7. The prosthetic heart valve of claim 1, wherein the rib is a spiral rib that spirals continuously around the outer skirt for one or more revolutions between the inflow and outflow edges of the outer skirt.

8. 8. The prosthetic heart valve of claim 7, wherein the spiral rib spirals continuously around the outer skirt for two revolutions.

9. 7. The prosthetic heart valve of claim 1, wherein the rib is a first rib and the outer skirt includes a second folded portion and stitching that extends through the second folded portion to form a radially projecting second rib, each of the first rib and the second rib extending around the entire circumference of the outer skirt and forming two radially projecting rings.

10. 10. The prosthetic heart valve of claim 1, wherein the outer skirt includes a first row of apertures and a second row of apertures parallel to one another, each extending around the circumference of the outer skirt, and the ribs are formed between the first and second rows of apertures by fastened sutures extending in an alternating pattern between adjacent apertures in the first and second rows of apertures, forming a plurality of spaced apart stitches extending around the circumference of the outer skirt.

11. 1. A prosthetic heart valve comprising: an annular frame including a plurality of interconnected struts; an outer skirt disposed about an outer surface of the annular frame; and the outer skirt comprises: an inner surface disposed adjacent to the outer surface of the frame, and an outer surface disposed opposite the inner surface; a first row of circumferentially extending first apertures and a second row of circumferentially extending second apertures; a plurality of stitches formed between the first row and the second row, each stitch of the plurality of stitches extending between a respective one of the first openings and a respective one of the second openings; a folded portion of the outer skirt between the first and second rows of openings forming a rib projecting radially outward from the outer surface of the outer skirt and in a direction away from the frame; An artificial heart valve comprising:

12. 12. The prosthetic heart valve of claim 11, wherein the first row of first openings and the second row of second openings are disposed parallel to one another and extend at a non-zero angle along the circumference of the outer skirt relative to an inflow edge of the outer skirt that is secured to an inflow end of the frame.

13. 13. The prosthetic heart valve of claim 11 or claim 12, wherein the ribs spiral around the circumference of the outer skirt from an inflow edge of the outer skirt to an outflow edge of the outer skirt.

14. 14. The prosthetic heart valve of claim 13, wherein the outer skirt further comprises a third row of first circumferentially extending apertures and a fourth row of second circumferentially extending apertures, the third and fourth rows being disposed parallel to one another and axially spaced from the first and second rows, the plurality of stitches being further formed between the third and fourth rows, a first turn of the ribs being formed between the first and second rows, and a second turn of the ribs being formed between the third and fourth rows.

15. 12. The prosthetic heart valve of claim 11, wherein the first row of first openings and the second row of second openings extend around a circumference of the outer skirt parallel to an inflow edge of the outer skirt that is secured to an inflow end of the frame.

16. The prosthetic heart valve of claim 15 , wherein the ribs form a ring around the entire circumference of the outer skirt.

17. 17. The prosthetic heart valve of claim 11, wherein the plurality of stitches includes alternating first and second stitches, each of the first stitches extending between a respective first and second opening on the outer surface of the outer skirt, and each of the second stitches extending between a respective first and second opening on the inner surface of the outer skirt.

18. 1. A prosthetic heart valve comprising: a radially expandable and compressible annular frame; a plurality of valve leaflets disposed within the frame; an outer skirt disposed about an outer surface of the frame, the outer skirt including one or more folded portions forming one or more radially outwardly projecting ribs that maintain the folded condition when the prosthetic heart valve is in a radially compressed condition and a radially expanded condition; An artificial heart valve comprising:

19. 20. The prosthetic heart valve of claim 18, wherein an inner surface of the outer skirt is positioned against the outer surface of the frame, and the one or more ribs project radially outward from an outer surface of the outer skirt disposed opposite the inner surface of the outer skirt.

20. 20. The prosthetic heart valve of claim 18 or claim 19, wherein the frame comprises a plurality of interconnected struts, and the outer skirt is positioned flush against an outer surface of the plurality of interconnected struts.

21. The prosthetic heart valve of any one of claims 18 to 20, wherein the one or more ribs extend between an inflow edge and an outflow edge of the outer skirt.

22. 22. The prosthetic heart valve of claim 21, wherein the inflow edge of the outer skirt is secured to the inflow end of the frame and the outflow edge of the outer skirt is secured to a strut disposed between the inflow and outflow ends of the frame.

23. The prosthetic heart valve of any one of claims 18 to 22, wherein each of the one or more ribs extends around the entire circumference of the outer skirt and the frame.

24. 24. The prosthetic heart valve of any one of claims 18 to 23, wherein the one or more ribs include a spiral rib that spirals continuously around the outer skirt between the inflow and outflow edges of the outer skirt for one or more revolutions.

25. 25. The prosthetic heart valve of any one of claims 18 to 24, wherein the outer skirt includes a first row of apertures and a second row of apertures parallel to one another, each extending circumferentially along the outer skirt, and the one or more ribs are formed between the first and second rows of apertures by fastened sutures extending in an alternating pattern between adjacent apertures in the first row of apertures and the second row of apertures, forming a plurality of spaced apart stitches extending circumferentially along the outer skirt.

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