Attachment of Marker to the Commissure of the Artificial Heart Valve

Abstract

A method and an assembly for attaching a radiopaque marker to an attachment member of an artificial valve are disclosed. As an example, an artificial heart valve can include a frame including struts forming cells of the frame, at least one commissure comprising an attachment member and commissure tabs of two adjacent valve leaflets coupled thereto, an attachment member disposed across the cells of the frame and attached to the struts defining the cells, and a radiopaque marker suspended within the cell and suspended relative to the attachment member by suture threads. The suture threads extend from a first portion of the attachment member, through one or more openings of the marker, to a second portion of the attachment member, and the suture threads form two knots at the second portion on opposite sides of the marker such that the suture threads form an X-pattern that does not cross through the marker and across the attachment member.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 368,859, filed on July 19, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to methods and systems for attaching markers to commissures of prosthetic heart valves.

Background Art

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can lead to severe heart dysfunction and may ultimately require repairing the native valve or replacing the native valve with a prosthetic valve. A number of repair devices (e.g., stents) and prosthetic valves are known, and also a number of methods for implanting those devices and valves into the human body are known. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to locations within the body that are not easily accessible surgically and to locations where access without surgery is desirable. In one specific example, a prosthetic heart valve can be attached in a crimped state on the distal end of a delivery device and advanced through a patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic valve can then be expanded to its functional size by, for example, inflating a balloon to which the prosthetic valve is attached, or by driving a mechanical actuator that applies an expanding force to the prosthetic valve, or by self - expanding the prosthetic valve from the sheath of the delivery device to its functional size.

[0004] For example, when deploying an artificial valve at the native valve by inflating a balloon of a delivery device, the radially expanded artificial valve can be deployed in a random radial orientation with respect to the native valve. In order to implant the artificial heart valve with a desired rotational alignment with respect to the native valve, it may be desirable to visualize the position of the commissure of the artificial valve during the implantation procedure. Therefore, in some embodiments, the artificial valve can include a radiopaque marker fixed to the commissure of the artificial heart valve to enable visualization of the commissure under imaging (e.g., fluoroscopy) during the implantation procedure. In some cases, the marker can be sutured to an attachment member of the commissure of the artificial valve, and the attachment member is disposed across the cells of the frame of the artificial valve.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Summary of the Invention

Means for Solving the Problems

[0006] An artificial heart valve, a delivery device, and a method for implanting an artificial heart valve are described herein. Also described herein is a method for attaching components such as radiopaque markers to commissural attachment members of an artificial heart valve that are disposed and fixed across the cells of the frame of the artificial heart valve. In some embodiments, the method may include suspending the marker within the cell using a plurality of sutures such that the marker remains taught with respect to the attachment member without constraining the cell during radial compression and expansion of the frame. The disclosed artificial heart valve, delivery device, and method can provide, for example, a commissural attachment member or means for attaching to a commissure for disposing a radiopaque marker across the cells of the frame of an artificial heart valve that retains suture tension without restricting frame elongation when the frame is radially compressed (e.g., during crimping). Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies associated with typical artificial heart valves and their delivery devices.

[0007] A commissural attachment member for an artificial device (such as an artificial valve) can include a body portion and a radiopaque marker fixed to the body portion.

[0008] In some embodiments, the radiopaque marker is fixed to the body portion by a suture.

[0009] In some embodiments, the suture extends from a first portion of the body portion of the attachment member disposed adjacent to the first end of the marker, through one or more openings of the marker, to a second portion of the body portion of the attachment member disposed adjacent to the second end of the marker.

[0010] In some embodiments, the suture comprises two sutures.

[0011] In some embodiments, the suture forms a non-crossing X-pattern through the marker and across the body portion of the commissural attachment member.

[0012] In some embodiments, the cross-linked attachment member comprises a body portion and a radiopaque marker secured to the body portion by a suture, the radiopaque marker extending from a first portion of the body portion of the attachment member disposed adjacent to the first end of the marker, through one or more openings of the marker, to a second portion of the body portion of the attachment member disposed adjacent to the second end of the marker. The suture forms two connections to the second portion of the attachment member, disposed on both sides of the marker, such that the suture forms an X-pattern that passes through the marker and does not cross over the body portion of the attachment member.

[0013] In some embodiments, the cross-linked attachment member comprises a body portion and a radiopaque marker secured to the body portion by two sutures extending through one or more openings of the marker. The two sutures are axially offset from the first end of the marker and laterally offset from the marker in a first direction, from a first position on the body portion of the attachment member, through one or more openings of the marker, to a second position on the body portion of the attachment member that is axially offset from the second end of the marker and laterally offset from the marker in the first direction, to form a first suture. The two sutures are axially offset from the first end of the marker and laterally offset from the marker in a second direction, from a third position on the body portion of the attachment member, through one or more openings of the marker, to a fourth position on the body portion of the attachment member that is axially offset from the second end of the marker and laterally offset from the marker in the second direction, to form a second suture.

[0014] In some embodiments, the cross-linked attachment member includes one or more of the components listed in Examples 86-103 below.

[0015] The artificial heart valve can include a frame and a valve leaflet structure coupled to the frame. In addition to these components, the artificial heart valve can further include one or more of the components disclosed herein.

[0016] In some embodiments, the artificial heart valve can include a sealing member configured to reduce perivalvular leakage.

[0017] In some embodiments, the frame is radially collapsible into a collapsed configuration and radially expandable into an expanded configuration.

[0018] In some embodiments, the frame includes a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame.

[0019] In some embodiments, the valve leaflet structure includes a plurality of leaflets disposed within the frame and at least one commissure including an attachment member and a commissural tab joining two adjacent leaflets coupled to the attachment member.

[0020] In some embodiments, the attachment member is disposed across a designated cell of the plurality of cells and is attached to a strut of the frame defining the designated cell.

[0021] In some embodiments, the artificial heart valve can include a radiopaque marker suspended within a designated cell and positioned relative to the attachment member by a suture.

[0022] In some embodiments, the suture extends from a first portion of the attachment member positioned adjacent a first end of the marker, through one or more openings of the marker, to a second portion of the attachment member positioned adjacent a second end of the marker.

[0023] In some embodiments, the suture forms two knots in the second portion of the attachment member such that the suture crosses over the marker and across the attachment member in an X - pattern without crossing itself.

[0024] In some embodiments, the suture is axially offset from a first end of the marker and laterally offset from the marker in a first direction, from a first position on the attachment member, through one or more openings of the marker, to a second position on the attachment member that is axially offset from a second end of the marker and laterally offset from the marker in the first direction, and extends to a first suture, and axially offset from a first end of the marker and laterally offset from the marker in a second direction, from a third position on the attachment member, through one or more openings of the marker, to a fourth position on the attachment member that is axially offset from a second end of the marker and laterally offset from the marker in the second direction, and extends to a second suture.

[0025] In some embodiments, the artificial heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame, the frame being radially collapsible into a collapsed configuration and radially expandable into an expanded configuration. The artificial heart valve further includes at least one commissure including a plurality of valve leaflets disposed within the frame and a commissural tab of two adjacent valve leaflets coupled to the attachment member. The attachment member is disposed across a designated cell of the plurality of cells and is attached to a strut of the frame defining the designated cell. The artificial heart valve further includes a radiopaque marker disposed relative to the attachment member by a suture extending from a first portion of the attachment member suspended within the designated cell and adjacent to a first end of the marker, through one or more openings of the marker, to a second portion of the attachment member adjacent to a second end of the marker. The suture forms two knots disposed on both sides of the marker such that the suture crosses through the marker and does not cross across the attachment member to form an X pattern.

[0026] In some embodiments, the prosthetic heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame, the frame being radially collapsible into a collapsed configuration and radially expandable into an expanded configuration. The prosthetic heart valve further includes at least one commissure including a plurality of leaflets disposed within the frame and a commissural tab of two adjacent leaflets coupled to the attachment member, the attachment member being disposed across a designated cell of the plurality of cells of the frame and attached to a strut of the frame forming the designated cell. The prosthetic heart valve further includes a radiopaque marker suspended within a designated cell having two sutures extending through one or more openings within the marker, the two sutures being axially offset from a first end of the marker and laterally offset in a first direction from the marker, from a first position on the attachment member, through the one or more openings of the marker, to a second position on the attachment member that is axially offset from a second end of the marker and laterally offset in the first direction from the marker, the first suture extending thereto, and being axially offset from a first end of the marker and laterally offset in a second direction from the marker, from a third position on the attachment member, through the one or more openings of the marker, to a fourth position on the attachment member that is axially offset from a second end of the marker and laterally offset in the second direction from the marker, the second suture extending thereto.

[0027] In some embodiments, the prosthetic heart valve includes one or more of the components recited in Examples 120, 70 - 85, and 105 below.

[0028] The assembly can include a delivery device and a prosthetic heart valve.

[0029] In some embodiments, the prosthetic heart valve is radially collapsible into a collapsed configuration and radially expandable into an expanded configuration.

[0030] In some embodiments, the folded artificial heart valve can be radially expanded into an expanded configuration while the delivery device is within the patient's body, with the folded artificial heart valve being attached around the valve attachment portion at the distal end of the delivery device.

[0031] In some embodiments, the artificial heart valve includes one or more of any one or more of the features of the artificial heart valve described above.

[0032] In some embodiments, the artificial heart valve can include at least one commissure comprising an attachment member and a commissure tab joining two adjacent valve leaflets coupled to the attachment member, the attachment member being disposed across a designated cell of the frame and attached to a strut of the frame defining the cell.

[0033] In some embodiments, the artificial heart valve can include a radiopaque marker secured to the attachment member by first and second sutures that extend from both sides of a first portion of the attachment member disposed adjacent a first end of the marker, through one or more openings of the marker, to a second portion of the attachment member disposed adjacent a second end of the marker.

[0034] In some embodiments, the tension of the first and second sutures on the marker is maintained when the frame of the artificial heart valve is in both the folded and expanded configurations.

[0035] In some embodiments, the assembly includes a delivery device and an implantable artificial heart valve that is radially foldable in a folded configuration and radially expandable in an expanded configuration. The artificial heart valve includes a frame including a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame, the frame being radially foldable in a folded configuration and radially expandable in an expanded configuration. The artificial heart valve further includes at least one commissure including a plurality of valve leaflets disposed within the frame and a commissure tab of two adjacent valve leaflets coupled to an attachment member, the attachment member being disposed across a designated cell of the plurality of cells of the frame and attached to a strut of the frame defining the designated cell. The artificial heart valve further includes a radiopaque marker fixed to the attachment member by first and second sutures extending from both sides of a first portion of the attachment member adjacent to a first end of the marker, through one or more openings of the marker, to a second portion of the attachment member adjacent to a second end of the marker. The first and second sutures form first and second knots, respectively, in a second portion of the attachment member disposed on both sides of the marker such that tension of the first and second sutures on the marker is maintained when the frame is in both the folded and expanded configurations. The folded artificial heart valve can be attached around a valve attachment portion of a distal end portion of the delivery device and radially expanded in an expanded configuration using the delivery device within a patient's body.

[0036] In some embodiments, the assembly includes one or more of the components listed in Examples 21 - 42 below.

[0037] In some embodiments, the method can include extending sutures from both sides of a first portion of a commissure attachment member, through one or more openings of a marker disposed on the attachment member, to both sides of a second portion of the attachment member.

[0038] In some embodiments, the first portion is disposed adjacent to the first end of the marker, the second portion is disposed adjacent to the second end of the marker, and the second end is axially disposed on the opposite side of the first end.

[0039] In some embodiments, the method may further include forming knots with suture threads on both sides of the second portion of the attachment member such that the marker is suspended within the cell.

[0040] In some embodiments, the method includes radially compressing an artificial heart valve on a delivery device from a radially expanded configuration to a radially compressed configuration, and moving the knots laterally towards each other away from the marker axially in response to axially extending the frame during radial compression of the artificial heart valve such that the distance along the suture thread between the knots and the marker is maintained between the radially expanded configuration and the radially compressed configuration.

[0041] In some embodiments, the method may further include fixing the commissural tabs of two adjacent leaflets of the artificial heart valve to the first surface of the attachment member to form a commissure, and the attachment member is configured to be disposed across the cells of the frame of the artificial heart valve.

[0042] In some embodiments, the radiopaque marker is positioned relative to the second surface of the attachment member disposed on the opposite side of the first surface.

[0043] In some embodiments, the method includes extending a suture from both sides of a first portion of the cross-linking attachment member, through one or more openings of a marker disposed on the attachment member, to both sides of a second portion of the attachment member, where the first portion is disposed adjacent a first end of the marker and the second portion is disposed adjacent a second end of the marker, and the second end is disposed axially opposite the first end. The attachment member forms a cross-link with two adjacent valve leaflets of an artificial heart valve and is disposed across cells of a frame of the artificial heart valve. The method further includes forming knots with the suture on both sides of the second portion of the attachment member such that the marker is suspended within the cell, radially compressing the artificial heart valve on a delivery device from a radially expanded configuration to a radially compressed configuration, and moving the knots axially away from the marker and laterally toward each other in response to axially elongating the frame during radial compression of the artificial heart valve such that a distance along the suture between the knots and the marker is maintained between the radially expanded configuration and the radially compressed configuration.

[0044] In some embodiments, the method includes fixing the commissural tabs of two adjacent valve leaflets of an artificial heart valve to a first surface of an attachment member to form a commissure, the attachment member being configured to be disposed across cells of a frame of the artificial heart valve. The method further includes positioning a radiopaque marker relative to a second surface of the attachment member disposed opposite the first surface, extending a first suture from a first position on the attachment member, through at least two openings of the marker, to a second position on the attachment member, and forming a first knot with the first suture fixed to the first position on the attachment member. The first position is offset from a first end of the marker in a first axial direction and a first transverse direction, and the second position is offset from a second end of the marker in a second axial direction and the first transverse direction. The method further includes extending a second suture from a third position on the attachment member, through at least two openings of the marker, to a fourth position on the attachment member, and forming a second knot with the second suture fixed to the second position on the attachment member. The third position is offset from the first end of the marker in the first axial direction and a second transverse direction, and the fourth position is offset from the second end of the marker in the second axial direction and the second transverse direction. The method further includes fixing the attachment member to struts of a frame defining the cells with a third suture such that the marker is disposed within the cell and not directly attached to struts defining the cell.

[0045] In some embodiments, the method includes one or more of the features recited in Examples 43 - 69 and 104 below.

[0046] The various innovations in this disclosure can be used in combination or individually. This summary is provided to introduce, in a simplified form, a selection of concepts that are further described in the following detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of this disclosure will become more apparent from the following detailed description, from the claims, and from the accompanying drawings.

Brief Description of the Drawings

[0047]

Figure 1A

Figure 1B

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14A

Figure 14B

Figure 15

[0048] General Considerations For the purposes of this specification, specific aspects, advantages, and novel features in the examples of this disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being in any way limiting. Instead, this disclosure is directed to all novel and non-obvious features and aspects relating to the various disclosed examples, alone, in various combinations with each other, and in various sub-combinations of each other. The methods, apparatuses, and systems are not limited to any particular aspect, feature, or combination thereof, and the disclosed examples do not require the presence of any one or more particular advantages or the solving of any problems.

[0049] Although the operations in some of the disclosed examples are described in a particular sequential order for the sake of presentation, it should be understood that this mode of description encompasses permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be performed concurrently. Moreover, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions with respect to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those of ordinary skill in the art.

[0050] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intermediate elements between the coupled or associated members unless a specific contrary statement is made.

[0051] As used herein, the term "proximal" refers to the position, orientation, or portion of the device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise explicitly defined.

[0052] As used herein, "e.g." means "for example," and "i.e." means "that is."

[0053] Summary of the Disclosed Technology As described above, an artificial heart valve includes a radiopaque marker fixed to the commissure of the artificial heart valve, so that the commissure can be visualized under imaging (e.g., fluoroscopy) during the implantation procedure. As a result, the user can determine the position of the commissure relative to the natural anatomical structure (the native heart valve) and more easily implant the artificial valve in the desired rotational, axial, and / or lateral orientation relative to the native heart valve. In some cases, the marker may be sutured to the attachment member of the commissure of the artificial valve, and the attachment member is disposed across the cells of the frame of the artificial valve.

[0054] The prosthetic valve disclosed herein can be radially compressible and radially expandable over a range between a radially compressed (or folded) state and a radially expanded state. The prosthetic valve can be crimped onto an implant delivery device in a radially compressed state or held by an implant delivery device when being advanced through a patient's vasculature on the delivery device. After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded into a radially expanded state. It will be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and implanted via a variety of delivery procedures, examples of which will be described in further detail hereinafter.

[0055] When radially compressing or crimping the prosthetic valve into a radially compressed state around the delivery device, the frame of the prosthetic valve becomes axially elongated, thereby laterally contracting the cells of the frame. In some embodiments, radiopaque markers are sutured to the attachment members using suture threads that are also used to secure the attachment members to the frame struts that define the top and bottom of the cells. In such examples, the markers essentially connect the top and bottom struts that define the cells. Thus, when the prosthetic valve is crimped into a radially compressed state, the markers can prevent the frame from fully elongating (into a fully folded state). As a result, the prosthetic valve can have a larger crimp profile (larger diameter) on the delivery device, thereby increasing the pushing force felt by the user as the artificial heart valve advances on the delivery device towards the implantation site.

[0056] An artificial heart valve, delivery device, and method for assembling and implanting an artificial heart valve are described herein. In some embodiments, such devices, apparatuses, and / or methods can provide a device and / or method for attaching a radiopaque marker to an attachment member of a commissure of an artificial heart valve such that the marker can move freely as the frame elongates while still maintaining the tension of the marker against the attachment member, across the cells of the frame of the artificial heart valve. As a result, the frame can be fully compressed into its compressed or folded state, minimizing the crimp profile of the radially compressed artificial heart valve on the delivery device. As a result, the pushing force felt by a user advancing the artificial heart valve on the delivery device to the implantation site can be reduced.

[0057] Exemplary artificial heart valves are shown in FIGS. 1A-1B. As described above, the artificial heart valve can be crimped onto a delivery device, such as the exemplary delivery device shown in FIG. 2, in a radially compressed state while being advanced through a patient's vasculature on the delivery device. After the artificial heart valve reaches the implantation site, the artificial heart valve can be radially expanded from a radially compressed state (FIG. 4) to a radially expanded state (FIG. 3). During radial compression of the artificial heart valve, its frame is radially compressed and axially elongated. As a result, the cells defined by the struts of the frame contract and become elongated.

[0058] In some embodiments, as shown in FIGS. 5-8, a commissure can be formed by attaching adjacent valve leaflet commissure tabs together to an attachment member (an exemplary attachment member is shown in FIG. 9). Each attachment member can then be disposed across the cells of the frame and the attachment member fixed to the struts defining the cells (as shown in FIGS. 3 and 4) to attach the commissure to the cells (e.g., outflow cells) of the frame of the artificial heart valve. In some cases, the attachment member can also be fixed to the strut of the cell using a suture used to connect the commissure tab and the attachment member together.

[0059] To avoid restricting the elongation and compression of the frame during crimping onto the delivery device of the valve, a radiopaque marker can be attached to the attachment member by a suture that suspends the marker across the cell, without directly suturing the marker to the struts forming the cell. For example, as shown in FIGS. 10 - 13, the sutures from both sides of the attachment member may extend through one or more openings of the marker and then, above the marker, knots can be made on both sides of the marker and the attachment member. As a result, when the prosthetic valve is crimped, the knots move upward toward each other as the frame elongates, thereby maintaining suture tension and holding the marker relative to the attachment member without restricting frame elongation. Then, additional (different) sutures can be used to secure the attachment member to the struts of the cell. The sutures suspending the marker within the cell form a non - intersecting "X" shape (or forward "C" and reverse "C" shapes) through the marker and onto the attachment member. Such a configuration allows the sutures to maintain their tension, thereby keeping the marker taut relative to the attachment member in both the radially expanded state (as shown in FIGS. 14A and 14B) and the radially compressed state (as shown in FIG. 15).

[0060] Examples of the disclosed technology FIGS. 1A and 1B show an exemplary prosthetic valve 50 according to one embodiment. Although all of the prosthetic valves disclosed herein are configured to be implanted in the native aortic valve annulus, in other embodiments, they can also be configured to be implanted in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valves can also be implanted inside blood vessels that communicate with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava 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 can also be implanted inside a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve - in - valve procedure.

[0061] In some embodiments, the disclosed prosthetic valves can be implanted within a docking 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, for example, in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at a native mitral valve, as disclosed, for example, in PCT Publication No. WO 2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior vena cava or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed, for example, in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0062] The prosthetic valve 50 can have three main components: a stent or frame 52, a valve structure 54, and a sealing member 56 (FIG. 1A). FIG. 1B is a perspective view of the prosthetic valve 50, with components outside the frame 52 (including the sealing member 56) shown in phantom for illustrative purposes. The prosthetic valve 50 can have an inflow end 66 and an outflow end 68.

[0063] The valvular structure 54 can include three leaflets 60 that collectively form the leaflet structure, and these three leaflets can be configured to fold in a tricuspid valve arrangement, although in other examples, there can be a greater or lesser number of leaflets (e.g., one or more leaflets 60). In some examples, the leaflets 60 can be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0064] Each leaflet 60 may be coupled to the frame 52 along its inflow edge 62 (also referred to as the lower edge in the figures, or "leaflet edge") and at a commissure 64 of the valvular structure 54 where adjacent portions of the two leaflets (e.g., commissure tabs) are connected to one another. In some embodiments, the commissure 64 may comprise an attachment member (e.g., comprising a fabric, a flexible polymer, or the like) disposed across a cell (e.g., a commissure cell) of the frame 52, the cell being formed by struts of the frame. The attachment member may be secured to the struts of the frame that form the cell, and adjacent portions of the two leaflets may be connected to the attachment member to form the commissure 64 (e.g., as shown in FIGS. 3-8, as further described below).

[0065] In some examples, a reinforcing element or connecting skirt, such as a fabric strip, can be connected directly to the leaflet margins of the leaflets and to the struts of the frame to couple the leaflet margins to the frame.

[0066] Frame 52 can be formed from any of a variety of suitable plastically expandable materials (such as, for example, stainless steel) or self-expanding materials (such as, for example, nitinol). When constructed of a plastically expandable material, frame 52 (and thus prosthetic valve 50) can be crimped into a radially collapsed configuration on a delivery device (e.g., a catheter) and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. Various crimping devices can be used to crimp the prosthetic valve 50 described herein and other prosthetic valves around a delivery device, such as the crimping device described in U.S. Pat. No. 7,530,253, incorporated herein by reference.

[0067] In some cases, the prosthetic valve 50 can be directly crimped onto the inflatable balloon of the delivery device such that the prosthetic valve 50 is axially aligned with the balloon and disposed radially outward of the balloon while advancing the prosthetic valve on the delivery device to the implantation site, as described, for example, in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference. In an alternative example, the prosthetic valve 50 is crimped onto a delivery device that is axially offset from the balloon and can then move over the balloon at the implantation site prior to inflation of the balloon and radial expansion of the prosthetic valve as described in U.S. Patent Application No. 9,339,384, which is incorporated herein by reference.

[0068] When constructed of a self-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped into a radially collapsed configuration and constrained in the collapsed configuration by insertion into the sheath of the delivery device or an equivalent mechanism. After being within the body, the prosthetic valve can be advanced from the delivery sheath, thereby allowing the prosthetic valve to expand to its functional size.

[0069] Suitable plastically expandable materials that can be used to form the frame 52 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, the frame 52 can include stainless steel. In some embodiments, the frame 52 can include cobalt-chromium. In some embodiments, the frame 52 can include nickel-cobalt-chromium. In some embodiments, the frame 52 can include a nickel-cobalt-chromium-molybdenum alloy such as MP35N (trademark) (a trade name of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N® / UNS R30035 includes 35 weight percent nickel, 35 weight percent cobalt, 20 weight percent chromium, and 10 weight percent molybdenum.

[0070] In the illustrated embodiment, the frame 52 comprises a plurality of circumferentially extending columns of angled struts 72 that define a column of open cells 74 (or apertures) of the frame. The frame 52 can have a cylindrical or substantially cylindrical shape with a constant diameter from the inlet end 66 to the outlet end 68 of the frame 52, as shown, or the frame 52 can have a diameter that varies along the height of the frame, as disclosed in U.S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0071] The frame 52 may include a plurality of vertices 80 spaced apart from each other around the circumference of the frame 52 at each of the inlet end 66 and the outlet end 68.

[0072] In the illustrated embodiment, the sealing member 56 is attached to the outside of the frame 52 and functions to create a seal against the surrounding tissue (e.g., the native leaflet and / or native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 56 can include an inner layer 76 (which can contact the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be connected to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be stitched to the frame 52 via a suture that extends around the strut 72 and through the inner layer 76. In an alternative embodiment, the inner layer 76 can be attached on the inner surface of the frame 52 while the outer layer 78 is on the outside of the frame 52.

[0073] The outer layer 78 can be configured or shaped to extend radially outwardly from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside the patient's body, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 78 to expand to contact the surrounding tissue.

[0074] Additional details regarding the artificial valve 50 and its various components are described in U.S. Patent Publication No. 2018 / 0028310, which is incorporated herein by reference.

[0075] FIG. 2 shows a delivery device 100 by way of example that can be used to implant an expandable artificial heart valve (e.g., the artificial valve 50 of FIGS. 1 and 1B, and / or any other artificial heart valve described herein). In some embodiments, the delivery device 100 is specifically configured for use in introducing an artificial valve into the heart.

[0076] The delivery device 100 in the example illustrated in FIG. 2 is a balloon catheter and includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 can further include an intermediate shaft 106 (which can also be referred to as a balloon shaft) extending proximally and distally from the handle 102, and the portion extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery device 100 can further include an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and 104 and extending proximally from the handle 102 coaxially through the intermediate shaft 106.

[0077] The outer shaft 104 and the intermediate shaft 106 can be configured to translate (e.g., move) longitudinally relative to each other along the central longitudinal axis 120 of the delivery device 100 to facilitate delivering and positioning the artificial valve at the implantation site within the patient's body.

[0078] The intermediate shaft 106 can include a proximal end portion 110 extending proximally from the proximal end of the handle 102 to the adapter 112. A rotatable knob 114 can be attached to the proximal end portion 110 and configured to rotate the intermediate shaft 106 relative to the outer shaft 104 about the central longitudinal axis 120.

[0079] The adapter 112 can include a first port 138 configured to receive a guide wire therethrough and a second port 140 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 140 can be in fluid communication with the lumen of the intermediate shaft 106.

[0080] The intermediate shaft 106 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable balloon 118 of the delivery device 100. The distal end portion of the inner shaft 108 can extend distally beyond the distal end portion of the intermediate shaft 106.

[0081] The balloon 118 can be coupled to the distal end portion of the intermediate shaft 106.

[0082] In some embodiments, the distal end of the balloon 118 can be coupled to the distal end of the delivery device 100, such as a nose cone 122 (as shown in FIG. 2), or to an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 100. The intermediate portion of the balloon 118 can cover the valve attachment portion 124 of the distal end portion of the delivery device 100, and the distal end portion of the balloon 118 can cover the distal shoulder 126 of the delivery device 100. The valve attachment portion 124 and the intermediate portion of the balloon 118 can be configured to receive an artificial heart valve in a radially compressed state. For example, as schematically shown in FIG. 2, an artificial heart valve 150 (which can be one of the artificial valves described herein) can be attached around the balloon 118 at the valve attachment portion 124 of the delivery device 100.

[0083] The balloon shoulder assembly, including the distal shoulder 126, is configured to maintain the artificial heart valve 150 (or other medical device) at a fixed position on the balloon 118 during delivery through the patient's vasculature.

[0084] The outer shaft 104 can include a distal tip portion 128 attached to its distal end. The outer shaft 104 and the intermediate shaft 106 can be axially translated relative to each other such that when the prosthetic valve 150 is attached in a radially compressed state on the valve attachment portion 124 (as shown in FIG. 2), and when delivering the prosthetic valve to the target implantation site, the distal tip portion 128 is positioned adjacent to the proximal end of the valve attachment portion 124. In this way, the distal tip portion 128 can be configured such that when the distal tip portion 128 is disposed adjacent to the proximal side of the valve attachment portion 124, the prosthetic valve 150 is axially proximal with respect to the balloon 118 and resists movement relative to the balloon 118.

[0085] An annular space can be defined between the outer surface of the inner shaft 108 and the inner surface of the intermediate shaft 106, and this annular space can be configured to receive fluid from a fluid source via a second port 140 of the adapter 112. The annular space can be in fluid communication with a fluid passage formed between the outer surface of the distal end portion of the inner shaft 108 and the inner surface of the balloon 118. In this way, fluid from the fluid source can flow from the annular space into the fluid passage, thereby inflating the balloon 118 and radially expanding and deploying the prosthetic valve 150.

[0086] The lumen of the inner shaft can be configured to receive a guide wire therethrough for maneuvering the distal end portion of the delivery device 100 to the target implantation site.

[0087] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the illustrated example, for instance, the handle 102 includes an adjustment member such as the illustrated rotatable knob 160, which is operably coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion fixed to or near the distal end of the outer shaft 104. By rotating the knob 160, the tension of the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details regarding the steering mechanism or bending mechanism in the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0088] The handle 102 can further include an adjustment mechanism 161 including an adjustment member such as the illustrated rotatable knob 162, and an associated locking mechanism including another adjustment member configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 100 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0089] Figures 3 and 4 are partial views of another exemplary artificial valve 200 including a frame 52 in a radially expanded configuration (Figure 3) and a radially compressed (or folded) configuration (Figure 4). The artificial valve 200 includes an exemplary outer skirt 201 disposed around an outer surface of the frame 52 and is similar to the artificial valve 50 of Figures 1A and 1B except that it includes a commissure 202 formed by securing a connection portion of a valve tip 208 (a commissural tab) adjacent to a radially inward facing surface of an attachment member 204 that is disposed across cells 74 of the frame 52 and secured (e.g., with suture 210) to struts 72 that define the cells 74. The attachment member 204 can include cloth, a flexible polymeric material, or a combination thereof. In some embodiments, the commissure 202 can be used in place of the commissure 64 of the artificial valve 50.

[0090] Detailed views showing an assembly of the commissure 202 are shown in FIGS. 5-8. FIG. 5 shows an exploded view of the commissure 202 before securing the attachment member 204 to a commissural tab of an adjacent valve tip 208. FIG. 6 shows a side view of the attachment member 204 secured to the commissural tab of the valve tip 208 before completion of folding of the commissural tab, and FIGS. 7 and 8 show top and bottom views, respectively, of the assembled commissure 202. As used herein with respect to the commissure 202, "top" or "top view" can refer to the end of the commissure that is disposed closest to the outflow end 68 of the frame 52 (compared to the opposite lower end), and "bottom" or "bottom view" can refer to the end of the commissure that is disposed closer to the inflow end 66 of the frame 52 than the upper end.

[0091] Further, an example of the attachment member 204 in a flat and unfolded state (before folding and commissure formation) is shown in FIG. 9. It should be noted that in alternative embodiments, the attachment member 204 can have a configuration different from that shown in FIG. 9, such as not including a flap 256 or having a different overall shape (e.g., rectangular shape, hexagonal shape, etc.).

[0092] To form each crosslink 202, the first crosslink tab 206a and the second crosslink tab 206b of adjacent first valve tips 208a and second valve tips 208b can be folded and arranged adjacent to each other (FIG. 5). In some cases, the attachment member 204 may also be folded into a selected shape and may include one or more creases. For example, as shown in FIGS. 3-5, the attachment member 204 may include a body portion 212 having a radially outward facing surface 214 (FIGS. 3 and 4) and a radially inward facing surface 216 (FIG. 5) configured to receive the crosslink tabs 206a, 206b folded thereon. The body portion 212 may be shaped to fit within the cell 74 of the frame 52. The attachment member 204 may also include a first folded side portion 220 and a second folded side portion 222 disposed opposite each other across the body portion 212 and extending radially inwardly from the radially inward facing surface 216 toward the central longitudinal axis 218 of the prosthetic valve 200. In some embodiments, each of the first folded side portion 220 and the second folded side portion 222 may include two layers of the attachment member 204 (for the crease).

[0093] After forming the crease, the folded cross - connecting tabs 206a, 206b can then be arranged relative to the surface 216 facing radially inward. The first folded side portion 220 extends over the crease 224a outside the first cross - connecting tab 206a, and the second folded side portion 222 extends over the crease 224b outside the second cross - connecting tab 206b. The folded cross - connecting tabs 206a, 206b can be fixed to the attachment member 204 by one or more stitch lines including a plurality of stitches (e.g., in - and - out stitches) of a sewing thread. FIG. 5 illustrates two sets of broken lines on the attachment member 204 and the folded cross - connecting tabs 206a, 206b, which represent two stitch lines on both sides of the cross - connection 202 used to fix the attachment member 204 and the cross - connecting tabs 206a, 206b together (the broken lines are shown on both the attachment member 204 and the cross - connecting tabs 206a, 206b in the exploded view of FIG. 5, but as shown in FIG. 6, when the cross - connecting tabs 206a, 206b are disposed relative to the attachment member 204, one stitch line can be formed at the same position on the attachment member 204 and on the cross - connecting tab).

[0094] More specifically, the stitch line may include a primary stitch line 226a extending through the folded cross - connecting tab 206a (formed by a primary sewing thread) adjacent to the first folded side portion 220 and the body portion 212, and a primary stitch line 226b extending through the folded cross - connecting tab 206b (formed by another primary sewing thread) adjacent to the second folded side portion 222 and the body portion 212. The stitch line may further include a secondary stitch line 228a (formed by a secondary sewing thread) extending radially inward from the body portion 212 and the primary stitch line 226a through the first folded side portion 220 and the folded cross - connecting tab 206a, and a secondary stitch line 228b (formed by another secondary sewing thread) extending radially inward from the body portion 212 and the primary stitch line 226b through the second folded side portion 222 and the folded cross - connecting tab 206b.

[0095] As shown in FIG. 6, the primary stitch line 226a can be formed of the primary suture 230a, and the secondary stitch line 228a can be formed of the secondary suture 232a. Similarly, the primary stitch line 226b can be formed of the primary suture 230b, and the secondary stitch line 228b can be formed of the secondary suture 232b. In some embodiments, the outer folds 224a and 224b can be formed by folding the interconnect tabs 206a, 206b around the primary stitch lines 226a, 226b such that the primary stitch lines 226a, 226b are pushed inside the interconnect 202 (as shown in the top view of FIG. 7). Additional examples of methods for folding the interconnect attachment members and the valve tip interconnect tabs and attachment members to form the interconnect can be found in PCT Application No. PCT / US2022 / 012873, which is incorporated herein by reference.

[0096] The formation of the primary stitch lines 226a, 226b and the secondary stitch lines 228a, 228b by the primary sutures 230a, 230b and the secondary sutures 232a, 232b, respectively, can result in primary suture tails and secondary suture tails formed at both the first or upper end (FIG. 7) and the second or lower end (FIG. 8) of the assembled interconnect 202 (the primary suture tails are not shown in FIG. 8). For example, as shown in FIG. 7, the upper primary suture tails 234a, 234b can extend from the center of the interconnect 202 on both sides of the interconnect 202 (and adjacent to the body portion 212 of the attachment member 204), and the upper secondary suture tails 236a, 236b can be tied together at the upper ends of the interconnect tabs 206a, 206b and extend away from the formed knot 238. As shown in FIG. 8, the bottom secondary suture tails 240a, 240b can be knotted together at the bottom ends of the interconnect tabs 206a, 206b and extend away from the formed knot 242. In some embodiments, the bottom primary suture tails 244a, 244b can extend outwardly through the body portion 212 of the attachment member 204 from a surface 214 that faces radially outward (e.g., as shown in FIG. 7).

[0097] The primary suture tails 234a, 234b, 244a, 244b, and the secondary suture tails 236a, 236b, 240a, 240b can be used to secure additional components to the attachment member 204 and / or to secure the attachment member 204 to the frame 52. Such additional components can include radiopaque markers configured to be visible under medical imaging such as fluoroscopy.

[0098] For example, in order to implant an artificial valve at a desired position (e.g., a desired rotational alignment and / or axial position) relative to a native valve, it may be desirable to visualize the position of one or more commissures of the artificial valve during the implantation procedure in the native valve. In some embodiments, it may be desirable to implant the artificial valve such that the commissures of the artificial valve are aligned with the commissures of the native valve. By attaching radiopaque markers to one or more commissures of the artificial valve, the position of the commissures relative to the native valve (or an alternative native anatomical structure) can be easily visualized under medical imaging (e.g., fluoroscopy) during the implantation procedure, thereby facilitating rotational positioning of the artificial valve relative to the native valve.

[0099] Exemplary radiopaque markers 250 (referred to herein as markers) that can be secured to the attachment member 204 are shown in FIGS. 9 - 11. The marker 250 can be configured to be visible under medical imaging. For example, the marker 250 can include a radiopaque material configured to be visible under medical imaging such as fluoroscopy and / or other types of X-ray images. In some embodiments, the marker 250 can include a radiopaque or other material configured to be visible under MRI, ultrasound, and / or echocardiogram. In some embodiments, the marker 250 can include tantalum. In some embodiments, the marker 250 can include another type of radiopaque material or combination of materials such as one or more of iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0100] Marker 250 is shown in FIGS. 9 (and FIGS. 10 - 13) as having an oblong or oval shape. However, in alternative embodiments, the marker may have different shapes such as rectangular, arcuate, ring-shaped, circular, etc., or may have the shape of a character (such as "C", "E", "e", etc.).

[0101] As shown in FIG. 9, marker 250 has two axially spaced-apart openings 252, 254. However, in alternative embodiments, marker 250 may have one or more openings such as two, three, four openings, etc. In still other embodiments, openings 252, 254 may be larger or smaller than those shown in FIG. 9 and / or may have different shapes (e.g., square, oblong, or hexagonal).

[0102] To attach marker 250 to attachment member 204, marker 250 can first be positioned relative to the elongated flap 256 of attachment member 204 (FIG. 9). For example, as shown in FIG. 9, attachment member 204 can include a first side portion 258 and a second side portion 260 that project laterally from a central portion 262 (or central region). In some embodiments, attachment member 204 can further include a tab 264 that projects from an edge of central portion 262 on the side opposite flap 256.

[0103] Marker 250 can be disposed on the first surface 266 of flap 256 and over the openings 268, 270 of flap 256 such that its openings 252, 254 overlap openings 268, 270. In alternative embodiments, flap 256 may not include pre-formed openings 252, 254. Next, flap 256 can be folded over the surface 214 of central portion 262 of attachment member 204 that faces radially outward. In this way, marker 250 is sandwiched between the second (outer) surface 272 of flap 256 (shown in FIG. 13) and the surface 214 of central portion 262 of attachment member 204 that faces radially outward (FIGS. 12 and 13).

[0104] In an alternative embodiment, the mounting member may not include the flap 256. In such an embodiment, the marker 250 can be disposed relative to the radially outward facing surface 214 of the central portion 262 of the mounting member without a flap covering the marker 250. Then, the same or a similar method can be implemented as further described below with reference to FIGS. 10 - 13.

[0105] As described above with reference to FIGS. 5 - 8, the mounting member 204 can be folded such that a body portion 212, a first folded side portion 220, and a second folded side portion 222 as shown in FIG. 5 are formed. By folding the first side portion 258 and the second side portion 260 of the mounting member 204, the first folded side portion 220 and the second folded side portion 222 can be formed (e.g., as shown in FIG. 5), and then the body portion can be defined by the central portions 262 of the respective first side portion 258 and second side portion 260 as well as the first edge 274 and the second edge 276.

[0106] Marker 250 may be attached to attachment member 204 using a suturing method that extends a suture thread through marker 250 and forms knots on both sides of attachment member 204 at a location remote from marker 250, whereby when attachment member 204 is secured to the struts that define the cell, marker 250 is suspended within the cell of the artificial valve frame and suture tension is maintained in both the radially expanded configuration and the radially compressed configuration of the frame. FIGS. 10 and 11 are schematic diagrams presenting a high-level representation of a method for suturing a marker (or alternative component) to an attachment member. FIGS. 10 and 11 depict suturing marker 250 to attachment member 204, but the method described below with reference to FIGS. 10 and 11 (as well as FIGS. 12 and 13) is applicable to alternative attachment members configured to be secured to the attachment member (e.g., attachment members having alternative shapes and / or including or not including flaps) and / or alternative markers or components. In FIGS. 10 and 11, flap 256 is omitted for clarity of illustration. However, flap 256 is shown in the more detailed FIGS. 12 and 13 as further described below. FIG. 12 is a schematic diagram showing a more specific example of the method introduced in FIGS. 10 and 11, where the primary suture tail and the secondary suture tail used to form crosslink 202 are used to suture marker 250 to attachment member 204.

[0107] Referring first to FIGS. 10 and 11, marker 250 is shown to be disposed relative to a surface 214 that faces radially outward of attachment member 204. When attachment member 204 is coupled to a cell (e.g., an outflow cell) of an artificial valve frame, the outflow end 255 of marker 250 may be oriented toward the outflow end of the frame, and the inflow end 257 of marker 250 may be oriented toward the inflow end of the frame (e.g., FIGS. 14A - 15). As shown in FIGS. 10 and 11, two suture threads 281a, 281b (which in some embodiments may be bottom primary suture tails 244a, 244b, as further described below with reference to FIGS. 12 and 13) extend from knots 284a, 282b (or other types of connection points or junctions) in the inflow portion 278 (or first portion) of attachment member 204, under marker 250 (e.g., over the first radial surface of marker 250), through first opening 252 of marker 250, over marker 250 between first opening 252 and second opening 254 (e.g., over the second radial surface 263 of marker 250), through second opening 252, under marker 250, and to the outflow portion 280 (second portion) of attachment member 204, with two knots 282a, 282b formed on both sides of attachment member 204 (across marker 250). In an alternative embodiment, knots 284a, 284b or knots 282a, 282b can be replaced by points within attachment member 204 through which suture threads 281a, 281b extend radially outwardly from the surface 214 that faces the rear of attachment member 204 (without tying or knotting the sutures).

[0108] The ends of the suture 281a (indicated by the knots 284a and 282a) are disposed on the first lateral side of the attachment member 204 and are laterally offset from the first lateral side 251 of the marker 250, thereby being able to substantially form a forward "C" shape. Conversely, the ends of the suture 281b (indicated by the knots 284b and 282b) are disposed on the second lateral side of the attachment member 204 and are laterally offset from the second lateral side 253 of the marker 250, thereby being able to substantially form a reverse "C" shape. As a result, the two sutures 281a, 281b form a non-crossing X pattern passing through the marker 250 and across the attachment member 204.

[0109] As used herein, a "non-crossing X pattern" can refer to the forward "C" and reverse "C" patterns shown in FIGS. 10-13, and it should be noted that the ends of the same suture or suture tails are disposed on the same side (not the opposite side) of the marker and the attachment member 204 (with respect to the central longitudinal axis 205 of the attachment member 204). In some embodiments, the intermediate portions of the suture or suture tails extending between the first opening 252 and the second opening 254 may cross or overlap each other while, for example, maintaining the overall non-crossing X pattern of the suture or suture tails.

[0110] As further described below, the non - intersecting X - pattern described above can advantageously maintain the outward suture tension of the suture threads 281a, 281b when the mounting member 204 stretches and elongates axially (e.g., when the frame is compressed radially). However, in an alternative embodiment, the two suture threads 281a, 281b may form an X - pattern that intersects through the marker 250. For example, the opposing first and second ends of the suture thread 281a may be disposed on both sides of the marker 250, and the opposing first and second ends of the suture thread 281b may be disposed on both sides of the marker 250. In some cases, because the frame expands and compresses radially, this intersecting X - pattern may not maintain the tension of the suture threads 281a, 281b, similar to the non - intersecting X - pattern further described below.

[0111] The non - intersecting X - stitch pattern shown in FIGS. 10 and 11 enables the suture tension to be maintained when the prosthetic valve frame and the mounting member 204 are in a radially expanded state (FIG. 10) and when the frame and the mounting member 204 are in a radially compressed state (FIG. 11). For example, the knots 282a, 282b and 284a, 284b (or ends) of the suture threads 281a, 281b move laterally towards each other as indicated by the arrow 286 and axially away from the outflow end 255 and the inflow end 257 of the marker 250 as the frame is radially compressed (e.g., crimped) and the mounting member 204 elongates axially (FIG. 10). Similarly, when the frame is radially expanded, the knots 282a, 282b and 284a, 284b (or ends) of the suture threads 281a, 281b move laterally away from each other and axially towards the outflow end 255 and the inflow end 257 of the marker 250 as indicated by the arrow 287 as the mounting member 204 shortens axially (FIG. 11).

[0112] In this way, the knots 282a, 282b and 284a, 284b (or ends) of the suture threads 281a, 281b move with the frame and the mounting member 204 as they are axially elongated (during crimping) and axially shortened (during expansion). This enables the first distance 283 (or the length of the suture thread) along the suture thread 281a or 281b between each of the knots 282a, 282b and 284a, 284b of the marker 250 and the end 255 or 257 in the expanded state (Figure 10) to be the same (or substantially equal) to the second distance 285 (or the length of the suture thread) along the suture thread 281a or 281b between the same knots 282a, 282b and 284a, 284b of the marker 250 and the end 255 or 257 in the compressed state (Figure 11). By maintaining the first distance 283 and the second distance 285, the suture threads 281a, 281b can hold a specific tension on the marker 250 through the crimping and expansion processes, thereby keeping the marker 250 positioned relative to the mounting member 204 (e.g., without bulging outwards as the frame compresses or expands). Further, since the suture threads 281a, 281b are not directly attached to the struts that define the cells in which the mounting member 204 is positioned (as will be further described below with reference to Figures 12 - 15), the frame can elongate as necessary during radial compression of the frame.

[0113] FIG. 12 is a schematic view showing a more specific example of the suture method introduced above with reference to FIGS. 10 and 11, which uses the primary suture tail and the secondary suture tail used to form the crosslink 202 (as shown in FIGS. 5-8) to attach the marker 250 to the attachment member 204 and suspend the marker 250 across the cells of the artificial valve frame. FIG. 13 shows a view of the attachment member 204 after following the suture method described below with reference to FIG. 12 (e.g., showing the knot formed as described below). Further, FIGS. 14A, 14B, and 15 show another view of the cell 74 of the frame 52 in which the attachment member 204 is fixed to the strut 72 defining the cell 74 and the marker 250 is fixed to the attachment member 204 (not directly to the strut 72) according to the method described below with reference to FIG. 12.

[0114] As described above with reference to FIG. 9, the marker 250 can be disposed relative to the first surface 266 of the flap 256 of the attachment member 204. Next, the flap can be folded over the central portion 262 of the attachment member 204 such that the second surface 272 on the opposite side of the flap 256 becomes the outer or radially outward facing surface of the attachment member 204 (when disposed within the cell of the artificial valve frame) and the marker 250 is covered by the flap 256. Thus, the marker 250 is shown by a dashed line in FIG. 12 (and FIGS. 13-15) to indicate its position under the flap 256. In FIG. 12, additional dashed lines are used to show the portion of a component (e.g., a suture) disposed under the flap 256 (or extending along the first surface 266 of the flap 256 on the opposite side of the second surface 272 visible in FIG. 12).

[0115] The bottom primary suture tails 244a, 244b can extend along both sides of the radially outward-facing surface 214 that is disposed under the flap 256 of FIG. 12 through the attachment member 204 (e.g., through the central portion 262). (Thus, these suture tails are shown by the dashed lines under the marker 250 of FIG. 12.) The bottom primary suture tail 244a is disposed axially offset from the inflow end 257 of the marker 250 and extends from a position 289 that is laterally offset in a first direction (e.g., under and to the right of the marker 250 in the view of FIG. 12) from the first lateral side 251 of the marker 250 toward the inflow end 257 of the marker 250. In some embodiments, the position 289 can be laterally offset from the central longitudinal axis of the marker 250 instead of the first lateral side 251 (e.g., the position 289 can be laterally aligned with or adjacent to the first lateral side 251 of the marker 250).

[0116] Next, the bottom primary suture tail 244a passes under the marker 250 (or, as shown in FIG. 9, the first radial surface 261 of the marker 250), through the first opening 252 and the flap 256 of the marker 250, and across the radially outward-facing surface (second surface 272) of the flap 256 between the first opening 252 and the second opening 254, through the flap 256 and the second opening 254 again, under the marker 250, through the flap 256 again, and extends to the radially outward-facing surface of the flap 256. Next, the bottom primary suture tail 244a extends across the second surface 272 of the flap 256, axially offset from the outflow end 255 of the marker 250, to a position laterally offset in a first direction (to the upper right of the marker 250 in the view of FIG. 12) from the first lateral side surface 251 of the marker 250 (or the central longitudinal axis of the marker 250). This position is indicated by a first knot 288 that may be formed by tying the bottom primary suture tail 244a to the upper secondary suture tail 236a on the radially outward-facing surface of the flap 256. For example, the upper secondary suture tail 236a may extend around or through the flap 256 so as to be tied to the bottom primary suture tail 244a. In this way, the bottom primary suture tail 244a forms an approximately forward "C" shape through the marker 250 and across the attachment member 204.

[0117] Similarly, the bottom primary suture tail 244b is axially offset from the inflow end 257 of the marker 250 and extends from a position 291 that is laterally offset in a second direction (e.g., below and to the left of the marker 250 in the view of FIG. 12) from the second lateral side 253 (or the central longitudinal axis) of the marker 250 toward the inflow end 257 of the marker 250. Next, the bottom primary suture tail 244b extends from under the marker 250, through the first opening 252 and the flap 256 of the marker 250, across the radially outward-facing surface of the flap 256 between the first opening 252 and the second opening 254, through the flap 256 and the second opening 254 again, under the marker 250, through the flap 256 again, and to the radially outward-facing surface of the flap 256. Next, the bottom primary suture tail 244b extends across the second surface 272 of the flap 256 to a position that is axially offset from the outflow end 255 of the marker 250 and is laterally offset in a second direction (to the upper left of the marker 250 in the view of FIG. 12) from the second lateral side 253 (or the central longitudinal axis) of the marker 250. This position is indicated by a second knot 290 that may be formed by tying the bottom primary suture tail 244b to the upper secondary suture tail 236b on the radially outward-facing surface of the flap 256. For example, the upper secondary suture tail 236b may extend around or through the flap 256 so as to be tied to the bottom primary suture tail 244b. In this way, the bottom primary suture tail 244b forms an approximately reverse “C” shape through the marker 250 and across the attachment member 204.

[0118] In an alternative embodiment, instead of forming knots 288 and 290, the bottom primary suture tails 244a, 244b can be connected to the outflow portion of the attachment member 204 in a different way (other than being tied to the upper secondary suture tails 236a, 236b), such as by gluing, mechanically fixing, or otherwise connecting the ends of the bottom primary sutures 244a, 244b to the attachment member at the same point on the attachment member 204 (e.g., replacing knots 288 and 290 with alternative connections to the attachment member 204).

[0119] The suture configuration shown in FIG. 12 may be referred to as a non - intersecting X - pattern. However, in some embodiments, the portions of the bottom primary suture tails 244a, 244b that extend over the flap 256 between the first opening 252 and the second opening 254 may overlap and / or intersect with each other while maintaining the overall non - intersecting X - pattern (e.g., the ends of both the bottom primary suture tail 244a are on the same first lateral side of the attachment member 204, while the ends of both the bottom primary suture tail 244b are on the same second lateral side of the attachment member 204).

[0120] In this way, using the bottom primary suture tails 244a, 244b, the marker 250 is attached to the attachment member 204 (for example, instead of the sutures 281a, 281b shown in FIGS. 10 and 11), and the marker 250 is suspended across the cells of the frame. In an alternative embodiment, a different suture can be used to attach the marker 250 to the attachment member 204 in a similar manner as described above with reference to FIG. 12. For example, in some cases, the suture from a position axially offset above or from the outflow end 255 of the marker 250 (such as the upper secondary suture tails 236a, 236b or the upper primary suture tails 234a, 234b) can be routed from above the marker 250, through the flap 256 and the marker 250, to the knots (such as at positions 289 and 291) formed under the marker 250. In this way, instead of routing the suture from the inflow end to the outflow end of the marker 250 (as shown in FIG. 12), it may also be possible to route the suture in the reverse direction, from the outflow end to the inflow of the marker 250.

[0121] Returning to FIG. 12, in some embodiments, the upper primary suture tails 234a, 234b can extend through the attachment member and to the second surface 272 of the flap 256 on both sides of the central longitudinal axis 205 of the attachment member 204. The upper primary suture tails 234a, 234b are then used to form whip stitches 292 around the struts 72 that define the cell 74 and through the perimeter of the body portion 212 of the attachment member 204, thereby coupling the attachment member 204 to the frame 52 of the prosthetic valve (as shown in FIGS. 14A, 14B, and 15).

[0122] A third knot 294 can be formed on the second surface 272 of the flap 256 that is axially offset from the inflow end 257 of the marker 250 (for example, at the inflow end of the flap 256 which can be the free end of the flap 256). The third knot 294 can be formed from the bottom secondary suture tails 240a, 240b (FIG. 13). The third knot 994 can secure the flap 256 to the body portion 212 of the attachment member 204.

[0123] The suture tails (upper primary suture tails 234a, 234b) that attach the attachment member 204 to the strut 72 of the frame 52 are different from the suture tails (bottom primary suture tails 244a, 244b) that attach the marker 250 to the attachment member 204. Thus, the marker 250 cannot be attached directly to the strut 72 that defines the cell 74. Further, by forming the knots 288 and 290 shown in FIGS. 12 and 13 at positions axially offset from the marker 250 (e.g., as described above), the marker 250 is able to move as the frame elongates (during crimping) into a compressed state (FIG. 15) and as it shortens (during expansion) into an expanded state (FIGS. 14A and 14B). As a result, the marker 250 does not limit the elongation of the frame 52 during radial compression of the prosthetic valve. Thereby, the crimp profile of the prosthetic valve is minimized, whereby the pushing force felt by the user advancing the prosthetic valve crimped on the delivery device to the implantation site can be reduced. Further, due to the non-crossing X-pattern (or forward and reverse C-pattern) of the sutures that attach the marker 250 to the attachment member 204, the suture tension of the sutures that hold the marker 250 relative to the attachment member 204 within the cell 74 remains relatively constant in both the radially expanded state (FIGS. 14A and 14B) and the radially compressed state (FIG. 15). As a result, the marker 250 remains within or near the cell on the exterior of the frame without expanding radially outwardly (e.g., as shown in FIG. 14B).

[0124] Delivery Technique To implant an artificial valve into the native aortic valve via a transfemoral delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta and through the descending aorta, around the aortic arch and through the ascending aorta. The artificial valve is positioned inside the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from the sheath to make the artificial valve self-expanding). Alternatively, the artificial valve can be implanted inside the native aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by means of a partial J sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta towards the native aortic valve.

[0125] To implant an artificial valve into the native mitral valve via a transseptal delivery approach, the artificial valve is attached in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made within the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted into the native mitral valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned inside the native mitral valve.

[0126] To implant an artificial valve inside the native tricuspid valve, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into the inferior vena cava and through the inferior vena cava into the right atrium, where the artificial valve is positioned inside the native tricuspid valve. A similar approach can be used to implant the artificial valve inside the native pulmonary valve or the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve into the right ventricle and towards the pulmonary valve / pulmonary artery.

[0127] Another delivery approach is the transatrial approach, in which the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision that is made through the atrial wall (the atrial wall of the right atrium or the left atrium) to access any of the native heart valves. Atrial delivery can also be performed intravascularly, for example, from the pulmonary vein. Yet another delivery approach is the transventricular approach, in which the artificial valve (on the distal end portion of the delivery device) is inserted through a chest incision that is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve inside the native tricuspid valve or the native pulmonary valve or the pulmonary artery.

[0128] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve 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.

[0129] Any system, device, apparatus, etc. in this specification can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients, and any method in this specification can include sterilizing the related system, device, apparatus, etc. as one of the steps of the method. Examples of sterilization by heating / heat include sterilization by steam and sterilization by autoclave. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide may be carried out, for example, using hydrogen peroxide plasma.

[0130] Additional examples related to the disclosed technology In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that one individual feature in one example, or two or more features in combination in that example, and optionally in combination with one or more features in one or more further examples, are further examples that fall within the disclosure of this application.

[0131] Example 1. An artificial heart valve, comprising a frame including a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame, the frame being radially foldable in a folded configuration and radially expandable in an expanded configuration, a plurality of valve leaflets disposed within the frame, and at least one commissure including an attachment member and a commissural tab of two adjacent valve leaflets coupled to the attachment member, wherein the attachment member is disposed across a designated cell of the plurality of cells and attached to a strut of the frame defining the designated cell, at least one commissure, a radiopaque marker disposed within the designated cell and positioned relative to the attachment member by a suture extending from a first portion of the attachment member suspended within the designated cell and adjacent to a first end of the marker, through one or more openings within the marker, to a second portion of the attachment member adjacent to a second end of the marker, the suture forming two knots at the second portion of the attachment member disposed on the opposite side of the marker such that the suture crosses across the attachment member without crossing through the marker in an X pattern.

[0132] Example 2. The artificial heart valve according to any embodiment of the present specification, particularly Example 1, wherein a first end of the marker is oriented towards the inflow end of the frame and a second end of the marker is oriented towards the outflow end of the frame.

[0133] Example 3. The artificial heart valve according to any embodiment of the present specification, particularly either Example 1 or Example 2, wherein the designated cell is disposed at the outflow end of the frame, the second portion of the attachment member is disposed at the outflow end of the designated cell, and the first portion of the attachment member is disposed at the inflow end of the designated cell.

[0134] Example 4. The artificial heart valve according to any embodiment of the present specification, particularly Example 1, wherein a first end of the marker is oriented towards the outflow end of the frame and a second end of the marker is oriented towards the inflow end of the frame.

[0135] Example 5. An artificial heart valve according to any example herein, particularly either Example 1 or Example 4, wherein the designated cell is disposed at the outflow end of the frame, the second portion of the attachment member is disposed at the inflow end of the designated cell, and the first portion of the attachment member is disposed at the outflow end of the designated cell.

[0136] Example 6. An artificial heart valve according to any example herein, particularly any one of Examples 1 to 5, wherein a first distance between each knot of two knots and a second end of a marker when the frame is in an expanded configuration, and a second distance between each knot of the marker and the second end of the marker when the frame is in a folded configuration are the same.

[0137] Example 7. An artificial heart valve according to any example herein, particularly any one of Examples 1 to 6, comprising a first suture that extends on a first radial side surface of a marker from a first portion of an attachment member to a first opening in the marker, through the first opening, from the first opening to a second opening in the marker on a second radial side surface of the marker, through the second opening to the first radial side surface of the marker, and from the second opening to a second portion of the attachment member where a first knot is formed by the first suture, the first knot being axially offset from a second end of the marker and laterally offset in a first lateral direction from a first lateral side surface of the marker.

[0138] Example 8. An artificial heart valve according to any example herein, particularly Example 7, wherein the first radial side surface is a surface facing radially inward, the second radial side surface is a surface facing radially outward of the marker with respect to the central longitudinal axis of the artificial heart valve, and the first opening and the second opening extend between the first radial side surface and the second radial side surface of the marker.

[0139] Example 9. The suture includes a second suture that extends on the first radial side of the marker from the first portion of the attachment member to the first opening in the marker, through the first opening, from the first opening to the second opening in the marker on the second radial side of the marker, through the second opening to the first radial side of the marker, and also from the second opening to the second portion of the attachment member where the second knot is formed by the second suture. The second knot is axially offset from the second end of the marker and is laterally offset in a second lateral direction from the second lateral side of the marker, where the second lateral direction is opposite to the first lateral direction. An artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in Example 7 or Example 8.

[0140] Example 10. An artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in Example 9, wherein the first suture extends from the first lateral side of the first portion of the attachment member, and the second suture extends from the second lateral side of the first portion of the attachment member, and the first and second lateral sides face each other across the central longitudinal axis of the attachment member.

[0141] Example 11. An artificial heart valve according to any embodiment of the present specification, particularly the artificial heart valve described in either Example 9 or Example 10, wherein the first knot is formed by the first suture and the third suture, and the first suture and the third suture are suture tails from the opposite ends of two different stitch lines extending across the first side of the commissure to fix the commissure tab and the attachment member together.

[0142] Example 12. An artificial heart valve according to any embodiment of the present specification, particularly any one of Examples 9 to 11, wherein the second knot is formed by the second suture and the fourth suture, and the second suture and the fourth suture are suture tails from the opposite ends of two different stitch lines extending across the second side of the commissure to fix the commissure tab and the attachment member together.

[0143] Example 13. An artificial heart valve according to any example herein, particularly any one of Examples 7 - 12, wherein the attachment member is attached to a strut of a frame defining a specified cell by fifth and sixth sutures that extend through the attachment member, wrap around the strut, and extend through the periphery of the attachment member around the specified cell.

[0144] Example 14. An artificial heart valve according to any example herein, particularly any one of Examples 1 - 13, wherein the attachment member comprises an elongated flap that extends axially outward from a body portion of the attachment member, a marker is disposed relative to a first surface of the flap, and the flap is folded over the body portion such that the marker is disposed between the flap and the body portion, such that a second surface of the flap, which is disposed opposite the first surface of the flap, faces radially outward of the attachment member.

[0145] Example 15. An artificial heart valve according to any example herein, particularly Example 14, wherein two knots are formed on a second surface of the flap, and a third knot is formed by seventh and eighth sutures that extend through the flap and join together on the second surface of the flap such that the flap is fixed to the body portion of the attachment member.

[0146] Example 16. An artificial heart valve according to any example herein, particularly any one of Examples 1 - 15, wherein the attachment member comprises one or more of cloth and a flexible polymer material.

[0147] Example 17. An artificial heart valve according to any example herein, particularly any one of Examples 1 - 16, wherein the marker comprises tantalum.

[0148] Example 18. An artificial heart valve according to any example herein, particularly any one of Examples 1 - 17, wherein the marker has an elliptical shape with its longest dimension disposed axially of the artificial heart valve.

[0149] Example 19. An artificial heart valve according to any one of the examples herein, particularly any one of Examples 1 to 18, wherein the marker includes two openings axially spaced from each other.

[0150] Example 20. An artificial heart valve according to any one of the examples herein, particularly any one of Examples 1 to 19, wherein the artificial heart valve is balloon-expandable and configured to expand from a folded configuration to an expanded configuration in response to pressure applied to the frame by inflation of a balloon of a delivery device.

[0151] Example 21. An assembly comprising a delivery device and a transplantable artificial heart valve that is radially foldable into a folded configuration and radially expandable into an expanded configuration, the artificial heart valve including a frame including a plurality of struts forming a plurality of cells of the frame disposed between an inflow end and an outflow end of the frame, the frame being radially foldable into the folded configuration and radially expandable into the expanded configuration, a plurality of valve leaflets disposed within the frame, and at least one commissure including an attachment member and a commissural tab of two adjacent valve leaflets coupled to the attachment member, the attachment member being disposed across a designated cell of the plurality of cells of the frame and attached to a strut of the frame to define the designated cell, at least one commissure, and a radiopaque marker fixed to the attachment member by first and second sutures extending from both sides of a first portion of the attachment member disposed adjacent to a first end of the marker through one or more openings within the marker to a second portion of the attachment member disposed adjacent to a second end of the marker, the first and second sutures forming first and second knots, respectively, in the second portion of the attachment member disposed on the opposite side of the marker such that tension of the first and second sutures against the marker is maintained when the frame is in both the folded and expanded configurations, the folded artificial heart valve being attached around a valve attachment portion of a distal end portion of the delivery device, and the delivery device being radially expandable into the expanded configuration while within the patient's body.

[0152] Example 22. An assembly of any example herein, particularly the assembly of Example 21, wherein the first and second sutures form a non-crossing X-pattern across the attachment member through the markers.

[0153] Example 23. An assembly of any example herein, particularly the assembly described in either Example 21 or Example 22, wherein the first suture forms a forward C-shape and the second suture forms a reverse C-shape across the attachment member.

[0154] Example 24. An assembly of any example herein, particularly the assembly described in any one of Examples 21 - 23, wherein the first end of the marker is disposed closer to the inlet end of the frame than the second end of the marker, and the second end of the marker is disposed closer to the outlet end of the frame than the first end of the marker.

[0155] Example 25. An assembly of any example herein, particularly the assembly described in any one of Examples 21 - 24, wherein the designated cell is disposed at the outlet end of the frame, the second portion of the attachment member is disposed at the outlet end of the designated cell, and the first portion of the attachment member is disposed at the inlet end of the designated cell.

[0156] Example 26. An assembly of any example herein, particularly the assembly of Example 25, wherein the marker is suspended within the middle portion of the cell designated by the first and second sutures, and the middle portion is disposed between the inlet end and the outlet end of the designated cell.

[0157] Example 27. An assembly of any example herein, particularly the assembly described in any one of Examples 21 - 23, wherein the first end of the marker is disposed closer to the outlet end of the frame than the second end of the marker, and the second end of the marker is disposed closer to the inlet end of the frame than the first end of the marker.

[0158] Example 28. An assembly according to any example herein, particularly any one of Examples 21-27, wherein a first distance defined between each one of the first and second knots and a second end of the marker when the frame is in an extended configuration is equal to a second distance defined between each one of the first and second knots of the marker and the second end of the marker when the frame is in a folded configuration.

[0159] Example 29. An assembly according to any example herein, particularly any one of Examples 21-28, wherein a first suture extends from a first position on a first portion of the attachment member to a first opening in the marker, through the first opening, across the marker between the first and second openings of the marker, through the second opening, to a second portion of the attachment member where a first knot is formed with the first suture, the first position being axially offset from a first end of the marker and laterally offset in a first lateral direction from a first lateral side of the marker, the first knot being axially offset from a second end of the marker and laterally offset in the first lateral direction from the first lateral side of the marker.

[0160] Example 30. An assembly according to any example herein, particularly the assembly according to Example 29, wherein a second suture extends from a second position on a first portion of the attachment member to a first opening in the marker, through the first opening, across the marker between the first and second openings of the marker, through the second opening, to a second portion of the attachment member where a second knot is formed with the second suture, the second position being axially offset from a first end of the marker and laterally offset in a second lateral direction from a second lateral side of the marker, the second knot being axially offset from a second end of the marker and laterally offset in the second lateral direction from the second lateral side of the marker, the second lateral direction being opposite the first lateral direction.

[0161] Example 31. An assembly according to any example herein, particularly Example 30, wherein a first knot is formed by a first suture and a third suture, a second knot is formed by a second suture and a fourth suture, and an attachment member is attached to a strut of a frame defining a specified cell by fifth and sixth sutures that extend through the attachment member, wrap around the strut, and extend through a periphery of the attachment member around the specified cell.

[0162] Example 32. An assembly according to any example herein, particularly Example 31, wherein the first and second sutures are suture tails extending from a first end of two primary stitch lines disposed on opposite sides of an intersection that fixes an intersection tab and an attachment member together, the third and fourth sutures are suture tails extending from a second end of two secondary stitch lines disposed on opposite sides of the intersection that fixes the intersection tab and the attachment member together, and the fifth and sixth sutures are suture tails extending from a second end of the two primary stitch lines.

[0163] Example 33. An assembly according to any example herein, particularly any one of Examples 21 - 32, wherein the attachment member includes a body portion and an elongated flap extending axially outward from the body portion, a marker is disposed on a first surface of the flap, and the flap is folded over the body portion such that the marker is disposed between the flap and the body portion of the flap, such that a second surface of the flap disposed on an opposite side of the first surface of the flap faces radially outwardly on an exterior of a specified cell and faces a surface of the attachment member.

[0164] Example 34. An assembly according to any example herein, particularly Example 33, wherein the first and second knots are formed on a second surface of the flap, and a third knot is formed by seventh and eighth sutures that extend through the flap and are joined together on the second surface of the flap such that the flap is fixed to the body portion of the attachment member.

[0165] Example 35. An assembly according to any example herein, particularly any one of Examples 21 to 34, wherein the attachment member includes one or more of cloth and a flexible polymer material.

[0166] Example 36. An assembly according to any example herein, particularly any one of Examples 21 to 35, wherein the marker includes tantalum.

[0167] Example 37. An assembly according to any example herein, particularly any one of Examples 21 to 36, wherein the marker has an elliptical shape with its longest dimension disposed in the axial direction of the artificial heart valve.

[0168] Example 38. An assembly according to any example herein, particularly any one of Examples 21 to 37, wherein the marker includes two openings axially spaced from each other.

[0169] Example 39. An assembly according to any example herein, particularly any one of Examples 21 to 38, wherein the delivery device includes a balloon, the folded artificial heart valve is attached around the balloon, and in a state where the balloon is in the patient's body, it can be radially expanded into an expanded configuration.

[0170] Example 40. An assembly according to any example herein, particularly the assembly of Example 39, wherein the artificial heart valve is in a folded configuration where the folded artificial heart valve is radially curled around the balloon so as to be disposed radially outward of the balloon.

[0171] Example 41. An assembly according to any example herein, particularly the assembly of Example 39, wherein the artificial heart valve is in a folded configuration where it is radially curled around the delivery device so as to be axially offset from the balloon.

[0172] Example 42. An assembly according to any example herein, particularly any one of Examples 21 to 38, wherein the artificial heart valve is self-expandable and is housed around the valve attachment portion of the delivery device in a folded configuration by a movable delivery capsule of the delivery device.

[0173] Example 43. Extending suture threads from both sides of the first part of the cross-linked attachment member, through one or more openings of markers disposed on the attachment member, to both sides of the second part of the attachment member, wherein the first part is disposed adjacent to the first end of the marker, the second part is disposed adjacent to the second end of the marker, the second end is disposed axially opposite to the first end, the attachment member forms a cross-link with two adjacent valve leaflets of an artificial heart valve and is disposed across cells of a frame of the artificial heart valve, the extending; forming knots with suture threads on both sides of the second part of the attachment member such that the marker is suspended within the cell; radially compressing the artificial heart valve on a delivery device from a radially expanded configuration to a radially compressed configuration such that the distance along the suture thread between the knot and the marker is maintained between the radially expanded configuration and the radially compressed configuration; and in response to axially elongating the frame during radial compression of the artificial heart valve, moving the knots axially away from the marker and laterally towards each other. A method comprising.

[0174] Example 44. The method according to any example herein, particularly Example 43, wherein the suture threads form an X-pattern that does not cross from the first part to the second part of the attachment member.

[0175] Example 45. The method according to any example herein, particularly either Example 43 or claim 44, wherein the knot includes a first knot that is laterally offset in a first direction from the second end of the marker and a second knot that is laterally offset in a second direction opposite to the first direction from the second end of the marker.

[0176] Example 46. Extending a suture and forming a knot, from a first position on a first portion of the attachment member, to a first opening of a marker, through the first opening, across the marker between the first opening and a second opening in the marker, through the second opening, to a second position on a second portion of the attachment member, extending a first suture, and forming a first knot at the second position, wherein the first position is axially offset from a first end of the marker and laterally offset in a first lateral direction from the first end of the marker, the second position is axially offset from a second end of the marker and laterally offset in a first lateral direction from the second end of the marker; forming, from a third position on the first portion of the attachment member, to the first opening of the marker, through the first opening, across the marker between the first opening and the second opening in the marker, through the second opening, to a fourth position on the second portion of the attachment member, extending a second suture, and forming a second knot at the fourth position, wherein the third position is axially offset from the first end of the marker and laterally offset in a second lateral direction from the first end of the marker, the fourth position is axially offset from the second end of the marker and laterally offset in a second lateral direction from the second end of the marker; the method according to any one of the examples herein, particularly any one of Examples 43 - 45.

[0177] Example 47. The method according to any one of the examples herein, particularly Example 46, wherein the first and second positions are axially offset from each other and laterally aligned, and the third and fourth positions are axially offset from each other and laterally aligned.

[0178] Example 48. The method according to any one of the examples herein, particularly any one of Examples 43 - 47, wherein the cross - link is formed by attaching a cross - link tab of two adjacent valve tips to a surface of the attachment member facing radially inward, and the knot is formed on a surface of the attachment member facing radially outward.

[0179] Example 49. Further comprising forming a crosslink by extending a plurality of suture threads through the crosslink tabs and the attachment members to fix the attachment members and the crosslink tabs together, forming a plurality of stitch lines that result in suture tails extending from both ends of each of the plurality of stitch lines, wherein extending the suture threads from both sides of the first portion of the attachment member comprises extending two first suture tails from a separate stitch line of the plurality of stitch lines through the attachment member to the radially outward facing surface of the attachment member, and then extending the two first suture tails through one or more openings in the marker to both sides of the second portion of the attachment member, the method according to any example herein, particularly the method described in Example 48.

[0180] Example 50. Forming a knot, the method according to any example herein, particularly the method described in Example 49, comprising forming a knot with two first suture tails and two second suture tails from an additional separate stitch line of the plurality of stitch lines.

[0181] Example 51. The first portion of the attachment member is disposed at the inlet end of the cell, the second portion of the attachment member is disposed at the outlet end of the cell, and the marker is disposed in the middle portion of the attachment member disposed between the first portion and the second portion, the method according to any example herein, particularly any one of Examples 43 - 50.

[0182] Example 52. The first portion of the attachment member is disposed at the outlet end of the cell, the second portion of the attachment member is disposed at the inlet end of the cell, and the marker is disposed on the middle portion of the attachment member disposed between the first portion and the second portion, the method according to any example herein, particularly any one of Examples 43 - 50.

[0183] Example 53. Further comprising attaching the attachment member to the struts of the frame defining the cell by extending additional suture threads around the attachment member and through the attachment member around the struts, wherein the marker is not directly attached to the struts, the method according to any example herein, particularly any one of Examples 43 - 52.

[0184] Example 54. The method according to any one of the examples herein, particularly any one of Examples 43 to 53, wherein the marker moves freely as the artificial heart valve is compressed radially and the frame becomes axially elongated, but remains as instructed with respect to the attachment member.

[0185] Example 55. The method according to any one of the examples herein, particularly any one of Examples 43 to 54, wherein the marker is a radiopaque marker comprising a radiopaque material.

[0186] Example 56. The method according to any one of the examples herein, particularly any one of Examples 43 to 55, wherein the marker comprises tantalum.

[0187] Example 57. The method according to any one of the examples herein, particularly any one of Examples 43 to 56, wherein the marker comprises two or more openings.

[0188] Example 58. Fixing the commissural tabs of two adjacent leaflets of an artificial heart valve to the first surface of the attachment member to form a commissure, the attachment member being configured to be disposed across the cells of the frame of the artificial heart valve, forming; positioning a radiopaque marker relative to the second surface of the attachment member disposed on the opposite side of the first surface; extending a first suture from a first position on the attachment member through at least two openings of the marker to a second position on the attachment member and forming a first knot with the first suture fixed to the first position of the attachment member, wherein the first position is offset from the first end of the marker in a first axial direction and a first lateral direction, and the second position is offset from the second end of the marker in a second axial direction and the first lateral direction, forming; extending a second suture from a third position on the attachment member through at least two openings of the marker to a fourth position on the attachment member and forming a second knot with the second suture fixed to the second position of the attachment member, wherein the third position is offset from the first end of the marker in a first axial direction and a second lateral direction, and the fourth position is offset from the second end of the marker in a second axial direction and the second lateral direction, forming; fixing the attachment member to the struts of the frame defining the cell with a third suture such that the marker is disposed within the cell and not directly attached to the struts defining the cell, the method comprising.

[0189] Example 59. Radially compressing an artificial heart valve on a delivery device from a radially expanded configuration to a radially compressed configuration; moving the first and second knots laterally towards each other away from the marker axially in response to axially elongating the frame during radial compression of the artificial heart valve such that the tension in the first and second sutures is maintained between the radially expanded configuration and the radially compressed configuration, further comprising the method according to any example herein, particularly Example 58.

[0190] Example 60. The method of any of the examples herein, particularly any one of Example 58 or Example 59, wherein a first end of the marker is oriented toward the inflow end of the frame and a second end of the marker is oriented toward the outflow end of the frame.

[0191] Example 61 The method of any example herein, particularly Example 58 or Example 59, wherein a first end of the marker is oriented toward the outflow end of the frame and a second end of the marker is oriented toward the inflow end of the frame.

[0192] Example 62. The method of any example herein, particularly any one of Examples 58-61, wherein the first and second locations are laterally aligned with one another, and the third and fourth locations are laterally aligned with one another.

[0193] Example 63. The method of any example herein, particularly any one of Examples 58-62, wherein securing the commissure tabs of two adjacent valve leaflets to a first surface of the attachment member to form the commissure includes forming a plurality of stitch lines with a plurality of sutures axially across the commissure through the commissure tabs and attachment member, the first and second sutures being first and second suture tails extending from first ends of the first and second stitch lines, respectively, from the plurality of stitch lines, and further comprising extending the first and second sutures through the attachment member from the first surface to the second surface at first and third locations on the attachment member.

[0194] Example 64. The method of any example herein, particularly example 63, wherein forming the first knot comprises forming the first knot with a third suture tail extending through the first suture and the attachment member, the third suture tail extending from a third stitch line of the plurality of stitch lines, and forming the second knot comprises forming the second knot with a fourth suture tail extending through the second suture and the attachment member, the fourth suture tail extending from a fourth stitch line of the plurality of stitch lines.

[0195] Example 65. The third suture is a fifth suture tail extending from the second end of the first stitch line, and fixing the attachment member to the strut of the frame defining the cell includes fixing the attachment member to the strut of the frame defining the cell with a fifth suture tail and a sixth suture tail extending through the attachment member from the second end of the second stitch line, and is the method according to any one of the embodiments herein, particularly any one of Example 63 or Example 64.

[0196] Example 66. The marker contains tantalum, and is the method according to any one of the embodiments herein, particularly any one of Examples 58 to 65.

[0197] Example 67. The marker includes two openings, the first and second sutures extend on the outer surface of the marker between the two openings, and extend on the inner surface of the marker between each of the two openings and the first and second ends of the marker, and is the method according to any one of the embodiments herein, particularly any one of Examples 58 to 66.

[0198] Example 68. Positioning the marker relative to the second surface of the attachment member disposed on the opposite side of the first surface includes positioning the marker between the second surface of the main body portion of the attachment member and an elongated flap extending from the main body portion and folded over the second surface to cover the marker, and the first and second sutures extend through the flap, and is the method according to any one of the embodiments herein, particularly any one of Examples 58 to 67.

[0199] Example 69. Further includes forming a third knot on the outer surface of the flap with a fourth suture and a fifth suture so that the flap is held against the second surface of the main body portion of the attachment member, and is the method according to any one of the embodiments herein, particularly the method described in Example 68.

[0200] Example 70. A frame including a plurality of struts forming a plurality of cells of the frame disposed between an inlet end and an outlet end of the frame, the frame being radially foldable in a folded configuration and radially expandable in an expanded configuration, a frame, a plurality of valve leaflets disposed within the frame, and at least one cross-link including an attachment member and a cross-link tab of two adjacent valve leaflets coupled to the attachment member, the attachment member being disposed across a designated cell of the plurality of cells of the frame and attached to a strut of the frame to form the designated cell, at least one cross-link, a radiopaque marker suspended within the designated cell specified by two suture threads extending through one or more openings within the marker, the two suture threads being axially offset from a first end of the marker and laterally offset from the marker in a first direction, from a first position on the attachment member, through one or more openings of the marker, to a second position on the attachment member that is axially offset from a second end of the marker and laterally offset from the marker in the first direction, a first suture thread extending thereto, and a third position on the attachment member that is axially offset from the first end of the marker and laterally offset from the marker in a second direction, from the third position on the attachment member, through one or more openings of the marker, to a fourth position on the attachment member that is axially offset from the second end of the marker and laterally offset from the marker in the second direction, a second suture thread extending thereto, an artificial heart valve.

[0201] Example 71. The artificial heart valve according to any embodiment of the present specification, particularly Example 70, wherein the first and third positions are at an inlet end portion of the attachment member connected to the inlet end of the designated cell, the second and fourth positions are at an outlet end portion of the attachment member connected to the outlet end of the designated cell, the marker is disposed relative to an intermediate portion of the attachment member, and the intermediate portion is defined between and separates the inlet end portion and the outlet end portion of the attachment member.

[0202] Example 72. An artificial heart valve according to any embodiment herein, particularly Example 70, wherein the first and third positions are at the outflow end portions of the mounting member connected to the outflow end of the designated cell, the second and fourth positions are at the inflow end portions of the mounting member connected to the inflow end of the designated cell, the marker is disposed relative to the intermediate portion of the mounting member, the intermediate portion is defined between the inflow end portion and the outflow end portion of the mounting member, and separates the inflow end portion and the outflow end portion.

[0203] Example 73. An artificial heart valve according to any embodiment herein, particularly any one of Examples 70 to 72, wherein the first and second positions are axially spaced apart from each other and are laterally aligned with each other.

[0204] Example 74. An artificial heart valve according to any embodiment herein, particularly any one of Examples 70 to 73, wherein the third and fourth positions are axially spaced apart from each other and are laterally aligned with each other.

[0205] Example 75. An artificial heart valve according to any embodiment herein, particularly any one of Examples 70 to 74, wherein one or more openings in the marker include a first opening and a second opening that are axially spaced apart from each other.

[0206] Example 76. An artificial heart valve according to any embodiment herein, particularly any one of Examples 70 to 75, wherein a first knot is formed at the second position with the first suture and the third suture, and a second knot is formed at the fourth position with the second suture and the fourth suture such that the first and second sutures hold the marker against the mounting member at a designated suture tension.

[0207] Example 77. An artificial heart valve according to any embodiment herein, particularly Example 76, wherein the designated suture tension is maintained when the artificial heart valve is in a folded configuration and an expanded configuration.

[0208] Example 78. When the frame is in an extended configuration, the first lengths of the first and second suture threads between the second end of the marker and the corresponding first and second knots are equal to the second lengths of the first and second suture threads between the second end of the marker and the corresponding first and second knots when the frame is in a folded configuration, an artificial heart valve according to any embodiment of the present specification, particularly either of Embodiment 76 or Embodiment 77.

[0209] Example 79. The first suture thread and the third suture thread are suture tails from two different stitch lines extending across the first side of the commissure to fix the commissure tab and the attachment member together, and the second suture thread and the fourth suture thread are suture tails from two different stitch lines extending across the second side of the commissure to fix the commissure tab and the attachment member together, an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 76 to 78.

[0210] Example 80. The attachment member is attached to a strut of a frame defining a designated cell with fifth and sixth suture threads that extend through the attachment member, wrap around the strut, and extend through the periphery of the attachment member around the designated cell, an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 76 to 79.

[0211] Example 81. The attachment member includes an elongated flap that extends axially outward from a body portion of the attachment member, the marker is disposed relative to a first surface of the flap, and the flap is folded over the body portion such that the marker is disposed between the flap and the body portion of the flap, such that a second surface of the flap disposed on the opposite side of the first surface of the flap faces a radially outward facing surface of the attachment member, an artificial heart valve according to any embodiment of the present specification, particularly any one of Embodiments 76 to 80.

[0212] Example 82. An artificial heart valve according to any example herein, particularly Example 81, wherein the first and second knots are formed on the second surface of the flap, and the third knot extends through the flap such that the flap is fixed to the body portion of the attachment member and is formed by seventh and eighth suture threads that are joined together on the second surface of the flap.

[0213] Example 83. An artificial heart valve according to any example herein, particularly any one of Examples 70 to 82, wherein the attachment member includes one or more of cloth and a flexible polymer material.

[0214] Example 84. An artificial heart valve according to any example herein, particularly any one of Examples 70 to 83, wherein the marker includes tantalum.

[0215] Example 85. An artificial heart valve according to any example herein, particularly any one of Examples 70 to 84, wherein the artificial heart valve is balloon-expandable and is configured to expand from a folded configuration to an expanded configuration in response to pressure applied to the frame by inflation of a balloon of a delivery device.

[0216] Example 86. A radiation-opaque marker fixed to the body portion by suture threads extending from the body portion and through one or more openings of the marker from a first portion of the body portion of the attachment member adjacent to the first end of the marker to a second portion of the body portion of the attachment member adjacent to the second end of the marker, the suture threads forming two connection portions at the second portion of the attachment member disposed on both sides of the marker such that the suture threads cross through the marker and do not cross over the body portion of the attachment member to form an X-pattern.

[0217] Example 87. An artificial heart valve according to any example herein, particularly the cross-linked attachment member of Example 86, wherein the marker is disposed with respect to a third portion of the body portion disposed between the first and second portions of the body portion.

[0218] Example 88. An interconnecting attachment member according to any example herein, particularly either Example 86 or Example 87, wherein the body portion is movable between a first state and a second state, the body portion is axially elongated and is laterally compressed in the second state relative to the first state, and a first distance between each connection portion of the two connection portions and the second end of the marker is the same as a second distance between each connection portion of the marker and the second end when the body portion is in the second state.

[0219] Example 89. An interconnecting attachment member according to any example herein, particularly any one of Examples 86 to 88, wherein the two connection portions are two separate knots in a second portion of the attachment member formed by suture threads.

[0220] Example 90. An interconnecting attachment member according to any example herein, particularly Example 89, comprising a first suture thread that extends on a first radial side surface of the marker from a first portion of the attachment member to a first opening in the marker, through the first opening, from the first opening to a second opening in the marker on a second radial side surface of the marker, through the second opening to the first radial side surface of the marker, and from the second opening to the second portion of the attachment member where the first knot is formed by the first suture thread, the first knot being axially offset from the second end of the marker and laterally offset in a first lateral direction from the central longitudinal axis of the marker.

[0221] Example 91. An interconnecting attachment member according to any example herein, particularly Example 90, wherein the first opening and the second opening extend between a first radial side surface and a second radial side surface of the marker.

[0222] Example 92. The suture includes a second suture that extends on a first radial side surface of the marker from a first portion of the attachment member to a first opening in the marker, through the first opening, from the first opening to a second opening in the marker on a second radial side surface of the marker, through the second opening to the first radial side surface of the marker, and also from the second opening to a second portion of the attachment member where a second knot is formed with a second suture. The second knot is arranged axially offset from a second end of the marker and laterally offset in a second lateral direction from a central longitudinal axis of the marker, the second lateral direction being opposite to the first lateral direction, of any example herein, particularly the cross-linked attachment member described in Example 90 or Example 91.

[0223] Example 93. A first suture extends from a first lateral side surface of a first portion of a body portion of the attachment member, and a second suture extends from a second lateral side surface of the first portion of the body portion of the attachment member, the first and second lateral side surfaces facing each other across a central longitudinal axis of the attachment member, of any example herein, particularly the cross-linked attachment member described in Example 92.

[0224] Example 94. A first knot is formed by the first suture and a third suture that extends through the body portion from a first surface of the body portion to a second surface, the first knot being formed on the second surface, of any example herein, particularly the cross-linked attachment member described in either Example 92 or Example 93.

[0225] Example 95. A second knot is formed by the second suture and a fourth suture that extends through the body portion from a first surface of the body portion to a second surface, the second knot being formed on the second surface, of any example herein, particularly the cross-linked attachment member described in any one of Examples 92 - 94.

[0226] Example 96. The body portion of the attachment member is disposed across cells of an artificial heart valve and is configured to be fixed to a frame strut of the artificial heart valve that defines the cells, of any example herein, particularly the cross-linked attachment member described in any one of Examples 86 - 95.

[0227] Example 97. The attachment member includes an elongated flap that extends axially outward from the main body portion of the attachment member, a marker is disposed on the first surface of the flap, and the flap is folded onto the main body portion such that the marker is disposed between the flap and the main body portion. As a result, the second surface of the flap, which is disposed on the opposite side of the first surface of the flap, becomes the surface facing radially outward of the attachment member. The cross-linked attachment member according to any one of the embodiments described herein, particularly any one of Embodiments 86 to 96.

[0228] Example 98. Two connection portions are two knots formed on the second surface of the flap, and a third knot extends through the flap such that the flap is fixed to the main body portion and is formed by the seventh and eighth suture threads that are tied together on the second surface of the flap. The cross-linked attachment member according to any one of the embodiments described herein, particularly the cross-linked attachment member of Embodiment 97.

[0229] Example 99. The main body portion of the attachment member includes one or more of cloth and a flexible polymer material. The cross-linked attachment member according to any one of the embodiments described herein, particularly any one of Embodiments 86 to 98.

[0230] Example 100. The marker includes tantalum. The cross-linked attachment member according to any one of the embodiments described herein, particularly any one of Embodiments 86 to 99.

[0231] Example 101. The marker has an elliptical shape whose longest dimension is disposed in the axial direction of the artificial heart valve. The cross-linked attachment member according to any one of the embodiments described herein, particularly any one of Embodiments 86 to 100.

[0232] Example 102. The marker includes two openings that are axially spaced apart from each other. The cross-linked attachment member according to any one of the embodiments described herein, particularly any one of Embodiments 86 to 101.

[0233] Example 103. A cross-linked attachment member comprising a body portion and a radiopaque marker fixed to the body portion by two sutures extending through one or more openings in the marker, wherein the two sutures are axially offset from a first end of the marker and laterally offset from the marker in a first direction, from a first position on the body portion of the attachment member, through the one or more openings of the marker, to a second position on the body portion of the attachment member that is axially offset from a second end of the marker and laterally offset from the marker in the first direction; and a second suture that is axially offset from a first end of the marker and laterally offset from the marker in a second direction, from a third position on the body portion of the attachment member, through the one or more openings of the marker, to a fourth position on the body portion of the attachment member that is axially offset from a second end of the marker and laterally offset from the marker in the second direction.

[0234] Example 104. A method comprising sterilizing an artificial heart valve, assembly, or cross-linked attachment member according to any one of Examples 1 to 103.

[0235] Example 105. An artificial heart valve according to any one of Examples 1 to 103, wherein the artificial heart valve is sterilized.

[0236] For any example, the features described herein can be combined with any one or more of the other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more features in one artificial valve can be combined with any one or more features in another artificial valve.

[0237] Considering the many possible aspects to which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative of examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. Artificial heart valves (50; 150; 200), A frame (52) comprising a plurality of support columns that form a plurality of cells of the frame (52) disposed between the inlet end (66) and the outlet end (68) of the frame (52), the frame (52) being radially foldable into a folded configuration and radially expandable into an extended configuration, A plurality of valve leaflets (60) are arranged within the frame (52), At least one commissar (64;202) comprising a mounting member (204) and commissar tabs of two adjacent valve leaflets (60) coupled to the mounting member (204), wherein the mounting member (204) is arranged across a specified cell among the plurality of cells and is attached to a support of the frame (52) defining the specified cell, An artificial heart valve (50; 150; 200) comprising: a radiopaque marker (250) suspended within a designated cell and positioned relative to the mounting member (204) by a suture extending from a first portion of the mounting member (204) positioned adjacent to a first end of the marker (250) through one or more openings of the marker (250) to a second portion of the mounting member (204) positioned adjacent to a second end of the marker (250), wherein the suture forms two knots in the second portions of the mounting member (204) positioned on either side of the marker (250) such that the suture forms an X-shaped pattern that passes through the marker (250) and does not cross across the mounting member (204).

2. The artificial heart valve (50; 150; 200) according to claim 1, wherein the first end of the marker (250) is directed toward the inlet end (66) of the frame (52), and the second end of the marker (250) is directed toward the outlet end (68) of the frame (52).

3. The designated cell is positioned at the outflow end of the frame (52), the second portion of the mounting member (204) is positioned at the outflow end (68) of the designated cell, the first portion of the mounting member (204) is positioned at the inflow end (66) of the designated cell, and / or Artificial heart valve (50;150;200) according to claim 1 or claim 2, wherein the first distance between each knot of the two knots and the second end of the marker (250) when the frame (52) is in the extended configuration and the second distance between each knot and the second end of the marker (250) when the frame (52) is in the folded configuration are the same.

4. The mounting member (204) comprises an elongated flap (256) extending axially outward from the main body portion of the mounting member (204), the marker (250) is positioned relative to the first surface of the flap (256), and the flap (256) is folded over the main body portion such that the marker (250) is positioned between the flap (256) and the main body portion, and as a result, the second surface of the flap (256) positioned on the opposite side of the first surface of the flap (256) becomes a surface facing radially outward of the mounting member (204), preferably, The artificial heart valve (50; 150; 200) according to any one of claims 1 to 3, wherein the two knots are formed on the second surface of the flap (256), and the third knot is formed by seventh and eighth sutures that extend through the flap (256) and are tied together on the second surface of the flap (256) so that the flap (256) is fixed to the main body portion of the mounting member (204).

5. The mounting member (204) includes one or more of cloth and flexible polymer materials, and / or The artificial heart valve (50; 150; 200) according to any one of claims 1 to 4, wherein the marker (250) contains tantalum.

6. It is an assembled product, Delivery device (100), A removable artificial heart valve (50;150;200) is radially foldable into a folded configuration and radially expandable into an extended configuration, wherein the artificial heart valve (50;150;200) is A frame (52) comprising a plurality of support columns that form a plurality of cells of the frame (52) disposed between the inlet end (66) and the outlet end (68) of the frame (52), the frame (52) being radially foldable into a folded configuration and radially expandable into an extended configuration, A plurality of valve leaflets (60) are arranged within the frame (52), At least one commissar (64;202) comprising a mounting member (204) and commissar tabs of two adjacent valve leaflets (60) coupled to the mounting member (204), wherein the mounting member (204) is arranged across designated cells among the plurality of cells of the frame (52) and attached to a support of the frame (52) defining the designated cells, A radiopaque marker (250) is fixed to the mounting member (204) by first and second sutures extending from both sides of a first portion of the mounting member (204) positioned adjacent to a first end of the marker, through one or more openings in the marker (250), to a second portion of the mounting member (204) positioned adjacent to a second end of the marker (250), wherein the first and second sutures form first and second knots, respectively, in the second portion of the mounting member (204) positioned on both sides of the marker (250), such that the tension of the first and second sutures on the marker (250) is maintained when the frame (52) is in both the folded and extended configurations. An assembly in which the folded artificial heart valves (50; 150; 200) are mounted around the valve mounting portion of the distal end of the delivery device, and which can be radially expanded into the expanded configuration while the delivery device is inside the patient's body.

7. The assembly according to claim 6, wherein the first suture forms a forward C-shape, and the second suture forms a reverse C-shape across the mounting member (204).

8. It is a method, The suture is extended from both sides of the first portion of the commissure attachment member (204) through one or more openings of markers (250) positioned on the attachment member (204) to both sides of the second portion of the attachment member (204), wherein the first portion is positioned adjacent to the first end of the marker (250), the second portion is positioned adjacent to the second end of the marker (250), the second end is positioned on the opposite side in the axial direction from the first end, and the attachment member (204) forms a commissure (64; 202) with two adjacent valve leaflets (60) of the artificial heart valve (50; 150; 200), and extends across the cells of the frame (52) of the artificial heart valve (50; 150; 200). To suspend the marker (250) within the cell, knots are formed on both sides of the second portion of the mounting member (204) with the suture thread, A method comprising: radially compressing the artificial heart valve (50;150;200) on a delivery device from a radially expanded configuration to a radially compressed configuration; and moving the knot laterally toward each other axially away from the marker (250) in response to axially extending the frame (52) during the radial compression of the artificial heart valve (50;150;200), such that the distance along the suture between the knot and the marker is maintained between the radially expanded configuration and the radially compressed configuration.

9. The knot includes a first knot laterally offset in a first direction from the second end of the marker (250), and a second knot laterally offset in a second direction opposite to the first direction from the second end of the marker, and / or Extending the suture and forming the knot, The first suture is extended from a first position on the first portion of the mounting member (204) through the first opening of the marker (250), across the marker (250) between the first and second openings, through the second opening, to a second position on the second portion of the mounting member (204), thereby forming a first knot at the second position, wherein the first position is axially offset from the first end of the marker (250) and laterally offset from the first end of the marker (250), and the second position is axially offset from the second end of the marker (250) and laterally offset from the second end of the marker (250), The method includes extending a second suture from a third position on the first portion of the mounting member (204) to the first opening of the marker (250), through the first opening, across the marker (250) between the first and second openings, through the second opening, to a fourth position on the second portion of the mounting member (204), thereby forming a second knot at the fourth position, wherein the third position is axially offset from the first end of the marker and laterally offset from the first end of the marker, and the fourth position is axially offset from the second end of the marker and laterally offset from the second end of the marker, Preferably, The method according to claim 8, wherein the first and second positions are offset from each other in the axial direction and aligned laterally, and the third and fourth positions are offset from each other in the axial direction and aligned laterally.

10. The commissural joint (64; 202) is formed by attaching the commissural tabs of the two adjacent valve leaflets (60) to the radially inward-facing surface of the mounting member (204), and the knot is formed on the radially outward-facing surface of the mounting member (204), Preferably, The method further includes extending a plurality of sutures through the commissar tab and the mounting member (204) to fix the mounting member (204) and the commissar (64;202) tab together, and forming the plurality of stitch lines that give rise to suture tails extending from both ends of each of the plurality of stitch lines, wherein extending the sutures from both sides of the first portion of the mounting member (204) includes extending two first suture tails from separate stitch lines of the plurality of stitch lines through the mounting member (204) to the radially outward-facing surface of the mounting member (204), and then extending the two first suture tails through the one or more openings in the marker to both sides of the second portion of the mounting member (204), Preferably, The method according to claim 8 or 9, wherein forming the knot involves forming the knot with the two first suture tails and two second suture tails from an additional separate stitch line among the plurality of stitch lines.

11. The mounting member (204) is further attached to the support column of the frame (52) defining the cell by extending an additional suture through the mounting member (204) around the mounting member (204) and the support column, wherein the marker is not directly attached to the support column and / or The method according to any one of claims 8 to 10, wherein the markers move freely as the artificial heart valves (50; 150; 200) are compressed radially and the frame (52) becomes elongated in the axial direction, but remain taught to the mounting member (204).

12. A connecting member (204), The main body and A radiopaque marker (250) is fixed to the main body portion of the mounting member (204) by a suture that extends from a first portion of the main body portion of the mounting member (204) positioned adjacent to a first end of the marker (250) through one or more openings in the marker (250) to a second portion of the main body portion of the mounting member (204) positioned adjacent to a second end of the marker (250), wherein the suture forms two connecting portions on the second portions of the mounting member (204) positioned on both sides of the marker (250) such that the suture forms an X-shaped pattern that does not intersect with the main body portion of the mounting member (204) through the marker (250).

13. The main body portion is movable between a first state and a second state, the main body portion is elongated in the axial direction and is compressed laterally in the second state relative to the first state, the first distance between each of the two connecting portions and the second end of the marker (250) when the main body portion is in the first state and the second distance between each of the connecting portions of the marker and the second end when the main body portion is in the second state are the same, and / or The two connecting portions are two separate knots in the second portion of the mounting member (204) formed by the suture thread, Preferably, The suture is a first suture, which extends on the first radial side surface of the marker (250) from the first portion of the mounting member (204) to the first opening in the marker (250), through the first opening, from the first opening to the second opening in the marker (250) on the second radial side surface of the marker (250), through the second opening to the first radial side surface of the marker (250), and from the second opening to the second portion of the mounting member (204) where the first knot is formed by the first suture, wherein the first knot is positioned axially offset from the second end of the marker (250) and laterally offset from the central longitudinal axis of the marker (250) in a first lateral direction. Preferably, (1) The suture is a second suture which extends from the first portion of the mounting member (204) to the first opening in the marker, through the first opening, from the first opening to the second opening in the marker on the second radial side of the marker, through the second opening to the first radial side of the marker, and from the second opening to the second portion of the mounting member (204) where the second knot is formed by the second suture, wherein the second knot is positioned axially offset from the second end of the marker, and laterally offset from the central longitudinal axis of the marker in a second lateral direction, and the second lateral direction is opposite to the first lateral direction. Preferably, (2) The cross-mounting member (204) according to claim 12, wherein the first suture extends from the first lateral side surface of the first portion of the main body portion of the mounting member (204), the second suture extends from the second lateral side surface of the first portion of the main body portion of the mounting member (204), and the first and second lateral side surfaces face each other across the central longitudinal axis of the mounting member (204).

14. The cross-connecting member (204) according to claim 13, which includes the feature of (1), or the feature of claim 13, which includes the feature of (1) and the feature of (2).

15. The second knot is formed by the second suture and a fourth suture extending from the first surface to the second surface of the main body portion, through the second suture and the main body portion, and the second knot is formed on the second surface, and / or A commissure mounting member (204) according to any one of claims 13, which includes the feature of (1), or the commissure mounting member (204) according to claim 13, which includes the features of (1) and (2). The main body portion of the mounting member (204) is arranged across the cells of the artificial heart valve (50;150;200) and is configured to be fixed to the frame (52) support of the artificial heart valve (50;150;200) that defines the cells.

Images