PROSTHETIC HEART VALVE

Described herein are prosthetic heart valves and methods for improving the functionality of native heart valves. An exemplary prosthetic heart valve may include one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal. The prosthetic heart valve may include a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway. The at least one support structure may be configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart.

TECHNICAL FIELD

The present disclosure generally relates to implantable cardiac devices and, more particularly, to prosthetic tricuspid valves.

BACKGROUND

Significant advancements have been made in the transcatheter treatment of heart valve disease. Initial clinical efforts focused on the pulmonary valve and were quickly followed by devices focused on the percutaneous replacement of the aortic valve to treat Aortic Stenosis. In parallel, there were numerous programs that attempted to address Mitral Regurgitation through transcatheter repair technologies and later through transcatheter mitral valve replacement.

Tricuspid valve disease is a condition in which the tricuspid valve located between the right ventricle and the right atrium of the heart of does not function properly. There are multiple forms of tricuspid valve disease, including, for example, tricuspid valve regurgitation, in which blood flows backwards from the right ventricle into the right atrium, tricuspid valve stenosis, in which the tricuspid valve is narrowed, thereby decreasing blood flow from the right atrium to the right ventricle, and tricuspid atresia, which is congenital non-formation or mal-formation of the tricuspid valve, thereby blocking or decreasing blood flow from the right atrium to the right ventricle. Tricuspid valve disease has been largely ignored as a “lesser” valve disease, relative to Aortic Stenosis (greatest level of mortality) and Mitral Regurgitation (greatest prevalence).

There are currently few tricuspid-specific prosthetic tricuspid valves. In many cases tricuspid valve defects have been treated using repurposed prosthetic aortic and mitral valves. Prosthetic aortic and mitral valves that have been repurposed for use in the tricuspid valve rigidly fix by asserting pressure on the native annulus of the tricuspid valve, making the prosthetic valve immobile. Because of the tricuspid valve's proximity to conductive regions of the heart, this rigid fixation of a prosthetic valve within the tricuspid valve may lead to heart block and/or other conduction abnormalities.

SUMMARY

Accordingly, there is a need for prosthetic valves specifically configured for the repair of the tricuspid valve, as replacement of the tricuspid presents unique issues. In addition, innovative aspects of a tricuspid-specific prosthetic valve may offer improvements to heart valves configured for other atrio-ventricular valves (i.e., mitral valve).

Described herein are embodiments of a prosthetic heart valve configured for tricuspid valve repair.

In one aspect, the disclosure features a prosthetic heart valve including one or more support structures, wherein at least one support structure defines an elongate central passageway having an longitudinal axis and wherein the at least one support structure is asymmetrical, from at least one perspective, about the longitudinal axis; and a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway, in which the at least one support structure is configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart.

Various embodiments of the prosthetic heart valve may include one or more of the following features.

The at least one support structure may be configured to biodynamically fix the prosthetic heart valve to the native leaflets such that the at least one support structure is moveable within a native annulus of the native heart valve responsive to changes in pressure on one or more sides of the native heart valve. The at least one support structure may include a cylindrical portion comprising an atrial end and a ventricular end, and the elongate central passageway is defined by the cylindrical portion of the at least one support structure. The at least one support structure may include an atrial set of arms, each arm of the atrial set of arms comprises a proximal atrial segment that is proximal to the cylindrical portion and a distal atrial segment that is distal to the cylindrical portion, at least one of a size, a shape, or an angle of a first atrial arm of the atrial set of arms is different from a corresponding one of a size, a shape, or an angle of a second atrial arm of the atrial set of arms. The angle may be an angle of the distal atrial segment and/or proximal atrial segment to the longitudinal axis.

The size of the first atrial arm may be greater than the size of the second atrial arm. The first atrial arm may have a first length in a direction parallel to the longitudinal axis and the second atrial arm may have a second length in the direction parallel to the longitudinal axis, and the first length may be greater than the second length. The first length may be greater than the second length when the prosthetic heart valve is implanted in the heart. The distal atrial segment of the first atrial arm has a first distal end at a first distance from the longitudinal axis and the distal atrial segment of the second atrial arm has a second distal end at a second distance from the longitudinal axis, and the distal atrial segment of the first atrial arm extends relative to the longitudinal axis such that the first distance is less than the second distance.

The prosthetic heart valve may include an atrial cover comprising a plurality of distal atrial covers configured to be disposed adjacent to the distal atrial segments of the atrial set of arms. Each distal atrial cover may include one or more pleats such that the distal atrial cover is configured to expand or contract as a corresponding one of the atrial set of arms increases or decreases in length. The atrial set of arms may be attached to the ventricular end of the cylindrical portion of the at least one support structure.

The at least one support structure may include a ventricular set of arms, each arm of the ventricular set of arms comprises a proximal ventricular segment that is proximal to the cylindrical portion and a distal ventricular segment that is distal to the cylindrical portion, at least one of a size, a shape, or an angle of a first ventricular arm is different from a corresponding one of a size, a shape, or an angle of a second ventricular arm. The angle may be an angle of the distal atrial segment and/or the proximal atrial segment to the longitudinal axis.

The size of the first ventricular arm may be greater than the size of the second ventricular arm. The first ventricular arm has a first length in a direction parallel to the longitudinal axis and the second ventricular arm has a second length in the direction parallel to the longitudinal axis, and the first length is greater than the second length. The first length may be greater than the second length when the prosthetic heart valve is implanted in the heart. In an implanted configuration, a first subset of the ventricular set of arms is proximate to a ventricular side of a first one of the native leaflets, and a second subset of the ventricular set of arms is proximate to an atrial side of a second one of the native leaflets. In the implanted configuration, at least one arm of a third subset of the ventricular set of arms is proximate to at least one of: a commissure of the native heart or an attial side of the first native leaflet.

At least one arm of the third subset may have a first length in a direction parallel to the longitudinal axis and another arm of the third subset may have a second length in a direction parallel to the longitudinal axis, and the first length is greater than the second length. Each arm of the first subset may be configured such that the arms of the first subset, when in the implanted configuration, do not contact a native annulus of the heart, thereby reducing trauma to the heart. A ventricular cover may be disposed adjacent to a perimeter of the proximal ventricular segments, in which the perimeter is opposite the cylindrical portion. A ventricular cover may be disposed adjacent to the proximal ventricular segments of the ventricular set of arms. A portion of the ventricular cover may extend to be disposed adjacent to the distal ventricular segments of a subset of the ventricular set of arms. The ventricular set of arms may be attached to the atrial end of the cylindrical portion of the at least one support structure. The cylindrical portion of the at least one support structure may be radially collapsible for transcatheter implantation.

In another aspect, the disclosure features a method for improving a functionality of a native heart valve of a heart. The method may include positioning, within the native heart valve, a prosthetic heart valve including one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal axis and the at least one support structure is asymmetrical, from at least one perspective, about the longitudinal axis; and a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway, in which the at least one support structure biodynamically fixes the prosthetic heart valve to native leaflets of the native heart valve.

In another aspect, the disclosure features a prosthetic heart valve including one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal axis and the at least one support structure is configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart. The prosthetic heart valve includes a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway; and a cover configured to be disposed between a portion of the at least one support structure and an atrial side of at least one of the native leaflets. When the prosthetic heart valve is implanted in the native heart valve, the cover is configured to reduce leakage around the prosthetic heart. valve.

DETAILED DESCRIPTION

It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

Because aortic and mitral valve replacements have generally been the focus of device development, there exists a need for a solution for Tricuspid Regurgitation (TR), particularly because there is growing evidence showing that TR is associated with higher mortality rates and should not be left untreated even if the other heart valves have been addressed.

Like the mitral valve, the tricuspid valve is generally in an atrio-ventricular position. Consequently, it might be expected, in some cases, that a mitral valve replacement may be repurposed for use in the tricuspid position. However, specific aspects of the tricuspid valve anatomy and the surrounding anatomy (e.g., the tricuspid valve's larger size and proximity to conductive regions of the heart) make a dedicated solution more favorable than such a repurposing of mitral valve devices. Examples of a prosthetic tricuspid valve and methods for implanting the same may be found in International Application No. PCT/US2020/024765, titled “PROSTHETIC HEART VALVE” and filed on Mar. 25, 2020, which is incorporated herein by reference in its entirety for all purposes.

In addition, innovative aspects of a tricuspid-specific prosthetic valve may offer improvements to heart valves designed for other atrioventricular valves (i.e., mitral valve). The term “tricuspid valve” will therefore be used herein in reference to a prosthetic valve that is preferentially intended for the tricuspid position but may also be used for other atria-ventricular valves.

In accordance with aspects of the disclosure, a biodynamic prosthetic tricuspid valve is provided herein. As mentioned above, as referred to herein, the term “biodynamic” with regard to a prosthetic tricuspid valve, refers to a configuration of the prosthetic tricuspid valve that allows the prosthetic tricuspid valve to maintain axial stabilization within a native tricuspid valve of a heart, but to move within the native tricuspid valve responsive to alternating pressure differentials on either side of the native tricuspid valve during cardiac cycles of the heart, without directly attaching to (and/or without contacting) a native annulus and/or native chords of the native tricuspid valve, thereby preserving the natural motion of the native annulus. Specifically, the prosthetic tricuspid valve is axially stabilized within the native tricuspid valve by grasping the native leaflets of the native tricuspid valve, rather than relying on annular force or direct annular or chordal attachment. As referred to herein, the term “axial stabilization” with regard to a prosthetic tricuspid valve located within a native tricuspid valve refers to a portion of the prosthetic tricuspid valve being interposed between any two diametrically opposed points on a native annulus of the native tricuspid valve.

In some embodiments, the prosthetic tricuspid valve includes one or more support structures. For example, as discussed in further detail below, the prosthetic tricuspid valve may include, in some cases, one, two, three, or more than three support structures. At least one of the one or more support structures includes, in some embodiments, a cylindrical portion having an atrial end and a ventricular end. In some embodiments, the cylindrical portion of the one or more support structures defines an elongate central passageway of the prosthetic tricuspid valve. In some embodiments, a central axis (also referred to as the “longitudinal axis”) of the elongate central passageway extends within the elongate central passageway from the atrial end of the cylindrical portion to the ventricular end of the cylindrical portion. When the prosthetic tricuspid valve is in an implanted configuration in a native tricuspid valve of a heart, blood generally flows through the elongate central passageway of the prosthetic tricuspid valve from an atrium of the heart to a ventricle of the heart, along the central axis of the elongate central passageway. Furthermore, in some additional embodiments, a plurality of leaflet elements attaches to the one or more support structures and are disposed within the elongate central passageway for control of blood flow through the elongate central passageway.

In some embodiments, ventricular arms extending from a first end of the cylindrical portion of the one or more support structures extend into the ventricle of the heart to contact the ventricular surface of the native leaflets, while atrial arms extending from a second end opposite the first end of the cylindrical portion of the one or more support structures extend into the atrium to contact the atrial surface of the native leaflets. Advantageously, in some embodiments, various features of the prosthetic tricuspid valve described herein configure the valve for transcatheter implantation, re-positioning, and/or removal. For example, the prosthetic tricuspid valve described herein may be easily positioned and deployed in a wide range of patients with the ability to control the deployment, assess complete functionality, and/or maintain the ability to recapture and remove the implant prior to full release.

A “patient” or “subject” as used herein generally refers to any animal such as a mammal (e.g., a human). Non-limiting examples of subjects include a human, a non-human primate, a cow, a horse, a pig, a sheep, a goat, a dog, a cat or a rodent such as a mouse, a rat, a hamster, a bird, a fish, or a guinea pig. Generally, the invention described herein is directed toward use with humans. However, other subjects are also possible. In some embodiments, a subject may demonstrate health benefits, e.g., upon implantation of the valves described herein.

Although various examples are described herein in which prosthetic tricuspid valves are configured for replacement of the native tricuspid valve, it should be appreciated that appropriate modifications may be made for use of the prosthetic tricuspid valves disclosed herein to replace other native heart valves (e.g., other atrioventricular valves) and/or in any other non-heart valves.

FIG. 1displays a side cross-sectional view of two versions100a,100bof an exemplary native heart. The embodiment100adepicts a normal anatomy of the native heart, in which blood flows from a right atrium102through a tricuspid valve104into a right ventricle106, then through a pulmonary valve to the pulmonary artery. Separating the right atrium102from other parts of the heart (e.g., the left atrium) is the atrial septal wall107. Embodiment100bdepicts a native heart with tricuspid regurgitation, in which blood leaks from the right ventricle106through the tricuspid valve104and into the right atrium102. Also depicted inFIG. 1are two leaflets108of the native tricuspid valve104which, in embodiment100b, are shown having chordae110attached to the ventricular side of the leaflets and which serve to control the opening of the valve104.

FIG. 2depicts a top view of an exemplary tricuspid valve104, including typical anatomical positioning of the three native leaflets (septal202, anterior204, and posterior206), as well as surrounding anatomical structures, such as the Atrioventricular Node (AV Node)208and Coronary Sinus210. In some embodiments, tricuspid annulus212circumferentially surrounds the three native leaflets202,204,206and, in this example, the tricuspid annulus212has a non-circular or asymmetric shape. The area between the anterior leaflet204and septal leaflet is generally referred to as the anteroseptal commissure214. The area between the septal leaflet202and posterior leaflet206is generally referred to as posteroseptal commissure216.

Support Structures

FIG. 3-FIG. 5show several views of one or more example support structures300of an exemplary prosthetic heart valve, which is configured to fit within a native tricuspid annulus212. However, in some embodiments, the prosthetic heart valve may have a generally symmetric shape.FIG. 3illustrates a perspective view of the support structures300. The exemplary support structures300may include an atrial support structure302and a ventricular support structure304. The atrial support structure302may include, in some embodiments, an atrial set of arms306(also referred to as “atrial arms”) and an atrial cylindrical portion308. The ventricular support structure304may include, in some embodiments, a ventricular set of arms310(also referred to as “ventricular arms”) and a ventricular cylindrical portion312. In some such embodiments, the atrial set of arms306extend generally above the atrial cylindrical portion308(in the atrial direction314) and the ventricular set of arms310extend generally below ventricular cylindrical portion312(in the ventricular direction316). In some embodiments, the atrial support structure302interfaces with ventricular support structure304such that the atrial cylindrical portion308“sits” in the ventricular cylindrical portion312. In some embodiments, the structures302and304interlock such that, once combined, structures302and304may operate as a single structure. In some embodiments, the atrial support structure302and ventricular support structure304may be shaped such that the atrial cylindrical portion308is aligned with the ventricular cylindrical portion312. In some embodiments, one or more atrial arms306, the atrial cylindrical portion308, one or more ventricular arms310, and/or the ventricular cylindrical portion312may be shaped such that the prosthetic heart valve has an asymmetric shape to avoid trauma to the surrounding anatomy (e.g., the septal wall107). In some embodiments, the prosthetic heart valve is generally symmetric in shape.

FIG. 4Aillustrates a side view of the exemplary support structures300. As illustrated in this view, one or more members of the atrial cylindrical portion308aligns with one or more members of the ventricular cylindrical portion312. In particular, the atrial cylindrical portion308and ventricular cylindrical portion312form a cylindrical space (also referred to as the “elongate central passageway”) about central axis402. In some embodiments, a distal portion404of one or more atrial arms306(e.g., atrial arm306a) may be bent towards the central axis402of the elongate central passageway such that the distal end404aof the arm306ahas a maximum distance406to the central axis402that is less than the distance408of the distal end404bof other arms (e.g., atrial arm306b) of the atrial set of arms to the central axis402. As illustrated inFIG. 4B, in some embodiments, a distal portion404of one or more atrial arms306(e.g., atrial arm306a) may be bent towards the central axis402such that the distal end404aof the arm306ahas an angle414ato the central axis402that is different from the angle414bof the distal end404bof other arms (e.g., atrial arm306b) of the atrial set of arms to the central axis402. For example, angle414amay be greater than angle414b.

As depicted inFIG. 4A, one or more arms of the atrial set of arms306depicted inFIG. 3-FIG. 5may have, in some embodiments, an axial length that is either less than or greater than the axial length of the other arms of the atrial set of arms306. An arm may, in some cases, have a first dimension parallel (also referred to as “axial length”) to the central axis402and a second dimension perpendicular (also referred to as “radial length”) to the central axis402. For example, atrial arm306aofFIG. 4Ahas a greater axial length410than the axial length412of atrial arm306b. In some embodiments, it may be desirable for one or more first arms of the atrial set of arms to be shorter than one or more second arms of the atrial set of arms in a compressed configuration such that, when deployed in a bent configuration, the first atrial arm(s) (e.g., arm306a) minimizes its coverage of the septal wall107, which may impede future ability to perform trans-septal cardiac procedures. As illustrated inFIG. 4A, one or more atrial arms306are asymmetric with respect to at least one other atrial arm, thereby forming an asymmetric atrial support structure302. In some embodiments, one or more atrial arms are symmetric with respect to at least one other atrial arm. In some embodiments, the atrial support structure is symmetric in shape.

In some embodiments, a ventricular aim (e.g310aof arms310inFIG. 4B) is configured to originate from the atrial side. Ventricular arm310bofFIG. 4B, in some embodiments, is configured to originate from the atrial side314. In some embodiments, an atrial arm (e.g., arm306bof arms306inFIG. 4A) is configured to originate from the ventricular side.

As illustrated inFIG. 5, in some embodiments, the diameter502of the atrial cylindrical portion308may be less than the diameter504of the ventricular cylindrical portion312. In some embodiments, one or more atrial arms306have a greater radial length506than one or more ventricular arms310. For example, atrial arm306bhas a greater radial length506than the radial length508of corresponding ventricular arm310b.

FIG. 6illustrates a front view of a cross-section of the support structures302and304.FIG. 6also depicts an embodiment in which the proximal segment702aof the one or more atrial arms (e.g., arm306c) has a first proximal curvature towards the ventricular end316of the atrial cylindrical portion308and a second distal curvature in the direction314of the atrial portion of the cylindrical portion. In some such embodiments, the distal segments704a,704b(collectively referred to as704) of the atrial arms serves to connect two adjacent proximal segments702a,702b(collectively referred to as702) of the atrial arms (e.g., of arm306c), where the distal segment704of the atrial arms curves towards the central axis402of the elongate central passageway to ensure the distal segment704is atraumatic to the surrounding anatomy.

FIG. 7shows a top view of the example support structures300of prosthetic heart valve in a deployed configuration in a native tricuspid annulus212in which one or more atrial arms (e.g., arms306e,306f,306g) form a circumferential region800that is configured to extend beyond the native tricuspid annulus212. In this example embodiment, the distal segments704a,704b(collectively referred to as704) of the atrial arms are joined to the proximal segments702ofFIG. 6of the atrial set of arms306at a location802that is beyond the interior edge of the native tricuspid annulus212. In this way, the atrial set of arms306of the prosthetic heart valve may be configured to prevent regurgitant blood flow from the native ventricle106to the native atrium102around the exterior of the cylindrical portion (indicated as area804within the atrial cylindrical portion308) of the prosthetic heart valve.

In some embodiments, the ventricular set of arms310may include three ventricular-directed arms (collectively referred to as602, e.g., as shown inFIG. 9below) configured to hold a native leaflet radially outward from a native tricuspid valve104in an open position. The ventricular-directed arms602of the ventricular set of arms and the arms of the atrial set of arms are configured to enable the outer edge of the cylindrical portion of the prosthetic heart valve to be located closer to a wall of the native heart, which may help to minimize paravalvular regurgitant flow if for example, a native leaflet of the native tricuspid valve104is held radially outward from the native tricuspid valve in an open position. In the example ofFIG. 7, the prosthetic heart valve is configured to be located closer to the septal wall806of the native heart. In another set of embodiments, the prosthetic heart valve is configured to be located closer to any other wall of the heart along the circumference of a native annulus212. Similarly, in the example ofFIG. 7, the prosthetic heart valve is configured to hold the septal leaflet radially outward from the native tricuspid valve104in an open position. In another set of embodiments, the prosthetic heart valve is configured hold the anterior and/or posterior leaflets radially outward from the native tricuspid valve in an open position.

In some embodiments, the ventricular set of arms310includes three ventricular-directed arms. In another set of embodiments, there may be one, two, or more than three ventricular-directed arms. Similarly, in the embodiments depicted inFIG. 3-FIG. 7, the atrial set of arms306includes three arms that are asymmetric relative to other arms of the atrial support structure302. However, in some embodiments, the atrial set of arms includes arms that are generally symmetric relative to other arms of the atrial support structure. In another set of embodiments, there may be one, two, or more than three arms that are asymmetric relative to other arms of the atrial support structure302. In yet another set of embodiments, there may be no arms that are asymmetric relative to other arms of the atrial support structure302.

FIG. 8Adepicts cross-sectional side views of the support structures300of a prosthetic heart valve implanted in a native tricuspid valve104in which the ventricular-directed arms of the ventricular set of arms310are shown to hold a leaflet902radially outward from the native tricuspid valve104in an open position and the the atrial set of arms306rest along a wall of the native heart. Also shown inFIG. 8Ais a distal portion404aof an atrial arm306acurving away from a wall904of the native heart so as to be atraumatic to the wall904of the native heart. The ventricular-directed arms of the ventricular set of arms310may, in some embodiments, also have a distal curvature toward a central axis402of the elongate central passageway to avoid trauma to the native leaflets, the wall of the native heart, and/or any other surrounding anatomy.

In some embodiments, the ventricular-directed arms of the ventricular set of arms310may be further configured to avoid obstruction of an Outflow Tract of a right ventricle106of the native heart.

FIG. SB also illustrates possible points of contact by ventricular arms310with a native heart. In particular, ventricular arm906(of arms310) is configured to originate from the atrial side314of the anterior or posterior leaflet902and contact the ventricular side of the leaflet902. Ventricular arm906may be shaped such that it exerts force (e.g., a pinching force with arm908) against leaflet902. Ventricular arm906may be shaped such that the arm906does not contact an annulus portion914. Ventricular arm908is configured to originate from the atrial side314and contact the atrial side of leaflet902. Ventricular arm910is configured to originate from the atrial side314and contact (e.g, exert force on) septal leaflet912against septal wall904.

The arms of the atrial set of arms may extend from an atrial side of an atrial cylindrical portion of a support structure. The atrial set of arms of the support structure may have a flat pattern.

FIG. 9depicts a view of an embodiment of a ventricular set of arms310of the ventricular support structure304in which three of the arms602have a ventricular-directed orientation316and are configured to contact a native leaflet on an atrial side of the native leaflet and six of the arms1402(including arm1402e) have an atrial-directed orientation314and are configured to contact a native leaflet on a ventricular side of the native leaflet. The atrial-directed arms1402of the ventricular set of arms may be configured to avoid contact with a native annulus212of a native heart. The arms of the ventricular set of arms extend from an atrial side of a ventricular cylindrical portion312of a ventricular support structure304. In another set of embodiments, the ventricular set of aims may include one, two, or more than three ventricular-directed arms602. The ventricular support structure304may further include a third set of arms such as an annular-directed set of arms1404, as further described below.

FIG. 9also depicts an embodiment in which the ventricular-directed arms602(e.g., a third set of arms) of the ventricular set of arms310are configured to be atraumatic to the surrounding anatomy. Each ventricular-directed arm602of the ventricular set of arms310has a distal segment1406with a first proximal curvature towards the central axis402of the elongate central passageway, a second intermediate curvature away from the central axis402of the elongate central passageway, and a third distal curvature towards the central axis402of the elongate central passageway such that the distal-most portion of the one or more arms602of the ventricular set of arms is approximately parallel with the central axis402of the elongate central passageway to avoid trauma to the surrounding anatomy.

FIG. 9also depicts a subset (1404g, and1404i) of the multiple (in this example, nine) arms (collectively referred to as1404, e.g., a third set of arms) of the ventricular set of arms, which are configured to contact the native leaflet on the atrial side of the native leaflet. In some embodiments, the arms have a maximum distance to the central axis of the elongate central passageway that is less than the maximum distance of any of the atrial-directed arms and/or the maximum distance of the ventricular-directed arms of the ventricular set of arms to central axis. In some embodiments, the maximum distance from one or more arms to the central axis of the elongate central passageway may be greater than the maximum distance of any of the atrial-directed arms and/or ventricular-directed arms of the ventricular set of arms to the central axis. The arms of the ventricular set of arms are shown to alternate with either the ventricular-directed arms of the ventricular set of arms or the atrial-directed arms of the ventricular set of arms. More specifically, the arms of the ventricular set of arms may extend away from the central axis of the elongate central passageway generally towards the ventricular end of the one or more support structures. Referring toFIG. 9, in the embodiment depicted, the arms1402of the ventricular set of arms has a first proximal bend that extends away from the central axis402of the elongate central passageway, for example, forming about a 45° angle, and a second distal bend that extends towards the central axis402of the elongate central passageway to prevent trauma to the surrounding anatomy. In some embodiments, the distal-most portion is pointed towards the central axis402.

The arms may have different lengths, depending on the desired function of the arms. In some embodiments, one or more arms are configured to engage a commissure of the native heart valve to prevent transvalvular regurgitant flow through one or more openings at the commissures. Two of the arms may be longer than the other arms and may extend farther radially from the central axis of the elongate central passageway to better fill an opening at the commissure. In some embodiments, three of the arms may be configured to engage the commissure of the native heart valve. In another set of embodiments, the arms may all be the same length.

FIG. 9shows that a distal end of the shorter arms of the ventricular set of arms does not, in some embodiments, extend in a ventricular direction316beyond the portion of the third set of arms that is perpendicular to the central axis of the elongate central passageway. In particular, the distal ends of the ventricular arms (e.g., arm1404g) do not, in some embodiments, extend beyond the bend1408of the atrial-directed arms (e.g., arm1402e). This configuration enables a cover (also referred to as a “skirt”) (e.g., cover2802,3202, or3302, described elsewhere) to be attached to the ventricular support structure304as illustrated inFIG. 16.

in some embodiments, the distal portion of the one or more arms1404may be configured to facilitate attachment of one or more covers (e.g., cover2802,3202, or3302, described elsewhere herein) to the ventricular set of arms310with a suture or other type of thread, string, wire, cable, or line. In some embodiments, one or more arms of the ventricular set of arms310may have one or more fenestrations located anywhere along the one or more arms, which may be desirable to aid in attaching one or more covers to the ventricular set of arms. In some embodiments, one or more arms have a single fenestration located at the distal tip of each arm, and the ventricular-directed arms each have three fenestrations of different sizes located near the distal tip of each ventricular-directed arm. In some embodiments, the fenestrations may be of equal sizes. According to some embodiments, the distal tips of the arms each has four protruding elements, which may be useful in providing an anchoring structure around which a suture may be wrapped. Other embodiments may have fewer or greater protrusions.

In some embodiments, the support structure comprises a third set of arms attached to the support structure. In some embodiments, the third set of arms is a subset of the ventricular set of arms. In some embodiments, the third set of arms is a subset of the atrial set of aims. In some embodiments, the third set of arms is independent of the ventricular set and atrial set of arms. The third set of arms may extend, in some embodiments, from the atrial side of the support structure. In another set of embodiments, the third set of arms extend from the ventricular side of the frame. The third set of arms may be, in some cases, used to support a cover (e.g., a ventricular cover, an atrial cover) that aids in sealing of the prosthetic heart valve. In an exemplary set of embodiments, the third set of arms support a ventricular cover. Advantageously, the incorporation of a cover such as a ventricular cover may facilitate a larger washout area for the prosthetic heart valve as compared to prosthetic heart valves without the cover. Without wishing to be bound by theory, increasing of the washout area with the covers described herein may, in some cases, advantageously lead to a reduction in areas of stagnated blood flow and/or thrombosis formation proximate the prosthetic heart valve. By way of example for illustrative purposes only, in prosthetic heart valves in which the native leaflets are permitted to sit against the prosthetic heart valve, the washout area would be relatively small as compared to the embodiments described herein.

In some embodiments, the third set of arms and/or cover may advantageously hold the native leaflets and/or native chordae away from the central cylindrical portion of the prosthetic heart valve. In some embodiments, such a configuration may advantageously maximize the outflow diameter of the prosthetic heart valve (e.g., serving as the outermost valve cylinder) and/or prevent native leaflets and/or chordae from contacting the support structure e.g., thereby minimizing damage of the native leaflets and/or chordae. In some embodiments, the cover may advantageously have cuts and/or openings which facilitate a greater amount of washout area (as compared to other configurations). For example, in some embodiments, the third set of arms may include a ventricular cover, thereby providing greater washout area and/or an improved sealing surface on the ventricular cover.

In some embodiments, the atrial and ventricular sets of arms are bent such that in an implanted configuration in which the at least one support structure biodynamically fixes the prosthetic heart valve to the native leaflets of the native heart valve, in the event of motion of the cylindrical portion of the at least one support structure toward the atrial side of the native heart valve due to a ventricular systolic pressure load, one or more arms of the ventricular set of arms resist the motion while one or more arms of the atrial set of arms relax to maintain contact with the atrial side of the native leaflets. Similarly, in the event of motion of the cylindrical portion of the at least one support structure toward the ventricular side of the native heart valve due to a ventricular diastole pressure load and/or an elimination of a previously applied ventricular systolic load, one or more arms of the atrial set of arms resist the motion while one or more arms of the ventricular set of arms relax to maintain contact with the ventricular side of the native leaflets. This also creates, in some embodiments, a trampoline effect where the native leaflets act as spring-like elements to least partially absorb the applied pressure load and/or elimination of a previously applied pressure load.

For example, securing the prosthetic tricuspid valve to either side (e.g., the atrial surface or the ventricular surface) of the native leaflets may, in some cases, create a trampoline effect where ventricular systolic pressure load may be partially absorbed by the upward (atrial) motion and tensioning of the native leaflets. For example, in the event of motion of the cylindrical portion of the support structure toward the atrial side of the native tricuspid valve (e.g., due to a ventricular systolic pressure load), the ventricular arms resist the motion while the atrial arms relax to maintain contact with the atrial side of the native leaflets. Additionally, in the event of motion of the cylindrical portion of the support structure toward the ventricular side of the native tricuspid valve, the atrial arms resist the motion while the ventricular arms relax to maintain contact with the ventricular side of the native leaflets. Furthermore, as a result of the trampoline effect, force from the distal segment of each ventricular arm against the ventricular side of the native leaflets may he further distributed throughout an atrial and/or ventricular sealing skirt (i.e., cover) to minimize the risk of erosion through the native leaflets. In this way, for example, the prosthetic tricuspid valve may be, in some cases, biodynamically fixed within the native tricuspid valve during the cardiac cycle.

In some embodiments, the third set of arms and/or cover may push against the native leaflets of the native heart thereby improving the seal and/or minimizing damage to the native leaflets of the native heart. Advantageously, the third set of arms and/or cover may serve to distribute the forces across the prosthetic heart valve, thereby improving and/or enhancing the above-described trampoline effect. The third set of arms may also serve to increase the total surface area for sealing against the native leaflets, thereby reducing the likelihood of paravalvular leak.

FIGS. 10A-10Cdepict several embodiments for a ventricular set of aims310in which the arms have different orientations, lengths, and shapes. InFIG. 10A, three of the arms1902(also referred to as “gutter” arms) of the ventricular set of arms have a distal portion that extends in an atrial direction to contact the native leaflets on a ventricular side of the native heart valve and six of the arms1904(also referred to as “up” arms) have an atrial-direction orientation with an atraumatic distal bend.FIG. 10Bdepicts a ventricular set of arms in which three of the arms1906(also referred to as “down” arms) have a ventricular-directed orientation and six of the arms1904(“up” arms) have an atrial-direction orientation with an atraumatic distal bend.FIG. 10Cdepicts a ventricular set of arms in which all of the arms1904(e.g., the nine “up” arms) have the same atrial-direction otientati on with an atraumatic distal bend.

Atrial Cover Embodiments

FIG. 11is a top view of an atrial cover2000for an atrial set of arms, which includes a central donut-shaped region and nine radially-extending members, according to one set of embodiments. In some embodiments, the atrial cover is configured to be attached to the atrial set of arms306. In its attached configuration, the central donut-shaped region is configured to contact an atrial side of the atrial set of arms, while the radially-extending members are configured to contact a ventricular side of the atrial set of arms. In the embodiment shown inFIG. 11, the atrial cover also has tabs extending perpendicularly from the edges of each radially-extending member and which are configured to wrap around a segment of the atrial set of arms and attach to a side of the atrial cover in order to facilitate attachment of the atrial cover to the atrial set of arms. In some embodiments, the tabs are attached to the atrial cover by means of a suture (or thread, string, wire, etc.). In some embodiments, the tabs, when attached to the atrial cover, are configured to slide along at least a portion of the distal segment of an arm of the atrial set of arms, which may be advantageous to enable the atrial cover to completely enclose the region between adjacent distal segments of the arms of the atrial set of arms when the atrial set of arms is in both an expanded and a compressed configuration. The atrial cover may have one or more fenestrations through which a suture (or thread, string, wire, etc.) may be passed to attach the tab of the atrial cover to the radially-extending member, thereby attaching the atrial cover to the atrial set of arms. In some embodiments, the atrial cover ofFIG. 11may be divided into thirds to create three similarly shaped or identically shaped covers that may be separately attached to the atrial set of arms. Using more than one atrial cover may be advantageous, for example, to facilitate assembly of the prosthetic heart valve. In some embodiments, two or more than three atrial covers may be used.

In the embodiment shown inFIG. 11, the donut-shaped portion of the atrial cover has fenestrations that are radially aligned with the proximal portion of the arms of the atrial set of arms and which may be used to attach the atrial cover to the atrial set of arms, for example using suture, thread, string, wire, etc. In some embodiments, one or more of the spices of the radially-extending members may have one or more fenestrations. As shown inFIG. 11, each apex of the radially-extending members has a single fenestration2002which may be used to attach the atrial cover to the atrial set of arms (see e.g., arms306inFIG. 12) by passing a hook of the distal portion of the arms of the atrial set of arms through the fenestrations2002, either temporarily to facilitate attachment, or permanently to further enhance attachment of the atrial cover2000to the atrial set of arms.

Also shown inFIG. 11are tabs2004lining the inner edge of the donut-shaped portion of the atrial cover, which may be used to allow the atrial cover to follow an atrial-directed curvature of the atrial set of arms without over-stretching the inner edge of the atrial cover. As shown, the atrial cover has 18 inner tabs2004; however. In another set of embodiments, the atrial cover may have as few as two inner tabs, more than 18 inner tabs, or any other number of inner tabs, for example nine (9), six (6), or three (3) inner tabs.

In some embodiments, the radially-extending members of the atrial cover may be configured to contact the atrial side of the atrial set of arms, in which case the tabs2006of the radially-extending members may be configured to wrap around a segment of the atrial set of arms to contact a ventricular side of the atrial cover in order to facilitate attachment of the atrial cover to the atrial set of arms.

InFIG. 11, the atrial cover2000is depicted as being produced from a flat, two-dimensional pattern. In another set of embodiments, the atrial cover may be produced as a three-dimensional structure, for example, by knitting, weaving, molding, forming, casting, or printing. In some embodiments, an atrial cover with a three-dimensional structure has a deployed configuration whose central diameter extends in a ventricular direction to create an elongate central passageway and which may be configured to cover the inner surface of a cylindrical portion of a support structure of a prosthetic heart valve.

FIG. 12shows a photograph of an exemplary atrial cover (e.g., atrial cover2000ofFIG. 11) attached to an atrial set of arms306, according to an exemplary embodiment. In some embodiments, the tabs2006of the radially-extending members of atrial cover2000are wrapped around segments of the atrial set of arms306to contact a ventricular side of atrial cover2000in order to facilitate attachment of atrial cover2000to the atrial set of arms306.

In some embodiments, one or more of the radially-extending members of the atrial cover may have one or more pleats configured to allow the atrial cover to increase or decrease the length of the one or more radially-extending members. In some embodiments, the radially-extending members of the cover may have a single pleat, comprising a peak in an atrial direction and a valley in a ventricular direction. The pleats of the atrial cover may, in some embodiments, allow the atrial cover to lengthen when attached to the atrial set of arms in which each arm of the atrial set of arms lengthens, as shown inFIG. 13. In some embodiments, the radially-extending members2502of a cover for the atrial set of arms306may have more than one pleat, or less than one pleat, for example, half of a pleat (one peak or one valley), two full pleats, (two peaks and two valleys), two and a half pleats (two peaks and three valleys or three peaks and two valleys), etc. Note that, once folded over the atrial arms, the tabs on the radially-extending members are configured to form a sleeve, in some embodiments. The sleeves and pleats may work together to conform to an atrial arm as the arm expands and contracts.

In some embodiments, one or more radially-extending members may be configured to attach to a delivery system for a prosthetic heart valve to help in deployment, positioning, repositioning, and/or recapture of the prosthetic heart valve.FIG. 14shows several embodiments of an atrial cover whose one or more radially-extending members extend farther radially. In one set of embodiments, the one or more radially-extending members2600may have one or more fenestrations at located distally to facilitate attachment to the delivery system. In another set of embodiments, the radially-extending members2602may have two or more farther-extending members. In one such embodiment, radially-extending members may have three farther-extending members that may be braided to form a single farther-extending member2604. In another embodiment, the one farther-extending member2606may be looped through a feature of the delivery system and attached to itself, for example using suture, thread, string, wire, adhesive, cable, or other means of attachment.

In some embodiments, the atrial cover2700may further include one or more fenestrations2702in the donut-shaped region of the atrial cover. In the embodiment depicted inFIG. 15, the fenestration is formed by connecting two edges of the donut-shaped region in such a way to create an opening between the connected regions of the edges,

Ventricular Cover Embodiments

FIG. 16is a top view of a ventricular cover2802for a ventricular set of arms310, which includes a central ventricular-directed flap portion2804and nine atrial-directed tabs2806, according to one set of embodiments. In some embodiments, the ventricular cover2802is configured to contact an outer surface of the ventricular set of arms310. The ventricular cover2802shown inFIG. 16has a first side and a second side, such that the first and second sides are configured to be placed adjacent one another to create a continuous circumference and which may be placed on the outer surface of the ventricular set of arms310. In some embodiments, the ventricular cover2802may be configured to contact an internal surface of the ventricular set of arms310. The ventricular cover2802may have one or more fenestrations through which a suture (or thread, string, wire, etc.) may be passed to attach the ventricular cover2802to the ventricular set of arms310.

The ventricular-directed flap portion2804of the ventricular cover2802is configured to contact an outer surface of the one or more ventricular-directed arms602of the ventricular set of arms. In the embodiment shown inFIG. 16, the central ventricular-directed flap portion of the ventricular cover2802is configured to cover three ventricular-directed arms602of the ventricular set of arms. In some embodiments, the ventricular cover2802may be configured to cover one, two, or more than three ventricular-directed arms602of the ventricular set of arms. In some embodiments, the flap portion2804is not centrally located but may be located closer to the first side of the ventricular set of arms, or closer to the second side of the ventricular set of arms.

In some embodiments, the ventricular cover2802may include two or more covers. For example, in the embodiment shown inFIG. 17, the ventricular cover may include a first cover3202that includes a ventricular-directed flap, and a second cover3204that includes one or more atrial-directed tabs extending from a single strip-like member. In some such embodiments, the first cover3202may be placed on an outer surface of the second cover3204, and the second cover3204may be placed on an outer surface of the ventricular set of arms310. In another embodiment, the first cover3202may be placed on an outer surface of the ventricular set of arms310, and the second cover3204may be placed on an outer surface of the first cover3202. In another set of embodiments, the first cover3202and/or the second cover3204may be placed on an inner surface of the ventricular set of arms310, and the two covers3202,3204and the ventricular set of arms310may be arranged to construct any combination of the aforementioned configurations.

The ventricular cover3302may further include ventricular-directed tabs3304, as shown inFIG. 18. The ventricular-directed tabs3304ofFIG. 18may be configured to attach to a cylindrical portion of one or more support structures of a prosthetic heart valve, which may be advantageous to provide additional structural support to the ventricular set of arms or to stabilize the one or more ventricular covers.

In some embodiments, the atrial-directed tabs of the ventricular cover each have an apex, which may be desirable to minimize the amount of cover material used in the construction of the prosthetic heart valve, to help reduce overall profile size in a compressed configuration.

In some illustrative embodiments, the ventricular cover is depicted as being produced from a flat, two-dimensional pattern; however, in another set of embodiments, the ventricular cover may be produced as a three-dimensional structure, for example, by knitting, weaving, molding, forming, casting, printing, etc. For example, the three-dimensional structure may include, at least in part, plastic, metal, fabric, etc. In some embodiments, a ventricular cover may have a three-dimensional structure in a deployed configuration whose central portion extends in a ventricular direction to create an elongate central passageway and which may be configured to cover the inner surface of a cylindrical portion of a support structure of a prosthetic heart valve.

FIG. 19depicts an embodiment of a ventricular cover3702in which a ventricular end of the ventricular cover extends farther in a ventricular direction beyond the ventricular-most portion of one or more arms of the ventricular set of arms. The ventricular cover3702ofFIG. 19further depicts multiple fenestrations3704configured to enable one or more arms of the ventricular set of arms to pass through the fenestrations in such a way that prevents leakage of blood through the fenestrations.

Cover Deployment

In some embodiments, one or more atrial covers are combined with one or more ventricular covers in a deployed configuration. For example, in some embodiments, the atrial cover2000ofFIG. 11is combined with the ventricular cover2802ofFIG. 16. As another example, in some embodiments, the atrial cover2000ofFIG. 11is combined with one of the two ventricular covers3202,3204depicted inFIG. 17. The atrial covers and ventricular covers of the prosthetic heart valve may include any combination of the aforementioned embodiments, as well as other embodiments not disclosed herein.

In some embodiments, the ventricular cover may further include one or more pleats configured to expand in a radial dimension when the ventricular cover is moved from a compressed to a deployed configuration. The one or more pleats may be configured to organize the ventricular cover in a compressed configuration to minimize a maximum radial thickness of the ventricular cover which may be desirable to minimize profile size of the prosthetic heart valve. As shown inFIGS. 20A-20D, the ventricular cover3902may have one, two, three, four, or more than four pleats that extend circumferentially around the body of the ventricular cover3902, and which expand radially when the ventricular set of arms310transitions to a deployed configuration. In another set of embodiments, the pleats may extend axially along the ventricular cover such that when compressed, the pleats bend radially inward and/or outward in a controlled manner which may facilitate crimping into a smaller profile size. For example, the ventricular cover may have nine symmetrically oriented and axially-directed pleats, although in other embodiments the ventricular cover may have one, two, three, or more than three axially-directed pleats, including more than nine axially-directed pleats. In some embodiments, the ventricular cover may have both axially-directed and circumferentially-directed pleats.

FIG. 21depicts an embodiment in which the prosthetic heart valve has a flared ventricular end of a support structure of the prosthetic heart valve, which may be desirable to further reduce transvalvular blood flow and/or lead to a reduction in areas of stagnated blood flow and/or thrombosis formation proximate the prosthetic heart valve.

As described herein, in some embodiments, the valve includes a third set of arms. In some embodiments, the third set of arms provide support to the cover. In some embodiments, the third set of arms may be an atrial set of arms that are annularly-directed. In some embodiments, the third set of arms may be a ventricular set of arms that are annularly-directed. In some embodiments, the third set of arms may be an independent set of arms that are annularly-directed. In some embodiments, the third set of arms may be an atrial set of arms that are atrially-directed. In some embodiments, the third set of arms may be a ventricular set of arms that are atrially-directed. In some embodiments, the third set of arms may be an independent set of arms that are atrially-directed.

In some embodiments, for example, one or more of the third set of arms are configured to contact the native leaflets on a ventricular side of the native heart valve at a time prior to the time at which one or more of the third set of arms contact the native leaflets on an atrial side of the native heart. In some embodiments, the contact (e.g., contact between the ventricular cover and the native leaflets) creates an external seal. In some embodiments, the third set of arms do not contact the native leaflets. In some such embodiments, the third set of arms are configured to expand the cover (e.g., the ventricular cover which contacts the atrial side of the native leaflets).

In some embodiments, the ventricular set of arms and/or the third set of arms may exert a clamping force on the native leaflets. Advantageously, such clamping may, in some embodiments, provide an additional or alternative means for biodynamic fixation of the prosthetic heart valve to the native leaflets.

For example, in the embodiment illustrated inFIGS. 22A-22D, the bend region of the distal segments of the third set of arms1402(e.g., of the ventricular set of arms) that extends perpendicularly away from the central axis402of the elongate central passageway is in greater proximity to the ventricular end of the cylindrical portion of the one or more support structures than the bend region of the one or more arms of the third set of1404of the ventricular set of arms configured to contact the native leaflets on an atrial side of the native heart that extends generally towards the ventricular end of the one or more support structures. In some embodiments, staggering the location of the bend regions in this way allows for a damping force4104to be exerted on the native leaflet4102due to the opposing forces imparted on the native leaflet by the arms1402and the arms1404.

FIG. 23shows a side view of one arm1404of the third set of arms ofFIG. 9with a distal fenestration and around which a suture pattern is depicted. One or more sutures4202may be used to attach one or more ventricular covers in such a way that only one knot is tied at the distal end of the arm1404. In some embodiments, the may have one or more than one fenestration, for example, two fenestrations located at the distal end may allow better fixation of sutures.

FIG. 24shows the support structures300of prosthetic heart valve ofFIG. 3-FIG. 7which further includes an atrial cover4302, a ventricular cover4304, a cylindrical cover4306configured to cover an inner surface of the cylindrical portion of the prosthetic heart valve and several sleeves4308configured to cover each of the third set of arms ofFIG. 9. The sleeves may provide a more atraumatic surface to further prevent damage to the native leaflets (e.g., perforation due to wear over time). In a preferred embodiment, the prosthetic heart valve includes sleeves4308, coveting each of the atrial-directed arms. In another set of embodiments, the prosthetic heart valve may include more or less than six sleeves4308. For example, nine sleeves4308may be used to cover the six atrial-directed arms and the three ventricular-directed arms. In another set of embodiments, each sleeve4308may be configured to cover only a portion of one or more arms of the ventricular set of arms, for example, only a distal portion of the atrial-directed arms. The sleeves may have an open or closed distal end. In some embodiments, the sleeves may be connected to the atrial cover, the ventricular cover, and/or the cylinder cover.

Any of the covers or sleeves previously described may be made of a biocompatible polymer material, such as polyester, nylon, or polytetrafluoroethylene, an elastomeric material such as silicone rubber, biological tissue such as porcine or bovine tissue, or any other flexible, biocompatible material. The covers or sleeves may be attached to any portion or portions of the prosthetic heart valve by using suture, thread, string, wire, or other type of line, through the use of heat to weld, stake, or melt the cover or sleeves material, through the use of hook and loop connection, or by any other means.

In some embodiments, one or more pads may be attached to the ventricular set of arms. As shown inFIG. 25, a pad4350may be attached to the atrial surface of the ventricular arms310to prevent direct contact of the ventricular arm with the native leaflet. In some embodiments, the pads may wrap around the distal end of the ventricular atm to contact at least a portion of the ventricular surface of the ventricular arm. The pads may be made of any kind of compliant material, such as a polyurethane foam, silicone, hydrogel, other polymer foam, bioabsorbable material, polyester fabric, and the like. In some embodiments, the pads may be attached to the ventricular arms using suture or other form of wire or line. In some embodiments, the ventricular skirt may have one or more extensions that extend to the distal end of one or more ventricular arms. The one or more extensions may cover all or a portion of one or more of the ventricular arms. The one or more extensions may be used in combination with a pad or sleeve or on its own. The one or more extensions may assist recapture of the ventricular arms into a delivery catheter by preventing any feature on the ventricular arm (e.g., a pad on the distal end) from catching on the edge of the delivery catheter. While the description above generally relates to one or more pads associated with a ventricular set of arms, one of ordinary skill in the art would understand, based upon the teachings of this specification, that one or more pads may be associated with a ventricular set of arms an atrial set of arms and/or a third set of arms.

FIG. 26shows a side cross-sectional view of an embodiment wherein the atrial set of arms306has an atrial cover4402configured to contact a ventricular side of the atrial set of arms306. The ventricular set of arms310has a ventricular cover4404configured to both contact an outer surface of the ventricular set of arms310and encompass one or more of the arms of the ventricular set of arms310, and the ventricular cover4404is further configured to expand in a radial direction when moved into a deployed configuration. As shown In some such embodiments, the atrial set of arms306extends from a cylindrical portion of a support structure of the prosthetic heart valve, which has a cylindrical cover4406configured to cover an inner surface of the cylindrical portion.

Prosthetic Leaflets

FIG. 27depicts the top view of a prosthetic leaflet4500for the prosthetic heart valve disclosed herein, which includes a main semi-circular shaped body, a first laterally-extending tab4502a, a second laterally-extending tab4502b(the tabs are referred to collectively as4502), and one or more fenestrations, which may be used as an assembly aid or to facilitate attachment of the tabs to portions of the prosthetic heart valve, for example, using suture, thread, string, wire, etc.

In some embodiment, the prosthetic heart valve may further include a second prosthetic leaflet having a first laterally-extending tab and a second laterally-extending tab, and a third prosthetic leaflet having a first laterally-extending tab and a second laterally-extending tab. According to some embodiments, the first laterally-extending tab of the first prosthetic leaflet is configured to contact the second laterally-extending tab of the third prosthetic leaflet, the second laterally-extending tab of the first prosthetic leaflet is configured to contact the first laterally-extending tab of the second prosthetic leaflet, and the first laterally-extending tab of the third prosthetic leaflet is configured to contact the second laterally-extending tab of the second prosthetic leaflet.

Cylinder Covers

FIG. 28depicts the top view of a two-dimensional cylinder cover4700configured to contact an inner surface of a cylindrical portion of one or more support structures300of a prosthetic heart valve. Although described as a “cylinder”, the cylinder cover4700may or may not be cylindrical in shape. For example, the cylinder cover4700may have a cross-sectional shape that is oval, oblong, or crescent-shaped. The cylinder cover4700includes a first side and a second side, in which the first and second sides are configured to be placed adjacent one another to create a continuous circumference, as depicted inFIG. 29. The cylinder cover4700is configured to be placed on the inner surface of the cylindrical portion of the one or more support structures300. In some embodiments, the cylinder cover4700may be configured to contact an outer surface of the cylindrical portion of the one or more support structures300. The cylinder cover4700may have one or more fenestrations through which a suture (or thread, string, wire, etc.) may be passed to attach the cylinder cover to one or more support structures300. The one or more fenestrations may also aid in alignment of mating components during assembly.

The prosthetic leaflets can, in some embodiments, be configured to contact an inner surface of the cylinder cover4700ofFIG. 29, wherein the tabs of the prosthetic leaflet4500are configured to extend through one or more fenestrations of the cylinder skirt4700, as depicted inFIG. 30. Also shown in the embodiment ofFIG. 30are sutures4900used to attach the prosthetic leaflets4500,4600,4602to the cylinder skirt4700approximately along the semi-circular edges of the prosthetic leaflets. In such a way, the non-attached edges of the prosthetic leaflets may move radially inward and outward in response to blood flow when implanted in a native heart.

FIG. 31depicts an embodiment of a cylindrical cover5000which includes three prosthetic leaflets5000a,5000b,5000cthat each have a first side and a second side, and which together are configured to form an assembled cylinder cover. In the embodiment ofFIG. 31, the first side of the first prosthetic leaflet5000ais configured to attach to the second side of the third prosthetic leaflet5000c, the second side of the first prosthetic leaflet5000ais configured to attach to the first side of the second prosthetic leaflet5000b, and the first side of the third prosthetic leaflet5000cis configured to attach to the second side of the second prosthetic leaflet5000b, as depicted inFIG. 31. Each cylinder cover further includes a first laterally-extending tab and a second laterally-extending tab, which may be configured to extend radially outward from an outer surface of the assembled cylinder cover, as shown inFIG. 31. However, in some embodiments, the laterally-extending tabs may be configured to extend radially inward towards the central axis of the elongate central passageway.

In some embodiments, one cover of a three-piece cylinder cover comprises an atrial side of the cylinder cover that includes three spices. In some embodiments, one cover of a three-piece cylinder cover comprises an atrial side of the cylinder cover that includes three spices and comprises a ventricular side that includes a region of lesser material than shown inFIG. 31, which may be desirable to prevent stagnation of blood on the ventricular side of the prosthetic heart valve.

Brackets for Prosthetic Leaflets

The embodiment shown inFIG. 32-FIG. 36comprises a bracket5300that is configured to support attachment of the laterally-extending tabs of the prosthetic leaflets4500ofFIG. 27to the prosthetic heart valve. In a preferred embodiment, the prosthetic heart valve includes three brackets5300that are located at the three commissures of the prosthetic heart valve. In another set of embodiments, the prosthetic heart valve may include one, two, or more than three brackets5300, depending on the desired result. The bracket5300, also depicted inFIG. 37, includes a head portion5400with a single fenestration, a neck portion5402inferior to the head portion5400with a width that is less than a width of the head portion5400and is also less than a width of the frame portion5404, a frame portion5404inferior to the neck portion5402, an ankle portion5500with a width that is less than the width of the frame portion5404and is also less than a width of a foot portion5502that is inferior to the ankle portion5500. The head portion5400of the bracket5300includes a single fenestration, which may be desirable to facilitate attachment to the least one support structure, for example, by laser welding, riveting, suturing, mechanical connection, or other means of attachment. The narrower width of the neck portion5402and/or ankle portion5500of the bracket5300may be advantageous to facilitate attachment of the bracket to the one or more support structures, for example, by using a thread-like element such as a suture. The bracket may be made from a metal (such as Nitinol, stainless steel, titanium, or gold), plastic (such as PTFE, PEEK, nylon, polyurethane, etc), rubber (such as silicone), or other stiff material. In a preferred embodiment, the bracket5300may be laser cut from a Nitinol or Nitinol alloy hypotube. In some embodiments, the bracket has only a frame portion. In some embodiments, the bracket may be attached directly to the cylinder skirt, e.g., as a grommet.

As shown inFIG. 32-FIG. 36, the bracket5300may be configured to receive the laterally-extending tabs4502of the prosthetic leaflets4500through the frame portion of the bracket5300. For example, advantageously, passing the laterally-extending tabs of the prosthetic leaflets through the bracket may reduce the stress that would otherwise be applied to the commissures of the prosthetic leaflets if they were sutured directly to the cylinder skirt, thus extending the lifetime of the prosthetic leaflets. The bracket5300may be further configured to contact an outer surface or an inner surface of the cylinder cover, such as the cover4700depicted inFIG. 28, where a circumference of the frame portion5404may be aligned with a window portion of the cylinder cover. In some embodiments, one or more cylinder covers6000may have window tabs6002extending within the window portion as shown inFIG. 38and are configured to bend outward from the cylinder cover6000to wrap around the frame portion5404of the bracket5300which is contacting an outer surface of the cylinder cover, as shown. The bracket may be advantageous, in some embodiments, by improving and securing alignment of the prosthetic leaflets with the cylindrical portion of the prosthetic heart valve. The bracket may also improve ease of assembly or allow flexibility in the manufacturing process by allowing subassemblies of prosthetic leaflets and brackets to be prepared in advance of attaching to the cylindrical portion of the prosthetic heart valve.

In the embodiment shown inFIG. 39, the window tabs6002may be configured to bend inward from the cylinder cover to wrap around the frame portion5404of the bracket5300which is contacting an inner surface of the cylinder cover.

The embodiments ofFIG. 38, andFIG. 39may be realized through use of preferably one, two, or three cylinder covers such as the ones shown inFIG. 28andFIG. 31, or through use of cylinder covers of different design or with more than three cylinder covers. A potential advantage of the use of a cylinder cover that includes three cylinder covers to realize the embodiments ofFIG. 38, andFIG. 39, is that the window tabs6002previously described may be of any length, which may be advantageous to more completely cover the surface of the frame and thereby protect the prosthetic leaflet from contacting the frame.

The one or more cylinder covers previously described may further include one or more atrial-directed tabs which may be configured to bend away from the central axis of the elongate central passageway and contact the laterally-extending tabs4502of the prosthetic leaflet outside the cylindrical portion of the prosthetic heart valve. In this way, the atrial-directed tabs of the one or more cylinder covers may be configured to prevent contact between any portion of the prosthetic leaflet and the one or more support structures of the prosthetic heart valve, which may be advantageous to reduce wear and extend the longevity of the prosthetic leaflets. In some embodiments, the atrial-directed tabs of the one or more cylinder covers may be configured to bend toward the central axis of the elongate central passageway into an interior portion of the cylindrical portion of the prosthetic heart valve.

In some embodiments, such as the one shown inFIG. 28, the cylinder cover may include one or more window portions configured to allow passage therethrough of the laterally-extending tabs4502of the prosthetic leaflets. Such embodiments may further include one or more frame sleeves configured to encompass at least a portion of a cross-sectional circumference of the frame portion of the bracket. The frame sleeves may be made from bioprosthetic tissue (e.g., bovine, porcine, etc.) or may be made from synthetic material (e.g. polyester, nylon, polyurethane, ePTFE, hydrogel, silicone rubber, etc.).FIG. 40depicts an embodiment comprising two frame sleeves6302, each of which includes a sheet of material that is configured to wrap around a vertically-oriented member of the frame such that two opposing sides of the sheet contact one another outside a central window portion of the frame portion5404, and the opposing sides may be attached to one another, for example, using suture, thread, wire, line, etc. In another set of embodiments, one or more sleeves may wrap around only a portion of one or more members of the frame without its ends coming into contact.

As shown inFIG. 41, the laterally-extending tabs4502of the prosthetic leaflet may be configured to pass through the central window portion of the bracket ofFIG. 40and contact an outer surface of one or more frame sleeves6302, which may be desirable to prevent contact between the prosthetic leaflets and the bracket, for example to reduce wear and extend the longevity of the prosthetic leaflets. The prosthetic leaflets ofFIG. 41may also be configured to bend in opposing directions towards an outer surface of the cylinder cover, and in some embodiments may be configured to contact the outer surface of the cylinder cover. In some embodiments, such as the one shown inFIG. 41, the bracket5300and the frame sleeves6302are located in an interior portion of the cylindrical portion6400of the prosthetic heart valve. In some embodiments, such as the one shown inFIG. 42, the bracket5300and the frame sleeves6302are located in an exterior portion of the cylindrical portion6400of the prosthetic heart valve.

FIGS. 43A-43Cdepict several embodiments of a bracket5300and one or more frame sleeves. The embodiment ofFIG. 43Aincludes two frame sleeves6600that wrap around the entire cross-sectional circumference of the frame portion5404of the bracket5300. The embodiment ofFIG. 43Bincludes two frame sleeves6602that wrap around only a portion of the cross-sectional circumference of the frame portion5404of the bracket5300and are secured in place using suture, thread, wire, line, or similar means. The embodiment ofFIG. 43Cdepicts a bracket5300with one frame sleeve6604that covers two vertically-oriented members of frame portion5404of the bracket5300.

FIGS. 44A-44Cdepict several embodiments in which the frame of the bracket6700a,6700b,6700cdoes not form a continuous loop by inclusion of a gap6702in the perimeter of the frame, which may be advantageous to allow one or more frame sleeves6704to be easily attached to the bracket. For example, in the embodiment depicted inFIG. 44B and 44C, the frame sleeves6704include two frame sleeves which are each a continuous cylinder and which may be attached to the frame of the bracket6700b,6700cby passing the frame sleeves6704over an open end at gap6702of the frame of the bracket. The embodiment ofFIG. 44Cdepicts a bracket6700cin which the frame does not form a continuous loop and which further includes an ankle portion inferior to the frame portion with a width that is less than a width of the frame portion and less than a width of a foot portion located inferior to the ankle portion. The inclusion of an ankle portion in a bracket without a continuous loop frame may be desirable to facilitate attachment of the bracket to one or more support structures of the prosthetic heart valve. In another set of embodiments, the frame may have a gap on any portion of the frame, or the frame may have more than one gap, and in some embodiments the gap may he larger or smaller than what is depicted inFIG. 44A-44C. In some embodiments, the vertically-oriented members of the frame portion of the bracket are not parallel, but instead converge or diverge at an angle of between about 0 and 45 degrees. In another set of embodiments, the bracket may consist of only one or two vertically oriented members.

FIGS. 45A-45Bdepict an embodiment of a bracket6800wherein the head portion of the bracket has a generally circular exterior shape, which may be desirable to match the generally circular shape of a mating portion of one or more of the support structures of the prosthetic heart valve. In some embodiments, the bracket6800may have a first face6902with concave curvature and a second face6904with convex curvature, as depicted inFIG. 46, which may be desirable to improve contact between a portion of the laterally-extending tab of the leaflet and a portion of the prosthetic heart valve. In some embodiments, the ankle portion of the bracket has an asymmetric shape, such as a circular region on only one side of the ankle portion as shown inFIG. 45AandFIG. 45B, which may be desirable to facilitate identification of the concave and convex faces of the bracket.

In some embodiments, the sleeve may be constructed from multiple windings of a thread-like element7000(e.g., a suture), which may be used to secure the frame to the one or more covers that extend within the elongate central passageway, as shown inFIG. 47A. In another set of embodiments, such as the one depicted inFIG. 47B, the frame of the bracket5300may have one or more fenestrations7002along one or more of the vertical members of the frame to facilitate connection to the one or more cylinder covers that extend within the elongate central passageway or directly to the one or more support structures, for example, using a thread-like element (e.g., a suture).

As shown in the embodiment ofFIG. 48, the head portion of the bracket7100may be configured to have one or more bends such that a face of the head portion creates an angle with a face of the frame portion that is less than 180 degrees. The head portion may further include a fenestration that may be configured to mate with a member of the one or more support structures300of the prosthetic heart valve to facilitate attachment of the bracket7100to one or more support structures300.

The embodiments ofFIG. 49depicts a bracket7200which includes an upper frame portion and a lower frame portion wherein the upper frame portion is configured to have one or more bends such that a face of the upper frame portion creates an angle with a face of the lower frame portion that is less than 180 degrees. For example,FIG. 49depicts a bracket7200where the angle between the upper face and the lower face is approximately 0 degrees, although in other embodiments the angle may be greater than 0 degrees. In some embodiments, the bracket may be configured to engage with the one or more support structures of the prosthetic heart valve to facilitate attachment of the bracket to one or more support structures. In some embodiments, the distance between a second face of the lower frame portion of the bracket and a second face of the upper frame portion of the bracket is equal to or less than the thickness of the mating portion of one or more support structures which may be desirable to cause a force fit between the bracket and one or more support structures to facilitate attachment.

In some embodiments, the bracket7300may be located such that a first face of the bracket that is closest to the central axis402of the elongate central passageway of the cylindrical portion of one or more support structures300is nearer to an outer edge of the one or more support structures than a second face of the bracket7300that is farther from the central axis402than the first face, as shown inFIG. 50. In some such embodiments, the laterally-extending tabs4502of the prosthetic leaflets may be configured to extend beyond a member of the one or more support structures before passing through the window portion of the bracket7300, as depicted in the top cross-sectional view ofFIG. 51. In some embodiments, the laterally-extending tabs4502of the prosthetic leaflets may be configured to contact an internal surface of the one or more support structures after first passing through the window portion of the bracket, as displayed inFIG. 51. In another set of embodiments, the laterally-extending tabs of the prosthetic leaflets may be configured to contact an external surface of the one or more support structures after first passing through the window portion of the bracket. In any of the aforementioned embodiments, one or more of the previously described frame sleeves may be configured to encircle a portion of the frame of the bracket and/or a portion of one or more members of the one or more support structures such that the laterally-extending tabs of the prosthetic leaflets contact the one or more frame sleeves instead of directly contacting the bracket or the one or more support structures.

FIG. 52depicts an embodiment in which a support structure (e.g.,302and/or304) of the prosthetic heart valve includes one or more slots7500configured to receive the laterally-extending tabs4502of the prosthetic leaflets as an alternative to using the bracket previously described.

Prosthetic Heart Valve Assembly

FIG. 53shows a perspective view of the prosthetic heart valve7600including the support structures300(refer toFIG. 3-FIG. 7) and the atrial cover2000ofFIG. 11, the ventricular cover2802ofFIG. 16, the prosthetic leaflets4500ofFIG. 27, and the cylinder cover4700ofFIG. 28.

In some embodiments, one or more covers over one or more ventricular arms may be attached to the atrial end (e.g., along atrial perimeter7602) of the cylindrical portion of one or more support structures300and the ventricular end (e.g., along portions7702) of the cylindrical portion of one or more support structures300to prevent areas of blood stagnation on the ventricular side of the prosthetic heart valve, as shown inFIG. 54. This embodiment may also serve to strengthen attachment of the ventricular set of arms and the ventricular covers to the cylindrical portion or the one or more support structures.

In an illustrative embodiment, a prosthetic heart valve includes a first support structure with a cylindrical portion and an atrial set of arms, a second support structure including a ventricular set of arms, a ventricular cover configured to contact an outer surface of the ventricular set of arms, a cylinder cover configured to contact an inner surface of the cylindrical portion of the first support structure, three prosthetic leaflets configured to move radially inward and outward within the cylindrical portion of the first support structure in order to enable blood flow in only one direction, and six sleeves configured to cover each of the atrial-directed arms of the ventricular set of arms.

Additional Embodiments

FIG. 55-FIG. 58depict several alternate embodiments of a prosthetic heart valve. InFIG. 55, the atrial set of arms may be configured to expand into one or more native commissures of the native heart valve.FIG. 56depicts an embodiment in which the atrial set of arms includes three arms.FIG. 57andFIG. 58depict an embodiment in which one or more arms of the ventricular set of arms is configured to contact a native leaflet on a ventricular side of the native leaflet at a distal portion of the one or more arms and is configured to contact a native leaflet on an atrial side of the native leaflet at a proximal portion of the one or more arms. The prosthetic heart valve ofFIG. 57andFIG. 58may be further configured to include one or more ventricular covers, such as the ventricular cover ofFIG. 16, configured to contact a native leaflet on the atrial side of the native leaflet.

In the embodiment ofFIG. 3, the prosthetic heart valve includes two support structures wherein the atrial ends of the cylindrical portions of each support structure include a head portion with a single fenestration, wherein the two fenestrations are configured to be approximately coaxial, which may facilitate attachment of the at least two eyelets, for example by laser welding, riveting, suturing, or other means of attachment. In some embodiments, the atrial ends of the cylindrical portions of each support structure may have a bend such that the head portions are nearer to a central axis of the elongate central passageway of the cylindrical portions than an inner surface of the cylindrical portions of the support structures, which may facilitate entry into a catheter of a transcatheter delivery system, for example.

In the embodiment shown inFIG. 3, one or more of the arms of the atrial set of arms may have one or more eyelets on the proximal or distal segment of the one or more arms to facilitate deployment, positioning, and or recapture of the prosthetic heart valve, for example, by routing a suture through the eyelets for controlling the motion of the one or more arms. In some embodiments, the one or more eyelets may be fully closed which may be advantageous to prevent an attachment mechanism such as a suture from disengaging with the one or more eyelets. In another set of embodiments, the one or more eyelets may he open, which may be advantageous to allow an attachment mechanism to be easily engaged with or to allow disengagement with the one or more eyelets,

FIG. 59Ashows an embodiment where the most distal segment of one or more of the arms of the atrial set of arms may have a curvature that extends back towards the same distal segment, such that the distal-most portion is substantially parallel to the portion of the distal segment where the curve originates. In this way, the distal segment forms a hook that is preferably open to allow an attachment mechanism such as a suture to be connected to the hook, although in some embodiments the hook may form a closed loop at the distal-most segment of one or more of the arms of the atrial set of arms. In some embodiments, the hook may have two or more openings, for example to allow more than one attachment mechanism such as a suture to be connected to the hook from different directions while preventing unintentional disengagement from the hook. In one set of embodiments, the one arm of the atrial set of arms that is shorter than the other arms of the atrial set of arms has a hook with a shape shown inFIG. 59Bto allow sutures that originate from two different directions to be attached to the hook.

In some embodiments, the prosthetic heart valve may include one or more thread-like elements having a first end and a second end, wherein the first end may be configured to attach to a portion of a delivery system for the prosthetic heart valve and the second end may he configured to attach to a portion of the prosthetic heart valve. In the embodiment ofFIG. 60, the one or more thread-like elements are attached to the hooks of the arms of the atrial set of arms of the prosthetic heart valve. The thread-like elements may be configured to transition the atrial set of arms from a compressed configuration to an expanded configuration, as shown inFIG. 60, and vice versa. In some embodiments, the thread-like elements are configured to be implanted in the native heart along with the prosthetic heart valve.

In some embodiments, the thread-like elements may be made from suture or other type of thread, string, wire, or line. In some embodiments, the thread-like elements may be bioabsorbable. In some embodiments, the thread-like elements may be made from a metal, such as Nitinol, stainless steel, or other flexible and biocompatible metal. In some embodiments, the thread-like elements may be Nitinol springs, which may be advantageous due to the superelastic properties of Nitinol which help resist plastic deformation of the thread-like elements when moving from a compressed configuration to an expanded or implanted configuration.

In some embodiments, the distal ends of the third set of arms (e.g., of a ventricular set of arms) extend farther radially than the embodiment ofFIG. 9, which may be desirable to provide a larger sealing surface against which the native leaflets may contact. The arms of the ventricular set of arms may be symmetrical about the central axis of the elongate central passageway; however, in another set of embodiments, one or more arms of the ventricular set of arms may be of a different size, shape, or orientation, depending on the desired function.

In some embodiments, the support structure includes connecting members that extend from an atrial side of the support structure in an atrial direction. These connecting members may be used to connect to a delivery system to aid in delivery of the prosthetic heart valve to a native heart valve.

According to some embodiments, a ventricular cover for a ventricular set of arms, is configured to extend over an outer surface of at least one of the arms of the ventricular set of arms. In some embodiments, the ventricular cover encloses at least a portion of one or more of the third set of arms and is configured to contact an atrial side of a native leaflet. In some embodiments, the cover encloses at least a portion of one or more atrial-directed arms of the ventricular set of arms. For example, the cover may enclose a proximal portion of one or more arms of the ventricular set of arms, and an intermediate U-shaped portion of one or more arms of the atrial-directed ventricular set of arms that is distal to the proximal portion. In some embodiments, a ventricular set of arms does not have connecting members, and has a ventricular cover enclosing the ventricular set of arms.

In some embodiments, a support structure includes a cylindrical portion and an atrial set of arms, wherein the atrial set of arms are all of equal size, shape, and orientation. The atrial arms may be relatively short in length, in some embodiments, which may be advantageous to reduce the overall length of the prosthetic heart valve when in a compressed configuration, which may facilitate maneuvering of the prosthetic heart valve in the native heart prior to implantation.

FIG. 61depicts an embodiment of a prosthetic heart valve that includes a support structure and a ventricular set of arms.

In some embodiments, the third set of arms may be configured to extend in a ventricular direction beyond the ventricular-most portion of the atrial-directed arms of the ventricular set of arms. In some embodiments, the ventricular cover for the ventricular set of arms may be attached to a distal end of the third set of arms and thereby extend the ventricular cover farther in a ventricular direction beyond the ventricular-most portion of the atrial-directed arms, which may be advantageous to increase a surface area of the cover for preventing paravalvular leakage around the prosthetic heart valve.

In some embodiments, the third set of arms may be configured to extend in a radial direction radially beyond a distal portion of the atrial-directed arms of the ventricular set of arms, as depicted inFIG. 62A-62B.FIG. 62Ashows a top view of an embodiment of a ventricular set of arms in which a cover for the ventricular set of arms has a contoured outer surface that extends radially beyond the distal portion of the atrial-directed arms between adjacent atrial-directed arms, thereby extending the ventricular cover closer towards the native leaflets, which may help prevent paravalvular leakage around the prosthetic heart valve. In some embodiments, a distal end of the third set of arms has a radial distance from the central axis of the elongate central passageway that is less than a radial distance between the distal portion of the atrial-directed arm and the central axis. In an illustrative embodiment,FIG. 62Adepicts a side view of an atrial-directed arm of the ventricular set of arms superimposed over an annular-directed arm of the ventricular set of arms, wherein a distal end of the annular-directed arm has a radial distance from the central axis of the elongate central passageway that is greater than a radial distance between the distal portion of the atrial-directed arm and the central axis. As one of ordinary skill in the art will appreciate based upon the teachings of this specification, the arms depicted inFIG. 62Aare not intended to be limiting and other arms from the third set of aims not necessarily annular-directed or atrial-directed may be present.

FIGS. 63A-63Ddepict several side views of an exemplary embodiments in which an atrial-directed arm is superimposed over an annular-directed arm wherein the annular-directed arms have different lengths, sizes, shapes, curvatures, or orientations.

In some embodiments, the distal end of the third set of arms may have different shapes, such as a bifurcation, as demonstrated in the embodiment ofFIG. 64. Depending on the embodiment, it may be desirable to provide additional radial extension of the ventricular cover between adjacent arms of the third set of arms. In some embodiments, the distal end of the third set of arms may have other shapes, such as the paddle-like shape depicted inFIG. 65. In some embodiments, the distal end of the third set of arms may have more than two extensions (e.g., three or four extending members). In some embodiments, the distal end of the annular-directed arms may be atraumatic to avoid damage to the surrounding tissue. In some embodiments, the distal end of the third set of arms may have one or more fenestrations or other features for facilitating attachment of one or more ventricular covers to the third set of arms. In some embodiments, the distal end of a first arm of the third set of arms may have a different length, size, shape, curvature, angle and/or orientation from a second arm of the third set of arms.

Any terms as used herein related to shape, orientation, alignment, and/or geometric relationship of or between, for example, one or more articles, structures, forces, fields, flows, directions/trajectories, and/or subcomponents thereof and/or combinations thereof and/or any other tangible or intangible elements not listed above amenable to characterization by such terms, unless otherwise defined or indicated, shall be understood to not require absolute conformance to a mathematical definition of such term, but, rather, shall be understood to indicate conformance to the mathematical definition of such term to the extent possible for the subject matter so characterized as would be understood by one skilled in the art most closely related to such subject matter. Examples of such terms related to shape, orientation, and/or geometric relationship include, but are not limited to terms descriptive of: shape—such as, round, square, gomboc, circular/circle, rectangular/rectangle, triangular/triangle, cylindrical/cylinder, elliptical/ellipse, (n)polygonal/(n)polygon, etc.; angular orientation—such as perpendicular, orthogonal, parallel, vertical, horizontal, collinear, etc.; contour and/or trajectory—such as, plane/planar, coplanar, hemispherical, semi-hemispherical, line/linear, hyperbolic, parabolic, flat, curved, straight, arcuate, sinusoidal, tangent/tangential, etc.; direction—such as, north, south, east, west, etc.; surface and/or bulk material properties and/or spatial/temporal resolution and/or distribution—such as, smooth, reflective, transparent, clear, opaque, rigid, impermeable, uniform(ly), inert, non-wettable, insoluble, steady, invariant, constant, homogeneous, etc.; as well as many others that would be apparent to those skilled in the relevant arts. As one example, a fabricated article that would described herein as being “square” would not require such article to have faces or sides that are perfectly planar or linear and that intersect at angles of exactly 90 degrees (indeed, such an article can only exist as a mathematical abstraction), but rather, the shape of such article should be interpreted as approximating a “ square,” as defined mathematically, to an extent typically achievable and achieved for the recited fabrication technique as would be understood by those skilled in the art or as specifically described. As another example, two or more fabricated articles that would described herein as being “aligned” would not require such articles to have faces or sides that are perfectly aligned (indeed, such an article can only exist as a mathematical abstraction), but rather, the arrangement of such articles should be interpreted as approximating “aligned,” as defined mathematically, to an extent typically achievable and achieved for the recited fabrication technique as would be understood by those skilled in the art or as specifically described.

It is understood that some or all steps, operations, or processes may be performed automatically, without the intervention of a user. Method claims may be provided to present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

The Title, Background, Brief Description of the Drawings, and Claims of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it may be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in any claim. Rather, as the following claims s reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claims standing on its own to represent separately claimed subject matter.