Patent Description:
The present disclosure relates generally to prosthetic heart valves, and more particularly to leaflet assemblies for prosthetic heart valves and methods for their assembly.

The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

Prosthetic valves that rely on a mechanical actuator for expansion can be referred to as "mechanically expandable" prosthetic heart valves. The actuator typically takes the form of pull cables, sutures, wires and/or shafts that are configured to transmit expansion forces from a handle of the delivery apparatus to the prosthetic valve.

Most expandable, transcatheter heart valves comprise a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. The leaflets may be attached to the frame at commissure tabs (also referred to as leaflet tabs) of the leaflets. For example, a commissure may be formed by connecting the commissure tabs of two adjacent leaflets to one another, and in some embodiments, to an attachment element configured to couple to a commissure support portion of the frame. The commissure or the attachment element can then be attached to the commissure support portion of the frame via a fastener, such as a suture. The cusp edge portions (the inflow edge portions) of the leaflets can be coupled to the frame, such as with a skirt that is sutured to struts of the frame and to the cusp edge portions of the leaflets.

Frames of prosthetic heart valves, in general, are foreshortened when radially expanded and axially elongated when radially compressed. As a result, the leaflets typically are stretched or elongated axially when the frame is radially compressed. To allow for such elongation of the leaflets without damaging the leaflets, the leaflets can include sub-commissure portions located between the commissures and the cusp edge portions that remain unattached to the frame. However, when the frame is radially expanded and the leaflets revert to their undeformed state, folds or slack can form in the unattached sub-commissure portions of the leaflets. These folds can contact the frame when the leaflets open under the pressure of retrograde blood, which can result in abrasion of the leaflets. Moreover, the folds can constrain the extent the leaflets can open under the pressure of retrograde blood, which limits the opening diameter of the leaflets and may result in higher pressure gradients across the prosthetic valve.

<CIT> discloses a radially collapsible and expandable prosthetic heart valve. The valve frame has a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve comprises generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt is secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt elongates axially with the frame. Side tabs of adjacent leaflets extend through and be secured to window frame portions of the frame to form commissures. The window frame portions are depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

Accordingly, a need exists for improved prosthetic heart valve leaflet assemblies, and methods for assembling leaflets to a frame of a prosthetic heart valve.

The claimed invention is defined in independent claim <NUM> and relates to a prosthetic heart valve. Preferred configurations of the claimed invention are defined in dependent claims <NUM> to <NUM>. Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims.

Described herein are embodiments of prosthetic heart valves and methods for assembling prosthetic heart valves including an annular frame and leaflet assembly. The frame can be radially expandable and compressible between a radially compressed state and a radially expanded state. The leaflet assembly can comprise a plurality of leaflets coupled to each other to form commissures, which can be coupled to the frame, such as by mounting the commissures to commissure support posts of the frame.

According to the invention, a prosthetic heart valve comprises an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and a plurality of leaflets situated within the frame, each leaflet comprising a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body. Each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame. Each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

In another representative embodiment, a method of assembling a prosthetic heart valve comprises providing a plurality of leaflets, wherein each leaflet comprises a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body; pairing each commissure tab with an adjacent commissure of an adjacent leaflet to form a plurality of commissures, and coupling the commissures to an annular frame, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and pairing each sub-commissure tab with an adjacent commissure of an adjacent leaflet, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

In another representative embodiment, a prosthetic heart valve comprises an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and a plurality of leaflets situated within the frame, each leaflet comprising a main body, a cusp edge portion, two opposing commissure tabs arranged on opposite sides of the main body, two sub-commissures edges forming notches on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs arranged on opposite sides of the main body and extending laterally from the sub-commissures edges. Each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame. Each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto.

In another representative embodiment, a method of assembling a prosthetic heart valve comprises providing a plurality of leaflets, wherein each leaflet comprises a main body, a cusp edge portion, two opposing commissure tabs arranged on opposite sides of the main body, two sub-commissures edges forming notches on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs arranged on opposite sides of the main body and extending laterally from the sub-commissures edges; pairing each commissure tab with an adjacent commissure of an adjacent leaflet to form a plurality of commissures, and coupling the commissures to an annular frame, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and pairing each sub-commissure tab with an adjacent commissure of an adjacent leaflet and connecting the sub-commissure tabs of each pair to each other.

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

Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below.

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

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

Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

<FIG> shows an exemplary prosthetic heart valve <NUM>, according to one example. The prosthetic heart valve <NUM> can be radially compressible and expandable between a radially compressed configuration for delivery into a patient and a radially expanded configuration.

Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in <CIT>. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in <CIT>. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in <CIT>.

The prosthetic heart valve <NUM> can include an annular stent or frame <NUM> having a first end <NUM> and a second end <NUM>. In the depicted embodiment, the first end <NUM> is an inflow end and the second end <NUM> is an outflow end. The outflow end <NUM> can be coupled to a delivery apparatus for delivering and implanting the prosthetic heart valve within the native aortic valve is a transfemoral, retrograde delivery approach. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end <NUM> is the proximal-most end of the prosthetic valve. In other embodiments, the inflow end <NUM> can be coupled to the delivery apparatus, depending on the particular native valve being replaced and the delivery technique that is used (e.g., trans-septal, transapical, etc.). For example, the inflow end <NUM> can be coupled to the delivery apparatus (and therefore is the proximal-most end of the prosthetic heart valve in the delivery configuration) when delivering the prosthetic heart valve to the native mitral valve via a trans-septal delivery approach.

The frame <NUM> can be made of any of various suitable materials, such as stainless steel, a cobalt chromium alloy, or a nickel titanium alloy ("NiTi"), for example Nitinol. Referring again to <FIG>, as shown, the frame <NUM> can include a plurality of interconnected struts <NUM> arranged in a lattice-type pattern. The struts <NUM> are shown as positioned diagonally, or offset at an angle relative to, and radially offset from, a longitudinal axis of the prosthetic heart valve <NUM> when the prosthetic heart valve <NUM> is in the expanded configuration. In other implementations, the struts <NUM> can be offset by a different amount than depicted in <FIG>, or some or all of the struts <NUM> can be positioned parallel to the longitudinal axis of the prosthetic heart valve <NUM>.

In the illustrated embodiment, the struts <NUM> are pivotably coupled to one another at one or more pivot joints along the length of each strut. For example, in the illustrated configuration, each of the struts <NUM> can be formed with apertures at opposing ends of the strut and apertures spaced along the length of the strut. Respective hinges can be formed at the locations where struts <NUM> overlap each other via fasteners or pivot members, such as rivets or pins <NUM> that extend through the apertures. The hinges can allow the struts <NUM> to pivot relative to one another as the frame <NUM> is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic heart valve <NUM>. In some embodiments, a pivot joint can comprise a rivet or pin <NUM> that extends through apertures of an inner strut and an outer strut that overlaps the inner strut at the pivot joint. In other embodiments, a pivot joint can comprise a rivet or pin <NUM> that is integrally formed on one of the inner or outer struts and extends through an aperture in the other one of the inner and outer strut.

<FIG> shows the frame <NUM> of the prosthetic valve in a radially compressed state and <FIG> shows the frame of the prosthetic valve in a radially expanded state. As shown, when radially compressed, the frame <NUM> elongates axially, and when radially expanded, the frame <NUM> foreshortens.

In some embodiments, the frame <NUM> can be constructed by forming individual components (e.g., the struts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. Further details regarding the construction of the frame and the prosthetic heart valve are described in <CIT>, <CIT>, <CIT>, and <CIT>, and <CIT>, and <CIT>.

In other embodiments, the struts <NUM> are not coupled to each other with respective hinges but are otherwise pivotable or bendable relative to each other to permit radial expansion and contraction of the frame <NUM>. For example, the frame <NUM> can be formed (e.g., via laser cutting, electroforming or physical vapor deposition) from a single piece of material (e.g., a metal tube). Examples of such frames are disclosed in <CIT> and <CIT>.

The prosthetic heart valve <NUM> can also include a valvular structure <NUM> which is coupled to the frame <NUM> and configured to regulate the flow of blood through the prosthetic heart valve <NUM> from the inflow end <NUM> to the outflow end <NUM>. The prosthetic heart valve <NUM> can further include a plurality of actuators <NUM> mounted to and equally spaced around the inner surface of the frame <NUM>. The actuators are configured to apply expansion and compression to the frame for radially expanding and compressing the prosthetic valve.

In the illustrated embodiment, the actuators <NUM> are linear actuators, each of which comprises an inner member, or piston, <NUM> and an outer member, or cylinder, <NUM>. The inner member <NUM> is pivotably coupled to a junction of the frame, such as at the first end <NUM>, while the outer member <NUM> is pivotably coupled to another junction of the frame closer to the second end <NUM>. Moving the inner member <NUM> proximally relative to the outer member <NUM> and/or moving the outer member <NUM> distally relative to the inner member <NUM> is effective to radially expand the prosthetic valve. Conversely, moving the inner member <NUM> distally relative to the outer member <NUM> and/or moving the outer member <NUM> proximally relative to the inner member <NUM> is effective to radially compress the prosthetic valve. The actuators <NUM> can include locking mechanisms that are configured to retain the prosthetic valve in an expanded state inside the patient's body.

In some embodiments, each of the actuators <NUM> can be configured to form a releasable connection with one or more respective actuators of a delivery apparatus of a transcatheter delivery system. The actuators of the delivery apparatus can transmit forces from a handle of the delivery apparatus to the actuators <NUM> for expanding or compressing the prosthetic valve. Further details of the actuators, locking mechanisms and delivery apparatuses for actuating the actuators can be found in <CIT>, <CIT> and <CIT>, <CIT>, and <CIT>. Further, any of the delivery apparatuses disclosed in the previously filed applications can be used to deliver and implant any of the prosthetic valves discloses herein.

In some embodiments, each of the actuators <NUM> can be used to support a respective commissure <NUM> (described below). As such, the actuators <NUM> can include commissure support portions for supporting and attaching commissures <NUM> of the valvular structure <NUM> to the frame <NUM>, as described further herein.

The valvular structure <NUM> can include, for example, a leaflet assembly comprising one or more leaflets <NUM> (three leaflets <NUM> in the illustrated embodiment) made of a flexible material. The leaflets <NUM> of the leaflet assembly can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials. Suitable biological material can include, for example, bovine pericardium (or pericardium from other sources). Each leaflet <NUM> includes two opposing commissure tabs arranged on opposite sides of a body of the leaflet. The body of the leaflet may be the portion of the leaflet that is adapted to bend and move during operation of the prosthetic heart valve <NUM>. The commissure tabs of adjacent leaflets <NUM> can be arranged to form commissures <NUM>, which can be, for example, mounted to commissure support portions of respective actuators <NUM>.

Further details regarding transcatheter prosthetic heart valves, including the manner in which the valvular structure can be mounted to the frame of the prosthetic valve can be found, for example, in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, <CIT>, <CIT>, and <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, and PCT Application Nos. <CIT>, <CIT>.

In some embodiments, as shown in <FIG>, the commissures <NUM> can be mounted (e.g., sutured) directly to commissure support portions of the actuators <NUM> of the frame <NUM> via commissure attachment elements <NUM>, which can be a piece of cloth or fabric. As one example, the commissure attachment elements <NUM> may include one or more stitches securing the commissures <NUM> to corresponding actuators <NUM>. In other embodiments, the commissures <NUM> can be mounted to support struts or posts of the frame that are separate from the actuators <NUM>. In still other embodiments, the commissures may be secured to an additional commissure attachment or support member (as described further herein) and the support member is then secured to a commissure support portion of an actuator <NUM> or support struts or posts of the frame.

The prosthetic heart valve <NUM> can also include one or more skirts or sealing members. For example, as shown in <FIG>, the prosthetic heart valve <NUM> can include an inner skirt <NUM> mounted on the inner surface of the frame <NUM>. As shown in <FIG>, the inner skirt <NUM> is a circumferential inner skirt that spans an entire circumference of the inner surface of the frame <NUM>. The inner skirt <NUM> can function as a sealing member to prevent or decrease perivalvular leakage (e.g., when the valve is placed at the implantation site) and as an attachment surface to anchor the leaflets <NUM> to the frame <NUM>. For example, the inflow (e.g., cusp) edges of the leaflets <NUM> can be sutured directly to the inner skirt <NUM> along a stitching line <NUM> (which can be referred to as a "scallop line"). The inner skirt <NUM> in turn can be directly connected to selected struts <NUM> of the frame, such as with sutures <NUM>, as shown in <FIG>.

The prosthetic heart valve <NUM> can also include an outer skirt mounted on the outer surface of the frame <NUM> (not shown in <FIG>). The outer skirt can function as a sealing member for the prosthetic valve by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve. The inner and outer skirts can be formed from any of various suitable biocompatible materials, including any of various synthetic materials (e.g., polyethylene terephthalate (PET)) or natural tissue (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using sutures, an adhesive, welding, and/or other means for attaching the skirts to the frame.

<FIG> shows an exemplary leaflet <NUM> that may be included in a valvular structure of a prosthetic heart valve (e.g., valvular structure <NUM> of prosthetic heart valve <NUM> of <FIG>). The leaflet <NUM> is laid flat for the purpose of illustration. The leaflet <NUM> can comprise a main body (e.g., body) <NUM> with cusp (e.g., inflow) edge portion <NUM> including a first (left) side cusp edge portion <NUM> and a second (right) side cusp edge portion <NUM> which connect together at an inflow-most end portion <NUM> of the leaflet <NUM>. Together, the first and second cusp edge portions <NUM> and <NUM> form a scallop line of the leaflet <NUM>. The upper end portions of the cusp edge portions <NUM>, <NUM> can form sub-commissure tabs <NUM>. The sub-commissure tabs <NUM> can be configured for engagement with corresponding sub-commissure tabs of adjacent leaflets to form sub-commissure portions, as further described below.

The leaflet <NUM> can include commissure tabs <NUM> and <NUM>, extending from opposite sides of the main body <NUM>. The commissure tabs can be configured for engagement with corresponding commissure tabs of adjacent leaflets to form commissures, and for attachment to the frame of the prosthetic heart valve (e.g., through an attachment member of the commissure, as described further herein). An outflow edge portion <NUM> extends across the leaflet <NUM>, between the commissure tabs <NUM> and <NUM>.

A curved edge portion <NUM>, <NUM> extends between and connects a corresponding one of the commissure tabs <NUM> and <NUM> and a corresponding one of the first and second cusp edge portions <NUM> and <NUM>. Each curved edge portion <NUM>, <NUM> defines an open region on either side of the leaflet <NUM>, referred to herein as a window or notch <NUM>, <NUM>.

As shown in <FIG>, each of the first and second cusp edge portions <NUM> and <NUM> are angled from a bottom edge of a corresponding one of the curved edge portions <NUM> and <NUM> to the inflow end portion <NUM>. An upper edge of each of the first and second cusp edge portions <NUM> and <NUM> is arranged inward of an outer edge of a corresponding one of the commissures tabs <NUM> and <NUM>, in a lateral direction that is arranged perpendicular to an axial direction, the axial direction running from the outflow edge portion <NUM> to the inflow end portion <NUM>, in parallel to a centerline <NUM> of the leaflet. As a result, the overall shape of the leaflet is tapered from the outflow edge portion <NUM> to the inflow end portion <NUM>.

In some embodiments, a shape of the leaflet <NUM> can be configured such that the commissure tabs <NUM> and <NUM> are angled relative to the axial direction which is parallel with the centerline <NUM> extending through a center of the leaflet <NUM>, between the outflow edge portion <NUM> and the inflow end portion <NUM>. For example, as shown in <FIG>, lateral (e.g., upper and lower) edges <NUM> and <NUM> of each commissure tab <NUM>, <NUM> can be angled, at an angle θ, from vertical (e.g., centerline <NUM>). As shown in <FIG>, the angle θ can be defined between the centerline <NUM> and line <NUM> which extends through the commissure tabs <NUM>, <NUM>, perpendicular to the lateral edges <NUM> and <NUM>.

In some embodiments, the angle θ can be selected to match or be similar to (e.g., within a selected, finite range of) a draft angle of the frame of the prosthetic heart valve. For example, the frame may be tapered from the outflow end to the inflow end of the frame, creating a tapered shape of the frame defined by the draft angle, as further disclosed in <CIT>. By selecting the angle θ to match or be close to matching (e.g., within <NUM>-<NUM>% or within <NUM>% of) the draft angle of the frame, stresses concentrated at the commissure tabs of the commissure may be reduced, while also allowing sufficient opening of the leaflet during operation of the valve, in vivo (e.g., during opening and closing of the leaflet).

In some embodiments, the angle θ can be selected based on the draft angle of the frame and/or based on the geometry of the leaflet, in order to reduce stresses experienced at the commissure while also allowing sufficient opening of the leaflet during valve operation, in vivo. In some embodiments, a tapered frame may facilitate a more cylindrical opening of the leaflets, while maintaining the distance between leaflets and the frame during the open phase (e.g., to reduce or avoid abrasion).

In some embodiments, dimensions of the windows <NUM> and <NUM> and/or neck regions <NUM> and <NUM> of the leaflet <NUM> can be selected to maximize a width of the leaflet <NUM> at each neck region <NUM>, <NUM>, while also minimizing a surface area of each window <NUM>, <NUM>. Each neck region <NUM>, <NUM> is defined between a corresponding one of the commissure tabs <NUM> and <NUM> and the main body <NUM> of the leaflet <NUM>. For example, in some embodiments, a width <NUM> of each neck region <NUM> and <NUM> and a window width <NUM> of each window <NUM> and <NUM> may be selected to help with leaflet stress distribution during the cyclic loading and unloading (e.g., during closing and opening of the leaflet assembly during valve operation) and decrease tissue strain on the leaflet, in order to increase longevity of the leaflet <NUM>.

In some embodiments, the commissure tabs <NUM> and <NUM> can include a plurality of columns or lines of apertures <NUM>, adapted to receive lines of fasteners (e.g., sutures) during folding and securing of the commissure tabs to form commissures (as described further below with reference to <FIG> and <FIG>). These lines of apertures <NUM> may be referred to herein as stitching lines. As shown in <FIG>, each commissure tab <NUM> and <NUM> includes four relatively straight stitching lines. However, in alternate embodiments, each commissure tab <NUM> and <NUM> can include more or less than four stitching lines (e.g., one, two, three, five, or the like). Further, in some embodiments, instead of a relatively straight stitching line (e.g., with all apertures <NUM> of the same stitching line arranged in a relatively straight line), one or more of the stitching lines may be non-straight with at least a portion (e.g., one or more apertures <NUM>) that is offset from a remaining portion of the stitching line.

As further shown in <FIG>, in some embodiments, each of the first and second edge portions <NUM> and <NUM> can include a line of apertures <NUM> adapted to receive a line of fasteners (e.g., sutures) which secures the first and second cusp edge portions <NUM> and <NUM> to a skirt (e.g., skirt <NUM> of <FIG>) that is configured to be attached to the frame of the prosthetic heart valve. In some embodiments, the skirt may extend from the line of apertures <NUM> or just above the line of apertures <NUM> and below (e.g., past) a bottom (inflow) edge of the first and second cusp edge portions <NUM> and <NUM>.

Other leaflet configurations that may be implemented in any of the prosthetic valves disclosed herein are described in <CIT> and <CIT>.

<FIG> show example commissure tab assemblies and attachments of commissure tab assemblies to a commissure post or other support structure of a frame of a prosthetic valve. <FIG> shows an example cross-sectional view of the commissure tab assembly and <FIG> and <FIG> show isometric views of an example commissure tab assembly from two different view angles.

A commissure tab assembly may be pre-assembled prior to attachment thereof to the frame by performing a pre-assembly process. The pre-assembly process includes, using the components of <FIG> in one example, placing a support strip <NUM> (which can also be referred to as a reinforcing member) (e.g., a flexible cloth/fabric) over a pair of adjacent commissure tabs 220a and 220b of respective leaflets 221a and 221b and folding end portions of the support strip over end portions of the commissure tabs. In some embodiments, the leaflets 221a, 221b can have the same configuration as leaflet <NUM>, described above, or leaflets <NUM> or <NUM>' described below, although other leaflet configurations, including any disclosed herein, can be used.

A reinforcing element <NUM>, described in more detail below, may be placed against a surface of the support strip on each opposing side of the support strip, such that at least a portion of the support strip is sandwiched between the reinforcing element <NUM> and a respective commissure tab 220a or 220b on each opposing side of the support strip. In order to secure the support strip to the commissure tabs and the reinforcing element, the pre-assembly process may further include extending a primary suture <NUM> through, in order (or in the reverse order, e.g., starting from the last-listed element and extending through the following list of elements, in reverse, to the first-listed element), a first portion of a reinforcing element <NUM>, a first portion on a first side of a support strip (e.g., a flexible cloth/fabric) <NUM>, a first commissure tab 220a, a second commissure tab 220b (where commissure tabs 220a and 220b are two commissure tabs of adjacent leaflets, e.g., leaflets 221a and 221b), a second portion on a second side of the support strip <NUM>, and a second portion of the reinforcing element <NUM>. The second side of the support strip is opposite the first side relative to a center of the support strip (e.g., a centerline that divides a width/longest dimension of the strip in half).

Although not shown in <FIG> and <FIG>, it is to be understood that a primary suture may be similarly applied to the commissure assembly shown therein in a similar manner as described above with respect to <FIG> (e.g., extending the primary suture through portions of reinforcing elements <NUM>, one or more layers of a support strip <NUM>, and commissure tabs 320a and 320b of leaflets 321a and 321b, respectively).

The support strip (e.g., support strip <NUM> of <FIG> and/or <NUM> of <FIG> and <FIG>) may be a strip of any suitable material (e.g., fabric), which may include material that is stronger (e.g., more resilient to tearing and/or deforming) than a material used for forming the leaflets and/or the commissure tab portions of the leaflets of the prosthetic valve. In one example, the support strip is a polyethylene terephthalate (PET) fabric, although various other suitable biocompatible fabrics can be used.

The support strip may be longer in one dimension than another (e.g., having a width/length that is greater than a height of the strip). The support strip may be continuous (e.g., with no gaps and/or having a substantially uniform distribution of the material forming the support strip, other than optional apertures forming the suture lines described herein) and may be relatively thin (e.g., having a thickness that is substantially smaller than the width and height of the strip and substantially smaller than a width or diameter of the reinforcing elements, discussed in more detail below).

The reinforcing elements, such as reinforcing element <NUM> of <FIG> and reinforcing element <NUM> of <FIG> and <FIG>, may include a string, a cord, and/or a relatively thick suture (e.g., an Ethibond suture), which may be substantially wider/thicker and/or have a substantially larger diameter (e.g., at least twice as wide/thick and/or have twice the diameter) than stitching sutures (e.g., primary sutures, secondary sutures, described in more detail below, tertiary sutures, described in more detail below, and/or other sutures of the commissure). The reinforcing elements may be substantially the same height (or slightly shorter, such as <NUM>-<NUM>% shorter to provide for machining tolerances and avoid extension of the inner reinforcing element past edges of the strip) as the height of the support strip. In other examples, the reinforcing elements can be a relatively narrow strip(s) of fabric, which can be folded lengthwise one or more times to increase its overall thickness. In still other examples, the reinforcing elements can be a metal wire(s) or a bar(s), such as a rectangular or cylindrical bar(s), formed from a metal and/or a polymer.

The reinforcing elements may include two individual reinforcing elements or two portions of a single reinforcing member that extends along outer surfaces of each of the first and the second commissure tabs. For example, a reinforcing member may be folded into a U-shape configuration to form the reinforcing elements (e.g., the reinforcing elements may be individual elements that are coupled to one another and/or form different sections of a single continuous element/member). In other examples, a reinforcing member may be discontinuous and include the reinforcing elements as discrete or separate elements in a spatially separated configuration (e.g., where a first reinforcing element is spatially separated from a second reinforcing element).

In some examples, the reinforcing elements may be aligned with one or more alignment markings and/or suture/stitching lines of the support strip. In some embodiments, the reinforcing elements are placed against outer surfaces of the commissure tabs, respectively, and opposing end or side portions of the support strip are positioned on an opposing side(s) of the reinforcing elements from the respective commissure tabs. For example, each reinforcing element may be sandwiched between a respective portion of the support strip and a respective one of the commissure tabs. In other embodiments, the support strip is at least partially wrapped or folded around the reinforcing elements to at least partially encase the reinforcing elements. In such examples, the portions of the support strip that at least partially encase the reinforcing elements may be placed against the outer surfaces of the commissure tabs, respectively.

Returning to the formation of the pre-assembled commissure, the primary suture <NUM> may only pass through a single layer of the support strip <NUM> on either side of the support strip (e.g., a respective layer of the support strip that is positioned between the reinforcing element <NUM> and a respective one of the commissure tabs 220a and 220b). In order to increase the strength and force distribution provided by the commissure assembly, end portions of each side of the support strip <NUM> may be further folded over respective portions of the reinforcing element <NUM> and positioned alongside the respective end portions of the commissure tabs 220a and 220b to form an additional layer of support strip on an outer region of the commissure assembly. For example, as shown in <FIG>, a single layer of the support strip <NUM> may be positioned between the support post <NUM> and the respective commissure tabs 220a and 220b (e.g., along an inner surface of the commissure tabs), while two layers of the support strip <NUM> may be provided on an opposing side of the respective commissure tabs 220a and 220b from the support post <NUM> (e.g., along an outer surface of the commissure tabs).

Additional, secondary sutures 260a and 260b may be used to secure the folded support strip to the commissure tabs as shown in <FIG>. For example, the secondary sutures 260a and 260b may form a plurality of in-and-out stitches that are extended, each, in order (or in the reverse order): through respective first layers of the support strip <NUM>, through respective second layers of the support strip <NUM>, through respective commissure tabs 220a and 220b and through respective third layers of the support strip <NUM> in a radial direction. The secondary sutures may extend through the multiple layers of the support strip adjacent a respective reinforcing element that is positioned on that side of the support strip (e.g., around which the associated respective side of the support strip is wrapped). As shown in more detail in <FIG>, the in-and-out stitches of an example secondary suture 360a may form a suture line <NUM> that includes a plurality of apertures and/or markings in at least an outer layer of the support strip through which the secondary suture passes.

As used herein, the term "suture line" can also be referred to as a "stitch line. " As further used herein in reference to the support strip, the term "aperture" refers to holes in the support strip used for stitching. In some examples, the holes are formed in the support strip while stitching and/or as a result of the stitching (e.g., the stitching formed by the secondary suture in the above example). In other examples, the holes may include pre-formed holes in the support strip that are made before stitching to provide a guide for the stitching that increases speed, integrity, and/or accuracy of assembly.

The pre-assembled commissure tab assembly, assembled as described in any of the examples above, may be attached to a corresponding commissure post, such as post <NUM> of <FIG> or post <NUM> of <FIG> and <FIG>, or other commissure support structure of the frame. The commissure post can be a component of an actuator <NUM> of the prosthetic valve <NUM> shown in <FIG>. For example, the upper portion of outer member <NUM> (<FIG>) can serve as the commissure post <NUM> of <FIG> and/or post <NUM> of <FIG> and <FIG>. In alternative embodiments, the prosthetic valve <NUM> can include commissure posts separate from the actuators. The separate commissure posts can be mounted to the inner surface of the frame <NUM>, or can be integral portions of the frame, at locations circumferentially spaced from the actuators.

As shown in <FIG>, the commissure tab assembly may be attached to the commissure post by extending a tertiary suture <NUM> across a first side of the commissure support post <NUM> between two opposing sides of the support strip <NUM>, which are respectively disposed adjacent a second and third side of the commissure support post, the second and third sides being two circumferentially opposite sides of the commissure post <NUM>. For example, the tertiary suture <NUM> may be used to form shoelace stitches around the post <NUM> and both ends of the suture <NUM> may be coupled together (e.g., forming a knot <NUM> at the top and/or bottom end). For illustrative clarity purposes, a tertiary suture and/or stitches formed by a tertiary suture is not shown with respect to the commissure assembly of <FIG> and <FIG>, however, it is to be understood that stitches formed by a tertiary suture may be provided therein as described above with respect to <FIG> (e.g., passing between two sides of the support strip <NUM> across a side of the support post <NUM>).

The pre-assembled commissure assembly may be further coupled to a support member of a frame of a prosthetic valve using additional reinforcing stitching, as will be described below. For example, the additional reinforcing stitching may be provided in addition to stitching that is formed using a tertiary suture (e.g., tertiary suture <NUM>). For example, an additional reinforcing suture <NUM> may be extended around a larger region of the support strip (e.g., support strip <NUM> of <FIG>) than the tertiary suture to form reinforcing stitching loops around a support post (e.g., support post <NUM>). As shown in <FIG>, the additional reinforcing suture <NUM> may wrap around a larger circumferential area of the commissure assembly (e.g., extending more than <NUM> degrees, or extending <NUM> degrees in some examples, around the support post <NUM> in the illustrated example) than the tertiary suture <NUM>.

As further shown in <FIG>, the additional reinforcing suture <NUM> passes through different layers of the commissure assembly components at a region of the commissure assembly that is opposite the first side of the commissure support post <NUM> (e.g., the side of the support post over which the tertiary suture <NUM> extends). For example, the additional reinforcing suture <NUM> may pass through, in order or in reverse order, one or more layers of the support strip <NUM> on a first side of the support strip, the first and second commissure tabs 220a and 220b, respectively, and one or more layers of the support strip <NUM> on a second side of the support strip opposite the first side. Ends of the additional reinforcing suture <NUM> may be tied together to form one or more knots <NUM> positioned along the first side of the support post <NUM>.

As shown in <FIG>, an additional reinforcing suture <NUM> may form a plurality of reinforcing stitches (which may form one or more corresponding suture loops) crossing over a first (e.g., external) side of the support post <NUM>, where at least one (e.g., each) stitch is secured using a respective knot <NUM> to tie ends of the additional reinforcing suture together. The illustrations in <FIG> and <FIG> do not show tertiary sutures or associated stitching for clarity purposes, in order to show the additional reinforcing sutures more clearly. However, it is to be understood that the additional reinforcing suture <NUM> may be provided in addition to a tertiary suture that is used to form stitches across the support post <NUM> as described above with respect to tertiary suture <NUM> <FIG> in some examples.

In order to reduce the number of apertures in the support strip, and thereby increase the strength of the support strip (as each aperture may compromise the structural integrity of the support strip), the additional reinforcing suture <NUM> may pass through at least a portion of the apertures in one or more layers of the support strip through which the secondary sutures 260a and 260b pass through. In this way, the additional reinforcing suture <NUM> may at least partially pass through apertures included in the suture lines formed by the secondary sutures 260a and 260b. For example, as shown in <FIG>, the additional reinforcing suture <NUM> passes through multiple apertures in the secondary suture line <NUM>. As shown, the suture loops extend substantially perpendicularly relative to the extension of the sutures forming stitches along the support strip in the secondary suture line <NUM>. In this way, the secondary suture line <NUM> extends substantially perpendicularly (e.g., at between an <NUM>-degree and a <NUM>-degree angle) to the suture loops formed by the additional reinforcing suture <NUM>.

In some examples, the additional reinforcing suture may include end portion extensions of one or more other sutures in the commissure assembly (e.g., end portion extensions of the secondary suture 260a/260b of <FIG> and/or secondary suture 360a of <FIG>). For example, end portion extensions of one or more sutures may be extended through the secondary suture line <NUM> and utilized to form additional suture loops around an external surface of the support strip <NUM> and the support post <NUM> (e.g., instead of being cut or directly tied off), pressing the support strip and/or adjacent commissure components onto the support post <NUM>. The suture extension may be looped around the support strip and the support post (e.g., crossing over one another by extending in the directions indicated by the illustrated arrows on loops formed by the suture <NUM>) to form a series of suture loops. For example, the suture loops may extend from a first region of an interior side of the support post <NUM> (e.g., a location of the suture line <NUM>), around a first lateral side of the support post, across an external side of the support post, around a second lateral side of the support post, and to a second region of the interior side of the support post (e.g., a location of a suture line opposite the suture line <NUM>, positioned on an opposite side of the support strip <NUM> from the suture line <NUM>), where the internal side of the support post is opposite of the external side of the support post and the first and second lateral sides of the support post are opposite of one another and extend between the internal side of the support post and the external side of the support post. In this way, the suture loops and/or the stitches forming the suture loops may extend along at least three sides of the support post. In the illustrated example, the suture loops and/or the stitches forming the suture loops further extend along a portion of a remaining side of the support post, thus, the suture loops and/or stitches forming the suture loops extend more than <NUM> degrees around a circumference of the support post.

The suture loops may be stitched together at a respective end by a knot <NUM> or other coupling mechanism (e.g., adhesion, twisting, etc.). Such a configuration may be advantageous, as it may be formed in a reduced time and with reduced efforts relative to other securing mechanisms.

In an alternative approach, the suture extensions may be knotted together at each suture loop (or at a subset of the suture loops, such as every other suture loop, a top half of the suture loops, a bottom half of the suture loops, etc.). Such a configuration may provide improved tightness around the support post, as well as improved durability, relative to configurations with a single knot (or fewer knots), as a tear along one loop does not affect all of the remaining loops in the configuration with multiple knots.

Additional details regarding the assembly of the leaflets to the frame are disclosed in <CIT>.

<FIG> shows a prosthetic heart valve <NUM>, according to another embodiment. The prosthetic valve <NUM> comprises a frame <NUM> comprising a plurality of struts <NUM> pivotably connected to each other at a plurality of pivot joints <NUM>. The frame <NUM> can have the same configuration as the frame <NUM> previously described. The frame <NUM> can further include a plurality of actuators <NUM>, each of which can include an outer member <NUM> and an inner member <NUM>. The outer member <NUM> can be pivotably coupled to a pivot joint of the frame, such as pivot joint 406a. The inner member <NUM> can be pivotably coupled to a pivot joint of the frame, such as pivot joint 406b. The actuators <NUM> can be push-pull type actuators wherein the outer member <NUM> and the inner member <NUM> are axially slidable relative to each other to effect radial compression and expansion of the frame <NUM>. In alternative embodiments, the actuators <NUM> can be screw type actuators wherein one of the inner or outer members are rotatable relative to the other to effect radial compression and expansion of the frame <NUM>. The actuators <NUM> can be any of the various actuators disclosed herein. The actuators <NUM> can also include locking mechanisms, as previously disclosed herein.

The prosthetic valve <NUM> includes a valvular structure to regulate the flow of blood in one direction through the frame <NUM>. The valvular structure can comprise one or more leaflets <NUM>, including leaflets 414a, 414b. In particular embodiments, the prosthetic valve <NUM> has three leaflets, such as shown in <FIG>. Adjacent leaflets <NUM> can be connected to each other to form commissures, which are connected to the frame. For example, as shown in <FIG>, leaflets 414a, 414b can have commissure respective commissure tabs 416a, 416b that are connected to each other to form a commissure <NUM> connected to a corresponding outer member <NUM> of an actuator <NUM>. In this manner, the outer member <NUM> functions as a commissure support post. Each leaflet <NUM> can be connected to two adjacent leaflets to form a plurality of commissures <NUM>. Each commissure <NUM> can be connected to the commissure support post <NUM> using the technique shown in <FIG>, and <FIG> and can include a support member (e.g., support member <NUM> or <NUM>) and reinforcing elements (e.g., reinforcing elements <NUM> or <NUM>) as previously described. In other embodiments, the commissure <NUM> can be connected to a commissure support post that is separate from an actuator <NUM>, or to one or more struts <NUM> of the frame.

In alternative embodiments, the commissures of the leaflets <NUM> can be formed and connected to the frame <NUM> using other techniques and mechanisms. For example, in some embodiments, pairs of commissure tabs can be connected to respective support members, such as clips or clamps, which in turn can be connected to respective commissure support posts. In other embodiments, pairs of commissures can be connected to selected struts <NUM> of the frame <NUM>. Any of the various commissure attachment techniques and mechanisms disclosed in the following applications can be used to couple the commissures of the leaflet assembly to the frame <NUM>: <CIT>, <CIT>, and <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>, and PCT Application Nos. <CIT>, <CIT>.

In particular embodiments, each leaflet <NUM> has the same configuration as the leaflet <NUM> of <FIG>. However, in alternative embodiments, the leaflets <NUM> can have various other configurations, including as of those disclosed herein (e.g., leaflet <NUM> or leaflet <NUM>', described below).

The prosthetic valve <NUM> can have one or more skirts or reinforcing members to connect the cusp edge portions of the leaflets <NUM> to the frame <NUM>. As shown in <FIG>, for example, the prosthetic valve <NUM> includes first and second reinforcing members <NUM>, <NUM>, respectively, (also referred to as reinforcing strips <NUM>, <NUM>) positioned on opposite sides of the cusp edge portions <NUM> of the leaflets <NUM>. The first reinforcing member <NUM> is positioned against the inner surfaces of the cusp edge portions <NUM> and the second reinforcing member <NUM> is positioned against the outer surfaces of the cusp edge portions <NUM>. In this manner, the cusp edge portions <NUM> are sandwiched between the first and second reinforcing members <NUM>, <NUM>. The cusp edge portions <NUM> can be connected to the first and second reinforcing members <NUM>, <NUM> with sutures, such as a scalloped suture line <NUM>, which can be formed by a plurality of in-and-out stitches that extend through the first and second reinforcing members <NUM>, <NUM> and the cusp edge portions <NUM>. As further shown in <FIG>, the first reinforcing member <NUM> can have an inflow edge portion that extends below the inflow edge of the leaflets <NUM> and the second reinforcing member <NUM> toward the inflow end of the frame.

The assembly of the leaflets <NUM> and the first and second reinforcing members <NUM>, <NUM> can be secured to the frame, such as with a plurality of sutures <NUM>. Each suture <NUM> can extend through one or more layers of the reinforcing members <NUM>, <NUM> and the leaflets and around a strut <NUM> or a component of an actuator <NUM> (such as an outer member <NUM>). As shown in <FIG>, the first reinforcing member <NUM> can include a pair of upper wings members <NUM> positioned below each commissure <NUM>. The wing members <NUM> can be folded downwardly against the main portion of the reinforcing member <NUM> and can be secured in place with sutures <NUM>.

Referring to <FIG> and <FIG>, each leaflet 414a, 414b can include a sub-commissure portion 432a, 432b, respectively (which can also be referred to as sub-commissure tabs 432a, 432b), similar to sub-commissure tabs <NUM> (<FIG>). In the embodiment of <FIG> and <FIG>, the sub-commissure portions 432a, 432b are folded relative to the cusp edge portions <NUM> and extend radially outwardly toward the frame <NUM>. The sub-commissure portions 432a, 432b can be connected to each other, such as with a suture <NUM>. The sub-commissure portions 432a, 432b are not fixed or directly connected to the frame (e.g., there are no sutures extending through the sub-commissure portions 432a, 432b and around any components of the frame). The leaflets 414a, 416b can have sub-commissure edges (similar to sub-commissure edges <NUM>, <NUM> of <FIG>) between the commissure tabs 416a, 416b and the sub-commissure tabs 432a, 432b that are not fixed or directly connected to the frame, which allows the leaflets to stretch to some degree along the sub-commissure edges when the prosthetic valve is radially compressed to the radially compressed state for delivery into a patient's body.

The first and second reinforcing members <NUM>, <NUM> can be formed from any of various suitable biocompatible materials, including any of various synthetic materials (e.g., polyethylene terephthalate (PET)) or natural tissue (e.g., pericardial tissue).

In particular embodiments, a leaflet assembly comprising the leaflets <NUM> and the first and second reinforcing members <NUM>, <NUM> can be pre-assembled prior to mounting these components to the frame <NUM>. For example, the pre-assembled leaflet assembly can include the first and second reinforcing members <NUM>, <NUM> sutured to the cusp edge portions <NUM> of the leaflets <NUM>. Once formed, the leaflet assembly can be positioned inside of the frame <NUM> and the commissures <NUM> and the cusp edge portions <NUM> can be secured to the frame <NUM> as described above.

In particular embodiments, each of the first and second reinforcing members <NUM>, <NUM> can be a unitary or continuous piece of material. In alternative embodiments, one or both of the reinforcing members <NUM>, <NUM> can comprise a plurality of discrete pieces of material, each of which is secured to the cusp edge portion <NUM> of a corresponding leaflet <NUM>. For example, if three leaflets <NUM> are provided, the first reinforcing member <NUM> can comprise three discrete sections, each of which is secured to the cusp edge portion <NUM> of a corresponding leaflet <NUM>. Similarly, the second reinforcing member <NUM> can comprise three discrete sections, each of which is secured to the cusp edge portion <NUM> of a corresponding leaflet <NUM>.

In alternative embodiments, one or both of the reinforcing members <NUM>, <NUM> can comprise a wider skirt (such as skirt <NUM> of <FIG>), which can be sized to cover a plurality of the cells or openings between the struts <NUM> of the frame and therefore can function to inhibit paravalvular leakage between the prosthetic valve and the surrounding tissue once implanted. Additionally, the prosthetic valve <NUM> can also include an outer skirt positioned around the outside of the frame <NUM> (such as outer skirt <NUM> shown in <FIG>).

It has been found that the orientation of the sub-commissure tabs 432a, 432b can affect the ability of the leaflets <NUM> to fully open under the forward flow of blood (e.g., during systole for a prosthetic aortic valve). In particular, it has been found that the leaflets <NUM> may not fully open when the sub-commissure tabs 432a, 432b extend radially outwardly toward the frame <NUM>, as shown in <FIG> and <FIG>.

<FIG> show an alternative orientation for the sub-commissure tabs 432a, 432b of the prosthetic valve <NUM>. In this embodiment, the sub-commissure tabs 432a, 432b are folded relative to the cusp edge portions <NUM> and extend radially inwardly away the frame <NUM> and toward the center of the lumen of the prosthetic valve. The the sub-commissure portions 432a, 432b are not fixed or directly connected to the frame (e.g., there are no sutures extending through the sub-commissure portions 432a, 432b and around any components of the frame). It has been found that the leaflets <NUM> can open to a greater extent under the forward flow of blood when the sub-commissure tabs 432a, 432b extend radially inwardly as compared to when the sub-commissure tabs 432a, 432b extend radially outwardly.

<FIG> is a top plan view of the prosthetic valve <NUM> having the sub-commissure tabs 432a, 432b oriented radially outwardly and the leaflets <NUM> in the open position under the forward flow of blood. <FIG> is a top plan view of the prosthetic valve <NUM> having the sub-commissure tabs 432a, 432b oriented radially inwardly and the leaflets <NUM> in the open position under the forward flow of blood. Comparing <FIG> and <FIG>, it can be seen that a greater extent of the free edges <NUM> (the outflow edges) of the leaflets <NUM> open wider (closer to the frame) in <FIG> than in <FIG>. Advantageously, orienting the sub-commissure tabs in the inward direction therefore can increase the effective outflow orifice of the prosthetic valve, thereby improving the hemodynamics of the prosthetic valve.

<FIG> shows a leaflet <NUM> for a prosthetic heart valve, according to another embodiment. Any of the prosthetic heart valves disclosed herein (e.g., any of the embodiments of <FIG>) can include a valvular structure comprising one or more of the leaflets <NUM> assembled within a frame of a prosthetic heart valve. The leaflet <NUM> is similar to leaflet <NUM> of <FIG> and includes many of the same features.

The leaflet <NUM> can comprise a main body <NUM> with a cusp (e.g., inflow) edge portion <NUM> including a first (left) side cusp edge portion <NUM> and a second (right) side cusp edge portion <NUM> which connect together at an inflow-most end portion <NUM> of the leaflet <NUM>. The upper end portions of the cusp edge portions <NUM>, <NUM> can form sub-commissure tabs <NUM>. The leaflet <NUM> can include commissure tabs <NUM> and <NUM>, extending from opposite sides of the main body <NUM>. An outflow edge portion <NUM> (also referred to as a coaptation edge portion) extends across the leaflet <NUM>, between the commissure tabs <NUM> and <NUM>. A curved edge portion <NUM>, <NUM> extends between and connects a corresponding one of the commissure tabs <NUM> and <NUM> and a corresponding one of the first and second cusp edge portions <NUM> and <NUM>. Each curved edge portion <NUM>, <NUM> defines an open region on either side of the leaflet <NUM>, referred to herein as a notch or window <NUM>, <NUM>.

The leaflet <NUM> can include upper tabs <NUM>, <NUM> extending upwardly from commissure tabs <NUM>, <NUM>, respectively. The leaflet <NUM> can include notches <NUM> between the upper tabs <NUM>, <NUM> and the commissure tabs <NUM>, <NUM>. Each notch <NUM> can extend from an inner edge <NUM> of a corresponding upper tab <NUM>, <NUM> to a location between the inner and outer edges <NUM>, <NUM> of the upper tab. In this manner, each upper tab <NUM>, <NUM> is connected to a corresponding commissure tab <NUM>, <NUM> for only part of the width the upper tab, so as to facilitate folding of the upper tabs against the commissure tabs during assembly of the leaflet assembly. In other embodiments, the leaflet <NUM> can be formed without notches <NUM> such that each upper tab is connected to a commissure tab along the entire width of the upper tab.

In some embodiments, the commissure tabs <NUM> and <NUM> and the upper tabs <NUM>, <NUM> can include a plurality of columns or lines of apertures <NUM>, adapted to receive lines of fasteners (e.g., sutures) during folding and securing of the commissure tabs to form commissures (as previously described above with reference to <FIG> and <FIG>). As further shown in <FIG>, in some embodiments, each of the first and second edge portions <NUM> and <NUM> can include one or more lines of apertures <NUM> adapted to receive fasteners (e.g., sutures) which secures the first and second cusp edge portions <NUM> and <NUM> to one or more skirts or reinforcing members (e.g., reinforcing members <NUM>, <NUM>) that is configured to be attached to the frame of the prosthetic heart valve.

In particular embodiments, a leaflet assembly comprising a plurality of leaflets <NUM> can be formed. In forming the leaflet assembly, the upper tabs <NUM>, <NUM> can be folded downwardly against the commissure tabs <NUM>, <NUM> along horizontal fold lines <NUM>. Each upper tab <NUM>, <NUM> can be secured to a corresponding commissure tab <NUM>, <NUM>, such as with sutures. A support strip (e.g., support strip <NUM> or <NUM>) can be sutured to each pair of commissure tabs, as previously described. One or more skirts or reinforcing members (e.g., reinforcing members <NUM>, <NUM>) can be sutured to the cusp edge portions of the leaflets, as previously described. Each sub-commissure tab <NUM> can be sutured to an adjacent sub-commissure tab <NUM> of an adjacent leaflet, such as shown in <FIG> or <FIG>. The leaflet assembly can be mounted to a frame of a prosthetic heart valve as previously described. For example, each commissure can be secured to a commissure support post (e.g., such as a component of an actuator), as previously described in connection with <FIG> and <FIG>, or using other techniques or mechanisms previously decsribed. The cusp edge portions of the leaflets and any skirts or reinforcing members can be connected to the frame, as previously described in connection with <FIG>.

<FIG> shows a top plan view of an exemplary prosthetic heart valve <NUM> comprising a frame <NUM> and three leaflets <NUM> mounted to the frame <NUM>. The frame <NUM> can have the same configuration as frame <NUM> or frame <NUM> and therefore is not further described. The leaflet assembly includes commissures <NUM> mounted to respective commissure posts <NUM> (which can be components of actuators).

When the prosthetic valve is radially expanded from a compressed (delivery) state, a small amount of slack can form along sub-commissure edge portions <NUM>, <NUM>, depending on the height and/or width of the windows <NUM>, <NUM>. As depicted in <FIG>, small folds <NUM> can form along the sub-commissure edge portions <NUM>, <NUM>. During cyclic operation of the prosthetic valve <NUM>, these folds <NUM> can transition between an open state under the forward flow of blood (e.g., during systole for a prosthetic aortic valve) and a closed state under the reverse flow of blood (e.g., during diastole for a prosthetic aortic valve). In the open state, the folds may contact the inner surface of the frame, which can cause abrasion of the leaflets, and may limit the extent that the leaflets <NUM> can fully open under the forward flow of blood.

<FIG> shows an exemplary leaflet <NUM>' for a prosthetic heart valve that can prevent or at least minimize the formation of folds <NUM> during operation of the prosthetic valve. Any of the prosthetic heart valves disclosed herein (e.g., any of the embodiments of <FIG>) can include a valvular structure comprising one or more of the leaflets <NUM> assembled within a frame of a prosthetic heart valve. The components of the leaflet <NUM> that are present in the leaflet <NUM>' are given the same reference numbers and therefore are not further described.

Unlike leaflet <NUM>, the leaflet <NUM>' includes additional sub-commissure tabs <NUM> extending laterally from the sub-commissure edge portions <NUM>, <NUM> within the windows <NUM>, <NUM>. The sub-commissure tabs <NUM> can be referred to as upper sub-commissure tabs <NUM> while the sub-commissure tabs <NUM> can be referred to as lower sub-commissure tabs <NUM>. Each sub-commissure tab <NUM> can be spaced from a lower edge <NUM> of a corresponding commissure tab <NUM>, <NUM> and an upper edge <NUM> of a corresponding tab <NUM>. In certain embodiments, each sub-commissure tab <NUM> can be positioned equidistant from the edges <NUM> and <NUM>. Each sub-commissure tab <NUM> can be formed with one or more lines of apertures <NUM> for receiving sutures.

A leaflet assembly comprising a plurality of leaflets <NUM>' can be formed in the same manner as described above for the leaflet <NUM>. Additionally, each sub-commissure tab <NUM> can be connected to an adjacent sub-commissure tab <NUM> of an adjacent leaflet, such as with sutures (which can extend through apertures <NUM>). In some embodiments, the sub-commissure tabs <NUM> can be folded inwardly relative to the edge portions <NUM>, <NUM> such that when assembled to a frame, each pair of connected sub-commissure tabs <NUM> extends radially inwardly toward the center of the prosthetic valve (similar to the tabs 432a, 432b of <FIG>). In alternative embodiments, each pair of connected sub-commissure tabs <NUM> can be folded outwardly relative to the edge portions <NUM>, <NUM> such that when assembled to a frame, each pair of connected sub-commissure tabs <NUM> extends radially outwardly toward the frame (similar to the tabs 432a, 432b of <FIG>).

By connecting the sub-commissure tabs <NUM> to each other, the formation of folds along the edge portions <NUM>, <NUM> can be prevented or minimized. Advantageously, this can prevent or minimize contact of the leaflets with the frame, thereby preventing or minimizing leaflet abrasion, and can promote full opening of the leaflets under the forward flow of blood to maximize the effective outflow orifice of the valve and to reduce the pressure gradient across the valve under the forward flow of blood. As described above in connection with <FIG>, folding the lower sub-commissure tabs <NUM> inwardly (like tabs 432a, 432b in <FIG>) can promote opening of the leaflets under the forward flow of blood. Thus, in some embodiments, both the lower sub-commissure tabs <NUM> and the upper sub-commissure tabs <NUM> are folded inwardly to further promote opening of the leaflets under the forward flow of blood.

The width of the sub-commissure tabs <NUM> (in the horizontal direction in <FIG>) can be selected to permit each tab to be connected to an adjacent tab <NUM> of an adjacent leaflet. The height of each tab <NUM> (in the vertical direction in <FIG>) can be selected to optimize performance of the leaflets, and in particularly, prevent or minimize fold formation and movement of the tabs relative to the frame, thereby mitigating abrasion and promoting leaflet opening under the forward flow of blood. In particular embodiments, the width of the tabs <NUM> is about <NUM> or greater and the height of the tabs is about <NUM> or greater.

The sub-commissure tabs <NUM> can be incorporated into leaflets having other overall shapes or configurations that are different than that shown in <FIG>. For example, in one implementation, a leaflet <NUM> (shown in <FIG>) can include sub-commissure tabs <NUM> extending laterally from edge portions <NUM>, <NUM>. In other embodiments, any of the leaflets disclosed in <CIT>, can include sub-commissure tabs <NUM>.

Although the present disclosure is described in the context of mechanically expandable heart valves, any of the leaflets, leaflet assemblies and valve assembly methods disclosed herein can be applied to other types of prosthetic heart valves, such as plastically-expandable (e.g., balloon expandable) heart valves or self-expandable heart valves. Thus, any of the leaflets, leaflet assemblies and assembly methods can be used to assemble a prosthetic valve comprising a frame made of a plastically-expandable material (e.g., stainless steel, a cobalt chromium alloy, etc.) or a shape memory, self-expanding material (e.g., a nickel titanium alloy (NiTi), such as nitinol) as known in the art. When constructed of a plastically-expandable material, the frame (and thus the prosthetic valve) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame (and thus the prosthetic valve) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size. Examples of prosthetic heart valves that have plastically-expandable frames are disclosed in <CIT> and <CIT>. Examples of prosthetic heart valves that have self-expandable frames are disclosed in <CIT> and Publication No. <CIT>.

<FIG> illustrates a delivery apparatus <NUM>, according to one example, adapted to deliver a prosthetic heart valve <NUM> (e.g., valve <NUM>, <NUM>, <NUM>). The prosthetic valve <NUM> can be releasably coupled to the delivery apparatus <NUM>. It should be understood that the delivery apparatus <NUM> and other delivery apparatuses disclosed herein can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

The delivery apparatus <NUM> in the illustrated embodiment generally includes a handle <NUM>, a first elongated shaft <NUM> (which comprises an outer shaft in the illustrated example) extending distally from the handle <NUM>, at least one actuator assembly <NUM> extending distally from the handle through the outer shaft <NUM>, and a second elongated shaft <NUM> (which comprises an inner shaft in the illustrated example) extending distally from the handle through the outer shaft <NUM>. The at least one actuator assembly <NUM> can be configured to radially expand and/or radially collapse the prosthetic valve <NUM> when actuated. A nosecone <NUM> can be mounted to the distal end of the second shaft <NUM>. The second shaft <NUM> and the nosecone <NUM> can define a guidewire lumen sized for receiving a guidewire so that the delivery apparatus can be advanced over a guidewire previously inserted into a patient's body.

Though the illustrated embodiment shows two actuator assemblies <NUM> for purposes of illustration, it should be understood that one actuator <NUM> can be provided for each actuator on the prosthetic valve. For example, three actuator assemblies <NUM> can be provided for a prosthetic valve having three actuators. In other embodiments, a greater or fewer number of actuator assemblies can be present.

In some embodiments, a distal end portion <NUM> of the shaft <NUM> can be sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end portion <NUM> functions as a delivery sheath or capsule for the prosthetic valve during delivery,.

The actuator assemblies <NUM> can be releasably coupled to the prosthetic valve <NUM>. For example, in the illustrated embodiment, each actuator assembly <NUM> can be coupled to a respective actuator of the prosthetic valve <NUM>. Each actuator assembly <NUM> can comprise a support tube, an actuator member, and optionally a locking tool. When actuated, the actuator assembly can transmit pushing and/or pulling forces to portions of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assemblies <NUM> can be at least partially disposed radially within, and extend axially through, one or more lumens of the outer shaft <NUM>. For example, the actuator assemblies <NUM> can extend through a central lumen of the shaft <NUM> or through separate respective lumens formed in the shaft <NUM>.

The handle <NUM> of the delivery apparatus <NUM> can include one or more control mechanisms (e.g., knobs or other actuating mechanisms) for controlling different components of the delivery apparatus <NUM> in order to expand and/or deploy the prosthetic valve <NUM>. For example, in the illustrated embodiment the handle <NUM> comprises first, second, and third knobs <NUM>, <NUM>, and <NUM>.

The first knob <NUM> can be a rotatable knob configured to produce axial movement of the outer shaft <NUM> relative to the prosthetic valve <NUM> in the distal and/or proximal directions in order to deploy the prosthetic valve from the delivery sheath <NUM> once the prosthetic valve has been advanced to a location at or adjacent the desired implantation location with the patient's body. For example, rotation of the first knob <NUM> in a first direction (e.g., clockwise) can retract the sheath <NUM> proximally relative to the prosthetic valve <NUM> and rotation of the first knob <NUM> in a second direction (e.g., counter-clockwise) can advance the sheath <NUM> distally. In other embodiments, the first knob <NUM> can be actuated by sliding or moving the knob <NUM> axially, such as pulling and/or pushing the knob. In other embodiments, actuation of the first knob <NUM> (rotation or sliding movement of the knob <NUM>) can produce axial movement of the actuator assemblies <NUM> (and therefore the prosthetic valve <NUM>) relative to the delivery sheath <NUM> to advance the prosthetic valve distally from the sheath <NUM>.

The second knob <NUM> can be a rotatable knob configured to produce radial expansion and/or contraction of the prosthetic valve <NUM>. For example, rotation of the second knob <NUM> can move the actuator member and the support tube axially relative to one another. Rotation of the second knob <NUM> in a first direction (e.g., clockwise) can radially expand the prosthetic valve <NUM> and rotation of the second knob <NUM> in a second direction (e.g., counter-clockwise) can radially collapse the prosthetic valve <NUM>. In other embodiments, the second knob <NUM> can be actuated by sliding or moving the knob <NUM> axially, such as pulling and/or pushing the knob.

The third knob <NUM> can be a rotatable knob configured to retain the prosthetic heart valve <NUM> in its expanded configuration. For example, the third knob <NUM> can be operatively connected to a proximal end portion of the locking tool of each actuator assembly <NUM>. Rotation of the third knob in a first direction (e.g., clockwise) can rotate each locking tool to advance the locking nuts to their distal positions to resist radial compression of the frame of the prosthetic valve, as described above. Rotation of the knob <NUM> in the opposite direction (e.g., counterclockwise) can rotate each locking tool in the opposite direction to decouple each locking tool from the prosthetic valve <NUM>. In other embodiments, the third knob <NUM> can be actuated by sliding or moving the third knob <NUM> axially, such as pulling and/or pushing the knob.

Although not shown, the handle <NUM> can include a fourth rotatable knob operative connected to a proximal end portion of each actuator member. The fourth knob can be configured to rotate each actuator member, upon rotation of the knob, to unscrew each actuator member from the proximal portion of a respective actuator. As described above, once the locking tools and the actuator members are uncoupled from the prosthetic valve <NUM>, they can be removed from the patient.

For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) are introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

In all delivery approaches, the delivery apparatus can be advanced over a guidewire and/or an introducer sheath previously inserted into a patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

A method of assembling a prosthetic heart valve, comprising: providing a plurality of leaflets, wherein each leaflet comprises a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body; pairing each commissure tab with an adjacent commissure of an adjacent leaflet to form a plurality of commissures, and coupling the commissures to an annular frame, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and pairing each sub-commissure tab with an adjacent commissure of an adjacent leaflet, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

The method of any example herein, wherein pairing each sub-commissure tab with an adjacent commissure of an adjacent leaflet comprises suturing the sub-commissure tabs of each pair to each other.

The method of any example herein, further comprising coupling the cusp edge portion of each leaflet to the frame, wherein the cusp edge portion of each leaflet extends from one sub-commissure tab to the other sub-commissure tab of the leaflet.

The method of any example herein, further comprising suturing a first reinforcing member the cusp edge portions of the leaflets and to selected struts of the frame.

The method of any example herein, further comprising suturing a second reinforcement member to the cusp edge portions of the leaflets, wherein the first and second reinforcing members are positioned on opposite sides of the cusp edge portions of the leaflets.

The method of any example herein, wherein the pairs of sub-commissure tabs are not directly connected to the frame.

The method of any example herein, wherein the main body of each leaflet is formed with pair of notches, each of which extends between a commissure tab and a sub-commissure tab, wherein the notches are not directly connected to the frame.

The method of any example herein, wherein the sub-commissure tabs comprise lower sub-commissure tabs and wherein each leaflet comprises two opposing upper sub-commissure tabs arranged on opposite sides of the main body, wherein the method further comprises connecting each upper sub-commissure tab to an adjacent upper sub-commissure tab of an adjacent leaflet to form pairs of upper sub-commissure tabs.

The method of any example herein, wherein each pair of upper sub-commissure tabs extends radially inwardly relative to the frame.

The method of any example herein, wherein each pair of upper sub-commissure tabs extends radially outwardly toward an inner surface of the frame.

The method of any example herein, wherein connecting each upper sub-commissure tab to an adjacent upper sub-commissure tab comprises suturing the upper sub-commissure tabs of each pair to each other.

The method of any example herein, wherein the pairs of upper sub-commissure tabs are not directly connected to the frame.

The method of any example herein, wherein each upper sub-commissure tab is arranged between and spaced from an adjacent commissure tab and an adjacent lower commissure tab on one side of the corresponding leaflet.

The method of any example herein, wherein each leaflet has two upper tabs connected to upper edges of the commissure tabs and the method comprises folding the upper tabs of each leaflet downwardly against the commissure tabs prior to coupling the commissures to the frame.

The method of any example herein, wherein the frame comprises a plurality of commissure support posts, and coupling the commissures to the frame comprises mounting the commissures to the commissure support posts.

The method of any example herein, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.

A prosthetic heart valve comprising: an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and a plurality of leaflets situated within the frame, each leaflet comprising a main body, a cusp edge portion, two opposing commissure tabs arranged on opposite sides of the main body, two sub-commissures edges forming notches on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs arranged on opposite sides of the main body and extending laterally from the sub-commissures edges; wherein each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame; wherein each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto.

The prosthetic heart valve of any example herein, wherein, according to a configuration not covered by the claimed invention, each pair of sub-commissure tabs extends radially outwardly toward an inner surface of the frame.

The prosthetic heart valve of any example herein, wherein the sub-commissure tabs of each pair of sub-commissure tabs are sutured to each other.

The prosthetic heart valve of any example herein, wherein each sub-commissure tab is arranged between and spaced from an adjacent commissure tab and an adjacent upper end portion of the cusp edge portion on one side of the corresponding leaflet.

The prosthetic heart valve of any example herein, wherein the sub-commissure tabs comprises upper sub-commissure tabs, and wherein the upper end portions of the cusp edge portion of each leaflet comprise lower sub-commissure tabs arranged on opposite sides of the main body, wherein each lower sub-commissure tab is paired with an adjacent lower sub-commissure tab of an adjacent leaflet and connected thereto.

The prosthetic heart valve of any example herein, wherein the lower sub-commissure tabs of each pair of lower sub-commissure tabs are sutured to each other.

The prosthetic heart valve of any example herein, wherein each pair of lower sub-commissure tabs extends radially inwardly relative to the frame.

The prosthetic heart valve of any example herein, wherein the pairs of lower sub-commissure tabs are not directly connected to the frame.

The prosthetic heart valve of any example herein, further comprising a first reinforcing member sutured to the cusp edge portions of the leaflets and to selected struts of the frame.

The prosthetic heart valve of any example herein, further comprising a second reinforcement member sutured to the cusp edge portions of the leaflets, wherein the first and second reinforcing members are positioned on opposite sides of the cusp edge portions of the leaflets.

The prosthetic heart valve of any example herein, wherein each leaflet has two upper tabs connected to upper edges of the commissure tabs and folded downwardly against the commissure tabs.

The prosthetic heart valve of any example herein, wherein the frame comprises a plurality of commissure support posts, and the commissures are mounted to the commissure support posts.

The prosthetic heart valve of any example herein, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.

A method of assembling a prosthetic heart valve, comprising: providing a plurality of leaflets, wherein each leaflet comprises a main body, a cusp edge portion, two opposing commissure tabs arranged on opposite sides of the main body, two sub-commissures edges forming notches on opposite sides of the main body between the commissure tabs and upper end portions of the cusp edge portion, and two opposing sub-commissure tabs arranged on opposite sides of the main body and extending laterally from the sub-commissures edges; pairing each commissure tab with an adjacent commissure of an adjacent leaflet to form a plurality of commissures, and coupling the commissures to an annular frame, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state; and pairing each sub-commissure tab with an adjacent commissure of an adjacent leaflet and connecting the sub-commissure tabs of each pair to each other.

The method of any example herein, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

The method of any example herein, wherein each pair of sub-commissure tabs extends radially outwardly toward an inner surface of the frame.

The method of any example herein, wherein connecting the sub-commissure tabs of each pair of sub-commissure tabs to each other comprises suturing the sub-commissure tabs of each pair of sub-commissure tabs to each other.

The method of any example herein, further comprising coupling the cusp edge portion of each leaflet to the frame.

The method of any example herein, further comprising suturing a first reinforcing member the cusp edge portions of the leaflets and to selected struts of the frame.

The method of any example herein, wherein the pairs of sub-commissure tabs and the two sub-commissure edges are not directly connected to the frame.

The method of any example herein, wherein each sub-commissure tab is arranged between and spaced from an adjacent commissure tab and an adjacent upper end portion of the cusp edge portion on one side of the corresponding leaflet.

The method of any example herein, wherein the sub-commissure tabs comprises upper sub-commissure tabs, and wherein the upper end portions of the cusp edge portion of each leaflet comprise lower sub-commissure tabs arranged on opposite sides of the main body, wherein the method further comprises connecting each lower sub-commissure tab to an adjacent lower sub-commissure tab of an adjacent leaflet to form pairs of lower sub-commissure tabs.

The method of any example herein, wherein connecting each lower sub-commissure tab to an adjacent lower sub-commissure tab of an adjacent leaflet comprises suturing the lower sub-commissure tabs of each pair of lower sub-commissure tabs to each other.

The method of any example herein, wherein each pair of lower sub-commissure tabs extends radially inwardly relative to the frame.

The method of any example herein, wherein the pairs of lower sub-commissure tabs are not directly connected to the frame.

Claim 1:
A prosthetic heart valve (<NUM>) comprising:
an annular frame (<NUM>) comprising a plurality of interconnected struts (<NUM>), wherein the frame (<NUM>) is radially compressible and expandable between a radially compressed state and a radially expanded state; and
a plurality of leaflets (<NUM>) situated within the frame (<NUM>), each leaflet comprising a main body (<NUM>), two opposing commissure tabs (416a, 416b) arranged on opposite sides of the main body (<NUM>) and two opposing sub-commissure tabs (432a, 432b) arranged on opposite sides of the main body (<NUM>);
wherein each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame (<NUM>);
wherein each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto to form a sub-commissure portion located between the commissure and inflow edge portions of the leaflets,
wherein each pair of sub-commissure tabs (432a, 432b) extends radially inwardly relative to the frame (<NUM>),
and wherein the pairs of sub-commissure tabs (432a, 432b) are not directly connected to the frame (<NUM>).