HK40073488A - Prosthetic heart valve - Google Patents

Description

Prosthetic heart valve

Cross Reference to Related Applications

This application claims the benefit of U.S. provisional application No. 63/006,190, filed on 7/4/2020, which is incorporated herein by reference.

Technical Field

The present disclosure relates to prosthetic heart valves, and to methods and assemblies for forming leaflet assemblies and attaching the leaflet assemblies to frames of such prosthetic heart valves.

Background

The human heart is afflicted with various valvular diseases. These valve diseases can lead to severe malfunction of the heart, eventually requiring repair of the native valve or replacement of the native valve with a prosthetic valve. There are many known prosthetic devices (e.g., stents) and prosthetic valves, and many known methods of implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in a variety of procedures to deliver prosthetic medical devices to locations within the body that are not readily accessible through surgery or are desired to be accessed without surgery. In one particular example, the prosthetic heart valve can be mounted on the distal end of the delivery device in a crimped state and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches an implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic heart valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of a delivery device such that the prosthetic heart valve is capable of self-expanding to its functional size.

Most expandable transcatheter heart valves are used for medium to high expansion diameters, for example diameters ranging from 23 to 29 mm. While smaller prosthetic valves are available, such as those having a diameter of about 20mm or less, smaller diameter valves are rarely used due to various challenges. For example, smaller diameter prosthetic valves often result in higher pressure gradients along the prosthetic valve, which can lead to various clinical risks, such as cavitation (cavitation). Also, smaller prosthetic valves typically have shorter perivalvular sealing elements, which makes it more challenging for the clinician to align the prosthetic valve at the native annulus. Smaller prosthetic valves may also have a relatively shorter frame, which may cause the leaflets to hang in with the native valve leaflets hanging over the outflow end of the prosthetic valve, thereby interfering with blood flow and/or preventing full opening of the prosthetic leaflets. In addition, smaller prosthetic valves have relatively smaller frame openings that can impede coronary access through the frame using a catheter in subsequent procedures. Finally, valve-in-valve (valve-in-valve) procedures involving a second prosthetic valve over a previously implanted prosthetic valve are more challenging with relatively smaller prosthetic valves because it is difficult to properly align and orient the second prosthetic valve within the previously implanted prosthetic valve while maintaining access to the coronary ostia.

Accordingly, there is a need for improved prosthetic heart valve leaflet assemblies and methods of assembling the leaflet assemblies to the frame of a prosthetic heart valve.

Disclosure of Invention

Embodiments of methods for assembling prosthetic heart valves including leaflet assemblies, methods of assembling leaflet sub-assemblies of leaflet assemblies, and prosthetic heart valves including leaflet assemblies are described herein.

In one representative embodiment, a prosthetic heart valve is provided. The prosthetic heart valve includes an expandable annular frame, a plurality of commissure support members external to the frame, and a plurality of quadrilateral valve leaflets. The expandable annular frame has an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis. Each of the plurality of quadrilateral valve leaflets has a body having an inflow edge and an outflow edge and a pair of opposing leaflet ears extending from opposite sides of the body, each leaflet ear paired with an adjacent leaflet ear of an adjacent leaflet, each pair of leaflet ears extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure ear assembly, wherein each commissure ear assembly is located on the exterior of the frame and the body of each leaflet is located on the interior of the frame. The inflow edge of the leaflet and the inflow end of the frame are aligned, and the outflow edge of the leaflet is axially offset from the outflow end of the frame along the longitudinal axis.

In another representative embodiment, a prosthetic heart valve includes an annular frame having an inflow end, an outflow end, a plurality of openings, and a longitudinal axis; a plurality of commissure support members, each commissure support member having an outer surface and an inner surface; and a plurality of valve leaflets, each valve leaflet having a main body with an inflow edge and an outflow edge and a pair of opposing leaflet tabs extending from opposing sides of the main body. Each leaflet lug mates with an adjacent leaflet lug of an adjacent leaflet, wherein each pair of leaflet lugs extends through a respective opening of the frame and is coupled to one of the commissure supports outside the frame to form a commissure lug assembly. Each leaflet tab forms a first fold extending radially outward from the body of the respective leaflet through the respective opening of the frame, a second fold extending circumferentially between an inner surface of the respective support member and an outer surface of the frame, and a third fold extending circumferentially along the outer surface of the support member.

In another representative embodiment, a prosthetic heart valve includes an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure support members external to the frame; and a plurality of valve leaflets, each valve leaflet having a main body with an inflow edge and an outflow edge and a pair of opposing leaflet tabs extending from opposing sides of the main body. Each leaflet lug mates with an adjacent leaflet lug of an adjacent leaflet, each pair of leaflet lugs extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure lug assembly, wherein each commissure lug assembly is located on the exterior of the frame and the body of each leaflet is located on the interior of the frame. For each commissure lug assembly, the commissure support members have a height that is greater than a height of the respective frame opening through which the pair of leaflet lugs extend.

In another representative embodiment, a leaflet assembly for a prosthetic heart valve includes a plurality of valve leaflets and a plurality of commissure support members. Each leaflet includes a body having an inflow edge and an outflow edge and opposing commissure lugs extending from opposing sides of the body. Each commissure support member has a pair of opposing faces. Each commissure lug is paired with an adjacent commissure lug of an adjacent leaflet, and for each pair of commissure lugs, the commissure lugs are partially wrapped around and coupled to the opposing face of one of the support members to form a commissure assembly.

In another representative embodiment, a method for assembling a prosthetic heart valve is provided. The method comprises forming a leaflet assembly from a plurality of leaflets, each leaflet comprising opposing commissure lugs, wherein the leaflet assembly is formed by mating the commissure lugs of each leaflet with adjacent commissure lugs of an adjacent leaflet and connecting each pair of commissure lugs to a commissure support member to form a respective commissure assembly of the leaflet assembly. The method further includes positioning the leaflet assembly within an interior of an expandable annular frame, wherein the frame defines a plurality of openings; and inserting each of the commissure components through a respective opening of the frame to position the commissure components on an exterior of the frame.

The above and other objects, features and advantages of the present invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Drawings

FIG. 1 is a perspective view of a prosthetic heart valve according to one embodiment.

Fig. 2 is a perspective view of a frame of the prosthetic valve of fig. 1 shown in a radially expanded state.

Fig. 3 is a side view of the prosthetic heart valve of fig. 1.

Fig. 4 is a perspective view of the prosthetic heart valve of fig. 1 shown with one of the leaflets removed for illustration purposes.

Fig. 5A-5D are plan views of four different leaflet embodiments that can be used in the prosthetic valve of fig. 1.

Fig. 6 is a plan view of a commissure tab assembly for the prosthetic heart valve of fig. 1.

Figures 7A-7C are front views of different embodiments of a commissure support member that can be used in forming the commissure tab assembly of the prosthetic valve of figure 1.

Fig. 8 is a top plan view of a preassembled valve structure for insertion into a prosthetic valve frame, such as the frame of fig. 2.

Fig. 9 is a side view of the preassembled valve structure of fig. 8.

Fig. 10 is a top plan view of the prosthetic valve of fig. 1.

Fig. 11 is a top plan view of the prosthetic heart valve of fig. 1, showing the valve structure in an open configuration.

Fig. 12 is a top plan view of the prosthetic heart valve of fig. 11, showing the valve structure in a closed configuration.

Fig. 13 is a perspective view of a prosthetic heart valve shown in a radially expanded state having an outer skirt mounted on an outer surface of a prosthetic valve frame.

Fig. 14 is a side view of the prosthetic heart valve of fig. 13.

Fig. 15 is a side view of a delivery apparatus for a prosthetic heart valve according to one embodiment.

Detailed Description

Examples of prosthetic implants are described herein, such as prosthetic valves that can be implanted within any native valve of the heart (e.g., the aorta, mitral valve, tricuspid valve, and pulmonary valve). The present disclosure also provides a frame for use with such a prosthetic implant. The frame can include struts having different shapes and/or sizes to avoid coronary occlusion and hanging of native leaflets. The prosthetic heart valve can also include a plurality of leaflets attached to the frame.

The present disclosure may also include a leaflet assembly for a prosthetic heart valve, a leaflet commissure lug assembly of the leaflet assembly, and a method for assembling the leaflet commissure lug assembly. The leaflet commissure lug assembly can include a plurality of leaflet commissure support members. Each leaflet commissure lug assembly can include a pair of adjacent leaflet lugs coupled to each other by a commissure support member. Each leaflet commissure assembly can be formed by folding and securing the lugs of each of the leaflets about the corresponding commissure support members. The adjacently disposed valve leaflets can then be coupled to one another prior to being attached to the frame of the prosthetic heart valve. Thus, the leaflet assembly for the prosthetic heart valve can be more easily assembled outside (off) the frame of the prosthetic heart valve, and the time and effort to secure the leaflet assembly to the frame of the prosthetic heart valve can be reduced.

Also disclosed herein are various small diameter prosthetic valves (e.g., 20mm) that can address one or more of the disadvantages associated with the known small diameter prosthetic valves discussed above. In particular, the disclosed embodiments can be configured to reduce pressure gradients, avoid hanging native leaflets, and/or maintain access and blood flow to the coronary arteries, all issues typically associated with smaller diameter valves. The disclosed embodiments can include a plurality of commissure lug assemblies of the leaflet assembly coupled to an outer surface of the frame. The disclosed commissure tab assembly can, for example, allow the valve leaflets to open wider than is typically allowed in conventional valves, which increases the overall blood flow through the prosthetic valve to reduce high pressure gradients.

The prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped onto or held in a radially compressed state by the implant delivery device during delivery, and then expanded to a radially expanded state after the prosthetic valve reaches the implantation site. It is to be understood that the valves disclosed herein can be used with a wide variety of implant delivery devices.

Fig. 1 illustrates an exemplary prosthetic heart valve 100, according to one embodiment. The prosthetic heart valve 100 is radially compressible and expandable between a radially compressed configuration for delivery into a patient and a radially expanded configuration. In a particular embodiment, the prosthetic heart valve 100 can be implanted within the native aortic annulus, but it can also be implanted at other locations in the heart, including within the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The prosthetic heart valve 100 can include an annular stent or frame 102 having a first end 104, a second end 106, an inner surface 108, and an outer surface 110.

In the depicted embodiment, the first end 104 is an inflow end and the second end 106 is an outflow end. The outflow end 106 can be coupled to a delivery apparatus for delivering and implanting the prosthetic heart valve within the native aortic valve in a transfemoral retrograde delivery method. Thus, in the delivery configuration of the prosthetic heart valve, the outflow end 106 is the most proximal end of the prosthetic valve. In other embodiments, the inflow end 104 can be coupled to a delivery device depending on the particular native valve being replaced and the delivery technique being used (e.g., transseptal, transapical, etc.). For example, when delivering the prosthetic heart valve to the native mitral valve via a transseptal delivery method, the inflow end 104 can be coupled to a delivery device (and thus the most proximal end of the prosthetic heart valve in the delivery configuration).

As shown in fig. 1 and 2, the frame 102 can include a plurality of interconnected lattice struts 112, the plurality of interconnected lattice struts 112 arranged in a lattice-type pattern and forming a plurality of apices 114 at the outflow end 106 of the prosthetic valve 100. The struts 112 can also form similar apices 116 at the inflow end 104 of the prosthetic valve 100. In fig. 1 and 2, the struts 112 are shown positioned diagonally or offset at an angle relative to the longitudinal axis 118 of the prosthetic valve 100 and radially offset from the longitudinal axis 118 of the prosthetic valve 100 when the prosthetic valve 100 is in the expanded configuration. In other embodiments, the struts 112 can be offset by a different amount than depicted in fig. 1, or some or all of the struts 112 can be positioned parallel to the longitudinal axis 118 of the prosthetic valve 100.

The frame 102 can be made of any of a variety of suitable plastically-expandable materials, such as stainless steel or cobalt-chromium alloys, and/or self-expanding materials, such as nickel-titanium alloys ("NiTi") (e.g., nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the prosthetic valve 100) can be crimped to a radially-compressed state on a delivery catheter and then expanded inside the patient by an inflatable balloon or any suitable expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the prosthetic valve 100) can be crimped to a radially compressed state and constrained in the compressed state by a sheath or equivalent mechanism inserted into the delivery catheter. Once inside the body, the prosthetic valve 100 can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

Still referring to fig. 1 and 2, the frame 102 can include a plurality of circumferentially extending rows of interconnected struts 112 arranged in a grid-type pattern. In the illustrated embodiment, the open lattice structure of the frame 102 can define a plurality of rows of open frame openings 120 between the struts 112. As shown in fig. 1 and 2, the frame opening 120 can be diamond shaped. The frame openings 120 are arranged in a plurality of circumferentially extending rows including a lowermost row at the inflow end of the frame, an uppermost row at the outflow end of the frame, and one or more intermediate rows between the lowermost row and the uppermost row. In the illustrated embodiment, there are four rows of frame openings, and all openings within a given row are the same size and shape.

In the illustrated embodiment, the struts 112 are pivotable or bendable relative to each other to allow radial expansion and contraction of the frame 102. For example, the frame 102 can be formed (e.g., via laser cutting, electroforming, or physical vapor deposition) from a single piece of material (e.g., a metal tube). Thus, when the frame 102 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic valve 100, the inflow end 104 and the outflow end 106 of the frame 102 can move axially parallel to the longitudinal axis 118 of the prosthetic valve 100.

In other embodiments, the frame 102 can be constructed by forming individual components (e.g., posts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. For example, the struts 112 can be pivotally coupled to one another at one or more pivot joints or pivot joints along the length of each strut. Each of the pivot joints or pivot joints (e.g., hinges) can allow the struts 112 to pivot relative to one another when the frame 102 is radially expanded or compressed.

Further details regarding the structure of the frame and prosthetic valve are described in U.S. publication No. 2018/0028310, which is incorporated herein by reference. Other frames that can be implanted in prosthetic valves are disclosed in U.S. publication nos. 2012/0123529, 2012/0239142, and 2018/0153689, which are incorporated herein by reference.

The prosthetic valve 100 can also include a valve structure 122, the valve structure 122 being coupled to the frame 102 and supported by the frame 102. Valve structure 122 is configured to regulate the flow of blood through prosthetic valve 100 from inflow end 104 to outflow end 106. The valve structure 122 can include, for example, a leaflet assembly that includes one or more leaflets 124 made of a flexible material. The leaflets 124 can be made, in whole or in part, of a biomaterial, a biocompatible synthetic material, or other such material. Suitable biological materials can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 124 can be secured to one another on adjacent sides to form commissures 126, each commissure 126 can be secured to a commissure support member 128, as discussed further below.

As shown in fig. 3-5A, each leaflet 124 of the valve structure 122 can be configured to have a quadrilateral shape (e.g., rectangular or square as shown) and can have an inflow edge 132 and an outflow edge 134 (also referred to as a coaptation edge), the outflow edge 134 contacting a respective outflow edge of the other leaflets during closure of the leaflet 124 (e.g., during diastole).

Leaflets commonly found in prosthetic valves typically have an arcuate scalloped shape, such as a lower tip edge portion between the tabs of each of the leaflets that is curved. Thus, the prosthetic leaflet is often attached to the frame with its lowest point (e.g., the closest point of approach to the inflow end of the valve) in a scalloped pattern, offset from the inflow end of the valve.

As shown in fig. 1 and 3-4, the inflow edges 132 of the quadrilateral-shaped leaflets 124 of the valve structure 122 can be aligned (or substantially aligned) with the inflow end 104 of the frame 102 and attached to the inflow end 104 of the frame 102. Thus, each of the leaflets 124 can also have an outflow end 134 that is axially offset from the frame's outflow end 106 along the longitudinal axis 118 of the valve 100. In this manner, the outflow edge 134 of each leaflet can be located before the inflow end 104 and the outflow end 106 of the frame 102, such that the frame opening 120, or a portion thereof downstream of the outflow edge, is open and accessible during a duty cycle of the prosthetic valve 100, thereby reducing occlusion of the coronary arteries by the leaflets 124.

As best shown in fig. 3, the outflow edges 134 of the leaflets 124 are upstream of a plane P that is perpendicular to the longitudinal axis 118 and bisects each of the uppermost ones of the openings 120 at the outflow end of the frame. In this manner, a majority of each of the frame openings 120 in the uppermost row is uncovered by the leaflets 124 in its open position, thereby providing access to the coronary arteries. In some embodiments, at least 60% of the frame openings in the uppermost row are uncovered by leaflets 124 in their open position; and more desirably, at least 80% of the frame openings in the uppermost row are uncovered by leaflets 124 in their open position; and more desirably, at least 80% of the frame openings in the uppermost row are uncovered by leaflets 124 in their open position; and more desirably, at least 90% of the frame openings in the uppermost row are uncovered by leaflets 124 in their open position; and more desirably 100% of the frame opening in the uppermost row is uncovered by leaflets 124 in its open position.

As shown in fig. 5A, each leaflet 124 of the valve structure 122 can have a body 143 and leaflet tabs 144a, 144b (also referred to as commissure tabs), the body 143 defining an inflow edge 132 and an outflow edge 134, the leaflet tabs 144a, 144b extending from opposite sides of the body 143. Each leaflet 124 can have a leaflet height H1 defined by the length extending from the inflow edge 132 (e.g., at the inflow end 104) to the outflow edge 134 and a width W1 measured from one side of the main body 143 to the other side of the main body. In the illustrated embodiment, each leaflet 124 is rectangular in shape, having a width W1 that is greater than a height H1. Although the prosthetic valve 100 is described herein as having quadrilateral leaflets, other configurations and structures of the leaflets may be used.

As further shown in fig. 5A, each leaflet tab 144a, 144b, in the illustrated embodiment, has a height or length L2 measured from the outflow edge 162 of the leaflet tab to the inflow edge 164 of the leaflet tab 164. The outlet edge 162 can be axially offset from the outlet edge 134 of the body 143 in an upstream direction, and the inlet edge 164 can be axially offset from the inlet edge 132 of the body 143 in a downstream direction.

The frame 102 can also have a diameter D and a height H2, the height H2 being defined by a length of the frame 102 extending along the longitudinal axis 118 between an outermost point of the apex 116 of the inflow end 104 and the apex 114 of the outflow end 106.

The selection of the height of the frame of the prosthetic valve is an important consideration, particularly for smaller diameter prosthetic valves (e.g., 20mm or less). In general, the frame of the prosthetic valve desirably should be short enough to avoid extending beyond the sinotubular junction (STJ) line and tilting the prosthetic valve from its intended implantation orientation, but long enough to avoid dangling native leaflets. The present inventors have found that for patients requiring a relatively smaller prosthetic valve (20mm or less), a prosthetic valve having a height of about 14mm or less can increase the risk of the leaflets hanging in the air, while a prosthetic valve having a height of more than 18mm may extend beyond the STJ line.

For smaller diameter prosthetic valves, the selection of the height of the individual leaflets is also an important consideration. Generally, the leaflets should be tall enough to promote complete closure of the leaflets during diastole, e.g., to prevent unwanted regurgitation through the prosthetic valve. On the other hand, the leaflets should also be low enough so as not to impede access to the coronary arteries when in the open and closed configurations.

Thus, in some embodiments, the prosthetic valve 100 can have a valve diameter D in the range of 18mm to 22mm, and more specifically 19mm to 21mm, with 20mm being a particular example; the frame height H2 can be in the range of 15mm to 18mm and more specifically 16mm to 17mm, with 15.5mm being a specific example; and each leaflet 124 can have a height H1 in a range of 11mm to 14mm, and more specifically 12mm to 13mm, with 12mm being a particular example. The inventors have found that prosthetic valves having these dimensions can reduce the risk of leaflet dangling while avoiding the STJ line, and can also enable complete closure of the leaflets while avoiding occlusion of the coronary access.

In addition, the use of the quadrilateral leaflets 124 allows the prosthetic valve 100 to be constructed with a minimum leaflet height H1 (e.g., 11 mm). For example, the quadrilateral shape of the leaflets 124 increases the surface area of the leaflets 124 that is in contact with blood flow entering the valve 100 without having to use taller (e.g., longer) leaflets that are typically used in valves having scalloped shaped leaflets. By constructing prosthetic valve 100 with quadrilateral leaflets 124 having a low leaflet height H1, resistance across valve 100 can be reduced and the opening of the leaflets widened during the working cycle of the valve. Thus, the overall pressure gradient across the valve can be reduced. In some embodiments, the pressure gradient across prosthetic valve 100 can be further reduced by using smooth leaflets and/or thinning the leaflets by, for example, source polarization (sourcing), skiving (skiving), and/or laser milling (laser milling).

According to embodiments described herein, diameter D and height H2 of frame 102 can have a proportional relationship with respect to each other, and can each have a proportional relationship with respect to leaflet height H1 of leaflets 124. For example, the prosthetic valve 100 can have a ratio D/H2 in the range of about 1.24 to 1.34, a ratio D/H1 in the range of about 1.61 to 1.71, and a ratio H2/H1 in the range of about 1.24 to 1.34. In some embodiments, when the prosthetic valve is sized, the prosthetic valve 100 can have a ratio D/H2 in the range of about 1.0 to 1.5, a ratio D/H1 in the range of about 1.3 to 1.9, and a ratio H2/H1 in the range of about 1.0 to 1.5. In other embodiments, the ratio D/H2 is approximately equal (or substantially equal) to the ratio H2/H1. In further embodiments, the ratio D/H1 is greater than or equal to the ratio D/H2 and/or the ratio H2/H1.

Referring to fig. 3, in some embodiments, one or more of the frame openings 120 above the outflow edges 134 of the leaflets 124 have a maximum width W4 and a height H3 (measured from the outflow edge of the leaflet to the inner edge of the tip 114) that are greater than the diameter of the native ostium. In particular embodiments, the width W4 and height H3 are at least 2 millimeters (which can allow a 6Fr coronary catheter to pass through the opening), or in some embodiments, at least 4 millimeters, or in some embodiments, at least 6 millimeters. In some embodiments, one or more of the frame openings 120 above the outflow edge 134 have a width W4 and a height H3 that is twice the diameter of the native ostium in which the prosthetic valve is implanted.

In the illustrated embodiment, the frame 102 has twelve openings 120 in each row of openings. In other embodiments, each row of openings 120, or at least the rows at the outflow end of the frame, can have a smaller number of openings 120 to increase the maximum width W4 of each opening. For example, in some embodiments, at least the upper row at the outflow end of the frame can have nine openings 120. Further, the number of rows of openings along the height H2 of the frame 102 can be less than four, such as two or three rows of openings 120, to increase the height H3 of at least the rows of openings at the outflow end of the frame.

Fig. 4 shows a perspective view of the prosthetic valve 100 with one of the valve structures 122 removed for illustration purposes. As shown in fig. 4, the valve structure 122 can comprise a leaflet assembly having a plurality of leaflets 124, a leaflet contact area 126, and a commissure tab assembly 130.

As shown in fig. 5A, each leaflet 124 of the prosthetic valve 100 (e.g., fig. 1) can have a pair of opposing leaflet tabs 144a, 144b (e.g., opposing side portions) extending laterally from the body 143 of the leaflet between the inflow edge 132 and the outflow edge 134 of the body 143, wherein the edges 132, 134 define a height H1 of the leaflet 124 and the body 143. In the illustrated embodiment, the leaflet tabs 144a, 144b can have a length L2, with the length L2 having a dimension that is less than the height H1 of the leaflet. In this configuration, the leaflet tabs 144a, 144b can extend circumferentially around the respective support member 128 and can extend through the opening 120 without deforming the main body 143 of the leaflet 124 positioned within the interior of the frame 102. Thus, the leaflet ears 144a, 144b can have a length L2 that is equal (or substantially equal) to the length L1 of the commissure ear assembly 130.

Referring to fig. 4 and 6, each commissure tab assembly 130 of the valve structure 122 can include a pair of leaflet tabs 144 connected to the respective support member 128. For example, as shown in fig. 6, each pair of leaflet tabs 144 from adjacent leaflets 124 (e.g., individual leaflets 124) can contact each other to form a respective contact region 126, each of the leaflet tabs 144 extending from the respective contact region 126 and wrapping over a surface (e.g., inner and outer surfaces) of the respective commissure support members 128.

As shown in fig. 6, each leaflet ear 144 can form a first radially extending fold 144a, a second circumferentially extending fold 144b radially inward of the support member 128, and a third circumferentially extending fold 144c radially outward of the support member 128. The second fold 144b extends along an inner surface 166 of the support member 128 and the third fold extends along an outer surface 168 of the support member 128. In some embodiments, each of the leaflet ears 144 can extend around the commissure support member 128 and wrap around the commissure support member 128 such that one leaflet ear overlaps another leaflet ear.

In the illustrated embodiment, each support member 128 is in the form of a rectangular plate having flat and parallel inner and outer surfaces 166, 168. In alternative embodiments, the support member 128 can have various other shapes, such as cylindrical, square, and the like.

The leaflet tabs 144 can also be secured to the commissure support member 128 by one or more sutures 148 extending through each of the adjacent leaflet tabs 144 and the commissure support member 128 and/or extending around each of the adjacent leaflet tabs 144 and the commissure support member 128 to form the commissure tab assembly 130. For example, as best shown in fig. 4, each leaflet tab 144 can be secured to the commissure support member 128 with one or more sutures 148 extending through the second fold 144b, the aperture 150 in the commissure support member 128, and the third fold 144c forming an access stitch.

As shown in fig. 4 and 7A-7C, the commissure support members 128 can be rigid plate-like structures (or partially rigid structures) made of various materials, including polymers, stainless steel, cobalt-chromium alloys, or nitinol, and/or combinations thereof, and have a plurality of apertures 150 sized and arranged to receive one or more sutures 148. In the illustrated embodiment of fig. 4 and 7A, the apertures 150 of the support member 128 are arranged in two columns (or alternatively rows) along the length L3 and side portions 146 of the commissure support member 128. The arrangement of the aperture 150 shown in fig. 7A can, for example, allow one or more sutures 148 to extend into the aperture 150 and out of the aperture 150 and through the second and third folds 144b, 144c of the leaflet tabs 144, such as in the illustrated embodiment depicted in fig. 4. In some embodiments, the length L3 of support member 128 can be greater than, less than, or equal to the height H1 of leaflet 124 and/or the length L2 of leaflet ledge 144.

In other embodiments (such as the illustrated embodiment shown in fig. 7B-7C), the apertures 150 of the support member can be arranged in various configurations. For example, as shown in fig. 7B, the support member 128' can have an alternating (or staggered) configuration such that one of the two rows that repeat along the length of the support member can have one or more additional apertures 150 than the other. Alternatively, as shown in fig. 7C, the support member 128 "can have a single column of apertures 150 arranged in a linear fashion along the length (e.g., L3) of the commissure support member 128". In some embodiments, the support member can have any number, arrangement, diameter, and/or shape of apertures 150 to receive one or more sutures 148.

In typical prior art valve structures, a leaflet assembly comprising a plurality of leaflets connected at adjacent tabs is placed within a frame, and the commissure assemblies are formed by suturing the leaflet tabs to a support member and/or other soft component (such as a fabric reinforcement member) of the frame. As should be appreciated, the process of forming the commissure components and securing them to the frame is a time consuming and laborious process. According to the commissure tab assembly 130 described herein, the valve structure 122 of the prosthetic valve 100 can be pre-assembled prior to its insertion into the frame 102 and attachment to the frame 102. For example, fig. 8 and 9 depict a pre-assembled valve structure 122 in which the leaflet tabs 144 of each leaflet 124 are wrapped around the respective commissure support members 128 and secured to the respective commissure support members 128 (e.g., by sutures 148). In this manner, the entire valve structure (including commissure tab assembly 130) can be pre-assembled prior to placement of the leaflets within the frame, which can significantly reduce the overall assembly time of the prosthetic valve.

The preassembled valve structure 122 of fig. 8 and 9 can, for example, be positioned within (or partially within) an interior (e.g., adjacent to the inner surface 108) of the frame 102 (e.g., the bare frame of fig. 2) such that each of the commissure lug assemblies 130 can be inserted into and through a respective open frame opening 120 to position the commissure lug assemblies 130 on an exterior (e.g., the outer surface 110) of the frame 102. The commissure assemblies 130 can be deformed at the folds 144a to facilitate insertion of the commissure assemblies through the respective openings 120.

For example, once the valve structure 122 is positioned within the frame 102, the commissure tab assemblies 130 can be twisted (e.g., turned, rotated, pivoted, etc.) relative to the body 143 of the leaflet and the frame 102 at the fold 144a (e.g., 90 degrees). This allows one end of each of the commissure lug assemblies 130 to be inserted through the respective open frame opening 120 until the entirety of each commissure lug assembly 130 is advanced through the frame opening 120. Once each of the commissure lug assemblies 130 reaches the exterior of the frame 102, the commissure lug assemblies 130 can be twisted or moved back to their non-deformed shape such that they extend parallel to the longitudinal axis 118 along the exterior surface of the frame 102. Thus, each of the commissure lug assemblies 130 can be disposed on the outer surface 110 of the frame 102, the fold 144a extends through the opening 120, and the body of the leaflet is disposed inside the frame 102.

Each of the support members 128 can have a size greater than the size of the frame opening 120, the support members 128 being inserted through the frame opening 120 to prevent the commissure assemblies 130 from pulling inward into the interior of the frame under normal working pressure. For example, in the illustrated embodiment, the commissure support members 128 can have a length L3 (fig. 7A) that is greater than a height L4 (fig. 3) of the respective open frame openings 120 through which the commissure lug assemblies extend to prevent the commissure lug assemblies 130 from pulling back through the open frame openings 120 after being on the exterior of the frame 102 under normal operating pressures. Instead of or in addition to having a length L3 greater than the height L4 of the opening 120, each support member 128 can have a width W2 (fig. 7A) greater than the width W3 (fig. 3) of the respective opening to prevent the pulling through of the commissure assemblies 130.

Once disposed on the outer surface 110, the commissure lug assembly 130 can be connected (e.g., stitched) to the frame 102 with one or more sutures 152 that can, for example, extend through the leaflet lugs 144 (e.g., via the folds 144a, 144c), one or more selected apertures 150 of the commissure support members 128, and around (or through) the struts 112 of the frame 102.

Valve structure 122 can also be constructed using any of a variety of leaflet configurations, such as those shown in the embodiment of fig. 5B-5D. As shown in fig. 5B, the valve structure 224 can be constructed from a single unitary piece of leaflet material (e.g., a single pericardial piece) rather than a unitary piece (e.g., the leaflets 124). For example, in the illustrated embodiment of fig. 5B, the valve structure 224 can define a plurality of leaflets 224a, 224B, 224c, each having a main body 243a, 243B, 243c, respectively. Each body has inflow and outflow edges 232, 234. The bodies can be interconnected to each other with integral middle leaflet tabs 244b and 244 c. The body 243a can have an integral outermost lug 244a on one side of the valve structure, and the body 243c can have an integral outermost lug 244d on the other side of the valve structure.

The valve structure 224 can be assembled using a plurality of support members 128 similar to that shown in fig. 8 by: each intermediate tab 244b, 244c is wrapped around the respective support member 128 and secured thereto as previously described for the valve structure 122 to form the respective commissure assemblies 130. The two outermost lugs 244a, 244d can be wrapped around the same support member 128 and secured to the same support member 128 to form another commissure assembly 130. The preassembled valve structure 224 can then be placed into the frame 102 and secured to the frame 102, as previously described for the valve structure 122.

The leaflets 224a, 224b, 224c can have the same (or substantially the same) dimensions as described above for the leaflet 124, such as the height H1 of the leaflet and/or the length L2 of the leaflet ears.

As shown in fig. 5C-5D, the valve structure can be constructed with individual or unitary leaflets having different leaflet tab sizes. For example, fig. 5C shows an individual leaflet 324 having opposing leaflet tabs 344a, 344b that extend to a height H1 (e.g., L2 equals H1) as defined by the inflow and outflow edges 332, 334. In this manner, the leaflet tabs 344a, 344b can provide additional strength, support, and/or be configured for a larger opening 120 within the frame 102.

Fig. 5D illustrates a valve structure 424 that can be constructed from a single unitary piece of leaflet material (e.g., a single pericardial piece) rather than a unitary piece (e.g., the leaflets 324). The valve structure 424 can define a plurality of leaflets 424a, 424b, 424c, each having a body 443a, 443b, 443c, respectively. Each body has inflow and outflow edges 432, 434. The bodies can be interconnected to each other with integral middle leaflet tabs 444b and 444 c. The body 443a can have an integral outermost lobe 444a on one side of the valve structure, and the body 443c can have an integral outermost lobe 444d on the other side of the valve structure. The valve structure 424 can be assembled using the support member 128 in the same manner as described above for the valve structure 224. In this example, the overall height H1 of the leaflet can be equal to the length L2 of the leaflet ledge.

As shown in fig. 1, the inflow edge 132 of each leaflet 124 can be connected to the frame 102, such as with one or more sutures 160 extending through the leaflet and surrounding (or passing through) the strut 112 forming a loop at the inflow end 132 of the frame 102. In some embodiments, the inflow end of the leaflets can be reinforced at their connection to the frame with one or more reinforcing strips (e.g., fabric strips) extending circumferentially along the outer and/or inner surface of each leaflet. Further details regarding the attachment of the inflow edge of leaflets with and without reinforcing tape are disclosed in U.S. Pat. No. 7,510,575 and U.S. publication nos. 2018/0028310, 2012/0123529 and 2012/0239142, which are incorporated herein by reference.

As best shown in fig. 10, placement of commissure tab assembly 130 on outer surface 110 of frame 102 allows contact areas 126 between adjacent leaflets 124 to be positioned against or very closely adjacent to inner surface 108 of frame 102. For each commissure component, the contact regions 126 define a bending axis about which the body of the leaflet moves during the working cycle of the valve. This placement of the contact region 126 of each commissure tab assembly 130 at the inner surface 108 (or in close proximity to the inner surface 108) maximizes the opening of the leaflets 124 by: the main body 143 of the leaflet 124 and/or the outflow edge 134 is allowed to contact the inner surface 108 of the frame 102 when the leaflet 124 is in the open configuration. Thus, when the valve structure 122 is in an open state (e.g., during systole), the leaflets 124 open wider than is typically permitted with known valves.

Generally, prosthetic valves can include one or more skirts or sealing members, such as an inner skirt mounted on an inner surface of the frame. These inner skirts often serve as a way to protect the leaflets from damage (e.g., abrasion) caused by contact with the frame when the prosthetic valve is radially compressed and during the working cycle of the prosthetic valve. However, wear that typically affects prosthetic leaflets can be negligible in smaller diameter valves (e.g., 20mm or less). Referring to fig. 1 and 4, when leaflets 124 open under the flow of blood, leaflets 124 can be circumferentially disposed along inner surface 108 of frame 102 without an inner skirt between leaflets 124 and frame 102 due to a small diameter 138 (e.g., 20mm or less) of valve 100. Thus, and in conjunction with the placement of commissure tab assembly 130, leaflets 124 can be in contact or intimate contact with frame 102 by omitting the inner skirt that lines between leaflets 124 and inner surface 108 of frame 102, thereby allowing the leaflets to open wider than would normally be allowed.

In some embodiments, it may be further desirable to omit the inner skirt from the prosthetic valve 100 to prevent or minimize tissue ingrowth within the interior of the frame 102. Moreover, as shown in fig. 1 and 3, it may also be desirable to omit any fabric components on or near the commissure components 130 to prevent or minimize tissue ingrowth that can initiate at the commissures and diffuse inward through the openings 120 of the frame. For example, tissue ingrowth extending into the interior of frame 102 and onto the inner skirt can prevent full opening of leaflets 124 during systole, increasing the pressure gradient across the valve. In some embodiments, prosthetic valve 100 does not include a fabric component within the interior of frame 102, on commissure tab assemblies 130, and/or at least in regions of the frame interior that can contact the movable portions of leaflets 124 to avoid tissue ingrowth at those regions of the prosthetic valve.

As shown in fig. 13 and 14, the prosthetic valve 100 can also include an outer skirt 154 mounted on the outer surface 110 of the frame 102. In embodiments where the inner skirt or fabric is omitted from the frame 102 and the commissure lug assembly 130 and/or on the frame 102 and the commissure lug assembly 130, the outer skirt 154 can serve as a sealing member for the prosthetic valve 100 by: sealing against the tissue of the native annulus and helping to reduce paravalvular leakage past the prosthetic valve. Outer skirt 154 can be formed from any of a variety of suitable biocompatible materials, including any of a variety of synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). Outer skirt 154 can be mounted to frame 102 using stitches, adhesives, welding, and/or other means for attaching outer skirt 154 to frame 102.

Fig. 15 illustrates a delivery device 500 that can be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of fig. 1 or any of the other prosthetic heart valves disclosed herein), according to an embodiment. In some embodiments, the delivery device 500 is particularly suitable for use when introducing a prosthetic valve into the heart.

The delivery apparatus 500 in the illustrated embodiment of fig. 15 is a balloon catheter that includes a handle 502 and a steerable outer shaft 504 extending distally from the handle 502. Delivery apparatus 500 can further include a middle shaft 506 (which can also be referred to as a balloon shaft), middle shaft 506 extending proximally from handle 502 and distally from handle 502, the portion extending distally from handle 502 also extending coaxially through outer shaft 504. Additionally, the delivery apparatus 500 can further include an inner shaft 508, the inner shaft 508 extending distally from the handle 502 coaxially through the intermediate shaft 506 and the outer shaft 504, and extending proximally from the handle 502 coaxially through the intermediate shaft 506.

The outer shaft 504 and the intermediate shaft 506 can be configured to translate (e.g., move) longitudinally relative to each other along a central longitudinal axis 520 of the delivery apparatus 500 to facilitate delivery and positioning of the prosthetic valve at an implantation site in a patient's body.

The middle shaft 506 can include a proximal end portion 510, the proximal end portion 510 extending proximally from the proximal end of the handle 502 to an adapter 512. A rotatable knob 514 can be mounted on the proximal end portion 510 and can be configured to rotate the intermediate shaft 506 about the central longitudinal axis 520 and relative to the outer shaft 504.

The adapter 512 can include a first port 538 configured to receive a guidewire therethrough and a second port 540 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 540 can be fluidly coupled to the inner lumen of the intermediate shaft 506.

The intermediate shaft 506 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 504 when the distal end of the outer shaft 504 is positioned distal to the inflatable balloon 518 of the delivery apparatus 500. A distal end portion of the inner shaft 508 can extend distally beyond a distal end portion of the intermediate shaft 506.

The balloon 518 can be coupled to the distal portion of the intermediate shaft 506.

In some embodiments, the distal end of the balloon 518 can be coupled to a distal end of the delivery device 500, such as a nose cone 522 (as shown in fig. 15) or an alternative component (e.g., a distal shoulder) at the distal end of the delivery device 500. The middle portion of the balloon 518 can overlap a valve mounting portion 524 of the distal portion of the delivery device 500, and the distal portion of the balloon 518 can overlap a distal shoulder 526 of the delivery device 500. The valve mounting portion 524 and the intermediate portion of the balloon 518 can be configured to receive the prosthetic heart valve in a radially compressed state. For example, as schematically shown in fig. 15, a prosthetic heart valve 550 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 518 at the valve mounting portion 524 of the delivery device 500.

The balloon shoulder assembly (including the distal shoulder 526) is configured to maintain the prosthetic heart valve 550 (or other medical device) at a fixed position on the balloon 518 during delivery through the vasculature of a patient.

The outer shaft 504 can include a distal tip portion 528 mounted on a distal end thereof. When the prosthetic valve 550 is mounted on the valve mounting portion 524 in a radially compressed state (as shown in fig. 15) and during delivery of the prosthetic valve to the target implantation site, the outer shaft 504 and the intermediate shaft 506 are axially translatable relative to each other to position the distal tip portion 528 near the proximal end of the valve mounting portion 524. Thus, the distal tip portion 528 can be configured to prevent movement of the prosthetic valve 550 relative to the balloon 518 proximally in the axial direction relative to the balloon 518 when the distal tip portion 528 is disposed proximally of the valve mounting portion 524.

An annular space can be defined between an outer surface of inner shaft 508 and an inner surface of intermediate shaft 506, and can be configured to receive fluid from a fluid source via second port 540 of adapter 512. The annular space can be fluidly coupled to a fluid channel formed between an outer surface of the distal portion of the inner shaft 508 and an inner surface of the balloon 518. Thus, fluid from the fluid source can flow from the annular space to the fluid channel to inflate the balloon 518 and radially expand and deploy the prosthetic valve 550.

The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 500 to the target implantation site.

The handle 502 can include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 500. In the illustrated embodiment, for example, the handle 502 includes an adjustment member, such as the illustrated rotatable knob 560, which in turn is operatively coupled to a proximal portion of a pull wire (pull wire). The pull wire can extend distally from the handle 502 through the outer shaft 504 and have a distal end portion affixed to the outer shaft 504 at or near the distal end of the outer shaft 504. Rotating the knob 560 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal portion of the delivery device 500. Further details regarding the steering or flexing mechanism for the delivery device can be found in U.S. patent No. 9,339,384, which is incorporated herein by reference.

The handle 502 can further include an adjustment mechanism 561 including an adjustment member (such as the illustrated rotatable knob 562) and an associated locking mechanism including another adjustment member configured as a rotatable knob 578. The adjustment mechanism 561 is configured to adjust the axial position of the intermediate shaft 506 relative to the outer shaft 504 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 500 can be found in U.S. provisional application nos. 63/069,567 and 63/138,890, which are incorporated herein by reference.

General considerations of

It should be noted that the disclosed embodiments can be adapted for implantation and delivery of prosthetic devices in any of the native annuli of the heart (e.g., aortic, pulmonary, mitral, and tricuspid annuli), and can be used with any of a variety of delivery devices for delivering prosthetic valves using any of a variety of delivery methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

For purposes of description, certain aspects, advantages, and novel features of embodiments of the disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with one another. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. Techniques from any example may be used in combination with techniques described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

Although the operations of some disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular order is required by specific language set forth herein. For example, in some cases, operations described sequentially may be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the description sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and may be readily discerned by one of ordinary skill in the art.

As used herein, with reference to a prosthetic heart valve and transcatheter delivery device apparatus, "proximal" refers to a location, direction, or portion of a component of the handle of the delivery apparatus that is closer to the user and outside the patient, while "distal" refers to a location, direction, or portion of a component that is further from the user and the handle and closer to the implantation site. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless expressly defined otherwise.

As used in this application and the claims, the singular forms "a", "an" and "the" include the plural forms unless the context clearly dictates otherwise. In addition, the term "comprising" means "including". Furthermore, the terms "coupled" and "connected" generally refer to an electrical, electromagnetic, and/or physical (e.g., mechanical or chemical) coupling or coupling and, in the absence of a specific contrary language, do not exclude the presence of intermediate elements between coupled or associated items.

Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms may be used, such as "inboard", "outboard", "top", "down", "inner", "outer", and the like. Such terms are used to provide some clarity of description when applicable, particularly with respect to the illustrated embodiments, when dealing with relative relationships. However, such terms are not intended to imply absolute relationships, orientations, and/or orientations. For example, for an object, the object may be turned over, and "up" may be changed to "down". However, it is still the same part and the object is still the same. As used herein, "and/or" means "and" or "as well as" and "or".

Additional examples of the disclosed technology

In view of the above-described embodiments of the disclosed subject matter, the present application discloses additional examples that are listed below. It should be noted that more than one feature of an example, taken alone or in combination and optionally in combination with one or more features of one or more other examples, is also other examples that fall within the disclosure of the present application.

Example 1: a prosthetic heart valve, comprising: an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure support members external to the frame; and a plurality of quadrilateral valve leaflets, each quadrilateral valve leaflet having a body with an inflow edge and an outflow edge and a pair of opposing leaflet ears extending from opposite sides of the body, each leaflet ear mated with an adjacent leaflet ear of an adjacent leaflet, each pair of leaflet ears extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure lug assembly, wherein each commissure lug assembly is located on the exterior of the frame and the body of each leaflet is located on the interior of the frame; wherein the inflow edge of the leaflet and the inflow end of the frame are aligned and the outflow edge of the leaflet is axially offset from the outflow end of the frame along the longitudinal axis.

Example 2: the prosthetic heart valve of any example herein (particularly example 1), wherein each leaflet tab is circumferentially wrapped around the respective commissure support members.

Example 3: the prosthetic heart valve of any example herein (specifically any of examples 1-2), wherein each leaflet lug forms a first fold extending radially outward from the body of the respective leaflet, a second fold extending circumferentially along an inner surface of the respective commissure support member, and a third fold extending circumferentially along an outer surface of the commissure support member.

Example 4: the prosthetic heart valve of any example herein (particularly example 3), wherein the first fold of each pair of leaflet tabs extends through a respective opening of the frame.

Example 5: the prosthetic heart valve of any example herein (specifically any of examples 3-4), wherein each leaflet tab is secured to a respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support members, and the third fold of the leaflet tab.

Example 6: the prosthetic heart valve of any example herein (specifically example 5), wherein each commissure support comprises a plurality of apertures through which the one or more sutures extend.

Example 7: the prosthetic heart valve of any example herein (specifically any of examples 1-6), wherein each leaflet tab has an outflow edge axially offset from the outflow edge of the body of the leaflet and an inflow edge axially offset from the inflow edge of the body of the leaflet.

Example 8: the prosthetic heart valve of any example herein (specifically any of examples 1-7), wherein each commissure tab assembly is coupled to the outer surface of the frame by one or more sutures.

Example 9: the prosthetic heart valve of any example herein (specifically any of examples 1-8), wherein for each commissure lug assembly, the commissure support members have a height that is greater than a height of the respective frame opening through which the pair of leaflet lugs extend.

Example 10: the prosthetic heart valve of any example herein (specifically any of examples 1-9), wherein for each commissure tab assembly, the commissure support members have a width that is greater than a width of the respective frame opening through which the pair of leaflet tabs extend.

Example 11: the prosthetic heart valve of any example herein (specifically any of examples 1-10), wherein the opening of the frame is defined by a row of angular struts of the frame.

Example 12: the prosthetic heart valve of any example herein (particularly example 11), wherein the openings of the frame are arranged in circumferentially-extending rows of openings, the circumferentially-extending rows comprising a first row at the inflow end of the frame and a second row at the outflow end of the frame.

Example 13: the prosthetic heart valve of any example herein (specifically example 12), wherein the openings have the same size for each row of openings.

Example 14: the prosthetic heart valve of any example herein (specifically any one of examples 12-13), wherein a majority of each opening of the second row is uncovered by the leaflet when the leaflet is in an open position.

Example 15: the prosthetic heart valve of any example herein (specifically any one of examples 1-14), further comprising an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, the outer skirt extending along the outer surface of the frame from the first end toward the second end.

Example 16: the prosthetic heart valve of any example herein (specifically any one of examples 1-15), wherein the frame has a diameter of less than 23 millimeters and a height of between 15 millimeters and 18 millimeters.

Example 17: the prosthetic heart valve of any example herein (specifically example 16), wherein the frame has a diameter of 20 millimeters or less.

Example 18: the prosthetic heart valve of any example herein (specifically any one of examples 1-17), wherein the leaflets have a height greater than or equal to 11 millimeters.

Example 19: the prosthetic heart valve of any example herein (specifically any one of examples 1-18), wherein the leaflets have a minimum height of 11 millimeters and the frame has a diameter of 20 millimeters or less and a height between 15 millimeters and 18 millimeters.

Example 20: the prosthetic heart valve of any example herein (specifically any of examples 1-19), wherein the frame has a diameter to height ratio of between about 1.24 and about 1.34.

Example 21: the prosthetic heart valve of any example herein (specifically any one of examples 1-20), wherein the diameter of the frame and the height of the leaflet have a diameter-to-height ratio of between about 1.61 and about 1.71.

Example 22: the prosthetic heart valve of any example herein (specifically any one of examples 1-21), wherein the height of the frame and the height of the leaflets have a frame-to-leaflet height ratio of between about 1.24 and about 1.34.

Example 23: the prosthetic heart valve of any example herein (specifically any of examples 1-22), wherein each opening of the frame between the outflow edge of the leaflet and the outflow end of the frame has a maximum width equal to or greater than 2 millimeters.

Example 24: a prosthetic heart valve, comprising: an annular frame having an inflow end, an outflow end, a plurality of openings, and a longitudinal axis; a plurality of commissure support members, each commissure support member having an outer surface and an inner surface; and a plurality of valve leaflets, each valve leaflet having a body with an inflow edge and an outflow edge and a pair of opposing leaflet tabs extending from opposite sides of the body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, wherein each pair of leaflet tabs extends through a respective opening of the frame and is coupled to one of the commissure supports outside the frame to form a commissure tab assembly; wherein each leaflet tab forms a first fold extending radially outward from the body of the respective leaflet through the respective opening of the frame, a second fold extending circumferentially between an inner surface of the respective support member and an outer surface of the frame, and a third fold extending circumferentially along the outer surface of the support member.

Example 25: the prosthetic heart valve of any example herein (particularly example 24), wherein each of the leaflets is configured to open under fluid pressure such that the outflow edges of the leaflets contact the frame.

Example 26: the prosthetic heart valve of any example herein (particularly any of examples 24-25), wherein each commissure support member comprises a rectangular plate having flat and parallel inner and outer surfaces.

Example 27: the prosthetic heart valve of any example herein (specifically any of examples 24-26), wherein each leaflet tab is secured to a respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support members, and the third fold of the leaflet tab.

Example 28: the prosthetic heart valve of any example herein (specifically example 27), wherein each commissure support comprises a plurality of apertures through which the one or more sutures extend.

Example 29: the prosthetic heart valve of any example herein (specifically any of examples 24-28), wherein for each commissure lug assembly, the commissure support members have a height that is greater than a height of the respective frame opening through which the pair of leaflet lugs extend.

Example 30: the prosthetic heart valve of any example herein (specifically any of examples 24-29), further comprising an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, the outer skirt extending along the outer surface of the frame from the first end to the second end.

Example 31: the prosthetic heart valve of any example herein (particularly example 30), wherein the outer skirt partially covers the commissure lug assembly.

Example 32: the prosthetic heart valve of any example herein (particularly any of examples 24-31), wherein the inflow edge of the leaflet is coupled to the inflow end of the frame by one or more sutures extending through the leaflet and around struts of the frame defining the inflow end of the frame.

Example 33: the prosthetic heart valve of any example herein (specifically any of examples 24-32), wherein the prosthetic heart valve is devoid of any fabric material inside the frame.

Example 34: the prosthetic heart valve of any example herein (specifically any of examples 24-33), wherein the commissure components are devoid of any fabric material.

Example 35: the prosthetic heart valve of any example herein (particularly any of examples 24-34), wherein the outflow edges of the leaflets are axially offset from the outflow end of the frame along the longitudinal axis.

Example 36: the prosthetic heart valve of any example herein (particularly example 35), wherein the openings of the frame are arranged in circumferentially-extending rows of openings, the circumferentially-extending rows comprising a first row at the inflow end of the frame and a second row at the outflow end of the frame.

Example 37: the prosthetic heart valve of any example herein (particularly example 36), wherein the outflow edge of the leaflet lies upstream of a plane that is perpendicular to the longitudinal axis and that bisects the openings of the second row of openings.

Example 38: the prosthetic heart valve of any example herein (particularly any of examples 24-37), wherein the leaflets are quadrilateral in shape.

Example 39: the prosthetic heart valve of any example herein (specifically example 38), wherein each leaflet is rectangular in shape and has a width greater than a height.

Example 40: a prosthetic heart valve, comprising: an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure support members external to the frame; and a plurality of valve leaflets, each valve leaflet having a body with an inflow edge and an outflow edge and a pair of opposing leaflet ears extending from opposite sides of the body, each leaflet ear mated with an adjacent leaflet ear of an adjacent leaflet, each pair of leaflet ears extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure ear assembly, wherein each commissure ear assembly is located on the exterior of the frame and the body of each leaflet is located on the interior of the frame; wherein for each commissure lug assembly, the commissure support members have a height that is greater than a height of the respective frame opening through which the pair of leaflet lugs extend.

Example 41: the prosthetic heart valve of any example herein (specifically example 40), wherein each leaflet tab forms a first fold extending radially outward from the body of the respective leaflet, a second fold extending circumferentially along an inner surface of the respective commissure support member, and a third fold extending circumferentially along an outer surface of the commissure support member.

Example 42: the prosthetic heart valve of any example herein (specifically example 41), wherein the first fold of each pair of leaflet tabs extends through a respective opening of the frame.

Example 43: the prosthetic heart valve of any example herein (specifically any of examples 41-42), wherein each leaflet tab is secured to a respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support members, and the third fold of the leaflet tab.

Example 44: the prosthetic heart valve of any example herein (specifically example 43), wherein each commissure support comprises a plurality of apertures through which the one or more sutures extend.

Example 45: the prosthetic heart valve of any example herein (particularly any of examples 40-44), wherein the inflow edge of the leaflet and the inflow end of the frame are aligned and the outflow edge of the leaflet is axially offset from the outflow end of the frame along the longitudinal axis.

Example 46: the prosthetic heart valve of any example herein (specifically any of examples 40-45), wherein the frame comprises a row of openings bounded by a row of struts of the frame defining the outlet end of the frame, and the outflow edge of the leaflet is upstream of a majority of each opening in the row.

Example 47: the prosthetic heart valve of any example herein (particularly any of examples 40-46), wherein the frame has a diameter of less than 23 millimeters and a height of between 15 millimeters and 18 millimeters.

Example 48: the prosthetic heart valve of any example herein (specifically example 47), wherein the frame has a diameter of 20 millimeters or less.

Example 49: the prosthetic heart valve of any example herein (specifically any of examples 40-48), wherein the leaflets have a height greater than or equal to 11 millimeters.

Example 50: the prosthetic heart valve of any example herein (specifically any of examples 40-49), wherein the leaflets have a minimum height of 11 millimeters and the frame has a diameter of 20 millimeters or less and a height between 15 millimeters and 18 millimeters.

Example 51: the prosthetic heart valve of any example herein (specifically any of examples 40-50), wherein the leaflets are quadrilateral in shape.

Example 52: the prosthetic heart valve of any example herein (specifically example 51), wherein each leaflet is rectangular in shape and has a width greater than a height.

Example 53: a leaflet assembly for a prosthetic heart valve, comprising: a plurality of valve leaflets, each leaflet comprising a body having an inflow edge and an outflow edge and opposing commissure lugs extending from opposing sides of the body; and a plurality of commissure support members, each having a pair of opposing faces; wherein each commissure lug mates with an adjacent commissure lug of an adjacent leaflet, and for each pair of commissure lugs, the commissure lugs are partially wrapped around and coupled to the opposing face of one of the support members to form a commissure assembly.

Example 54: the leaflet assembly of any example herein (specifically example 53), wherein each commissure lug forms a first fold extending radially outward from the body of the respective leaflet, a second fold extending circumferentially along an inner surface of the respective commissure support member, and a third fold extending circumferentially along an outer surface of the commissure support member.

Example 55: the leaflet assembly of any example herein (specifically example 54), wherein each commissure tab is secured to the respective commissure support member with one or more sutures extending through the second fold of the commissure tab, the commissure support members, and the third fold of the commissure tab.

Example 56: the leaflet assembly of any example herein (specifically example 55), wherein each commissure support comprises a plurality of apertures through which the one or more sutures extend.

Example 57: the leaflet assembly of any example herein (specifically example 56), wherein the apertures are arranged in a two-column configuration.

Example 58: the leaflet assembly of any example herein (specifically example 56), wherein the leaflet assembly is arranged in a single row configuration.

Example 59: the leaflet assembly of any example herein (specifically any one of examples 53-58), wherein the valve leaflet is made from a discrete (discrete) pericardium.

Example 60: the leaflet assembly of any example herein (specifically any of examples 53-58), wherein the valve leaflet is a section of monolithic pericardium.

Example 61: the leaflet assembly of any example herein (specifically any one of examples 53-60), wherein the leaflet is quadrilateral in shape.

Example 62: the leaflet assembly 61 according to any example herein (particularly any one of the examples), wherein each leaflet is rectangular in shape and has a width that is greater than a height.

Example 63: a method of assembling a prosthetic heart valve, comprising: forming a leaflet assembly from a plurality of leaflets, each leaflet comprising opposing commissure lugs, wherein the leaflet assembly is formed by mating the commissure lugs of each leaflet with adjacent commissure lugs of an adjacent leaflet and connecting each pair of commissure lugs to a commissure support member to form a respective commissure assembly of the leaflet assembly; positioning the leaflet assembly within an interior of an expandable annular frame, wherein the frame defines a plurality of openings; and inserting each of the commissure components through a respective opening of the frame to position the commissure components on an exterior of the frame.

Example 64: the method of any example herein (specifically example 63), wherein inserting each of the commissure components of the leaflet assembly through the respective opening of the frame further comprises: deforming each of the commissure components from a first position to a second position relative to the body of the leaflet such that the commissure components are in a deformed orientation in the second position; inserting each of the commissure components in the second position through the respective opening of the frame such that each commissure support member is positioned entirely on the exterior of the frame; and moving each of the commissure components from the second position back to the first position after inserting each commissure component through the respective opening.

Example 65: the method of any example herein (specifically any one of examples 63-64), wherein positioning the leaflet assembly within the interior of the frame further comprises: aligning an inflow edge of the leaflet assembly with an inflow end of the frame; and positioning an outflow edge of the leaflet assembly between the inflow end and an outflow end of the frame.

Example 66: the method of any example herein (specifically example 65), further comprising stitching the inflow edge of the leaflet to a strut of the frame at the inflow end of the frame.

Example 67: the method of any example herein (particularly any one of examples 63-66), wherein the leaflets are quadrilateral in shape.

Example 68: the method of any example herein (specifically example 67), wherein each leaflet is rectangular in shape and has a width greater than a height.

Example 69: the method of any example herein (specifically any one of examples 63-68), wherein connecting each pair of commissure lugs to a commissure support member to form a respective commissure assembly comprises: folding each commissure lug of the pair to form a first fold against a first side of the commissure support member and a second fold against a second side of the commissure support member; and stitching the first and second folds to the commissure support members.

Example 70: the method of any example herein (specifically any one of examples 63-69), wherein each commissure support member has a size that is larger than a size of a respective frame opening through which the commissure support member is inserted to prevent the commissure assembly from being pulled inward into the frame after the commissure assembly is positioned outside of the frame.

In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the appended claims. I therefore claim my invention that is within the scope and spirit of these claims.

Claims (29)

1. A prosthetic heart valve, comprising:

an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis;

a plurality of commissure support members external to the frame; and

a plurality of quadrilateral valve leaflets, each quadrilateral valve leaflet having a body with an inflow edge, an outflow edge, and a pair of opposing leaflet ears extending from opposing sides of the body, each leaflet ear mated with an adjacent leaflet ear of an adjacent leaflet, each pair of leaflet ears extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure lug assembly, wherein each commissure lug assembly is located on the exterior of the frame and the body of each leaflet is located on the interior of the frame;

wherein the inflow edge of the leaflet and the inflow end of the frame are aligned and the outflow edge of the leaflet is axially offset from the outflow end of the frame along the longitudinal axis.

2. The prosthetic heart valve of claim 1, wherein each leaflet tab is wrapped circumferentially around the respective commissure support members.

3. The prosthetic heart valve of any preceding claim, wherein each leaflet tab forms a first fold extending radially outward from the body of the respective leaflet, a second fold extending circumferentially along an inner surface of the respective commissure support member, and a third fold extending circumferentially along an outer surface of the commissure support member.

4. The prosthetic heart valve of claim 3, wherein the first fold of each pair of leaflet tabs extends through a respective opening of the frame.

5. The prosthetic heart valve of any of claims 3-4, wherein each leaflet tab is secured to the respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support members, and the third fold of the leaflet tab.

6. The prosthetic heart valve of any preceding claim, wherein each leaflet tab has an outflow edge axially offset from the outflow edge of the body of the leaflet and an inflow edge axially offset from the inflow edge of the body of the leaflet.

7. The prosthetic heart valve of any preceding claim, wherein each commissure tab assembly is coupled to the outer surface of the frame by one or more sutures.

8. The prosthetic heart valve of any preceding claim, wherein for each commissure tab assembly, the commissure support members have a height that is greater than a height of the respective frame opening through which the pair of leaflet tabs extend.

9. The prosthetic heart valve of any preceding claim, wherein for each commissure tab assembly, the commissure support members have a width that is greater than a width of the respective frame opening through which the pair of leaflet tabs extend.

10. The prosthetic heart valve of any preceding claim, wherein the openings of the frame are arranged in circumferentially extending rows of openings, the circumferentially extending rows comprising a first row at the inflow end of the frame and a second row at the outflow end of the frame.

11. The prosthetic heart valve of claim 10, wherein a majority of the openings of the second row are uncovered by the leaflets when the leaflets are in an open position.

12. A prosthetic heart valve, comprising:

an annular frame having an inflow end, an outflow end, and a plurality of openings;

a plurality of commissure support members, each commissure support member having an outer surface and an inner surface; and

a plurality of valve leaflets, each valve leaflet having a body with an inflow edge, an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, wherein each pair of leaflet tabs extends through a respective opening of the frame and is coupled to one of the commissure supports outside the frame to form a commissure tab assembly;

wherein each leaflet tab forms a first fold extending radially outward from the body of the respective leaflet through the respective opening of the frame, a second fold extending circumferentially between an inner surface of the respective support member and an outer surface of the frame, and a third fold extending circumferentially along the outer surface of the support member.

13. The prosthetic heart valve of claim 12, each leaflet configured to open under fluid pressure such that the outflow edge of the leaflet contacts the frame.

14. The prosthetic heart valve of any of claims 12-13, wherein each commissure support member comprises a rectangular plate having flat and parallel inner and outer surfaces.

15. The prosthetic heart valve of any of claims 12-14, wherein each leaflet tab is secured to the respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support members, and the third fold of the leaflet tab.

16. The prosthetic heart valve of claim 15, wherein each commissure support comprises a plurality of apertures through which the one or more sutures extend.

17. The prosthetic heart valve of any of claims 12-16, further comprising an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, the outer skirt extending along the outer surface of the frame from the first end to the second end.

18. The prosthetic heart valve of claim 17, wherein the outer skirt partially covers the commissure lug assembly.

19. The prosthetic heart valve of any of claims 12-18, wherein the prosthetic heart valve is devoid of any fabric material inside the frame.

20. The prosthetic heart valve of any of claims 12-19, wherein the commissure components are devoid of any fabric material.

21. The prosthetic heart valve of any of claims 12-20, wherein the valve leaflets are made from discrete pieces of pericardium.

22. The prosthetic heart valve of any of claims 12-20, wherein the valve leaflets are sections of a unitary piece of pericardium.

23. A method of assembling a prosthetic heart valve, comprising:

forming a leaflet assembly from a plurality of leaflets, each leaflet comprising opposing commissure lugs, wherein the leaflet assembly is formed by mating the commissure lugs of each leaflet with adjacent commissure lugs of an adjacent leaflet and connecting each pair of commissure lugs to a commissure support member to form a respective commissure assembly of the leaflet assembly;

positioning the leaflet assembly within an interior of an expandable annular frame, wherein the frame defines a plurality of openings; and

inserting each of the commissure components through a respective opening of the frame to position the commissure components on an exterior of the frame.

24. The method of claim 23, wherein inserting each of the commissure components of the leaflet assembly through the respective opening of the frame further comprises:

deforming each of the commissure components from a first position to a second position relative to the body of the leaflet such that the commissure components are in a deformed orientation in the second position;

inserting each of the commissure components in the second position through the respective opening of the frame such that each commissure support member is positioned entirely on the exterior of the frame; and

moving each of the commissure components from the second position back to the first position after inserting each commissure component through the respective opening.

25. The method of any of claims 23-24, wherein positioning the leaflet assembly within the interior of the frame further comprises:

aligning an inflow edge of the leaflet assembly with an inflow end of the frame; and

positioning an outflow edge of the leaflet assembly between the inflow end and an outflow end of the frame.

26. The method of claim 25, further comprising stitching the inflow edge of the leaflet to struts of the frame at the inflow end of the frame.

27. The method of any of claims 23-26, wherein the leaflets are quadrilateral in shape.

28. The method of any one of claims 23-27, wherein connecting each pair of commissure lugs to a commissure support member to form a respective commissure assembly comprises:

folding each commissure lug of the pair to form a first fold against a first side of the commissure support member and a second fold against a second side of the commissure support member; and

stitching the first and second folds to the commissure support members.

29. The method of any of claims 23-28, wherein each commissure support member has a size larger than a size of a respective frame opening through which the commissure support member is inserted to prevent the commissure assemblies from being pulled inward into the frame after the commissure assemblies are positioned outside of the frame.