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.
Accordingly, a need exists for improved prosthetic heart valve leaflet assemblies, and methods for assembling leaflets to a frame of a prosthetic heart valve.
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.
In one 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, 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.
The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
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. For example, operations described sequentially may in some cases 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. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
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.
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 U.S. Publication No. 2017/0231756, which is incorporated by reference herein. 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 PCT Publication No. WO2020/247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated herein by reference.
The prosthetic heart valve 10 can include an annular stent or frame 12 having a first end 14 and a second end 16. In the depicted embodiment, the first end 14 is an inflow end and the second end 16 is an outflow end. The outflow end 16 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 16 is the proximal-most end of the prosthetic valve. In other embodiments, the inflow end 14 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 14 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 12 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
In the illustrated embodiment, the struts 28 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 28 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 28 overlap each other via fasteners or pivot members, such as rivets or pins 30 that extend through the apertures. The hinges can allow the struts 28 to pivot relative to one another as the frame 12 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic heart valve 10. In some embodiments, a pivot joint can comprise a rivet or pin 30 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 30 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.
In some embodiments, the frame 12 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 U.S. Pat. Application Publication Nos. 2018/0153689, 2018/0344456, 2019/0060057, and 2019/0105153, and U.S. Pat. Application Nos. 16/788,090, filed Feb. 11, 2020, and 62/945,000, filed Dec. 6, 2019, all of which are incorporated herein by reference.
In other embodiments, the struts 28 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 12. For example, the frame 12 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 U.S. Pat. No. 9,393,110 and U.S. Publication No. 2018/0028310, which are incorporated herein by reference.
The prosthetic heart valve 10 can also include a valvular structure 18 which is coupled to the frame 12 and configured to regulate the flow of blood through the prosthetic heart valve 10 from the inflow end 14 to the outflow end 16. The prosthetic heart valve 10 can further include a plurality of actuators 80 mounted to and equally spaced around the inner surface of the frame 12. 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 80 are linear actuators, each of which comprises an inner member, or piston, 90 and an outer member, or cylinder, 92. The inner member 90 is pivotably coupled to a junction of the frame, such as at the first end 14, while the outer member 92 is pivotably coupled to another junction of the frame closer to the second end 16. Moving the inner member 90 proximally relative to the outer member 92 and/or moving the outer member 92 distally relative to the inner member 90 is effective to radially expand the prosthetic valve. Conversely, moving the inner member 90 distally relative to the outer member 92 and/or moving the outer member 92 proximally relative to the inner member 90 is effective to radially compress the prosthetic valve. The actuators 80 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 80 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 80 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 U.S. Pat. Application Publication Nos. 2018/0153689, 2019/0060057 and 2018/0325665, U.S. Application No. 62/990,299, filed Mar. 16, 2020, and PCT Application No. PCT/US2021/022467, filed Mar. 16, 2021, each of which is incorporated herein by reference in its entirety. Any of the actuators and locking mechanisms disclosed in the previously filed applications can be incorporated in any of the prosthetic valves disclosed herein. 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 80 can be used to support a respective commissure 24 (described below). As such, the actuators 80 can include commissure support portions for supporting and attaching commissures 24 of the valvular structure 18 to the frame 12, as described further herein.
The valvular structure 18 can include, for example, a leaflet assembly comprising one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 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 22 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 10. The commissure tabs of adjacent leaflets 22 can be arranged to form commissures 24, which can be, for example, mounted to commissure support portions of respective actuators 80.
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 U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,252,202, U.S. Publication Nos. 2018/0325665, 2019/0105153, and 2019/0192296, U.S. Pat. Application Nos. 62/797,837, filed Jan. 28, 2019, 62/823,905, filed Mar. 26, 2019, 62/854,702, filed May 30, 2019, 62/928,993, filed Oct. 31, 2019, 62/959,723, filed Jan. 10, 2020, 62/971,011, filed Feb. 6, 2020, 62/985,558, filed Mar. 5, 2020, and 62/960,838, filed Jan. 14, 2020, and PCT Application Nos. PCT/US2019/61392, filed Nov. 14, 2019, PCT/US2020/18664, filed Feb. 18, 2020, all of which are incorporated herein by reference in their entireties.
In some embodiments, as shown in
The prosthetic heart valve 10 can also include one or more skirts or sealing members. For example, as shown in
The prosthetic heart valve 10 can also include an outer skirt mounted on the outer surface of the frame 12 (not shown in
The leaflet 100 can include commissure tabs 112 and 114, extending from opposite sides of the main body 102. 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 110 extends across the leaflet 100, between the commissure tabs 112 and 114.
A curved edge portion 116, 118 extends between and connects a corresponding one of the commissure tabs 112 and 114 and a corresponding one of the first and second cusp edge portions 104 and 106. Each curved edge portion 116, 118 defines an open region on either side of the leaflet 100, referred to herein as a window or notch 120, 122.
As shown in
In some embodiments, a shape of the leaflet 100 can be configured such that the commissure tabs 112 and 114 are angled relative to the axial direction which is parallel with the centerline 124 extending through a center of the leaflet 100, between the outflow edge portion 110 and the inflow end portion 108. For example, as shown in
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 U.S. Application No. 63/024,951, filed May 14, 2020, which is incorporated herein by reference. By selecting the angle θ to match or be close to matching (e.g., within 5-10% or within 5% 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 120 and 122 and/or neck regions 130 and 132 of the leaflet 400 can be selected to maximize a width of the leaflet 100 at each neck region 130, 132, while also minimizing a surface area of each window 120, 122. Each neck region 130, 132 is defined between a corresponding one of the commissure tabs 112 and 114 and the main body 102 of the leaflet 100. For example, in some embodiments, a width 134 of each neck region 130 and 132 and a window width 136 of each window 120 and 122 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 100.
In some embodiments, the commissure tabs 112 and 114 can include a plurality of columns or lines of apertures 138, 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
As further shown in
Other leaflet configurations that may be implemented in any of the prosthetic valves disclosed herein are described in U.S. Publication No. 2018/0028310 and U.S. Application No. 62/978,455, filed Feb. 19, 2020, which are incorporated herein by reference.
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
A reinforcing element 232, 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 232 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 250 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 232, a first portion on a first side of a support strip (e.g., a flexible cloth/fabric) 230, 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 230, and a second portion of the reinforcing element 232. 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
The support strip (e.g., support strip 230 of
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 232 of
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 250 may only pass through a single layer of the support strip 230 on either side of the support strip (e.g., a respective layer of the support strip that is positioned between the reinforcing element 232 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 230 may be further folded over respective portions of the reinforcing element 232 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
Additional, secondary sutures 260a and 260b may be used to secure the folded support strip to the commissure tabs as shown in
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 210 of
As shown in
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 270). For example, an additional reinforcing suture 266 may be extended around a larger region of the support strip (e.g., support strip 230 of
As further shown in
As shown in
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 266 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 266 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
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
The suture loops may be stitched together at a respective end by a knot 368 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 U.S. Application No. 62/985,558, filed Mar. 5, 2020, which is incorporated herein by reference.
The prosthetic valve 400 includes a valvular structure to regulate the flow of blood in one direction through the frame 402. The valvular structure can comprise one or more leaflets 414, including leaflets 414a, 414b. In particular embodiments, the prosthetic valve 400 has three leaflets, such as shown in
In alternative embodiments, the commissures of the leaflets 414 can be formed and connected to the frame 402 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 404 of the frame 402. 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 402: U.S. Publication Nos. 2018/0325665, 2019/0105153, and 2019/0192296, U.S. Pat. Application Nos. 62/797,837, filed Jan. 28, 2019, 62/823,905, filed Mar. 26, 2019, 62/854,702, filed May 30, 2019, 62/928,993, filed Oct. 31, 2019, 62/959,723, filed Jan. 10, 2020, 62/971,011, filed Feb. 6, 2020, 62/985,558, filed Mar. 5, 2020, and 62/960,838, filed Jan. 14, 2020, and PCT Application Nos. PCT/US2019/61392, filed Nov. 14, 2019, PCT/US2020/18664, filed Feb. 18, 2020, all of which are incorporated herein by reference in their entireties.
In particular embodiments, each leaflet 414 has the same configuration as the leaflet 100 of
The prosthetic valve 400 can have one or more skirts or reinforcing members to connect the cusp edge portions of the leaflets 414 to the frame 402. As shown in
The assembly of the leaflets 414 and the first and second reinforcing members 420, 422 can be secured to the frame, such as with a plurality of sutures 426. Each suture 426 can extend through one or more layers of the reinforcing members 420, 422 and the leaflets and around a strut 404 or a component of an actuator 408 (such as an outer member 410). As shown in
Referring to
The first and second reinforcing members 420, 422 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 414 and the first and second reinforcing members 420, 422 can be pre-assembled prior to mounting these components to the frame 402. For example, the pre-assembled leaflet assembly can include the first and second reinforcing members 420, 422 sutured to the cusp edge portions 424 of the leaflets 414. Once formed, the leaflet assembly can be positioned inside of the frame 402 and the commissures 418 and the cusp edge portions 424 can be secured to the frame 402 as described above.
In particular embodiments, each of the first and second reinforcing members 420, 422 can be a unitary or continuous piece of material. In alternative embodiments, one or both of the reinforcing members 420, 422 can comprise a plurality of discrete pieces of material, each of which is secured to the cusp edge portion 424 of a corresponding leaflet 414. For example, if three leaflets 414 are provided, the first reinforcing member 420 can comprise three discrete sections, each of which is secured to the cusp edge portion 424 of a corresponding leaflet 414. Similarly, the second reinforcing member 422 can comprise three discrete sections, each of which is secured to the cusp edge portion 424 of a corresponding leaflet 414.
In alternative embodiments, one or both of the reinforcing members 420, 422 can comprise a wider skirt (such as skirt 20 of
It has been found that the orientation of the sub-commissure tabs 432a, 432b can affect the ability of the leaflets 414 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 414 may not fully open when the sub-commissure tabs 432a, 432b extend radially outwardly toward the frame 402, as shown in
The leaflet 100 can comprise a main body 502 with a cusp (e.g., inflow) edge portion 503 including a first (left) side cusp edge portion 504 and a second (right) side cusp edge portion 506 which connect together at an inflow-most end portion 508 of the leaflet 500. The upper end portions of the cusp edge portions 504, 506 can form sub-commissure tabs 542. The leaflet 500 can include commissure tabs 512 and 514, extending from opposite sides of the main body 502. An outflow edge portion 510 (also referred to as a coaptation edge portion) extends across the leaflet 500, between the commissure tabs 512 and 514. A curved edge portion 516, 518 extends between and connects a corresponding one of the commissure tabs 512 and 514 and a corresponding one of the first and second cusp edge portions 504 and 506. Each curved edge portion 516, 518 defines an open region on either side of the leaflet 500, referred to herein as a notch or window 520, 522.
The leaflet 500 can include upper tabs 524, 526 extending upwardly from commissure tabs 512, 514, respectively. The leaflet 500 can include notches 528 between the upper tabs 524, 526 and the commissure tabs 512, 514. Each notch 528 can extend from an inner edge 530 of a corresponding upper tab 524, 526 to a location between the inner and outer edges 530, 532 of the upper tab. In this manner, each upper tab 524, 526 is connected to a corresponding commissure tab 512, 514 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 500 can be formed without notches 528 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 512 and 514 and the upper tabs 524, 526 can include a plurality of columns or lines of apertures 538, 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
In particular embodiments, a leaflet assembly comprising a plurality of leaflets 500 can be formed. In forming the leaflet assembly, the upper tabs 524, 526 can be folded downwardly against the commissure tabs 512, 514 along horizontal fold lines 542. Each upper tab 524, 526 can be secured to a corresponding commissure tab 512, 514, such as with sutures. A support strip (e.g., support strip 230 or 330) can be sutured to each pair of commissure tabs, as previously described. One or more skirts or reinforcing members (e.g., reinforcing members 420, 422) can be sutured to the cusp edge portions of the leaflets, as previously described. Each sub-commissure tab 542 can be sutured to an adjacent sub-commissure tab 542 of an adjacent leaflet, such as shown in
When the prosthetic valve is radially expanded from a compressed (delivery) state, a small amount of slack can form along sub-commissure edge portions 516, 518, depending on the height and/or width of the windows 520, 522. As depicted in
Unlike leaflet 500, the leaflet 500′ includes additional sub-commissure tabs 554 extending laterally from the sub-commissure edge portions 516, 518 within the windows 520, 522. The sub-commissure tabs 554 can be referred to as upper sub-commissure tabs 554 while the sub-commissure tabs 542 can be referred to as lower sub-commissure tabs 542. Each sub-commissure tab 554 can be spaced from a lower edge 556 of a corresponding commissure tab 512, 514 and an upper edge 558 of a corresponding tab 542. In certain embodiments, each sub-commissure tab 554 can be positioned equidistant from the edges 556 and 558. Each sub-commissure tab 554 can be formed with one or more lines of apertures 560 for receiving sutures.
A leaflet assembly comprising a plurality of leaflets 500′ can be formed in the same manner as described above for the leaflet 500. Additionally, each sub-commissure tab 554 can be connected to an adjacent sub-commissure tab 554 of an adjacent leaflet, such as with sutures (which can extend through apertures 560). In some embodiments, the sub-commissure tabs 554 can be folded inwardly relative to the edge portions 516, 518 such that when assembled to a frame, each pair of connected sub-commissure tabs 554 extends radially inwardly toward the center of the prosthetic valve (similar to the tabs 432a, 432b of
By connecting the sub-commissure tabs 554 to each other, the formation of folds along the edge portions 516, 518 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
The width of the sub-commissure tabs 554 (in the horizontal direction in
The sub-commissure tabs 554 can be incorporated into leaflets having other overall shapes or configurations that are different than that shown in
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 U.S. Pat. No. 9,393,110 and U.S. Publication No. 2018/0028310. Examples of prosthetic heart valves that have self-expandable frames are disclosed in U.S. Pat. No. 8,652,202 and Publication No. 2016/0317301, which are incorporated herein by reference.
The delivery apparatus 700 in the illustrated embodiment generally includes a handle 704, a first elongated shaft 706 (which comprises an outer shaft in the illustrated example) extending distally from the handle 704, at least one actuator assembly 708 extending distally from the handle through the outer shaft 706, and a second elongated shaft 716 (which comprises an inner shaft in the illustrated example) extending distally from the handle through the outer shaft 706. The at least one actuator assembly 708 can be configured to radially expand and/or radially collapse the prosthetic valve 702 when actuated. A nosecone 718 can be mounted to the distal end of the second shaft 716. The second shaft 716 and the nosecone 718 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 708 for purposes of illustration, it should be understood that one actuator 708 can be provided for each actuator on the prosthetic valve. For example, three actuator assemblies 708 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 720 of the shaft 706 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 720 functions as a delivery sheath or capsule for the prosthetic valve during delivery,
The actuator assemblies 708 can be releasably coupled to the prosthetic valve 702. For example, in the illustrated embodiment, each actuator assembly 708 can be coupled to a respective actuator of the prosthetic valve 702. Each actuator assembly 708 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 708 can be at least partially disposed radially within, and extend axially through, one or more lumens of the outer shaft 706. For example, the actuator assemblies 708 can extend through a central lumen of the shaft 706 or through separate respective lumens formed in the shaft 706.
The handle 704 of the delivery apparatus 700 can include one or more control mechanisms (e.g., knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 700 in order to expand and/or deploy the prosthetic valve 702. For example, in the illustrated embodiment the handle 704 comprises first, second, and third knobs 710, 712, and 714.
The first knob 710 can be a rotatable knob configured to produce axial movement of the outer shaft 706 relative to the prosthetic valve 702 in the distal and/or proximal directions in order to deploy the prosthetic valve from the delivery sheath 720 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 710 in a first direction (e.g., clockwise) can retract the sheath 720 proximally relative to the prosthetic valve 702 and rotation of the first knob 710 in a second direction (e.g., counter-clockwise) can advance the sheath 720 distally. In other embodiments, the first knob 710 can be actuated by sliding or moving the knob 710 axially, such as pulling and/or pushing the knob. In other embodiments, actuation of the first knob 710 (rotation or sliding movement of the knob 710) can produce axial movement of the actuator assemblies 708 (and therefore the prosthetic valve 702) relative to the delivery sheath 720 to advance the prosthetic valve distally from the sheath 720.
The second knob 712 can be a rotatable knob configured to produce radial expansion and/or contraction of the prosthetic valve 702. For example, rotation of the second knob 712 can move the actuator member and the support tube axially relative to one another. Rotation of the second knob 712 in a first direction (e.g., clockwise) can radially expand the prosthetic valve 702 and rotation of the second knob 712 in a second direction (e.g., counter-clockwise) can radially collapse the prosthetic valve 702. In other embodiments, the second knob 712 can be actuated by sliding or moving the knob 712 axially, such as pulling and/or pushing the knob.
The third knob 714 can be a rotatable knob configured to retain the prosthetic heart valve 102 in its expanded configuration. For example, the third knob 714 can be operatively connected to a proximal end portion of the locking tool of each actuator assembly 708. 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 714 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 702. In other embodiments, the third knob 714 can be actuated by sliding or moving the third knob 714 axially, such as pulling and/or pushing the knob.
Although not shown, the handle 704 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 702, 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 enumerated 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.
Example 1. 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, 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; 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, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.
Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the sub-commissure tabs of each pair of sub-commissure tabs are sutured to each other.
Example 3. The prosthetic heart valve of any example herein, particularly any of examples 1-2, wherein each leaflet has a cusp edge portion extending from one sub-commissure tab to the other sub-commissure tab of the leaflet, wherein the cusp edge portion is coupled to the frame.
Example 4. The prosthetic heart valve of any example herein, particularly example 3, further comprising a first reinforcing member sutured to the cusp edge portions of the leaflets and to selected struts of the frame.
Example 5. The prosthetic heart valve of any example herein, particularly example 4, 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.
Example 6. The prosthetic heart valve of any example herein, particularly any of examples 1-5, wherein the pairs of sub-commissure tabs are not directly connected to the frame.
Example 7. The prosthetic heart valve of any example herein, particularly any of examples 1-6, 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.
Example 8. The prosthetic heart valve of any example herein, particularly any of examples 1-7, 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 each upper sub-commissure tab is paired with an adjacent upper sub-commissure tab of an adjacent leaflet and connected thereto.
Example 9. The prosthetic heart valve of any example herein, particularly example 8, wherein each pair of upper sub-commissure tabs extends radially inwardly relative to the frame.
Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein each pair of upper sub-commissure tabs extends radially outwardly toward an inner surface of the frame.
Example 11. The prosthetic heart valve of any example herein, particularly any of examples 8-10, wherein the upper sub-commissure tabs of each pair of upper sub-commissure tabs are sutured to each other.
Example 12. The prosthetic heart valve of any example herein, particularly any of examples 8-11, wherein the pairs of upper sub-commissure tabs are not directly connected to the frame.
Example 13. The prosthetic heart valve of any example herein, particularly any of examples 8-12, 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.
Example 14. The prosthetic heart valve of any example herein, particularly any of examples 1-13, wherein each leaflet has two upper tabs connected to upper edges of the commissure tabs and folded downwardly against the commissure tabs.
Example 15. The prosthetic heart valve of any example herein, particularly any of examples 1-14, wherein the frame comprises a plurality of commissure support posts, and the commissures are mounted to the commissure support posts.
Example 16. The prosthetic heart valve of any example herein, particularly example claim 15, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.
Example 17. 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.
Example 18. The method of any example herein, particularly example 17, 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.
Example 19. The method of any example herein, particularly any of examples 17-18, 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.
Example 20. The method of any example herein, particularly example 19, further comprising suturing a first reinforcing member the cusp edge portions of the leaflets and to selected struts of the frame.
Example 21. The method of any example herein, particularly example 20, 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.
Example 22. The method of any example herein, particularly any of examples 17-21, wherein the pairs of sub-commissure tabs are not directly connected to the frame.
Example 23. The method of any example herein, particularly any of examples 17-22, 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.
Example 24. The method of any example herein, particularly any of examples 17-23, 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.
Example 25. The method of any example herein, particularly example 24, wherein each pair of upper sub-commissure tabs extends radially inwardly relative to the frame.
Example 26. The method of any example herein, particularly example 24, wherein each pair of upper sub-commissure tabs extends radially outwardly toward an inner surface of the frame.
Example 27. The method of any example herein, particularly any of examples 24-26, 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.
Example 28. The method of any example herein, particularly any of examples 24-27, wherein the pairs of upper sub-commissure tabs are not directly connected to the frame.
Example 29. The method of any example herein, particularly any of examples 24-28, 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.
Example 30. The method of any example herein, particularly any of examples 17-29, 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.
Example 31. The method of any example herein, particularly any of examples 17-30, 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.
Example 32. The method of any example herein, particularly example 31, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.
Example 33. 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.
Example 34. The prosthetic heart valve of any example herein, particularly example 33, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.
Example 35. The prosthetic heart valve of any example herein, particularly example 33, wherein each pair of sub-commissure tabs extends radially outwardly toward an inner surface of the frame.
Example 36. The prosthetic heart valve of any example herein, particularly any of examples 33-35, wherein the sub-commissure tabs of each pair of sub-commissure tabs are sutured to each other.
Example 37. The prosthetic heart valve of any example herein, particularly any of examples 33-36, wherein the pairs of sub-commissure tabs and the two sub-commissure edges are not directly connected to the frame.
Example 38. The prosthetic heart valve of any example herein, particularly any of examples 33-37, 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.
Example 39. The prosthetic heart valve of any example herein, particularly any of examples 33-38, 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.
Example 40. The prosthetic heart valve of any example herein, particularly example 39, wherein the lower sub-commissure tabs of each pair of lower sub-commissure tabs are sutured to each other.
Example 41. The prosthetic heart valve of any example herein, particularly any of examples 39-40, wherein each pair of lower sub-commissure tabs extends radially inwardly relative to the frame.
Example 42. The prosthetic heart valve of any example herein, particularly any of examples 39-41, wherein the pairs of lower sub-commissure tabs are not directly connected to the frame.
Example 43. The prosthetic heart valve of any example herein, particularly any of examples 33-42, further comprising a first reinforcing member sutured to the cusp edge portions of the leaflets and to selected struts of the frame.
Example 44. The prosthetic heart valve of any example herein, particularly example 43, 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.
Example 45. The prosthetic heart valve of any example herein, particularly any of examples 33-44, wherein each leaflet has two upper tabs connected to upper edges of the commissure tabs and folded downwardly against the commissure tabs.
Example 46. The prosthetic heart valve of any example herein, particularly any of examples 33-45, wherein the frame comprises a plurality of commissure support posts, and the commissures are mounted to the commissure support posts.
Example 47. The prosthetic heart valve of any example herein, particularly example 46, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression of the frame.
Example 48. 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.
Example 49. The method of any example herein, particularly example 48, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.
Example 50. The method of any example herein, particularly example 48, wherein each pair of sub-commissure tabs extends radially outwardly toward an inner surface of the frame.
Example 51. The method of any example herein, particularly any of examples 49-50, 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.
Example 52. The method of any example herein, particularly any of examples 48-51, further comprising coupling the cusp edge portion of each leaflet to the frame.
Example 53. The method of any example herein, particularly example 52, further comprising suturing a first reinforcing member the cusp edge portions of the leaflets and to selected struts of the frame
Example 54. The method of any example herein, particularly example 53, 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.
Example 55. The method of any example herein, particularly any of examples 48-54, wherein the pairs of sub-commissure tabs and the two sub-commissure edges are not directly connected to the frame.
Example 56. The method of any example herein, particularly any of examples 48-55, 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.
Example 57. The method of any example herein, particularly any of examples 48-56, 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.
Example 58. The method of any example herein, particularly example 57, 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.
Example 59. The method of any example herein, particularly any of examples 57-58, wherein each pair of lower sub-commissure tabs extends radially inwardly relative to the frame.
Example 60. The method of any example herein, particularly any of examples 57-59, wherein the pairs of lower sub-commissure tabs are not directly connected to the frame.
Example 61. The method of any example herein, particularly any of examples 48-60, 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.
Example 62. The method of any example herein, particularly any of examples 48-61, 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.
Example 63. The method of any example herein, particularly example 62, wherein the commissure support posts are components of actuators that are configured to produce radial expansion and compression 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 following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.
The present application is a continuation of PCT Application No. PCT/US2021/052574, filed Sep. 29, 2021, which claims the benefit of U.S. Application No. 63/085,444, filed Sep. 30, 2020, which is incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
63085444 | Sep 2020 | US |
Number | Date | Country | |
---|---|---|---|
Parent | PCT/US2021/052574 | Sep 2021 | WO |
Child | 18124688 | US |