COMMISSURE ATTACHMENT FEATURE WITH STRESS ISOLATION

Abstract

In some embodiments, a prosthetic heart valve system comprises a stent having a plurality of commissure attachment features, a cuff coupled to the stent, a plurality of valve leaflets, the cuff and the plurality of valve leaflets forming a valve assembly, and a plurality of patches, each of the plurality of patches disposed around and coupled to a selected one of the plurality of commissure attachment features, the plurality of valve leaflets coupled to the plurality of patches.

Description

Cross-reference to related applications

[0001] This application claims priority to US Provisional Serial No. 63 / 379,814, filed October 17, 2022, the disclosure of which is hereby incorporated by reference in its entirety as if fully set forth herein. Background of the Revelation

[0002] Heart valve disease, particularly aortic and mitral valve disease, is a major health concern in the United States. Valve replacement is one option for treating heart valve disease. Prosthetic heart valves, including surgical heart valves and collapsible / expandable heart valves for transcatheter aortic valve replacement ("TAVR") or transcatheter mitral valve replacement ("TMVR"), are well known in the patent literature. Surgical or mechanical heart valves can be sutured into a patient's native annulus during open-heart surgery, for example. Collapsible / expandable heart valves can be delivered into the patient via a tube-like delivery device such as a catheter, trocar, laparoscopic instrument, or the like, avoiding a more invasive procedure such as full open-heart surgery.The term "collapsible / expandable" heart valve includes heart valves that are designed with a small cross-section that allows them to be inserted into a patient through a tube-like delivery device in a minimally invasive procedure and that then expand or are expanded to a functional state once in place, as well as heart valves that, after construction, are first collapsed to a small cross-section for insertion into a patient and then expanded to a functional size once placed in the valve annulus.

[0003] Collapsible / expandable prosthetic heart valves typically take the form of a disposable valve structure (often referred to herein as a valve unit) attached to / within an expandable stent. Generally, these collapsible / expandable heart valves comprise a self-expanding or balloon-expandable stent, often made of nitinol or another shape-memory metal or metal alloy (for self-expanding stents) or steel or cobalt-chromium (for balloon-expandable stents). Existing collapsible / expandable TAVR devices are known to utilize various configurations of stent layouts—including straight vertical struts connected by "V"s, as in U.S. Pat. No. 8,454,685, or diamond-shaped cell arrays, as in U.S. Pat. No. 9,326,856, both of which are hereby incorporated by reference.The one-way valve, attached to / inside the stent, comprises one or more valve leaflets and may also include a cuff or skirt. The cuff can be placed on the inner or luminal surface of the stent, on its outer or abluminal surface, and / or on both surfaces. A cuff helps prevent blood from simply bypassing the valve leaflets if the valve or valve assembly is not optimally seated within a valve annulus. A cuff, or part of a cuff, attached to the outside of the stent can help prevent leaks on the outside of the valve (the latter are referred to as paravalvular, or "PV," leaks).

[0004] Balloon-expandable valves are typically delivered collapsed (or crimped) onto a deflated balloon of a balloon catheter into the native annulus, with the collapsed valve either covered or exposed by an overlying sheath. Once the crimped prosthetic valve is positioned within the annulus of the valve to be replaced, the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped state to an expanded or deployed state, with the prosthetic valve tending to remain in the shape into which it was expanded by the balloon. Once the position of the collapsed prosthetic valve is in the desired position relative to the native annulus (e.g., by visualization under fluoroscopy), a fluid (typically a liquid, although gas can also be used), such asSaline solution is pressed through the balloon catheter via a syringe (manual, automatic or semi-automatic) so that the balloon begins to fill and expand, thus expanding the heart valve prosthesis lying on it into the native annulus.

[0005] When self-expandable prosthetic heart valves are implanted in a patient to replace a defective native heart valve, the self-expandable prosthetic heart valve is almost always held in a collapsed state within a capsule of the delivery device. While the capsule can ensure that the prosthetic heart valve does not prematurely expand itself, the overlying capsule (with or without the aid of additional internal retention devices) helps prevent the prosthetic heart valve from prematurely contacting tissue and ensures that the prosthetic heart valve remains in the desired position and orientation relative to the delivery device during delivery. Balloon-expandable prosthetic heart valves, however, are typically compressed onto the balloon of a delivery device without a separate capsule covering and / or protecting the prosthetic heart valve.One reason for this is that space in delivery devices and systems for transcatheter heart valve prostheses is always at a premium, and adding a capsule in addition to the prosthesis and underlying balloon may not be feasible given the size profile requirements of these procedures.

[0006] The constant opening and closing of a prosthetic heart valve can lead to mechanical stress on the valve tissue. This stress can be modulated by incorporating deflecting components into the stent (e.g., deflectable commissure attachment features) to absorb at least some of the forces during valve operation. This technique can work well with nitinol-based stents, but reaches its limitations when harder and / or stronger stent materials are used (e.g., cobalt-chromium in balloon-expandable valves). Among other advantages, it would be beneficial to provide new prosthetic heart valve configurations with improved stress isolation in or near a commissure. Brief Summary of Revelation

[0007] In some embodiments, a prosthetic heart valve system comprises a stent having a plurality of commissure attachment features, a cuff coupled to the stent, a plurality of valve leaflets, the cuff and the plurality of valve leaflets forming a valve assembly, and a plurality of patches, each of the plurality of patches disposed around and coupled to a selected one of the plurality of commissure attachment features, the plurality of valve leaflets coupled to the plurality of patches.

[0008] In some embodiments, a prosthetic heart valve system comprises a stent having a plurality of commissure attachment features, a cuff coupled to the stent, a plurality of valve leaflets, the cuff and the plurality of valve leaflets forming a valve assembly, and a plurality of expandable patches, each of the plurality of expandable patches coupled to a selected one of the plurality of commissure attachment features, the plurality of valve leaflets coupled to the plurality of expandable patches. Brief description of the drawings Fig. 1A is a perspective view of a stent of a heart valve prosthesis according to an embodiment of the disclosure. Fig. Figure 1B is a schematic front view of a portion of the stent of Fig. 1A. Fig. 1C is a schematic front view of a portion of a stent according to an alternative embodiment of the heart valve prosthesis of Fig. 1A. Fig. 1D-E are front views of the stent section of Fig. 1C in a collapsed or expanded state. Fig. 1F-G are side views of a portion of the stent according to the embodiment of Fig. 1C in a collapsed or expanded state. Fig. Figure 1H is a development view of the stent according to the embodiment of Fig. 1C, as if it were cut and rolled out flat. Fig. 1I-J are front and side views of a heart valve prosthesis with the stent made of Fig. 1C. Fig. 1K shows the settlement view of Fig. 1H with an additional outer cuff on the stent. The Fig. 2A-B show a prosthetic heart valve (PHV) crimped over a balloon in the deflated and inflated states. The Fig. 3A and Fig. 3B show an example of the attachment of a commissure attachment feature and an inner patch, viewed from the outer diameter and the inner diameter, respectively. In Fig. Figure 4A shows an example of a package leaflet. The Fig. 4B-D illustrate the steps for attaching tabs of adjacent valve leaflets to the inner patches of the Fig. 3A-B. The Fig. 5A-C show another example of the attachment of a commissure fixation feature and a bulgeable patch to the valve leaflets. Fig. Figure 6A shows a schematic top view of a heart valve prosthesis with expandable patches. Fig. Figure 6B is a schematic diagram showing an example of the expansion of a bulkable patch. Detailed description

[0009] In the context of a prosthetic heart valve, the term "inflow end" refers to the end of the prosthesis into which blood first enters when the prosthesis is implanted in the intended position and orientation, while the term "outflow end" refers to the end of the prosthesis at which blood exits when the prosthesis is implanted in the intended position and orientation. For example, in an aortic valve prosthesis, the inflow end is the end closer to the left ventricle, while the outflow end is the end closer to the aorta. The intended position and orientation are provided to simplify the description of the valves disclosed herein. It should be noted, however, that the use of the valves is not limited to the intended position and orientation, but can be deployed in any type of lumen or passageway.Although the prosthetic heart valve is described here as an aortic valve, the same or similar structures and features can be used in other heart valves, such as the pulmonary valve, mitral valve, or tricuspid valve. Furthermore, the term "proximal" in the context of a delivery device or delivery system refers to a direction that is closer to the user of that device or system during intended use, whereas the term "distal" refers to a direction farther away from the user of the device. In other words, the leading end of a delivery device or delivery system is distal to a trailing end of the delivery device or delivery system during intended use.As used herein, the terms "substantially," "generally," "approximately," and "about" are intended to indicate that minor deviations from the absolute value are within the scope of the modified term. As used herein, the stent can assume an "expanded state" and a "collapsed state," which refer to the relative radial size of the stent.

[0010] Fig. 1A shows a perspective view of a stent 100 of a prosthetic heart valve according to an embodiment of the disclosure. The stent 100 may include a frame extending axially between an inflow end 101 and an outflow end 103. The stent 100 includes three generally symmetrical sections, each section extending approximately 120 degrees around the circumference of the stent 100. The stent 100 includes three vertical struts 110a, 110b, 110c extending in an axial direction substantially parallel to the direction of blood flow through the stent, which may also be referred to as a central longitudinal axis. Each vertical strut 110a, 110b, 110c may extend substantially the entire axial length between the inflow end 101 and the outflow end 103 of the stent 100 and may be disposed between and divided by two sections.In other words, each section is defined by the portion of stent 100 between two vertical struts. Thus, each vertical strut 110a, 110b, 110c is also separated by approximately 120 degrees around the circumference of stent 100. When stent 100 is used in a prosthetic heart valve with three leaflets, the stent may have three sections as shown. However, in other embodiments, when the prosthetic heart valve has two leaflets, the stent may have only two sections.

[0011] Fig. Figure 1B shows a schematic view of a stent section 107 of the stent 100, which is described in more detail here and is representative of all three sections. Fig. The stent portion 107 illustrated in Figure 1B includes a first vertical strut 110a and a second vertical strut 110b. The first vertical strut 110a extends axially between a first inflow node 102a and a first outer node 135a. The second vertical strut 110b extends axially between a second inflow node 102b and a second outer node 135b. As illustrated, the vertical struts 110a, 110b may extend almost the entire axial length of the stent 100. In some embodiments, the stent 100 may be formed as an integral unit, for example, by laser cutting the stent from a tube. The term "node" may refer to the location where two or more struts of the stent 100 meet.A pair of consecutive inverted Vs extends between the inflow nodes 102a, 102b, comprising a first inverted V 120a and a second inverted V 120b joined at an inflow node 105. The first inverted inflow V 120a includes a first outer lower strut 122a extending between the first inflow node 102a and a first central node 125a. The first inverted inflow V 120a further includes a first inner lower strut 124a extending between the first central node 125a and the inflow node 105. A second inverted inflow V 120b includes a second inner lower strut 124b extending between the inflow node 105 and a second central node 125b. The second inverted V 120b further includes a second outer lower strut 122b extending between the second central node 125b and the second inflow node 102b.Although these structures are described as inverted V's, they can also be described as half-cells, where each half-cell is a half-diamond cell, the open part of which is located at the inflow end 101 of the stent 100.

[0012] The stent portion 107 further includes a first central strut 130a extending between the first central node 125a and an upper node 145. The stent portion 107 also includes a second central strut 130b extending between the second central node 125b and the upper node 145. The first central strut 130a, the second central strut 130b, the first inner lower strut 124a, and the second inner lower strut 124b form a diamond cell 128. The stent portion 107 includes a first outer upper strut 140a extending between the first outer node 135 and a first outflow node 104a. The stent portion 107 further includes a second outer upper strut 140b extending between the second outer node 135b and a second outflow node 104b. The stent portion 107 includes a first inner upper strut 142a extending between the first outflow node 104a and the upper node 145.The stent portion 107 further includes a second inner upper strut 142b extending between the upper node 145 and the second outflow node 104b. The stent portion 107 includes an inverted outflow V 114 extending between the first and second outflow nodes 104a, 104b. The first vertical strut 110a, the first outer upper strut 140a, the first inner upper strut 142a, the first middle strut 130a, and the first outer lower strut 122a form a first generally kite-shaped cell 133a. The second vertical strut 110b, the second outer upper strut 140b, the second inner upper strut 142b, the second middle strut 130b, and the second outer lower strut 122b form a second generally kite-shaped cell 133b. The first and second kite-shaped cells 133a, 133b are symmetrical and lie opposite each other on the stent section 107.Although the term "kite-shaped" is used above, it should be understood that such a shape is not limited to the exact geometric definition of kite-shaped. The inverted outflow V 114, the first inner upper strut 142a, and the second inner upper strut 142b form the upper cell 134. The upper cell 134 is generally kite-shaped and is axially aligned with the diamond cell 128 on the stent portion 107. It should be understood that the various struts described herein, although referred to as separate struts, may be part of a single, unitary structure, as mentioned above. However, in other embodiments, the stent 100 need not be formed as a unitary structure, so that the struts may be different structures (or parts of different structures) that are connected together.

[0013] Fig. 1C shows a schematic view of a stent section 207 according to an alternative embodiment of the disclosure. Unless otherwise indicated, like reference numerals refer to like elements of the stent 100 described above, but within the numerical series 200. The stent section 207 is substantially similar to the stent section 107, including the inflow nodes 202a, 202b, the vertical struts 210a, 210b, the first and second inverted V-shaped inflow nodes 220a, 220b, and the outflow nodes 204a, 204b. The structure of the stent section 207 differs from that of the stent section 107 in that it does not have an inverted outflow V. The purpose of an embodiment having such a structure of the in Fig. The purpose of the stent portion 207 shown in Figure 1C is to reduce the force required to expand the outflow end 203 of the stent 200 compared to the stent 100 to promote uniform expansion relative to the inflow end 201. The outflow nodes 204a, 204b are connected by a properly aligned V formed by the first inner upper strut 242a, the upper node 245, and the second inner upper strut 242b. In other words, the struts 242a, 242b can form a half diamond cell 234, with the open end of the half cell oriented toward the outflow end 203. The half diamond cell 234 is axially aligned with the diamond cell 228. By adding an inverted V between the outflow nodes 204a, 204b, additional material is introduced, which increases the resistance to changing the stent shape and requires additional force to expand the stent.Excluding material from the outflow end 203 reduces the resistance to expansion at the outflow end 203, which may promote uniform expansion of the inflow end 201 and the outflow end 203. In other words, the inflow end 201 of the stent 200 does not have a continuous circumferential structure, but rather has predominantly or entirely open half-cells, with the open portion of the half-cells oriented toward the inflow end 201, while most of the outflow end 203 has a substantially continuous circumferential structure via struts corresponding to struts 140a, 140b. All other things being equal, a substantially continuous circumferential structure may require more force for expansion compared to a similar but open structure. For example, the inflow end 101 of the stent 100 may require more force for radial expansion compared to the outflow end 103.By omitting the inverted V 114, resulting in a stent 200, the force required to expand the outflow end 203 of the stent 200 can be reduced to a value closer to that of the inflow end 201.

[0014] Fig. Figure 1D shows a front view of the stent portion 207 in a collapsed state and Fig. Figure 1E shows a front view of the stent portion 207 in an expanded state. It is understood that the stent 200 is in the Fig. 1D-E with an opaque tube extending through the interior of the stent, only to illustrate the stent, and which may represent a balloon over which the stent portion 207 is curved. As described above, a stent comprises three symmetrical sections, each section extending approximately 120 degrees around the circumference of the stent. The Fig. Stent section 207, shown in Figures 1D-E, is defined by the area between the vertical struts 210a, 210b. Stent section 207 is representative of all three sections of the stent. Stent section 207 has an arcuate structure such that the three sections, when connected together, form a complete cylindrical shape. Fig. 1F-G shows a part of the stent in a side view. In other words, the view of the stent 200 in the Fig. 1F-G is compared to the view in the Fig. 1D-E rotated by 60 degrees. The Fig. The view of the stent shown in Figures 1F-G is centered on the vertical strut 210b and shows approximately half of each of two adjacent stent sections 207a, 207b on either side of the vertical strut 210b. The sections 207a, 207b surrounding the vertical strut 210b are mirror images of each other. Fig. Figure 1F shows the stent sections 207a, 207b in a collapsed state, while Fig. 1G shows the stent sections 207a, 207b in an expanded state.

[0015] Fig. Figure 1H shows a developed view of the stent 200 with three stent sections 207a, 207b, 207c, as if the stent had been cut longitudinally and laid flat on a table. As illustrated, the sections 207a, 207b, 207c are symmetrical to each other, and adjacent sections share a common vertical strut. As described above, the stent 200 is illustrated as a developed view, but each section 207a, 207b, 207c has an arcuate shape extending 120 degrees and forming a full cylinder. Further, Fig. 1H shows the valve leaflets 250a, 250b, 250c connected to the stent 200. However, it should be understood that in Fig. 1H, only the connection of the prosthetic valve leaflets 250a-c is shown. In other words, each valve leaflet 250a-c would typically have a free edge, with the free edges acting to abut against each other to prevent retrograde blood flow through the stent 200, and the free edges moving radially outward toward the inner surface of the stent to allow antegrade blood flow through the stent. These free edges are shown in Fig. 1H is not shown. Rather, the attached edges of the valve leaflets 250a-c are shown in Fig. 1H in dashed lines. Although attachment may be accomplished via any suitable modality, the attached edges may preferably be sutured to the stent 200 and / or to an intermediate cuff or skirt between the stent and the leaflets 250a-c. Each of the three leaflets 250a, 250b, 250c extends at an angle of approximately 120 degrees around the stent 200 from one end to the other, and each leaflet includes a belly that may extend toward the radial center of the stent 200 when the leaflets are joined together. Each leaflet extends between the upper nodes of adjacent sections. The first leaflet 250a extends from the first upper node 245a of the first stent section 207a to the second upper node 245b of the second stent section 207b. The second valve leaflet 250b extends from the second upper node 245b to the third upper node 245c of the third stent section 207c.The third leaflet 250c extends from the third superior node 245c to the first superior node 245a. Thus, each superior node includes a first end of a first leaflet and a second end of a second leaflet connected thereto. In the illustrated embodiment, each end of each leaflet is connected to its respective node by a suture. However, any suitable connecting means may be used to attach the leaflets to the stent. Further, the stent may have any number of sections and / or leaflets. For example, the stent may have two sections, each section extending 180 degrees around the circumference of the stent. Further, the stent may have two leaflets to form a bicuspid valve.Further, it should be noted that each leaflet may include tabs or other structures (not shown) at the junction between the free edges and the attached edges of the leaflets, and each tab of each leaflet may be connected to a tab of an adjacent leaflet to form commissures. In the illustrated embodiment, the leaflets are attached at the nodes where the struts cross. However, in other embodiments, the stent 200 may include commissure attachment features integrated into the stent to facilitate such attachment. For example, commissure attachment features may be molded into the stent 200 at nodes 245a-c, with the commissure attachment features including one or more openings to facilitate suturing the leaflet commissures to the stent. Furthermore, the leaflets 250a-c may be formed from a biological material, such asanimal pericardium, or synthetic materials such as ultra-high molecular weight polyethylene (UHMWPE).

[0016] The Fig. 1I-J show a prosthetic heart valve 206 comprising a stent 200, a cuff 260 connected to the stent 200 (e.g., by sutures), and valve leaflets 250a, 250b, 250c attached to the stent 200 and / or the cuff 260 (e.g., by sutures). The prosthetic heart valve 206 is intended for replacing an aortic valve, although the same or similar structures may be used in a prosthetic valve to replace other heart valves. The cuff 260 is disposed on a luminal or inner surface of the stent 200, although the cuff could alternatively or additionally be disposed on an abluminal or outer surface of the stent. The cuff 260 may have an inflow end disposed substantially along the inflow end 201 of the stent 200. Fig. Figure 11 shows a front view of the valve 206 showing a stent portion 207 between the vertical struts 210a, 210b including the cuff 260 and an outline of two leaflet flaps 250a, 250b sutured to the cuff 260. Various methods may be used for suturing the valves to the cuff, as well as the valves and / or the cuff to the stent, many of which are described in U.S. Pat. No. 9,326,856, which is hereby incorporated by reference. In the illustrated embodiment, the upper (or outflow) edge of the cuff 260 is sutured to the first central knot 225a, the upper knot 245, and the second central knot 225b, and extends along the first central strut 230a and the second central strut 230b. The upper (or outflow) edge of the cuff 260 further extends approximately between the second central node of one section and the first central node of an adjacent section.The cuff 260 extends between the upper node 245 and the inflow end 201. Thus, the cuff 260 covers the cells of the stent section 207 formed by the struts between the upper node 245 and the inflow end 201, including the diamond cell 228. . Fig. Figure 1J shows a side view of the stent 200 with the cuff 260 and an outline of the valve leaflet 250b. In other words, the view of the valve 206 in Fig. 1J is compared to the view of Fig. 1I rotated by 60 degrees. The Fig. The view shown in Figure 1J is centered on the vertical strut 210b and shows approximately half of each of the two adjacent stent sections 207a, 207b on either side of the vertical strut 210b. The sections 207a, 207b surrounding the vertical strut 210b are mirror images of each other. As described above, the cuff can be disposed on the inner or luminal surface of the stent, on its outer or abluminal surface, and / or on both surfaces. A cuff ensures that blood does not simply flow around the valve leaflets if the valve or valve assembly is not optimally seated within a valve annulus. A cuff or a portion of a cuff disposed on the outside of the stent can help reduce leaks on the outside of the valve (the latter are referred to as paravalvular leaks or “PV” leaks). In the Fig. 1I-J, the cuff 260 covers only about half of the stent 200, leaving about half of the stent uncovered by the cuff. In this configuration, less cuff material is required than a cuff that covers more or all of the stent 200. Less cuff material may allow the prosthetic heart valve 206 to fold into a smaller profile when collapsed. It is conceivable that the cuff may cover any portion of the surface of the cylinder formed by the stent. For example, the upper edge of the cuff may extend just around the circumference of any cross-section of the cylinder formed by the stent. The cuff 260 may be made of any suitable material, including a biological material such as animal pericardium or a synthetic material such as UHMWPE.

[0017] As already mentioned, the Fig. 1I-J a cuff 260 attached to the inside of the stent 200. An example of an additional outer cuff 270 is shown in Fig. 1K. It is understood that the outer sleeve 270 may have other shapes than those shown in Fig. 1K shown. The Fig. 1K may be included without an inner cuff 260, but is preferably provided in addition to an inner cuff 260. The outer cuff 270 may be formed integrally with the inner cuff 260 and folded over (e.g., wrapped around) the inflow edge of the stent, or it may be provided as a separate member from the inner cuff 260. The outer cuff 270 may be made of any of the materials described herein in connection with the inner cuff 260. In the illustrated embodiment, the outer cuff 270 includes an inflow edge 272 and an outflow edge 274. If the inner cuff 260 and the outer cuff 270 are formed separately, the inflow edge 272 may be connected to an inflow end of the stent 200 and / or an inflow edge of the inner cuff 260, for example, by suturing, ultrasonic welding, or another suitable attachment method.The connection between the inflow edge 272 of the outer cuff 270 and the stent 200 and / or the inner cuff 260 preferably results in a seal between the inner cuff 260 and the outer cuff 270 at the inflow end of the prosthetic heart valve, so that retrograde blood flowing into the space between the inner cuff 260 and the outer cuff 270 cannot pass beyond the inflow edges of the inner cuff 260 and the outer cuff 270. The outflow edge 274 can be connected to struts of the stent 200 and / or to the inner cuff 260 at selected locations around the circumference of the stent 200, for example, by sutures.In this configuration, an opening can be formed between the inner cuff 260 and the outer cuff 270 circumferentially between adjacent connection points, so that retrograde blood flow tends to flow through the openings into the space between the inner cuff 260 and the outer cuff 270 without being able to continue beyond the inflow edges of the cuffs. As blood flows into the space between the inner cuff 260 and the outer cuff 270, the outer cuff 270 can bulge outward, creating an even better seal between the outer cuff 270 and the native valve annulus against which the outer cuff 270 presses.The outer cuff 270 may be secured together as a continuous cylindrical member or as a strip wrapped around the outer circumference of the stent 200 with side edges that may or may not be parallel to a central longitudinal axis of the heart valve prosthesis, such that the outer cuff 270 encloses the entire circumference of the stent 200.

[0018] The stent may be constructed of biocompatible materials, including metals and metal alloys such as cobalt-chromium (or cobalt-chromium) or stainless steel, although in some embodiments, the stent may be constructed of a shape-memory material such as nitinol or similar. The stent is thus configured to collapse when compressed to a smaller diameter and / or expand when forced open, e.g., by an expanding balloon within the stent, and the stent essentially retains the shape to which it was altered when at rest. The stent can be crimped to collapse in the radial direction and elongate (to some extent) in the axial direction, thereby reducing its profile at any given cross-section. The stent can also be expanded in the radial direction and shortened (to some extent) in the axial direction.

[0019] The heart valve prosthesis can be delivered via any suitable transvascular route, for example, transapically or transfemorally. Generally, transapical delivery uses a relatively stiff catheter that pierces the apex of the left ventricle through the patient's chest, causing relatively greater trauma compared to transfemoral delivery. In transfemoral delivery, a deliverer containing the valve is inserted through the femoral artery and advanced against the blood flow into the left ventricle. In both delivery methods, the valve may first be collapsed over an expandable balloon while the expandable balloon is deflated. The balloon may be coupled to or contained within a delivery system that transports the valve through the body and heart to the aortic valve, with the valve positioned over the balloon (and possibly under an overlying sheath).Upon arrival at or near the aortic valve, the surgeon or delivery system operator can align the prosthetic valve as desired within the native valve annulus while the prosthetic valve is collapsed over the balloon. Once the desired alignment is achieved, the overlying sheath, if present, can be retracted (or advanced) to expose the prosthetic valve, and the balloon can then be expanded, causing the prosthetic valve to expand radially and shorten at least a portion of the prosthetic valve axially.

[0020] In Fig. 2A illustrates an example of a prosthetic heart valve (PHV) that may include a stent similar to stents 100 or 200 crimped over a balloon 380 of a balloon catheter 390 while the balloon 380 is in a deflated state. It is understood that other components of the delivery device, such as a handle used for steering and / or deployment, as well as a syringe for inflating the balloon 380, may be incorporated into the Fig. 2A-B are not shown. The PHV heart valve prosthesis can be inserted intravascularly, e.g., through the femoral artery, around the aortic arch and into the native aortic valve annulus, while in the Fig. 2A. Once the desired position is reached, fluid can be forced through the balloon catheter 390 to inflate the balloon 380, as shown in Fig. 2B. In Fig. 2B, the prosthetic heart valve PHV is not shown, but it should be clear that when inflated, the balloon 380 forces the prosthetic heart valve PHV to expand into the native aortic valve annulus (however, it should be understood that other heart valves can also be replaced with the concepts described here). In the illustrated example, fluid flows from a syringe (not shown) through a lumen in the balloon catheter 390 into the balloon 380 and into one or more openings 385 located inside the balloon 380. In the Fig. 2B, a first port 385 may be one or more openings in a side wall of the balloon catheter 390, and a second port 385 may be the distal open end of the balloon catheter 390, which may terminate within the interior of the balloon 380.

[0021] The present disclosure provides several techniques, devices, and methods to reduce stresses in a valve leaflet material by enabling movement (e.g., deflection) of one component relative to another during valve operation. In particular, the present disclosure focuses on approaches that do not necessarily require a change in the stent architecture. Rather, the devices, methods, and techniques presented herein relate to unique attachment methods between the valve leaflets, cuffs, stents, and / or an intermediate buffer material to enable deflection in highly stressed areas of the valve. Although the described deflection most often relates to the commissure region, these techniques and methods can also be applied to other locations of the valve attachment.For simplicity, reference is made in this disclosure to the commissure area, but other locations around the valve attachment line are also conceivable (e.g., below the commissure, at the abdominal attachment, etc.).

[0022] In an embodiment described in the Fig. 3A-B, a commissure region 400 is shown including a commissure attachment feature 410 connected to an inner patch 440. In some examples, the inner patch 440 may be a single member. Alternatively, the term "inner patch" may refer to a portion that is adjacent to or connected to another member; that is, the inner patch may comprise or be assembled with a portion of another member (e.g., an inner valve cuff or an outer valve cuff). Fig. 3A shows the commissure area 400 from the outer diameter, while Fig. 3B shows the same commissure area as viewed from the inner diameter of the prosthetic heart valve PHV. The inner patch 440 is shown partially translucent to better illustrate its relationship to the commissure attachment feature 410. In this example, the commissure attachment feature 410 is generally rectangular and extends between a proximal end 402 and a distal end 404. The commissure attachment feature 410 may be coupled or unitarily formed with one or more struts at the proximal and / or distal ends. In this example, two struts 405a, 405b converge near the proximal end 402 of the commissure attachment feature 410, and two additional struts 405c, 405d converge near the distal end 404. The commissure attachment feature 410 may also include a number of eyelets 415, including square and / or rectangular eyelets.It is understood that the shape and / or size of the eyelets can be varied as desired, and that the eyelets can be arranged in one or more rows and / or columns. In addition to or instead of eyelets, the commissure attachment feature 410 can also include one or more external notches 411 to assist in attaching the commissure attachment feature 410 to a valve leaflet and / or cuff.

[0023] The inner patch 440 may be made of a biological material (e.g., bovine, porcine, or the like) or a synthetic material, such as a polymer. In at least some examples, the inner patch 440 is made of a fabric (e.g., knitted, woven, electrospun, etc.), pericardium, native cusps, or other suitable material. In some examples, the material chosen for the inner patch may have a desired stiffness and / or elasticity to allow it to stretch and return to its original shape during valve closure to provide less whiplash and distribute load more evenly.

[0024] In this example, a discrete rectangular inner patch 440 may be wrapped around each of the commissure attachment features 410, as shown, such that a continuous inner layer 442 covers the inner surface of the commissure attachment feature 410, while two outer segments 444 are contiguous at the outer surface (i.e., abluminal) of the commissure attachment feature 410. In at least some examples, the outer segments 444 are joined together at a seam (not shown). The inner patch 440 may be joined to the commissure attachment feature 410 by one or more sutures S1. In the example shown, a single suture S1 is depicted having two tails T1, T2, the suture forming a pattern as shown by both the inner and outer diameters and being sewn in place by passing through one or more of the eyelets 415, around the commissure attachment feature 410 and / or at external notches 411.Once the inner patch 440 is properly attached to the commissure attachment feature 410, the valve leaflets can be connected to the commissure region 400.

[0025] For illustration purposes, Fig. 4A illustrates that each leaflet 460 may include tabs 461 or other structures at the junction between the free edges 462 and the attached edges 464 (often referred to as the belly) of the leaflets, and each tab 461 of each leaflet 460 may be coupled to a tab 461 of an adjacent leaflet 460 to collectively form commissures formed from the tabs. The term "commissure," when used alone, refers to two tabs of adjacent leaflets. In this example, the commissures may be attached only to an inner patch 440, rather than directly attached to the commissure attachment features 410 of the stent. That is, the commissure may be indirectly (rather than directly) attached to the commissure attachment features 410 via the inner patch 440.The distance between the sutures holding the valve leaflets and those attaching the inner patch to the stent can determine the amount of stretch between these components. In at least some examples, the maximum stretch or sag between these components can be between 0.05 mm and 0.25 mm, or less than 1 mm. The material properties of the patch and / or the valve leaflet can also affect deflection.

[0026] As previously mentioned, the attachment of the valve leaflets or commissures can be achieved by attaching the valve leaflets to the inner patch 440 and not directly to the stent or the commissure attachment feature 410. The Fig. 4B-D illustrate the connection of the valve leaflet to the inner patch. First, one or more sutures can be used to connect two flaps 461a, 461b of adjacent valve leaflets to an inner patch 440 of a commissure area 400, as shown in the inner diameter view of Fig. 4B (the stent is omitted for clarity). The same or a different suture may be used to connect the valves to the inner patch 440. In the example shown, the same suture S1 is used to connect the valve leaflets only to the inner patch 440 and not to the wrapped commissure attachment feature 410. In this example, one end of the suture S1 is Fig. 4B and is used to connect the two flaps together to form an ohm or horseshoe shape. The second end of the suture S1 can be passed around the perimeter of the commissure attachment feature 410 without connecting thereto and close the suture to connect to the inner patch 440, as shown in Fig. 4C, which shows an inner diameter view. Note that one or both ends T1, T2 are used to couple the valve leaflet to the inner patch and not directly to the stent or commissure attachment feature. After creating patterns with ends T1, T2, both ends can terminate near the lower rectangular eyelet and be tied together at knot K1, as shown in the outer diameter view of Fig. 4D. It should be understood that multiple sutures and / or different suture patterns may be used to connect the commissures (i.e., the flaps of adjacent valve leaflets) to the inner patch 440. Furthermore, although three discrete inner patches 440 are illustrated, it is possible for a single continuous inner patch to be connected to the three commissure attachment features.

[0027] Another example of voltage isolation is in the Fig. 5A-C, which illustrate a bulky patch. The commissure region 500 includes a commissure attachment feature 410 extending between a proximal end 402 and a distal end 404, similar to that previously described, which is attached to the struts 405a-d and includes eyelets 415. A bulky patch 540 is connected to the commissure attachment feature 410 via suture S2. The bulky patch 540 may be comprised of discrete elements or may comprise a portion of another element (e.g., an inner cuff). Fig. Figure 5A shows the suture pattern as viewed from the outer diameter of the stent. In this example, the patch 540 is wider than the commissure attachment feature 410 and can be folded over itself to form at least two layers, including an outer layer 542 positioned closest to and connected to the commissure attachment feature and an inner layer 544 positioned relatively farther from the commissure attachment feature ( Fig. 5B). Additional layers can be added to modulate the stiffness and / or bending of the region. The patch 540 can be doubled and the edges sewn together so that the outer and inner layers 542, 544 form a cylinder that can be folded together or expanded and used as a deflection feature. Instead of a cylinder, the patch 540 can also take other shapes, such as a pyramid or a prism. A pair of valve leaflets can be joined to the inner layer 544 of the patch 540 by the same or a different suture S3. Fig. Figure 6A shows a PHV with three leaflets connected at their flaps to three expandable patches 540, each expandable patch connected to a corresponding commissure attachment feature. With three leaflets, the three commissure attachment features and the three expandable patches can be arranged at a 120-degree angle around the circumference of the stent.

[0028] As best shown in the schematic representation of Fig.6B, a bulking patch 540 can be connected to each of the commissure attachment features 410, with the bulking patch 540 defining outer and inner layers 542, 544. The outer layer 542 can be connected to the commissure attachment features 410. Two tabs 461a, 461b from two adjacent valve leaflets are attached to the inner layer 544 of the bulking patch 540. The bulking patch 540 can be collapsed until tension is applied to the commissure area, after which the patch 540 can expand as shown, separating the inner and outer layers to create a space between them and reduce tension on a portion of the valve leaflet (e.g., the leaflet tabs). At least in some examples, the inner and outer layers may be separated by a maximum clearance of between 0.05 mm and 0.25 mm.

[0029] During use, a heart valve prosthesis can be crimped, loaded, and deployed into position. The prosthesis incorporates elements that serve as commissure distraction or isolation features (e.g., an internal patch or a bulkable patch). These elements can serve to isolate the valve leaflets or flaps and reduce stress on the valve components during use. For example, the commissures of the valve leaflets can be connected to internal or bulkable patches to create clearance between the leaflets and the stent.

[0030] Although the invention has been described herein with reference to specific embodiments, these embodiments are intended merely to illustrate the principles and applications of the present invention. It is therefore to be understood that numerous changes may be made to the illustrated embodiments and that other arrangements may be devised without departing from the scope of the present invention as defined by the appended claims. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 63 / 379,814

[0001] US 8,454,685

[0003] US 9,326,856

[0003]

Claims

[1] A heart valve prosthesis system comprising: a stent having a plurality of commissure fixation features; a cuff connected to the stent; a plurality of valve leaflets, wherein the cuff and the plurality of valve leaflets form a valve assembly; and a plurality of patches, each of the plurality of patches disposed about and connected to a selected one of the plurality of commissure attachment features, the plurality of valve leaflets connected to the plurality of patches. [2] The heart valve prosthesis system of claim 1, wherein the plurality of patches and the cuff form a unit. [3] The prosthetic heart valve system of claim 1, wherein the plurality of valve leaflets are directly connected to the plurality of patches. [4] The prosthetic heart valve system of claim 1, wherein the plurality of valve leaflets are indirectly connected to the commissure attachment features via the plurality of patches. [5] The prosthetic heart valve system of claim 1, wherein each of the plurality of patches is wrapped around a selected one of the plurality of commissure attachment features. [6] The prosthetic heart valve system of claim 5, wherein each of the plurality of patches forms a continuous inner layer on an inner diameter surface of the selected one of the plurality of commissure attachment features. [7] The prosthetic heart valve system of claim 1, wherein each of the plurality of commissure attachment features comprises eyelets and the plurality of patches are attached to the commissure attachment features at the eyelets. [8] The prosthetic heart valve system of claim 1, wherein each of the plurality of patches is connected to the selected one of the plurality of commissure attachment features via a suture pattern formed by a single suture strand. [9] The prosthetic heart valve system of claim 8, wherein the single suture strand further connects each of the plurality of patches to two of the plurality of valve leaflets. [10] A heart valve prosthesis system comprising: a stent having a plurality of commissure fixation features; a cuff connected to the stent; a plurality of valve leaflets, wherein the cuff and the plurality of valve leaflets form a valve assembly; and a plurality of expandable patches, each of the plurality of expandable patches connected to a selected one of the plurality of commissure attachment features, wherein the plurality of valve leaflets are connected to the plurality of expandable patches. [11] The heart valve prosthesis system of claim 10, wherein the plurality of expandable patches and the cuff form a unit. [12] The prosthetic heart valve system of claim 10, wherein the plurality of valve leaflets are directly connected to the plurality of expandable patches. [13] The prosthetic heart valve system of claim 10, wherein the plurality of valve leaflets are indirectly connected to the commissure attachment features via the plurality of expandable patches. [14] The prosthetic heart valve system of claim 10, wherein each of the plurality of expandable patches is cylindrical and is connected to an interior of a selected one of the plurality of commissure attachment features. [15] The prosthetic heart valve system of claim 10, wherein each of the plurality of expandable patches comprises an outer layer connected to a selected one of the plurality of commissure attachment features and an inner layer, wherein a selected one of the plurality of valve leaflets is connected to the inner layer. [16] The prosthetic heart valve system of claim 10, wherein each of the plurality of expandable patches is connected to the selected one of the plurality of commissure attachment features via a suture pattern formed by a single suture strand. [17] The prosthetic heart valve system of claim 16, wherein the single suture strand further connects each of the plurality of expandable patches to two of the plurality of valve leaflets. [18] The heart valve prosthesis system of claim 10, wherein the plurality of expandable patches are discrete.

Images