Protection of balloon expandable blade during clamping

Abstract

In accordance with one aspect of the present disclosure, a prosthetic heart valve system includes a prosthetic heart valve including a stent, a cuff, and a plurality of vanes, the cuff and the plurality of vanes forming a valve assembly; and an expandable balloon having a deflated state and an inflated state, the expandable balloon configured and arranged to transition the prosthetic heart valve from the folded state to the expanded state and to protect various portions of the valve assembly during curling and delivery.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 349,241 filed on June 6, 2022, the contents of which are incorporated herein by reference. Background Art

[0003] Valvular heart disease, particularly aortic valve disease and mitral valve disease, is a significant health problem in the United States. Valve replacement is an option for treating valvular heart disease. Artificial heart valves, including surgical heart valves and foldable / expandable heart valves intended for transcatheter aortic valve replacement ("TAVR") or transcatheter mitral valve replacement ("TMVR"), are well known in the patent literature. For example, a surgical heart valve or a mechanical heart valve can be sutured to the patient's native valve annulus during open heart surgery. The foldable / expandable heart valve can be delivered to the patient via a tubular delivery device (such as a catheter, a trocar, a laparoscopic instrument, etc.) to avoid more invasive surgery (such as full-chest surgery, open heart surgery). As used herein, reference to a "foldable / expandable" heart valve includes forming a heart valve having a small cross-section that enables the heart valve to be delivered to a patient via a tubular delivery device during a minimally invasive procedure and then expanded to an operable state once in place, as well as a heart valve that, after construction, is first folded into a small cross-section for delivery to a patient and then expanded to an operable size once in place in the valve annulus.

[0004] Foldable / expandable artificial heart valves are usually in the form of a one-way valve structure (generally referred to as a valve assembly in this article) mounted to an expandable stent / located in an expandable stent. Typically, these foldable / expandable heart valves include a self-expanding stent or a balloon-expandable stent, which is usually made of nitinol or another shape memory metal or metal alloy (for self-expanding stents) or steel or cobalt chromium (for balloon-expandable stents). Known existing foldable / expandable TAVR devices use different configurations of stent layouts-including straight vertical struts connected by "V" as shown in U.S. Patent No. 8,454,685, or a diamond unit layout as shown in U.S. Patent No. 9,326,856, both of which are incorporated herein by reference. The one-way valve assembly mounted to the stent / located in the stent includes one or more blades, and may also include a cuff or skirt. The cuff can be set on the inner surface or lumen surface of the stent, its outer surface or lumen outer surface, and / or these two surfaces. The cuff helps ensure that blood does not just flow around the valve leaflets if the valve or valve component is not optimally seated in the valve annulus. The cuff or a portion of the cuff disposed on the outside of the stent can help slow leakage around the outside of the valve (the latter is called paravalvular leakage or "PV" leakage).

[0005] The balloon expandable valve is typically delivered to the native annulus while being folded (or "curled") onto the deflated balloon of a balloon catheter, wherein the folded valve is covered or uncovered by an overlying sheath. Once the curled artificial heart valve is positioned within the annulus of the native heart valve being replaced, the balloon is inflated to force the balloon expandable valve to transition from a folded or curled state to an expanded or deployed state, wherein the artificial heart valve tends to remain in the shape into which it is expanded by the balloon. Typically, when the position of the folded artificial heart valve is determined to be in a desired position relative to the native annulus (e.g., via visualization under fluoroscopy), a fluid (typically a liquid, but a gas may also be used) such as saline is pushed through the balloon catheter via a syringe (manually, automatically, or semi-automatically) to begin filling and expanding the balloon, thereby expanding the overlying artificial heart valve into the native annulus.

[0006] When a self-expanding artificial heart valve is delivered to a patient to replace a malfunctioning natural heart valve, the self-expanding artificial heart valve is almost always kept in a folded state within the capsule of the delivery device. Although the capsule can ensure that the artificial heart valve does not self-expand prematurely, the covering capsule (with or without the help of additional internal retention features) helps to ensure that the artificial heart valve does not contact any tissue prematurely, and helps to ensure that the artificial heart valve remains in a desired position and orientation relative to the delivery device during delivery. However, balloon-expandable artificial heart valves are usually curled on the balloon of the delivery device without a separate capsule that covers and / or protects the artificial heart valve. One reason for this situation is that space in transcatheter artificial heart valve delivery devices and systems is always at a premium, and considering the size profile requirements of these surgeries, it may not be feasible to add a capsule in addition to the artificial valve and the balloon below.

[0007] During delivery and / or crimping, damage to the valve components (e.g., leaflets and / or cuff) may occur. Specifically, the leaflets of the valve may be pressed against the hard metal stent due to the high pressure when the frame of the valve is reduced to the desired delivery diameter. This may cause localized stress and / or damage to the leaflets. Additionally, if the stent includes larger opening cells, the compressed leaflets may protrude through the openings between the struts of the opening cells and become clamped. Summary of the invention

[0008] In some embodiments, an artificial heart valve system includes an artificial heart valve, which includes a stent, a cuff and a plurality of leaflets, which form a valve assembly; and an expandable balloon having a deflated state and an inflated state, which is configured and arranged to transition the artificial heart valve from a folded state to an expanded state and to protect various parts of the valve assembly during curling and delivery.

[0009] In some embodiments, a method for delivering an artificial heart valve system includes providing an artificial heart valve, which includes a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and placing an expandable balloon in the artificial heart valve in a deflated state, the expandable balloon having a feature for protecting the artificial heart valve during curling and delivery, and the feature protecting various parts of the valve assembly while the artificial heart valve and the expandable balloon are curled. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1A is a perspective view of a stent for an artificial heart valve according to an embodiment of the present disclosure.

[0011] Figure 1B yes Figure 1A Schematic front view of a section of a bracket.

[0012] Figure 1C is based on Figure 1A Schematic front view of a segment of a stent of an alternative embodiment of an artificial heart valve.

[0013] Figure 1D to Figure 1E They are Figure 1C Front view of the stent segment in a folded state and an expanded state.

[0014] Figure 1F to Figure 1G According to Figure 1C A side view of a portion of a stent of an embodiment in a folded state and an expanded state.

[0015] Figure 1H is based on Figure 1C A flattened view of a stent of an embodiment of the invention as if it had been cut and flattened.

[0016] Figures 1I to 1J They include Figure 1C Front view and side view of an artificial heart valve with a stent.

[0017] Figure 1K The figure shows an additional outer cuff on the bracket. Figure 1H of the view.

[0018] FIG. 2A to FIG. 2B The prosthetic heart valve PHV is illustrated crimped on a balloon in a deflated state and in an inflated state.

[0019] FIG. 3A to FIG. 3C is a schematic top view of a prosthetic heart valve for use with an expandable balloon having a leaflet protection feature.

[0020] FIG. 4A to FIG. 4B is a schematic top view of another example of a prosthetic heart valve for use with an expandable balloon having a leaflet protection feature.

[0021] Figure 5 is a schematic side view of a prosthetic heart valve with a protective sleeve.

[0022] Fig. 6A is a schematic top view of an expandable balloon having protrusions and pockets.

[0023] FIG. 6B to FIG. 6E is a schematic top view of another example of an expandable balloon and its use with a prosthetic heart valve. DETAILED DESCRIPTION

[0024] As used herein, when used in conjunction with an artificial heart valve, the term "inflow end" refers to the end of the artificial valve that blood first enters when the artificial valve is implanted in the expected position and orientation, and the term "outflow end" refers to the end of the artificial valve that blood leaves when the artificial valve is implanted in the expected position and orientation. Further, for an artificial aortic valve, the inflow end is the end closer to the left ventricle, and the outflow end is the end closer to the aorta. The expected position and orientation are used for convenience in describing the valve disclosed herein, however, it should be noted that the use of the valve is not limited to the expected position and orientation, but can be deployed in any type of lumen or channel. For example, although the artificial heart valve is described herein as an artificial aortic valve, the same or similar structures and features can be used for other heart valves (e.g., pulmonary valves, mitral valves, or tricuspid valves). Further, when used in conjunction with a delivery device or system, the term "proximal end" refers to the direction relatively close to the user of the device or system when used as intended, and the term "distal end" refers to the direction relatively far from the user of the device. In other words, when used as intended, the front end of the delivery device or system is positioned away from the rear end of the delivery device or system. As used herein, the terms "substantially," "generally," "approximately," and "about" are intended to indicate that slight deviations from the absolute values ​​are also included within the scope of the modified terms. As used herein, a stent can assume an "expanded state" and a "folded state," which refers to the relative radial dimensions of the stent.

[0025] Figure 1A The stereogram of the stent 100 of the artificial heart valve according to the embodiment of the present disclosure is illustrated. The stent 100 may include a frame extending in an axial direction between an inflow end 101 and an outflow end 103. The stent 100 includes three generally symmetrical sections, wherein each section spans about 120 degrees around the circumference of the stent 100. The stent 100 includes three vertical struts 110a, 110b, 110c, which extend in an axial direction substantially parallel to the direction of blood flow through the stent, which axial direction may also be referred to as a central longitudinal axis. Each vertical strut 110a, 110b, 110c may extend substantially over the entire axial length between the inflow end 101 and the outflow end 103 of the stent 100, and may be disposed between two sections and shared by the two sections. In other words, each section is defined by the portion of the stent 100 between the two vertical struts. Furthermore, each vertical strut 110a, 110b, 110c is also separated by about 120 degrees around the circumference of the stent 100. It should be understood that if the stent 100 is used in an artificial heart valve with three leaves, the stent may include three sections as shown. However, in other embodiments, if the artificial heart valve has two leaves, the stent may only include two of the sections.

[0026] Figure 1BIllustrated is a schematic diagram of a stent segment 107 of stent 100 , which will be described in greater detail herein and is representative of all three segments. Figure 1B The support segment 107 depicted in FIG. 1 includes a first vertical strut 110a and a second vertical strut 110b. The first vertical strut 110a extends axially between the first inflow node 102a and the first external node 135a. The second vertical strut 110b extends axially between the second inflow node 102b and the second external node 135b. As shown, the vertical struts 110a, 110b can extend over almost the entire axial length of the support 100. In some embodiments, the support 100 can be formed as an integral unit, for example, by cutting the support from a tube with a laser. The term "node" can refer to the place where two or more struts of the support 100 meet each other. A pair of sequential inverted V-shaped inverted V-shaped inverted V-shaped 120a and a second inflow inverted V-shaped 120b connected to each other at the inflow node 105. The first inflow inverted V-shaped 120a includes a first outer lower strut 122a extending between the first inflow node 102a and the first central node 125a. The first inflow inverted V-shape 120a also includes a first inner lower strut 124a extending between the first center node 125a and the inflow node 105. The second inflow inverted V-shape 120b includes a second inner lower strut 124b extending between the inflow node 105 and the second center node 125b. The second inflow inverted V-shape 120b also includes a second outer lower strut 122b extending between the second center node 125b and the second inflow node 102b. Although described as inverted V-shapes, these structures can also be described as half units, each half unit being a half diamond unit, wherein the opening portion of the half unit is located at the inflow end 101 of the stent 100.

[0027] The support segment 107 further includes a first center support 130a extending between the first center node 125a and the upper node 145. The support segment 107 also includes a second center support 130b extending between the second center node 125b and the upper node 145. The first center support 130a, the second center support 130b, the first inner lower support 124a, and the second inner lower support 124b form a diamond unit 128. The support segment 107 includes a first outer upper support 140a extending between the first outer node 135 and the first outflow node 104a. The support segment 107 further includes a second outer upper support 140b extending between the second outer node 135b and the second outflow node 104b. The support segment 107 includes a first inner upper support 142a extending between the first outflow node 104a and the upper node 145. The support segment 107 further includes a second inner upper support 142b extending between the upper node 145 and the second outflow node 104b. The support section 107 includes an outflow inverted V-shape 114 extending between a first outflow node 104a and a second outflow node 104b. The first vertical strut 110a, the first outer upper strut 140a, the first inner upper strut 142a, the first center strut 130a, and the first outer lower strut 122a form a first overall kite-shaped unit 133a. The second vertical strut 110b, the second outer upper strut 140b, the second inner upper strut 142b, the second center strut 130b, and the second outer lower strut 122b form a second overall kite-shaped unit 133b. The first kite-shaped unit 133a and the second kite-shaped unit 133b are symmetrical and opposite to each other on the support section 107. Although the term "kite-shaped" is used above, it should be understood that this shape is not limited to the precise geometric definition of a kite shape. The outflow inverted V-shape 114, the first inner upper strut 142a, and the second inner upper strut 142b form an upper unit 134. The upper cell 134 is generally kite-shaped and axially aligned with the diamond-shaped cells 128 on the stent segment 107. It should be understood that, although designated as individual struts, the various struts described herein can be part of a single unitary structure as described above. However, in other embodiments, the stent 100 need not be formed as a unitary structure, and thus the struts can be different structures (or parts of different structures) coupled together.

[0028] Figure 1CA schematic diagram of a support segment 207 according to an alternative embodiment of the present disclosure is illustrated. Unless otherwise noted, like reference numerals refer to elements similar to those in support segment 100 described above but with 200-series reference numerals. Support segment 207 is substantially similar to support segment 107, including inflow nodes 202a, 202b, vertical struts 210a, 210b, first inflow inverted V-shapes 220a and second inflow inverted V-shapes 220b, and outflow nodes 204a, 204b. The structure of support segment 207 differs from that of support segment 107 in that it does not include an outflow inverted V-shape. Having Figure 1C The purpose of this embodiment of the structure of the stent segment 207 shown in the embodiment 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 oriented V-shape formed by the first internal upper strut 242a, the upper node 245 and the second internal upper strut 242b. In other words, the struts 242a, 242b can form a half diamond unit 234, wherein the open end of the half unit is oriented toward the outflow end 203. The half diamond unit 234 is axially aligned with the diamond unit 228. Adding the outflow inverted V-shape connected between the outflow nodes 204a, 204b helps to increase the additional material that modifies the resistance of the stent shape, and requires additional force to expand the stent. Excluding material from the outflow end 203 reduces the resistance to expansion on the outflow end 203, which can 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 include a continuous circumferential structure, but rather has a half-unit that is mostly or completely open, the open portion of the half-unit being oriented toward the inflow end 201, and a majority of the outflow end 203 including a substantially continuous circumferential structure via struts corresponding to struts 140a, 140b. Other things being equal, a substantially continuous circumferential structure may require greater force to expand than a similar but open structure. Furthermore, the inflow end 101 of the stent 100 may require greater force to expand radially than the outflow end 103. By omitting the inverted V-shape 114, a stent 200 is obtained in which the force required to expand the outflow end 203 of the stent 200 can be reduced to an amount closer to the inflow end 201.

[0029] Figure 1D shows a front view of the support section 207 in a folded state, and Figure 1E 207 is shown in a front view of the stent segment 207 in an expanded state. It should be understood that Figure 1D to Figure 1EThe stent 200 in FIG. 1 is illustrated with an opaque tube extending through the interior of the stent, this is purely for the purpose of helping to illustrate the stent, and this may represent the balloon on which the stent segment 207 is crimped. As described above, the stent includes three symmetrical segments, each spanning approximately 120 degrees around the circumference of the stent. Figure 1D to Figure 1E The support segment 207 shown in FIG. 2 is defined by the area between the vertical struts 210a, 210b. The support segment 207 represents all three segments of the support. The support segment 207 has an arc-shaped structure so that when the three segments are connected, they form a complete cylindrical shape. Figure 1F to Figure 1G A portion of the bracket is shown in a side view. Figure 1D to Figure 1E Compared with the view Figure 1F to Figure 1G The view of the bracket 200 in FIG. 1 is rotated approximately 60 degrees. Figure 1F to Figure 1G The view of the stent depicted in FIG is centered on a vertical strut 210b, showing approximately half of each of the two adjacent stent segments 207a, 207b located on each side of the vertical strut 210b. The segments 207a, 207b surrounding the vertical strut 210b are mirror images of each other. Figure 1F The support sections 207a, 207b are shown in a folded state, and Figure 1G Stent segments 207a, 207b are shown in an expanded state.

[0030] Figure 1H A flattened view of a support 200 comprising three support sections 207a, 207b, 207c is illustrated, as if the support had been cut longitudinally and laid flat on a table. As depicted, the sections 207a, 207b, 207c are symmetrical to each other, and adjacent sections share a common vertical support. As described above, the support 200 is shown in a flattened view, but each section 207a, 207b, 207c has an arc spanning 120 degrees to form a complete cylinder. Figure 1H 250a, 250b, 250c are further depicted coupled to the bracket 200. However, it should be understood that Figure 1H Only the connection of the blades 250a, 250b, 250c is illustrated in the figure. In other words, each blade 250a, 250b, 250c generally includes a free edge, wherein the free edges are used to engage with each other to prevent retrograde blood flow through the stent 200, and the free edges move radially outward toward the inner surface of the stent to allow antegrade blood flow through the stent. These free edges are not shown in the figure. Figure 1H In contrast, the attachment edges of blades 250a, 250b, 250c are Figure 1H250a, 250b, 250c. Each of the three blades 250a, 250b, 250c extends about 120 degrees from one end to the other around the support 200, and each blade includes a belly that can extend toward the radial center of the support 200 when the blades are joined together. Each blade extends between the upper nodes of adjacent sections. The first blade 250a extends from the first upper node 245a of the first support segment 207a to the second upper node 245b of the second support segment 207b. The second blade 250b extends from the second upper node 245b to the third upper node 245c of the third support segment 207c. The third blade 250c extends from the third upper node 245c to the first upper node 245a. Therefore, each upper node includes a first end of a first blade and a second end of a second blade coupled thereto. In the illustrated embodiment, each end of each blade is coupled to its corresponding node by suturing. However, any coupling device can be used to attach the blade to the support. It is also conceivable that the support may include any number of segments and / or blades. For example, the support may include two segments, each of which extends 180 degrees around the circumference of the support. Further, the support may include two blades to simulate a bicuspid valve. In addition, it should be noted that each blade may include a protrusion or other structure (not shown) at the junction between the free edge and the attachment edge of the blade, and each protrusion of each blade may be coupled to the protrusion of an adjacent blade to form a joint. In the illustrated embodiment, the blade joint is illustrated as being attached to the node where the pillars intersect. However, in other embodiments, the support 200 may include a joint attachment feature that is built into the support to facilitate such attachment. For example, commissure attachment features can be formed in the stent 200 at nodes 245a, 245b, 245c, wherein the commissure attachment features include one or more holes to facilitate suturing the leaf commissures to the stent. In addition, the leaflets 250a, 250b, 250c can be formed of a biological material such as animal pericardium, or can be additionally formed of a synthetic material such as ultra-high molecular weight polyethylene (UHMWPE).

[0031] Figures 1I to 1JAn artificial heart valve 206 is shown, which includes a stent 200, a cuff 260 coupled to the stent 200 (e.g., via sutures), and leaflets 250a, 250b, 250c attached to the stent 200 and / or the cuff 260 (e.g., via sutures). The artificial heart valve 206 is intended for use in replacing the aortic valve, but the same or similar structure can be used in artificial valves for replacing other heart valves. The cuff 260 is disposed on the lumen or inner surface of the stent 200, but the cuff can be alternatively or additionally disposed outside the lumen or on the outer surface of the stent. The cuff 260 may include an inflow end disposed substantially along the inflow end 201 of the stent 200. Fig. 1I A front view of the valve 206 is shown, showing a stent portion 207 located between vertical struts 210a, 210b, including a cuff 260 and the profile of two blades 250a, 250b sewn to the cuff 260. Different methods of sewing the blades to the cuff and sewing the blades and / or cuffs to the stent can be used, many of which are described in U.S. Patent No. 9,326,856, which is incorporated herein by reference. In the illustrated embodiment, the upper (or outflow) edge of the cuff 260 is sewn to the first central node 225a, the upper node 245, and the second central node 225b, extending along the first central strut 230a and the second central strut 230b. The upper (or outflow) edge of the cuff 260 continues to extend roughly between the second central node of a segment and the first central node of the adjacent segment. The cuff 260 extends between the upper node 245 and the inflow end 201. Furthermore, the cuff 260 covers the cells of the stent portion 207 formed by struts between the upper nodes 245 and the inflow end 201 , including the diamond-shaped cells 228 . Figure 1J 2 shows a side view of the support 200, including the outlines of the cuff 260 and the blade 250b. Fig. 1I Compared with the view Figure 1J The view of valve 206 in FIG. 2 is rotated approximately 60 degrees. Figure 1J The view depicted in is centered on the vertical strut 210b and shows approximately half of each of the two adjacent stent segments 207a, 207b located on each side of the vertical strut 210b. The segments 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, its outer or luminal surface, and / or both surfaces. The cuff ensures that blood does not flow solely around the valve leaflets if the valve or valve assembly is not optimally seated in the valve annulus. The cuff, or a portion of the cuff disposed on the outside of the stent, can help slow leakage around the outside of the valve (the latter being referred to as paravalvular leakage or "PV" leakage). In Figures 1I to 1JIn the illustrated embodiment, cuff 260 only covers about half of stent 200, so that about half of stent is not covered by cuff. Compared with the cuff covering most or all of stent 200, the cuff material required by this configuration is less. Less cuff material can allow artificial heart valve 206 to curl downward to a smaller profile when folded. It is conceivable that the cuff can cover any size of the surface area of ​​the cylinder formed by the stent. For example, the upper edge of the cuff can extend straightly around the circumference of any cross section of the cylinder formed by the stent. Cuff 260 can be formed by any suitable material, including biomaterials such as animal pericardium, or synthetic materials (e.g., UHMWPE).

[0032] As mentioned above, Figures 1I to 1J A cuff 260 is shown positioned on the interior of the support 200 . Figure 1K An example of an additional outer cuff 270 is shown in FIG. It should be understood that the outer cuff 270 may take any form other than Figure 1K Shapes other than those shown in . Figure 1KThe outer cuff 270 shown in the figure may not include the inner cuff 260, but is preferably provided together with the inner cuff 260. The outer cuff 270 can be integrally formed with the inner cuff 260 and folded (e.g., wrapped) over the inflow edge of the stent, or can be provided as a separate component from the inner cuff 260. The outer cuff 270 can be formed of any material 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 can be coupled to the inflow end of the stent 200 and / or the inflow edge of the inner cuff 260 (e.g., via suturing, ultrasonic welding, or any other suitable attachment means). The connection between the inflow edge 272 of the outer cuff 270 and the stent 200 and / or the inner cuff 260 is preferably such that a seal is formed 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 edge of the inner cuff 260 and the outer cuff 270. The outflow edge 274 can be connected (e.g., via sutures) to the struts of the stent 200 and / or to the inner cuff 260 at selected locations around the circumference of the stent 200. In this configuration, an opening can be formed between the inner cuff 260 and the outer cuff 270 in the circumferential direction between adjacent connection points, so that retrograde blood flow will tend to flow into the space between the inner cuff 260 and the outer cuff 270 via the opening, and cannot continue to pass beyond the inflow edge of the cuff. As blood flows into the space between the inner cuff 260 and the outer cuff 270, the outer cuff 270 can roll outward, thereby creating an even better seal between the outer cuff 270 and the native valve annulus against which the outer cuff 270 is pressed. The outer cuff 270 can be provided as a continuous cylindrical member or a strip wrapped around the outer circumference of the stent 200 with side edges that may or may not be parallel to the central longitudinal axis of the artificial heart valve, attached to each other so that the outer cuff 270 is wrapped around the entire circumference of the stent 200.

[0033] The stent can be formed of biocompatible materials, including metals and metal alloys (e.g., cobalt chromium (or cobalt chromium alloy) or stainless steel), but in some embodiments, the stent can be formed of a shape memory material (e.g., nitinol, etc.). The stent is further configured to fold when curled to a smaller diameter and / or expand when forced to open, such as via a balloon expansion within the stent, and the stent will substantially remain in its modified shape when at rest. The stent can be curled to fold in the radial direction and elongate in the axial direction (to some extent), thereby reducing its profile at any given cross-section. The stent can also expand in the radial direction and shorten in the axial direction (to some extent).

[0034] Artificial heart valve can be delivered via any suitable transvascular approach (for example, including transapical approach or transfemoral approach). Typically, transapical approach delivery uses a relatively hard catheter to penetrate the apex of the left ventricle through the patient's chest, which can cause a relatively large degree of trauma compared to delivery via the femoral approach. In delivery via the femoral approach, the delivery device that accommodates the valve is inserted through the femoral artery and resists the blood flow to the left ventricle. In either delivery method, the valve can be folded on an expandable balloon at first, and the expandable balloon is deflated at the same time. The balloon can be connected to a delivery system or arranged in a delivery system, and the delivery system can transport the valve through the body and the heart to reach the aortic valve, and the valve is arranged above the balloon (and in some cases, arranged below the sheath covering it). When arriving at the aortic valve or adjacent to the aortic valve, the surgeon or operator of the delivery system can align the artificial valve as desired in the natural valve ring, while folding the artificial valve on the balloon. When the desired alignment is achieved, the overlying sheath (if included) can be withdrawn (or advanced) to expose the prosthetic valve, and the balloon can be inflated to expand the prosthetic valve in a radial direction with at least a portion of the prosthetic valve shortened in an axial direction.

[0035] refer to Figure 2A , an example of a prosthetic heart valve PHV (which may include a stent similar to stent 100 or stent 200) is shown curled over a balloon 380 of a balloon catheter 390, with the balloon 380 in a deflated state. It should be understood that FIG. 2A to FIG. 2B Other components of the delivery device are omitted (e.g., handles for steering and / or deployment, and syringes for inflating balloon 380). The artificial heart valve PHV can be delivered intravascularly, for example, through the femoral artery, around the aortic arch, into the native aortic valve ring, and at the same time in Figure 2A Once the desired position is achieved, fluid can be pushed through balloon catheter 390 to inflate balloon 380, such as Figure 2B shown. Figure 2B The artificial heart valve PHV is omitted, but it should be understood that when the balloon 380 is inflated, it forces the artificial heart valve PHV to expand into the native aortic valve ring (but it should be understood that the concepts described herein can be used to replace other heart valves). In the example shown, fluid flows from a syringe or inflation device (not shown) through the lumen within the balloon catheter 390 into the balloon 380 and into one or more ports 385 located inside the balloon 380. Figure 2B In the particular illustrated example, the first port 385 can be one or more holes in the sidewall of the balloon catheter 390 , and the second port 385 can be the distal open end of the balloon catheter 390 , which can terminate within the interior space of the balloon 380 .

[0036] Figure 3A An example of a prosthetic heart valve PHV is shown, which has a stent 400 and a plurality of leaflets 450, which together with a cuff form a valve assembly. For clarity, the skirt or cuff of the valve and the sutures that connect the leaflets and skirt to the stent are not shown. In this configuration, an expandable balloon 490 is shown disposed inside the prosthetic heart valve PHV. The expandable balloon 490 may have a Figure 3A The expandable balloon 490 can have an interior configured to receive a fluid (e.g., a liquid such as saline, or air) to inflate the balloon, which in turn provides sufficient radial force to expand the prosthetic heart valve PHV. Suitable materials for the balloon 490 include Elastomer, nylon, polyester, PET or a multilayer material of various hardness listed. In the example shown, the expandable balloon 490 includes a plurality of pleats 492, which allows the balloon to present a generally star-shaped configuration when deflated. Specifically, the pleats 492 form a plurality of radially extending or winding arms 494, and a plurality of recesses 496 are provided between adjacent arms to receive various parts of the valve assembly (e.g., various parts of one or more blades) to protect the valve assembly during curling and delivery. The pleats 492 may include a V-shaped fold, and in one example, three pleats 492 are provided in the expandable balloon to form three arms 494. Alternatively, six pleats 492 are provided in the expandable balloon to form six arms 494. In at least some examples, the number of pleats is equal to the number of blades of the valve assembly, or is related to the number of blades (e.g., the number of pleats is a multiple of the number of blades).

[0037] As described above, the plurality of recesses 496 are sized, configured, and arranged to receive portions of the plurality of blades, and the arms 494 may be configured and arranged to gather and wrap portions of the plurality of blades 450. Figure 3B In the embodiment, the star-shaped balloon 490 is generally rolled in a first direction (e.g., clockwise), and the plurality of leaves 450 are arranged to match this pattern so that they are also rolled in the same direction (e.g., clockwise). It should be understood that both the balloon 490 and the leaves 450 can be wound in a counterclockwise direction instead. When the artificial heart valve PHV is rolled to a smaller radial dimension for delivery ( Figure 3C ), the spiral or winding pattern of the blades and / or balloon may be increased or made tighter. FIG. 4A to FIG. 4B As shown, it can be understood that the artificial heart valve PHV may also include a star-shaped balloon 490 wound in a first direction (eg, counterclockwise) and leaflets 450 wound in an opposite direction (eg, clockwise).

[0038] In this way, the expandable balloon 490 itself can perform dual functions, both expanding the artificial heart valve PHV and providing leaflet protection during crimping and delivery through its leaflet protection features (e.g., pleats and recesses). The rotation of the star-shaped or iris-shaped balloon 490 can gather the various parts of the leaflets during crimping and prevent or reduce the possibility of damaging the leaflets or valve components during crimping and delivery. When the leaflets 450 gather or get stuck between the pleats, the balloon 490 acts as a protective barrier between the various parts of the leaflets 450 and the interior of the stent 400. This gathering process may include gradually twisting the balloon 490 relative to the stent while radially crimping the artificial heart valve PHV over the balloon.

[0039] In addition to or in lieu of the protective features of the balloon described above, a removable protective sleeve 575 may be disposed between various portions of the stent 500 and the blades 550 and / or cuff 560 ( Figure 5 ). The removable protective sleeve 575 can be placed or introduced between the valve component and the stent during the crimping process, and can also be introduced into the body and removed with the balloon during delivery. In at least some examples, the protective sleeve 575 can be Elastomer, nylon, polyethylene (HDPE, or MWPE).

[0040] In an alternative embodiment, if Fig. 6A As shown, the balloon 690A may include an asymmetric configuration with several protrusions 694, adjacent protrusions defining recesses 696 sized to receive portions of the valve assembly (e.g., portions of one or more leaflets) to protect the valve assembly during crimping and delivery. The balloon may be non-circular to form an area that offsets the peak area of ​​the leaflets of the valve. See another example. Figure 6B , wherein the balloon 690B includes pairs of radially extending fingers 698 alternating with recesses 696. Specifically, each pair of radially extending fingers includes a first finger 698a, a second finger 698b, and a small gap 699 formed therebetween. Three pairs of fingers 698 are shown, each pair being approximately 120 degrees apart from each other. It should be understood that the fingers 698 can be provided individually or in pairs, as shown. Additionally, the number of fingers 698 can correspond to the number of leaves of the artificial heart valve PHV. For example, three fingers 698 can be used for three leaves. Alternatively, the fingers 698 can be a set multiple of the number of leaves (e.g., two fingers for each leaf, three fingers for each leaf, etc.). The spacing between the fingers or between the finger pairs can be adjusted as desired to set the recess spacing for the leaves of the PHV.

[0041] exist Figure 6C, a balloon 690B is shown disposed within the interior of a prosthetic heart valve PHV, and in particular within a stent 600 and a plurality of leaflets 650. Fingers 698 may be disposed between the folds 651 of the leaflets 650 to allow for safer, more controlled crimping. In addition to preventing or reducing damage to the leaflets, these configurations also allow the device to be crimped to an even smaller size. In this case, as with other embodiments, the balloon may be rotated or twisted during or prior to crimping to wrap around the leaflets and the fingers of the balloon. Fig.6D , the fingers 698 begin to coil counterclockwise and the leaflets 650 also begin to coil in the same direction. In at least some examples, the balloon 690B is introduced into the interior of the artificial heart valve PHV and then coiled or rotated relative to the support 600 so that the leaflets begin to gather and coil. After coiling the leaflets 650 and the balloon 690B, the device can be curled to a smaller circumferential diameter. In another embodiment, the coiling of the balloon 690B and the leaflets 650 is performed simultaneously with the curling process, rather than as part of a process that occurs sequentially. That is, the balloon 690B can be rotated relative to the support 600, and such coiling can occur while the artificial heart valve PHV is circumferentially reduced or curled. Based on the material used for the balloon 690B and the configuration and spacing of the fingers 698, the curled artificial heart valve 600 may be in a non-circular, fully folded state, such as Fig.6D As shown. For example, due to the size and configuration of the balloon 690B and the overall result of the winding process of both the balloon and the leaflets 650, the artificial heart valve PHV' is generally shown in the shape of a triangle or guitar pick. This concept can form larger recesses in the balloon at locations that may receive a large amount of leaflet material and valve components. The spacing and location of these recesses further maximize and control the packaging spacing during curling. Additionally, this configuration can reduce the force on the leaflets to reduce the possibility of damage, and can result in non-circular curling, which can be more easily loaded, transported, and ultimately deployed because the commissures of the leaflets are easily located.

[0042] In use, the artificial heart valve can be loaded and transported according to any of the above-mentioned modes and configurations. First, a balloon-expandable artificial heart valve can be provided, including a stent, a cuff and a plurality of leaflets, which form a valve assembly. In a partially expanded state or a fully expanded state of the artificial heart valve PHV, an expandable balloon can be introduced through the interior of the artificial heart valve PHV, and the balloon is generally in a deflated state. The artificial heart valve PHV and the balloon can form an artificial heart valve system together. The balloon can have the above-mentioned pleats, fingers or other leaflet protection features, and in some cases, the various parts of the balloon can be arranged between the various parts of the valve assembly, or the various parts of the valve assembly can be gathered in the concave part or cavity of the balloon. Optionally, the balloon can also be rotated to roll it and gather the leaflets therein. Then, the rolled balloon and leaflets can be rolled with the stent to reduce the circumferential diameter of the artificial heart valve PHV. Alternatively, when the artificial heart valve PHV is rolled, the rolling of the leaflets and / or balloon can also be completed. It should be understood that the winding of the balloon and the blades can be in the same direction (e.g., both clockwise or both counterclockwise), or the winding of the balloon and the blades can be in different directions (e.g., the first of the balloon and the blade is wound clockwise and the second of the balloon and the blade is wound counterclockwise).

[0043] According to one aspect of the present disclosure, an artificial heart valve system includes an artificial heart valve, which includes a stent, a cuff and a plurality of leaflets, which form a valve assembly; and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the artificial heart valve from a folded state to an expanded state and to protect various parts of the valve assembly during curling and delivery.

[0044] According to another aspect of the present disclosure, a method for delivering an artificial heart valve system includes providing an artificial heart valve, which includes a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and placing an expandable balloon inside the artificial heart valve in a deflated state, the expandable balloon having a feature for protecting the artificial heart valve during curling and delivery, and the feature protects various parts of the valve assembly while curling the artificial heart valve and the expandable balloon.

[0045] Although the present invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely exemplary illustrations of the principles and applications of the present invention. Therefore, it should be understood that many changes may be made to the exemplary embodiments and other arrangements may be designed without departing from the spirit and scope of the present invention as defined in the appended claims.

Claims

1. An artificial heart valve system, comprising: An artificial heart valve, the artificial heart valve comprising a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly; as well as An expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the artificial heart valve from a folded state to an expanded state and to protect various portions of the valve assembly during crimping and delivery.

2. An artificial heart valve system according to claim 1, wherein the expandable balloon comprises a plurality of pleats.

3. An artificial heart valve system according to claim 2, wherein the plurality of pleats includes three pleats.

4. An artificial heart valve system according to claim 2, wherein the plurality of pleats includes six pleats.

5. An artificial heart valve system according to claim 2, wherein the plurality of pleats correspond to the plurality of leaflets.

6. An artificial heart valve system according to claim 2, wherein the plurality of pleats define a plurality of internal recesses, and the internal recesses are configured and arranged to receive respective portions of the plurality of leaflets.

7. An artificial heart valve system according to claim 1, wherein the expandable balloon is star-shaped and includes a plurality of arms in the deflated state.

8. An artificial heart valve system according to claim 7, wherein the plurality of arms are configured and arranged to gather and wrap around respective portions of the plurality of leaflets.

9. An artificial heart valve system according to claim 8, wherein the star-shaped balloon is wound in a first direction and the plurality of leaflets are wound in a second direction, and the first direction and the second direction are similar.

10. The artificial heart valve system according to claim 8, wherein the star-shaped balloon is wound in a first direction and the plurality of leaflets are wound in a second direction, the first direction and the second direction being different.

11. The prosthetic heart valve system of claim 1, further comprising a removable protective sleeve disposed between the valve assembly and the stent frame during delivery.

12. An artificial heart valve system according to claim 1, wherein the artificial heart valve has a non-circular folded state.

13. An artificial heart valve system according to claim 12, wherein the artificial heart valve has a substantially triangular folded state.

14. A method of delivering a prosthetic heart valve system, the method comprising: Providing an artificial heart valve, the artificial heart valve comprising a stent, a cuff and a plurality of leaflets, wherein the cuff and the plurality of leaflets form a valve assembly; placing an expandable balloon within the prosthetic heart valve in a deflated state, the expandable balloon having features for protecting the prosthetic heart valve during crimping and delivery; and The features protect the various portions of the valve assembly while crimping the prosthetic heart valve and the expandable balloon.

15. The method of claim 14, further comprising rotating the expandable balloon relative to the stent of the prosthetic heart valve prior to or during crimping of the prosthetic heart valve.

16. The method of claim 14, wherein placing an expandable balloon comprises placing an expandable balloon having a plurality of pleats within an interior portion of the prosthetic heart valve.

17. The method of claim 16, wherein placing an expandable balloon comprises placing an expandable balloon having a plurality of pleats and a plurality of internal recesses, and further comprises placing portions of the plurality of leaves in the internal recesses of the expandable balloon.

18. The method of claim 14, further comprising coiling the expandable balloon into a helical configuration.

19. The method of claim 14, further comprising rolling the expandable balloon in a first direction and rolling the plurality of leaves in a second direction, the first direction and the second direction being similar.

20. The method of claim 14, further comprising coiling the expandable balloon in a first direction and coiling the plurality of leaves in a second direction, the first direction and the second direction being different.

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