Perivalvular leakage protection for balloon expandable valves

Abstract

A prosthetic heart valve system includes a balloon expandable prosthetic heart valve and a delivery catheter. A prosthetic heart valve has an inflow end portion, an outflow end portion, and a central portion. The delivery catheter has a balloon assembly on a distal end portion of the delivery catheter, the balloon assembly having a proximal end portion, a distal end portion, and a central portion. In a delivery state of the system, the prosthetic heart valve crimps on the balloon while the balloon assembly is deflated. In a deployed state of the system, the balloon assembly is inflated such that the distal end portion of the balloon assembly has a diameter greater than a diameter of the central portion of the balloon assembly and such that the outflow end portion of the prosthetic heart valve flaps radially outward relative to the central portion of the prosthetic heart valve.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 343,492 filed on May 18, 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 an open heart surgical procedure. 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 heart valves formed with a small cross-section that enable the heart valve to be delivered to a patient via a tubular delivery device in a minimally invasive procedure and then expanded to an operable state once in place, as well as heart valves that are first folded into a small cross-section after construction 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 herein as a valve assembly) mounted in an expandable stent / expandable stent. Typically, these foldable / expandable heart valves include a self-expanding or 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 in the stent / 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 on both 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 maintain the shape into which it was expanded by the balloon. Typically, when 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 the artificial heart valve expands to the natural valve ring of the replaced valve, it may be difficult to achieve a perfect seal between the outside of the artificial heart valve and the inner circumference of the natural valve ring. As described above, if a perfect seal does not occur, blood may flow through any space or gap between the outside of the artificial heart valve and the inside of the natural valve ring. Therefore, even if the valve component of the artificial heart valve functions perfectly and there is no blood backflow through the valve component, blood backflow may occur via PV leakage, thereby reducing the effectiveness of the artificial heart valve replacement surgery. If the patient is a candidate for artificial valve replacement, the patient may be more likely than the average person to have a highly calcified natural valve ring. This calcification may make it difficult to achieve a perfect seal by deploying an artificial heart valve therein. Some artificial heart valve features (e.g., an outer cuff) can help reduce the likelihood of PV leaks and / or the severity of the leak if PV leaks occur. For balloon-expandable prosthetic heart valves, certain modifications may be made to the balloon (including how the prosthetic heart valve is crimped onto the balloon, or how the balloon expands the prosthetic heart valve) or to the prosthetic heart valve itself to further reduce the likelihood and / or severity of PV leaks. Summary of the invention

[0007] According to one aspect of the present disclosure, an artificial heart valve system includes a balloon-expandable artificial heart valve and a delivery catheter. The artificial heart valve has an inflow end portion, an outflow end portion, and a central portion located between the inflow end portion and the outflow end portion. The delivery catheter has a balloon assembly located at the distal end portion of the delivery catheter, and the balloon assembly has a proximal end portion, a distal end portion, and a central portion located between the proximal end portion and the distal end portion. In the delivery state of the system, the artificial heart valve is curled on the balloon, and the balloon assembly is deflated. In the deployed state of the system, the balloon assembly is inflated so that the distal end portion of the balloon assembly has a diameter greater than the diameter of the central portion of the balloon assembly, and the outflow end portion of the artificial heart valve is radially opened outward relative to the central portion of the artificial heart valve.

[0008] According to another aspect of the present disclosure, a method for implanting an artificial heart valve includes delivering the artificial heart valve to a natural valve ring while crimping the artificial heart valve on a balloon assembly of a balloon catheter, and the balloon assembly is deflated. The method also includes inflating the balloon assembly to expand the artificial heart valve so that the central portion of the artificial heart valve contacts the natural valve ring and the inflow end portion of the artificial heart valve opens radially outward relative to the central portion of the artificial heart valve.

[0009] According to another aspect of the present disclosure, an artificial heart valve system includes an artificial heart valve, a delivery catheter, and a first outer cuff. The artificial heart valve includes a balloon-expandable stent and an artificial valve assembly installed in the stent. The delivery catheter has a balloon at the distal end portion of the delivery catheter, and the system has (i) a delivery state, in which the artificial heart valve is curled on the balloon while the balloon is deflated; (ii) a partially deployed state, in which the artificial heart valve is partially expanded and the balloon is partially inflated; and (iii) a fully deployed state, in which the artificial heart valve is fully expanded and the balloon is fully inflated. The first outer cuff is formed by a thread having a first end connected to the balloon and a second end connected to the stent, wherein in the delivery state, the first outer cuff has a middle portion that is wrapped around the stent and wrapped around a portion of the first end of the balloon that is positioned beyond the stent. 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] Figure 2Ais a side view of a prosthetic heart valve crimped onto a deflated balloon of a prosthetic heart valve delivery device.

[0019] Figure 2B It is in the inflated state Figure 2A Illustration of the balloon.

[0020] Figure 3A is a highly schematic illustration of a balloon expanding a prosthetic heart valve into the native aortic valve annulus.

[0021] FIG. 3B to FIG. 3C The diagram shows the Figure 3A A double balloon configuration with a balloon shape.

[0022] Figure 3D The diagram shows the Figure 3A A single balloon configuration with a single compliance of the balloon shape.

[0023] FIG. 3E to FIG. 3F The diagram shows the Figure 3A The balloon shape has a dual compliance single balloon configuration.

[0024] FIG. 4A to FIG. 4D Schematic diagram of the different stages of a balloon-expandable prosthetic heart valve being deployed into the native valve annulus.

[0025] FIG. 5A to FIG. 5C is a schematic diagram of a prosthetic heart valve at the same stage of being deployed via balloon dilation according to another aspect of the present disclosure. DETAILED DESCRIPTION

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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 expansion resistance 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, wherein the open portion of the half-unit is oriented toward the inflow end 201, and the majority of the outflow end 203 includes a substantially continuous circumferential structure via struts corresponding to struts 140a, 140b. Under other conditions 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, and 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.

[0031] 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, purely to help 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.

[0032] 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 respective 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 into 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 leaves 250a, 250b, 250c can be formed of a biological material (such as animal pericardium), or can be formed of a synthetic material (such as ultra-high molecular weight polyethylene (UHMWPE)).

[0033] 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, which shows a stent portion 207 between the vertical struts 210a, 210b of the cuff 260 and the profile of two blades 250a, 250b sutured to the cuff 260. Different methods of suturing the blades to the cuff and suturing 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 sutured 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 the figure is centered on the vertical strut 210b, showing approximately half of each of the two adjacent stent segments 207a, 207b 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 surface or luminal surface of the stent, its outer surface or luminal outer surface and / or both surfaces. The cuff ensures that if the valve or valve assembly is not optimally positioned in the valve annulus, the blood is not merely flowing around the valve leaflets. 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).

[0034] exist Figures 1I to 1JIn the illustrated embodiment, the cuff 260 covers only about half of the stent 200, so that about half of the stent is not covered by the cuff. Less cuff material is required using this configuration compared to a cuff that covers most or all of the stent 200. Less cuff material can allow the artificial heart valve 206 to curl down to a smaller profile when folded. It is envisioned that the cuff can cover any size surface area of ​​the cylinder formed by the stent. For example, the upper edge of the cuff can extend straight around the circumference of any cross-section of the cylinder formed by the stent. The cuff 260 can be formed of any suitable material, including a biological material such as animal pericardium, or a synthetic material (e.g., UHMWPE). As described 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 from any material described herein in relation to 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 the inner cuff 260 and the outer cuff 270 form a seal at the inflow end of the artificial 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 through 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 having side edges wrapped around the outer circumference of the stent 200, wherein the side edges 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.

[0035] 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).

[0036] Artificial heart valves can be delivered via any suitable transvascular approach (e.g., including transapical approach or transfemoral approach). Typically, transapical approach delivery uses a relatively hard catheter to penetrate the patient's chest and pierce the apex of the left ventricle, 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 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.

[0037] 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 other heart valves can be replaced using the concepts described herein). In the example shown, fluid flows from a syringe (not shown) through a lumen within a 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 .

[0038] Figure 3A is a highly schematic illustration of a prosthetic heart valve PHV expanded via a balloon 480 into the native valve annulus VA of a patient's aortic valve. In this particular embodiment, a balloon catheter 490 has been advanced through the patient's femoral artery, around the aortic arch, through the aorta A, the distal tip of the delivery device is located within the left ventricle LV, and the prosthetic heart valve PHV is expanded via the balloon 480 into the native aortic valve annulus VA, wherein the prosthetic heart valve PHV presses the native valve leaflets VL aside. The prosthetic heart valve PHV may be combined with Figures 1A to 1K The description is similar and may include an outer cuff similar to outer cuff 270, or such an outer cuff may be omitted. It should be understood that the concepts associated with this aspect of the disclosure may be used with other balloon expandable prosthetic heart valves that take forms other than those specifically described herein.

[0039] Continue to refer Figure 3A When the balloon 480 expands and forces the artificial heart valve PHV to expand into the native aortic valve ring VA, the inflow end of the artificial heart valve PHV is forced to open radially outward relative to the outflow end of the artificial heart valve PHV. After the balloon 480 is deflated, the artificial heart valve PHV remains open outward at its inflow end, which can form a better seal with the native aortic valve ring VA and thereby reduce the possibility or severity of PV leakage. Various options can be implemented to allow the balloon 480 to achieve a desired shape when inflated, which forces the artificial heart valve PHV to open outward at its inflow end.

[0040] FIG. 3B to FIG. 3C Diagram showing the implementation Figure 3A A first choice of desired balloon shape is shown in . Figure 3B is a side view of the distal end of a balloon catheter 490, which includes a catheter that can be connected to the urethra via two ports 485. Figure 2B The balloon 480 is inflated in the same manner as the balloon catheter. However, the balloon catheter includes a secondary inner balloon 481, Figure 3B The deflated state is shown in Figure 3C485. The inner balloon 481 can be positioned on a separate inflation port 486, which can be isolated from the lumen leading to the inflation port 485. The end of the inner balloon 481 can be connected to the shaft of the balloon catheter 490 so that when the fluid flows into the balloon 480 via the port 485, the inner balloon 481 will not be inflated. The inner balloon 481 can be positioned in a distal portion (e.g., a distal portion at half, a distal portion at one-third, or a distal portion at one-quarter) along the length of the balloon 480. In use, when the artificial heart valve PHV is curled on the deflated balloons 480, 481 of the balloon catheter 490, the inflow end of the artificial heart valve PHV can be positioned on the inner balloon 481. During delivery, when the prosthetic heart valve PHV is positioned within the native valve annulus, the balloon 480 may first be inflated by passing fluid through the balloon catheter 490 and through the port 485 (eg, Figure 3B Then, after the balloon 480 is inflated, fluid can flow through the balloon catheter 490 (e.g., via a different lumen that does not lead to the port 485) and out of the port 486 to inflate the inner balloon 481 to a larger diameter than the proximal side of the balloon 480. As the inner balloon 481 expands, it forces the distal end of the outer balloon 480 to also increase in diameter, forcing the inflow end of the prosthetic heart valve PHV to flare radially outward, as shown. Figure 3A Although the second balloon 481 is shown and described as being a balloon inside the balloon 480, other configurations are permitted for achieving similar results. For example, the second balloon 481 can be positioned around the outside of the first balloon 480, generally at a position similar to the first balloon 480. FIG. 3B to FIG. 3C The same axial position as shown, except that a portion of the external second balloon will be connected to the shaft of the balloon catheter 490 at a location with a dedicated port so that the second balloon can be inflated separately after the first balloon is inflated. In this embodiment, the second balloon will not push the first balloon outward, but rather during the inflation of the first balloon, the first balloon pushes the second balloon outward, and then the second balloon will be inflated in a separate second step to force the inflow end of the artificial heart valve PHV to open outward, as shown in FIG. Figure 3AAs shown. Instead of positioning the first balloon 480 and the second balloon 481 so that one is located inside the other, the second balloon 481 can be arranged as an axially separated (e.g., sequential) balloon located distal to the first balloon 480 so that there is little or no radial overlap between the two. In this embodiment, the second balloon 481 can be configured to expand to a larger diameter than the first balloon 480, and the balloons 480, 481 can be inflated simultaneously, or in a sequential manner, with the first (in this case, proximal) balloon 480 being inflated first and the second (in this case, distal) balloon 481 being inflated second. Whether inflated sequentially or simultaneously, because the second balloon 481 is inflated to a larger diameter than the first balloon 480, the inflow end of the prosthetic heart valve PHV will flare radially outward relative to the rest of the prosthetic heart valve PHV, as shown in FIG. Figure 3A shown.

[0041] Instead of using two balloons 480, 481 to achieve Figure 3A Instead of opening the inflow end of the artificial heart valve PHV shown, a single balloon 480' can be used to achieve the desired effect. Figure 3D As shown, the balloon 480' may be formed of a uniform material along the axial length of the balloon 480', but the distal end 480b' of the balloon 480' may be formed to have a slightly bulbous shape compared to the generally cylindrical proximal portion 480a' of the balloon 480' (e.g., the proximal portion at three-quarters, the proximal portion at two-thirds, or the proximal portion at one-half), wherein the distal bulbous shape 480b' has a larger diameter than the proximal cylindrical portion 480a' when inflated.

[0042] Another option (such as FIG. 3E to FIG. 3F 4. As shown in FIG. 4, a balloon 480" is formed having a proximal portion 480a" formed of a semi-compliant material and a distal portion 480b" formed of a less compliant material. With this configuration, when fluid is pushed into the balloon 480", the two portions 480a", 480b" are inflated until the balloon 480" has a diameter that forces the artificial heart valve PHV to expand into the natural valve ring VA, as shown in FIG. Figure 3E However, as additional fluid is pushed into the balloon 480", the less compliant distal segment 480b" will continue to expand, while the more compliant proximal segment 480a" will not expand significantly further. As a result, the inflow end of the artificial heart valve PHV will be forced to open radially outward relative to the rest of the artificial heart valve PHV, as shown in FIG. Figure 3A shown.

[0043] FIG. 4A to FIG. 4D Different stages of deployment of a prosthetic heart valve PHV using a balloon catheter 590 according to another embodiment of the present disclosure are illustrated. Figure 4A The balloon catheter 590 is shown in the figure in the native valve annulus VA ( FIG. 4B to FIG. 4D The valve ring is shown in Figure 4A The artificial heart valve PHV (which may be any balloon-expandable artificial heart valve, including the artificial heart valve described herein) is curled on the balloon 580 of the balloon catheter 590, and the balloon 580 is in a deflated state. Figure 4A In the illustrated state, the ribbon 510 surrounds the artificial heart valve PHV, while the artificial heart valve PHV is located above the balloon 580. In the example shown, the ribbon 510 constrains the artificial heart valve PHV and the balloon 580 to a position located at or near the axial midpoint of each component. In other words, as shown, the artificial heart valve PHV is axially centered along the length of the balloon 580, and the ribbon 510 is axially centered along the length of the balloon 580 and the artificial heart valve PHV. It should be understood that in some embodiments, other positioning may be acceptable. In other words, the ribbon 510 may be positioned to be offset to the axial center of the balloon 580 and / or the artificial heart valve PHV, but it may not be desirable for the ribbon 510 to significantly deviate from the axial center of one or both of these components.

[0044] Figure 4B The balloon 580 is illustrated at the beginning of expansion. In the illustrated embodiment, the balloon 580 may be made of a substantially uniform material and / or construction so that it is configured to expand into a generally cylindrical shape in the absence of a contractile force. The balloon 580 may begin to expand via a fluid, for example, by pushing a liquid (e.g., saline) through the lumen of a balloon catheter 590 that is fluidly connected to the interior volume of the balloon 580. It should be understood that the balloon catheter 590 and the balloon 580 may have any of the above-described configurations, or any general balloon catheter configuration, excluding the ribbon 510. The ribbon 510 limits the expansion of the balloon 580 and the artificial heart valve PHV at this axial position when the balloon 580 begins to expand, compared to other axial positions. This causes both the balloon 580 and the artificial heart valve PHV to begin to have a shape that is roughly the shape of a bone (e.g., the proximal and distal ends of the balloon 580 expand to a larger diameter than the axial center of the balloon 580). Similarly, this causes the inflow and outflow ends of the prosthetic heart valve PHV to initially expand to a larger diameter than the axial center of the prosthetic heart valve PHV (or wherever the ribbon 510 is positioned relative to the prosthetic heart valve PHV).

[0045] Figure 4CThe balloon 580 is illustrated after initial expansion has begun, the artificial heart valve PHV has been expanded to a generally dog-bone shape, such that the inflow end and outflow end of the artificial heart valve PHV are radially outwardly opened relative to the axial center of the artificial heart valve PHV, and the opened portions are generally wrapped around or otherwise outline the inflow side and outflow side of the native valve ring VA (in this case, the native aortic valve ring). The ribbon 510 is preferably designed to be perforated, torn, or otherwise broken once the balloon 580 has reached a predetermined pressure. For example, the ribbon 510 may have a generally continuous annular shape and provide perforations to partially interrupt the continuity of the annular shape. In one example, a plurality of holes or apertures may be positioned in the ribbon 510, each hole being positioned to be spaced a distance from an adjacent hole, and the holes being aligned with each other in a direction parallel to the longitudinal axis of the artificial heart valve PHV. These holes can form a preferential breaking line in the ribbon 510, so that when the balloon 580 has been pressurized enough to begin forcing the open end of the prosthetic heart valve PHV to generally wrap around or outline the natural valve annulus VA, the ribbon 510 tears along the perforation line. It should be understood that although one perforation line is described, multiple perforation lines can be provided. In other embodiments, when the expansion force of the balloon 580 exceeds the annular strength of the ribbon 510, the perforations can be omitted and the ribbon 510 can simply break. In some embodiments, the ribbon 510 is configured to break when the balloon 580 reaches a pressure between about 3 atm and about 6 atm. In some embodiments, the ribbon 510 can be made of a thermoplastic resin or elastomer (for example, Tecothane TM or ChronoPrene TM Those provided under the trade names of ) are formed.

[0046] like Figure 4C and Figure 4D As shown, the axial center of the artificial heart valve PHV can be in contact with, or almost in contact with, the natural valve ring VA when the ribbon 510 is broken. Figure 4C ), the ribbon 510 stops limiting the expansion of the balloon 580, and the axial center of the balloon 580 may expand rapidly if it has not yet contacted the native valve ring VA. In other words, before or after the ribbon 510 breaks, the axial center of the artificial heart valve PHV contacts the native valve ring VA, and the inflow end and outflow end of the artificial heart valve PHV are wrapped around the inflow side and outflow side of the native valve ring VA, or otherwise outlined (e.g., radially expanded outward), contacting the inflow side and outflow side of the native valve ring VA. The final positioning is as shown in FIG. Figure 4DAs shown, the ribbon 510 remains trapped between the exterior of the prosthetic heart valve PHV and the anatomical structures at the native valve annulus VA. In some embodiments, the ribbon 510 may have one or more portions fixed to the prosthetic heart valve PHV (e.g., via adhesive sutures) to hold the ribbon 510 in place after rupture, thereby preventing the ribbon 510 from entering circulation after rupture.

[0047] Although the above embodiments of the ribbon 510 refer to the ribbon 510 breaking or other perforations that allow for temporary contraction, it should be understood that the ribbon 510 can provide similar functionality without breaking, but rather expanding or stretching upon application of a threshold pressure or force. For example, the ribbon 510 can be formed from a stretchable polyurethane without requiring the ribbon 510 to break. In some embodiments, the ribbon 510 can be formed from polyethylene or a polyurethane known under the trade name In the stretchable ribbon 510 embodiment, the ribbon 510 can be configured to start stretching or expanding only after the artificial heart valve PHV is opened from the balloon. Figure 4B In the embodiment, the ribbon 510 may not yet have any significant stretching or expansion, and the stretching or expansion begins when additional force is applied by the balloon, such as FIG. 4C to FIG. 4D shown.

[0048] like Figure 4D As shown, the configuration of the band 510 temporarily limits the expansion of the central portion of the artificial heart valve PHV and / or the balloon 580, allowing the artificial heart valve PHV to be contoured to wrap along the surface of the native valve ring VA. This can help reduce or eliminate the possibility of PV leakage (for example, because the fit between the artificial heart valve PHV and the native valve ring VA is very tight). It should be understood that the balloon-expandable artificial heart valve PHV is generally formed of a stent with plastic expansion properties (for example, stainless steel or cobalt-chromium alloy), so the artificial heart valve PHV generally presents the shape that the balloon and / or the patient's anatomical structure forces the artificial heart valve PHV to present. Therefore, unlike self-expanding artificial heart valves, balloon-expandable artificial heart valves generally have a generally cylindrical shape when implanted, at least in part because the balloon presents a generally cylindrical shape during expansion. The above-mentioned temporary limiting band 510 can alternatively allow this open shape of the balloon-expandable artificial heart valve PHV, thereby potentially reducing or eliminating PV leakage after implantation.

[0049] although FIG. 4A to FIG. 4DIt is shown and described as a single ribbon used at the axial center of the balloon / valve assembly, but it is understood that multiple ribbons may be used and that the positioning of one or more ribbons may be different from the position shown. In some embodiments, it may be desirable or sufficient to use a configuration of the ribbons so that only the outflow end of the prosthetic heart valve PHV has an outward flare when implanted, or only the inflow end of the prosthetic heart valve PHV has an outward flare.

[0050] Similar to FIG. 4A to FIG. 4D The effects shown in the figure can be provided with other mechanisms other than the ribbon 510. For example, the frame or stent of the prosthetic heart valve PHV can be designed to have variable expansion characteristics. As an example, the strut geometry of the frame near the axial center can be different from the strut geometry near one or both ends of the stent, where the frame near the axial center requires a greater force to expand. Thus, as the balloon 580 expands, one or both ends of the frame of the prosthetic heart valve PHV will begin to expand in a manner similar to Figure 4B 580, the stent may be expanded in the manner shown, with the different strut geometries near the axial center of the stent resisting expansion until additional force is applied from the balloon 580. In some examples, the struts may be thicker near the axial center of the frame, and / or the cells may have a smaller area near the axial center of the frame, so as to achieve greater resistance to expansion at the axial center portion of the frame compared to one or both end portions of the frame. Further, while much of the present disclosure is directed to preventing or mitigating PV leakage, the outflow shape of the opening of the prosthetic heart valve PHV (e.g., Figure 4D The shape shown in ) can alternatively or additionally provide better hemodynamics than a comparable artificial heart valve that does not include such an outflow flare.

[0051] FIG. 5A to FIG. 5C The prosthetic heart valve 600 is illustrated at different stages of deployment via a balloon catheter 690, the prosthetic heart valve 600 including a PV leak mitigation feature in the form of an untied cuff. Specifically, Figure 5A The artificial heart valve 600 is shown in a folded or curled state on a deflated balloon 680 of a balloon catheter 690. The artificial heart valve 600 can take the form of any other artificial heart valve described herein, but it can include additional components in the form of one or more untied cuffs. Thus, the artificial heart valve 600 can include a cuff similar to Figures 1A to 1K The inner cuff and / or outer cuff described in the and the undone cuff may be provided as an additional PV leak mitigation feature, but preferably the style of the outer cuff 270 may be presented such that the outer cuff is omitted relative to the artificial heart valve 600.

[0052] Please still refer to Figure 5A, the artificial heart valve 600 may include a first outer cuff 670a located at the inflow end of the artificial heart valve 600, and a second outer cuff 670b located at the outflow end of the artificial heart valve 600. In some embodiments, the first outer cuff 670a can be omitted, and the second outer cuff 670b can also be omitted. Different from the outer cuff 270, each of the outer cuffs 670a to 670b is in the form of a thread, cable or other strap, which preferably has a plush or fluffy texture. In some examples, the thread, cable or other strap may be in the form of a suture, which may be twisted and fuzzy in some examples, and may be formed by PET, PE or UHMWPE. In some embodiments, the thread, cable or other strap may be formed into a multilayer structure with a high fiber count. Each outer cuff 670a, 670b may include a first end 671a, 671b of a stent connected (e.g., tied or sutured) to the artificial heart valve 600. Each outer cuff 670a, 670b can extend to a second opposite end 672a, 672b that is reversibly secured to the balloon 680. The length of each outer cuff 670a, 670b extending between the two opposite ends can generally be wrapped around the circumference of the stent of the artificial heart valve 600, partially woven into the unit (and / or wrapped around the struts that form the unit), thereby forming the stent of the artificial heart valve 600. In some embodiments, each of the outer cuffs 670a, 670b can be interwoven with the frame 1 to 10 times. When the artificial heart valve 600 is in a curled state, such as Figure 5A As shown, excess length of each outer cuff 670a, 670b can be wrapped around the balloon 680, including at a location beyond the end of the prosthetic heart valve 600.

[0053] like Figure 5B As shown, when fluid (e.g., liquid, including saline) enters balloon 680 through the lumen of balloon catheter 690, balloon 680 begins to expand, forcing artificial heart valve 600 to expand. When this happens, due to the circumferential expansion of artificial heart valve 600, outer cuffs 670a and 670b are untied. Figure 5B The balloon 680 and the artificial heart valve 600 are shown in a partially expanded state. When the balloon 680 is fully inflated, the artificial heart valve 600 reaches a state as shown in FIG. Figure 5CWhen fully expanded as shown, the outer circumference of the artificial heart valve 600 becomes equal to or substantially equal to the length of each outer cuff 670a, 670b, so that each outer cuff 670a, 670b forms a substantially circular thread at the respective inflow end / outflow end of the artificial heart valve 600. The material of the outer cuff 670a, 670b (especially if the material has a plush and / or fleecy texture) will help to reduce or eliminate PV leakage because the outer cuff 670a, 670b is pressed into the natural valve ring when the artificial heart valve 600 is fully expanded. Although some materials are described above as suitable examples of plush and / or fleecy materials / textures, other suitable examples may include poly-dacron polyester suture, polyurethane, nylon, or polyethylene. In some examples, depending on the profile of the balloon 680 when folded, the outer cuff 670a, 670b may protrude outward far enough to act as an edge protector during delivery, especially when the balloon 680 is passed through the aortic arch. In other words, the presence of one or both outer cuffs 670a, 670b prevents undesirable contact between the leading edge of the prosthetic heart valve and the anatomical structure when the balloon 680 passes through the vasculature on which the prosthetic heart valve is mounted (which contact could cause the prosthesis to fall out of the balloon 680). Said another way, if the leading edge of the balloon 680 comes into contact with the patient's anatomical structure during the dissection, the contact may occur preferentially at one or both outer cuffs 670a, 670b rather than at the edge of the prosthetic heart valve due to their positioning.

[0054] refer to Figure 5B , the second ends 672a, 672b of the outer cuffs 670a, 670b can be releasably coupled to the balloon 680 or the nose cone of the delivery device. For example, the second ends 672a, 672b can be glued or slightly stuck in the nose cone or at the proximal or distal end of the balloon coupling area. With these configurations, when the artificial heart valve 600 is in Figure 5A In the folded state, only a small portion of the length of the outer cuffs 670a, 670b needs to overlap with the artificial heart valve 600, and at least half, at least two-thirds, or at least three-quarters of the length of the outer cuffs 670a, 670b are positioned beyond the respective ends of the artificial heart valve 600. This allows the outer cuffs 670a, 670b to form a relatively small volume, especially compared to other outer cuffs that are always positioned directly above the stent of the artificial heart valve (whether folded or expanded). When the balloon 680 expands, the frame of the artificial heart valve will also expand, and the pressure may break the adhesiveness of the second ends 672a and 672b of the fixed outer cuffs.

[0055] In some embodiments, both ends of the wire or cable forming the outer cuff can be attached to the frame of the prosthetic heart valve, the slack in the wire or cable being pulled over the balloon, and then tightened during inflation, pulling the wire or cable into place to prevent or mitigate PV leaks.

[0056] According to one aspect of the present disclosure, an artificial heart valve system comprises:

[0057] a balloon expandable prosthetic heart valve having an inflow end portion, an outflow end portion, and a central portion between the inflow end portion and the outflow end portion; and

[0058] a delivery catheter having a balloon assembly located on a distal portion of the delivery catheter, the balloon assembly having a proximal portion, a distal portion, and a central portion located between the proximal portion and the distal portion,

[0059] In the delivery state of the system, the artificial heart valve is curled on the balloon, and the balloon assembly is deflated, and

[0060] wherein, in the deployed state of the system, the balloon assembly is inflated so that the distal portion of the balloon assembly has a diameter greater than the diameter of the central portion of the balloon assembly and the outflow end portion of the artificial heart valve is radially expanded outward relative to the central portion of the artificial heart valve; and / or

[0061] The balloon assembly includes a first balloon and a second balloon; and / or

[0062] The second balloon is positioned within the first balloon, the second balloon is positioned only at the distal portion of the balloon assembly, and in the deployed state of the system, the second balloon is inflated to a diameter greater than the diameter of the central portion of the balloon assembly; and / or

[0063] The first balloon is positioned within a second balloon, the second balloon is positioned only at a distal portion of the balloon assembly, and in a deployed state of the system, the second balloon is inflated to a diameter greater than a diameter of a central portion of the balloon assembly; and / or

[0064] The balloon assembly includes only a single balloon; and / or

[0065] The single balloon has uniform compliance along the length of the single balloon, the single balloon being contoured such that when the single balloon is inflated, a distal portion of the single balloon has a diameter that is greater than a diameter of a central portion of the single balloon; and / or

[0066] The single balloon has a proximal portion and a distal portion, the proximal portion having a first compliance, and the distal portion having a second compliance less than the first compliance, such that when the single balloon is inflated, the distal portion of the single balloon has a diameter greater than a diameter of the central portion of the single balloon when the central portion of the single balloon is positioned within the patient's native valve annulus; and / or

[0067] In a delivery state of the system, the ribbon constrains a central portion of the prosthetic heart valve; and / or

[0068] In the deployed state of the system, the band limits expansion of the balloon assembly to maintain the diameter of the central portion of the balloon assembly; and / or

[0069] The system has a final implant state in which the band either (i) does not constrain a central portion of the prosthetic heart valve and the band is configured to break when transitioning from the expanded state to the final implant state; or (ii) constrains a central portion of the prosthetic heart valve and the band is configured to stretch when transitioning from the expanded state to the final implant state.

[0070] According to another aspect of the present disclosure, a method of implanting an artificial heart valve includes:

[0071] delivering the prosthetic heart valve to the native valve annulus while the prosthetic heart valve is crimped onto a balloon assembly of the balloon catheter and the balloon assembly is deflated; and

[0072] Inflating the balloon assembly to expand the prosthetic heart valve so that the central portion of the prosthetic heart valve contacts the native valve ring and the inflow end portion of the prosthetic heart valve opens radially outward relative to the central portion of the prosthetic heart valve; and / or

[0073] Inflating the balloon assembly includes inflating a first balloon of the balloon assembly to a first diameter, and inflating a second balloon of the balloon assembly to a second diameter greater than the first diameter, such that the second balloon forces the inflow end of the prosthetic heart valve to expand radially outward relative to a central portion of the prosthetic heart valve; and / or

[0074] The balloon assembly includes a single balloon having uniform compliance, and inflating the balloon assembly includes inflating the single balloon into a predetermined shape in which a distal end of the single balloon has a larger diameter than a central portion of the single balloon; and / or

[0075] The balloon assembly includes a single balloon having a proximal portion and a distal portion, the proximal portion having a first compliance, the distal portion having a second compliance less than the first compliance, and inflating the balloon assembly includes inflating the single balloon until the proximal portion presses the artificial heart valve into the native valve annulus, and continuing to inflate the balloon assembly so that the distal portion of the single balloon has a diameter greater than the diameter of the central portion of the single balloon; and / or

[0076] Inflating the balloon assembly includes starting to inflate the balloon assembly while the band constrains the central portion of the prosthetic heart valve and the central portion of the balloon assembly, and continuing to inflate the balloon assembly so that the distal portion of the balloon assembly is inflated to a diameter greater than the diameter of the central portion of the balloon assembly while the band still constrains the central portion of the prosthetic heart valve and the central portion of the balloon assembly; and / or

[0077] Further inflating the balloon assembly until the ribbon breaks and no longer constrains the central portion of the prosthetic heart valve and the central portion of the balloon assembly; and / or

[0078] The artificial heart valve includes a frame formed by struts having a strut geometry, wherein the strut geometry of the frame located at the central portion of the artificial heart valve is different from the strut geometry of the frame located at the inflow end of the artificial heart valve, so that more force is required to expand the frame at the central portion of the artificial heart valve than to expand the frame at the inflow portion of the artificial heart valve.

[0079] According to yet another aspect of the present disclosure, an artificial heart valve system comprises:

[0080] An artificial heart valve, the artificial heart valve comprising a balloon expandable stent and an artificial valve assembly mounted in the stent;

[0081] a delivery catheter having a balloon located on a distal portion of the delivery catheter, the system having (i) a delivery state in which the prosthetic heart valve is crimped on the balloon while the balloon is deflated, (ii) a partially deployed state in which the prosthetic heart valve is partially expanded and the balloon is partially inflated, and (iii) a fully deployed state in which the prosthetic heart valve is fully expanded and the balloon is fully inflated; and

[0082] a first outer cuff formed of a thread having a first end coupled to the balloon and a second end coupled to the stent, wherein in a delivery state the first outer cuff has a middle portion wrapped around the stent and around a portion of the balloon positioned beyond the first end of the stent; and / or

[0083] The first outer cuff is untied when the system transitions from the delivery state to the partially deployed state to the fully deployed state; and / or

[0084] In the fully deployed state of the system, the length of the first outer cuff is substantially equal to the circumference of the stent; and / or

[0085] A second outer cuff is formed by a thread having a first end connected to the balloon and a second end connected to the stent, wherein in a delivery state, the second outer cuff has a middle portion wrapped around the stent and wrapped around a portion of the second end of the balloon positioned beyond the stent, the first outer cuff is positioned at the inflow end of the artificial heart valve, and the second outer cuff is positioned at the outflow end of the artificial heart valve.

[0086] Although the present invention has been described according to specific embodiments, it should be understood that these embodiments are merely exemplary of the principles and applications of the present invention. Therefore, it should be understood that many changes can be made to the exemplary embodiments and other arrangements can 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: a balloon expandable prosthetic heart valve having an inflow end portion, an outflow end portion, and a central portion located between the inflow end portion and the outflow end portion; as well as a delivery catheter having a balloon assembly located on a distal portion of the delivery catheter, the balloon assembly having a proximal portion, a distal portion, and a central portion located between the proximal portion and the distal portion, wherein, in the delivery state of the system, the artificial heart valve is curled on the balloon, and the balloon assembly is deflated, and Wherein, when the system is in an expanded state, the balloon assembly is inflated so that the distal portion of the balloon assembly has a diameter greater than the diameter of the central portion of the balloon assembly, and so that the outflow end portion of the artificial heart valve opens radially outward relative to the central portion of the artificial heart valve.

2. An artificial heart valve system according to claim 1, wherein the balloon assembly includes a first balloon and a second balloon.

3. An artificial heart valve system according to claim 2, wherein the second balloon is positioned inside the first balloon, the second balloon is positioned only at the distal portion of the balloon assembly, and in the expanded state of the system, the second balloon is inflated to form a diameter greater than the diameter of the central portion of the balloon assembly.

4. An artificial heart valve system according to claim 2, wherein the first balloon is positioned inside the second balloon, the second balloon is positioned only at the distal portion of the balloon assembly, and in the expanded state of the system, the second balloon is inflated to form a diameter greater than the diameter of the central portion of the balloon assembly.

5. An artificial heart valve system according to claim 1, wherein the balloon assembly includes only a single balloon.

6. An artificial heart valve system according to claim 5, wherein the single balloon has uniform compliance along the length of the single balloon, and the single balloon is contoured so that when the single balloon is inflated, the distal portion of the single balloon has a diameter greater than the diameter of the central portion of the single balloon.

7. An artificial heart valve system according to claim 5, wherein the single balloon has a proximal portion and a distal portion, the proximal portion has a first compliance, and the distal portion has a second compliance less than the first compliance, so that when the single balloon is inflated, when the central portion of the single balloon is positioned within the patient's natural valve ring, the distal portion of the single balloon has a diameter greater than the diameter of the central portion of the single balloon.

8. An artificial heart valve system according to claim 1, wherein in the delivery state of the system, the ribbon constrains a central portion of the artificial heart valve.

9. An artificial heart valve system according to claim 8, wherein in the deployed state of the system, the band limits the expansion of the balloon assembly to maintain the diameter of the central portion of the balloon assembly.

10. An artificial heart valve system according to claim 9, wherein the system has a final implantation state, in which the band either (i) does not constrain the central portion of the artificial heart valve, and the band is configured to break when transitioning from the expanded state to the final implantation state; or (ii) constrains the central portion of the artificial heart valve, and the band is configured to stretch when transitioning from the expanded state to the final implantation state.

11. A method for implanting an artificial heart valve, the method comprising: delivering a prosthetic heart valve to a native valve annulus while the prosthetic heart valve is crimped onto a balloon assembly of a balloon catheter, and the balloon assembly is deflated; as well as The balloon assembly is inflated to expand the prosthetic heart valve, so that the central portion of the prosthetic heart valve contacts the native valve annulus, and the inflow end portion of the prosthetic heart valve opens radially outward relative to the central portion of the prosthetic heart valve.

12. A method according to claim 11, wherein inflating the balloon assembly includes inflating a first balloon of the balloon assembly to a first diameter, and inflating a second balloon of the balloon assembly to a second diameter greater than the first diameter, so that the second balloon forces the inflow end of the artificial heart valve to expand radially outward relative to the central portion of the artificial heart valve.

13. A method according to claim 11, wherein the balloon assembly includes a single balloon having uniform compliance, and inflating the balloon assembly includes inflating the single balloon into a predetermined shape, in which the distal end of the single balloon has a diameter greater than the central portion of the single balloon.

14. A method according to claim 11, wherein the balloon assembly includes a single balloon, the single balloon having a proximal portion and a distal portion, the proximal portion having a first compliance, and the distal portion having a second compliance less than the first compliance, and inflating the balloon assembly includes inflating the single balloon until the proximal portion presses the artificial heart valve into the natural valve ring, and continuing to inflate the balloon assembly so that the distal portion of the single balloon has a diameter greater than the diameter of the central portion of the single balloon.

15. A method according to claim 11, wherein inflating the balloon assembly includes starting to inflate the balloon assembly while a band constrains the central portion of the artificial heart valve and the central portion of the balloon assembly, and continuing to inflate the balloon assembly so that the diameter formed by inflating the distal portion of the balloon assembly is larger than the diameter of the central portion of the balloon assembly while the band still constrains the central portion of the artificial heart valve and the central portion of the balloon assembly.

16. The method of claim 15, further comprising inflating the balloon assembly until the ribbon breaks and no longer constrains the central portion of the prosthetic heart valve and the central portion of the balloon assembly.

17. A method according to claim 11, wherein the artificial heart valve includes a frame, the frame being formed by struts having a strut geometry, the strut geometry of the frame located at the central portion of the artificial heart valve being different from the strut geometry of the frame located at the inflow end of the artificial heart valve, so that more force is required to expand the frame at the central portion of the artificial heart valve than to expand the frame at the inflow portion of the artificial heart valve.

18. An artificial heart valve system, comprising: An artificial heart valve, the artificial heart valve comprising a balloon-expandable stent and an artificial valve assembly mounted in the stent; a delivery catheter having a balloon located on a distal portion of the delivery catheter, the system having (i) a delivery state in which the prosthetic heart valve is crimped on the balloon while the balloon is deflated, (ii) a partially deployed state in which the prosthetic heart valve is partially expanded and the balloon is partially inflated, and (iii) a fully deployed state in which the prosthetic heart valve is fully expanded and the balloon is fully inflated; and A first outer cuff is formed by a thread having a first end connected to the balloon and a second end connected to the stent, wherein in the delivery state, the first outer cuff has a middle portion wrapped around the stent and wrapped around a portion of the balloon positioned beyond the first end of the stent.

19. The prosthetic heart valve system of claim 18, wherein the first outer cuff is untied when the system transitions from the delivery state to the partially deployed state to the fully deployed state.

20. The prosthetic heart valve system of claim 19, wherein in the fully expanded state of the system, the length of the first outer cuff is substantially equal to the circumference of the stent.

21. The artificial heart valve system according to claim 18 further includes a second outer cuff, which is formed by a thread-like object, and the thread-like object has a first end connected to the balloon and a second end connected to the stent, wherein in the delivery state, the second outer cuff has a middle portion wrapped around the stent and wrapped around a portion of the second end of the balloon positioned to exceed the stent, the first outer cuff is positioned at the inflow end of the artificial heart valve, and the second outer cuff is positioned at the outflow end of the artificial heart valve.

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