Active edge protection for balloon expandable valves

Abstract

A prosthetic heart valve system may include a balloon expandable prosthetic heart valve and a delivery catheter. The delivery catheter may have a balloon on a distal portion of the delivery catheter. In a delivery state of the system and in an activated state of the system, the prosthetic heart valve is mounted on the balloon such that a leading edge of the prosthetic heart valve points toward a distal end of the delivery catheter and such that the prosthetic heart valve has an outer radial extent. The delivery catheter may include a protective member operably coupled to the delivery catheter. In a delivery state of the system, the protective member does not extend radially beyond an outer radial extent of the prosthetic heart valve. In an activated state of the system, the protective member extends radially beyond an outer radial extent 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 / 343,483 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, after construction, are 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 herein as a valve assembly) 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 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 the folded or curled state to an expanded or deployed state, wherein the artificial heart valve tends to remain in the shape it is expanded into 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 cause the balloon to begin filling and expanding, 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. While an uncovered balloon expandable prosthetic heart valve may be at risk of being moved out of a desired position relative to a delivery device during any heart valve replacement procedure, this risk may be particularly acute for a transfemoral aortic valve replacement procedure because of the significant bending required as the delivery catheter is moved around the aortic arch to the native aortic valve. And while any portion of a prosthetic heart valve may be at risk of being contacted by tissue and may be moved to an undesirable position or orientation relative to a delivery device, the leading edge of the prosthetic heart valve (which is the inflow edge in a transfemoral aortic valve replacement procedure) may be at a higher risk of such contact than other portions of the prosthetic heart valve. 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 delivery catheter may have a balloon located on the distal portion of the delivery catheter. In the delivery state of the system and in the activated state of the system, the artificial heart valve is mounted on the balloon so that the leading edge of the artificial heart valve points to the distal end of the delivery catheter and the artificial heart valve has an outer radial range. The delivery catheter may include a protective member operably connected to the delivery catheter. In the delivery state of the system, the protective member does not radially extend beyond the outer radial range of the artificial heart valve. In the activated state of the system, the protective member radially extends beyond the outer radial range of the artificial heart valve.

[0008] According to another aspect of the present disclosure, an artificial heart valve system includes a balloon-expandable artificial heart valve and a delivery catheter. The delivery catheter may have a balloon located on the distal portion of the delivery catheter. In the delivery state of the system and in the activated state of the system, the artificial heart valve is mounted on the balloon so that the front edge of the artificial heart valve points to the distal end of the delivery catheter. The delivery catheter may include a front cone connected to an axis extending through the delivery catheter, and the axis can translate relative to the balloon so that the front cone translates relative to the balloon. In the delivery state of the system, the front cone is positioned at a first axial position relative to the balloon so that a portion of the balloon and the front edge of the artificial heart valve are covered by the proximal portion of the front cone. In the expanded state of the system, the front cone is positioned at a second axial position relative to the balloon, located at the distal end of the first axial position, so that the proximal portion of the front cone does not cover the front edge of the artificial heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A is a perspective view of a stent for an artificial heart valve according to an embodiment of the present disclosure.

[0010] Figure 1B yes Figure 1A Schematic front view of a section of a bracket.

[0011] 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.

[0012] Figure 1D to Figure 1E They are Figure 1C Front view of the stent segment when it is in a folded state and an expanded state.

[0013] Figure 1F to Figure 1G They are Figure 1C A side view of a portion of a stent of an embodiment in a folded state and an expanded state.

[0014] 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.

[0015] Figures 1I to 1J They include Figure 1C Front view and side view of an artificial heart valve with a stent.

[0016] Figure 1K The figure shows an additional outer cuff on the bracket. Figure 1H of the view.

[0017] Figure 2A A prosthetic heart valve is illustrated crimped onto the balloon of a delivery device.

[0018] Figure 2B yes Figure 2A Schematic diagram of the balloon after it has been inflated.

[0019] Figure 3 It is a three-dimensional view of an artificial heart valve delivery device with a protective cable in an expanded state.

[0020] Figure 4A is a side view of a prosthetic heart valve delivery device with a protective cable in a retracted state according to another aspect of the present disclosure.

[0021] FIG. 4B to FIG. 4C They are Figure 4A Side and end views of an artificial heart valve delivery device with the protective cable in an expanded state.

[0022] FIG. 5A to FIG. 5B 4 are a side view and a front view, respectively, of a protective cable according to another aspect of the present disclosure.

[0023] Figure 5C yes FIG. 5A to FIG. 5B Side view of the protective cable passing through the balloon of the balloon catheter.

[0024] Figure 5D yes Figure 5A Highly schematic illustration of a protected cable being introduced into a blood vessel by an introducer.

[0025] Fig. 6A is a side view of a distal end of a balloon catheter with a protective cable in a deployed state according to one aspect of the present disclosure.

[0026] Figure 6B It is located in the aortic arch Fig. 6A Side view of the distal end of the balloon catheter and protective cable.

[0027] Fig. 7A is a side view of the distal end of the protection cable in the inflated state.

[0028] Figure 7B is a side view of the distal end of a protection cable positioned through a balloon catheter when in an inflated state.

[0029] Figure 7C is generally similar in function to FIG. 7A to FIG. 7B A side view of an alternative embodiment of an inflatable buffer.

[0030] FIG. 8A to FIG. 8B Schematic diagrams of a balloon catheter with a protective member in a folded state and an expanded state according to another aspect of the present disclosure, respectively.

[0031] Figure 8C yes FIG. 8A to FIG. 8BA highly schematic illustration of an alternative version of a balloon catheter with the protective member in an expanded state.

[0032] FIG. 8D to FIG. 8E yes Figure 8B Schematic diagram of an alternative version of a balloon catheter with a protective member in a retracted state and an expanded state, respectively.

[0033] FIG. 9A to FIG. 9B The diagrams are schematic diagrams of a balloon catheter with a protective member according to another aspect of the present disclosure in a folded state and an expanded state, respectively.

[0034] Fig. 9C yes FIG. 9A to FIG. 9B Schematic representation of an alternative version of the balloon catheter.

[0035] FIG. 10A to FIG. 10C is a schematic diagram of another version of a balloon catheter with a protective member, wherein the protective member is in different stages of deployment.

[0036] FIG. 11A to FIG. 11B Schematic diagrams of a balloon catheter with a protective member in a folded state and a deployed state according to different aspects of the present disclosure, respectively.

[0037] Fig. 11C It is along Fig. 10A The section line 11C-11C is taken Fig.11A A cross-sectional view of a protective component.

[0038] Fig.11D It is along Fig. 10B The section line 11D-11D is taken Fig. 11B A cross-sectional view of a protective component. DETAILED DESCRIPTION

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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. All 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.

[0044] 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.

[0045] 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)).

[0046] 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 that replace 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 can 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 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 an inner or luminal surface of the stent, an outer or luminal surface thereof, 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 exterior of the stent, can help slow leakage around the exterior of the valve (the latter being referred to as paravalvular leakage or "PV" leakage). In the Figures 1I to 1JIn the illustrated embodiment, the cuff 260 only covers about half of the stent 200, so that about half of the stent is not covered by the cuff. Compared with the cuff covering most or all of the stent 200, the cuff material required by this configuration is less. Less cuff material can allow the artificial heart valve 206 to curl down to a smaller profile when folded. It is conceivable that the cuff can cover the surface area of ​​any size 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. The cuff 260 can be formed by any suitable material, including biomaterials such as animal pericardium, or synthetic materials (e.g., UHMWPE).

[0047] 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 over the inflow edge of the stent (e.g., wrapped around 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.

[0048] 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).

[0049] 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.

[0050] 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 crimped 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 (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 .

[0051] Figure 3 The distal end of a delivery device 400 for delivering and deploying a balloon-expandable prosthetic heart valve PHV is illustrated. The prosthetic heart valve PHV used with the delivery device 400 may be one of the balloon-expandable prosthetic heart valves described above, or may be virtually any balloon-expandable prosthetic heart valve. It should be understood that various components of the delivery device 400, such as a control handle located at or near the proximal end of the delivery device, a balloon to be inflated to deploy the prosthetic heart valve PHV, and the prosthetic heart valve PHV itself, have been omitted for clarity. Specifically, Figure 3 The distal portion of the delivery device 400 is shown, which includes a balloon catheter 410, which includes a balloon (not shown), and the artificial heart valve PHV (also not shown) will be curled on the balloon during delivery. The balloon catheter 410 may include a central lumen 430 extending therethrough, which may be a guide wire lumen, so that the balloon catheter 410 can be advanced on a guide wire GW that has previously been delivered to or near the natural heart valve ring to be replaced. In addition to the central lumen 430, there are multiple peripheral lumens 440. In the illustrated embodiment, four peripheral lumens 440 are shown, each of which is radially positioned outside the central lumen 430 and is about 90 degrees apart from each other. Alternatively, as few as two peripheral lumens 440 may be provided, or as many as eight or more peripheral lumens 440 may be provided, and although the peripheral lumens are preferably evenly spaced, they may have any desired spacing relative to each other.

[0052] Each peripheral lumen 440 can terminate at the distal end of the balloon catheter 410, just distal to the balloon and the artificial heart valve PHV configured to be curled over the balloon. The proximal end of the peripheral lumen 440 can be open at the proximal end of the delivery device, or can terminate at or near the handle, so that the protection cable 450 described in more detail below can be controllable via one or more actuators on the handle. The protection cable 450 can extend through each peripheral lumen 440. In the example shown, the protection cable 450 can be formed of a shape memory material (e.g., a nickel-titanium alloy, such as Nitinol), and each protection cable 450 includes a distal free end 452. The proximal end (not shown) of each protection cable 450 can be free and extend through the proximal end of the delivery device 400, so that the user can grasp and manipulate the protection cable 450 (e.g., by pulling or pushing the protection cable 450 through the peripheral lumen 440). In another embodiment, the proximal end of each protection cable 450 may be coupled to an actuator on the handle of the delivery device 400 such that sliding the actuator translates the protection cable 450 through the peripheral lumen 440 .

[0053] The distal end of the protective cable 450 can be shaped (e.g., via heat setting) so that the distal end tends to bend away from the central lumen 430 (e.g., bend back toward the proximal end of the delivery device 400). In other words, the distal end of the protective cable 450 can be shaped so that the distal-facing portion of the cable just extending beyond the peripheral lumen 440 has a generally convex curvature, while the opposing surface has a generally concave curvature. In the absence of applied force, the distal end of the protective cable 450 can be bent less than 360 degrees or greater than 360 degrees as shown. Each protective cable can be formed as only a single cable, or other shapes and / or features can be provided. For example, as shown, the distal end portion of each protective cable 450 includes a generally diamond-shaped structure 454 that can be folded when located inside the peripheral lumen 440 and expanded into the illustrated diamond shape when extending beyond the end of the peripheral lumen 440.

[0054] In use, the artificial heart valve PHV will be curled on the deflated balloon near the distal end of the balloon catheter 410, and each protective cable 450 will be completely withdrawn into their respective peripheral lumens 440 before the balloon catheter 410 is introduced into the patient. The central lumen 430 of the balloon catheter 410 can be passed through the guide wire GW, and the balloon catheter 410 can be advanced into the patient. When the distal end of the balloon catheter 410 reaches near the beginning of the aortic arch, the protective cables 450 can be advanced distally. When the protective cables 450 leave their respective peripheral lumens 440, they take on their set shape and bend proximally, as shown in FIG. Figure 3 As shown. In this case, the distance that the distal end of the protection cable 450 extends radially outward from the outer surface of the balloon catheter 410 is greater than the distance that the artificial heart valve PHV extends from the outer surface of the balloon catheter 410. In this configuration, the front edge of the curled artificial heart valve will be protected by the protection cable 450. In other words, any tissue that will be at risk of contacting the front edge of the artificial heart valve during delivery will instead contact the protection cable 450, thereby shielding the front edge of the artificial heart valve from being contacted and possibly deviating from the desired position and orientation relative to the folded balloon. In the illustrated embodiment, the diamond 454 can provide an increased protection area compared to the protection cable 450 being formed as a single cable without the diamond shape feature. By forming the front end of the protection cable 450 to present a convex profile, the protection cable 450 can contact when the delivery device 400 is advanced distally through the aortic arch.

[0055] Although the protection cable 450 is described above as being activated or deployed only when the balloon catheter 410 approaches the aortic arch, it should be understood that the protection cable 450 can be deployed earlier in the operation, such as during insertion (whether sheathless or through a sheath, such as an expandable sheath), if necessary. Furthermore, for all embodiments described herein, active edge protection can be effective during traversing the aortic arch, during insertion into the patient, or at any other desired point during the operation. And it should be understood that the protection cable 450 can be used in a delivery system 400 using other delivery routes other than transfemoral artery delivery. In other words, the protection cable 450 can be used for anatomy, not just for the aortic arch. Once the distal end of the balloon catheter 410 is located at or near the native valve ring (e.g., native aortic valve), the protection cables 450 can be withdrawn into their corresponding peripheral lumens 440 so that the balloon can be expanded and the artificial heart valve can be deployed into the native valve ring without interference from the protection cable 450. After implantation is complete, the protective cables 450 may remain retracted within their respective peripheral tubes 430 such that the protective cables 450 do not cause trauma to the patient's tissue.

[0056] It should be understood that, although not shown, the balloon catheter 410 may include additional lumens, such as an inflation lumen to allow fluid (eg, liquid such as saline) to pass through the balloon catheter 410 to inflate a balloon (not shown) to deploy the prosthetic heart valve PHV.

[0057] Figure 4A The distal end of a delivery device 500 for delivering and deploying a balloon expandable prosthetic heart valve PHV is illustrated. The prosthetic heart valve PHV used with the delivery device 500 can be any suitable balloon expandable prosthetic heart valve, including any of those described above, including a balloon expandable prosthetic heart valve in combination with the stent 200. As with the delivery device 400, certain components of the delivery device 500 are omitted for clarity, such as a control handle located at or near the proximal end of the delivery device. However, as with the Figure 3 different, FIG. 4A to FIG. 4B The prosthetic heart valve PHV is illustrated in a crimped state on a deflated balloon 580 of a balloon catheter 510. Similar to the delivery device 400, the balloon catheter 510 may include a central lumen 530 extending therethrough for receiving a guide wire GW. In addition, as with the delivery device 400, the balloon catheter 510 may include a peripheral lumen 540 (including the alternatives described therewith) in the same manner as described in conjunction with the peripheral lumen 440. Thus, FIG. 4A to FIG. 4C A specific embodiment includes four peripheral lumens 540 positioned radially outside of the central lumen 530, each peripheral lumen 540 being evenly spaced apart from an adjacent one of the peripheral lumens 540.

[0058] In the example shown, the protective cables 550 extending through their respective peripheral lumens 540 can be formed of a shape memory material (e.g., nitinol), but the protective cables 550 can be formed of other materials, including non-shape memory materials (e.g., stainless steel or any suitable polymer, such as polyether block amide (Pebax)). Although each protective cable 450 includes a distal free end 452, each protective cable 550 includes a distal fixed end 552. Similar to the protective cables 450, each protective cable 550 can have a proximal end that is connected to an actuator (e.g., an actuator on a delivery device handle) or otherwise accessible to a user for manipulation. The distal fixed end 552 of each protective cable 550 can be connected to the balloon catheter 510 only at the distal end of the balloon 580, and the connection can be via any suitable mechanism (e.g., via an adhesive, welding, mechanical connection, or any other suitable mechanism).

[0059] In the folded state, Figure 4A As shown, each of the proximal ends of the protection cable 550 can be positioned at a relatively proximal position so that the protection cable 550 is relatively tight. In other words, the protection cable 550 extends distally through the peripheral lumen 540 ( Figure 4A The protective cables 550 extend inside the balloon catheter 510 (shown in dashed lines in the figure), and at the point where the protective cables 550 leave the distal end of the peripheral lumen 540, the protective cables 550 are tightly folded back proximally to their connection points 552 with the balloon catheter 510. Therefore, in the retracted state, no part of the protective cables 550 extends radially outward beyond the artificial heart valve PHV.

[0060] In the deployed or actuated state of the protection cable 550, as shown FIG. 4B to FIG. 4C As shown, the distal end of the protective cable 550 forms an annular portion 554 that extends from the connection point 552 to the point where the protective cable 550 enters the respective peripheral lumen 540. The protective cable 550 can be transitioned to an expanded or actuated state by advancing the proximal end of the protective cable 550 distally. Because the distal-most end of the protective cable 550 is fixed to the balloon catheter 510, the protective cable 550 tends to form a ring or curved shape when actuated. This can occur regardless of whether the protective cable 550 is formed from a shape memory material (the shape memory material is shaped to present the annular shape shown in the figure). When the protective cable 550 is actuated to form the annular portion 554, as shown Figure 4CAs best shown in FIG. 5 , annular portion 554 extends radially outwardly, extending radially beyond the prosthetic heart valve PHV. Delivery device 500 can be used in substantially the same manner as delivery device 400, and therefore an exemplary use will not be described in detail. The primary difference is that the distal-most end 552 of protection cable 550 is always positioned outside of peripheral lumen 540. In other respects, the function and use of delivery device 500 and protection cable 550 are substantially the same as the function and use of delivery device 400 and protection cable 450.

[0061] Figure 5A 650 is a side view of a protective cable 650 according to another embodiment of the present disclosure, the protective cable 650 being shown in an expanded state. Preferably, the protective cable 650 is formed of a shape memory material (e.g., nitinol), but other shape memory materials are also suitable. As with other embodiments herein, it should be understood that the term "cable" does not necessarily require any specific material - for example, in some embodiments, the protective cable does not need to be formed of a metal or metal alloy. In the illustrated embodiment, the protective cable 650 includes a main shaft portion 651, which is sized and shaped to extend through the lumen of the delivery device, which will be described in more detail below. The distal end or front end of the protective cable 650 can be shaped (e.g., via heat setting) so that in the absence of applied force, the protective cable 650 forms an end cap 654 at the distal end. The end cap 654 may be formed of one or more (preferably three, four or more) separate cable portions 652 that first extend distally from the main shaft 651 and then extend a short distance in the proximal direction to present a generally convex profile at the front end of the protective cable 650. Figure 5A Only two such cable portions 652 are visible in the side view of FIG. , but more than two cable portions 652 may be included, such as Figure 5B The front view or end view of Figure 5B In the particular embodiment shown, the main shaft 651 transitions into eight separate cable sections 652, each of which is hooked at the proximal end to form a shape similar to the frame of an umbrella. In some embodiments, material can cover and / or span across each cable section 652. For example, Figure 5BAs shown, an optional cover 656 is provided across each cable portion 652. The combination of the cover 656 and the individual cable portions 652 can be conceptually similar to the material covering the frame of an umbrella to help protect objects positioned below the cover 656. The cover 656 can be formed of any suitable material (e.g., polyurethane). It should be understood that the protective cable 650 including the individual cable portions 652 and any covers 656 disposed thereon can be capable of transitioning to a substantially straight state to pass through a generally cylindrical or circular lumen of a delivery device, wherein the individual cable portions 652 and any associated covers 656 can transition to a set shape after leaving the constraints of such a lumen.

[0062] In use, such as Figure 5C As shown, the protective cable 650 can extend through the lumen (e.g., the central lumen or the peripheral lumen) of a balloon catheter on which a balloon 680 is mounted, wherein the artificial heart valve PHV (including the stent 200) is crimped on the balloon 680 while the balloon 680 is in a deflated state. Figure 5C In the view of FIG. 1 , the catheter structure of the balloon catheter is omitted from the view for clarity. In use, the balloon catheter can have a structure similar to other balloon catheters described herein or other commonly known balloon catheters. The protective cable 650 can be transitioned to the catheter at any point during the delivery process, including at the very beginning (e.g., upon entry into the patient) or at a later time (e.g., just before traversing the aortic arch). Figure 5C When the protective cable 650 is in the deployed or activated state shown in Figure 5C In the expanded state shown, if desired, the protective cable can be moved proximally relative to the balloon 680 and the artificial heart valve PHV to be positioned close to the artificial heart valve PHV as desired, including so that a portion of the cover 654 actually partially surrounds the artificial heart valve PHV. However, the cover 654 does not actually need to partially surround the artificial heart valve PHV to provide a protective effect.

[0063] The use of the protective cable 650 can be similar to that described above. In other words, because the cover 654 is positioned at the distal end of the artificial heart valve PHV when deployed and extends radially beyond the radial extent of the curled artificial heart valve PHV, when the assembly is advanced through the vascular system, the deployed cover 654 will contact tissue that might otherwise directly contact the artificial heart valve PHV (particularly the leading edge of the artificial heart valve PHV). Therefore, the position and shape of the deployed cover 654 help protect the artificial heart valve PHV from inadvertent contact with any tissue, which may cause the artificial heart valve PHV to lose its desired position and / or orientation relative to the balloon 680 and / or the balloon catheter. When the artificial heart valve PHV is at or near the final deployment site (e.g., the native aortic valve ring), the main shaft 651 of the protective cable 650 can be withdrawn proximally, forcing the cover 654 to become generally flat when it is pulled within the lumen (through which the protective cable 650 extends). The balloon 680 can then be inflated to deploy the prosthetic heart valve PHV without interference from the protective cable 650, and the protective cable 650 has been completely withdrawn from the body or otherwise retracted within the lumen inside the balloon catheter. From the above description, it can be understood that the cap 654 can function appropriately with or without the additional covering 656, but if the additional covering 656 is used, additional protection can be provided.

[0064] Figure 5D An alternative use of a protective cable 650 is illustrated, but the protective mechanism remains essentially the same. Rather than passing directly through the balloon catheter on which the prosthetic heart valve PHV is crimped, the protective cable 650 may extend through a lumen formed in the side wall of the introducer. Figure 5D As shown, the protective cable 650 can extend through the side wall of the introducer that has been introduced into the blood vessel V, so that the main central lumen of the introducer can still be passed through the balloon catheter. In other respects, the operation is basically similar, wherein the end cap 654 is positioned at the distal end of the balloon catheter (and the artificial heart valve PHV received thereon) to help protect the directional contact between the artificial heart valve PHV and the anatomical structure, which may otherwise cause an undesirable deviation in the position and / or orientation of the artificial heart valve PHV.

[0065] Fig. 6AA side view of the distal portion of a balloon catheter 710 in a delivery state is shown, wherein the artificial heart valve PHV is curled on a balloon (not shown separately). The balloon catheter 710 can be similar to those described above or any general balloon catheter, and can include a central lumen for riding on a guide wire (not shown). The balloon catheter 710 can also include one or more peripheral cavities similar to the peripheral lumen 440 of the balloon catheter 410. The protective cable 750 can extend through the peripheral lumen. In the illustrated embodiment, the protective cable 750 is in an actuated or deployed state. The protective cable 750 is preferably formed by a shape memory material (e.g., nitinol) and has the ability to be straight in the peripheral lumen or form a set shape without applying force (e.g., after exiting the constraint of the peripheral lumen). The protective cable 750 can be shaped (e.g., by heat setting) to have a distal tip that is bent backward toward the proximal end so as to present an atraumatic front end. Although the above-mentioned protective cables are generally used as a kind of "buffer", the protective cable 750 is configured to help keep the prosthetic heart valve PHV away from the tissue wall during delivery. Figure 6B As shown, the balloon catheter 710 is approaching the aortic arch AA. During delivery, the protective cable 750 can be retracted in a substantially straight state within the peripheral lumen of the balloon catheter 710. When the balloon catheter 710 approaches the aortic arch AA (or, if necessary, at an earlier point), the protective cable 750 can be advanced distally so that the distal end of the protective cable 750 leaves the peripheral lumen and maintains its set shape. Preferably, the peripheral lumen accommodating the protective cable 750 is positioned near the outer curvature of the aortic arch AA (for example, positioned on the side relatively above the uppermost part of the aortic arch AA, or on the side with a large radius of curvature). It should be understood that when the balloon catheter 710 is directed toward the natural aortic valve ( Figure 6BWhen the protective cable 750 is advanced through the aortic arch AA (not shown in the figure), the balloon catheter 710 will tend to "want" to track along the outer curvature of the aortic arch AA. This may not be desired, for example because the inflow end of the artificial heart valve PHV may have a relatively large probability of contacting tissue at the outer curvature of the aortic arch AA and undesirably shifting the position or orientation of the artificial heart valve PHV relative to the balloon and / or the balloon catheter 710. However, before advancing the balloon catheter 710 through the aortic arch AA, the protective cable 750 can be unfolded and formed into a fixed shape in which the distal tip of the protective cable 750 bends proximally and away from the outer curvature of the aortic arch AA. When the protective cable 750 is unfolded, the protective cable 750 will tend to contact the outer curvature of the aortic arch AA. The force on the protective cable 750 in contact with the outer curvature of the aortic arch AA will tend to move the distal tip of the balloon catheter 710 (and thus the artificial heart valve PHV mounted thereon) slightly away from the wall of the aortic arch AA, which helps to avoid direct contact between the artificial heart valve PHV and the wall of the aortic arch AA when the balloon catheter 710 is advanced through the aortic arch AA. In some use cases, when the balloon catheter 710 rides on the protective cable 750, the protective cable 750 can remain stationary relative to the anatomical structure. In other use cases, the protective cable 750 can move with the balloon catheter 710, for example, the protective cable 750 extends beyond the balloon catheter 710 by a set distance.

[0066] Fig. 7A 850 is a side view of a distal portion of a protective cable 850 according to another aspect of the present disclosure. As described above, the term "cable" does not necessarily require any particular material. In the illustrated embodiment, the protective cable 850 includes a main shaft 851 terminating in an inflatable cap 854. The cap 854 is Fig. 7A 854 and is shown in an inflated state, and when inflated forms a hemispherical (or bullet-shaped, rounded, or conical) shape, but other shapes may also be suitable. The main shaft 851 can be formed of any suitable material, but preferably includes an inflation lumen that is fluidly connected to the internal volume of the cover 854 and is preferably strong enough to be relatively easily pushed distally through the lumen (e.g., the central lumen or the peripheral lumen) of the balloon catheter 810. The cover 854 can be formed of any suitable material, including compliant, semi-compliant, or non-compliant balloon materials, including materials similar to the materials forming balloon 880. In some embodiments, a perfusion channel can be provided (e.g., within or on the cover 854) to allow blood to flow through or through the protective cable even when the artificial heart valve is actively protected. The perfusion channel can be provided in a manner similar to the other embodiments described herein, for example in conjunction with the following. FIG. 8A to FIG. 8B Described protective member 954.

[0067] When the cover 854 is deflated, the protective cable 850 can be partially or completely contained within the lumen of the balloon catheter 810. In other words, in the deflated state, the cover 854 can fit completely inside the lumen of the balloon catheter 810. At any desired point during delivery of the prosthetic heart valve PHV (e.g., just after insertion into the patient, or just before movement through the aortic arch), the main shaft 851 of the protective cable 850 can be advanced until the cover 854 is disengaged from the lumen of the balloon catheter 810. The cover 854 can then be inflated, for example by passing a fluid (including a liquid such as saline) through the interior lumen of the main shaft 851 and into the cover 854, so that the cover 854 is inflated. Figure 7B The overall hemispherical shape shown in . When inflated, the cover 854 can be just positioned at the distal end of the curled artificial heart valve PHV. Preferably, if the cover 854 has a hemispherical shape when inflated, the spherical portion of the shape is located at the front end or distal end of the protection cable 850, and the overall flat side is located at the rear end of the cover 854. In addition, the diameter of the inflated cover 854 is preferably large enough so that it extends radially outward at the radially outermost range of the curled artificial heart valve PHV. In this configuration, when the balloon catheter 810 and the protection cable 850 are advanced distally through the vascular system, the artificial heart valve PHV will be protected from direct contact with the tissue due to the inflated cover 854, and from undesirable repositioning or reorientation relative to the balloon 880 and / or the balloon catheter 810. When it is necessary to inflate the balloon 880 to deploy the artificial heart valve PHV, the cover 854 can be first deflated by withdrawing fluid from the cover 854 through the lumen of the main shaft 851, and then the main shaft 851 can be retracted until the deflated cover 854 is completely positioned in the lumen of the balloon catheter 810 (or is otherwise completely withdrawn from the patient's body). In turn, when the artificial heart valve PHV expands into the native valve ring, the cover 854 will not interfere with such deployment.

[0068] Figure 7C An alternative embodiment is illustrated in which an inflatable cover 854' is positioned over the balloon catheter 810'. Rather than being part of a separate protective cable, the inflatable cover 854' may be positioned directly on the outer surface of the balloon catheter 810', just distal to the balloon catheter 880' and the prosthetic heart valve PHV curled thereon. The cover 854' may be formed of urethane or another inflatable material, and an inflation lumen may pass through the balloon catheter 810' and into the interior volume of the cover 854'. When inflated, the cover 854' may have a generally donut or ring-shaped shape, with the structure of the balloon catheter 810' passing through the center of the cover 854'. FIG. 7A to FIG. 7BSimilar to the embodiment of the present invention, when the cover 854' is inflated, it radially extends beyond the outermost radial extent of the crimped prosthetic heart valve PHV, thereby providing a sealant for the combined use. FIG. 7A to FIG. 7B As with cap 854, cap 854' can be inflated prior to being moved through the aortic arch, or can be inflated at any desired time during delivery of the prosthetic heart valve PHV to the native valve annulus. Cap 854', as well as cap 854, can additionally provide a centering function when inflated, tending to force balloon catheter 810' (or balloon catheter 810) toward the center of the blood vessel in contact with the inflated cap 854' (or cap 854). Figure 7C In embodiments, it may not be necessary to deflate the cover 854' prior to deploying the prosthetic heart valve PHV, but it may still be desirable to do so to avoid any interference between the inflated cover 854' and the patient's anatomy or with deployment of the prosthetic heart valve PHV.

[0069] FIG. 8A to FIG. 8B Schematic diagrams of a balloon catheter 910 with a protective member 954 in a collapsed and expanded state are respectively illustrated. The balloon catheter 910 can have a generally similar construction to other balloon catheters described herein, including a balloon 980 near its distal end (at FIG. 8A to FIG. 8B 950 is shown as a folded or deflated state), and the prosthetic heart valve PHV can be configured to be curled on the balloon 980 during delivery. The balloon catheter 910 can extend to a distal tip 955 and can include a shaft 951 fixedly coupled to the distal tip 955. It should be understood that for clarity, FIG. 8A to FIG. 8B Other internal components (such as a guidewire lumen or balloon inflation lumen) are omitted. The shaft of the balloon catheter 910 may include a protective member 954 in the form of a highly compressible material that is flanked on either side by more conventional catheter material. FIG. 8A to FIG. 8BIn the illustrated embodiment, the main portion of the catheter shaft (including a short distance from the distal end of the balloon 980) is formed of conventional materials, such as a braided reinforced soft-melt welded shaft with a polymer (e.g., polyether block amide) sheath, which is semi-rigid but allows the operability of the balloon catheter 910 to pass through the vascular system. The polymer sheath may have a Shore D hardness between about 25D and about 72D (including about 40D), and may be formed of polyether block amide (as described above) or other materials including thermoplastic polyurethane (Pellethane), nylon or polyethylene (including high-density polyethylene). The catheter shaft from the distal tip 955 to a distance slightly close to the distal tip 955 can be formed of the same material as the main portion of the catheter shaft. However, the intermediate section between the above two sections can be formed of a highly compressible material, an example of which is silicone or urethane with a Shore hardness between about 20 and about 80 Shore A hardness. In some embodiments, more conventional but thin-walled polymer materials such as polyether block amides may be used in place of materials such as silicone or urethane to provide the desired material properties. FIG. 8D to FIG. 8E In the embodiment described above, the protective member 954 is not formed of a highly compressible material. Instead, the protective member 954 can be formed to have a heat-set shape (e.g., configured to adopt Fig. 8A or Figure 8B The protective member 954 is a nitinol braided or laser cut material (shaped as shown), and when a force is applied, the protective member 954 transitions to a shape away from the set shape. In some embodiments, the middle section is not formed of a highly compressible material, but can be formed as a multilayer material with a softer outer layer and a harder inner layer, so that the outer layer expands when the inner layer is retracted. The middle section is preferably located at the distal end of the balloon 980 and the artificial heart valve PHV carried thereon. In use, the balloon catheter 910 can pass through the patient's vascular system with the protective member 954 in a retracted state, in which the protective member has a diameter approximately equal to the adjacent portion of the balloon catheter shaft and less than the diameter of the deflated balloon 980 and the artificial heart valve PHV curled thereon. At a desired point during delivery (which can be just before reaching the aortic arch, or any other point when the balloon catheter 910 is inserted into the patient's body), the shaft 951 can be pulled proximally. By pulling the shaft 951 proximally, the distal tip 955 is also pulled proximally. Due to the high compressibility (and / or low Shore durometer) of the material forming the protective member 954, when the distal-most section of the shaft of the balloon catheter 910 is retracted toward the main section of the shaft of the balloon catheter 910, the protective member 954 will tend to expand outwardly to Figure 8B. Then, pulling the shaft 951 proximally activates the protective member 954, preferably such that the diameter of the protective member 954 is larger than the diameter of the deflated balloon 980 and the artificial heart valve PHV curled thereon. With the protective member 954 in the activated or expanded state, the balloon catheter 910 can be advanced, wherein the protective member 954 tends to ensure that the leading edge of the artificial heart valve PHV is not able to inadvertently contact tissue, which may cause the position and / or orientation of the artificial heart valve PHV to shift undesirably relative to the balloon 980 and / or the balloon catheter 910. Before the artificial heart valve PHV is deployed by inflating the balloon 980, if necessary, the protective member 954 can be transitioned back to the retracted state by advancing the shaft 951 distally. Then, preferably, the shaft 951 is capable of transmitting both tension and axial force directed distally. However, in other embodiments, the shaft 951 may only be capable of transmitting tension, and when the tension on the shaft 951 is released, the protective member 954 may tend to return to the retracted state. Fig. 8A It should also be understood that although FIG. 8A to FIG. 8B Only a single protective member 954 is illustrated, but in another embodiment, a second protective member similar or identical to that shown may be positioned just proximal to the balloon 980, such that when the protective member is deployed, the balloon 980 (and the prosthetic heart valve PHV mounted thereon) is flanked at both distal and proximal ends by the expanded protective member. This second proximal protective member may help prevent the rear end of the prosthetic heart valve PHV from contacting tissue, as well as help center the prosthetic heart valve PHV within the vasculature, and help track around the aortic arch. In addition, as described above, the protective members described herein may also be used to provide protection to the prosthetic heart valve PHV while the prosthetic heart valve PHV is inserted into a patient, or even to withdraw the undeployed prosthetic heart valve PHV from the patient through the vasculature and insertion sheath when the procedure is aborted.

[0070] Figure 8C A highly schematic diagram of the distal portion of a balloon catheter 910' is shown that is generally similar in function and structure to balloon catheter 910. Figure 8CAs shown, the balloon catheter 910' includes a front cone 955' located at the farthest end. The main shaft 956' of the balloon catheter 910' is illustrated as a balloon not mounted on the shaft, but it should be understood that the inflatable balloon similar to other embodiments described herein will be mounted on the main shaft 956', a short distance from the proximal end of the front cone 955'. An inner shaft 951' is also shown, wherein the distal end of the shaft 951' is fixedly mounted to the inner portion of the front cone 955'. For example, the shaft 951' can be hollow to allow a wire to pass therethrough, and the distal end of the shaft 951' can be directly connected to the interior of the front cone 955', or a coupling member (e.g., a ring) can be used to facilitate the connection. In the illustrated embodiment, the main shaft 956' is formed by conventional catheter materials (e.g., those materials described above in conjunction with the balloon catheter 910). However, at least the portion of the nose cone 955' proximal to the connection to the shaft 951' and the portion distal to the main shaft 956' where the balloon will be mounted are formed of a highly compressible material similar to that described above in conjunction with the protective member 954. In one embodiment, only the portion of the nose cone 955' proximal to the connection to the shaft 951' is formed of a highly compressible material such that the nose cone is formed of different materials along the length of the nose cone. In some embodiments, the entire nose cone 955' can be formed of the same material, but the proximal portion of the nose cone can include features (e.g., slits in the material) to allow the proximal portion to expand to form the protective member 954'. In this configuration, similar to the balloon catheter 910, when the shaft 956' is pulled proximally, a portion of the nose cone 955' expands radially outward to form the protective member 954'. FIG. 8A to FIG. 8B As in the embodiment of Figure 8C In the expanded state shown, the protective member 954' has a diameter that is greater than the diameter of the curled artificial heart valve PHV mounted on the deflated balloon (which is connected to the main shaft 956'). In the illustrated embodiment, the height H1 of the front cone 955' can be approximately twice the height H2 between the point where the shaft 951' is connected to the front cone 955' and the distal end of the front cone 955'. This particular relationship may not be important, but it should be understood that the height H2 represents the portion of the front cone 955' that may remain unchanged, and the height H2 is preferably large enough to allow the front cone 955' to still perform its role as the leading atraumatic tip of the delivery device. The use of the balloon catheter 910' can be substantially similar or identical to the use of the balloon catheter 910 described above, and thus will not be repeated here.

[0071] FIG. 8D to FIG. 8EA balloon catheter 910" with a protective member 954" is illustrated in a collapsed state and a deployed state, respectively. The balloon catheter 910" may be the same as the balloon catheter 910 except for the protective member 954", and therefore the other components are not described. Rather than being formed of a highly compressible (e.g., low durometer) material that expands outward under compression as the protective member 954 is, the protective member 954" may be formed of a shape memory material. For example, the protective member 954" may be formed into a universal stent-like structure or a mesh or lattice of a shape memory material, such as a nickel-titanium alloy (e.g., Nitinol). It should be understood that a coating or other covering may be provided on the mesh or lattice structure so that the interior of the balloon catheter 910" is sealed to the exterior across the protective member 954". However, the covering is preferably formed of a soft or compressible material so that the material does not significantly interfere with the protective member 954" during deployment. Fig.8D The collapsed state shown is the same as Fig. 8E Transitions between deployed or actuated states are shown. Fig.8D , the protective member 954" is illustrated with jagged lines, but it should be understood that this section of the catheter 910" can be generally cylindrical in this retracted state, having the same or similar outer diameter as the portions of the catheter 910" just proximal and distal to the protective member 954". As two examples, the protective member 954" can include a braided mesh or a laser cut tube of nitinol, which can be shaped (e.g., by heat setting) to form a generally conical or umbrella-like shape without the application of force. As shown in FIG. Fig. 8E As shown, in this set shape, the conical or umbrella-shaped open proximal end can radially extend beyond the outer range of the curled artificial heart valve PHV, and can optionally axially cover a portion of the artificial heart valve PHV (e.g., cover the front edge of the artificial heart valve PHV). In use, the protective member can be in a position when entering the patient's body. Fig.8D The stowed state of the protective member 954" may be such that a generally smooth surface is provided at the protective member 954", and a generally smooth transition is provided at the more typical shaped portions of the shaft of the catheter 910" where both ends of the protective member 954" are connected. If the protective member 954" is shaped to have Fig. 8E 951 may be used to hold the distal tip 955 in place. Fig.8D” so as to prevent the protective member 954” from changing shape. At a desired point during delivery (e.g., just before traversing the aortic arch), the shaft 951 can be pulled proximally, which, together with the protective member 954’s “desire” to return to its set shape, causes the protective member 954’ to form a protective cover 954’. As with the other embodiments described herein, the leading edge of the prosthetic heart valve PHV is thereby protected from contact with tissue, which would otherwise cause an undesirable deviation in the position and / or direction of the prosthetic heart valve PHV relative to the balloon 980 and / or balloon catheter 910’. Prior to deploying the prosthetic heart valve PHV, the shaft 951 can be advanced to transition the protective member 954’ back to the retracted state to reduce potential interference with the prosthetic heart valve PHV as it is deployed. It should be understood that even if the protective member 954’ is shaped to have Fig. 8E Even with the conical or umbrella-like shape shown in FIG. 9 , the biasing force may not be strong enough to allow the shaft 951 to be pulled from the Fig.8D The shape shown in the transition to Fig. 8E In other words, even though the protective member 954" can be shaped into a conical or umbrella-like shape, it may not spontaneously assume that shape during use of the balloon catheter 910" without applying additional force to overcome other forces at work (e.g., the connection point to a more rigid portion of the main shaft of the balloon catheter 910").

[0072] FIG. 9A to FIG. 9B is a schematic diagram of a balloon catheter 1010 according to another aspect of the present disclosure. Figure 5C , FIG. 9A to FIG. 9B Many components of the balloon catheter 1010 are omitted from the view of FIG. 1 , including the shaft on which the balloon 1080 is mounted, and the proximal section of the balloon catheter 1010 (including the control handle). Fig.9A The nose cone 1054 of the balloon catheter 1010 for delivering a prosthetic heart valve PHV is illustrated in a collapsed state. The nose cone 1054 can be formed as a generally conical or bullet-shaped member, preferably with an atraumatic tip and a gentle taper from the largest proximal section to a narrowed distal section. FIG. 9A to FIG. 9B The cross-sectional view of FIG. 1 shows that the front cone 1054 can be two separate, unconnected parts, but the front cone 1054 can be formed as a single, integral member. Fig. 9B As best shown in FIG. 1 , the front cone 1054 can form an inner cavity that is generally complementary to the shape of the deflated balloon 1080 and the prosthetic heart valve PHV crimped thereon. FIG. 9A to FIG. 9BThe anterior cone 1054 may be substantially solid but with a central lumen extending therethrough that is sized and shaped to receive a guide wire (not shown) therethrough. The axial central portion of the nose cone 1054 may have an inner cavity that is generally shaped to receive a distal portion of a deflated balloon, such as Fig.9A The most proximal section of the nose cone 1054 may include an even larger lumen than the central portion, the lumen being sized such that the most proximal section of the nose cone 1054 receives the leading end of a prosthetic heart valve PHV mounted on the deflated balloon 1080 .

[0073] Similar to the above-described embodiments, the balloon catheter 1010 may include an inner shaft 1051 coupled to a nose cone 1054 . The shaft 1051 can be a solid member or a member having a tubular cavity (e.g., sized and shaped to receive a guide wire (not shown) therethrough). In either case, the shaft 1051 is preferably capable of transmitting pushing and pulling forces to the front cone 1054. In use, before the balloon catheter 1010 is advanced into the patient's body, after the artificial heart valve PHV is crimped onto the deflated balloon 1080, the front cone 1054 is pulled proximally (e.g., by pulling the shaft 1051 proximally). Once the distal end of the balloon 1080 is received in the lumen of the front cone 1054 and the proximal end of the front cone 1054 covers the front edge of the artificial heart valve PHV, the balloon catheter 1010 can be advanced into and through the patient's vascular system. As long as the proximal end of the front cone 1054 covers the proximal end of the artificial heart valve PHV The front edge of the prosthetic heart valve PHV is protected from inadvertent contact with tissue and movement of the position of the prosthetic heart valve PHV by the front cone 1054. When the prosthetic heart valve PHV is located in or adjacent to the intended target site (e.g., the native aortic valve), the front cone 1054 can be advanced distally (e.g., by sliding the shaft 1051 distally). Once the proximal end of the front cone 1054 leaves the prosthetic heart valve PHV (and preferably also leaves the balloon 1080), the balloon 1080 can be inflated to deploy the prosthetic heart valve PHV without interference from the front cone 1054. After deployment, the balloon 1080 can be deflated by withdrawing fluid from the balloon 1080, and before withdrawing the balloon catheter 1010 from the patient's body, the front cone 1054 can be pulled proximally to receive the distal end of the balloon 1080 again.

[0074] FIG. 9A to FIG. 9BOne potential disadvantage of the configuration of the balloon catheter 1010 shown in is that the profile of the assembly may be larger relative to a similar device having a nose cone that does not cover the prosthetic heart valve PHV. In other words, the thickness of the nose cone 1054 covering the prosthetic heart valve PHV increases the overall diameter of the assembly during delivery, and it is generally desirable to minimize the diameter of the assembly during delivery when possible. In turn, Fig. 9C An alternative configuration of a balloon catheter 1010' is shown, which is similar in most respects to FIG. 9A to FIG. 9B The balloon catheter 1010' is similar to the balloon catheter 1010'. The main difference is that the artificial heart valve PHV is curled on the balloon 1080' in a tapered configuration, wherein the leading edge of the artificial heart valve PHV is positioned closer to the longitudinal center of the balloon catheter 1010' than the rear end of the artificial heart valve PHV. The front cone 1054' can be similar to the front cone 1054, with the main difference that the inner cavity of the front cone 1054' can have a complementary tapered profile to receive the leading edge of the artificial heart valve PHV therein. In this configuration, the maximum outer diameter of the front cone 1054' can be slightly smaller than the maximum outer diameter of the front cone 1054, thereby allowing a smaller profile during delivery. Balloon catheter 1010' operates identically to balloon catheter 1010 in other respects. It should be understood that even though the prosthetic heart valve PHV is crimped onto the balloon 1080' with a tapered profile, the balloon 1080' and the prosthetic heart valve PHV may assume a generally cylindrical shape when the balloon 1080' expands during deployment.

[0075] FIG. 10A to FIG. 10B is a schematic illustration of a distal portion of a balloon catheter 1110 according to another aspect of the present disclosure. As with other embodiments described herein, the balloon catheter 1110 can include a balloon 1180 mounted to the shaft 1112 of the balloon catheter 1110, and the artificial heart valve PHV can be curled onto the deflated balloon 1180 for delivery. A guidewire lumen 1130 can pass through a central portion of the balloon catheter 1110 so that the balloon catheter 1110 can ride on a guidewire (not shown) previously inserted into the patient. The material forming the guidewire lumen 1130 can be any suitable material, including, for example, a braided or non-braided polyimide, or a braided or non-braided high-density polyethylene ("HDPE"). Although not shown, the balloon catheter 1110 can still include an atraumatic distal tip or nose cone located at the distal end of the protective member 1154, which will be described in more detail below.

[0076] The protective member 1154 can be positioned within the shaft 1112 of the balloon catheter 1110 and outside the guidewire lumen 1130, near or at the distal end of the shaft 1112. In the illustrated embodiment, the protective member 1154 can be formed as a braided structure that is generally cylindrical when stowed within the balloon catheter 1110. The material forming the braided structure of the protective member 1154 can be a polymer or a shape memory alloy, such as nickel titanium (including Nitinol). If formed from a shape memory material, the protective member 1154 can be shaped as described below, but it should be understood that the protective member 1154 can function as intended without having a specifically set shape. Although in FIG. 10A to FIG. 10C Not shown, the protective member 1154 may extend proximally (or the connector member may extend proximally), for example to a handle of a delivery device including the balloon catheter 1110, so that the protective member 1154 can translate distally or proximally relative to the axis 1112 of the balloon catheter 1110.

[0077] During delivery of the prosthetic heart valve PHV, the protective member 1154 can be in a retracted state, wherein the protective member 1154 is completely located inside the shaft 1112 of the balloon catheter 1110. When it is desired to activate the protective function of the protective member 1154 (e.g., just before traversing the aortic arch), the user can slide the protective member 1154 distally. Fig. 10B As shown, when the distal end of the protective member 1154 leaves the constraint of the shaft 1112 of the balloon catheter 1110, the distal end of the protective member 1154 is allowed to expand. In some embodiments, the shape of the protective member 1154 can be set to expand to Fig. 10B In some embodiments, merely releasing the restraint on protective member 1154 can cause or allow protective member 1154 to begin expanding.

[0078] When the balloon catheter 1110 is advanced after activating the protection member 1154, the distal end of the protection member 1154 may remain Fig. 10B In the case where the distal end of the protective member 1154 contacts the tissue during delivery, the distal end of the protective member 1154 can be forced to flip backward, such as Fig. 10C As shown, the protective member 1154 covers the front edge of the artificial heart valve PHV. When the front edge of the artificial heart valve PHV is covered by the protective member 1154, the artificial heart valve PHV will be protected from direct contact with tissue and undesirable changes in its position or orientation. In some embodiments, if the protective member 1154 is formed of a shape memory material, the protective member 1154 can be shaped as Fig. 10CWhen the artificial heart valve PHV needs to be deployed, no matter the protective member 1154 is in Fig. 10B or Fig. 10C In the state shown in , the protective member 1154 can be retracted by pulling it proximally, forcing the protective member 1154 to slide back into the space between the shaft 1112 of the balloon catheter 1110 and the guidewire lumen 1130. Then, the artificial heart valve PHV can be deployed via the expansion of the balloon 1180 without interference from the protective member 1154.

[0079] FIG. 11A to FIG. 11B 1 is a schematic illustration of a distal portion of a balloon catheter 1210 according to another aspect of the present disclosure. As with other embodiments described herein, the balloon catheter 1210 can include a balloon 1280 mounted to the shaft of the balloon catheter 1210, and the prosthetic heart valve PHV can be crimped onto the deflated balloon 1280 for delivery. A guidewire lumen (not shown) can pass through the central portion of the balloon catheter 1210 so that the balloon catheter 1110 can ride on a guidewire (not shown) previously inserted into the patient's body. An atraumatic tip 1255 can be disposed at the distal-most end of the balloon catheter 1210.

[0080] A protective member 1254 in the form of a capsule can be disposed proximate to (and coupled to) the distal tip 1255. The capsule 1254 and / or the tip 1255 can be coupled to an inner shaft (not shown) that can translate relative to the balloon 1280 in a manner similar to that described above for other shafts described herein (e.g., shafts 951, 1051). Fig.11A As shown, capsule 1254 can be generally cylindrical. Fig. 11C As shown, the generally cylindrical shape may include one or more folded regions to reduce the profile of the capsule 1254 when in the collapsed state. When in the extended or collapsed state, the balloon catheter 1210 may be passed through the introducer and into the patient's vasculature.

[0081] At any point after the balloon catheter 1210 has entered the patient's vasculature, the capsule 1254 can transition to an expanded state to protect the prosthetic heart valve PHV. To accomplish this transition, the inner shaft coupled to the distal tip 1255 and / or the capsule 1254 can be retracted. When the capsule 1254 is retracted relative to the prosthetic heart valve PHV, the capsule 1254 will slide along the inclined portion 1213, forcing the capsule to expand and increase its inner diameter as it covers the prosthetic heart valve PHV thereon. Fig.11DAs shown, when unfolded, the capsule 1254 can be substantially cylindrical, without (or with relatively small) folds, so that it is large enough to cover the artificial heart valve PHV. This is compared to the extended or retracted state, in which, due to the folding of the capsule 1254, the outer diameter of the capsule 1254 is approximately equal to the outer diameter of the deflated balloon 1280 and / or the curled artificial heart valve PHV. In one embodiment, the capsule 1254 can be formed together with a low friction lining (e.g., HDPE or PTFE) and a reflow polymer sheath (e.g., polyether block amide). A hydrophilic coating can also be provided on the outside of the capsule 1254 to achieve smoother navigation. Similar hydrophilic coatings can be provided to other embodiments described herein for similar purposes. The use of the balloon catheter 1210 can be substantially similar to the other embodiments described herein, and therefore will not be described in detail here.

[0082] According to one aspect of the present disclosure, an artificial heart valve system comprises:

[0083] Balloon-expandable prosthetic heart valves; and

[0084] a delivery catheter having a balloon at a distal portion of the delivery catheter, wherein in a delivery state of the system and in an activated state of the system, the prosthetic heart valve is mounted on the balloon such that a leading edge of the prosthetic heart valve points toward the distal end of the delivery catheter and such that the prosthetic heart valve has an outer radial extent,

[0085] wherein the delivery catheter comprises a protective member operably coupled to the delivery catheter, and in a delivery state of the system, the protective member does not extend radially beyond the outer radial extent of the artificial heart valve, and in an activated state of the system, the protective member extends radially beyond the outer radial extent of the artificial heart valve; and / or

[0086] The delivery catheter includes a plurality of peripheral lumens extending through a sidewall thereof, and the protective member includes a plurality of protective cables, each protective cable extending through a respective one of the peripheral lumens; and / or

[0087] Each of the plurality of protective cables is formed of a shape memory material; and / or

[0088] Each of the plurality of protective cables has a distal free end that is positioned within a corresponding one of the peripheral lumens in a delivery state of the system, the distal free end extending beyond the peripheral lumen and bending proximally in an activated state of the system; and / or

[0089] Each of the plurality of protective cables has a distal end, each of the distal ends of the protective cables being fixed to a corresponding connection point on the outer surface of the delivery catheter so that a distal end portion of each of the plurality of protective cables exits a corresponding one of the peripheral lumens and turns proximally of the connection point; and / or

[0090] The protective member is a protective cable having a main axis and a plurality of distal cable end portions extending from the main axis, the distal cable portions forming an umbrella-like shape in the absence of applied force; and / or

[0091] a covering material coupled to a distal cable portion that protects the cable; and / or

[0092] In an activated state of the system, the distal cable portion of the protective cable covers the leading edge of the artificial heart valve; and / or

[0093] The protective member comprises a shaft and an inflatable member at a distal end of the shaft, the inflatable member having a hemispherical or bullet shape when inflated, the inflatable member being inflated in an activated state of the system; and / or

[0094] The axis of the protective member is translatable relative to the delivery catheter, and the inflatable member is received within the delivery catheter when the inflatable member is deflated in the delivery state; and / or

[0095] The protective member is directly coupled to a delivery catheter distal to the balloon, the protective member being an inflatable member that is deflated in a delivery state of the system and inflated in an activated state of the system; and / or

[0096] The protective member is a portion of a delivery catheter positioned distal to the balloon, the protective member having a compressibility greater than the compressibility of other portions of the delivery catheter adjacent to the protective member; and / or

[0097] a shaft coupled to a distal tip of the delivery catheter, wherein proximally retracting the shaft pulls the distal tip proximally to transition the prosthetic heart valve system from a delivery state to an activated state; and / or

[0098] The protective member is part of a delivery catheter positioned distal to the balloon, the protective member comprising a woven mesh formed of a shape memory material; and / or

[0099] In the delivery state of the system, the protective member is generally cylindrical, and in the activated state of the system, the braided mesh forms a conical or umbrella-like shape covering the leading edge of the prosthetic heart valve; and / or

[0100] The protective member is a generally cylindrical woven mesh that is contained within a delivery catheter radially inward of the balloon in a delivery state of the system; and / or

[0101] The protective member is translatable relative to the balloon, the distal portion of the protective member extending beyond the distal end of the delivery catheter in an activated state of the system; and / or

[0102] The protective member is a capsule positioned distal to the balloon when the system is in a delivery state, the protective member comprising a plurality of folds in the delivery state of the system; and / or

[0103] The capsule covers the balloon and the artificial heart valve in an activated state of the system, and the protective member does not include a plurality of folds in the activated state of the system.

[0104] According to another aspect of the present disclosure, an artificial heart valve system comprises:

[0105] Balloon-expandable prosthetic heart valves; and

[0106] a delivery catheter having a balloon located at a distal portion of the delivery catheter, wherein in a delivery state of the system and in an activated state of the system, the prosthetic heart valve is mounted on the balloon such that a leading edge of the prosthetic heart valve points toward the distal end of the delivery catheter,

[0107] wherein the delivery catheter includes a nose cone coupled to a shaft extending through the delivery catheter, the shaft being translatable relative to the balloon such that the nose cone translates relative to the balloon,

[0108] wherein in a delivery state of the system, the nose cone is positioned at a first axial position relative to the balloon such that a portion of the balloon and a leading edge of the prosthetic heart valve are covered by a proximal portion of the nose cone, and

[0109] Wherein, in the deployed state of the system, the front cone is positioned at a second axial position relative to the balloon, distal to the first axial position, so that the proximal portion of the front cone does not cover the front edge of the artificial heart valve.

[0110] Although the present invention has been described with respect 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 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: balloon-expandable prosthetic heart valves; as well as a delivery catheter having a balloon at a distal portion of the delivery catheter, wherein in a delivery state of the system and in an activated state of the system, the artificial heart valve is mounted on the balloon such that a leading edge of the artificial heart valve points toward the distal end of the delivery catheter and such that the artificial heart valve has an outer radial extent, The delivery catheter includes a protective member, which is operably connected to the delivery catheter, and in the delivery state of the system, the protective member does not radially extend beyond the outer radial range of the artificial heart valve, and in the activated state of the system, the protective member radially extends beyond the outer radial range of the artificial heart valve.

2. An artificial heart valve system according to claim 1, wherein the delivery catheter includes a plurality of peripheral lumens extending through the side wall of the delivery catheter, and the protective member includes a plurality of protective cables, each protective cable extending through a corresponding one of the peripheral lumens.

3. An artificial heart valve system according to claim 2, wherein each of the plurality of protective cables is formed of a shape memory material.

4. An artificial heart valve system according to claim 3, wherein each of the multiple protective cables has a distal free end, which is positioned in a corresponding peripheral lumen in the peripheral lumen in the delivery state of the system, and the distal free end extends beyond the peripheral lumen in the activated state of the system and bends proximally.

5. An artificial heart valve system according to claim 2, wherein each of the multiple protective cables has a distal end, and each of the distal ends of the protective cables is fixed to a corresponding connection point on the outer surface of the delivery catheter, so that the distal end portion of each of the multiple protective cables leaves the corresponding one of the peripheral lumens and turns toward the proximal end of the connection point.

6. An artificial heart valve system according to claim 1, wherein the protective component is a protective cable, the protective cable having a main axis and a plurality of distal cable end portions, the plurality of distal cable end portions extending from the main axis, and the distal cable portions forming an umbrella shape when no force is applied.

7. The prosthetic heart valve system of claim 6, further comprising a covering material coupled to the distal cable portion of the protective cable.

8. An artificial heart valve system according to claim 5, wherein in the activated state of the system, the distal cable portion of the protective cable covers the front edge of the artificial heart valve.

9. An artificial heart valve system according to claim 1, wherein the protective member includes an axis and an inflatable member located at the distal end of the axis, the inflatable member having a hemispherical or bullet-shaped shape when inflated, and the inflatable member is inflated in the activated state of the system.

10. An artificial heart valve system according to claim 9, wherein the axis of the protective member is translatable relative to the delivery catheter, and when the inflatable member is deflated in the delivery state, the inflatable member is received in the delivery catheter.

11. An artificial heart valve system according to claim 1, wherein the protective member is directly connected to the delivery catheter located at the distal end of the balloon, and the protective member is an inflatable member, which is deflated in the delivery state of the system and inflated in the activated state of the system.

12. An artificial heart valve system according to claim 1, wherein the protective member is a portion of the delivery catheter positioned at the distal end of the balloon, and the protective member has a compressibility greater than the compressibility of other portions of the delivery catheter adjacent to the protective member.

13. The artificial heart valve system according to claim 12 further comprises an axis connected to the distal tip of the delivery catheter, wherein proximal retraction of the axis pulls the distal tip proximally to transition the artificial heart valve system from the delivery state to the activation state.

14. An artificial heart valve system according to claim 1, wherein the protective member is a portion of the delivery catheter positioned distal to the balloon, the protective member comprising a woven mesh formed of a shape memory material.

15. An artificial heart valve system according to claim 14, wherein in the delivery state of the system, the protective member is generally cylindrical, and in the activated state of the system, the woven mesh forms a conical or umbrella shape covering the front edge of the artificial heart valve.

16. An artificial heart valve system according to claim 1, wherein the protective member is a generally cylindrical woven mesh, and the protective member is contained in the delivery catheter located radially inside the balloon in the delivery state of the system.

17. An artificial heart valve system according to claim 16, wherein the protective member is translatable relative to the balloon, and the distal portion of the protective member extends beyond the distal end of the delivery catheter in the activated state of the system.

18. The prosthetic heart valve system of claim 1, wherein the protective member is a capsule positioned distal to the balloon when the system is in the delivery state, the protective member comprising a plurality of folds in the delivery state of the system.

19. The prosthetic heart valve system of claim 18, wherein the capsule covers the balloon and the prosthetic heart valve in the activated state of the system, and the protective member does not include the plurality of folds in the activated state of the system.

20. An artificial heart valve system, comprising: balloon-expandable prosthetic heart valves; as well as a delivery catheter having a balloon located at a distal portion of the delivery catheter, wherein in a delivery state of the system and in an activated state of the system, the artificial heart valve is mounted on the balloon such that a leading edge of the artificial heart valve points toward the distal end of the delivery catheter, wherein the delivery catheter includes a nose cone coupled to a shaft extending through the delivery catheter, the shaft being translatable relative to the balloon such that the nose cone translates relative to the balloon, wherein in the delivery state of the system, the nose cone is positioned at a first axial position relative to the balloon such that a portion of the balloon and the leading edge of the prosthetic heart valve are covered by a proximal portion of the nose cone, and Wherein in the expanded state of the system, the front cone is positioned at a second axial position relative to the balloon, distal to the first axial position, so that the proximal portion of the front cone does not cover the front edge of the artificial heart valve.

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