Prosthetic heart valve delivery device and system

Abstract

A delivery device includes a catheter and an inflatable balloon coupled to the catheter, the inflatable balloon forming an anterior occipital portion and a posterior occipital portion spaced apart from the anterior occipital portion, the anterior occipital portion and the posterior occipital portion defining a valve seat therebetween to retain a prosthetic heart valve during tracking of the delivery device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 382,812, filed on November 8, 2022, the contents of which are incorporated herein by reference in their entirety as if fully set forth. Background Art

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

[0004] Foldable / expandable artificial heart valves are usually in the form of a one-way valve structure (generally referred to herein as a valve assembly) mounted 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 stent layouts of different configurations-including straight vertical struts connected by "V" as shown in U.S. Patent No. 8,454,685, or a diamond unit layout as shown in U.S. Patent No. 9,326,856, both of which are incorporated herein by reference. The one-way valve assembly mounted in the stent / stent includes one or more blades and may also include a cuff or skirt. The cuff may be arranged on the inner surface or lumen surface of the stent, on its outer surface or lumen outer surface, and / or on both surfaces. If the valve or valve components are not optimally seated in the valve annulus, the cuff helps ensure that blood does not just flow around the valve leaflets. The cuff or a portion of the cuff disposed on the outside of the stent can help slow leakage around the outside of the valve (the latter 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, with the folded valve being covered or uncovered by an overlying sheath. Once the curled artificial heart valve is positioned within the annulus of the native heart valve being replaced, the balloon is inflated to force the balloon expandable valve to transition from a folded or curled state to an expanded or deployed state, wherein the artificial heart valve tends to remain in the shape into which it was expanded by the balloon. Typically, when the position of the folded artificial heart valve is determined to be in a desired position relative to the native annulus (e.g., via visualization under fluoroscopy), a fluid (typically a liquid, but a gas may also be used) such as saline is pushed through the balloon catheter via a syringe (manually, automatically, or semi-automatically) to begin filling and expanding the balloon, thereby expanding the overlying artificial heart valve into the native annulus.

[0006] It is desirable for TAVR devices to have acceptable trackability to ensure atraumatic contact with the vasculature, as well as reliable implant performance, including proper valve retention around the delivery device during the delivery process. This is particularly true for prosthetic valves that are exposed to the anatomy during tracking, such as most balloon expandable valves. The embodiments described herein may generally relate to features for improving the trackability of TAVR devices and / or delivery devices and for improving TAVR device retention during delivery and deployment. Summary of the invention

[0007] A delivery device includes a catheter and an inflatable balloon connected to the catheter, the inflatable balloon forming an anterior occipital portion and a posterior occipital portion spaced apart from the anterior occipital portion, the anterior occipital portion and the posterior occipital portion defining a valve seat therebetween to hold an artificial heart valve during tracking of the delivery device.

[0008] A method for delivering an artificial heart valve, the method comprising providing a delivery device, the delivery device having a catheter and an inflatable balloon connected to the catheter, an anterior occipital portion and a posterior occipital portion spaced apart from the anterior occipital portion being formed on the balloon, the anterior occipital portion and the posterior occipital portion defining a valve seat, placing the artificial heart valve on the valve seat, and when the artificial heart valve is disposed between the anterior occipital portion and the posterior occipital portion of the delivery device, advancing the delivery device to the patient's natural aortic 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 in a folded state and an expanded state.

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

[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 inflation.

[0019] FIG. 3A to FIG. 3B is a schematic illustration of the balloon before and after formation of the occipital part.

[0020] FIG. 4A to FIG. 4C is a schematic illustration showing the formation of a pillow on a balloon via a heat setting process.

[0021] FIG. 5A to FIG. 5B is a schematic illustration of a balloon having a shoulder.

[0022] FIG. 6A to FIG. 6B is a schematic illustration of the shortening of the saccule during occipital formation.

[0023] Figure 6C is a schematic illustration of the addition of a curved cone to improve trackability.

[0024] FIG. 7A to FIG. 7B is a schematic illustration of the internal retaining elements.

[0025] FIG. 8A to FIG. 8D are schematic illustrations of several examples of balloons having an occipital portion. DETAILED DESCRIPTION

[0026] As used herein, when used in conjunction with an artificial heart valve, the term "inflow end" refers to the end of the artificial valve that blood first enters when the artificial valve is implanted in the expected position and orientation, and the term "outflow end" refers to the end of the artificial valve that blood leaves when the artificial valve is implanted in the expected position and orientation. Further, for an artificial aortic valve, the inflow end is the end closer to the left ventricle, and the outflow end is the end closer to the aorta. The expected position and orientation are used for convenience in describing the valve disclosed herein, however, it should be noted that the use of the valve is not limited to the expected position and orientation, but can be deployed in any type of lumen or channel. For example, although the artificial heart valve is described herein as an artificial aortic valve, the same or similar structure and features can be used for other heart valves (e.g., pulmonary valve, mitral valve, or tricuspid valve). Further, when used in conjunction with a delivery device or system, the term "near" refers to the direction relatively close to the user of the device or system when used as intended, and the term "far" 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 farther than 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 included within the scope of the modified term. As used herein, a stent can assume an "expanded state" and a "folded state," which refers to the relative radial dimensions of the stent.

[0027] Figure 1A A perspective view of a stent 100 of an artificial heart valve according to an 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, each of which 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 the entire axial length between the inflow end 101 and the outflow end 103 of the stent 100, and may be disposed between 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 having three leaves, the stent may include three sections as shown. However, in other embodiments, if the artificial heart valve has two leaves, the stent may only include two of the sections.

[0028] Figure 1B Illustrated 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 1BThe 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 consecutive inverted V-shaped inflow nodes 102a, 102b extend between, including a first inflow 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 open portion of the half unit is located at the inflow end 101 of the stent 100.

[0029] The support segment 107 further includes a first center support 130a extending between the first center node 125a and the upper node 145. The support segment 107 also includes a second center support 130b extending between the second center node 125b and the upper node 145. The first center support 130a, the second center support 130b, the first inner lower support 124a, and the second inner lower support 124b form a diamond unit 128. The support segment 107 includes a first outer upper support 140a extending between the first outer node 135 and the first outflow node 104a. The support segment 107 further includes a second outer upper support 140b extending between the second outer node 135b and the second outflow node 104b. The support segment 107 includes a first inner upper support 142a extending between the first outflow node 104a and the upper node 145. The support segment 107 further includes a second inner upper support 142b extending between the upper node 145 and the second outflow node 104b. The support section 107 includes an outflow inverted V-shape 114 extending between a first outflow node 104a and a second outflow node 104b. The first vertical strut 110a, the first outer upper strut 140a, the first inner upper strut 142a, the first center strut 130a, and the first outer lower strut 122a form a first overall kite-shaped unit 133a. The second vertical strut 110b, the second outer upper strut 140b, the second inner upper strut 142b, the second center strut 130b, and the second outer lower strut 122b form a second overall kite-shaped unit 133b. The first kite-shaped unit 133a and the second kite-shaped unit 133b are symmetrical and opposite to each other on the support section 107. Although the term "kite-shaped" is used above, it should be understood that this shape is not limited to the precise geometric definition of a kite shape. The outflow inverted V-shape 114, the first inner upper strut 142a, and the second inner upper strut 142b form an upper unit 134. The upper cell 134 is generally kite-shaped and axially aligned with the diamond-shaped cells 128 on the stent segment 107. It should be understood that, although designated as individual struts, the various struts described herein can be part of a single integral structure as described above. However, in other embodiments, the stent 100 need not be formed as a unitary structure, and thus the struts can be different structures (or parts of different structures) coupled together.

[0030] Figure 1CA schematic diagram of a support segment 207 according to an alternative embodiment of the present disclosure is illustrated. Unless otherwise noted, like reference numerals refer to elements similar to those in support segment 100 described above but with 200-series reference numerals. Support segment 207 is substantially similar to support segment 107, including inflow nodes 202a, 202b, vertical struts 210a, 210b, a first inflow inverted V-shape 220a and a second inflow inverted V-shape 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. Figure 1C The purpose of this embodiment of the structure of the stent segment 207 shown in 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 inner upper strut 242a, the upper node 245 and the second inner upper strut 242b. In other words, the struts 242a, 242b can form a half-diamond 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 will bring additional material, which will increase the resistance to modifying the shape of the stent and require additional force to expand the stent. Excluding material from the outflow end 203 reduces the resistance to expansion on the outflow end 203, which can promote uniform expansion of the inflow end 201 and the outflow end 203. In other words, the inflow end 201 of the stent 200 does not include a continuous circumferential structure, but rather has a half-unit that is mostly open or completely open, the open portion of the half-unit being oriented toward the inflow end 201, and a majority of the outflow end 203 comprising 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.

[0031] Figure 1D shows a front view of the support section 207 in a folded state, and Figure 1E 207 is shown in a front view of the stent segment 207 in an expanded state. It should be understood that Figure 1D to Figure 1EThe stent 200 in FIG. 1 is illustrated with an opaque tube extending through the interior of the stent, purely for the purpose of helping to illustrate the stent, and this may represent the balloon on which the stent segment 207 is crimped. As described above, the stent includes three symmetrical segments, each spanning approximately 120 degrees around the circumference of the stent. Figure 1D to Figure 1E The support segment 207 shown in FIG. 2 is defined by the area between the vertical struts 210a, 210b. The support segment 207 represents all three segments of the support. The support segment 207 has an arc-shaped structure so that when the three segments are connected, they form a complete cylindrical shape. Figure 1F to Figure 1G A portion of the bracket is shown in the figure from a side view. Figure 1D to Figure 1E Compared with the view Figure 1F to Figure 1G The view of the bracket 200 in FIG. 1 is rotated approximately 60 degrees. Figure 1F to Figure 1G The view of the stent depicted in FIG is centered on a vertical strut 210b, showing approximately half of each of the two adjacent stent segments 207a, 207b located on each side of the vertical strut 210b. The segments 207a, 207b surrounding the vertical strut 210b are mirror images of each other. Figure 1F The support sections 207a, 207b are shown in a folded state, and Figure 1G Stent segments 207a, 207b are shown in an expanded state.

[0032] Figure 1H A flattened view of a support 200 comprising three support sections 207a, 207b, 207c is illustrated, as if the support had been cut longitudinally and laid flat on a table. As depicted, the sections 207a, 207b, 207c are symmetrical to each other, and adjacent sections share a common vertical support. As described above, the support 200 is shown in a flattened view, but each section 207a, 207b, 207c has an arc spanning 120 degrees to form a complete cylinder. Figure 1H 250a, 250b, 250c are further depicted coupled to the bracket 200. However, it should be understood that Figure 1H Only the connection of the blades 250a, 250b, 250c is illustrated in the figure. In other words, each blade 250a, 250b, 250c generally includes a free edge, wherein the free edges are used to engage with each other to prevent retrograde blood flow through the stent 200, and the free edges move radially outward toward the inner surface of the stent to allow antegrade blood flow through the stent. These free edges are not shown in the figure. Figure 1H In contrast, the attachment edges of blades 250a, 250b, 250c are Figure 1H250a, 250b, 250c. Each of the three blades 250a, 250b, 250c extends about 120 degrees from one end to the other around the support 200, and each blade includes a belly that can extend toward the radial center of the support 200 when the blades are joined together. Each blade extends between the upper nodes of adjacent sections. The first blade 250a extends from the first upper node 245a of the first support segment 207a to the second upper node 245b of the second support segment 207b. The second blade 250b extends from the second upper node 245b to the third upper node 245c of the third support segment 207c. The third blade 250c extends from the third upper node 245c to the first upper node 245a. Therefore, each upper node includes a first end of a first blade and a second end of a second blade coupled thereto. In the illustrated embodiment, each end of each blade is coupled to its corresponding node by suturing. However, any coupling device can be used to attach the blade to the support. It is also conceivable that the support may include any number of sections and / or blades. For example, the support may include two sections, 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 projection or other structure (not shown) at the junction between the free edge and the attachment edge of the blade, and each projection of each blade may be coupled to the projection of an adjacent blade to form a joint. In the illustrated embodiment, the blade joint is illustrated as a node attached to the intersection of the struts. However, in other embodiments, the support 200 may include a joint attachment feature that is built into the support to facilitate such attachment. For example, commissure attachment features can be formed in the stent 200 at nodes 245a, 245b, 245c, wherein the commissure attachment features include one or more holes to facilitate suturing the leaf commissures to the stent. In addition, the leaves 250a, 250b, 250c can be formed of a biological material (such as animal pericardium), or can be formed of a synthetic material (e.g., plastic, fabric and / or polymer, including ultra-high molecular weight polyethylene (UHMWPE)).

[0033] Figures 1I to 1JAn artificial heart valve 206 is shown, which includes a stent 200, a cuff 260 coupled to the stent 200 (e.g., via sutures), and leaflets 250a, 250b, 250c attached to the stent 200 and / or the cuff 260 (e.g., via sutures). The artificial heart valve 206 is intended for use in replacing the aortic valve, but the same or similar structure can be used in an artificial valve to 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, showing a stent portion 207 located between vertical struts 210a, 210b, including a cuff 260 and the profile of two blades 250a, 250b sewn to the cuff 260. Different methods of sewing the blades to the cuff and sewing the blades and / or cuffs to the stent can be used, many of which are described in U.S. Patent No. 9,326,856, which is incorporated herein by reference. In the illustrated embodiment, the upper (or outflow) edge of the cuff 260 is sewn to the first central node 225a, the upper node 245, and the second central node 225b, extending along the first central strut 230a and the second central strut 230b. The upper (or outflow) edge of the cuff 260 continues to extend roughly between the second central node of a segment and the first central node of the adjacent segment. The cuff 260 extends between the upper node 245 and the inflow end 201. Furthermore, cuff 260 covers the cells of stent portion 207 formed by struts between upper nodes 245 and inflow end 201 , including diamond-shaped cells 228 . Figure 1J 2 shows a side view of the support 200, including the outlines of the cuff 260 and the blade 250b. Fig. 1I Compared with the view Figure 1J The view of valve 206 in FIG. 2 is rotated approximately 60 degrees. Figure 1J The view depicted in is centered on the vertical strut 210b and shows approximately half of each of the two adjacent stent segments 207a, 207b located on each side of the vertical strut 210b. The segments 207a, 207b surrounding the vertical strut 210b are mirror images of each other. As described above, the cuff can be disposed on the inner or luminal surface of the stent, its outer or luminal surface, and / or both surfaces. If the valve or valve assembly is not optimally seated in the valve annulus, the cuff ensures that blood does not flow simply around the valve leaflets. The cuff, or a portion of the cuff disposed on the outside of the stent, can help slow leakage around the outside of the valve (the latter is referred to as paravalvular leakage or "PV" leakage). In Figures 1I to 1JIn the illustrated embodiment, cuff 260 only covers about half of stent 200, so that about half of stent is not covered by cuff. Compared with the cuff covering most or all of stent 200, the cuff material required by this configuration is less. Less cuff material can allow artificial heart valve 206 to curl downward to a smaller profile when folded. It is conceivable that the cuff can cover any size of the surface area of ​​the cylinder formed by the stent. For example, the upper edge of the cuff can extend straight around the circumference of any cross section of the cylinder formed by the stent. Cuff 260 can be formed by any suitable material, including biomaterials such as animal pericardium, or synthetic materials (e.g., UHMWPE).

[0034] As mentioned above, Figures 1I to 1J A cuff 260 is shown positioned on the interior of the support 200 . Figure 1K An example of an additional outer cuff 270 is shown in FIG. It should be understood that the outer cuff 270 may take any form other than Figure 1K Shapes other than those shown in . Figure 1KThe outer cuff 270 shown in the figure may not include the inner cuff 260, but is preferably provided together with the inner cuff 260. The outer cuff 270 can be integrally formed with the inner cuff 260 and folded (e.g., wrapped) over the inflow edge of the stent, or can be provided as a separate component from the inner cuff 260. The outer cuff 270 can be formed of any material described herein in connection with the inner cuff 260. In the illustrated embodiment, the outer cuff 270 includes an inflow edge 272 and an outflow edge 274. If the inner cuff 260 and the outer cuff 270 are formed separately, the inflow edge 272 can be coupled to the inflow end of the stent 200 and / or the inflow edge of the inner cuff 260 (e.g., via suturing, ultrasonic welding, or any other suitable attachment means). The connection between the inflow edge 272 of the outer cuff 270 and the stent 200 and / or the inner cuff 260 is preferably such that a seal is formed between the inner cuff 260 and the outer cuff 270 at the inflow end of the prosthetic heart valve, so that retrograde blood flowing into the space between the inner cuff 260 and the outer cuff 270 cannot pass beyond the inflow edge of the inner cuff 260 and the outer cuff 270. The outflow edge 274 can be connected (e.g., via sutures) to the struts of the stent 200 and / or to the inner cuff 260 at selected locations around the circumference of the stent 200. In this configuration, an opening can be formed between the inner cuff 260 and the outer cuff 270 in the circumferential direction between adjacent connection points, so that retrograde blood flow will tend to flow into the space between the inner cuff 260 and the outer cuff 270 via the opening, and cannot continue to pass beyond the inflow edge of the cuff. As blood flows into the space between the inner cuff 260 and the outer cuff 270, the outer cuff 270 can roll outward, thereby creating an even better seal between the outer cuff 270 and the native valve annulus against which the outer cuff 270 is pressed. The outer cuff 270 can be provided as a continuous cylindrical member or a strip wrapped around the outer circumference of the stent 200 with side edges that may or may not be parallel to the central longitudinal axis of the artificial heart valve, attached to each other so that the outer cuff 270 is wrapped around the entire circumference of the stent 200.

[0035] The stent can be formed of biocompatible materials, including metals and metal alloys (e.g., cobalt chromium (or cobalt chromium alloy) or stainless steel), but in some embodiments, the stent can be formed of a shape memory material (e.g., nitinol, etc.). The stent is further configured to fold when curled to a smaller diameter and / or expand when forced to open, such as via a balloon expansion within the stent, and the stent will substantially remain in its modified shape when at rest. The stent can be curled to fold in the radial direction and elongate in the axial direction (to some extent), thereby reducing its profile at any given cross-section. The stent can also expand in the radial direction and shorten in the axial direction (to some extent).

[0036] Artificial heart valves can be delivered via any suitable transvascular approach (e.g., including transapical approach or transfemoral approach). Typically, transapical approach delivery uses a relatively hard catheter to penetrate the patient's chest and pierce the apex of the left ventricle, which can cause a relatively large degree of trauma compared to delivery via the femoral approach. In delivery via the femoral approach, a delivery device that accommodates the valve is inserted through the femoral artery and flows against the blood flow to the left ventricle. In either delivery method, the valve can first be folded on an expandable balloon, when the expandable balloon is deflated. The balloon can be connected to a delivery system or arranged in a delivery system, which 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 overlying sheath). When arriving at the aortic valve or adjacent to the aortic valve, a surgeon or operator of the delivery system can align the artificial valve as desired in the natural valve ring, when the artificial valve is folded on the balloon. When the desired alignment is achieved, the overlying sheath (if included) can be withdrawn (or advanced) to uncover the prosthetic valve, and the balloon can be inflated to expand the prosthetic valve in a radial direction with at least a portion of the prosthetic valve shortened in an axial direction.

[0037] refer to Figure 2A , an example of a prosthetic heart valve PHV (which may include a stent similar to stent 100 or stent 200) is shown crimped over a balloon 280 of a balloon catheter 290, with the balloon 280 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 280). 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 290 to inflate balloon 280, such as Figure 2B shown. Figure 2B The artificial heart valve PHV is omitted, but it should be understood that when the balloon 280 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 290 into the balloon 280 and into one or more ports 285 located inside the balloon 280. Figure 2B In the particular illustrated example, the first port 285 may be one or more holes in a sidewall of the balloon catheter 290 , and the second port 285 may be a distal open end of the balloon catheter 290 , which may terminate within the interior space of the balloon 280 .

[0038] During the normal operation of the artificial heart valve, with the contraction and relaxation of the heart chamber, the artificial leaflet is periodically opened and closed. For example, when the left ventricle relaxes and the left atrium contracts, the mitral valve opens and the aortic valve closes. For the artificial aortic valve, when the left ventricle relaxes, the artificial leaflet engages to prevent blood from flowing back to the left ventricle from the aorta in a retrograde direction. When the artificial leaflet opens and closes, especially when they are closed, the artificial leaflet will be subjected to stress because the artificial leaflet resists the pressure gradient across the closed valve assembly. This stress can mainly act on the point where the artificial leaflet is attached to the frame (or intermediate component). Because the artificial heart valve may need to last for several years, decades or longer, it is important to minimize the amount of stress that the artificial leaflet experiences during normal operation to reduce the amount of wear on the artificial leaflet, because this wear may reduce the life of the artificial leaflet. A method of reducing the stress on the artificial leaflet is to allow the deflection of the structure to which the artificial leaflet is attached. For example, if the artificial leaflets are sutured directly to the commissure attachment features of the frame, allowing the frame to deflect slightly (eg, about 1 mm) as the artificial leaflets close can help reduce stress as the artificial leaflets engage.

[0039] The present disclosure provides various embodiments that improve trackability, minimize transitions along the length of the delivery device, and / or improve valve retention during delivery or deployment.It should be understood that the embodiments described herein are illustrative and that the principles of the embodiments may be combined with each other. Figure 3A The delivery system 300 is shown extending from a distal end 302 to a proximal end 304, the delivery system having a balloon 350 coupled to a delivery catheter 360 and a prosthetic heart valve PHV disposed around the balloon 350. Placing the prosthetic heart valve PHV radially outside the balloon 350 may present trackability and valve retention issues as previously described. Instead, a pillow-shaped process of the balloon 350 may be performed prior to delivery and / or implantation. Figure 3B As shown, the balloon 350 can be manufactured to include an anterior occipital portion 352a, a posterior occipital portion 352b, and a substantially linear seat 354 extending between the two occipitals 352a, 352b and capable of receiving the prosthetic heart valve PHV therein. The occipitals 352a, 352b can be formed in a variety of ways. In one example, pillowing the balloon 350 occurs during the loading process and includes maintaining the prosthetic heart valve PHV at a predetermined constant diameter while partially inflating the balloon 350 to form a posterior occipital portion 352a, 352b. Figure 3BThat is, the pillows 352a, 352b do not initially exist, but are formed after the prosthetic heart valve PHV is placed on the balloon and the balloon transitions from a deflated state to a partially inflated loaded state. After loading, the pillows 352a, 352b can exist during the delivery of the device, with the prosthetic heart valve PHV securely placed therebetween. Alternatively, the pillows can be formed in the catheterization room via an expansion process, i.e., by injecting a small volume of inflation medium into the balloon to form a balloon such as Figure 3B The gradual slope or occiput shown in .

[0040] In another embodiment, the pillow may be pre-formed via heat setting, and the pillow-shaped balloon may be delivered to the operator ready for loading. FIG. 4A to FIG. 4C The various steps for forming an occipital portion without a prosthetic heart valve PHV are illustrated. Figure 4A In the embodiment of the present invention, the balloon 350 can be placed in a hollow cylindrical mold 420, and the mold can be used to heat set the balloon to a pre-pillow state. It should be understood that the shape of the mold 420 can result in a variable shape and curvature to define one or more of the body diameter, cone diameter and / or shoulder geometry, or to customize and control the slope from the distal tip to the implant. After removing the mold 420, the pre-pillow state is formed, and the pillows 352a, 352b appear before the artificial heart valve PHV loading process ( Figure 4B The prosthetic heart valve PHV can then be loaded onto the balloon 350 between the occipitals 352a, 352b for delivery ( Figure 4C ).

[0041] FIG. 5A to FIG. 5BThe addition of the balloon shoulder is illustrated. As shown, the delivery system 500 extending between the distal end 502 and the proximal end 504 includes a balloon 550 and a prosthetic heart valve PHV arranged around the balloon. In this example, the balloon 550 includes a radially extending front shoulder 553a orthogonal to the seat 554 and a radially extending rear shoulder 553b, and the seat 554 has a sufficient length to keep the prosthetic heart valve PHV between the shoulders 553a, 553b. The addition of shoulders 553a, 553b can help to keep the prosthetic heart valve PHV in place during tracking and expansion, and can form a non-traumatic transition between the balloon 550 and the prosthetic heart valve PHV to control and minimize any gap between them. This may be desirable because the edge of the stent curled on the catheter without the feature of non-traumatic may cause trauma to the vascular system, especially when the catheter is forced to pass through a curved blood vessel with a small radius. In some examples, the shoulder has a predetermined height equal to or greater than the thickness of the prosthetic heart valve PHV. In other words, when properly disposed within the seat 554 of the balloon 550, the prosthetic heart valve PHV may be recessed below or aligned with the shoulder line S1.

[0042] FIG. 6A to FIG. 6B Another embodiment of a delivery system 600 is illustrated extending between a distal end 602 and a proximal end 604. In this example, a balloon 650 coupled to a delivery catheter 660 may have a first balloon length L1 ( Fig. 6A ), and the balloon 650 can be axially collapsed when partially inflated when forming a pillow, shoulder, or trackable feature. Figure 6B As shown, the balloon 650 has been contracted to a second balloon length L2 that is less than the first balloon length L1. Due to the shortened section S1, the resulting delivery system can have improved traceability, and the shortened section S1 is relatively rigid when compared to the proximal catheter shaft section S2. In some examples, when tracking around the aortic arch, a shorter balloon length can provide better steering of the valve. This is because the turning point we expect is at the proximal end of the balloon, where the steerable axis ends at the proximal end. The shorter the balloon length, the more deflection of the valve can be achieved. Additionally, the process of pushing more material into the central curling section can help reduce the second balloon length to make L2. In some examples, the first length is between 60mm and 66mm (e.g., 65.6mm) and the second length is between 50mm and 65mm (e.g., 62mm). This can also reduce shortening during balloon inflation.

[0043] In another variation, Figure 6CAs shown, the delivery system 600C may include curved cones 670, 672 on either side of the balloon and formed to be used to introduce the balloon 650C into the sheath and navigate the vasculature, insert through a stenotic native valve, insert through an existing bioprosthetic valve, and withdraw from the vasculature and sheath to provide a more seamless transition and / or the ability to withdraw the valve for potential rescue. The curved cone may include a front curved cone 670 and a rear curved cone 672, and both of these together with the balloon may define a continuous curvature C1 extending from the front curved cone 670 through the balloon 650C to the rear curved cone. In at least some examples, the two cones and the balloon 650 may form an oblate spheroid shape, an egg shape, or a football shape.

[0044] In at least some examples, additional internal features can be used in conjunction with the pillow described above to aid in trackability. Fig. 7A As shown, the delivery system 700 can extend between a distal end 702 and a proximal end 704 and include an inner shaft 710 that includes a helical tube 715. In at least some examples, the helical tube 715 is nitinol, and all or part of the inner shaft 710 can be formed by the helical tube. Expandable or expandable cages 720a, 720b can be disposed on opposite ends of the inner shaft 710. In at least some examples, the cages 720a, 720b are formed by an expandable nitinol basket. The inner shaft, the helical tube, and the cage can collectively form an internal valve retention feature configured to be disposed within a balloon, and the artificial heart valve PHV can be crimped onto or between the internal retention features. Figure 7B A similar delivery system is shown, except that the helical tube 715 has been replaced by a braided wire tube 717 comprising, for example, Nitinol, and the entire assembly is shown within a balloon 750.

[0045] The above embodiments generally describe a balloon having a two-pillow configuration, but it should be understood that a single pillow or three or more pillows may be used to improve trackability. Fig. 8AAs shown, the delivery system 800A can extend between the distal end 802 and the proximal end 804 and include a balloon 850A having an anterior occipital portion 852a and a posterior occipital portion 852b. The balloon 850 can also have an intermediate occipital portion 854 disposed between the anterior occipital portion 852a and the posterior occipital portion 852b. As shown, when the artificial heart valve PHV is disposed around the balloon, the stent 810 can be disposed between the anterior occipital portion 852a and the posterior occipital portion 852b. The block of the valve assembly 820 of the artificial heart valve PHV including, for example, leaflets, one or more cuffs, paravalvular leakage components and / or anchoring components can be disposed in the valve cavity 856, between the anterior occipital portion 852a and the intermediate occipital portion 854. Most or all of the valve assembly can be disposed between the occipital portion 852a and the intermediate occipital portion 854 around the first seat 857, but it should be understood that other portions of the artificial heart valve PHV (e.g., a portion of the cuff near the aortic end of the stent) can extend through the intermediate occipital portion 854. The intermediate occipital portion 854 can be equidistant from the anterior and posterior occipital portions, or can be closer to one than the other. The intermediate occipital portion 854 can vary in shape and / or size. In some examples, the intermediate occipital portion 854 is in the shape of a "mini occipital portion" that is shorter in the radial direction and / or narrower in the axial direction than the anterior occipital portion 852a and / or the posterior occipital portion 852b.

[0046] In another example, Figure 8B As shown, the delivery system 800B can extend between the distal end 802 and the proximal end 804, and includes a balloon 850B having a front occipital portion 852a and a rear occipital portion 852b. The balloon 850B can be similar to those listed above and formed in any manner previously described. As shown, when the artificial heart valve PHV is arranged around the balloon, the support 810 and the valve assembly 820 can be arranged between the front occipital portion 852a and the rear occipital portion 852b. In this example, the occipital portions 852a, 852b are formed to have overhanging lips 855a, 855b, respectively, which extend at least partially above the support 810 to fix the artificial heart valve PHV. In at least some examples, the overhanging lips 855a, 855b are configured to cover the front end and / or rear end of the support 810 to reduce the edge stuck on the anatomical structure or other environmental structures during delivery.

[0047] exist Figure 8C, the use of a loader sheath is shown to ensure that the occipital portion maintains atraumatic edges during preparation / degassing of the delivery system in the catheterization laboratory. The delivery system 800C can extend between a distal end 802 and a proximal end 804 and include a balloon 850C having an anterior occipital portion 852a, a posterior occipital portion 852b, and an intermediate occipital portion 854 to secure the valve body 820. In this example, a loader sheath 870 is disposed above the balloon 850C, the loader sheath 870 having an optional radially inwardly protruding ramp 872 to maintain the stent 810 near the balloon 850C after the degassing process. Specifically, during degassing of the balloon 850c, a fluid is injected, which pressurizes the balloon. In the absence of the protruding ramp 872, the stent and particularly the struts at the ends of the stent can be expanded to a diameter greater than the posterior occipital portion 852b. In this example, the front occipital portion 852a can also be used as a stopper to prevent the valve from being displaced proximally during insertion and passing through the anatomical structure. It is also worth noting in this example that the support 810 can be curled asymmetrically (for example, it can be curled to a first diameter near the distal end 802 and a second diameter less than the first diameter near the proximal end 804, or vice versa). In some examples, the proximal end of the support can be curled between 4mm and 6mm, and the distal end of the support can be curled between 6mm and 8mm. In some examples, the difference between the proximal end curling diameter and the distal end curling diameter is between 1mm and 3mm, and the proximal end is smaller. In some examples, the support can be curled so that the curling diameter of the support has a proximal end to distal end curling diameter ratio between 60% and 90%.

[0048] In another example, Fig.8D As shown, an anti-kink feature is described, which reinforces the area that is easy to kink in the inner shaft of the balloon (also referred to as the balloon catheter or BIC) during tracking. The delivery system 800D can extend between the distal end 802 and the proximal end 804 and include a balloon 850D having a front occipital portion 852a and a rear occipital portion 852b to fix the artificial heart valve PHV including the stent 810 and the valve assembly 820. In this example, a rigid anti-kink feature 880 can be arranged around the inner shaft 890 extending through the balloon 850D. The anti-kink feature 880 can be connected to the inner shaft 890 via glue, welding or any suitable mechanism to reinforce the weakest point of the inner shaft 890 adjacent to the rear occipital portion 852b. In at least some examples, a single anti-kink feature is used. Alternatively, multiple anti-kink features can be used, including forming an anti-kink feature near each of the occipital portions. The anti-kink feature can also extend the length of the balloon and / or extend into the PHV section of the balloon.

[0049] Any one or more of the features described herein (end pillows, intermediate pillows, shoulders, suspended pillows, anti-kink features, internal retention features, etc.) may be used alone or in combination to improve trackability, minimize transitions along the length of the delivery device and / or improve valve retention during delivery or deployment.

[0050] Although the present invention has been described with respect to specific embodiments, it should be understood that these embodiments are merely exemplary illustrations of the principles and applications of the present invention. Therefore, it should be understood that many changes may be made to the exemplary embodiments, and other arrangements may be designed, without departing from the spirit and scope of the present invention as defined in the appended claims. In addition, it should be understood that the different embodiments described herein may be combined with other embodiments described herein to achieve the benefits of both embodiments.

Claims

1. A conveying device, comprising: catheter; as well as An inflatable balloon is coupled to the catheter, the inflatable balloon forming an anterior occipital portion and a posterior occipital portion spaced apart from the anterior occipital portion, the anterior occipital portion and the posterior occipital portion defining a valve seat therebetween to hold a prosthetic heart valve during tracking of the delivery device.

2. A system comprising: The conveying device according to claim 1; as well as An artificial heart valve comprises a stent and a valve component. 3 . The delivery device according to claim 1 , further comprising a middle pillow portion disposed between the front pillow portion and the rear pillow portion. 4 . The delivery apparatus according to claim 3 , wherein the middle pillow portion is shorter than at least one of the front pillow portion and the rear pillow portion in a radial direction. 5 . The delivery apparatus according to claim 3 , wherein the middle pillow portion is shorter than at least one of the front pillow portion and the rear pillow portion in the axial direction.

6. The delivery device of claim 3, wherein the intermediate occipital portion and the anterior occipital portion define a valve cavity configured and arranged to receive a majority of a valve assembly.

7. The conveying apparatus according to claim 3, wherein the middle pillow portion is disposed equidistantly from the front pillow portion and the rear pillow portion.

8. The delivery apparatus according to claim 3, wherein the middle pillow portion is disposed closer to the front pillow portion than the rear pillow portion.

9. The delivery apparatus according to claim 3, wherein the middle pillow portion is disposed closer to the rear pillow portion than the front pillow portion.

10. The system of claim 2, wherein the anterior occipital portion and the posterior occipital portion extend radially outward farther than the prosthetic heart valve.

11. The system of claim 2, wherein the anterior occipital portion and the posterior occipital portion depend from an edge of the stent of the prosthetic heart valve.

12. The system of claim 2, further comprising a loader sheath having a radially inwardly projecting ramp to hold the stent proximate the balloon during a degassing process.

13. The delivery device of claim 1, further comprising an inner shaft extending through the balloon and having at least one rigid kinking feature disposed adjacent at least one of the anterior occipital portion and the posterior occipital portion.

14. The delivery device of claim 13, wherein the at least one rigid kinking feature is disposed adjacent the occipital portion.

15. The delivery device of claim 1, further comprising an inner shaft having at least one cage disposed within the balloon.

16. The delivery device of claim 15, wherein the inner shaft comprises at least one of a helical tube and a braided tube.

17. A method of delivering a prosthetic heart valve, the method comprising: providing a delivery device having a catheter and an inflatable balloon coupled to the catheter; forming a front pillow portion and a rear pillow portion spaced apart from the front pillow portion on the balloon, wherein the front pillow portion and the rear pillow portion define a valve seat; placing an artificial heart valve on the valve seat; as well as When the prosthetic heart valve is disposed between the anterior and posterior occipital portions of the delivery device, the delivery device is advanced to the patient's native aortic valve.

18. The method of claim 17, wherein forming an anterior occipital portion and a posterior occipital portion comprises heat setting the balloon to form the anterior occipital portion and the posterior occipital portion prior to placing the prosthetic heart valve on the valve seat.

19. The method of claim 17, further comprising forming a middle occipital portion between the front occipital portion and the rear occipital portion.

20. The method of claim 19, constraining a valve component of the prosthetic heart valve between the medial occipital portion and the anterior occipital portion.

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