The funnel determines the folding and expression patterns of prosthetic heart valves

Abstract

The loading funnel for the prosthetic heart valve includes a proximal connector configured to releasably secure the funnel to a holding tube for the prosthetic heart valve, a distal end for receiving the prosthetic heart valve in at least a partially expanded state, and a passageway extending between the distal end and the proximal connector. The passageway includes a conical portion that is wider at the distal end and narrower at the proximal end and centered along a cone axis. One or more internal fins each extend from a relatively proximal position within the cone portion to a relatively distal position within the cone portion and project toward the cone axis.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 322,397, filed March 22, 2022, the disclosure of which is hereby incorporated by reference. [Background technology]

[0002] Valve heart disease, specifically aortic and mitral valve disease, is a significant health problem in the United States. Traditional valve replacement, or orthotopic replacement of a heart valve, is an "open-heart" surgical procedure. Briefly, the procedure requires surgical incision of the chest, initiation of extracorporeal circulation with cardiopulmonary bypass, stopping and opening the heart, removal and replacement of the diseased valve, and restarting the heart. Valve replacement typically carries a 1–4% mortality risk in otherwise healthy individuals, with the mortality rate associated with this procedure significantly higher, primarily due to the need for extracorporeal circulation. Furthermore, open-heart surgery is often poorly tolerated by elderly patients. Therefore, eliminating the extracorporeal component of the procedure would significantly reduce mortality and the cost of valve replacement therapy.

[0003] Although transcatheter aortic valve replacement has been the subject of intense investigation, the mitral valve has received less attention, reflecting in part the high level of complexity associated with the native mitral valve and, therefore, the difficulty associated with inserting and anchoring a replacement prosthesis.

[0004] Recent developments in the field have provided devices and methods for mitral valve replacement that are less invasive and less risky for the patient. Such devices typically include a prosthetic valve that is positioned within the native annulus and held in place using anchors seated on the exterior surface of the heart near the apex, preferably at least sized to provide sufficient security for placement in the heart.

[0005] Such valves are typically delivered using a long, narrow device into which the valve can be pulled and from which it can emerge in the opposite direction. As the valve is pulled into the device, it also collapses radially to first fit within the device and then travels along the delivery lumen. The delivery lumen must be narrow enough to extend through the patient's body and into the native annulus without undue trauma. Thus, the valve folds when loaded and typically unfolds in the reverse of the folding pattern when exiting the lumen.

[0006] Other recent developments in the field have provided prosthetic valves with asymmetric designs that correspond to the asymmetric structure of the native mitral valve. Such valves have asymmetric frames with specific structures intended to land on the recognized segments of the native mitral valve leaflets (A1, A2, A3, P1, P2, P3). Precision in placing the implanted valve in a desired rotational orientation (sometimes referred to as "clocking") relative to the native leaflets generally tends to improve the stability and therapeutic outcome of the implanted prosthetic valve.

[0007] The prosthetic valve may be loaded into the delivery device such that the fold pattern is unpredictable and the rotational orientation of the valve within the delivery device is unknown. Therefore, the clinician can refer to images of the patient early and repeatedly during valve delivery to observe how the valve unfolds and determine the rotational orientation of the prosthetic valve relative to the delivery device. Depending on the unfolding pattern and orientation observed from the images, the clinician can carefully rotate or otherwise adjust the delivery device. If the clinician knew the valve's fold pattern and orientation in advance, the valve delivery procedure could be more efficient. It should be understood that the terms "fold" and "unfold," as used herein, generally refer to the collapsing and expanding, respectively, of the prosthetic heart valve, or to the loading and deploying of the prosthetic heart valve into and from the delivery device, respectively. Summary of the Invention

[0008] According to some aspects of the present disclosure, a loading funnel for a prosthetic heart valve can include one or more fins extending through the funnel toward a central axis of a conical portion of a passageway. Each fin can extend from a respective relatively proximal position within the passageway to a respective relatively distal position within the passageway. Each fin can extend along a respective fin axis that intersects with the central axis. The relatively proximal and relatively distal positions can each be within the conical portion of the passageway. The funnel can include just one fin or multiple fins. The multiple fins can be evenly angularly distributed about the central axis. In another example, the multiple fins can be two fins extending along different respective fin axes, each having a radial component relative to the central axis, with the angle between the two radial components being less than 180°. The radial components can be perpendicular to each other. Alternatively or additionally, the angle between the radial components may correspond to the angle between the hips of a prosthetic valve intended to be loaded through the funnel, the hips being defined at two angular positions on the cuff of the valve where the portion of the cuff intended to reach the anterior leaflet of the native heart valve meets the portion of the cuff intended to reach the posterior leaflet of the native heart valve. The funnel may have a visible angle indicator on its outer surface so that the placement of the one or more fins can be determined by observing the outer surface of the funnel.

[0009] During the loading process, the prosthetic valve can be angularly oriented in the funnel so that one or more fins bias each portion of the valve inward so that the valve deploys in a desired pattern when delivered. In some examples where the one or more fins are just one fin or just three evenly distributed fins, the valve can be placed in the funnel so that the center of the portion of the collar intended to reach the posterior leaflet of the native heart valve is aligned with the fin. In some examples where the funnel includes at least two fins, the valve can be angularly oriented in the funnel so that each hip is aligned with two fins. The valve can be placed in the funnel so that either or both the portion of the cuff intended to reach the anterior leaflet of the native heart valve and the portion of the cuff intended to reach the posterior leaflet of the native heart valve contact the conical portion of the funnel only in an area where no fins are present, which area can be defined between two fins. In some configurations within any of the foregoing examples, the valve can be placed in the funnel so that the hips are symmetrically located on either side of the plane where the one or more fins are symmetrically distributed. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is an exploded view of an exemplary prosthetic heart valve. [Figure 2] 2 is a side view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Figure 3] FIG. 2 is a front view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Figure 4] 2 is a top view of the inner and outer frame assembly of the valve of FIG. 1 in an expanded configuration. [Figure 5] FIG. 1 is a schematic diagram of a valve loading device according to one embodiment. [Figure 6A] FIG. 6 is a side view of the outer funnel of the valve loading device of FIG. 5. [Figure 6B] FIG. 6B is a cross-sectional view of the outer funnel of FIG. 6A. [Figure 6C]FIG. 6B is a perspective view of the inside of the passage of the outer funnel of FIG. 6A. [Figure 7A] FIG. 6B is a distal end view of the conical portion of the outer funnel of FIG. 6A. [Figure 7B] 7B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone portion of FIG. 7A. FIG. [Figure 7C-1-7C-2] 7B shows a side view and an end view, respectively, of the first stage of deployment of the valve of FIG. 1 after loading according to FIG. 7B. [Figure 7D-1-7D-2] 7C-1 and 7C-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7C-1 and FIG. 7C-2. [Figure 7E-1-7E-2] 7D-1 and 7D-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7D-1 and FIG. 7D-2. [Figure 7F-1-7F-2] 7E-1 and 7E-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 7E-1 and FIG. 7E-2. [Figure 8A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 8B] 8B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 8A. [Figure 9A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 9B] 9B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 9A. [Figure 10A] FIG. 6B is a distal end view of another example of a cone that can be incorporated into the outer funnel of FIG. 6A. [Figure 10B] 10B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 10A. [Figure 10C] 10B is a distal end view of the valve of FIG. 1 being partially compressed by pulling proximally through the cone of FIG. 10A, with the valve in a different angular orientation within the cone than shown in FIG. 10B. [Figure 11A-1-11A-2]10D and 10E show side and end views, respectively, of the first stage of deployment of the valve of FIG. 1 after loading according to FIG. 10C. [Figure 11B-1-11B-2] 11A-1 and 11A-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 11A-1 and FIG. 11A-2. [Figures 11C-1-11C-2] 11B-1 and 11B-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 11B-1 and FIG. 11B-2. [Figure 11D-1-11D-2] 11C-1 and 11C-2 show side and end views, respectively, of a deployment step subsequent to the step shown in FIG. 11C-1 and FIG. 11C-2. DETAILED DESCRIPTION OF THE INVENTION

[0011] As used herein, the term "proximal" when used in connection with a delivery device or a component of a delivery device refers to the end of the device that is closer to the user when the device is being used as intended, while the term "distal" when used in connection with a delivery device or a component of a delivery device refers to the end of the device that is farther from the user when the device is being used as intended. As used herein, the terms "substantially," "generally," "approximately," and "about" are intended to mean that small deviations from absolute values ​​are included within the scope of the term so modified.

[0012] An exemplary prosthetic heart valve 110 that can be used in various embodiments of the present disclosure is shown in an exploded view in Figure 1. The valve 110 includes an inner structure or assembly 112 and an outer structure or assembly 114. The valve 110 can be connected to a tether 160 and a tether anchor 154, which may or may not be compressible.

[0013] The inner assembly 112 includes an inner frame 140, an outer wrap 152, which may be tubular, and a leaflet structure 136 (including articulating leaflets 138 that define the valve function). The leaflet structure 136 may be sutured to the inner frame 140, or a portion of the inner frame 140 may be used for this purpose. The inner assembly 112 is positioned and secured within the outer assembly 114, as described in more detail below.

[0014] The outer assembly 114 includes an outer frame 170. The outer frame 170 may, in various embodiments, have an outer frame covering of tissue or fabric (not shown), or may be without an outer covering, providing an exposed wire frame to promote tissue ingrowth. The outer frame 170 may also have an articulating collar or cuff (not shown) covered by a tissue or fabric covering 148.

[0015] The tether 160 is connected to the valve 110 by the inner frame 140. The inner frame 140 therefore includes a tether connecting or clamping portion 144 that connects the inner frame 140, and thus the expanded valve 110, to the tether 160.

[0016] The outer frame 170 and the inner frame 140 are shown connected to one another in Figures 2-4, which are front, side, and top views, respectively. Together, the two frames form structural support for a valve leaflet structure, such as the leaflet structure 136 of Figure 1. Specifically, the inner frame 140 supports the leaflet structure 136, the outer frame 170 anchors the prosthetic valve 110 to the native annulus, and the inner frame 140 maintains a generally cylindrical configuration even when forces applied to the outer frame 170 deform the outer frame 170. As explained more fully below, the frames support the leaflet structure 136 in a desired relationship relative to the native annulus, support coverings for the two frames to provide a barrier against blood leakage between the atria and ventricles, and connect (by the inner frame 140) to tethers 160 to help hold the prosthetic valve in place in the native annulus by connecting the free ends of the tethers and tether anchors 154 to the ventricular wall. The two frames may be joined at multiple connection points (representative points are identified as "C"), for example, six connection points. In this embodiment, the frame connection is implemented by passing mechanical fasteners, such as short lengths of suture or wire, through openings in the connection portion 171 of the outer frame 170 and corresponding openings in the longitudinal posts 142 in the body portion of the inner frame 140. Thus, the inner frame 140 is positioned within and securely connected to the outer frame 170.

[0017] As shown in Figures 2-4, the assembly formed by combining outer frame 170 and inner frame 140 includes a neck portion 184 that serves as a scaffolding for the neck of the assembled valve 110. The neck of valve 110 extends through the native mitral annulus after valve 110 is implanted, allowing blood to flow from the left atrium to the left ventricle while preventing or at least inhibiting blood flow from the left ventricle to the left atrium. Neck portion 184 is generally contained within the area surrounded by dashed border 180 in Figure 4, and the portion of outer frame 170 extending radially outward from dashed border 180 defines a collar that surrounds neck portion 184.

[0018] The collar defined by the outer region of the outer frame 170 provides a scaffolding for the portion of the valve 110 intended to reach the leaflets of the native mitral valve. Accordingly, the collar can be considered to include regions A1, A2, A3, P1, P2, and P3, which correspond to similarly identified regions of the native valve leaflets. That is, the typical anatomy of the anterior leaflet of a native human mitral valve includes regions or segments commonly referred to as A1, A2, and A3, and the typical anatomy of the posterior leaflet of a native human mitral valve includes regions or segments commonly referred to as P1, P2, and P3, and the collar provides a scaffolding for the portion of the valve 110 intended to reach those regions when the valve 110 is implanted. These regions appear frequently in the literature on human cardiac anatomy and are known to those skilled in the art of mitral valve prosthesis design or implantation. As shown in FIG. 4 , the A1, A2, A3, P1, P2, and P3 regions of the outer frame 170 each provide a scaffold for a respective region of the valve 110 intended to reach a similarly named portion of one of the native valve leaflets. The portions of the valve 110 that reach the native leaflets secure the valve 110 to the atrial side of the mitral valve and prevent the valve 110 from sliding into the left ventricle. The security of the seating of the valve 110 on the atrial side of the native mitral valve generally improves in cooperation with the precision of the alignment of the A1, A2, A3, P1, P2, and P3 regions of the outer frame 170 with the corresponding regions of the native mitral valve. In other words, the native mitral valve annulus and leaflets have a complex and irregular shape, and a prosthetic mitral valve shaped and designed with properties that complement the complex and irregular shape can be expected to provide better anchorage and function compared to a rotationally symmetric prosthetic heart valve that is not specifically designed to follow the complex contours of the native mitral valve.

[0019] The collar (sometimes referred to as the atrial flare) provided by the portion of outer frame 170 outside dashed boundary 180 is asymmetrical, mimicking the asymmetry of a typical human mitral valve. Because the anterior leaflet of the human mitral valve is larger than the posterior leaflet of the human mitral valve, anterior regions A1, A2, A3 of outer frame 170 extend radially farther from the center of neck portion 184 than do posterior regions P1, P2, P3 of frame 170. Thus, the anterior portion of the collar provided by frame 170, including A1, A2, and A3, is larger and extends radially farther from the center of neck portion 184 and the entire neck of valve 110 than the posterior portion of the collar, including P1, P2, and P3.

[0020] The hip 186 is defined by two portions of the collar where the anterior portions A1, A2, A3 of the collar meet the posterior portions P1, P2, P3 of the collar. The hip 186 tends to align with the commissures of the native mitral valve when the prosthetic heart valve 110 is implanted. Although the term "hip" is used herein, the hip can also be considered to be the lateral or commissure portions of the collar of the outer frame 170. While the A1-A3 and P1-P3 segments of the collar of the outer frame 170 are shown by dashed lines in FIG. 4 , it should be further understood that some variation from the exact depiction shown may exist, as it should be understood that the collar of the outer frame 170 is a continuous structure and that not every patient's mitral valve is identical to every other patient's mitral valve. In other words, the relative placement of the A1-A3 and P1-P3 segments is static, but the A1-A3 and P1-P3 segments may be slightly larger or smaller than the particular depiction shown in Figure 4. As a result, the hips 186 that separate the A1-A3 and P1-P3 segments of the collar may be positioned slightly differently than shown in Figure 4, although it should still be understood that Figure 4 accurately represents where each of the A1-A3 and P1-P3 and hip segments may typically be positioned. For example, in some embodiments, the hips 186 may be more closely aligned with the major axis of the ellipse of the dashed boundary line 180.

[0021] Valve 110 is merely one example of a prosthetic valve that can be used with the concepts of the present disclosure. Accordingly, elsewhere in this disclosure, reference is made to valve 110 for purposes of describing other devices and concepts, which may interact in a similar manner with different prosthetic valves. Indeed, the concepts disclosed herein may be most useful in connection with the placement of rotationally asymmetric expandable prosthetic heart valves, but may also be useful in connection with the placement of rotationally symmetric expandable prosthetic heart valves.

[0022] FIG. 5 is a schematic diagram of a valve loading device 260. The valve loading device 260 includes a funnel assembly 215, a loading handle assembly 265, and a valve retention tube 125. Prior to connecting the valve retention tube 225 to the handle assembly and catheter assembly for the prosthetic valve 110, the valve is loaded into the valve retention tube 225 using the valve loading device 260. The valve 110 is first placed within the funnel assembly 215 to move the valve from an expanded configuration to a compressed configuration. It should be understood that without an applied force, the valve 110 will tend to return to the expanded configuration and therefore require some type of manipulation to transition the valve 110 to the compressed configuration for delivery. The funnel assembly 215 includes an outer funnel 264 and an inner funnel or centering cone 262. The valve 110 is placed within the outer funnel 264, and then the inner funnel 262 is connected to the outer funnel 264 to sandwich the valve therebetween and compress the valve into the desired shape and configuration in a controlled manner. The valve retention tube 225 can be releasably connected to the funnel assembly 215 and the loading handle assembly 265, for example, via a quick-connect coupler or any other type of releasable connection mechanism. While the inner funnel 262 and outer funnel 264 are shown and described in connection with FIG. 5 , it should be understood that in other embodiments, only a single funnel may be used without the need to sandwich the valve between two funnels.

[0023] Loading handle assembly 265 includes handle 257 (also referred to as a "main loading knob" or "actuator"), a retention mechanism 268 for securing tether 160, and a loading lead screw 266 operably connected to handle 257. With valve retention tube 225 connected to funnel assembly 215 and loading handle assembly 265 and tether 160 extending from valve 110 secured to retention mechanism 268, valve loading device 260 can be actuated to move valve 110 from a first position in which valve 110 is disposed within funnel assembly 215 to a second position in which valve 110 is disposed within valve retention tube 225. More specifically, handle 257 can be actuated or rotated, thereby moving lead screw 266 relative to handle 257, which in turn moves valve retention tube 225 and funnel assembly 215 away from handle 257. During operation, with the valve 110 in a fixed position (i.e., stationary) relative to the handle 257 (by securing the tether to the retention mechanism 268), the funnel assembly 215 is moved away from the handle, and the valve retention tube 225 is moved over the valve, positioning the valve within the interior region of the valve retention tube 225. However, it should be understood that other mechanisms may be suitable for moving the prosthetic valve 110 through the funnel assembly 215 and into the valve retention tube 225. For example, an actuator may be used to pull the retention mechanism 268 proximally, pulling the valve 110 proximally through the funnel assembly 215 and into the valve retention tube 225. In other embodiments, the user may simply grasp the tether 160 (instead of being held by the retention mechanism 268) and pull it proximally to pull the valve 110 through the funnel assembly 215 and into the valve retention tube 225.

[0024] After the valve 110 is loaded into the valve retention tube 225, the valve retention tube 225 can be disconnected from the valve loading device 260 and then connected to a valve delivery device, or the valve loading device 260 can be reconfigured to act as a valve delivery device. In either case, a catheter is connected to the valve loading tube 225, and the valve 110 can be delivered to the native mitral valve by the catheter.

[0025] Further details regarding the various components and operation of valve loading device 260 and devices for delivering prosthetic valves can be found in U.S. Patent No. 10,667,905, filed October 11, 2017, which is incorporated herein by reference in its entirety. Further details regarding valve 110 and other examples of devices for loading and delivering prosthetic valves can be found in U.S. Patent Application Publication No. 2021 / 0186695, filed December 16, 2020, which is incorporated herein by reference in its entirety.

[0026] The outer funnel 264 of the valve loading device 260 described above is shown in FIGS. 6A-6C . The outer funnel 264 extends between a distal end 270 and a proximal end 272. The distal end 270 may include external threads 274 that serve as an attachment point for the inner funnel 262 so that the inner funnel 262 can seal and close the distal end 270; however, as noted above, in other embodiments, a single funnel may serve the functions of the assembled inner funnel 262 and outer funnel 264. The proximal end 272 may include a lip 276 to facilitate releasable connection of the outer funnel 264 to the valve retention tube 225. The external threads 274 and lip 276 are merely examples of engagement features that may be provided on either end 270, 272 of the outer funnel 264 to releasably connect the inner funnel 262 and valve retention tube 225 to the outer funnel 264. Thus, either or both of the external threads 274 and lip 276 may be replaced with a different type of engagement feature, such as an internal thread, a quick connect mechanism, or any other releasable engagement mechanism.

[0027] The outer surface of the outer funnel 264 can include a visible angle indicator 280, which in the illustrated example may be a flat portion of the otherwise rounded outer surface, but in other embodiments may be other examples of notches, protrusions, ribs, contrasting color markings, or any other visible indicia. The visible angle indicator 280 preferably differs from the appearance of the outer surface of the outer funnel 264 at other circumferential locations, meaning that an observer can determine the angular orientation of an internal feature of the outer funnel 264, such as the fins 288, from the placement of the visible angle indicator 280. Two visible angle indicators 280 are shown in the illustrated example, one located on the lip 276 and the other just proximal to the external threads 274, but in other examples, any number of visible angle indicators 280 can be provided at any location along the outer surface of the outer funnel 264.

[0028] A passageway 282 extends within the outer funnel 264 from the proximal end 272 to the distal end 270. The passageway 282 includes a cavity 284 at the distal end 270 that provides a distal opening for the outer funnel 264, the cavity 284 being large enough in diameter to receive the valve 110 in at least a partially expanded state. Proximal to the cavity 284 is a tapered or conical portion 286 of the passageway 282, which may be defined within a tapered portion or cone 278 of the outer funnel 264. The central longitudinal axis 279 of the passageway 282 and the entire outer funnel 264 is also the central or cone axis of the conical portion 286; that is, the axis 279 extends through the center point of a theoretical circular base at the distal end of the conical portion 286 and through the theoretical proximal point where the conical portion 286 would converge if it were not truncated. Similarly, although cavity 284 is cylindrical in the illustrated example, cavity 284 may be of any other shape that allows valve 110 to be received therethrough, including, for example, a polygonal rather than circular cross section, a shape that varies in size along axis 279, or other non-cylindrical shapes.

[0029] For purposes of this disclosure, references to cone 278 and cone portion 286 include, by way of example, perfect cone or truncated cone shapes, but are not limited to perfect cones. For example, the interior of cone portion 286 can be a truncated trapezoid with a concave or convex curve, a pyramid shape, or any other three-dimensional shape in which the cross-sectional shape perpendicular to axis 279 is perfectly or substantially constant and tapers more widely at the distal end and more narrowly at the proximal end. The exterior shape of cone 278 can be any shape, including any of the possible cone portion 286 shapes described above.

[0030] The passageways 282 may include ribs or fins 288 that extend inward from the outer surface of the passageways 282 toward the central axis 279. Referring specifically to FIG. 6C , in the illustrated example, each fin 288 extends within the conical portion 286 of the passageways 282 between a respective relatively proximal point 290 and a respective relatively distal point 291. A fin axis 293 is defined for each fin 288 as a line that includes the relatively proximal point 290 and the relatively distal point 291 of the corresponding fin 288. Thus, each illustrated fin 288 extends along a respective fin axis 293 that includes the respective relatively proximal point 290 and the respective relatively distal point 291. Because the fin axes 293 are straight, but the tapered or conical portions 278 may have curved internal profiles, the phrase "extend along" in this example includes both fins that may conform exactly to the trajectory of their respective fin axes, and fins 288 that deviate from their respective fin axes 293 radially relative to the central axis 279, as shown in the illustrated example. Each fin axis 293 in the illustrated example intersects the central axis 279. In other examples, some or all of the fins may not extend along any discernible axis, some or all of the fins may deviate tangentially to their respective axes, some or all of the fin axes may not intersect the central axis 279, or any combination of the foregoing.

[0031] In the illustrated example, relatively proximal point 290 and relatively distal point 291 are each located within conical portion 286, i.e., fin 288 is confined to conical portion 286. However, in other examples, relatively proximal point 290, alone or together with relatively distal point 291, may be located proximal to conical portion 286. In further examples, relatively distal point 291, alone or together with relatively proximal point 290, may be located within cavity 284 or at least distal to conical portion 286. Thus, in various examples, fin 288 can extend either proximally and / or distally to conical portion 286, or may be located entirely proximally or entirely distally to conical portion 286. For the outer cone 264 of the illustrated example, the presence of fins 288 only on the cone portion 286 is effective for controlling the folding pattern of the valve 110 as it is pulled proximally through the outer funnel 264, but the location of fins 288 in any of the other positions previously described may be effective for controlling the folding pattern of the valve 110 for outer funnels 264 of other proportions.

[0032] In Figure 7A, the cone 278 is shown alone from a distal perspective, facing proximally along a central axis 279 that is not visible in Figure 7A. Thus, Figure 7A shows the radial components of the fin axes 293 relative to the central axis 279. As can be seen, exactly two fins 288 are defined within the cone 278, with the radial components of the fin axes 293 extending in opposite directions from the central axis 279. Thus, the fin angle 294 defined between the radial components of the fin axes 293 is 180°, and the fins 288 are symmetrically disposed on either side of the plane of symmetry 295. Two sections without fins 288 are defined on either side between the fins 288.

[0033] 7B, valve 110 has a fold pattern influenced by fins 293 when it is mounted on cone 278 (not visible in FIG. 7B) and pulled proximally. Valve 110 is mounted such that neck portion 184 and tether 160 (neither neck portion 184 nor tether 160 are visible in FIG. 7B) extend proximally into cone 278, with at least tether 160 extending through a narrow proximal opening in cone 278. Thus, the collar of valve 110 seats on the wider, distally facing portion of cone 278 and narrows, compresses, or folds over as tension on tether 160 pulls valve 110 proximally.

[0034] Additionally, the valve 110 is also mounted substantially symmetrically with respect to the plane of symmetry 295. Thus, both the hips 186 and the fins 288 are symmetrically distributed on either side of the plane of symmetry 295. The hips 186 and the anterior portion of the collar, including regions A1, A2, and A3 (only A2 is labeled in FIG. 7B for clarity), of the valve 110 all contact only the cone 278 in one of the finless regions defined between the fins 288 on one side. However, the posterior portion of the collar of the valve 110, including regions P1, P2, and P3 (only P2 is labeled in FIG. 7B for clarity), contacts both fins 288. Specifically, in this example, the hips 186, and also (but not necessarily) the P1 and P3 segments, contact the fins 288 when pulled through the cone 278. Thus, the pinch point 296 where the valve 110 initially buckles as it is pulled against the fin 288 can be seen symmetrically and behind or at the hip 186 .

[0035] In addition to being the location where the valve 110 first bends during loading into the delivery catheter (or into a valve holder connected to the delivery catheter), the pinch point 296 is also the location where the valve 110 last unfolds during deployment from the delivery catheter. Furthermore, once the pinch point 296 is established, the valve 110 tends to bend consistently and predictably throughout loading and, therefore, conversely, to unfold consistently and predictably when deployed. Thus, the fins 288 allow for a priori knowledge of the unfolding or “expression pattern” for each, or at least most, delivery or deployment of a given type of valve 110 loaded through the cone 278. The rotational orientation of the loaded valve 110 within the valve retention tube 225 can also be priori known by paying attention to the angular orientation of the valve 110 relative to the fins 288. Observation of the visible angle indicator 280 can aid in determining the angular placement of the valve 110 and fins 288 during loading.

[0036] Knowing the angular placement and expression pattern of valve 110 in advance can reduce the need for patient image references and delivery device adjustments during the procedure for delivery or placement and implantation of valve 110, thus making the procedure faster, simpler, and more efficient. The folding pattern produced by cone 278 in FIG. 7A is merely an example, and cones adapted to produce other folding patterns can be used to accommodate different patient anatomies, different valve types and sizes, and variations in clinician preferences, among other things. Other examples of producing various pinch points, folding patterns, and expression patterns are described below.

[0037] 7C-7F illustrate successive stages in the deployment of the valve 110 from a tube in which the valve 110 is loaded through the cone 278 in the orientation shown in FIG. 7B. The stages are indicated in the side view of each figure labeled "-1" and the end view of each figure labeled "-2." That is, the first stage shown is shown in the side view of FIG. 7C-1 and the end view of FIG. 7C-2, the next stage is shown in the side view of FIG. 7D-1 and the end view of FIG. 7D-2, and so on. As can be seen, during deployment, the A2 region of the valve 110 emerges first and generally extends the furthest in each stage, followed by the P2 region. Due to the two pinch points 296, the hips 186 exhibit limited radial emergence until the final stage shown in FIG. 7F, where the sides of the valve 110 are the last portions of the valve 110 to radially expand during deployment. While Figures 7C-7F are described herein with respect to the placement of valve 110, reviewing Figures 7C-7F in reverse order can illustrate the bending stages that valve 110 undergoes as it is loaded through cone 278.

[0038] FIG. 8A shows another example cone 378. The cone 378 can be used in place of the cone 278 in the outer funnel 264 or another otherwise similar funnel. The interior of the cone 378 thus provides a conical section 386 of the passageway, with ribs or fins 388 extending inward toward the central axis of the cone section 386, each fin 388 also extending along a respective fin axis 393. Like FIGS. 7A and 7B, FIG. 8A is from a distal perspective, facing proximally along the central axis of the cone 378. Thus, FIG. 8A shows the radial components of the fin axes 393. The fin angles 394 between the radial components of the fin axes 393 are equal between each pair of adjacent fin axes 393. Because the cone 378 includes exactly three fins 393, each fin angle 394 is 120°. Three finless areas are defined within conical portion 386 , with each such area being defined between a pair of adjacent fins 388 .

[0039] The fins 388 are distributed symmetrically with respect to a plane of symmetry 395, with one fin 388 extending rearward on the plane of symmetry 395. Thus, when the valve 110 is placed on the cone 378, with the hips 186 also symmetrically located on either side of the plane of symmetry 395 in a manner similar to that described above with respect to FIG. 7B, the center of the P2 region of the collar of the valve 110, and therefore the entire rear portion, is aligned with the fin 388 extending along the plane of symmetry 395. Thus, as shown in FIG. 8B, a pinch point 396 exists in the angular center of the rear portion of the collar of the valve 110.

[0040] Because the hips 186 in the illustrated example of valve 110 are 120° apart from each other on the anterior side, each hip 186 contacts one of the fins 388, so that two pinch points 396 are aligned with the hips 186 and one pinch point 196 is posterior to the hips 186. Thus, the anterior portion of the collar of the valve 110 contacts the cone 378 only in the finless area defined between two of the fins 388. However, in other examples where the angles between the hips 186 or fins 388 are different, the hips 186 may contact the fins 388 or may contact the cone 378 in different or common finless areas, and the proximal or anterior portion of the collar of the valve 110 contacts both fins 388. For example, if the hips 186 were positioned generally along the major axis of the ellipse indicated by the dashed boundary line 180 in FIG. 4, then both hips 186 would be positioned aft of the two forward fins 388.

[0041] 9A shows another example cone 478. Similar to cone 378, cone 478 can be used in place of cone 278 in outer funnel 264 or another otherwise similar funnel. The interior of cone 478 thus provides a conical portion 486 of the passageway. Cone 478 includes exactly one rib or fin 488 extending inward toward the central axis of cone portion 486. Thus, a single finless area extends across the entire cone portion 486, excluding fin 488 itself.

[0042] 7A-8B, the view is from a distal perspective, looking proximally along the central axis of cone 478. Thus, Figure 9A shows the radial component of fin axis 493. As can be seen, fin axis 493 is encompassed by plane of symmetry 495, and the radial component of fin axis 493 extends rearward.

[0043] 7B, when the valve 110 is placed symmetrically on the cone 478 relative to the plane of symmetry 495, the P2 region and the posterior portion of the collar of the valve 110 are generally centered and aligned with the fins 488. Thus, when the valve 110 is pulled proximally through the cone 478, a single pinch point 496 is created in the center of the P2 region, and the remainder of the valve 110, including both the hip 186 and the entire anterior portion of the collar of the valve 110, contacts the cone 478 only in the fin-free area. The single pinch point 496 can be observed in FIG. 9B.

[0044] FIG. 10A shows another example cone 578. Like cones 278, 378, and 478, cone 578 can be used in place of cone 278 in outer funnel 264 or another otherwise similar funnel. The interior of cone 578 thus provides a conical portion 586 of the passageway, with ribs or fins 588 extending inward toward the central axis of cone portion 586, each fin 588 also extending along a respective fin axis 593. Like FIGS. 7A-9B, FIG. 10A is from a distal perspective, facing proximally along the central axis of cone 578. Thus, the radial component of fin axis 593 is shown in FIG. 10A. Because cone 578 includes exactly two fins 588 and the radial components of fin axes 593 are not in opposite directions, a narrow fin angle 594 is defined on one side between the radial components of fin axes 593 and a wide fin angle 597 is defined on the other side between the radial components of fin axes 593. Similarly, a narrow finless area is defined between fin axes 593 on one side and a wide finless area is defined between fin axes 593 on the other side.

[0045] In the illustrated configuration, when the valve 110 is mounted generally symmetrically in the cone 578 with respect to the plane of symmetry 595 as described above with respect to FIG. 7A , and in particular when the anterior portion of the collar of the valve 110 is positioned against the narrow, finless section of the cone portion 586 and the posterior portion of the collar of the valve 110 is positioned against the wide, finless section of the cone portion 586, the narrow fin angle 594 may be less than the acute angle between the hips 186, such that the hips 186 may be angularly aligned slightly posterior to the fins 588. Specifically, in the configuration shown in FIGS. 10A-10C , the acute angle between the hips 186 is at or about 120°, and the narrow fin angle 594 is 90°. Thus, when the valve 110 is pulled proximally through the cone 578, a pinch point 596 is created just forward of each hip 186. In other configurations, the fin angles 594, 597 may be approximately equal to the angle between the hips 186 so that when the valve 110 is placed symmetrically in the cone 578 relative to the plane of symmetry 595, the hips 186 may contact and be angularly aligned with the fins 588.

[0046] Figure 10C shows the valve 110 partially folded when pulled proximally through the cone 578, which is inverted relative to the valve 110 compared to the configuration shown in Figure 10B. Thus, while in Figure 10B the fins 588 were symmetrically aligned in front of the hip 186, in Figure 10C both fins 588 contact the P2 region of the valve 110. Thus, two pinch points 596' are created in the P2 region.

[0047] 10A-10C, narrow fin angle 594 is 90°, wide fin angle 597 is 270°, and the angles between hips 186 are equal. However, these angles are merely an example. The angle between hips 186 is limited by human anatomy but may vary slightly according to different valve designs, and the angle between fins 588 may vary accordingly. On the other hand, a cone can have just two fins with an angle other than 90°, 180°, or 270° between them, which may or may not match the angle between the hips of the valve with which it is used.

[0048] 11A-11D illustrate successive steps in deploying the valve 110 from the tube in which it is loaded through the cone 578, with the hip 186 on the opposite side of the fin 588 as shown in FIG. 10C. The steps are shown in the side views labeled "-1" and the end views labeled "-2" in FIGS. 11A-11D. That is, the first step shown is shown in the side view of FIG. 11A-1 and the end view of FIG. 11A-2, the next step shown is shown in the side view of FIG. 11B-1 and the end view of FIG. 11B-2, and so on. As shown, during deployment, the A2 region of the valve 110 emerges first and generally extends the furthest with each step. Radial deployment of P2 and the entire posterior portion of valve 110 is delayed by the presence of posterior pinch point 596', which causes the posterior portion of valve 110 to remain folded inward during the intermediate stages shown in FIGS. 8D and 8E. Although none of the fins contact the anterior portion of valve 110 when loaded as shown in FIG. 10C, loading valve 110 in the orientation shown in FIG. 10C creates an inward fold at hip 186 as shown in FIGS. 11A-11D. Thus, as is particularly evident in FIGS. 11B and 11C, regions A1 and A3 radially expand later than region A2. However, in the illustrated example, the posterior portion of valve 110 expands last. While Figures 11A-11D are described herein with respect to the placement of valve 110, reviewing Figures 11A-11D in reverse order can illustrate the bending stages that valve 110 undergoes when loaded through cone 578 oriented as shown in Figure 10C.

[0049] Each of the aforementioned cones 278, 378, 478, and 578 includes a different configuration of fins that can be used to create different fold patterns, such as those shown and described above. For each of the aforementioned cones, different fold patterns can also be created by angularly aligning the cone with respect to the valve differently from the specific example described above. For example, any of the previously described cones can be inverted, with both the ribs and hips 186 remaining symmetrical on either side of a common plane of symmetry. However, the valve 110 can also be mounted on any of the previously described cones such that the fins of the cone are not symmetrical with respect to the plane of symmetry of the hips 186. Furthermore, the illustrated and previously described cones are merely examples of how fins can be arranged. Cones of other configurations can have any number of fins, evenly or unevenly distributed angularly around the cone.

[0050] While any of the above-described combinations of ribs or fins can be used to achieve a variety of different, predictable folding patterns, it should be understood that some folding patterns are particularly desirable in certain situations. In other words, while the predictability and repeatability of deployment or deployment itself is a primary advantage of the present disclosure, another advantage may lie in using that predictability to have an ordered valve deployment or emergence from the delivery device. For example, when utilizing a prosthetic mitral valve having a shape that generally corresponds to the shape of the native mitral valve, it may be most preferable to deploy the A1, A2, and A3 segments of the outer stent first from the delivery catheter without significant bending within the A1-A3 segments. Such a configuration may allow for particularly easy visualization of the valve orientation, which may allow for particularly good rotational alignment of the prosthetic valve relative to the native mitral valve annulus. Furthermore, the A1-A3 segments are typically the largest areas of the outer cuff collar, and when deployed first from the delivery catheter, they can exert a relatively large radial force on the native annulus to ensure successful placement of the prosthetic valve early in the deployment phase, for example, by positioning the A1-A3 segments at the atrial base. It may also be desirable for the hips 186 to "pop out" toward the native commissures of the mitral valve during deployment. For example, with reference to the folding patterns shown in FIGS. 7B and 10C , it may be predictable that the A1-A3 segments will be the first to deploy or deploy from the delivery catheter, with the hips remaining pinched or folded while the A1-A3 segments begin deployment. As deployment continues and the hips 186 begin to emerge from the delivery catheter, the hips 186 will unfold or expand or "pop out" toward the native commissures. While cones 278 and 578 may be most suitable for achieving the goals listed above, it should be understood that any of the cones described above may be utilized to achieve a particularly desirable (and predictable / reproducible) deployment or placement or expression pattern of the prosthetic heart valve.

[0051] Although not shown, the prosthetic mitral valve may include additional anchoring features, such as protrusions, barbs, or spokes, extending radially outward from the outer stent so that they engage with native tissue during deployment of the prosthetic mitral valve, helping to further secure the prosthetic heart valve within the native tissue. Such protrusions or similar structures may be strategically positioned to engage only specific regions of the native mitral valve, or in other embodiments, they may be positioned generally uniformly around the outer stent circumference to maximize the likelihood of the protrusions engaging tissue for enhanced anchoring. When such protrusions or other anchoring structures are provided, a predictable deployment pattern can be achieved, allowing a user, such as surgical personnel, to determine where the protrusions will initially engage tissue. In some instances, it may be desirable for the protrusions to initially engage the anterior A2 (or near A2) segment of the native mitral valve, which may be considered a straight region of a "D" shape, since the mitral valve annulus is often described as having a "D" shape. Thus, if it is desired that the protrusions or barbs or outer stent first engage the A2 segments of the native anterior leaflet, a folding pattern can be selected in which the A2 segments of the collar of the outer stent are deployed and deployed first to contact the corresponding A2 segments of the native anterior leaflet. It should be understood that this particular use of the protrusions of the mitral valve stent to achieve ordered and / or targeted engagement of the native valve tissue is merely exemplary, and that any of the cones and funnels described above, with or without the deformers, can be used to create specific, desirable, predictable, and reproducible expression patterns to achieve the desired ordered and / or targeted engagement of the anchors with the native tissue.

[0052] In summary of the foregoing, a loading funnel for a prosthetic heart valve is disclosed. The funnel has a distal end and an opposite proximal end. The distal end is for receiving the prosthetic heart valve in a partially expanded state or, in some instances, a fully expanded state. The funnel also includes a passage extending between the distal end and a proximal connector. The passage includes a conical and / or tapered portion that is wider at the distal end of the conical and / or tapered portion than at the proximal end of the conical and / or tapered portion. The passage is centered along a cone axis. The passage also includes at least two internal fins, each extending from a respective relatively proximal position within the passage to a respective relatively distal position within the passage. Each example includes a loading funnel having the aforementioned characteristics; and / or each fin may extend along a different respective fin axis that intersects the cone axis; and / or the radial components of the two fin axes relative to the cone axis may be 90° apart from each other; and / or the loading funnel may have only two fins in the cone portion; and / or the radial components of the two fin axes relative to the cone axis may be 180° apart from each other; and / or the funnel may have three internal fins in the cone portion. the internal fins may project toward the central axis and extend from a relatively proximal position to a relatively distal position along different respective fin axes that intersect the cone axis, and / or the radial components of the three fin axes relative to the cone axis may be 120° apart from each other, and / or the funnel may include a visible radial indicator on an outer surface of the funnel, and / or both the relatively proximal and relatively distal positions for each of the fins may be located within the conical portion of the passage.

[0053] A method for compressing a prosthetic heart valve for delivery to a patient is also disclosed. The method includes placing the prosthetic heart valve in a loading funnel. The prosthetic heart valve includes a frame defining a collar configured to contact the annulus of the native heart valve. The collar includes an anterior portion configured to contact an annulus of the annulus and a posterior portion configured to contact a posterior portion of the annulus, the anterior portion extending radially farther from the neck than the posterior portion. The method also includes translating the prosthetic heart valve through the loading funnel from a distal end of the loading funnel to a proximal end of the loading funnel to compress the prosthetic heart valve. The loading funnel includes a passage extending between the distal and proximal ends of the loading funnel. The passage includes a tapered portion that is wider at the distal end than at the proximal end. The passage further includes at least two fins on an inner surface of the tapered portion of the passage. The at least two fins protrude away from the inner surface of the tapered portion of the passage toward a central longitudinal axis of the passage. During translation of the prosthetic heart valve through the loading funnel, each portion of the collar advances along at least two fins.Examples include a method having the aforementioned characteristics; and / or the anterior and posterior portions can together provide the entire circumference of the collar; and / or the anterior portion of the collar can contact only the anterior section of the tapered portion during translation of the prosthetic heart valve through the loading funnel, the anterior section being devoid of internal fins; and / or the method can include pulling the valve proximally against the fins and into a retaining tube secured to the proximal end of the loading funnel, the fins can each extend from a respective relatively proximal position to a respective relatively distal position; and / or the valve can include a neck configured to permit fluid flow in a flow direction and inhibit fluid flow in an opposite direction to the flow direction, the frame can define a collar around an end of the neck, the collar including an anterior portion and a posterior portion, the anterior portion extending radially farther from the neck than the posterior portion, the frame further defining two hips, each hip located at a respective point where the anterior portion meets the posterior portion, and the positioning step The valve may include symmetrically aligning the hips on either side of a plane along which the fins are symmetrically distributed; and / or the arranging step may include angularly aligning two of the fins and the hips about the cone axis; and / or the arranging step may include placing a front portion of the valve so that it contacts the cone portion only at a front section of the cone portion and placing a rear portion of the valve so that it contacts the cone portion only at a rear section of the cone portion, the front and rear sections being defined between the two fins and devoid of fins; and / or the arranging step may include angularly aligning the valve about the cone axis so that only the rear section contacts the fins; and / or the at least two fins may be exactly two fins, each of which extends along a respective fin axis, the cone axis and the fin axis being encompassed by a common plane; and / or the at least two fins may be exactly three fins.

[0054] A loading funnel for a prosthetic heart valve is also disclosed. The funnel has a distal end and an opposite proximal end. The distal end is adapted to receive the prosthetic heart valve in a partially expanded state or, in some instances, a fully expanded state. The funnel includes a passage extending between the distal end and a proximal connector. The passage includes a conical and / or tapered portion that is wider at the distal end of the conical and / or tapered portion than at the proximal end of the conical and / or tapered portion. The passage is centered along a cone axis. The passage also includes at least two internal fins. Each internal fin extends from a respective relatively proximal position within the passage to a respective relatively distal position within the passage. Each fin extends along a different respective fin axis that intersects the cone axis. The radial components of the two fin axes relative to the cone axis may be 90° apart or 180° apart. The funnel includes a visible radial indicator on an exterior surface of the funnel, and for each of the fins, both the relatively proximal and relatively distal positions are located within the conical portion of the passageway.

[0055] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. 1. A loading funnel for a prosthetic heart valve, said loading funnel comprising: a proximal end; a distal end for receiving the prosthetic heart valve in an at least partially expanded state; and a passageway extending between the distal end and the proximal end; The passage comprises: a cone portion that is wider at its distal end and thinner at its proximal end and that is centered along the cone axis; at least two internal fins projecting toward the cone axis and each extending from a respective relatively proximal position within the passage to a respective relatively distal position within the passage; The loading funnel further comprises a radial indicator visible on an exterior surface of the loading funnel.

2. The loading funnel of claim 1 , wherein each fin extends along a different respective fin axis that intersects the cone axis.

3. 3. The loading funnel of claim 2, wherein the radial components of the two fin axes relative to the cone axis are 90 degrees apart from each other.

4. 4. The loading funnel of claim 3, wherein said conical portion has only two fins.

5. 3. The loading funnel of claim 2, wherein the radial components of the two fin axes relative to the cone axis are 180 degrees apart from each other.

6. 3. The loading funnel of claim 2, comprising three internal fins within the cone portion, the internal fins projecting toward the cone axis and extending from a relatively proximal position to a relatively distal position along different respective fin axes that intersect the cone axis.

7. 7. The loading funnel of claim 6, wherein the radial components of the three fin axes relative to the cone axis are 120 degrees apart from each other.

8. The loading funnel of claim 1 , wherein for each of the fins, the relatively proximal position and the relatively distal position are both located within the conical portion of the passageway.

9. a loading handle assembly configured to receive and apply tension to a tether of the prosthetic valve; a valve retention tube configured to be connected to a distal end of the loading handle assembly and configured to receive the prosthetic valve through the distal end of the valve retention tube; a valve assembly connected to the distal end of the valve retainer tube and including a loading funnel according to claim 1 and a centering cone receivable in the conical portion of the passage of the loading funnel; A valve loading assembly comprising:

10. 1. A method of compressing a prosthetic heart valve for delivery to a patient, comprising: placing the prosthetic heart valve in a loading funnel, the prosthetic heart valve including a frame defining a collar configured to contact an annulus of a native heart valve, the collar including an anterior portion configured to contact an anterior portion of the annulus and a posterior portion configured to contact a posterior portion of the annulus; translating the prosthetic heart valve through the loading funnel from a distal end of the loading funnel to a proximal end of the loading funnel to compress the prosthetic heart valve, the loading funnel including a passage extending between the distal and proximal ends of the loading funnel, the passage including a tapered portion that is wider at the distal end than at the proximal end, the passage further including at least two fins on an inner surface of the tapered portion of the passage, the at least two fins protruding away from the inner surface of the tapered portion of the passage toward a central longitudinal axis of the passage; Including, each portion of the collar advances along the at least two fins during translation of the prosthetic heart valve through the loading funnel; method.

11. The method of claim 10 , wherein the anterior portion and the posterior portion together provide a full periphery of the collar.

12. 11. The method of claim 10, wherein during translation of the prosthetic heart valve through the loading funnel, the anterior portion of the collar contacts only an anterior section of the tapered portion, the anterior section lacking internal fins.

13. 11. The method of claim 10, further comprising pulling the prosthetic heart valve proximally against the fins and into a retaining tube secured to the proximal end of the loading funnel, wherein each of the fins extends from a respective relatively proximal position to a respective relatively distal position.

14. The artificial heart valve comprises: a generally tubular neck configured to extend through the native heart valve when the prosthetic heart valve is implanted; the frame defines the collar around an end of the neck, the collar including the forward portion and the rearward portion, the forward portion extending radially farther from the neck than the rearward portion, two hips respectively located at points where the forward portion meets the rearward portion, and the positioning step comprises: symmetrically aligning the hips on either side of a plane along which the fins are symmetrically distributed; The method of claim 10.

15. The method of claim 14 , wherein the positioning step includes angularly aligning two of the fins and the hip about the central longitudinal axis.

16. 16. The method of claim 15, wherein the placing step includes placing the anterior portion of the prosthetic heart valve so that it contacts the tapered portion only within a anterior section of the tapered portion, and placing the posterior portion of the prosthetic heart valve so that it contacts the tapered portion only within a posterior section of the tapered portion, the anterior and posterior sections being defined between the two fins, and the anterior and posterior sections being free of fins.

17. 11. The method of claim 10, wherein the positioning step includes angularly aligning the prosthetic heart valve about the central longitudinal axis so that only the posterior portion contacts the fins.

18. 11. The method of claim 10, wherein the at least two fins are exactly two fins, each of the fins extending along a respective fin axis, and the central longitudinal axis and the fin axis are encompassed by a common plane.

19. The method of claim 10 , wherein the at least two fins is exactly three fins.

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