Tip for transcatheter aortic heart valve delivery system

Abstract

A delivery system for delivering a prosthetic valve in a compressed condition over an inner shaft of a catheter. The delivery system includes a tip extending distally from the inner shaft. The tip has a proximal section and an opposite distal section extending to an end of the tip. The proximal section is configured to support an end of the prosthetic valve during loading and delivery of the prosthetic heart valve and includes a first portion, a second portion, and a third portion. The first portion is adjacent the distal section. The second portion is between the first portion and third portion. The third portion is adjacent a proximal end of the tip. An outer diameter of the first portion is greater than an outer diameter of the inner shaft, an outer diameter of the second portion, and an outer diameter of the third portion.

Description

107669-00021A0012942W001TIP FOR TRANSCATHETER AORTIC HEART VALVE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Application No. 63 / 705,765 filed October 10, 2024 titled “TIP FOR TRANSCATHETER AORTIC HEART VALVE DELIVERY SYSTEM,” the subject matter of which is incorporated by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to catheter-based devices for delivery a prosthesis. More particularly, the present disclosure relates to a tip for a transcatheter prosthetic heart valve delivery device.BACKGROUND

[0003] Transcatheter aortic valve replacement (TAVR) is a procedure that replaces a diseased aortic valve with a man-made valve. In general terms, an expandable prosthetic valve is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart. The heart valve prosthesis employed with catheter-based, or transcatheter, procedures generally includes an expandable multi-level frame or stent that supports a valve structure having a plurality of leaflets. The frame can be contracted during percutaneous transluminal delivery and expanded upon deployment at or within the native valve. One type of valve stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed about a balloon portion of a catheter. The balloon is subsequently inflated to expand and deploy the prosthetic heart valve. With other stented prosthetic heart valve designs, the stent frame is formed to be selfexpanding. With these systems, the prosthetic heart valve is crimped down to a desired size and held in that compressed state within a sheath for transluminal delivery. Retracting the sheath from this prosthetic heart valve allows the prosthetic heart valve to self-expand to a larger diameter, fixating at the native valve site. In some instances, the prosthetic heart valve may experience infolding when loaded onto a catheter-based device. Infolding can result in serious complications and may be difficult to detect because of the 2-dimensional nature of fluoroscopic projection imaging.107669-00021A0012942W001SUMMARY

[0004] Some aspects of the present disclosure are directed to an apparatus and system including a tip for a delivery device and a delivery system for a prosthetic heart valve. In an embodiment, a delivery system for delivering a prosthetic valve in a compressed condition over an inner shaft of a catheter, includes a tip extending distally from inner shaft. The tip has a proximal section and an opposite distal section extending to an end of the tip. The proximal section is configured to support an end of the prosthetic valve during loading and delivery of the prosthetic heart valve and includes a first portion, a second portion, and a third portion. The first portion is adjacent the distal section. The second portion is between the first portion and third portion. The third portion is adjacent a proximal end of the tip. An outer diameter of the first portion is greater than an outer diameter of the inner shaft, an outer diameter of the second portion, and an outer diameter of the third portion. The outer diameter of the second portion is greater than the outer diameter of the third portion.

[0005] In embodiments, the outer diameter of the second portions decreases in a direction from the first portion to the third portion.

[0006] In embodiments, the outer diameter of the first portion is within a range of 3.5 - 4.5 mm.

[0007] In embodiments, a length of the first portion is greater than a length of the second portion.

[0008] In embodiments, a length of the second portion is greater than a length of the third portion.

[0009] In embodiments, the proximal section includes a plurality of slots along an outer diameter of the proximal section for increasing the flexibility of the proximal section.

[0010] In embodiments, the tip includes a chamfered edge that connects the proximal section to the distal section.

[0011] In embodiments, the tip includes a fillet edge that connects the proximal section to the distal section.107669-00021A0012942W001

[0012] In embodiments, the proximal section includes a groove configured to control overlap of the end of the prosthetic heart valve.

[0013] In embodiments, the groove extends from the second portion into the third portion.

[0014] In embodiments, the groove extends at least partially along a length of the second portion.

[0015] In embodiments, the third portion supports an inner surface of the prosthetic valve.

[0016] In embodiments, only the third portion supports the inner surface of the prosthetic valve.

[0017] In embodiments, the first and second portion are configured to be distal to the end of the prosthetic valve when the prosthetic valve is loaded

[0018] In embodiments, a system includes a prosthetic heart valve and a catheter configured for delivering the prosthetic heart valve. The catheter includes an inner shaft and a tip extending distally from the inner shaft. The tip defines a proximal section opposite a distal section and an outer diameter of the proximal section is greater than an outer diameter of the inner shaft. The proximal section includes a concave groove configured to control overlap of the end of the prosthetic heart valve.

[0019] In embodiments, the tip includes a chamfered or fillet edge between the proximal section and the distal section.

[0020] In embodiments, the proximal section includes a plurality of slots along an outer diameter of the proximal section for increasing the flexibility of the proximal section.

[0021] In embodiments, the proximal section includes a first portion, a second portion, and a third portion. The first portion is adjacent the distal section, the second portion is between the first portion and third portion, and the third portion is adjacent a proximal end of the tip. An outer diameter of the first portion is greater than an outer diameter of the inner shaft, an outer diameter of the second portion, and an outer diameter of the third portion. The outer diameter of the second portion decreases from adjacent the first portion the third portion.107669-00021A0012942W001

[0022] In embodiments, a length of the first portion is greater than a length of the second portion.

[0023] In embodiments, a portion of the proximal section including the concave groove supports an inner surface of the prosthetic heart valve and a remaining portion distal to the portion including the groove does not support the inner surface of the prosthetic heart valve.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is a side view illustrating a non-limiting example of a prosthetic valve configured for replacing an aortic valve and that may be used with the systems and apparatuses of the present disclosure;

[0025] FIG. 2 illustrates the prosthetic valve of FIG. 1 loaded on to a non-limiting example of a portion of a delivery system, according to an embodiment of the present disclosure;

[0026] FIG. 3 is a cross-sectional view of a tip of the delivery system, according to an embodiment of the present disclosure;

[0027] FIG. 4 is a side view of the tip for the delivery system shown in FIG. 3, according to an embodiment of the present disclosure;

[0028] FIG. 5 is a side view of the tip for the delivery system shown in FIG. 3, according to an embodiment of the present disclosure;

[0029] FIG. 6 is a side view of the tip for the delivery system shown in FIG. 3, according to an embodiment of the present disclosure;

[0030] FIG. 7 is a cross-sectional view of the tip including a plurality of slots shown in FIGS. 4-6, according to an embodiment of the present disclosure;

[0031] FIG. 8 is a cross-sectional view of the tip shown in FIGS. 4-6, according to an embodiment of the present disclosure;

[0032] FIG. 9 is a perspective view of the tip including an groove according to an embodiment of the present disclosure; and107669-00021A0012942W001

[0033] FIG. 10 is a perspective view of the groove according to an embodiment of the present disclosure.

[0034] FIG. 11 is a side view of a tip of a delivery system, according to an embodiment in which an inflow bump is provided.

[0035] FIG. 12 is a perspective view of the inflow bump according to an embodiment.

[0036] FIG. 13 A is a side view of a tip of the delivery system, according to an embodiment; FIG. 13B is a cross-sectional view of the tip of FIG. 13 A.

[0037] FIG. 14A is a side view of a tip of the delivery system, according to another embodiment; FIG. 14B is a cross-sectional view of the tip of FIG. 14A.DETAILED DESCRIPTION

[0038] Embodiments of the present disclosure are described herein. It is to be understood, however, that the disclosed embodiments are merely examples and other embodiments can take various and alternative forms. The figures are not necessarily to scale; some features could be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative bases for teaching one skilled in the art to variously employ the embodiments. As those of ordinary skill in the art will understand, various features illustrated and described with reference to any one of the figures can be combined with features illustrated in one or more other figures to produce embodiments that are not explicitly illustrated or described. The combinations of features illustrated provide representative embodiments for typical application. Various combinations and modifications of the features consistent with the teachings of this disclosure, however, could be desired for particular applications or implementations.

[0039] “A”, “an”, and “the” as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a processor” programmed to perform various functions refers to one processor programmed to perform each and every function, or more than one processor collectively programmed to perform each of the various functions.107669-00021A0012942W001

[0040] Catheter-based devices and systems for delivering a prosthetic heart valve are shown in PCT Application Publication No. WO2023214288, the entirety of which is incorporated by reference herein. Aspects of the disclosure are beneficial for use with prosthetic heart valves and heart valve repair methods including the implantation of a prosthetic heart valve, particularly, prosthetic heart valves delivered via a transcatheter procedure. As referred to herein, prosthetic heart valves can include a bioprosthetic heart valve structure having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing or repairing valves of the human heart. In one nonlimiting example, the valve of the human heart is an aortic valve, although the apparatuses and systems of the present disclosure can be useful with the mitral, tricuspid, or pulmonary heart valve.

[0041] The prosthetic heart valves of the present disclosure may be self-expandable, balloon expandable and / or mechanically expandable, or combinations thereof. In general terms, the prosthetic heart valves of the present disclosure can include a stent or stent frame having an internal lumen maintaining a valve structure (tissue or synthetic), with the stent frame having a normal, expanded condition or arrangement and being collapsible to a compressed condition or arrangement for loading within the delivery device. For example, the stents or stent frames are support structures that include a number of struts or wire segments arranged relative to each other to provide a desired compressibility and strength to the prosthetic valve. The struts or wire segments are arranged such that they are capable of self-transitioning from, or being forced from, a compressed or collapsed arrangement to a normal, radially expanded arrangement. The struts or wire segments can optionally be formed from a shape memory material, such as a nickel titanium alloy (e.g., nitinol). The stent frame can be laser-cut from a single piece of material, or can be assembled from a number of discrete components.

[0042] FIG. 1 illustrates a non-limiting example of a prosthetic valve 10 configured for replacing an aortic valve and that may be used with the systems and apparatuses of the present disclosure. The prosthetic valve 10 is shown in a normal or expanded condition. The prosthetic valve 10 includes a frame 12 and valve structure 14 assembled to the frame 12. The valve structure 14 includes leaflets 16 and defines an outflow region 18 opposite an inflow region 20. The outflow region 18 extends to a first end 22 and the inflow region 20 extends to a second end 24 of the frame 12. Crowns 26 are formed at the first end 22 and the second end 24. During deployment or loading of the prosthetic valve 10 to a delivery device, the prosthetic valve 10107669-00021A0012942W001 may experience infolding, inflow overlap, or strut crossing. In general, strut crossing or inflow overlap is a non-uniform rearranging of a self-expanding prosthetic valve 10 stent frame 12 end crowns 26 under the delivery device’s capsule which can occur during initial loading of the prosthetic valve 10. This phenomena can lead to infolding of the stent frame during recapture or deployment. Infolding is a fold in the frame 12 that extends inward away from the anatomy (vessel wall or tissue) and in a vertical line along the frame. Infolding can have shortterm and long-term consequences, as a result of blood flow bypassing the prosthetic valve 10.

[0043] FIG. 2 illustrates a non-limiting example of a portion of a delivery system 30 in accordance with an embodiment and the principles of the present disclosure. The delivery system 30 includes a catheter 32 comprising a shaft assembly 34 and a prosthetic valve 10 coupled to the catheter 32. The shaft assembly 34 includes an inner shaft 38 and a capsule 40 configured to surround the inner shaft 38. The catheter 32 has a proximal end (not shown) connected to a handle (not shown) for controlling the delivery of the prosthetic valve 10 at a target site. In general, the delivery system 30 is configured for percutaneously delivering the prosthetic valve 10 in a compressed condition, to the target site and deploying the prosthetic valve 10 at the target site. For example, the delivery system 30 provides a delivery state in which the prosthetic valve 10 is coupled to the inner shaft 38 and compressively retained within the capsule 40. The shaft assembly 34 can be manipulated to withdraw the capsule 40 proximally from the prosthetic valve 10 via operation of the handle. In the deployment state, withdrawing the capsule 40 permits the prosthesis 16 to self-expand (alternatively, be caused to expand) and release from the inner shaft 38. The features and components of the delivery system 30 can be modified or replaced with differing structures or mechanism. Thus, the present disclosure is in no way limited to the catheter 32, inner shaft 38, capsule 40, as shown and described herein. More generally, some delivery devices in accordance with principles of the present disclosure provide features capable of retaining a self-deploying stented prosthetic heart valve (e.g., the capsule 40).

[0044] A tip 42 extends distally from the inner shaft 38 and is located at a distal end of the catheter 32. The tip 42 is configured to support the prosthetic valve 10 during loading onto the inner shaft 38 and while in the delivery state. As will be described further herein, the tip 42 is further configured to minimize or prevent crossing or infolding of the prosthetic valve 10 (e.g., crossing or infolding of a stent frame). For example, the tip 42 is configured to prevent107669-00021A0012942W001 the frame 12 or valve structure 14 of the inflow region 20 and / or the second end 24 from infolding and the infolding propagating to the first end 22.

[0045] FIG. 3 illustrates a cross-sectional view of the tip 42 according to an embodiment of the present disclosure. A shape or profile of the tip 42 defines a proximal section 44 and a distal section 46 along a longitudinal axis A. The distal section 46 can have a distally tapering outer profile in extension from the proximal section 44 to a tip end 48 that is adapted to promote atraumatic contact with bodily tissue, for example. The proximal section 44, or a portion thereof, is configured to support a corresponding region of the prosthetic valve 10 (such as the inflow region 20) during loading, delivery, or recapture of the prosthetic valve 10 over the inner shaft 38 so as to minimize the propensity of the prosthetic valve 10 to experience strut crossing or overlap. The tip 42 may be located so as to position the proximal section 44, or a portion thereof, to be axially aligned with and / or axially disposed in side of at least a portion of the inflow region 20 or adjacent to the second end 24 of the prosthetic valve 10. For example, FIG. 2 shows a simplified representation of a portion of the prosthetic valve 10 having been crimped to the collapsed condition over the inner shaft 38 (i.e., the delivery state) in which the capsule 40 constrains the prosthetic valve 10 in the collapsed condition. The proximal section 44, or a portion thereof, effectively increases a packing density inside the capsule 40 (as compared to a packing density were the proximal section 44 is not present or is shorter and does not axially overlap with the prosthetic valve 10 and / or the valve structure 14). This increased packing density serves to minimize or prevent the struts and the crowns 26 of the inflow region 20 of the frame 12 from folding over one another when loading the prosthetic valve 10 to the delivery system 30 (as well as after the prosthetic valve 10 has been loaded, such as during a recapturing step). The increased packing density also increases a loading force required to load or recapture the prosthetic valve 10 with the capsule 40. If the loading force is too great, the capsule 40 may not be able to properly load or recapture the prosthetic valve 10. Accordingly, when the prosthetic valve 10 is crimped on to the proximal section 44 (or a portion thereof), the crimped prosthetic valve 10 profile results in a loading force that may be safely overcome by the capsule 40, or the like.

[0046] The shape or profile of the proximal section 44 may define a first portion 50, a second portion 52, and a third portion 54. The first portion 50 is adjacent the distal section 46, the second portion 52 is between the first portion 50 and the third portion 54, and the third portion 54 is at a proximal end of the tip 42. The second end 24 of the prosthetic valve 10 may107669-00021A0012942W001 be aligned with and crimped or compressed onto the first, second, and / or third portions 50, 52, 54, with the proximal section 44 providing a surface for supporting the prosthetic valve 10 (e.g., the struts, crown, stent frame, or the like). In certain embodiments, a slight gap may exist between the prosthetic valve 10 and the surface of the proximal section 44, or a portion thereof. In some embodiments, the first, second, and / or third portion 50, 52, 54 may be identical such that the respective portions are essentially equivalent to each other (e.g., the second portion 52 may be essentially equivalent to the first portion 50 such that it is an extension of the first portion 50).

[0047] FIGS. 4-6 show three additional embodiments of an outer shape or profile of the tip 42. In embodiments, the first portion 50 has an outer diameter ODi that may be equal to, greater, or less than an outer diameter OD2 of the second portion 52, an outer diameter OD3 of the third portion, and an outer diameter ODis of the inner shaft 38. The outer diameters OD2 and OD3 may be greater than the outer diameter ODis of the inner shaft 38. The outer diameter OD2 of the second portion 52 may be greater than the outer diameter OD3 and decrease from adjacent the first portion 50 to third portion 54. The decrease of the outer diameter OD2 may be gradual, exponential, step-wise, or the like. Similarly, the outer diameter OD3 may decrease from adjacent the second portion 52 to the inner shaft 38. In some embodiments, the outer diameter OD3 may be overmolded to the inner shaft 38, wherein the decrease in the outer diameter OD3 provides a tapered transition to the inner shaft 38 for preventing the tip 42 from catching on an implanted prosthetic valve 10 (as shown in FIG. 3). The outer diameters ODi, OD2, and OD3 may be defined by a percentage relative to one another (e.g., outer diameter OD3 may be 30-90% less than the outer diameter ODi, or the like).

[0048] The outer diameters ODi, OD2, and OD3 may be within a range of 0.1 - 10 mm, or the like, or a sub-range thereof. For example, outer diameters ODi, OD2, and OD3 may be 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, or the like, or a sub-range thereof. In some embodiments, the outer diameters ODi, OD2, and OD3 may correspond to the size of the prosthetic valve 10. For example, for a 29 mm prosthetic valve 10 the outer diameters ODi, OD2, and OD3 may be 1.9 mm, 2.8 mm, or the like, or a sub-range thereof, and for a 34 mm prosthetic valve 10 the outer diameters ODi, OD2, and OD3 may be 1.42 mm, 4.0 mm, or the like, or a sub-range thereof. As discussed above, the outer diameter ODi may be 2.8 mm or 4.0 mm and the outer diameter OD3 may be 1.9 mm or 1.42 mm, wherein the outer diameter OD2 decreases from the outer diameter ODi to the outer diameter107669-00021A0012942W001OD3. It should be appreciated that the ranges and sizes disclosed herein for the outer diameters ODi, OD2, and OD3 may include variations of ±0.05 mm, ±0.10 mm, ±0.25 mm, or the like, or a sub -range thereof.

[0049] As previously mentioned, the outer diameters ODi, OD2, and OD3 are configured to fill space between the prosthetic valve 10 and the inner shaft 38 (i.e., packing density). The outer diameters ODi, OD2, and OD3 prevent infolding of the inflow region 20 and / or the second end 24 of the prosthetic valve 10 (i.e., the proximal section 44, or a portion thereof, prevents the inflow region 20 from deflecting radially inwards towards the inner shaft 38 in a manner that may otherwise have a propensity to allow the struts and / or the crowns 26 along the second end 24 to undesirably overlap or cross). Accordingly, support provided by the proximal section 44, or a portion thereof, minimizes or prevents strut crossing or overlap from occurring at or adjacent to the second end 24 and propagating towards the first end 22 of the prosthetic valve 10. However, if the outer diameters ODi, OD2, and / or OD3 are too large, then the prosthetic valve 10 may push radially outward against the capsule 40 and require a greater loading force to load or recapture the prosthetic valve 10. Therefore, the outer diameters ODi, OD2, and / or OD3 may be selected so as to balance the loading force and support to the inflow region 20 and / or the second end 24 of the prosthetic valve 10. In some embodiments, the distal section 46 has a maximum outer diameter ODD that is greater than the outer diameter ODi of the first portion 50 and that tapers (i.e., decreases gradually) to the tip end 48.

[0050] In embodiments, the proximal section 44 has a length Lp defined by a distance from the distal section 46 and the proximal end. The first portion 50 has a length Li defined by a distance from the distal section 46 and the second portion 52. The second portion 52 has a length L2 defined by a distance from the first portion 50 and the third portion 54. The third portion 54 has a length L3 defined by a distance from the second portion 52 and the proximal end. The distal section 46 has a length LD defined by a distance from the proximal section 44 to the tip end 48. In some embodiments, the length Li may greater, less than, or equal to the lengths L2 and L3, the length L2 may be greater, less than, or equal to the lengths Li and L3, or the length L3 may be greater, less than, or equal to the lengths Li and L2, or the like, or a combination or sub-combination thereof (e.g., the length Li may greater than the lengths L2 and L3 and the length L2 may be greater than the length L3, or in other words, the length L3 may be less than the lengths Li and L2). The lengths Li, L2, L3 may be defined by a percentage relative107669-00021A0012942W001 to one another (e.g., the lengths L2 and L3, individually or collectively, may be less than 50% of the length Li, or the like).

[0051] The lengths Lp and LD may be within a range of 5 - 200 mm, or the like, or a combination or sub-combination thereof. The lengths Li, L2, L3 may be collectively and individually within a range of 0.1 - 5 mm, 5 - 10 mm, 10 - 30 mm, or the like, or a combination or sub-combination thereof. The lengths Li, L2, L3 may be selected as a result of the desired inflow support, size of the prosthetic valve 10, the loading force, or the like. The lengths Li, L2, L3 extend the support of the outer diameters ODi, OD2, and OD3 to prevent infolding or overlapping of the prosthetic valve 10. In some embodiments, the second end 24 of the prosthetic valve 10 may be aligned with and crimped onto the first portion 50 or the second portion 52. In some embodiments, the lengths Li, L2, L3 may collectively be within a range of 1- 15 mm. In some embodiments, the lengths Li, L2, L3 may be sized based on a distance between a location of the proximal section 44 where the second end 24 may be crimped onto and the valve structure 14 and / or leaflets 16, such as 10-20 mm, or the like. In some embodiments, the lengths Li, L2, L3 may correspond to the size of the prosthetic valve 10. For example, for a 29 mm diameter prosthetic valve 10 the distance between the crimped second end 24 and the valve structure 14 may be 11.8 mm and the lengths Li, L2, L3 may be collectively sized to provide at least 1 mm of support. In other words, lengths Li, L2, L3 may be collectively 6.4 ± 5.4 mm. For a 34 mm diameter prosthetic valve 10 the distance between the crimped second end 24 and the valve structure 14 may be 12.7 mm and the lengths Li, L2, L3 may be collectively sized to provide at least 1 mm of support, such that the lengths Li, L2, L3 may be collectively 6.85 ± 5.85 mm. It should be appreciated that the ranges and sizes disclosed herein for the lengths Li, L2, L3 may include variations of ±0.05 mm, ±0.10 mm, ±0.25 mm, or the like, or a sub-range thereof. In some embodiments, the valve structure 14 and / or leaflets 16 may not be aligned with the second portion 52, the third portion 54, or the proximal section 44.

[0052] For example, as shown in FIG. 4, the length Li is greater than the lengths L2 and L3, and the length L3 is greater than the length L2. The length Li is approximately greater than the combined lengths of L2 and L3, and the lengths of L2 and L3 are less than 40-60% of the length Li. The outer diameter ODi is greater than the outer diameter OD3 and the outer diameter OD2 decreases from the outer diameter ODi to the outer diameter OD3. The outer diameter OD3 is approximately 20-50% less than the outer diameter ODi. As shown in FIG. 5, the length L3 is greater than the lengths Li and L2, and the lengths Li and L2 are approximately equal. The107669-00021A0012942W001 length L3 is less than the combined lengths of Li and L2, and the length L3 is greater than 5- 20% of the length Li.The outer diameter ODi is greater than the outer diameter OD3 and the outer diameter OD2 decreases from the outer diameter ODi to the outer diameter OD3. As shown in FIG. 6, the length L2 is greater than the lengths Li and L3, and the length Li is greater than the length L3. The length L2 is greater than the combined lengths of Li and L3. The length L2 is 30-50% greater than the length Li and 300-350% greater than the length L3 (i.e., the length L3 is 67-72% less than the length L2). The outer diameter ODi is greater than the outer diameter OD3 and the outer diameter OD2 decreases from the outer diameter ODi to the outer diameter OD3. The outer diameter OD3 is approximately 50-90% less than the outer diameter ODi.

[0053] Referring to FIGS. 3 and 4-6, in embodiments, the tip 42 includes a first edge 56 for providing a smooth transition from the proximal section 44 to the distal section 46 and a second edge 58 for providing a smooth transition from the proximal section 44 to the inner shaft 38. The first edge 56 and the second edge 58 are configured reduce the potential for the tip 42 to catch the prosthetic valve 10 once it has been implanted at the target site. For example, a tip with a sharp edges or distinct transitions can pull on and disrupt the implanted prosthetic valve 10, dislodging it from the tissue and or causing infolding, crossing, or the like. As shown in FIGS. 4-6, the first edge 56 and the second edge 58 may be chamfered (e.g., a transitional, angled edge or bevel), tapered, convex (e.g., a fillet or rounded edge), concave, or the like, or a combination or sub-combination thereof. The second edge 58 may be located within the third portion 54 of the proximal section 44. The first edge 56 may be configured to prevent the capsule 40 from extending past the first edge 56 toward the distal section 46.

[0054] In some embodiments, all or substantially all of the proximal section 44 may be configured to support the inflow end or second end 24 of the prosthetic heart valve 10. In other embodiments, only a portion of the proximal section 44 may be configured to support the inflow end or second end 24. In one embodiment, the first portion 50 does not support the inflow end 20 or second end 24, but rather sits distal to the second end 24 when the implant is loaded in the delivery system (e.g., within capsule 40). In at least one embodiment, the third portion 54 does support the inflow end 20 or second end 24. In one embodiment, both the second and third portions 52, 54 support the inflow end 20 or second end 24, while in another embodiment only the third portion 50 supports the inflow end 20 or second end 24 (e.g., the first and second portions 50, 52 both sit distal to the second end 24). As used herein, “support” may mean that the portion contacts an inner surface of the prosthetic heart valve 10 at the107669-00021A0012942W001 inflow end 20 or second end 24. The inner surface may comprise the frame (e.g., metal struts) or a skirt material, such as pericardial tissue or a synthetic materials meant to improve sealing. As described above, by supporting (e.g., contacting) the inner surface of the inflow end 20 or second end 24, infolding of the frame struts may be reduced or eliminated during a loading, delivery, or recapture process. As also described above, in certain embodiments, the portion supporting the inflow end 20 or second end 24 may not directly contact the inner surface, but may be spaced a very small amount from the inner surface such that when an infold starts to occur, the struts contact the supporting portion and the infolding is minimized, halted, or reversed. These embodiments may reduce loading force while also reducing infolding.

[0055] Referring to FIGS. 7 and 8, in an embodiment, the proximal section 44 may have a cross-sectional profile configured to provide radial support to the prosthetic valve 10 for preventing infolding, crossing, or the like. For example, the cross-sectional profile of the proximal section 44 may be circular. In some embodiments, as shown in FIG. 7, the cross- sectional profile of the proximal section 44 may include a plurality of slots 60 for allowing the proximal section 44 to retain flexibility. The first, second, and / or third portions 50, 52, 54 may include the plurality of slots 60. The plurality of slots 60 may be uniformly or non-uniformly distributed along the outer diameters ODi, OD2, and OD3 and the lengths Li, L2, L3. The slots 60 may extend in the longitudinal direction, thereby defining a plurality of spaced apart fins 62 extending radially from the center of the proximal section 44. In the embodiment shown, the slots 60 are triangular to define the fins 62 having a substantially rectangular cross-section, however, the slots 60 and the fins 62 may have any suitable shape. In other embodiments, as shown in FIG. 8, the proximal section 44 may have a substantially solid cross-section, except for a central lumen 64 (e.g., guidewire lumen).

[0056] Referring to FIGS. 9 and 10, in embodiments, the proximal section 44 includes a groove 66 configured to control overlapping or infolding of a region of the prosthetic valve 10 and prevent propagation of the overlapping or infolding while reducing the loading force required to retain or recapture the prosthetic valve 10. The groove 66, which may also be referred to as a trench, trough, channel, or extrusion, may be concaved, recessed, or the like, and may be curved, angular, or the like, or a combination, or sub-combination thereof. The groove 66 may be a recessed shape that is formed into the surface of the proximal section 44; in other words, the outer surface of the proximal section 44 may be convex or cylindrical with the exception of the groove 66, which is concave. The groove 66 has a length LE, a width, and107669-00021A0012942W001 a depth (e.g., a peak) that may be defined by a distance from the longitudinal axis A, wherein the depth is less than at least one of the outer diameters ODi, OD2, and OD3. The width and depth of the groove 66 may be uniform or non-uniform along the length LE. For example, the width and depth of the groove 66 may increase or decrease along the length LE. The groove(s) 66 may provide a region for a limited level of overlapping to occur in a preferred and controlled location, while also limiting the axial distance the overlapping can propagate or extend in the axial direction. The limited overlapping allowed may be of a degree which will resolve itself upon expansion of the implant.

[0057] The first, second, and / or third portions 50, 52, 54 may include the groove 66 entirely or partially along the respective lengths Li, L2, L3. For example, as shown in FIG. 9, the second portion 52 and the third portion 54 include the groove 66, wherein the groove 66 extends along the entire length L2 and partially along the length L3 (i.e., the groove 66 extends from the second portion 52 to the third portion 54). In the embodiment of FIG. 9, the groove 66 may terminate in a tapering portion of third portion 54. The groove 66 may have a constant depth relative to the longitudinal axis A, which may result in the proximal end of the groove having a tapered, arrow-like shape that provides a gradual barrier to overlap. As shown in FIG. 10, the second portion 52 includes the groove 66 extending partially along the length L2, wherein the groove 66 extends from adjacent the first portion 50 towards the third portion 54. In this embodiment, the groove 66 terminates in a cylindrical portion of second portion 52. Accordingly, a proximal end of the groove 66 may be substantially perpendicular to the longitudinal axis A, forming a proximal wall 68. In this way, the length LE of the groove 66 may be reduced and an abrupt barrier may be included to limit the distance the overlap of the prosthetic valve 10 can propagate.

[0058] In some embodiments, the proximal section 44 includes a plurality of grooves 66. For example, the second portion 52 may include the plurality of grooves 66, or the second portion 52 may include at least one of the plurality of grooves 66 and the third portion 54 may further include at least one of plurality of grooves 66, or the like. The plurality of grooves 66 may be uniformly or non-uniformly arranged around at least one of the first, second, and / or third portions 50, 52, 54. For example, the second portion 52 may include two grooves 66 adjacent or opposite one another. In some embodiments, at least one of the plurality of grooves 66 of the first, second, and / or third portions 50, 52, 54 may be aligned or not aligned with another of the plurality grooves 66 of a respective first, second, and / or third portions 50, 52,107669-00021A0012942W00154. For example, the second portion 52 may include a first groove 66 and the third portion 54 may include a second groove 66, wherein the first groove 66 and the second groove 66 are aligned relative to one another (i.e., radially aligned so as to form a line along the second portion 52 and the third portion 54).

[0059] In some embodiments, the groove 66 and / or the plurality of grooves 66 may be configured to be a visual indicator to a surgeon for identifying proper deployment, alignment, or orientation of the prosthetic valve 10. For example, the groove 66 may be aligned with the prosthetic valve 10 and / or the tip 42 and indicate that the prosthetic valve 10 is being deployed with the proper orientation. The groove 66 may include markers (e.g., radiopaque materials, or the like) for further assisting the surgeon during deployment or recapture of the prosthetic valve 10

[0060] According the present disclosure, the elements of the proximal section 44 (e.g., the outer diameters ODi, OD2, and OD3, the lengths Li, L2, L3, the cross-sectional profile, edges 58, 60, and groove 66) can be customized to fit various delivery systems 30, tip 42 profiles, and prosthetic valves 10. These elements can be configured to balance inflow support and loading forces for the prosthetic valve 10. For example, certain patients may require larger or smaller prosthetic valve 10 sizes and / or may have significant valve calcifications. The embodiments of the present disclosure may be particularly advantageous for preventing the occurrence of infolding for patients requiring large prosthetic valve 10 sizes of 29 mm or larger and having significant valve calcifications.

[0061] Similar to FIGS. 3-6, in embodiments having groove(s) 66 either all or substantially all of the proximal section 44 may support the inflow end 20 or second end 24 or only a portion thereof may provide support. In embodiments where only a portion of proximal section 44 provides support, the portion having the groove(s) 66 may support the inflow end 20 or second end 24 (e.g., by direct contact with an inner surface or via a small gap, as described above). In one embodiment, the portion containing the groove(s) 66 may support the inflow end 20 or second end 24 and any remaining portion of the tip 42 distal to said portion may not support the implant. The portion of the tip 42 proximal to the groove(s) 66 may or may not support the inflow end 20 or second end 24, depending on their diameter, however they may extend within the prosthetic valve 10 or an implant.107669-00021A0012942W001

[0062] In embodiments, the tip 42 may be formed as a homogenous, integral body (e.g., a molded polymeric body). In other embodiments, the tip 42 can be formed or defined by separately formed bodies. For example, the first, second, and / or third portions 50, 52, 54 may be integrally formed or formed as separate bodies coupled to one another and the inner shaft 38 in various manners (e.g., threading, compression, snap fit, over molding, or the like).

[0063] In at least one embodiment, the tip 42 may include a radiopaque (RO) material, either as a marker or incorporated into the material of the tip itself. The RO material may assist in visualization of the tip 42 during imaging, such as fluoroscopy. In at least one embodiment, there may be a portion of the tip 42 that includes a RO material and a portion that does not include a RO material. In one embodiment, the portion of the tip 42 that does not include a RO material may be disposed in or near a portion of the delivery system that includes a RO material, such as the capsule 40. Not having a RO material in the tip 42 in a same region or location as another portion of the delivery system that does have a RO marker may allow for easier visualization of the RO marker, since a RO material in the tip may obfuscate or otherwise make it difficult to see, identify, or distinguish the RO marker (e.g., a RO band or other marker on the capsule).

[0064] In one embodiment, a distal portion of the tip 42 may include or be formed of a RO material and a proximal portion may not include a RO material. With reference to Figures 3-6, in one embodiment second portion 52 and / or third portion 54 may not include a RO material, while first portion 50 and portions distal to first portion 50 may include a RO material (e.g., a marker or incorporated into the material). With reference to Figures 9-10, proximal section 44 may not include a RO material, while the portion of the tip 42 distal to the proximal section 44 may include a RO material. For example, the portion of the tip 42 including the groove 66 may not include a RO material, while the portion of the tip distal to the groove 66 may include a RO material. As used herein, “may not include a RO material” may mean an absence of a RO material in that entire portion of the tip 42 (e.g., sections 52, 54, and / or 44), while including an RO material may mean some or all of that portion has a RO material (e.g., one or more discrete markers (a dot, shape, band, etc.) or a RO material incorporated into the tip material itself). In one embodiment, the portion with a RO material may be comprised primarily of a polymer material, with a RO material additive included and mixed therein. In some embodiments, substantially the entire tip 42 may include a RO material.107669-00021A0012942W001

[0065] In other embodiments, substantially the entire tip 42 may include a RO material. In some embodiments, different portions or regions of the tip 42 may have differing amounts of RO material. In one embodiment, a distal portion of the tip may have more RO material than a proximal portion of the tip. Having some RO material but less than a distal portion of the tip may allow the proximal portion to be visible but not obfuscate or otherwise make it difficult to identify other RO markers that may be present on the delivery system (e.g., a RO band on the sheath or capsule). With reference to Figures 3-6, in one example, the first portion 50 and the portion of the tip distal to first portion 50 may have more RO material than portions proximal to first portion 50 (e.g., second and third portions 52, 54). Similarly, with reference to Figures 9-10, the portion of the tip 42 including the groove 66 may include less RO material, while the portion of the tip distal to the groove 66 may include more RO material. As used herein, having less or more RO material may refer to an overall amount of RO material or to an average composition (e.g., by weight or volume percent). In one embodiment, the distal portion of the tip (e.g., portions described above) may comprise at least 20 percent by weight of a RO material (e.g., barium sulfate), such as at least 25 percent by weight, and the proximal portion of the tip (e.g., portions described above) may have a lower percentage by weight of the RO material, such as less than or equal to 25 percent or less than or equal to 20 percent. In one example, the distal portion of the tip may have about 30 percent by weight of the RO material (e.g., + / - 3%) and the proximal portion of the tip may have about 15 percent by weight of the RO material (e.g., + / - 3%). Examples of suitable RO materials that may be added to a polymer composition may include barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tantalum, tungsten, or others. Examples of suitable RO metals that may be used include gold, platinum, tungsten, tantalum, aluminum, and gadolinium, alloys thereof, or others.

[0066] In one aspect of the invention, a delivery system 30 is provided for delivering a prosthetic valve 10 in a compressed condition over an inner shaft 38 of a catheter 32, the delivery system 30 comprising a tip 42 extending distally from the inner shaft 38, the tip 42 having a proximal section 44 and an opposite distal section 46 extending to an end 48 of the tip 42. The proximal section 44 is configured to support an end 24 of the prosthetic valve 10 during loading of the prosthetic heart valve 10 and includes a first portion 50, a second portion 52, and a third portion 54, wherein the first portion 50 is adjacent the distal section 46, the second portion 52 is between the first portion 50 and third portion 54, and the third portion 54 is adjacent a proximal end of the tip 42. An outer diameter OD1 of the first portion 50 is greater than an outer diameter ODIS of the inner shaft 38, an outer diameter OD2 of the second portion107669-00021A0012942W00152, and an outer diameter OD3 of the third portion 54; and the outer diameter OD2 of the second portion 52 is greater than the outer diameter OD3 of the third portion 54.

[0067] In one aspect of the invention, the delivery system 30 is provided wherein the outer diameter OD2 of the second portion 52 decreases in a direction from the first portion 50 to the third portion 54.

[0068] In one aspect of the invention, the outer diameter OD1 of the first portion 50 is within a range of 3.5 - 4.5 mm.

[0069] In one aspect of the invention, the proximal section 44 includes a plurality of slots 60 along an outer diameter of the proximal section 44 for increasing the flexibility of the proximal section 44.

[0070] In one aspect of the invention, the tip 42 includes a chamfered or a fillet edge 56 that connects the proximal section 44 to the distal section 46.

[0071] In one aspect of the invention, the proximal section 44 includes a groove 66 configured to control overlap of the end 24 of the prosthetic heart valve 10.

[0072] In one aspect of the invention, the groove 66 extends from the second portion 52 into the third portion 54.

[0073] In one aspect of the invention, the groove 66 extends at least partially along a length L2 of the second portion 52.

[0074] In one aspect of the invention, the third portion 54 supports an inner surface of the prosthetic valve 10.

[0075] In one aspect of the invention, only the third portion 54 supports the inner surface of the prosthetic valve 10, and wherein the first portion 50 and the second portion 52 are configured to be distal to the end 24 of the prosthetic valve 10 when the prosthetic valve 10 is loaded.

[0076] In one aspect of the invention, a system is provided comprising a prosthetic heart valve 10 and a catheter 32 configured for delivering the prosthetic heart valve 10, the catheter 32 including an inner shaft 38 and a tip 42 extending distally from the inner shaft 38, wherein the tip 42 defines a proximal section 44 opposite a distal section 46 and an outer107669-00021A0012942W001 diameter of the proximal section 44 is greater than an outer diameter ODIS of the inner shaft 38, and wherein the proximal section 44 includes a concave groove 66 configured to control overlap of an end 24 of the prosthetic heart valve 10.

[0077] In one aspect of the invention, the tip 42 includes a chamfered or fillet edge 56 between the proximal section 44 and the distal section 46.

[0078] In one aspect of the invention, the proximal section 44 includes a plurality of slots 60 along the outer diameter of the proximal section 44 for increasing the flexibility of the proximal section 44.

[0079] In one aspect of the invention, the proximal section 44 includes a first portion 50, a second portion 52, and a third portion 54, wherein the first portion 50 is adjacent the distal section 46, the second portion 52 is between the first portion 50 and third portion 54, and the third portion 54 is adjacent a proximal end of the tip 42; an outer diameter OD1 of the first portion 50 is greater than an outer diameter ODIS of the inner shaft 38, an outer diameter OD2 of the second portion 52, and an outer diameter OD3 of the third portion 54; and the outer diameter OD2 of the second portion 52 decreases from adjacent the first portion 50 to the third portion 54.

[0080] In one aspect of the invention, a portion of the proximal section 44 including the concave groove 66 supports an inner surface of the prosthetic heart valve 10 and a remaining portion distal to the portion including the groove 66 does not support the inner surface of the prosthetic heart valve 10.

[0081] Referring now to FIGS. 11 and 12, an embodiment of an inflow bump 70 is shown for use with the tip of the delivery system. The inflow bump 70 is generally cylindrical in shape and is positioned proximal to the catheter shaft tip 42. The inflow bump 70 is designed to sit between adjacent nodes of the prosthetic valve frame 12, providing localized support to the inflow region of the valve 10. The bump 70 may include tapered surfaces 72 and 74 at its proximal and distal ends, respectively, which taper toward the center longitudinal axis of the tip along its length. These tapered surfaces 72, 74 facilitate smooth engagement with the prosthetic valve and minimize the risk of catching or damaging the valve frame during loading and delivery. In this embodiment, the inflow bump 70 may be described as barrel-shaped.107669-00021A0012942W001

[0082] The inflow bump 70 serves the purpose of preventing node overlap and strut crossing at the inflow region of the prosthetic valve 10. By providing a raised, contoured support surface, the bump 70 distributes compressive forces more evenly across the valve frame during crimping and recapture, thereby reducing the likelihood of infolding. The bump 70 is axially spaced from the proximal end of the distal catheter shaft tip 42, and fixed to surround a portion of the inner shaft 38. The connection to the shaft 38 ensures that the bump 70 remains properly aligned with the valve frame during all stages of the procedure. Compared to the embodiments of FIGS. 3-6 and 9-10, the inflow bump 70 may provide a similar function (e.g., reducing infolding) but may reduce the packing density within the delivery system. This may be because the inflow bump is spaced from the tip and provides a gap where an inner and / or outer skirt material of the implant may be located.

[0083] In one embodiment, the bump 70 may be configured to contact and / or support certain portions of the implant frame. For example, the bump 70 may be configured to contact and / or support the frame from nodes 2 to 5 or any subset therein, such as 2 to 4, 3 to 5, or 3 to 4. Nodes of the frame may be described as horizontal planes where two stent legs meet. For example, the inflow edge of the frame may define stent crowns that are designated as node 0, the lateral vertices of the diamond shapes cells may be designated as node 1, the location where the top vertex of the first diamond row meets the bottom vertex of the second diamond row made be node 2, and so on. Stated another way, in at least one embodiment, the bump 70 may be axially spaced from the proximal end of the distal catheter shaft tip 42 by X-Y mm.

[0084] In certain embodiments, a bump similar to the inflow bump 70 may be incorporated in addition to, or as an alternative to, bump 70. In this design, the bump is formed as an extension of the strain relief located at the proximal end of the delivery system, adjacent to the spindle. This proximal bump is strategically positioned to interact with the outflow region of the prosthetic valve, rather than the inflow region. By providing localized support at the outflow end, this bump helps to prevent asymmetrical deformation or strut crossing from propagating during loading, crimping, or deployment of the valve. The extension of the strain relief ensures that the outflow crowns and frame elements remain properly aligned and supported, reducing the risk of infolding or other structural irregularities that could compromise valve function. This embodiment offers additional protection against valve asymmetry and enhances the overall reliability of the delivery system, particularly in cases where anatomical or procedural challenges may increase the risk of outflow region distortion.107669-00021A0012942W001

[0085] Turning now to FIGS. 13A and 13B, a first embodiment of a two-shot overmolded tip 76 is illustrated. The tip includes a distal region 78 and a proximal region 80, each formed from different materials using a two-shot molding process. The distal region 78 can be typically formed from a material with higher radiopacity, such as a polymer loaded with barium sulfate or tantalum, to enhance visualization under fluoroscopy. The proximal region 80 can be formed from a material selected for optimal flexibility and biocompatibility, such as a softer polymer. The proximal region 80 may also be formed with a radiopaque material included therein. In one embodiment, the radi opacity (e.g., percentage of radiopaque material) of the distal region 78 may be greater than the radiopacity of the proximal region 80. In one embodiment, the distal portion of the tip (e.g., portions described above) may comprise at least 20 percent by weight of a RO material (e.g., barium sulfate), such as at least 25 percent by weight, and the proximal portion of the tip (e.g., portions described above) may have a lower percentage by weight of the RO material, such as less than or equal to 25 percent or less than or equal to 20 percent. In one example, the distal portion of the tip may have about 30 percent by weight of the RO material (e.g., + / - 3%) and the proximal portion of the tip may have about 15 percent by weight of the RO material (e.g., + / - 3%)

[0086] The interface between the distal region 78 and the proximal region 80 includes a mechanical interlock 82, which may comprise interlocking tabs, grooves, or other features that securely join the two materials and prevent separation during use. In this embodiment, the mechanical interlock 82 between the distal region 78 and the proximal region 80 includes a projection, button, or peg 90 that extends proximally from the distal region 78. This projection 90 is received within a corresponding receptacle 92 formed in the proximal region 80. The engagement of the projection 90 within the receptacle 92 provides a secure connection between the two regions, ensuring that the distal region 78 and proximal region 80 remain firmly joined during use and resist separation under mechanical stress. This interlocking arrangement enhances the structural integrity of the tip and maintains the desired alignment of the two materials throughout the delivery and deployment of the prosthetic valve.

[0087] Referring now to FIGS. 14A and 14B, a second embodiment of a two-shot overmolded tip 76’ is shown. In this embodiment, once again the distal region 78 and proximal region 80 are provided with similar material composition as the previous embodiment shown in FIGS. 13A and 13B. In this embodiment, as shown in FIGS. 14A and 14B, a mechanical interlock 94 between the proximal region 80 and the distal region 78 includes the distal region107669-00021A0012942W00178 including a receptacle 96, and the proximal region 80 including a projection, button, or peg 98 extending distally from the proximal region 80. The peg 98 is received within the receptacle 96 to make the interlocking connection between the distal region 78 and the proximal region 80.

[0088] In either embodiment, the peg maybe formed with circumferential ridges 99 or the like that are received within corresponding grooves of the receptacle. This enhances the secure connection, preventing the two parts of the tip from disconnecting. While the two-shot overmolded tip 76 is illustrated with a certain shape and profile in FIGS. 13A-14B, any of the distal tips disclosed herein may be formed using the two-shot molding method described, such as the tips shown in FIGS. 3-6 and 9-10.

[0089] While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes can be made without departing from the spirit and scope of the disclosure. As previously described, the features of various embodiments can be combined to form further embodiments of the invention that may not be explicitly described or illustrated. While various embodiments could have been described as providing advantages or being preferred over other embodiments or prior art implementations with respect to one or more desired characteristics, those of ordinary skill in the art recognize that one or more features or characteristics can be compromised to achieve desired overall system attributes, which depend on the specific application and implementation. These attributes can include, but are not limited to cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, etc. As such, to the extent any embodiments are described as less desirable than other embodiments or prior art implementations with respect to one or more characteristics, these embodiments are not outside the scope of the disclosure and can be desirable for particular applications.

Claims

107669-00021A0012942W001WHAT IS CLAIMED IS:

1. A delivery system (30) for delivering a prosthetic valve (10) in a compressed condition over an inner shaft (38) of a catheter (32), the delivery system (30) comprising: a tip (42) extending distally from the inner shaft (38), the tip (42) having a proximal section (44) and an opposite distal section (46) extending to an end (48) of the tip (42); wherein the proximal section (44) is configured to support an end (24) of the prosthetic valve (10) during loading of the prosthetic heart valve (10) and includes a first portion (50), a second portion (52), and a third portion (54), wherein: the first portion (50) is adjacent the distal section (46); the second portion (52) is between the first portion (50) and third portion (54); the third portion (54) is adjacent a proximal end of the tip (42); wherein: an outer diameter (ODi) of the first portion (50) is greater than an outer diameter (ODis) of the inner shaft (38), an outer diameter (OD2) of the second portion (52), and an outer diameter (OD3) of the third portion (54); and the outer diameter (OD2) of the second portion (52) is greater than the outer diameter (OD3) of the third portion (54).

2. The delivery system (30) of claim 1 wherein the outer diameter (OD2) of the second portion (52) decreases in a direction from the first portion (50) to the third portion (54).

3. The delivery system (30) of claim 1 wherein the outer diameter (ODi) of the first portion (50) is within a range of 3.5 - 4.5 mm.

4. The delivery system (30) of claim 1 wherein the proximal section (44) includes a plurality of slots (60) along an outer diameter of the proximal section (44) for increasing the flexibility of the proximal section (44).

5. The delivery system (30) of claim 1 wherein the tip (42) includes a chamfered or a fillet edge (56) that connects the proximal section (44) to the distal section (46).

6. The delivery system (30) of claim 1 wherein the proximal section (44) includes a groove (66) configured to control overlap of the end (24) of the prosthetic heart valve (10).107669-00021A0012942W0017. The delivery system (30) of claim 6 wherein the groove (66) extends from the second portion (52) into the third portion (54).

8. The delivery system (30) of claim 6 wherein the groove (66) extends at least partially along a length (L2) of the second portion (52).

9. The delivery system (30) of claim 1, wherein the third portion (54) supports an inner surface of the prosthetic valve (10).

10. The delivery system (30) of claim 9, wherein only the third portion (54) supports the inner surface of the prosthetic valve (10); and wherein the first portion (50) and the second portion (52) are configured to be distal to the end (24) of the prosthetic valve (10) when the prosthetic valve (10) is loaded.

11. A system comprising: a prosthetic heart valve (10); a catheter (32) configured for delivering the prosthetic heart valve (10), the catheter (32) including an inner shaft (38) and a tip (42) extending distally from the inner shaft (38); wherein the tip (42) defines a proximal section (44) opposite a distal section (46) and an outer diameter of the proximal section (44) is greater than an outer diameter (ODis) of the inner shaft (38); and wherein the proximal section (44) includes a concave groove (66) configured to control overlap of an end (24) of the prosthetic heart valve (10).

12. The system of claim 11 wherein the tip (42) includes a chamfered or fillet edge (56) between the proximal section (44) and the distal section (46).

13. The system of claim 11 wherein the proximal section (44) includes a plurality of slots (60) along the outer diameter of the proximal section (44) for increasing the flexibility of the proximal section (44).

14. The system of claim 11 wherein the proximal section (44) includes a first portion (50), a second portion (52), and a third portion (54), wherein:107669-00021A0012942W001 the first portion (50) is adjacent the distal section (46), the second portion (52) is between the first portion (50) and third portion (54), and the third portion (54) is adjacent a proximal end of the tip (42); an outer diameter (ODi) of the first portion (50) is greater than an outer diameter (ODis) of the inner shaft (38), an outer diameter (OD2) of the second portion (52), and an outer diameter (OD3) of the third portion (54); and the outer diameter (OD2) of the second portion (52) decreases from adjacent the first portion (50) to the third portion (54).

15. The system of claim 11, wherein a portion of the proximal section (44) including the concave groove (66) supports an inner surface of the prosthetic heart valve (10) and a remaining portion distal to the portion including the groove (66) does not support the inner surface of the prosthetic heart valve (10).

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