Nosecone for a transcatheter delivery apparatus

Abstract

A nosecone for a transcatheter delivery apparatus includes a body portion defining a central lumen and having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting die tapered surface and extending radially outward from the tapered surface of die body portion at a location between the proximal end portion and the distal tip portion.

Description

NOSECONE FOR A TRANSCATHETER DELIVERY APPARATUS RELATED APPLICATION

[0001] The present application claims priority to and all benefit of U.S. Provisional Patent Application Ser. No. 63 / 560,850, filed on March 4, 2024, for NOSECONE FOR A TRANSCATHETER DELIVERY APPARATUS, the disclosure of which is incorporated herein by reference in its entirety. FIELD

[0002] The present disclosure concerns embodiments of a delivery system for implantation of a prosthetic valve, such as a prosthetic pulmonary valve. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally- invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size.

[0004] Transcatheter heart valves may be appropriately sized to be placed inside most native aortic valves. However, with larger native valves, blood vessels, and grafts, aortic transcatheter valves might be too small to secure into the larger implantation or deployment site. In this case, the transcatheter valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site to be secured in place.

[0005] Replacing the pulmonary valve, which is sometimes referred to as the pulmonic valve, presents significant challenges. The geometry of the pulmonary artery can vary greatly from patient to patient. Typically, the pulmonary artery outflow tract after corrective surgery is too wide to provide adequate support structure for effective placement of a prosthetic heart valve.

[0006] One example approach to overcome such challenge is to use a docking device, or docking station, which is configured to be pre-implanted in the target implantation site, and then the prosthetic valve can be deployed within the docking device. The docking device can be configured to compensate for the deployed prosthetic valve being smaller than the annular space in which it is to be placed. However, conventional delivery systems for aortic valve implantation may not be convenient for delivering and implanting a prosthetic valve at the native pulmonary valve. Accordingly, improvements to the transcatheter delivery apparatus are desirable. SUMMARY

[0007] This summary is meant to provide examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the feature. The description discloses exemplary embodiments of transcatheter delivery apparatuses, including exemplary nosecones of transcatheter delivery apparatuses.

[0008] In some examples, a nosecone for a transcatheter delivery apparatus includes a body portion defining a central lumen and having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion.

[0009] In some examples, when the nosecone is advanced proximate an interior surface of a circulatory system, the offset nodule can contact the interior surface to maintain an offset between the distal tip portion of the nosecone and the interior surface.

[0010] In some examples, the offset nodule includes a convex outer radial surface.

[0011] In some examples, a maximum diameter portion of the offset nodule is located less than about 50% of a distance from the distal tip portion to the proximal end portion, or less than about 30% of the distance from the distal tip portion to the proximal end portion, or about 12% to about 22% of the distance from the distal tip portion to the proximal end portion.

[0012] In some examples, a maximum diameter portion of the offset nodule has a diameter less than or equal to a diameter of the proximal end portion, or less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion.

[0013] In some examples, a maximum diameter portion of the offset nodule has a diameter at least about 50% greater than a diameter of longitudinally aligned tangent points of the nosecone tapered surface, or at least about 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 210% greater than the diameter of the longitudinally aligned tangent points.

[0014] In some examples, a distal end of the offset nodule is joined to the tapered surface by a concave junction.

[0015] In some examples, a proximal end of the offset nodule is joined to the tapered surface by a concave junction.

[0016] In some examples, the concave junction has a radius of curvature greater than about 25%, or about 35% to 45%, or greater than about 50%, or about 75% to 85% of a convex maximum diameter portion of the offset nodule.

[0017] In some examples, the nosecone further comprises an interface portion extending proximally from the body portion for engagement with a valve sheath of the transcatheter delivery apparatus.

[0018] In some examples, the body portion comprises one of a barium sulfate filled polymer, Pebax®, polyurethane, barium sulfate filled Pebax®, and barium sulfate filled polyurethane.

[0019] In some examples, the body portion comprises a material having a Shore D durometer of less than about 35 D.

[0020] In some examples, the offset nodule is sized and positioned to maintain an offset gap between the distal tip portion and a uniform interior surface when the nosecone is directed toward the uniform interior surface at a maximum angle of incidence of about 20°.

[0021] In some examples, the body portion comprises an increased flexibility section longitudinally located between the offset nodule and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

[0022] In some examples, when the nosecone is advanced proximate an interior surface of a circulatory system such that the offset nodule contacts the interior surface, the distal tipportion of the nosecone body bends primarily about the increased flexibility section to direct the distal tip portion away from the contacted interior surface.

[0023] In some examples, a longitudinal center point of the increased flexibility section is located greater than about 50% of a distance from the distal tip portion to the proximal end portion, or greater than about 65% of the distance from the distal tip portion to the proximal end portion, or about 70% to about 80% of the distance from the distal tip portion to the proximal end portion.

[0024] In some examples, a longitudinal center point of the increased flexibility section is located greater than about 30% of a distance from a maximum diameter portion of the offset nodule to the proximal end portion, or greater than about 50% of the distance from the maximum diameter portion of the offset nodule to the proximal end portion, or about 55% to about 65% of the distance from the maximum diameter portion of the offset nodule to the proximal end portion.

[0025] In some examples, the increased flexibility section includes a material having a lower flexural modulus that a material of the distal tip portion and the proximal end portion of the nosecone body.

[0026] In some examples, the increased flexibility section includes one or more necked down portions.

[0027] In some examples, the one or more necked down portions has a minimum wall thickness of less than about 80% or less than about 65% of a wall thickness of a non-necked down portion of the body portion immediately distal to the increased flexibility section.

[0028] In some examples, an outer surface of the body portion includes a hydrophilic coating.

[0029] In some examples, a nosecone for a transcatheter delivery apparatus includes a body portion defining a central lumen and having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an increased flexibility section longitudinally located between the distal tip portion and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

[0030] In some examples, when the nosecone is advanced proximate an interior surface of a circulatory system such that a portion of the nosecone body distal to the increased flexibility section contacts the interior surface, the distal tip portion of the nosecone body bendsprimarily about the increased flexibility section to direct the distal tip portion away from the contacted interior surface.

[0031] In some examples, a longitudinal center point of the increased flexibility section is located greater than about 50% of a distance from the distal tip portion to the proximal end portion, or greater than about 65% of the distance from the distal tip portion to the proximal end portion, or about 70% to about 80% of the distance from the distal tip portion to the proximal end portion.

[0032] In some examples, the increased flexibility section includes a material having a lower flexural modulus that a material of the distal tip portion and the proximal end portion of the nosecone body.

[0033] In some examples, the increased flexibility section includes one or more necked down portions.

[0034] In some examples, the one or more necked down portions has a minimum wall thickness of less than about 80% or less than about 65% of a wall thickness of a non-necked down portion of the body portion immediately distal to the increased flexibility section.

[0035] In some examples, an outer surface of the body portion includes a hydrophilic coating.

[0036] In some examples, the nosecone further comprises an interface portion extending proximally from the body portion for engagement with a valve sheath of the transcatheter delivery apparatus.

[0037] In some examples, the body portion comprises one of a barium sulfate filled polymer, Pebax®, polyurethane, barium sulfate filled Pebax®, and barium sulfate filled polyurethane.

[0038] In some examples, the body portion comprises a material having a Shore D durometer of less than about 35 D.

[0039] In some examples, the nosecone body portion further comprises an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the increased flexibility section and the distal tip portion.

[0040] In some examples, a transcatheter delivery apparatus includes a user operable actuating device, a shaft having a proximal end connected to the actuating device for axial movement of the shaft, and a nosecone connected to a distal end of the shaft.

[0041] In some examples, at least one radiopaque marker is disposed on the shaft.

[0042] In some examples, a transcatheter delivery apparatus includes a sheath surrounding the shaft.

[0043] In some examples, at least one radiopaque marker is disposed on the sheath.

[0044] In some examples, a method of installing a prosthetic valve in a vessel includes deploying an expandable docking station at a target location within the vessel, such that an annular first end of the docking station expands radially outward to engage an inner surface of the vessel to retain the docking station at the target location.

[0045] In some examples, a transcatheter delivery apparatus is provided, including a shaft, a sheath surrounding the shaft and retaining the prosthetic valve in a radially compressed condition around the shaft, and a nosecone secured to a distal end of the shaft, the nosecone including a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion.

[0046] In some examples, the transcatheter delivery apparatus is inserted into the vessel, such that the offset nodule is engageable with the inner surface of the vessel beyond the first end of the docking station to position the distal tip portion of the nosecone radially inward of the annular first end of the docking station.

[0047] In some examples, the nosecone is advanced into the docking station to align the radially compressed prosthetic valve with a valve seat portion of the docking station.

[0048] In some examples, the sheath is retracted to uncover the radially compressed prosthetic valve.

[0049] In some examples, the prosthetic valve is expanded into seating engagement with the valve seat portion of the docking station.

[0050] In some examples, at least one radiopaque marker on the transcatheter delivery apparatus is visually aligned with a portion of the docking station to align the radially compressed prosthetic valve with the valve seat portion of the docking station.

[0051] In some examples, the nosecone includes an increased flexibility section longitudinally located between the offset nodule and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

[0052] In some examples, the distal tip portion is bent about the increased flexibility section to direct the distal tip portion away from the inner surface of the vessel.

[0053] The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] FIG.1 is a side elevation view of an exemplary docking stent, according to one embodiment of the present disclosure;

[0055] FIG.2 is a side elevation view of an exemplary delivery apparatus for a docking stent, according to one embodiment of the present disclosure;

[0056] FIG. 2A is an enlarged view of a stent connecting portion of the delivery apparatus depicted in FIG.2;

[0057] FIG. 3 is a perspective view of an exemplary transcatheter prosthetic valve, according to one embodiment of the present disclosure;

[0058] FIG. 4 is a perspective view of an exemplary delivery apparatus for a transcatheter prosthetic valve, according to one embodiment of the present disclosure, with a valve sheath shown in a distal position covering a distal end portion of a balloon catheter;

[0059] FIG.4A is a perspective view of the delivery apparatus depicted in FIG.4, with the valve sheath shown in a proximal position uncovering the distal end portion of the balloon catheter;

[0060] FIG. 5A is a side elevation view of a nose cone and a distal shoulder of the delivery apparatus of FIG.4;

[0061] FIG.5B is a side cross-sectional view of the nosecone of FIG.5A;

[0062] FIG. 6 is a schematic side view of an exemplary nosecone having an offset nodule, according to one embodiment of the present disclosure;

[0063] FIG. 7 is a side view of an exemplary nosecone having an offset nodule, according to another embodiment of the present disclosure;

[0064] FIG.7A is a side cross-sectional view of the nosecone of FIG.7;

[0065] FIG.8 is a schematic illustration of a delivery apparatus including the nosecone of FIG.7 shown in engagement with a docking stent engaging interior surface of a circulatory system;

[0066] FIG. 9 is a side view of another exemplary nosecone having an offset nodule, according to another embodiment of the present disclosure;

[0067] FIG.10 is a schematic side view of an exemplary nosecone having an increased flexibility section, according to an embodiment of the present disclosure;

[0068] FIG. 11 is a schematic side view of an exemplary nosecone having an offset nodule and an increased flexibility section, according to an embodiment of the present disclosure;

[0069] FIG. 12 is a side view of an exemplary nosecone having an offset nodule and an increased flexibility section, according to another embodiment of the present disclosure;

[0070] FIG.12A is a side cross-sectional view of the nosecone of FIG.12;

[0071] FIG. 13A is a schematic illustration of a delivery apparatus including the nosecone of FIG.12 shown in engagement with a docking stent engaging interior surface of a circulatory system;

[0072] FIG.13B is a is a schematic illustration of the delivery apparatus of FIG.13A, shown with the nosecone bent at the increased flexibility section of the nosecone body;

[0073] FIG. 14 is a side view of another exemplary nosecone having an offset nodule and an increased flexibility section, according to another embodiment of the present disclosure;

[0074] FIG.15A is a partial side view of the distal end portion of the balloon catheter depicted in FIG.4;

[0075] FIG. 15B is a partial side view of a prosthetic valve mounted on the distal end portion of the balloon catheter depicted in FIG.4;

[0076] FIG. 16 is a side view of an exemplary prosthetic valve retained by an exemplary docking stent, which is shown anchored at an annulus of a native valve, according to one embodiment of the present disclosure;

[0077] FIG.17A shows introducing a first delivery apparatus into a pulmonary artery, according to one embodiment of the present disclosure;

[0078] FIG. 17B shows partially expanding a docking stent from the first delivery apparatus at a location corresponding to the native pulmonary valve, according to one embodiment of the present disclosure;

[0079] FIG.17C shows fully expanding the docking stent at the location corresponding to the native pulmonary valve, according to one embodiment of the present disclosure;

[0080] FIG. 17D shows withdrawing the first delivery apparatus from the pulmonary artery, according to one embodiment of the present disclosure;

[0081] FIG. 17E shows introducing a second delivery apparatus carrying a prosthetic valve into the pulmonary artery, according to one embodiment of the present disclosure;

[0082] FIG.17F shows positioning the second delivery apparatus to align the prosthetic valve with the waist region of the docking stent, according to one embodiment of the present disclosure;

[0083] FIG.17G shows retracting a sheath of the second delivery apparatus to expose the prosthetic valve and positioning the prosthetic valve within the docking stent, according to one embodiment of the present disclosure;

[0084] FIG. 17H shows expanding the prosthetic valve within the docking stent member using an inflatable balloon of the second delivery apparatus, according to one embodiment of the present disclosure; and

[0085] FIG.17I shows withdrawing the second delivery apparatus from the pulmonary artery, according to one embodiment of the present disclosure. DETAILED DESCRIPTION

[0086] While various inventive aspects, concepts and features of the inventions may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present inventions. Still further, while various alternative embodiments as to the various aspects, concepts and features of the inventions--such as alternative materials, structures, configurations, methods, devices and components, alternatives as to form, fit and function, and so on--may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts or features into additional embodiments and uses within the scope of the present inventions even if such embodiments are not expressly disclosed herein. Additionally, even though some features, concepts or aspects of the inventions may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present disclosure, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated. Parameters identified as “approximate” or “about” a specified value are intended to include both the specified value and values within 10% of thespecified value, unless expressly stated otherwise. Further, it is to be understood that the drawings accompanying the present disclosure may, but need not, be to scale, and therefore may be understood as teaching various ratios and proportions evident in the drawings. Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of an invention, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts and features that are fully described herein without being expressly identified as such or as part of a specific invention, the inventions instead being set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated.

[0087] Prosthetics, including docking stations, may be utilized in a variety of subjects and procedures. Subjects include (but are not limited to) medical patients, veterinary patients, animal models, cadavers, and simulators of the cardiac and vasculature system (e.g., anthropomorphic phantoms and explant tissue). Procedures include (but are not limited to) medical and training procedures.

[0088] In exemplary embodiments described herein, a prosthetic valve is implanted in a wider or irregularly shaped implant site (e.g., a pulmonary artery or right ventricular outflow tract (“RVOT”) by first implanting an expandable docking device or a docking station at the target implantation site, and subsequently installing and expanding the prosthetic valve into seating engagement with the implanted docking station, which provides a landing zone into which the prosthetic valve can be deployed, as described below. Such approaches can be helpful for transcatheter implantation of prosthetic valves at sites with a large annulus, where the prosthetic valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site to be secured in place. One such example is replacing the pulmonary valve, which presents significant challenges because the pulmonary artery can have a wide variety of different shapes and sizes. These differences can be even more significant in pulmonary arteries that suffer from certain conditions and / or have been compromised by previous surgery. For example, the treatment of Tetralogy of Fallot (TOF) or Transposition of the Great Arteries (TGA) often results in larger and more irregularly shaped pulmonary arteries.

[0089] A wide variety of docking devices or docking stations may be used. FIG. 1 shows one such exemplary embodiment of a docking device 300 configured to receive anothertranscatheter device, such as a transcatheter prosthetic valve. The docking device 300 includes an expandable frame 302, shown in FIG. 1 in its unconstrained, expanded condition, which may be made from a highly resilient or compliant material (e.g., nitinol or other shape memory material, other metal alloys, polymers, open cell foams) to accommodate large variations in the anatomy. When expanded (e.g., self-expandable or manually, e.g., by balloon expansion), the frame 302 can be configured or shaped to conform to an interior shape of a portion of the vasculature in which it is to be implanted, such as the pulmonary annulus. The frame 302 may form a wide stent comprised of a plurality of metal struts 310 that form cells 312. The docking device 300 can include one or more sealing members 316, which can be made of blood impermeable fabric (e.g., PET), polymer, or other covering and are attached to a portion of the frame 302. The sealing members 316 can be configured to contact an interior surface of the circulatory system at the implantation site so as to inhibit or prevent paravalvular leakage. The docking device 300 may also include a valve seat 318 (e.g., defined by an impermeable frame covering material) configured to receive and support the transcatheter prosthetic valve after the docking device 300 is implanted in the circulatory system, and one or more retaining members 320 (e.g., flared apices of the frame 302), which can be any structure that sets the position of the docking device 300 in the circulatory system.

[0090] In the depicted example, when fully expanded, the frame 302 can have an hourglass shape defined by a relatively wider proximal inflow portion 304 and distal outflow portion 306, and a relatively narrower waist portion 308 between the inflow and outflow portions 304 and 306, at which the valve seat 318 is disposed. The frame 302 can also include one or more retaining tabs 314 extending from the inflow end 305 (or alternatively from the outflow end 307), which can be releasably connected to a retaining member of a delivery catheter, as described below. Further details regarding exemplary embodiments of the docking device are disclosed in U.S. Patent Application Pub. Nos. 2017 / 0231756 and 2019 / 0000615, which are incorporated herein by reference.

[0091] FIGS. 2 and 2A shows an exemplary embodiment of a delivery apparatus 400 for delivering and deploying the docking device 300. The delivery apparatus 400 can take a wide variety of different forms. In the illustrated example, the delivery apparatus 400 includes an actuating device (e.g., handle) 402, an outer shaft 404 connected to the actuating device 402, an inner shaft 406 extending through a lumen of the outer shaft 404, a docking device retaining member 408 that is connected to the inner shaft 406, and a nosecone 410 that is connected to the docking device retaining member 408 by a connecting tube 412. The outer shaft 404 canbe axially moveable relative to the inner shaft 406, for example, by rotating a drive member 414 (e.g., a rotatable knob) located on the actuating device 402. The distal end portion 416 of the outer shaft 404 can form a delivery sheath or capsule that is configured to extend over the docking device 300 during delivery. In addition, a guidewire 420 (see FIG. 17A) can extend through a lumen of the inner shaft 406 and the nosecone 410 such that the inner shaft 406 and outer shaft 404 can be routed over the guidewire to position the docking device 300 at the implantation site.

[0092] In a delivery configuration, the docking device 300 can be disposed along a distal end portion of the inner shaft 406 and retained in a compressed configuration by the delivery sheath 416, which extends cover the radially compressed docking device. The retaining tabs 314 of the frame 302 can be releasably connected to the docking device retaining member 408 (see FIG.2A). A radiopaque marker 418 can be placed along the delivery sheath 416, either on the outer surface of the delivery sheath or embedded within the wall of the delivery sheath. The outer shaft 404 can be progressively retracted (e.g., by actuating the drive member 414) in a proximal direction relative to the inner shaft 406, the retaining member 408, and the nosecone 410 to deploy the docking device 300, as described below. Further details regarding the delivery apparatus 400 and methods for implanting the docking device 300 are disclosed in U.S. Patent Publications Nos.2017 / 0231756 and 2019 / 0000615.

[0093] A wide variety of transcatheter prosthetic valves may be used. FIG. 3 shows perspective view of one such prosthetic valve 10. The illustrated valve can be adapted to be implanted in the native pulmonary valve annulus, although in other examples it can be adapted to be implanted in the other native annuluses of the heart, such as the native aortic annulus. The valve 10 can have four main components: an expandable stent or frame 12, an inner skirt 16 secured to the inside of the frame, a valvular structure 14 (e.g., three leaflets 40, as shown) secured to the inner skirt and movable to block or permit the flow of blood through the prosthetic valve, and an outer skirt 18 secured to the outside of the frame for sealing against the docking station. Further details of one such exemplary valve 10 and its components are described in U.S. Pat. No.9,393,110, which is incorporated herein by reference.

[0094] FIGS.4 and 4A show a delivery apparatus 100, which can be used to implant a prosthetic valve (such as the prosthetic valve 10) at a target implantation side of a patient, such as the native pulmonary annulus, according to one embodiment. In some examples, the delivery apparatus 100 can be used to implant a prosthetic valve within a docking stent ordocking device implanted in the native pulmonary annulus or the pulmonary artery, as described in detail below.

[0095] As shown, the delivery apparatus 100 can include an actuating device 102, a first or outer shaft 104 (which is an outer shaft in the illustrated embodiment) extending from a distal end of the actuating device 102, an intermediate second or balloon shaft 106 (which is an intermediate shaft in the illustrated embodiment), and a third or inner shaft 108 extending through a lumen of the balloon shaft 106. A distal end of the inner shaft 108 can be connected to a nosecone 110 (e.g., any of the nosecones 110-0 through 110-7 described herein), which can have a tapered (e.g. uniform taper, as shown) distal end portion for atraumatic navigation through the patient's vasculature. In some examples, a guidewire (not shown) can extend through a lumen of the inner shaft 108 and the nosecone 110 so that the delivery apparatus 100 can navigate through the patient's vasculature over the previously inserted guidewire.

[0096] As shown, the actuating device 102 may include a handle 113 and gripper 112 operable for axial movement of the balloon shaft 106 relative to the outer shaft 104 and axial movement of the inner shaft 108 relative to the outer shaft 104. An exemplary delivery apparatus including handle and gripper mechanisms is more fully described in U.S. Patent Application Pub. No.2023 / 0210658, incorporated herein by reference.

[0097] In some examples, a nosecone for a delivery apparatus may include a body portion having a tapered shape with a progressively decreasing diameter from a proximal end portion of the body portion to a distal tip portion of the body portion, for example, to facilitate atraumatic navigation through the patient’s vasculature. FIGS. 5A and 5B illustrate one such exemplary nosecone configuration, with the nosecone 110-0 having a body portion 101-0 defining a central lumen 117-0 and an interface portion 103-0 extending proximally from the body portion 101-0 for example, for engagement with a valve sheath, as described herein. The body portion 101-0 can have a tapered shape with a progressively decreasing diameter (e.g., a taper angle of between about 10° and about 15°, or about 12°) from a wider proximal end portion 101p-0 of the body portion 101-0 to a narrower distal tip portion 101d-0 of the body portion 101-0. One such exemplary nosecone for a delivery apparatus is shown and described in greater detail in U.S. Patent Application Pub. No. 2023 / 0210658, which is incorporated herein by reference.

[0098] According to an exemplary aspect of the present disclosure, a nosecone for a delivery apparatus may be provided with an enlargement or offset nodule extending radially outward from, and interrupting, the tapered surface of the nosecone body, for example, toprovide a minimum offset between the distal tip of the nosecone and the inner surface of the circulatory system as the nosecone is guided toward the implantation site. This offset may effectively prevent the distal tip of the nosecone from being impeded or snagged by an endmost portion of the installed docking stent or wedged between the end portion of the docking stent and the inner surface of the circulatory system.

[0099] FIG. 6 schematically illustrates an exemplary nosecone 110-1 for a delivery apparatus, having an offset nodule 105-1 in accordance with exemplary aspects of the present disclosure. The nosecone 110-1 includes a body portion 101-1 defining a central lumen 117-1 and an interface portion 103-1 (e.g., similar to the interface portion 103-0 of the nosecone 110- 0 of FIGS. 5A and 5B) extending proximally from the body portion 101-1 for example, for engagement with a valve sheath. The body portion 101-1 can have a generally tapered shape with a progressively decreasing diameter from a wider proximal end portion 101p-1 (e.g., a diameter of about 0.37 inches) of the body portion to a narrower distal tip portion 101d-1 (e.g., a diameter of about 0.07 inches) of the body portion, but with the enlargement or offset nodule 105-1 interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion. The schematically depicted offset nodule 105-1 is shown in broken lines to indicate that the size, shape, and location of the offset nodule may be selectively varied in a wide range of suitable configurations.

[00100] The offset nodule 105-1 may be sized and positioned such that when the nosecone 110-1 is guided or otherwise advanced proximate a docking stent engaging interior surface of the circulatory system near the implant site, the offset nodule can contact the interior surface to maintain an offset between the nosecone distal tip 101d-1 and the interior surface sufficient to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent. The contoured surface of the offset nodule 105-1 may facilitate sliding movement of the distal end portion of the nosecone 110-1 against the interior surface, as compared to, for example, the more discrete angled engagement of a distal tip of a nosecone lacking the offset nodule.

[00101] The offset nodule 105-1 may be positioned at a wide variety of locations along the length of the nosecone body portion 101-1. In some examples, the offset nodule 105- 1 may be located closer to the distal tip 101d-1 of the nosecone body portion 101-1, for example, to more effectively provide a desired offset when the nosecone 110-1 is advanced toward the docking stent engaging interior surface at an angle of incidence. For example, amaximum diameter portion 105m-1 of the offset nodule 105-1 may be located less than about 50% of the distance from the distal tip to the proximal end (i.e., closer to the distal tip 101d-1 than to the proximal end portion 101p-1), or less than about 30% of the distance from the distal tip to the proximal end, or about 12% to 22% of the distance from the distal tip to the proximal end.

[00102] The offset nodule may be provided in a range of sizes corresponding to the desired offset, for example, up to the diameter of the proximal end portion of the nosecone body portion. For example, a maximum diameter portion 105m-1 of the offset nodule 105-1 may have a diameter d1 less than a diameter d2 of the proximal end portion 101p-1, or less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion. In one such example, the maximum diameter portion 105m-1 has a diameter d1 of about 0.25 inches, and the proximal end portion 101p-1 has a diameter d2 of about 0.37 inches. As another example, the maximum diameter portion 105m- 1 of the offset nodule 105-1 may have a diameter d1 at least about 50% greater than a diameter d3 of longitudinally aligned tangent points t of the nosecone tapered surface, or at least about 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 210% greater than the diameter of the longitudinally aligned tangent points. In one such example, the maximum diameter portion 105m-1 has a diameter d1 of about 0.25 inches, and the longitudinally aligned tangent points t have a diameter d3 of about 0.12 inches.

[00103] The offset nodule 105-1 may be provided in a variety of shapes. In some examples, the offset nodule 105-1 may include a convex outer portion defining the maximum diameter portion 105m-1, and a concave distal junction 105d-1 joining the offset nodule to the tapered surface at the distal end 101d-1 of the nosecone body 101-1, for example, to facilitate atraumatic navigation through the patient's vasculature. The offset nodule 105-1 may also include a concave proximal junction 105p-1 joining the offset nodule to the tapered surface at the proximal end 101p-1 of the nosecone body 101.

[00104] FIGS. 7 and 7A illustrate an exemplary nosecone 110-2 for a delivery apparatus, having an offset nodule 105-2 in accordance with exemplary aspects of the present disclosure. The nosecone 110-2 includes a body portion 101-2 defining a central lumen 117-2 and an interface portion 103-2 (e.g., similar to the interface portion 103-0 of the nosecone 110- 0 of FIGS. 5A and 5B) extending proximally from the body portion 101-2. The body portion 101-2 has a generally tapered shape with a progressively decreasing diameter from a wider proximal end portion 101p-2 of the body portion to a narrower distal tip portion 101d-2 of thebody portion, but with the enlargement or offset nodule 105-2 interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion.

[00105] In the illustrated example, a maximum diameter portion 105m-2 of the offset nodule 105-2 is located closer to the distal tip 101d-2 than to the proximal end portion 101p-2, and as shown, may be less than 30% of the distance from the distal tip to the proximal end, or about 12% to 22% of the distance from the distal tip to the proximal end.

[00106] The maximum diameter portion 105m-2 of the exemplary offset nodule 105-2 has a diameter d1 less than a diameter d2 of the proximal end portion 101p-2, and as shown, may be less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion. The maximum diameter portion 105m-2 of the exemplary offset nodule 105-2 is at least 50% greater than a diameter d3 of longitudinally aligned tangent points t of the nosecone tapered surface, and as shown, may be at least 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 120% greater than the diameter of the longitudinally aligned tangent points.

[00107] The exemplary illustrated offset nodule 105-2 includes a convex outer portion defining the maximum diameter portion 105m-2, and a concave distal junction 105d-2 joining the offset nodule to the tapered surface at the distal end 101d-2 of the nosecone body 101-2, for example, to facilitate atraumatic navigation through the patient's vasculature. The offset nodule 105-2 may also include a concave proximal junction 105p-2 joining the offset nodule to the tapered surface at the proximal end 101p-2 of the nosecone body 101-2. The radius of curvature at the offset nodule junctions 105d-2, 105p-2 may, for example, be at least about 25%, or about 35% to 45% of a radius of curvature of the maximum diameter portion 105m-2 of the offset nodule 105-2. In one such example, the offset nodule maximum diameter portion 105m-2 has a radius of curvature of about 0.125 inches or diameter of about 0.25 inches, and the offset nodule junctions 105d-2, 105p-2 have a radius of curvature of about 0.10 inches.

[00108] The exemplary offset nodule 105-2 is sized and positioned such that when the nosecone 110-2 is guided or otherwise advanced proximate a docking stent engaging interior surface of the circulatory system near the implant site, the offset nodule can contact the interior surface to maintain an offset between the nosecone distal tip 101d-2 and the interior surface sufficient to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent. The contoured surface of the offset nodule 105-2 mayfacilitate sliding movement of the distal end portion of the nosecone 110-2 against the interior surface, as compared to, for example, the more discrete angled engagement of a distal tip of a nosecone lacking the offset nodule.

[00109] FIG. 8 schematically illustrates engagement of the nosecone 110-2 of FIG. 7 with the docking stent engaging interior surface 70 of the circulatory system, for example, during implantation of a prosthetic transcatheter valve in a deployed docking stent 300. As shown, when the nosecone 110-2 is directed toward a uniform interior surface 70 at an angle of incidence β (e.g., a maximum estimated angle of incidence, for example, up to about 20°), the offset nodule 105-2 contacts the interior surface before the distal tip 101d-2 can come into contact with the interior surface, maintaining a minimum offset distance or gap g (e.g., up to about 0.1 inches) between the distal tip and the interior surface. This minimum offset gap g may be sized, for example, to ensure clearance between the distal tip 101d-2 of the nosecone and the radial thickness of the docking stent end portion 320.

[00110] In applications where the maximum estimated angle of incidence β is smaller, or where the desired minimum offset gap g is smaller, the offset nodule 105-2 may be provided in a smaller size and / or at a location further from the distal tip 101d-2 of the nosecone body 101-2. In applications where the maximum estimated angle of incidence β is larger, or where the desired minimum offset gap g is larger, the offset nodule 105-2 may be provided in a larger size and / or at a location closer to the distal tip 101d-2 of the nosecone body 101-2.

[00111] FIG. 9 illustrate another exemplary nosecone 110-3 for a delivery apparatus, having an offset nodule 105-3 similar to the offset nodule 105-2 of the nosecone 110-2 of FIGS.7 and 7A, but with elongated, more gradual junctions 105d-3, 105p-3 between the nodule and the tapered surface of the nosecone body 101-3, for example, to further facilitate atraumatic navigation through the patient's vasculature. The radius of curvature at the offset nodule junctions 105d-3, 105p-3 may, for example, be greater than about 50%, or about 75% to 85% of a radius of curvature of the maximum diameter portion 105m-3 of the offset nodule 105-3. In one such example, the offset nodule maximum diameter portion 105m-3 has a radius of curvature of about 0.125 inches, and the offset nodule junctions 105d-3, 105p-3 have a radius of curvature of about 0.10 inches.

[00112] The body portions of the nosecones described herein, including the distal tip portions, can comprise a flexible material so that the distal tip portion can flex during insertion of the delivery apparatus and / or tracking of the patient's vasculature in the implantation procedure. Exemplary flexible materials include thermoplastic elastomers (TPE),including, for example Pebax® or barium sulfate filled Pebax®, or polyurethane or barium sulfate filled polyurethane. Such materials may, for example, have a shore D durometer of less than 35D. The nosecone may be manufactured using a variety of suitable processes including, for example, injection molding and additive manufacturing.

[00113] According to an exemplary aspect of the present disclosure, a nosecone for a delivery apparatus may be provided with a nosecone body having a section of increased flexibility between the distal tip and the proximal end of the nosecone body, for example, to provide a discrete bending location spaced apart from the distal tip to facilitate bending of the distal tip away from the interior surface of the circulatory system and / or from the end portions of the docking stent.

[00114] FIG. 10 schematically illustrates an exemplary nosecone 110-4 for a delivery apparatus, having an increased flexibility section 109-4, having greater flexibility than portions of the nosecone body portion immediately distal to and proximal to the increased flexibility section, in accordance with exemplary aspects of the present disclosure. The exemplary nosecone 110-4 includes a body portion 101-4 defining a central lumen 117-4 and an interface portion 103-4 (e.g., similar to the interface portion 103-0 of the nosecone 110-0 of FIGS.5A and 5B) extending proximally from the body portion 101-4. The body portion 101- 4 can have a generally tapered shape with a progressively decreasing diameter from a wider proximal end portion 101p-4 of the body portion to a narrower distal tip portion 101d-4 of the body portion. The schematically depicted increased flexibility section 109-4 is shown in broken lines to indicate that the size, location, and construction of the increased flexibility section may be selectively varied in a wide range of suitable configurations.

[00115] The increased flexibility section 109-4 may be sized, positioned, and otherwise constructed such that when a more distal portion of the nosecone (e.g., the distal tip 101d-4) engages an interior surface of the circulatory system and / or an implant site defining docking stent, the distal portion of the nosecone bends primarily about the increased flexibility section 109-4 to direct the distal tip 101d-4 away from the engaged surface(s), for example, to minimize or prevent tissue damage and / or to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent.

[00116] The increased flexibility section 109-4 may be positioned at a wide variety of locations along the length of the nosecone body portion 101-4. In some examples, the increased flexibility section 109-4 may be located closer to the proximal end portion 101p- 4 of the nosecone body portion 101-4, for example, to increase the bending displacement ofthe distal tip 101d-4. For example, a longitudinal center point c of the increased flexibility section 109-4 may be located greater than about 50% of the distance from the distal tip to the proximal end (i.e., closer to the proximal end portion 101p-4 than to the distal tip 101d-4), or greater than about 65% of the distance from the distal tip to the proximal end, or about 70% to 80% of the distance from the distal tip to the proximal end.

[00117] The increased flexibility section 109-4 may be provided in a range of sizes and configurations corresponding to the desired degree of bending, for example, up to about a desired angle of bending about the increased flexibility section 109-4, and / or a desired radius of bending.

[00118] The increased flexibility section 109-4 may be provided in a variety of flexibility increasing constructions. As one example, the increased flexibility section 109-4 may include a reduced wall thickness section having, for example, a reduced outer diameter (e.g., grooved, or necked-down portions) or a hollow annular wall portion. As another example, increased flexibility section 109-4 may additionally or alternatively be formed from a material having a greater degree of flexibility or lower flexural modulus.

[00119] According to another exemplary aspect of the present disclosure, a nosecone for a delivery apparatus may be provided with a nosecone body having an offset nodule (e.g., as described above) between the distal tip and the proximal end portion and a section of increased flexibility between the offset nodule and the proximal end of the nosecone body, for example, to facilitate bending of the distal tip away from the interior surface of the circulatory system and / or from the end portions of the docking stent upon engagement of the offset nodule with the interior surface.

[00120] FIG. 11 schematically illustrates an exemplary nosecone 110-5 for a delivery apparatus, having an offset nodule 105-5 (e.g., similar to any of the exemplary offset nodules described herein) and an increased flexibility section 109-5 (e.g., similar to any of the exemplary increased flexibility sections described herein) in accordance with exemplary aspects of the present disclosure. The exemplary nosecone 110-5 includes a body portion 101- 5 defining a central lumen 117-5 and an interface portion 103-5 (e.g., similar to the interface portion 103-0 of the nosecone 110-0 of FIGS.5A and 5B) extending proximally from the body portion 101-5. The body portion 101-5 can have a generally tapered shape with a progressively decreasing diameter from a wider proximal end portion 101p-5 of the body portion to a narrower distal tip portion 101d-5 of the body portion, but with the offset nodule 105-5 interrupting the tapered surface and extending radially outward from the tapered surface of thebody portion at a location between the proximal end portion and the distal tip portion, and the increased flexibility section 109-5 optionally (depending on the construction of the increased flexibility section) interrupting the tapered surface at a location between the proximal end portion and the offset nodule. The schematically depicted offset nodule 105-5 and increased flexibility section 109-5 are shown in broken lines to indicate that the size, location, and construction of these features may be selectively varied in a wide range of suitable configurations.

[00121] The offset nodule 105-5 may be positioned at a wide variety of locations along the length of the nosecone body portion 101-5, in a range of sizes corresponding to the desired offset, and in a variety of shapes, as described above.

[00122] The offset nodule 105-5 may be sized and positioned such that when the nosecone 110-5 is guided or otherwise advanced proximate a docking stent engaging interior surface of the circulatory system near the implant site, the offset nodule can contact the interior surface to maintain an offset between the nosecone distal tip 101d-5 and the interior surface sufficient to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent. The contoured surface of the offset nodule 105-5 may facilitate sliding movement of the distal end portion of the nosecone 110-5 along the interior surface, as compared to, for example, the more discrete angled engagement of a distal tip of a nosecone lacking the offset nodule.

[00123] The increased flexibility section 109-5 may be sized, positioned, and otherwise constructed such that when the offset nodule 105-5 engages an interior surface of the circulatory system and / or an implant site defining docking stent, the distal portion of the nosecone bends primarily about the increased flexibility section 109-5 to direct the distal tip 101d-5 away from the engaged surface(s), for example, to minimize or prevent tissue damage and / or to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent.

[00124] The increased flexibility section 109-5 may be positioned at a wide variety of locations along the length of the nosecone body portion 101-5, in a range of sizes and configurations corresponding to the desired degree of bending, and in a variety of flexibility increasing constructions, as described above.

[00125] FIGS.12 and 12A illustrate an exemplary nosecone 110-6 for a delivery apparatus, having an offset nodule 105-6 and an increased flexibility section 109-6 in accordance with exemplary aspects of the present disclosure. The nosecone 110-6 includes abody portion 101-6 defining a central lumen 117-6 and an interface portion 103-6 (e.g., similar to the interface portion 103-0 of the nosecone 110-0 of FIGS.5A and 5B) extending proximally from the body portion 101-6. The body portion 101-6 has a generally tapered shape with a progressively decreasing diameter from a wider proximal end portion 101p-6 of the body portion to a narrower distal tip portion 101d-6 of the body portion, but with the enlargement or offset nodule 105-6 interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion, and a recessed or narrowed increased flexibility section 109-6 interrupting the tapered surface and extending radially inward from the tapered surface of the body portion at a location between the proximal end portion and the offset nodule.

[00126] In the illustrated example, a maximum diameter portion 105m-6 of the offset nodule 105-6 is located closer to the distal tip 101d-6 than to the proximal end portion 101p-6, and as shown, may be less than 30% of the distance from the distal tip to the proximal end, or about 12% to 22% of the distance from the distal tip to the proximal end.

[0127] The maximum diameter portion 105m-6 of the exemplary offset nodule 105-6 has a diameter d1 less than a diameter d2 of the proximal end portion 101p-6, and as shown, may be less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion. The maximum diameter portion 105m-6 of the exemplary offset nodule 105-6 is at least 50% greater than a diameter d3 of longitudinally aligned tangent points t of the nosecone tapered surface, and as shown, may be at least 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 120% greater than the diameter of the longitudinally aligned tangent points.

[00128] The exemplary illustrated offset nodule 105-6 includes a convex outer portion defining the maximum diameter portion 105m-6, and a concave distal junction 105d-6 joining the offset nodule to the tapered surface at the distal end 101d-6 of the nosecone body 101-6, for example, to facilitate atraumatic navigation through the patient's vasculature. The offset nodule 105-6 may also include a concave proximal junction 105p-6 joining the offset nodule to the tapered surface at the proximal end 101p-6 of the nosecone body 101-6.

[00129] The exemplary offset nodule 105-6 is sized and positioned such that when the nosecone 110-6 is guided or otherwise advanced proximate a docking stent engaging interior surface of the circulatory system near the implant site, the offset nodule can contact the interior surface to maintain an offset between the nosecone distal tip 101d-6 and the interior surface sufficient to prevent snagging, wedging, or other such obstruction of the distal tip withthe end portion of the docking stent. The contoured surface of the offset nodule 105-6 may facilitate sliding movement of the distal end portion of the nosecone 110-6 along the interior surface, as compared to, for example, the more discrete angled engagement of a distal tip of a nosecone lacking the offset nodule.

[00130] The increased flexibility section 109-6 may be sized, positioned, and otherwise constructed such that when the offset nodule 105-6 engages the interior surface of the circulatory system and / or the implant site defining docking stent, the distal portion of the nosecone bends primarily about the increased flexibility section 109-6 to direct the distal tip 101d-6 away from the engaged surface(s), for example, to minimize or prevent tissue damage and / or to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion of the docking stent.

[00131] The increased flexibility section 109-6 may be positioned at a wide variety of locations along the length of the nosecone body portion 101-6. In the illustrated embodiment, the increased flexibility section 109-6 is located closer to the proximal end portion 101p-6 of the nosecone body portion 101-6, for example, to increase the bending displacement of the distal tip 101d-6. As shown, a longitudinal center point c of the exemplary increased flexibility section 109-6 is located greater than 50% of the distance from the distal tip to the proximal end (i.e., closer to the proximal end portion 101p-6 than to the distal tip 101d-6), or greater than about 65% of the distance from the distal tip to the proximal end, or about 70% to 80% of the distance from the distal tip to the proximal end. Additionally or alternatively, the longitudinal center point c of the exemplary increased flexibility section 109- 6 may be located greater than about 30% of the distance from the maximum diameter portion 105m-6 of the offset nodule 105-6 to the proximal end, or greater than about 50% of the distance from the maximum diameter portion of the offset nodule to the proximal end, or about 55% to 65% of the distance from the maximum diameter portion of the offset nodule to the proximal end.

[00132] The increased flexibility section 109-6 may be provided in a range of sizes and configurations corresponding to a desired degree of bending, and / or a desired radius of bending.

[00133] The increased flexibility section 109-6 may be provided in a variety of flexibility increasing constructions. In the illustrated example, the increased flexibility section 109-6 includes one or more (e.g., one, as shown, or two or more) narrowed or necked down portions 109a-6 defining a reduced wall thickness section having a reduced outer diameter.The necked down portion 109a-6 may, for example, have a minimum wall thickness (e.g., at the longitudinal center line c) of less than about 65% of the wall thickness of the non-necked down portion of the nosecone body 101-6 immediately distal to the increased flexibility section, for example, to provide concentrated bending at the reduced wall thickness portion(s) of the nosecone body. Additionally or alternatively, the necked down portion 109a-6 may, for example, have an outer diameter at the longitudinal center line c of less than about 80%, or about 60% to 70%, of the diameter of longitudinally aligned tangent points t of the nosecone tapered surface. In one such example, the necked down portion 109a-6 has an outer diameter of about 0.10 inches to about 0.15.

[00134] As shown, the necked down portion 109a-6 may have a gradual contoured profile, for example, to facilitate uniform application of a coating (e.g., a hydrophilic coating, for example, for lubricity) to the exterior surfaces of the nosecone body. In one such exemplary embodiment, the necked down portion 109a-6 has a contoured surface with a radius of curvature of about 0.20 inches.

[0135] FIG.13A and 13B schematically illustrate engagement of the nosecone 110-6 of FIG.12 with the docking stent engaging interior surface 70 of the circulatory system, for example, during implantation of a prosthetic transcatheter valve in a deployed docking stent 300. As shown in FIG. 13A, when the nosecone 110-6 is directed toward the interior surface 70 at an angle of incidence β (e.g., a maximum estimated angle of incidence), the offset nodule 105-6 contacts the interior surface before the distal tip 101d-6 can come into contact with the interior surface, maintaining a minimum offset distance or gap g between the distal tip and the interior surface. This minimum offset gap g may be sized, for example, to ensure clearance between the distal tip 101d-6 of the nosecone and the radial thickness of the docking stent end portion 320.

[00136] In applications where the maximum estimated angle of incidence β is smaller, or where the desired minimum offset gap g is smaller, the offset nodule 105-6 may be provided in a smaller size and / or at a location further from the distal tip 101d-6 of the nosecone body 101-6. In applications where the maximum estimated angle of incidence β is larger, or where the desired minimum offset gap g is larger, the offset nodule 105-6 may be provided in a larger size and / or at a location closer to the distal tip 101d-6 of the nosecone body 101-6.

[00137] As shown in FIG. 13B, when the nosecone 110-6 is further advanced against the docking stent engaging interior surface 70, the force of the interior surface 70 against the offset nodule 105-6 causes the nosecone distal end to bend about the increasedflexibility section 109-6 to direct the distal tip 101d-6 away from the engaged surface(s), for example, to minimize or prevent tissue damage at the interior surface and / or to prevent snagging, wedging, or other such obstruction of the distal tip with the end portion 320 of the docking stent 300.

[00138] In applications where the maximum estimated angle of incidence β is smaller, the flexibility of the increased flexibility section 109-6 may be more limited. In applications where the maximum estimated angle of incidence β is larger, the flexibility of the increased flexibility section 109-6 may be greater, for example, to limit tissue damage at the interior surface 70.

[00139] FIG. 14 illustrate another exemplary nosecone 110-7 for a delivery apparatus, having an offset nodule 105-7, which may be similar to the offset nodule 105-6 of the nosecone 110-6 of FIGS.12 and 12A, and an increased flexibility section 109-7 having one or more (e.g., two, as shown, or one, or more than two) annular grooves or necked down portions 109a-7 defining a reduced wall thickness section having a reduced outer diameter. The grooves 109a-7 may, for example, provide a minimum wall thickness of about 50% to 80% of the wall thickness of the non-grooved portion of the nosecone body 101-7 immediately distal to the increased flexibility section, for example, to provide concentrated bending at the reduced wall thickness portion(s) of the nosecone body. As shown, the grooves 109a-7 may have radially extending sides, or alternatively, may have tapered or contoured sides.

[00140] As shown in FIG. 4A and FIGS. 15A and 15B, a distal end portion of the delivery apparatus 100 can have a balloon shoulder assembly 120 configured to mount an inflatable balloon thereto. The balloon shoulder assembly 120 includes a proximal shoulder 122 connected to a distal end portion of the balloon shaft 106 and a distal shoulder 124 connected to a distal end portion of the inner shaft 108. The proximal shoulder 122 and the distal shoulder 124 are spaced apart from one another, in an axial direction relative to a central longitudinal axis of the delivery apparatus 100. The distal shoulder 124 can have a distal leg portion 124d and a proximal flared portion 124p that has a larger diameter than the distal leg portion (see, e.g., FIG. 5A). Similarly, the proximal shoulder 122 can have a proximal leg portion and a distal flared portion that has a larger diameter than the proximal leg portion.

[00141] The proximal end portion 101p of the nosecone body portion 101 (e.g., of any of the nosecones 110-0 through 110-7 described herein) can have an engagement end 111 configured to engage with a distal end of a valve sheath (e.g., 138), as described further below. The outer diameter at the engagement end 111 can define the largest outer diameter ofthe nosecone 110. As shown in FIGS. 5A and 5B, the interface portion 103-0 can have a generally cylindrical shape and have an outer diameter that is smaller than the outer diameter at the engagement end 111-0. Thus, there can be a step decrease of diameter from the proximal end of the body portion 101-0 to the interface portion 103-0, forming a vertical wall 107-0 that is substantially perpendicular to the central longitudinal axis of the delivery apparatus 100. In other examples, the interface portion can have a partially spherical shape.

[00142] As described herein, a valve sheath (e.g., 138) can be in a covered position (see, e.g., FIG. 4) to cover a radially compressed prosthetic valve folded or crimped around the balloon shoulder assembly 120. In the covered position, the engagement end 111 of the nosecone 110 can abut a distal end of the valve sheath. As a result, when the distal tip portion 101d of the nosecone 110 flexes during the insertion and / or tracking procedures, the distal end of the valve sheath can remain in contact with the vertical wall 107 of the nosecone 110 (i.e., preventing axial separation and / or gap between the engagement end 111 of the nosecone 110 and the distal end of the valve sheath).

[0143] In some examples, the outer diameter of the interface portion 103 can be about the same as or slightly smaller than an inner diameter of a valve sheath so that a distal end portion of the valve sheath can frictionally engage an outer surface of the interface portion 103. In addition, the outer diameter at the engagement end 111 can be about the same as an outer diameter of the valve sheath. In other words, the height of the vertical wall 107 (i.e., the difference between the outer diameter at the engagement end 111 and the outer diameter of the interface portion 103) can be about the same as the thickness of the valve sheath (i.e., the difference between the outer diameter and inner diameter of the valve sheath). Thus, when the valve sheath is in the covered position, the outer surface of the valve sheath and the outer surface of the body portion 101 of the nosecone 110 can form a continuous smooth surface (i.e., no step increase or decrease of outer diameter).

[0144] As depicted in FIG. 5B, the nosecone 110-0 can have an inner lumen 117-0 configured to receive a guidewire 129 and a proximal recess 121-0 configured to receive the distal leg portion 124d of the distal shoulder 124. FIG.5A shows the distal end portion of the delivery apparatus 100, with the distal shoulder displaced away from the nosecone 110-0, and FIG. 5B shows a cross-sectional view of the nosecone 110-0. As shown in FIG. 5B, the diameter of the proximal recess 121-0 can be larger than the diameter of the inner lumen 117- 0. The proximal recess 121-0 can extend from a proximal end of the interface portion 103 into the body portion 101-0. The inner lumen 117-0 can extend from a distal end of the proximalrecess 121-0 to a distal end of the body portion 101-0. During assembly, the distal leg portion 124d can be inserted into the recess 121-0. The distal leg portion 124d can be bonded to the nosecone 110-0, such as with induction welding, an adhesive, etc. The nosecone 110-0 can be made of the same material as the distal shoulder 124. In some examples, the nosecone 110-0 and the distal shoulder 124 are made of Pebax®, such as, for example, a barium sulfate filled Pebax® having a Shore D durometer of less than about 55 D, or less than about 35 D.

[00145] As illustrated in FIG.15B, the prosthetic heart valve 10 can be crimped onto the valve retaining portion 128 of the balloon 126 between the proximal and distal shoulders, which prevent or reduce axial movement of the prosthetic valve 10 relative to the balloon 126 during insertion of the delivery apparatus 100 into the patient's vasculature and delivery of the prosthetic valve 10 to the target implantation site.

[00146] In some examples, a radiopaque marker 136 (FIG.15A) may be placed between the proximal shoulder 122 and the distal shoulder 124. For example, the radiopaque marker 136 can be placed on the outer surface of the inner shaft 108 and aligned with the center of the valve retaining portion 130 of the balloon 126. As described below, the radiopaque marker 136 can be used for aligning the prosthetic valve 10 with the native valve under fluoroscopy during an implantation procedure.

[00147] Further details regarding the balloon shoulder assembly, methods of mounting the folding the balloon onto the balloon shoulder assembly, and methods of crimping a prosthetic valve onto the valve retaining portion of the balloon are disclosed in U.S. Publication Nos. 2007 / 0005131, 2009 / 0281619, 2013 / 0030519, 2017 / 0065415, and U.S. Application No.62 / 911,861, all of which are incorporated herein by reference.

[00148] As shown in FIGS.4, 4A, 15A, and 15B, the delivery apparatus 100 can further include a valve sheath 138 (also referred to as a delivery capsule) which is configured to cover the prosthetic valve 10 mounted on the balloon 126 (FIG. 15B) in a radially compressed state. In the depicted embodiment, a proximal end 138p of the valve sheath 138 is connected to a distal end 104d of the outer shaft 104, for separation of the proximal shoulder 122 (connected to balloon shaft 106) by actuating device movement of the balloon shaft, to move the valve sheath 138 between a covered position (FIG. 4) and an uncovered position (FIG. 4A), in which the prosthetic valve 10 and balloon 126 are exposed. In some examples, the proximal end 138p of the valve sheath 138 can be fixedly coupled to the distal end 104d of the outer shaft 104 by any known means, such as welding, an adhesive, etc. As described below, the prosthetic valve 10 is retained inside the valve sheath 138 when navigating throughthe patient's vasculature (e.g., through the tricuspid chordae). Thus, the sheath 138 serves to protect the inside of the patient's vasculature against contact with the outer surface of the prosthetic valve 10 as the delivery apparatus and the prosthetic valve are inserted into and advanced through the patient's vasculature to the implantation site.

[00149] In some examples, the nosecone 110 and the distal shoulder 124 can be a one-piece or unitary component, that is, the nosecone 110 is a distal portion of the unitary component and the distal shoulder 124 is a proximal portion of the unitary component. In other examples, the nosecone 110 and the distal shoulder 124 can be separate components, and each can be mounted on the inner shaft 108 next to each other or at axially spaced locations.

[00150] FIG.16 illustrates an exemplary prosthetic valve 10 received within an exemplary docking device 300 implanted in the circulatory system, such as in the pulmonary artery. In the depicted embodiment, the sealing member 316 of the docking device 300 provides a seal between the docking device and an interior surface 70 of the circulatory system. In some examples, the sealing member 316 can cover the lower (near the inflow end 305), rounded, radially outward extending portion 322 of the frame 302, and may extend to the valve seat 318, such that blood flowing in the direction from the inflow end 305 toward the outflow end 307 is directed to the valve seat 318 (and the prosthetic valve 10 once installed or deployed in the valve seat 318). As shown, portions of the outflow portion 306 of the docking device may be permeable (e.g., with the frame uncovered), for example, to allow the docking device 300 to be placed higher in the pulmonary artery without restricting blood flow.

[00151] In the illustrated arrangement, the retaining members 320 of the docking device 300 have an outwardly curving flare that helps secure the docking device within the pulmonary artery. In the depicted embodiment, when the docking device 300 is compressed by the interior surface 70, the retaining members 320 can engage the surface 70 at an angle α (e.g., between about 30 and 60 degrees, such as about 45 degrees) between the normal direction to the surface 70 and the tangent of the retaining member 320, with inward bending of the retaining members 320 acting to retain the docking device 300 in the circulatory system. When an axial force is applied to the docking device 300, the flared retaining members 320 are pushed by the force into the surrounding tissue to resist migration of the docking device 300.

[00152] The illustrated docking device 300 and prosthetic valve 10 may be suited to be deployed in the pulmonary artery or right ventricular outflow tract for pulmonary valve replacement. However, the docking device 300 and prosthetic valve 10 can be deployed in any interior surface within the heart or a lumen of the body. For example, the various dockingdevices and valves described herein can be deployed in the superior vena cava, the inferior vena cava, the tricuspid valve, the mitral valve, the aortic valve, aorta, or other vasculature / lumens in the body.

[00153] FIGS. 17A-17I illustrate certain steps of an exemplary method of implanting the docking device 300 and the prosthetic valve 10 at the RVOT for pulmonary valve replacement, according to one embodiment.

[00154] FIG.17A shows a guidewire 420 inserted through a patient's vasculature and into the pulmonary bed. Specifically, the guidewire 420 can be advanced to the pulmonary artery 50 by way of the femoral vein, inferior vena cava, right atrium, tricuspid valve, right ventricle, and the right ventricular outflow tract. The delivery apparatus 400 (only the outer shaft 404 and the nosecone 410 are shown) that retains the docking device 300 can be delivered over the guidewire 420. The delivery apparatus 400 can be advanced until a radiopaque marker 418 is positioned at a distal end of the intended landing zone 60 where the docking device 300 is to be deployed.

[00155] Then, as shown in FIG. 17B, the outer shaft 404 of the delivery apparatus 400 can be progressively retracted with respect to inner shaft 406 to deploy the docking device 300. As the distal portion of the docking device 300 becomes uncovered by the outer shaft 404, the distal portion of the frame 302 begins to self-expand. When the radiopaque marker 418 is at about the waist portion 308 of the frame 302, the distal half of the frame 302 is fully expanded at the intended landing zone 60. In some arrangements, when the frame is partially expanded, the deployment position of the docking device 300 can be reassessed. If repositioning of the docking device 300 is needed, the distal portion of the frame 302 can be compressed and recaptured by the delivery sheath 416 of the outer shaft 404. This can be achieved, for example, by moving the outer shaft 404 distally until it contacts the nosecone 410. Then the radiopaque marker 418 can be repositioned relative to the intended landing zone 60 to redeploy the docking device 300.

[00156] Further retracting the outer shaft 404 past the waist portion 308 of the docking device 300 can release the proximal half of the frame 302 from the delivery sheath 416. When the outer shaft 404 is retracted to a position that exposes the retaining tabs 314, the retaining tabs 314 can be released from the docking device retaining member 408 due to the expanding force of the frame 302. Thus, as shown in FIG. 17C, the frame 302 can be fully expanded and frictionally engage the inner wall of the pulmonary artery (or right ventricular outflow tract), i.e., the docking device 300 is fully deployed at the intended landing zone 60.

[0157] As shown in FIG. 17D, after deploying the docking device 300 at the intended landing zone 60, the delivery apparatus 400 can be retracted from the patient's vasculature over the guidewire 420 while leaving the guidewire 420 in place. After withdrawing the delivery apparatus 400 from the patient's vasculature, the prosthetic valve 10 can then be delivered to and received by the docking device 300 via the delivery apparatus 100, as described below (although the delivery apparatus 100 is described as an example for illustration, similar steps can be performed using the delivery apparatus 400).

[00158] For pulmonary valve implantation, the prosthetic valve 10 is oriented so that its inflow end 22 is located proximal to the outflow end 24 when the valve 10 is crimped on the valve retaining portion 130 of the balloon 126 (see e.g., FIG.15B).

[00159] In one example embodiment, the nosecone 110, the valve sheath 138, and the sheath 116 of the inline introducer (FIGS. 4 and 4A) are inserted together into the patient's vasculature (e.g., through a surgical opening in a femoral vein) as a single unit over the guidewire 420, desirably with the distal end 116d of the sheath 116 adjacent or abutting the proximal end 138p of the valve sheath 138.

[00160] After the sheath 116 is fully inserted into the vasculature, the shafts 104, 106, 108 of the delivery apparatus 100 can be advanced over the guidewire 420 and relative to the sheath 116 through the patient's vasculature, with the prosthetic valve 10 remaining covered by the valve sheath 138 (so as to protect against damage to the prosthetic valve as well as the inner wall of the vasculature and the tricuspid valve chordae tendineae) until the nosecone 110 is advanced to the intended landing zone 60 marked by the pre-implanted docking device 300. As shown in FIG.17E, when / if the distal tip 101d of the nosecone 110 approaches the interior surface 70 proximate the end portion 320 of the docking device 300, the offset nodule 105 engages the interior surface to provide a minimum offset between the distal tip of the nosecone and the inner surface of the circulatory system, and to impart bending movement of the distal end of the nosecone about the increased flexibility section 109 of the nosecone and away from the interior surface as the nosecone is guided toward the implantation site, as described in greater detail above. This offset and / or bending movement may effectively prevent the distal tip of the nosecone from being impeded or snagged by the end portion 320 of the installed docking device 300 or wedged between the end portion of the docking device and the inner surface 70 of the circulatory system.

[00161] After reaching the intended landing zone 60 (e.g., as confirmed, for example, by aligning the radiopaque marker 136 of the delivery apparatus 100 with the waistregion 308 based on the fluoroscopic views), as shown in FIG.17F, the delivery apparatus 100 can be manipulated so that the prosthetic valve 10 is placed within the waist 308 region of the docking device 300.

[00162] The outer shaft 104 and the valve sheath 138 connected thereto can then be retracted in the proximal direction to uncover the prosthetic valve 10 (FIG. 17G), and the balloon 126 can be inflated, e.g., by injecting an inflation fluid into the balloon shaft 106 to radially expand the prosthetic valve 10 within the interior of the docking device 300 for seating engagement with the docking device (FIG. 17H). The position of the prosthetic valve 10 can be verified under fluoroscopy.

[00163] As shown in FIG.17I, after the prosthetic valve 10 is fully expanded and securely docked to the docking device 300, the balloon 126 can be deflated (e.g., by withdrawing the inflation fluid out of the balloon 126 and the balloon shaft 106), and the shafts 104, 106, 108 of the delivery apparatus 100 can be retracted, over the guidewire 420, into the vena cava, with the deflated balloon 126 being resheathed (i.e., captured or covered) by the valve sheath 138 for smooth retraction of the balloon with the shafts 104, 106, 108 of the delivery apparatus 100 as a single unit, out of the patient's vasculature. The guidewire 420 can then be removed as well. EXAMPLES

[00164] In view of the above described implementations of the disclosed subject matter, this disclosure provides additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0165] Example 1. A nosecone for a transcatheter delivery apparatus, the nosecone comprising a body portion defining a central lumen, the body portion having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion.

[00166] Example 2. The nosecone of Example 1, wherein when the nosecone is advanced proximate an interior surface of a circulatory system, the offset nodule can contact the interior surface to maintain an offset between the distal tip portion of the nosecone and the interior surface.

[0167] Example 3. The nosecone of any of Examples 1 and 2, wherein the offset nodule includes a convex outer radial surface.

[00168] Example 4. The nosecone of any of Examples 1-3, wherein a maximum diameter portion of the offset nodule is located less than about 50% of a distance from the distal tip portion to the proximal end portion, or less than about 30% of the distance from the distal tip portion to the proximal end portion, or about 12% to about 22% of the distance from the distal tip portion to the proximal end portion.

[00169] Example 5. The nosecone of any of Examples 1-4, wherein a maximum diameter portion of the offset nodule has a diameter less than or equal to a diameter of the proximal end portion, or less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion.

[00170] Example 6. The nosecone of any of Examples 1-5, wherein a maximum diameter portion of the offset nodule has a diameter at least about 50% greater than a diameter of longitudinally aligned tangent points of the nosecone tapered surface, or at least about 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 210% greater than the diameter of the longitudinally aligned tangent points.

[00171] Example 7. The nosecone of any of Examples 1-6, wherein a distal end of the offset nodule is joined to the tapered surface by a concave junction.

[00172] Example 8. The nosecone of any of Examples 1-7, wherein a proximal end of the offset nodule is joined to the tapered surface by a concave junction.

[00173] Example 9. The nosecone of any of Examples 7 and 8, wherein the concave junction has a radius of curvature greater than about 25%, or about 35% to 45%, or greater than about 50%, or about 75% to 85% of a radius of curvature of a convex maximum diameter portion of the offset nodule.

[00174] Example 10. The nosecone of any of Examples 1-9, further comprising an interface portion extending proximally from the body portion for engagement with a valve sheath of the transcatheter delivery apparatus.

[00175] Example 11. The nosecone of any of Examples 1-10, wherein the body portion comprises one of a barium sulfate filled polymer, Pebax®, polyurethane, barium sulfate filled Pebax®, and barium sulfate filled polyurethane.

[00176] Example 12. The nosecone of any of Examples 1-11, wherein the body portion comprises a material having a Shore D durometer of less than about 35 D.

[0177] Example 13. The nosecone of any of Examples 1-12, wherein the offset nodule is sized and positioned to maintain an offset gap between the distal tip portion and a uniform interior surface when the nosecone is directed toward the uniform interior surface at a maximum angle of incidence of up to about 20°.

[00178] Example 14. The nosecone of any of Examples 1-13, wherein the body portion comprises an increased flexibility section longitudinally located between the offset nodule and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

[00179] Example 15. The nosecone of Example 14, wherein when the nosecone is advanced proximate an interior surface of a circulatory system such that the offset nodule contacts the interior surface, the distal tip portion of the nosecone body bends primarily about the increased flexibility section to direct the distal tip portion away from the contacted interior surface.

[00180] Example 16. The nosecone of any of Examples 14 and 15, wherein a longitudinal center point of the increased flexibility section is located greater than about 50% of a distance from the distal tip portion to the proximal end portion, or greater than about 65% of the distance from the distal tip portion to the proximal end portion, or about 70% to about 80% of the distance from the distal tip portion to the proximal end portion.

[00181] Example 17. The nosecone of any of Examples 14-16, wherein a longitudinal center point of the increased flexibility section is located greater than about 30% of a distance from a maximum diameter portion of the offset nodule to the proximal end portion, or greater than about 50% of the distance from the maximum diameter portion of the offset nodule to the proximal end portion, or about 55% to about 65% of the distance from the maximum diameter portion of the offset nodule to the proximal end portion.

[00182] Example 18. The nosecone of any of Examples 14-17, wherein the increased flexibility section includes a material having a lower flexural modulus that a material of the distal tip portion and the proximal end portion of the nosecone body.

[00183] Example 19. The nosecone of any of Examples 14-18, wherein the increased flexibility section includes one or more necked down portions.

[00184] Example 20. The nosecone of Example 19, wherein the one or more necked down portions has a minimum wall thickness of less than about 80% or less than about65% of a wall thickness of a non-necked down portion of the body portion immediately distal to the increased flexibility section.

[00185] Example 21. The nosecone of any of Examples 1-20, wherein an outer surface of the body portion includes a hydrophilic coating.

[00186] Example 22. A nosecone for a transcatheter delivery apparatus, the nosecone comprising a body portion defining a central lumen, the body portion having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an increased flexibility section longitudinally located between the distal tip portion and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

[00187] Example 23. The nosecone of Example 22, wherein when the nosecone is advanced proximate an interior surface of a circulatory system such that a portion of the nosecone body distal to the increased flexibility section contacts the interior surface, the distal tip portion of the nosecone body bends primarily about the increased flexibility section to direct the distal tip portion away from the contacted interior surface.

[00188] Example 24. The nosecone of any of Examples 22 and 23, wherein a longitudinal center point of the increased flexibility section is located greater than about 50% of a distance from the distal tip portion to the proximal end portion, or greater than about 65% of the distance from the distal tip portion to the proximal end portion, or about 70% to about 80% of the distance from the distal tip portion to the proximal end portion.

[00189] Example 25. The nosecone of any of Examples 22-24, wherein the increased flexibility section includes a material having a lower flexural modulus that a material of the distal tip portion and the proximal end portion of the nosecone body.

[00190] Example 26. The nosecone of any of Examples 22-25, wherein the increased flexibility section includes one or more necked down portions.

[00191] Example 27. The nosecone of Example 26, wherein the one or more necked down portions has a minimum wall thickness of less than about 80% or less than about 65% of a wall thickness of a non-necked down portion of the body portion immediately distal to the increased flexibility section.

[00192] Example 28. The nosecone of any of Examples 22-27, wherein an outer surface of the body portion includes a hydrophilic coating.

[0193] Example 29. The nosecone of any of Examples 22-28, further comprising an interface portion extending proximally from the body portion for engagement with a valve sheath of the transcatheter delivery apparatus.

[0194] Example 30. The nosecone of any of Examples 22-29, wherein the body portion comprises one of a barium sulfate filled polymer, Pebax®, polyurethane, barium sulfate filled Pebax®, and barium sulfate filled polyurethane.

[00195] Example 31. The nosecone of any of Examples 22-30, wherein the body portion comprises a material having a Shore D durometer of less than about 35 D.

[00196] Example 32. The nosecone of any of Examples 22-31, wherein the nosecone body portion further comprises and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the increased flexibility section and the distal tip portion.

[00197] Example 33. A transcatheter delivery apparatus comprising: a user operable actuating device; a shaft having a proximal end connected to the actuating device for axial movement of the shaft; and a nosecone connected to a distal end of the shaft, wherein the nosecone comprises the nosecone of any of Examples 1-32.

[00198] Example 34. The transcatheter delivery apparatus of Example 33, further comprising at least one radiopaque marker disposed on the shaft.

[00199] Example 35. The transcatheter delivery apparatus of any of Examples 33-34, further comprising a sheath surrounding the shaft.

[00200] Example 36. The transcatheter delivery apparatus of any of Examples 33-35, further comprising at least one radiopaque marker disposed on the sheath.

[00201] Example 37. A method of installing a prosthetic valve in a vessel, the method comprising: deploying an expandable docking station at a target location within the vessel, such that an annular first end of the docking station expands radially outward to engage an inner surface of the vessel to retain the docking station at the target location; providing a transcatheter delivery apparatus including a shaft, a sheath surrounding the shaft and retaining the prosthetic valve in a radially compressed condition around the shaft, and a nosecone secured to a distal end of the shaft, the nosecone including a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion; inserting the transcatheter delivery apparatus into the vessel, such that the offset nodule is engageable withthe inner surface of the vessel beyond the first end of the docking station to position the distal tip portion of the nosecone radially inward of the annular first end of the docking station; advancing the nosecone into the docking station to align the radially compressed prosthetic valve with a valve seat portion of the docking station; retracting the sheath to uncover the radially compressed prosthetic valve; and expanding the prosthetic valve into seating engagement with the valve seat portion of the docking station.

[00202] Example 38. The method of Example 37, wherein advancing the nosecone into the docking station to align the radially compressed prosthetic valve with the valve seat portion of the docking station comprises visually aligning at least one radiopaque marker on the transcatheter delivery apparatus with a portion of the docking station.

[00203] Example 39. The method of any of Examples 37-38, wherein the nosecone includes an increased flexibility section longitudinally located between the offset nodule and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section, and wherein advancing the nosecone into the docking station to align the radially compressed prosthetic valve with the valve seat portion of the docking station comprises bending the distal tip portion about the increased flexibility section to direct the distal tip portion away from the inner surface of the vessel.

[00204] Example 40. The method of any of Examples 37-39, wherein the transcatheter delivery apparatus comprises the transcatheter delivery apparatus of any of Examples 33-36.

[0205] Example 41. A method of installing a prosthetic valve in a vessel, the method comprising: deploying an expandable docking station at a target location within the vessel, such that an annular first end of the docking station expands radially outward to engage an inner surface of the vessel to retain the docking station at the target location; providing a transcatheter delivery apparatus including a shaft, a sheath surrounding the shaft and retaining the prosthetic valve in a radially compressed condition around the shaft, and a nosecone secured to a distal end of the shaft, the nosecone including a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an increased flexibility section longitudinally located between the distal tip portion and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section; inserting the transcatheter delivery apparatus into the vessel, such that engagement of the nosecone with the inner surface of thevessel causes the distal tip portion of the nosecone to bend about the increased flexibility section to direct the distal tip portion away from the inner surface of the vessel; advancing the nosecone into the docking station to align the radially compressed prosthetic valve with a valve seat portion of the docking station; retracting the sheath to uncover the radially compressed prosthetic valve; and expanding the prosthetic valve into seating engagement with the valve seat portion of the docking station.

[00206] Example 42. The method of Example 41, wherein advancing the nosecone into the docking station to align the radially compressed prosthetic valve with the valve seat portion of the docking station comprises visually aligning at least one radiopaque marker on the transcatheter delivery apparatus with a portion of the docking station.

[00207] Example 43. The method of any of Examples 41-42, wherein the transcatheter delivery apparatus comprises the transcatheter delivery apparatus of any of Examples 33-36.

[00208] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only some examples of the invention and should not be taken as limiting the scope of the invention. All combinations or sub-combinations of features of the foregoing exemplary embodiments are contemplated by this application. The scope of the claimed invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims

WHAT IS CLAIMED IS:

1. A nosecone for a transcatheter delivery apparatus, the nosecone comprising a body portion defining a central lumen, the body portion having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion.

2. The nosecone of claim 1, wherein when the nosecone is advanced proximate an interior surface of a circulatory system, the offset nodule can contact the interior surface to maintain an offset between the distal tip portion of the nosecone and the interior surface.

3. The nosecone of any of claims 1-2, wherein a maximum diameter portion of the offset nodule is located less than about 50% of a distance from the distal tip portion to the proximal end portion, or less than about 30% of the distance from the distal tip portion to the proximal end portion, or about 12% to about 22% of the distance from the distal tip portion to the proximal end portion.

4. The nosecone of any of claims 1-3, wherein a maximum diameter portion of the offset nodule has a diameter less than or equal to a diameter of the proximal end portion, or less than about 80% of the diameter of the proximal end portion or about 63% to 73% of the diameter of the proximal end portion.

5. The nosecone of any of claims 1-4, wherein a maximum diameter portion of the offset nodule has a diameter at least about 50% greater than a diameter of longitudinally aligned tangent points of the nosecone tapered surface, or at least about 80% greater than the diameter of the longitudinally aligned tangent points, or about 110% to 210% greater than the diameter of the longitudinally aligned tangent points.

6. The nosecone of any of claims 1-5, wherein the offset nodule is sized and positioned to maintain an offset gap between the distal tip portion and a uniform interior surface when the nosecone is directed toward the uniform interior surface at a maximum angle of incidence of up to about 20°.

7. The nosecone of any of claims 1-6, wherein the body portion comprises an increased flexibility section longitudinally located between the offset nodule and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

8. A nosecone for a transcatheter delivery apparatus, the nosecone comprising a body portion defining a central lumen, the body portion having a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an increased flexibility section longitudinally located between the distal tip portion and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section.

9. The nosecone of claim 8, wherein when the nosecone is advanced proximate an interior surface of a circulatory system such that a portion of the nosecone body distal to the increased flexibility section contacts the interior surface, the distal tip portion of the nosecone body bends primarily about the increased flexibility section to direct the distal tip portion away from the contacted interior surface.

10. The nosecone of any of claims 8-9, wherein a longitudinal center point of the increased flexibility section is located greater than about 50% of a distance from the distal tip portion to the proximal end portion, or greater than about 65% of the distance from the distal tip portion to the proximal end portion, or about 70% to about 80% of the distance from the distal tip portion to the proximal end portion.

11. The nosecone of any of claims 8-10, wherein the increased flexibility section includes a material having a lower flexural modulus that a material of the distal tip portion and the proximal end portion of the nosecone body.

12. The nosecone of any of claims 8-11, wherein the increased flexibility section includes one or more necked down portions.

13. The nosecone of any of claims 8-12, wherein the nosecone body portion further comprises and an offset nodule interrupting the tapered surface and extending radiallyoutward from the tapered surface of the body portion at a location between the increased flexibility section and the distal tip portion.

14. A transcatheter delivery apparatus comprising: a user operable actuating device; a shaft having a proximal end connected to the actuating device for axial movement of the shaft; and a nosecone connected to a distal end of the shaft, wherein the nosecone comprises the nosecone of any of claims 1-13.

15. A method of installing a prosthetic valve in a vessel, the method comprising: deploying an expandable docking station at a target location within the vessel, such that an annular first end of the docking station expands radially outward to engage an inner surface of the vessel to retain the docking station at the target location; providing a transcatheter delivery apparatus including a shaft, a sheath surrounding the shaft and retaining the prosthetic valve in a radially compressed condition around the shaft, and a nosecone secured to a distal end of the shaft, the nosecone including a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an offset nodule interrupting the tapered surface and extending radially outward from the tapered surface of the body portion at a location between the proximal end portion and the distal tip portion; inserting the transcatheter delivery apparatus into the vessel, such that the offset nodule is engageable with the inner surface of the vessel beyond the first end of the docking station to position the distal tip portion of the nosecone radially inward of the annular first end of the docking station; advancing the nosecone into the docking station to align the radially compressed prosthetic valve with a valve seat portion of the docking station; retracting the sheath to uncover the radially compressed prosthetic valve; and expanding the prosthetic valve into seating engagement with the valve seat portion of the docking station.

16. The method of claim 15, wherein advancing the nosecone into the docking station to align the radially compressed prosthetic valve with the valve seat portion of the dockingstation comprises visually aligning at least one radiopaque marker on the transcatheter delivery apparatus with a portion of the docking station.

17. The method of any of claims 15-16, wherein the transcatheter delivery apparatus comprises the transcatheter delivery apparatus of claim 14.

18. A method of installing a prosthetic valve in a vessel, the method comprising: deploying an expandable docking station at a target location within the vessel, such that an annular first end of the docking station expands radially outward to engage an inner surface of the vessel to retain the docking station at the target location; providing a transcatheter delivery apparatus including a shaft, a sheath surrounding the shaft and retaining the prosthetic valve in a radially compressed condition around the shaft, and a nosecone secured to a distal end of the shaft, the nosecone including a tapered outer surface extending from a wider proximal end portion to a narrower distal tip portion, and an increased flexibility section longitudinally located between the distal tip portion and the proximal end portion, the increased flexibility section having greater flexibility than portions of the body portion immediately distal to and proximal to the increased flexibility section; inserting the transcatheter delivery apparatus into the vessel, such that engagement of the nosecone with the inner surface of the vessel causes the distal tip portion of the nosecone to bend about the increased flexibility section to direct the distal tip portion away from the inner surface of the vessel; advancing the nosecone into the docking station to align the radially compressed prosthetic valve with a valve seat portion of the docking station; retracting the sheath to uncover the radially compressed prosthetic valve; and expanding the prosthetic valve into seating engagement with the valve seat portion of the docking station.

19. The method of claim 18, wherein advancing the nosecone into the docking station to align the radially compressed prosthetic valve with the valve seat portion of the docking station comprises visually aligning at least one radiopaque marker on the transcatheter delivery apparatus with a portion of the docking station.

20. The method of any of claims 18-19, wherein the transcatheter delivery apparatus comprises the transcatheter delivery apparatus of claim 14.

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