Delivery system with split distal tip for improved transcatheter heart valve positioning

Abstract

A delivery system includes: a handle; an inner shaft having a distal portion configured to receive a heart valve prosthesis on the distal portion; a push wire slidably disposed through a lumen of the inner shaft; and an outer sheath configured to cover the heart valve prosthesis during delivery. A split distal tip or nose cone is attached to the distal end of the inner shaft and includes at least one cutout portion formed through a sidewall of the nose cone. The proximal end of the push wire is operatively coupled to an actuator of the handle, and the distal end of the push wire is attached to the cutout portion of the nose cone. When the nose cone is in a delivery configuration, the cutout portion is substantially flush with the sidewall of the nose cone. When the nose cone is in an expanded configuration, the cutout portion is spaced apart from the sidewall of the nose cone.

Description

Technical Field

[0001] The present invention relates to delivery systems for self-expanding prostheses and methods of delivering self-expanding prostheses. Background Art

[0002] Flexible prosthetic valves supported by stent structures that can be delivered percutaneously using catheter-based delivery systems have been developed for use in heart and venous valve replacements. These prosthetic valves can include self-expanding, balloon-expandable, or mechanically expandable stent structures in which valve leaflets are attached to the interior of the stent structure. The prosthetic valve can be reduced in diameter by curling onto a balloon catheter or by being housed in a sheath component of a delivery catheter, mechanically mounted on the delivery catheter, and advanced through the venous or arterial vasculature. When the prosthetic valve is positioned at the treatment site, such as in an insufficient natural valve, the stent frame structure can be expanded to securely hold the prosthetic valve in place.

[0003] In general, rather than undergoing an open surgical procedure, which can be traumatic and invasive, the prosthesis is preferably deployed through a less invasive intraluminal delivery procedure. More specifically, the lumen or vasculature is accessed percutaneously at a convenient and less traumatic entry point, and the prosthesis is guided through the vasculature to the site where the prosthesis is to be deployed. Intraluminal deployment is typically performed using a delivery catheter having coaxial inner and outer tubes that are arranged for relative axial movement. For example, a self-expanding valve prosthesis can be compressed and positioned within the distal end of an outer tube or sheath of a delivery catheter. The delivery catheter is then manipulated, typically guided through the body cavity, until the end of the delivery catheter and the prosthesis are positioned at the intended treatment site. The inner tube or shaft is then held stationary while the outer tube or sheath of the delivery catheter is withdrawn. A stopper can be utilized to prevent the prosthesis from being withdrawn along with the outer tube or sheath. As the outer tube or sheath is withdrawn, the prosthesis is released from the confines of the outer tube or sheath and radially self-expands such that at least a portion of the prosthesis contacts and substantially conforms to a portion of the surrounding interior of a lumen, such as a blood vessel wall, an anatomical conduit, and / or cardiac anatomy.

[0004] Although transcatheter delivery methods have provided a safer and less invasive method for replacing defective native heart valves, complications may arise, including vascular trauma due to percutaneous delivery within highly tortuous anatomical structures and / or due to the large delivery profile of the prosthesis, inaccurate placement of the heart valve prosthesis, conduction interference, coronary artery obstruction, and / or undesirable paravalvular leakage and / or regurgitation at the implantation site. More specifically, for example, a prosthesis positioned too deep relative to the native annulus or unevenly placed within the native annulus with respect to depth may cause conduction interference. In another example, if the prosthesis is not circumferentially centered relative to the native annulus, the deployed prosthesis may be displaced from the implantation site and / or undesirable paravalvular leakage and / or regurgitation may occur. Therefore, before the prosthesis is fully deployed, it must be precisely positioned relative to the native annulus.

[0005]

[0014] Embodiments of the present invention are directed to a delivery system for a transcatheter valve prosthesis for positioning the valve prosthesis in situ with improved accuracy to address one or more of the complications discussed above. Summary of the Invention

[0006] Embodiments of the present invention relate to a delivery system for percutaneously delivering a valve prosthesis to a native heart valve, the delivery system comprising: a handle having at least one actuator thereon; an inner shaft having a distal portion configured to receive the heart valve prosthesis thereon; and at least one push wire. The inner shaft defines at least one lumen therethrough, and the at least one push wire is slidably disposed through the at least one lumen of the inner shaft. A nose cone is attached to the distal end of the inner shaft and includes at least one cutout portion formed through a sidewall of the nose cone. A proximal end of the at least one push wire is operatively coupled to the at least one actuator of the handle, and a distal end of the at least one push wire is attached to the at least one cutout portion of the nose cone. When the nose cone is in a delivery configuration, the at least one cutout portion is substantially flush with the sidewall of the nose cone. When the nose cone is in an expanded configuration, the at least one cutout portion is spaced apart from the sidewall of the nose cone.

[0007] Embodiments of the present invention also relate to a method for positioning a valve prosthesis within a native heart valve. A valve prosthesis mounted on a delivery system is advanced through the vasculature to the native heart valve. The delivery system includes an inner shaft defining at least one lumen therethrough and a nose cone attached to a distal end of the inner shaft. The nose cone includes at least one cutout portion formed through a sidewall of the nose cone. At least one push wire is slidably disposed through the at least one lumen of the inner shaft, with the distal end of the at least one push wire attached to the at least one cutout portion of the nose cone. During the step of advancing the valve prosthesis, the nose cone is in a delivery configuration in which the at least one cutout portion is substantially flush with the sidewall of the nose cone, and during the step of advancing the valve prosthesis, the valve prosthesis is in the delivery configuration. The valve prosthesis is positioned within the native heart valve. The nose cone is deployed by longitudinally advancing the at least one push wire to an deployed configuration in which the at least one cutout portion is spaced apart from the sidewall of the nose cone. The at least one cutout portion is moved into contact with the anatomy of the native heart valve. The at least one cutout portion again pushes against the anatomy of the native heart valve to deflect the heart valve prosthesis, thereby radially centering the heart valve prosthesis within the native heart valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings, incorporated herein, form part of the specification and illustrate embodiments of the delivery system. Together with the specification, the drawings further explain the principles by which a person skilled in the relevant art can make, use, and implant the prosthesis described herein. In the accompanying drawings, like reference numerals represent identical or functionally similar elements.

[0009] Figure 1 is a side view of a delivery system in accordance with an embodiment of the present invention, wherein the delivery system is in a delivery configuration in which the heart valve prosthesis is in a radially compressed configuration and the nose cone of the delivery system is in the delivery configuration.

[0010] Figure 1A For the Figure 1 The line AA intercepts Figure 1 Cross-sectional view of the delivery system.

[0011] Figure 1B For the Figure 1 sectional view of a delivery system according to another embodiment of the present invention taken along line AA.

[0012] Figure 1C for Figure 1 A perspective view of a distal portion of a delivery system of FIG. 1 , wherein the delivery system is in a delivery configuration and the outer sheath of the delivery system is not shown for illustrative purposes only.

[0013] Figure 2 for Figure 1 Side view of a delivery system of FIG. 1 , wherein the heart valve prosthesis is in a radially expanded configuration and the nose cone of the delivery system is in a delivery configuration.

[0014] Figure 3 is a side perspective view of a heart valve prosthesis used in an embodiment of the present invention.

[0015] Figure 4 for Figure 3 End view of a heart valve prosthesis.

[0016] Figure 5 for Figure 1 Side view of the nose cone of the delivery system, wherein the nose cone is in the delivery configuration.

[0017] Figure 6 for Figure 1 Side view of the nose cone of the delivery system, with the nose cone in the deployed configuration.

[0018] Figure 7 is a perspective view of a nose cone of a delivery system according to another embodiment of the present invention, wherein the nose cone includes two cutout portions and the nose cone is in a delivery configuration.

[0019] Figure 7A For the Figure 7 The line AA intercepts Figure 7 Cross-sectional view of the delivery system.

[0020] Figure 7B For the Figure 7 sectional view of a delivery system according to another embodiment of the present invention taken along line AA.

[0021] Figure 8 is an end view of a nose cone of a delivery system according to another embodiment of the present invention, wherein the nose cone includes three cutout sections.

[0022] Figure 9 is an end view of a nose cone of a delivery system according to another embodiment of the present invention, wherein the nose cone includes four cutout portions.

[0023] Figure 10 is a cross-sectional view of an inner shaft of a delivery system according to another embodiment of the present invention, removed from the delivery system for illustrative purposes only, wherein the inner shaft includes five lumens formed therethrough.

[0024] Figure 11 Illustrated using Figure 1 delivery system to expand Figure 3 The present invention provides steps of a method for providing a heart valve prosthesis, wherein the heart valve prosthesis is shown in a delivery or radially compressed configuration at a target treatment site.

[0025] Figure 12 Illustrated using Figure 1 delivery system to expand Figure 3 Another step in the method of providing a heart valve prosthesis wherein the cutout portion of the nose cone is in the process of being deployed.

[0026] Figure 13 Illustrated using Figure 1 delivery system to expand Figure 3 Another step of the method of providing a heart valve prosthesis wherein the cutout portion of the nose cone contacts the ventricular septum.

[0027] Figure 14 Illustrated using Figure 1 delivery system to expand Figure 3 Another step in a method of providing a heart valve prosthesis, wherein the heart valve prosthesis is shown transitioning from a delivery or radially compressed configuration to a deployed or radially expanded configuration at a target treatment site, and wherein the cutout portion of the nose cone contacts the ventricular septum.

[0028] Figure 15 Illustrated using Figure 1 delivery system to expand Figure 3 Another step in a method of providing a heart valve prosthesis, wherein the heart valve prosthesis is shown in a deployed or radially expanded configuration at a target treatment site and wherein the cutout portion of the nose cone contacts the ventricular septum.

[0029] Figure 16 Illustrated using Figure 1 delivery system to expand Figure 3 Another step in a method of providing a heart valve prosthesis, wherein the heart valve prosthesis is shown in a deployed or radially expanded configuration at a target treatment site, and wherein the cutout portion of the nose cone is repositioned back to the delivery configuration.

[0030] Figure 17 Illustrated using Figure 1 delivery system to expand Figure 3 Another step in the method of administering a heart valve prosthesis is shown in which the heart valve prosthesis is in a deployed or radially expanded configuration after deployment at a target treatment site and the delivery system is removed. DETAILED DESCRIPTION

[0031] Specific embodiments of the present invention will now be described with reference to the accompanying drawings, in which identical reference numerals indicate identical or functionally similar elements. Unless otherwise indicated, for delivery systems, in the following description, the terms "distal" and "proximal" are used with respect to a position or direction relative to a treating clinician. "Distal" and "distally" are positions away from a clinician or in a direction away from a clinician, and "proximal" and "proximally" are positions close to a clinician or in a direction toward a clinician. For a prosthesis, "proximal" is the upstream portion or the direction of blood flow when the prosthesis is deployed, and "distal" is the downstream portion or the direction of blood flow when the prosthesis is deployed. In addition, the term "self-expanding" is used with reference to one or more stent structures of the prosthesis of the present invention in the following description, and is intended to convey that these structures are formed or formed by a material that can provide mechanical memory so that the structure is returned to a radially expanded deployment configuration from a radially compressed or contracted delivery configuration. Non-exhaustive illustrative self-expanding materials include stainless steel, pseudo-elastic metals such as nickel titanium alloy or nitinol, various polymers, or so-called superalloys, which may have a base metal of nickel, cobalt, chromium, or other metals. Mechanical memory can be imparted to a wire or stent structure by heat treatment, for example, to achieve spring tempering in stainless steel or to set shape memory in sensitive metal alloys such as nitinol. Various polymers that can be made to have shape memory properties are also suitable for use in embodiments of the present invention, including polymers such as polynorbornene, trans-polyisoprene, styrene-butadiene, and polyurethane. Poly (LD) lactic acid copolymers, oligomeric caprolactone copolymers, and polycyclooctane may also be used alone or in combination with other shape memory polymers.

[0032] The following detailed description is merely illustrative in nature and is not intended to limit the invention or the applications and uses of the invention. Although the description of the embodiments of the present invention is in the context of a delivery system for delivering a heart valve prosthesis within a native aortic valve, the delivery system of the present invention can also be used in other areas of the body, such as for delivering a heart valve prosthesis within a native mitral valve, for delivering a heart valve prosthesis within a native pulmonary valve, for delivering a heart valve prosthesis within a native tricuspid valve, for delivering a venous valve, or for delivering a heart valve prosthesis within a previously implanted prosthesis. Furthermore, no one wishes to be bound by any expressed or implied theory presented in the foregoing technical field, background, summary of the invention, or the following detailed description.

[0033] Embodiments of the present invention relate to a delivery system for percutaneously delivering a heart valve prosthesis with improved positioning accuracy. The delivery system includes a nose cone having at least one cutout portion formed through a side wall of the nose cone. When the nose cone is in a delivery configuration, the cutout portion is substantially flush with the side wall of the nose cone. When the nose cone is in an expanded configuration, the cutout portion is spaced apart from the side wall of the nose cone and can be advanced to contact or push against a heart wall, for example, a ventricular wall such as the ventricular septum or an atrial wall such as the atrial septum, to accurately position or center the heart valve prosthesis within the native valve annulus.

[0034] The delivery system will be described in more detail with reference to the accompanying drawings. The delivery system 100 includes a heart valve prosthesis 101 and a delivery device 110 configured to deliver the heart valve prosthesis 101 percutaneously with improved positioning accuracy. More specifically, the delivery system 100 is Figure 1 、 Figure 1A 、 Figure 1C and Figure 2 Shown in. Figure 1 is a side view of delivery system 100 with optional outer sheath 112 surrounding heart valve prosthesis 101 ( Figure 1 (not shown). For self-expanding heart valve prostheses, the outer sheath may surround and constrain the prosthesis. For mechanically expandable or balloon expandable heart valve prostheses, the outer sheath (if present) may surround but not constrain the prosthesis. Delivery devices configured to deliver mechanically expandable or balloon expandable prostheses do not require an outer sheath. Figure 1 In the delivery configuration, the delivery system 100 is in a delivery configuration in which the heart valve prosthesis 101 ( Figure 1 100) is in a radially curled, compressed, or collapsed configuration within the outer sheath 112, and the split distal tip or nose cone 133 of the delivery system 100 is in a delivery configuration. Figure 1A For the Figure 1A A cross-sectional view taken along line AA. Figure 1C is a perspective view of the distal portion of the delivery system 100 in a delivery configuration, with the outer sheath 112 not shown. Figure 2 1 is a side view of the delivery system 100 after the outer sheath 112 has been retracted to allow the heart valve prosthesis 101 to be deployed, e.g., self-expanded, to a deployed or expanded configuration. For a balloon or mechanically expandable prosthesis 101, the prosthesis is mechanically or balloon-expanded to the deployed configuration. The delivery device 110 includes a handle 140 having a first actuator 142 for manipulating a push wire 150 (as will be explained in more detail herein) and an optional second actuator 144 for manipulating the optional outer sheath 112 (as will be explained in more detail herein). The handle 140 can have any shape or size suitable for convenient operation by the user.

[0035] In addition to an optional outer sheath 112 operatively coupled to the handle 140, the delivery device 110 further comprises a shaft for retaining the heart valve prosthesis 101. In some embodiments, the distal end portion of the prosthesis retaining shaft comprises a prosthesis retaining member that is releasably coupled to the heart valve prosthesis 101. In some embodiments, the distal end portion of the shaft comprises a balloon for expanding a balloon-expandable prosthesis. In some embodiments, the distal end of the prosthesis retaining shaft is attached to or coupled to a split distal tip or nose cone, as described herein. The outer sheath, if present, may define a cavity and be slidably and concentrically disposed over the prosthesis retaining shaft. In some embodiments, the split distal tip or nose cone is attached to or coupled to a second shaft and the prosthesis 101 is retained by or coupled to the first shaft, wherein the first shaft or intermediate shaft may define a cavity and be concentrically disposed over the second shaft or inner shaft.

[0036] In one embodiment, delivery device 110 includes an outer sheath 112 operatively coupled to handle 140, an intermediate shaft 122 disposed within outer sheath 112, and an inner shaft 132 disposed within intermediate shaft 122. Outer sheath 112, intermediate shaft 122, and inner shaft 132 each extend distally from within handle 140.

[0037] The outer sheath 112 has a proximal end (not shown) disposed within the handle 140 and a distal end 116. Figure 1A As best shown, the outer sheath 112 defines a lumen 118 and is slidably and concentrically disposed on the intermediate shaft 122. As used herein, "slidably" means in a longitudinal direction along or generally parallel to the central longitudinal axis L of the delivery system 100. A The distal portion of outer sheath 112 defines capsule 120. Capsule 120 is configured to maintain heart valve prosthesis 101 in a collapsed configuration for delivery to a desired treatment location. Although capsule 120 is described herein as a distal portion of outer sheath 112, capsule 120 may be a separate component coupled to the distal end of outer sheath 112. Furthermore, although outer sheath 112 is described herein as a single component, this is not meant to limit this design, and outer sheath 112 may include components such as, but not limited to, a proximal shaft or other components suitable for the purposes described herein.

[0038] Second actuator 144 of handle 140 is configured for retracting capsule 120. Second actuator 144 is coupled to outer sheath 112 and is generally configured to provide for selective proximal retraction and distal advancement of outer sheath 112, and in particular capsule 120 attached thereto, relative to heart valve prosthesis 101 held in a radially compressed delivery configuration within the capsule to cover and uncover heart valve prosthesis 101. Second actuator 144 may employ any configuration capable of providing the desired sheath actuation function, such as those described in U.S. Patent No. 8,579,963 to Tabor, assigned to the same assignee as the present disclosure, and incorporated herein by reference in its entirety.

[0039] The intermediate shaft 122 is slidably disposed between the outer sheath 112 and the inner shaft 132. The intermediate shaft 122 has a proximal end disposed within the handle 140 and a distal end 126 disposed within the outer sheath 112 when the outer sheath 112 is disposed over the heart valve prosthesis 101. The distal end 126 of the intermediate shaft 122 includes a prosthesis retaining member or spindle 108 that is releasably coupled to the end of the heart valve prosthesis 101. Figure 1C As best shown in a perspective view of FIG, with outer sheath 112 removed for illustrative purposes only, mandrel 108 is a tubular member having at least one recess 107A formed on its outer surface that is configured to receive a paddle 107B extending proximally from heart valve prosthesis 101. Paddle 107B fits within or mates with recess 107A of mandrel 108. Although Figure 1B Only one recess 107A is visible in the figure, but one of ordinary skill in the art will understand that mandrel 108 may include two or more recesses for receiving mating paddles of heart valve prosthesis 101, such as, for example, a first recess and a second recess at opposite locations on mandrel 108. Figure 1A As best shown, the intermediate shaft 122 defines a cavity 128 and is concentrically disposed on the inner shaft 132. Additionally, in embodiments, the intermediate shaft 122 terminates at the mandrel 108.

[0040] The inner shaft 132 has a proximal end (not shown) and a distal end 136 that terminates within the handle 140. Figure 1 and Figure 2 As shown, nose cone 133 is coupled to distal end 136 of inner shaft 132. Figure 1A Middle Edge Figure 1As best shown in the cross-sectional view of the delivery system 100 taken along line AA, the inner shaft 132 defines a lumen 138 and is concentrically disposed over the guidewire shaft 146. The guidewire shaft 146 defines a lumen 148 such that the delivery system 100 is slidably disposed over and along the guidewire 109. The push wire 150 is slidably disposed within the lumen 138 of the inner shaft 132. In other words, the push wire 150 is slidably disposed within the annular space defined between the inner surface of the inner shaft 132 and the outer surface of the guidewire shaft 146. In another embodiment of the present invention, the guidewire shaft 146 may be omitted, and the inner shaft may alternatively be constructed as a dual-lumen shaft, for example, formed by extrusion of a multi-lumen profile. More specifically, as Figure 1B Middle Edge Figure 1 As shown in a cross-sectional view of a delivery system according to another embodiment of the present invention taken along line AA, the inner shaft 132B defines a first lumen or C-shaped lumen 138B that is pre-formed in the wall of the inner shaft 132B and is configured to slidably receive a push wire 150 having a C-shaped cross-section. The inner shaft 132B further defines a second lumen or guidewire lumen 148B that is configured to slidably receive a guidewire 109. In another embodiment (not shown), the first lumen or C-shaped lumen 138B and the push wire 150 disposed therethrough can have different configurations or shapes, including oval or circular.

[0041] The proximal end of the push wire 150 (not shown) is operatively coupled to the first actuator 142 of the handle 140, and the distal end of the push wire 150 is attached to the cutout portion 135 of the nose cone 133. In an embodiment, the push wire 150 is formed of nitinol or stainless steel, and the distal end of the push wire 150 is attached to the cutout portion 135 of the nose cone 133 using welding, bonding, or adhesive. Figure 5-Figure 6 138 of the inner shaft 132. The nose cone 133 is configured to move the push wire 150 longitudinally within the lumen 138 of the inner shaft 132. The nose cone 133 is configured to move the push wire 150 longitudinally within the lumen 138 of the inner shaft 132. The nose cone 133 is configured to move the push wire 150 longitudinally within the lumen 138 of the inner shaft 132. The first actuator 142 is generally configured to provide for selective proximal retraction and distal advancement of the push wire 150, and in particular, the nose cone 133, to which the push wire is attached. The first actuator 142 may take any configuration capable of providing the desired push-wire actuation functionality, such as those described in US Pat. No. 10,278,852 to Griffin, assigned to the same assignee as the present disclosure, and incorporated herein by reference in its entirety.

[0042] The inner shaft 132 is configured to receive the heart valve prosthesis 101 on a distal portion thereof, and the outer sheath 112 is configured to compressively retain the heart valve prosthesis 101 on the distal portion of the inner shaft 132 during delivery, as shown. Figure 1 In other words, the outer sheath 112 surrounds the heart valve prosthesis 101 and constrains it in the radially compressed or delivery configuration. As previously described, the distal end 126 of the intermediate shaft 122 comprises the heart shaft 108 to which the heart valve prosthesis 101 is releasably coupled. Figure 2 shown in the view, but in Figure 1 107B is obscured from view by outer sheath 112. During in situ deployment of prosthetic heart valve 101, outer sheath 112 is proximally retracted relative to prosthetic heart valve 101, thereby gradually exposing prosthetic heart valve 101 until self-expanding prosthetic heart valve 101 is fully exposed and thereby released from delivery device 110. As outer sheath 112 is proximally retracted, intermediate shaft 122, inner shaft 132, and prosthetic heart valve 101 remain stationary. When outer sheath 112 is proximally retracted beyond mandrel 108, paddles 107B of prosthetic heart valve 101 are no longer retained within recesses 107A of mandrel, and prosthetic heart valve 101 is allowed to fully self-expand to its deployed configuration.

[0043] Figure 3 and Figure 4 A side perspective view and an end view, respectively, of a heart valve prosthesis 301 that can be used as the heart valve prosthesis 101 according to an embodiment of the present invention are illustrated. Heart valve prosthesis 301 is merely exemplary and is described in greater detail in U.S. Patent No. 7,914,569 to Nguyen et al., which is incorporated herein by reference in its entirety. It should be understood that any number of alternative heart valve prostheses can be used with the delivery devices and methods described herein. In addition, delivery device 110 can also be used with other self-expanding prostheses, such as stent-graft prostheses, uncovered stents, bare metal stents, drug-eluting stents, and any self-expanding structure configured to shorten during deployment.

[0044] Heart valve prosthesis 301 includes an expandable stent or frame 306 that supports a prosthetic valve component 308 within the interior of frame 306. In an embodiment thereof, frame 306 is self-expanding to return from a compressed or contracted delivery state to an expanded state. Figure 3 and Figure 4In the embodiment depicted in FIG, the frame 306 has an expanded, longitudinally asymmetric hourglass configuration comprising a first end or portion 302 and a relatively enlarged second end or portion 304. Each portion of the frame 306 can be designed to have a variety of different configurations and sizes to meet the different requirements of the location where the frame may be implanted. When configured as an aortic valve replacement, for example as described in more detail herein, Figure 15-17 As shown, first end 302 serves as the inflow end of heart valve prosthesis 301 and extends into and is anchored in the aortic annulus of the patient's left ventricle, while enlarged second end 304 serves as the outflow end of heart valve prosthesis 301 and is positioned in the patient's ascending aorta. When configured as a mitral valve replacement, enlarged second end 304 serves as the inflow end of heart valve prosthesis 301 and is positioned in the patient's left atrium, while first end 302 serves as the outflow end of heart valve prosthesis 301 and extends into and is anchored in the mitral annulus of the patient's left ventricle. For example, U.S. Patent Application Publication No. 2012 / 0301572 to Kovalsky et al. and U.S. Patent Application Publication No. 2012 / 0035722 to Tuval describe heart valve prostheses configured for placement in the mitral valve, each of which is incorporated herein by reference in its entirety. Each portion of the frame 306 may have the same or different cross-sections, which may be, for example, circular, ellipsoidal, rectangular, hexagonal, rectangular, square, or other polygonal shapes, although it is presently believed that a circular or ellipsoidal shape may be preferred when providing a heart valve prosthesis to replace the aortic valve or mitral valve. Figure 3 and 4 As an alternative to the deployed asymmetric hourglass configuration, the frame 306 can have a symmetrical hourglass configuration, a generally tubular configuration, or other stent configurations or shapes known in the art for valve replacement.

[0045] As previously described, heart valve prosthesis 301 includes a prosthetic valve component 308 within a frame 306. Artificial valve component 308 is capable of blocking flow in one direction to regulate flow therethrough via valve leaflets, which may form a bicuspid or tricuspid replacement valve. Figure 4 yes Figure 3, and illustrates an exemplary tricuspid valve having three leaflets, although a mitral valve leaflet configuration may alternatively be used in embodiments of the present invention. More specifically, if the heart valve prosthesis 301 is configured to be placed within a native valve having three leaflets, such as the aortic valve, tricuspid valve, or pulmonary valve, the heart valve prosthesis 301 may include three leaflet leaflets. If the heart valve prosthesis 301 is configured to be placed within a native valve having two leaflets, such as the mitral valve, the heart valve prosthesis 301 may include two leaflets. However, this is not meant to be limiting, and if the heart valve prosthesis 301 is configured to be placed within a native valve having three leaflets or two leaflets, the heart valve prosthesis 301 may include a prosthetic valve component 308 having two leaflets, three leaflets, four leaflets, or any number of leaflets deemed appropriate for the particular situation. As is known to those of ordinary skill in the art of prosthetic tissue valve construction, the valve leaflets are sutured or otherwise securely and sealingly attached to the frame 306 and / or the inner surface of the graft material 307 surrounding or lining the frame 306. The leaflets are attached to the graft material 307 along their bases, for example, using sutures or a suitable biocompatible adhesive. Adjacent pairs of leaflets are attached to each other at their lateral ends to form commissures. The orientation of the leaflets within the frame 306 will vary depending on which end of the heart valve prosthesis 301 is the inflow end and which end of the heart tube valve prosthesis 301 is the outflow end, thereby ensuring unidirectional blood flow through the heart valve prosthesis 301.

[0046] The leaflets may be made of pericardial material; however, the leaflets may alternatively be made of another material. Natural tissue for replacement valve leaflets may be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue such as pericardial patches, bypass grafts, blood vessels, intestinal submucosa, umbilical tissue, and the like from humans or animals. Synthetic materials suitable for use as leaflets include those commercially available from Invista North America SARL of Wilmington, DE. Polyester, other cloth materials, nylon blends, polymeric materials, and vacuum deposited nitinol manufacturing materials. One polymeric material from which the leaflets can be made is an ultra-high molecular weight polyethylene material commercially available from Royal DSM of the Netherlands under the trade name DYNEEMA. For certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the leaflet material be durable and not subject to stretching, deformation, or fatigue.

[0047] The graft material 307 can also be a natural or biological material, such as pericardium or another membranous tissue, such as the intestinal submucosa. Alternatively, the graft material 307 can be a low-porosity woven fabric, such as polyester, Dacron, or PTFE, which forms a one-way fluid channel when attached to the stent. In one embodiment, the graft material 307 can be a knitted or woven polyester, such as a polyester or PTFE knit, which can be used when it is necessary to provide a medium for tissue ingrowth and to allow the fabric to stretch to conform to a curved surface. Alternatively, a polyester velvet fabric can be used, such as when it is necessary to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. For example, these and other suitable cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz., USA.

[0048] Now go to Figure 5-Figure 6 , the nose cone 133 of the delivery system 100 will now be described in greater detail. Nose cone 133 is a split distal tip including a cutout portion 135 formed through the sidewall of the nose cone, such that the cutout portion 135 of the nose cone 133 can be advanced distally from the remainder of the nose cone 133 to contact and push against anatomical structures, thereby deflecting and radially centering the heart valve prosthesis 101 disposed within the capsule 120 within the native heart valve. Push wire 150 is configured to be longitudinally translated via first actuator 142 of handle 140 to alternate the nose cone 133 between a delivery configuration and a deployed configuration. Figure 5 is a perspective view of the nose cone 133 in the delivery configuration, and Figure 6 is a perspective view of the nose cone 133 in the deployed configuration. The cutout portion 135 is a detachable, integral portion of the sidewall of the nose cone 133 that can be formed by drilling, stamping, puncturing, or otherwise penetrating the sidewall of the nose cone 133 through the thickness of the sidewall or into the interior of the nose cone. After the cutout portion 135 is formed, the nose cone 133 includes an opening or hole 137 formed in the sidewall of the nose cone that is configured to receive the cutout portion 135. The outer edge or perimeter of the cutout portion 135 mates with or corresponds to the inner edge of the opening 137. In an embodiment, the cutout portion 135 has the same thickness as the remaining sidewall of the nose cone 133 and is formed from the same material as the remaining sidewall of the nose cone. When the nose cone 133 is in the delivery configuration, the cutout portion 135 is positioned or received within the opening 137, and the outer surface of the cutout portion 135 is substantially flush with the outer surface of the sidewall of the nose cone 133. As used herein, "substantially flush" means that the nose cone 133 has an atraumatic or smooth profile that will not snag on anatomical structures when the delivery system 100 is maneuvered in situ within the vasculature.

[0049] It is not required that the cutout portion 135 have the same thickness and be formed of the same material as the remaining sidewalls of the nose cone. In another embodiment, the cutout portion 135 may be formed of the same material as the remaining sidewalls of the nose cone 133, but may be thicker or thinner than the remaining sidewalls of the nose cone 133. Furthermore, in another embodiment, the cutout portion 135 may be formed of a different material having the same or a different thickness as the remaining sidewalls of the nose cone 133. However, if formed of different materials, the materials of the nose cone 133 and the cutout portion 135 should not be so different that the nose cone and the cutout portion separate when the delivery device 110 advances along the guidewire 109. Regardless of the material and thickness of the cutout portion 135, the cutout portion 135 is configured to be positioned or received within the opening 137, wherein the outer surface of the cutout portion 135 is substantially flush with the outer surface of the sidewalls of the nose cone 133. In other words, in the delivery configuration, the cutout portion 135 is juxtaposed with the remaining sidewalls of the nose cone 133 such that the geometry of the assembly is smooth and atraumatic.

[0050] When the nose cone is in the expanded configuration, the cutout portion 135 is no longer positioned within the opening 137, but is instead spaced apart from the opening 137 and the sidewalls of the nose cone 133. More specifically, when the nose cone 133 is in the expanded configuration, the cutout portion 135 is configured to contact an anatomical structure of the heart. In an embodiment, the natural heart valve is the aortic valve, and the cutout portion 135 of the nose cone 133 is configured to contact a wall of the heart, such as the ventricular septum. The ventricular septum is a solid wall that separates the left and right ventricles of the heart from one another. The cutout portion 135 of the nose cone 133 is configured to contact and push against the ventricular septum while avoiding interfering with the chordae tendineae in the left ventricle that connect to the mitral valve.

[0051] like Figure 5 As best shown in FIG, the push wire 150 includes a pre-formed bend 151 along its length adjacent its distal end. Due to the pre-formed bend 151 of the push wire 150, the cutout portion 135 of the nose cone 133 is directed radially outward as the push wire 150 is advanced distally in the longitudinal direction. More specifically, the pre-formed bend 151 of the push wire 150 ensures that the cutout portion 135 is perpendicular to the central longitudinal axis L of the delivery system 100 as the push wire 150 is advanced distally in the distal direction. AMovement. This vertical movement causes an opposite, reactive movement of the remainder of the nose cone 133 when the cutout portion 135 is opposed to the ventricular septum. Thus, when the cutout portion 135 contacts the ventricular septum in the expanded configuration, the cutout portion 135 of the nose cone 133 can be used to radially center the delivery system 100 within the native heart valve. More specifically, during delivery, the delivery system 100 can abut the outer edge of the aortic arch, and thus the capsule 120 and the heart valve prosthesis 101 therein can be radially offset within the native valve annulus. When the cutout portion 135 contacts the ventricular septum in the expanded configuration, the delivery system 100, with the heart valve prosthesis 101 mounted thereon, deflects and repositions relative to the native valve annulus. The cutout portion 135 of the nose cone 133 contacts and pushes against the ventricular septum to center the capsule 120 and the heart valve prosthesis 101 therein within the plane of the native valve annulus. Utilizing the nose cone 133 as a centering mechanism is particularly advantageous because the nose cone 133 is remote from the capsule 120 and is a fixed point that does not move axially or linearly during valve deployment or recapture. Thus, the cutout portion 135 of the nose cone 133 can remain deployed throughout the valve deployment process without moving or changing position in situ. After valve deployment is complete, the cutout portion 135 of the nose cone 133 can be retracted into a delivery configuration in which the outer surface of the cutout portion 135 is substantially flush with the outer surfaces of the sidewalls of the nose cone 133. The cutout portion 135 substantially fits back into the opening 137 so that the nose cone 133 has an atraumatic profile during removal that will not snag on anatomical structures when the delivery system 100 is removed.

[0052] Push wire 150 is configured to transmit a lateral force of between 2 N and 3 N to cutout portion 135 of nose cone 133 to deflect capsule 120 having heart valve prosthesis 101 disposed therein, thereby repositioning and aligning heart valve prosthesis 101 relative to the native valve annulus. In other words, the force transmitted by push wire 150 is configured to deflect the entire distal portion of delivery device 110, including capsule 120 having heart valve prosthesis 101 disposed therein, to reposition heart valve prosthesis 101 prior to deployment. In an embodiment, push wire 150 is a ribbon element having a C-shaped cross-section that provides push wire 150 with sufficient pushability to transmit the necessary lateral force to deflect and reposition heart valve prosthesis 101 relative to the native valve annulus. In another embodiment, push wire 150 may have an alternative cross-section, such as a circular or oval shape, if such a configuration transmits the desired lateral force to deflect and reposition heart valve prosthesis 101 relative to the native valve annulus. Furthermore, the surface area of ​​cutout portion 135 of nose cone 133 is configured to transmit the desired lateral force to deflect capsule 120 having heart valve prosthesis 101 disposed therein while minimizing trauma to the anatomy. Thus, in an embodiment, cutout portion 135 of nose cone 133 is at least 20% of the sidewall of nose cone 133, such that cutout portion 135 has a surface area sufficient to transmit the desired lateral force to deflect and reposition heart valve prosthesis 101 relative to the native valve annulus. In another embodiment, cutout portion 135 of nose cone 133 is between 20% and 45% of the sidewall of nose cone 133.

[0053] When positioned in situ, the nose cone 133 and the contours of the native anatomy are visible to the physician under fluoroscopy, and the physician can twist or rotate the delivery system 100 to properly orient the cutout portion 135 of the nose cone 133 so that the cutout portion 135 is deployed toward the ventricular septum. Additionally, in another embodiment, the nose cone may include multiple cutout portions integrally formed on the nose cone to provide the physician with multiple options for deployment, thereby ensuring that one of the multiple cutout portions of the nose cone is deployed toward the ventricular septum. In other words, the physician can deploy the cutout portion that is positioned or oriented toward the ventricular septum (i.e., oriented to contact the ventricular septum when deployed) without the physician having to twist or rotate the nose cone 133. More specifically, Figure 7 is a perspective view of a nose cone 733 of a delivery system according to another embodiment of the present invention, and Figure 7A It is along Figure 7 The nose cone 733 includes two cutout portions 735A, 735B that are circumferentially spaced apart around the outer surface of the nose cone 733. In an embodiment, the two cutout portions 735A, 735B are opposed such that they are formed on opposite sides of the nose cone 733.

[0054] Similar to cutout portion 135, each of cutout portions 735A, 735B is a separable, integral portion of the sidewall of nose cone 733 that can be formed by drilling, punching, puncturing, or otherwise penetrating the sidewall of nose cone 733 through the thickness of the sidewall or into the interior of the nose cone. Each of cutout portions 735A, 735B is formed through the sidewall of nose cone 733. Figure 7 The nose cone 733 is illustrated in its delivery configuration in which the outer surface of each cutout portion 735A, 735B is substantially flush with the outer surface of the side wall of the nose cone 733, but one of ordinary skill in the art will understand that each of the cutout portions 735A, 735B of the nose cone 733 can be advanced distally from the remainder of the nose cone 733 into an expanded configuration so as to contact and push against the native anatomy to center the delivery system.

[0055] Each of the cutout portions 735A, 735B is attached to a corresponding push wire 750A, 750B, respectively. The proximal end (not shown) of push wire 750A is operatively coupled to a dedicated actuator (not shown) of a handle (not shown), and the distal end of push wire 750A is attached to cutout portion 735A of nose cone 733. The proximal end of push wire 750A is accessible via the handle for pulling or pushing, which results in controlled longitudinal movement of cutout portion 735A of nose cone 733. Similarly, the proximal end (not shown) of push wire 750B is operatively coupled to a dedicated actuator (not shown) of the handle (not shown), and the distal end of push wire 750B is attached to cutout portion 735B of nose cone 733. The proximal end of push wire 750B is accessible via the handle for pulling or pushing, which results in controlled longitudinal movement of cutout portion 735B of nose cone 733. Similar to push wire 150, push wire 750A includes a preformed bend 751A along its length adjacent its distal end that guides the cutout portion 735A of nose cone 733 radially outward as push wire 750A is advanced distally in the longitudinal direction. Similarly, push wire 750B includes a preformed bend 751B along its length adjacent its distal end that guides the cutout portion 735B of nose cone 733 radially outward as push wire 750B is advanced distally in the longitudinal direction. The preformed bends 751A, 751A turn or bend in opposite directions.

[0056] A nose cone 733 is attached to the distal end of the inner shaft 732. Figure 7AAs best shown in the cross-sectional view of , the inner shaft 732 defines a lumen 738 and is concentrically disposed above the guidewire shaft 146 defining the guidewire lumen 148. Each of the push wires 750A, 750B has a C-shaped cross-section and is slidably disposed within the lumen 738 of the inner shaft 732. In other words, each of the push wires 750A, 750B is slidably disposed within an annular space defined between the inner surface of the inner shaft 732 and the outer surface of the guidewire shaft 146. In another embodiment of the present invention, the guidewire shaft 146 may be omitted and the inner shaft may alternatively be constructed as a three-lumen shaft, for example, formed by extrusion of a multi-lumen profile. More specifically, as Figure 7B Middle Edge Figure 7 As shown in the cross-sectional view of the delivery system of another embodiment of the present invention taken along line AA, inner shaft 732B limits a first lumen or C-shaped lumen 738A, which is preformed in the wall of the inner shaft and is configured to slideably receive a push wire 750A with a C-shaped cross section. Inner shaft 732B also limits a second lumen or C-shaped lumen 738B, which is preformed in the wall of the inner shaft and is configured to slideably receive a push wire 750B with a C-shaped cross section. Finally, inner shaft 732B also limits a third lumen or guidewire lumen 748 configured to slideably receive a guidewire 109 (not shown). In another embodiment (not shown), the first lumen 738A and the second lumen 738B and the push wires 750A, 750B provided through the two lumens can have different configurations or shapes, including elliptical or circular.

[0057] Despite Figure 7 The embodiment of is depicted as having two integral parts, but the nose cone may have a greater number of cutout parts. For example, Figure 8 is an end view of a nose cone 833 of a delivery system according to another embodiment of the present invention, wherein the nose cone 833 includes three cutout portions 835A, 835B, 835C circumferentially spaced around the outer surface of the nose cone 833. In another example, Figure 9 is an end view of a nose cone 933 of a delivery system according to another embodiment of the present invention, wherein the nose cone includes four cutout portions 935A, 935B, 935C, 935D spaced circumferentially around the outer surface of the nose cone 933. In order to accommodate a dedicated push wire for each of the cutout portions 935A, 935B, 935C, 935D, as shown in FIG. Figure 10 The inner shaft 932 shown is configured as a multi-lumen shaft, for example, by extrusion of a multi-lumen profile. Figure 10is a cross-sectional view of the inner shaft 932. More specifically, the inner shaft 932 defines a first lumen 938A, which is preformed in the wall of the inner shaft and configured to slidably receive a push wire 950A having a substantially circular or circular cross-section and attached to the cutout portion 935A; a second lumen 938B, which is preformed in the wall of the inner shaft and configured to slidably receive a push wire 950B having a substantially circular or circular cross-section and attached to the cutout portion 935B; a third lumen 938C, which is preformed in the wall of the inner shaft and configured to slidably receive a push wire 950C having a substantially circular or circular cross-section and attached to the cutout portion 935C; and a fourth lumen 938D, which is preformed in the wall of the inner shaft and configured to slidably receive a push wire 950D having a substantially circular or circular cross-section and attached to the cutout portion 935D. Finally, the inner shaft 932 further defines a fifth lumen or guidewire lumen 948 configured to slidingly receive the guidewire 109. While these lumens are depicted as circular or near-circular to accommodate correspondingly circular or near-circular push wires, these lumens may be oval, rectangular, or semicircular to accommodate push wires of other cross-sections.

[0058] A method of delivering and deploying a heart valve prosthesis 301 using a delivery device 110 is described. Figures 11-17 As described in Figure 11 As shown, a delivery system 100 comprising a delivery device 110 and a heart valve prosthesis 301 disposed therein is advanced transluminally in a retrograde manner through the vasculature to a treatment site, in this example a target diseased native aortic valve AV extending between the patient's left ventricle LV and the patient's aorta A, in accordance with techniques known in the art of interventional cardiology and / or interventional radiology. Delivery of the delivery system 100 to the native aortic valve AV is achieved via a percutaneous, retrograde transfemoral approach, wherein the delivery system is advanced through the femoral artery, up the aorta, and around the aortic arch to reach the native aortic valve AV. The delivery system 100 can also be positioned in a desired region of the heart via various delivery methods known in the art for accessing heart valves, such as a retrograde approach, an antegrade approach, a direct or transaortic approach, a subclavian approach, a transfemoral venous or arterial approach, a transapical approach, a transatrial approach, or a transseptal approach. As shown, the delivery system 100 is advanced along a guidewire 109 that has been previously inserted into the patient's vasculature. During delivery, because the heart valve prosthesis 301 is self-expanding, the heart valve prosthesis 301 remains compressed within the capsule 120 of the outer sheath 112 as the delivery system 100 is manipulated and navigated through the vasculature. The delivery system 100 is advanced until its distal tip 133 is at the distal end of the native aortic valve AV and positioned within the left ventricle LV, as shown in FIG. Figure 1113. As shown, the nose cone 133 is positioned such that the first end 302 of the heart valve prosthesis 301 (the first end being the inflow end and proximal end of the heart valve prosthesis 301 when the heart valve prosthesis 301 is configured to be placed in the native aortic valve) is positioned at the annulus of the native aortic heart valve. During advancement to the treatment site, the nose cone 133 is in a delivery configuration in which the cutout portion 135 of the nose cone is substantially flush with the sidewalls of the nose cone 133.

[0059] If necessary, before deploying the cutout portion 135, the physician may twist or rotate the delivery system 100 to orient the cutout portion 135 toward the desired heart wall (eg, the ventricular septum). Figure 12 The cutout portion 135 of the nose cone 133 is shown during deployment. The push wire 150 is longitudinally translated via the first actuator 142 of the handle 140 to distally advance the cutout portion 135 of the nose cone 133 to a deployed configuration in which the cutout portion 135 is spaced apart from the sidewalls of the nose cone 133. Figure 12 The nose cone 133 is shown as having a single cutout portion 135, but it should be understood that the nose cone may be cutout if it includes multiple cutout portions, such as but not limited to Figure 7 、 Figure 8 or Figure 9 In one of the embodiments depicted in , the physician will select or choose to deploy one or more incision portions that are positioned or oriented to contact and push against one or more walls of the heart, such as one or more walls of a ventricle including the ventricular septum, when deployed.

[0060] like Figure 13 As shown, the cutout portion 135 of the nose cone 133 is further advanced or moved distally via the push wire 150 into contact with the anatomy of the native heart valve, such that the cutout portion 135 contacts and pushes against the anatomy of the native heart valve to radially center the distal portion of the delivery system 110 (including the capsule 120 having the heart valve prosthesis 301 disposed therein) within the native heart valve. In this embodiment, the native heart valve is the aortic valve, and the cutout portion 135 of the nose cone 133 contacts and pushes against the ventricular septum. The push wire 150 is configured to transmit a lateral force of between 2N and 3N to the cutout portion 135 of the nose cone 133 to deflect and reposition the heart valve prosthesis 301 relative to the native valve annulus. More specifically, when the cutout portion 135 contacts the ventricular septum in the expanded configuration, the delivery system 100 having the heart valve prosthesis 301 mounted thereon deflects and repositions relative to the native valve annulus. The cutout portion 135 of the nose cone 133 contacts and pushes against the ventricular septum to deflect the capsule 120 and the heart valve prosthesis 301 therein so as to radially center the heart valve prosthesis within the native heart valve.

[0061] After the capsule 120 and the heart valve prosthesis 301 are centered within the native valve annulus, the heart valve prosthesis 301 is deployed at the annulus of the native aortic heart valve AV, as shown in FIG. Figure 14 As shown, Figure 14 is a cross-sectional view of a native aortic heart valve AV.During deployment of the heart valve prosthesis 301, the outer sheath 112 (and the capsule 120 forming the distal portion of the outer sheath 112) are retracted proximally. Figure 14 The heart valve prosthesis 301 is shown transitioning from a delivery or radially compressed configuration to a deployed or radially expanded configuration. Notably, nose cone 133 remains in the deployed configuration as heart valve prosthesis 301 is deployed. Nose cone 133 is at the distal end of capsule 120 and is a fixed point that does not move axially or linearly during valve deployment or recapture. Therefore, cutout portion 135 of nose cone 133 can remain deployed throughout the valve deployment process.

[0062] During this deployment phase, the positioning of delivery system 100 may still be adjusted and / or outer sheath 112 and capsule 120 may be advanced distally to recapture heart valve prosthesis 301. For example, in an embodiment, outer sheath 112 and capsule 120 may be advanced distally to recapture heart valve prosthesis 301 until a predetermined length of heart valve prosthesis 301 is exposed, e.g., until approximately two-thirds of the length of heart valve prosthesis 301 is exposed. If, after retraction of outer sheath 112 and capsule 120 has been initiated, it is determined that the rotational position of heart valve prosthesis 301 is not optimal, the user may recapture heart valve prosthesis 301, retract cutout portion 135 of nose cone, and reposition delivery system 100 by pushing, pulling, and / or twisting delivery device 110. Once positioned as desired, cutout portion 135 may be redeployed, and deployment of heart valve prosthesis 301 may be attempted again.

[0063] When outer sheath 112 is retracted so that the entirety of heart valve prosthesis 301 is uncovered, heart valve prosthesis 301 is released from the prosthesis retaining member of delivery system 100 , such as by being released from spindle 108 on distal end 126 of intermediate shaft 122 . Figure 15 Heart valve prosthesis 301 is illustrated in a fully deployed or radially expanded configuration at a target treatment site, with nose cone 133 still in the deployed configuration.

[0064] After valve deployment is complete, the cutout portion 135 of the nose cone 133 is repositioned or retracted to a delivery configuration in which the outer surface of the cutout portion 135 is substantially flush with the outer surface of the sidewall of the nose cone 133, as shown in FIG. Figure 16As shown. By longitudinally retracting the push wire 150, the nose cone 133 is repositioned back to the delivery configuration. The cutout portion 135 generally fits back into the opening 137 so that the nose cone 133 has an atraumatic profile during removal that will not snag on anatomical structures when the delivery system 100 is removed. Figure 17 As shown, after deployment of the heart valve prosthesis 301 is complete and the nose cone 133 returns to its delivery configuration, the delivery device 110 is then removed and the heart valve prosthesis 301 remains deployed within the native target heart valve.

[0065] The foregoing description has been presented for the purpose of illustration and implementation, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. In light of the foregoing teachings, other modifications and variations are possible. In order to best explain the principles of the invention and its practical application, embodiments and examples have been selected and described, and the embodiments and examples thus enable other persons skilled in the art to best utilize the invention in various embodiments and various modifications suitable for the specific purposes envisioned. The appended claims are intended to be interpreted as including other alternative embodiments of the present invention.

Claims

1. A delivery system for percutaneously delivering a heart valve prosthesis to a native heart valve, the delivery system comprising: a handle having at least one actuator thereon; an inner shaft having a distal portion configured to receive the heart valve prosthesis thereon, the inner shaft defining at least one lumen therethrough and including a nose cone attached to a distal end of the inner shaft, wherein the nose cone includes at least one cutout portion formed through a sidewall of the nose cone; and at least one push wire slidably disposed through the at least one lumen of the inner shaft, wherein a proximal end of the at least one push wire is operatively coupled to the at least one actuator of the handle and a distal end of the at least one push wire is attached to the at least one cutout portion of the nose cone; wherein the at least one cutout portion is substantially flush with the sidewall of the nose cone when the nose cone is in the delivery configuration, and wherein the at least one cutout portion is spaced apart from the sidewall of the nose cone when the nose cone is in the deployed configuration.

2. The delivery system of claim 1 , wherein the at least one push wire comprises a pre-formed bend adjacent the distal end of the at least one push wire and is configured to translate longitudinally to alternate the nose cone between the delivery configuration and the deployed configuration.

3. The delivery system of claim 1 , further comprising an outer sheath configured to cover the heart valve prosthesis during delivery, wherein the inner shaft is disposed within the outer sheath and the outer sheath is retractable relative to the inner shaft.

4. The delivery system of claim 3, further comprising an intermediate shaft slidingly disposed between the outer sheath and the inner shaft, wherein a distal end of the intermediate shaft is configured to be releasably attached to the heart valve prosthesis.

5. The delivery system of claim 3, wherein the heart valve prosthesis is self-expanding and the distal portion of the outer sheath comprises a capsule configured to compressively hold the heart valve prosthesis during delivery.

6. A delivery system according to claim 3, wherein the outer sheath includes a proximal end operatively connected to the handle and is configured to cover a distal portion of the heart valve prosthesis during delivery, and wherein the handle includes a first actuator and a second actuator, the first actuator being configured to longitudinally move the at least one push wire and the second actuator being configured to proximally retract the outer sheath.

7. The delivery system of claim 1, wherein the at least one lumen of the inner shaft comprises a first lumen and a second lumen, the at least one push wire being slidably disposed through the first lumen, and the second lumen being configured to slidably receive a guide wire.

8. The delivery system of claim 1 , wherein the at least one cutout portion of the nose cone is configured to contact and push against the anatomy of the native heart valve and radially center the delivery system within the native heart valve.

9. The delivery system of claim 8, wherein the native heart valve is an aortic valve and the at least one cutout portion of the nose cone is configured to contact the ventricular septum.

10. The delivery system of claim 9, wherein the at least one push wire is configured to impart a lateral force of between 2N and 3N to radially center the delivery system within the native heart valve.

11. The delivery system of claim 1 , wherein the at least one cutout portion of the nose cone is at least 20% of the sidewall of the nose cone.

12. The delivery system of claim 1 , wherein the at least one cutout portion comprises a plurality of cutout portions, the plurality of cutout portions being circumferentially spaced around the outer surface of the nose cone, and wherein the at least one push wire comprises a plurality of push wires, wherein push wires in the plurality of push wires are attached to corresponding cutout portions in the plurality of cutout portions.

13. The delivery system of claim 1 , wherein the at least one cutout portion is disposed within an opening formed in the side wall of the nose cone when the nose cone is in the delivery configuration, and wherein the at least one cutout portion is spaced apart from the opening formed in the side wall of the nose cone when the nose cone is in the deployed configuration.

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