POSITION

Background of the Invention

[001] The present disclosure relates to novel and advantageous systems and methods for transcatheter delivery of a replacement heart valve prosthesis, and more particularly how the replacement heart valve prosthesis may be loaded onto a catheter.

[002] The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.

[003] Transcatheter valve replacement (TVR) is a minimally invasive heart procedure to repair or replace a valve of the heart by using an implantable valve prosthesis delivered to the patient’s native valve via a catheter. The implantable valve prosthesis typically comprises an expandable frame with multiple flat prosthetic leaflets attached to the interior of the expandable frame. The prosthetic leaflets are intended to mimic the action of healthier native leaflets. The expandable frame may either be self-expanding using a shape memory alloy or may be expandable with a balloon or otherwise mechanically expandable when deployed into the native valve. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. TVR procedures typically involve the introduction of a catheter to the patient’s vasculature transfemorally, where the valve prosthesis is loaded into the catheter and advanced through the patient’s vasculature to the native valve.

[004] Because of the size of the vessels to be traversed by the catheter in advancing the valve prosthesis to the native valve in this minimally invasive procedure, it is desirable for the catheter to have a relatively small diameter. For balloon expandable devices, this can be particularly challenging because the valve prosthesis needs to be positioned on a balloon with a lumen in fluid communication with a gas or fluid source, thus creating a relatively bulky, large diameter delivery device as opposed to self-expanding devices. Transitions from the balloon catheter to the valve frame and from the valve frame to the steerable catheter must be atraumatic to prevent damage to vasculature after passing through an introducer. Radial misalignment can also cause potential for the valve frame to skive, or get caught upon, the native valve leaflets. It is therefore desirable to have a reduced delivery profile with smooth transitions between these complex components for the delivery of a prosthetic valve, particularly for balloon expandable valves.

[005] One typical way that has been used to reduce the delivery profile of a balloon expandable valve has been to load the valve and crimp it down either directly onto the balloon or proximally to the balloon prior to introducing the catheter into the patient’s vasculature. Where the valve is loaded proximally to the balloon, a pusher device is typically used to facilitate moving the valve distally over the balloon into a deployable state by pushing it over the valve. This can sometimes lead to stacking issues and misalignment. It would be desirable to have a smoother transition mechanism from the loaded state to the deployable state for the valve while maintaining a reduced profile.

Brief Summary of the Invention

[006] The following presents a simplified summary of one or more embodiments of the present disclosure in order to provide a basic understanding of such embodiments. This summary is not an extensive overview of all contemplated embodiments, and is intended to neither identify key or critical elements of all embodiments, to limit any embodiments supported by the disclosure or otherwise, nor to delineate the scope of any or all embodiments.

[007] The present disclosure relates to novel and advantageous systems and methods for loading a valve onto a catheter and deploying the loaded valve. As described generally herein, the embodiments describe herein comprise a valve with a balloon expandable frame. The valve’s frame is retained onto the catheter when crimped, which allows the balloon to remove through the lumen of a crimped valve to allow longitudinal alignment onto the working section of the balloon. Once the desired alignment between the valve and the balloon is achieved, in some embodiments, the valve may be released from the catheter. In other embodiments, like those having the puffed portion of the balloon, one or more of expansion of the balloon or retraction of the outer sheath releases the valve from the catheter. Generally speaking, in any event, once the balloon is fully exposed and able to inflate, the valve can be deployed by inflating the balloon. [008] A replacement heart valve for repair of a native valve using a catheter, the replacement heart valve comprises a balloon expandable frame having a distal end and a proximal end. The expandable frame has at least two commissural posts arranged radially around the expandable frame; a plurality of interconnected struts between the distal end and the proximal end, the interconnected struts connected by nodes, wherein at least one node at the proximal end of the balloon expandable frame has a frame retention feature for engagement with a retention sheath of a catheter; and a valve construct mounted to the frame and attached at least at the commissural posts. The valve construct may be a single piece construction that has at least two leaflets. The valve construct may have three leaflets. The frame retention features may be a hole, a slot, or a pin. In at least one embodiment, the pin extends axially from the node in a proximal direction. In at least one embodiment, the pin has a hammerhead configuration. In at least one embodiment, the pin extends radially inward from the node. In at least one embodiment, the pin extends radially outward from the node.

[009] A delivery system for transcatheter repair of a native valve, the delivery system comprises a handle with at least one actuator; an outer sheath having an outer diameter and an inner diameter; a retention sheath having an inner diameter and an outer diameter less than the inner diameter of the outer sheath, the retention sheath having a proximal end and a distal end; a delivery shaft having a distal end and an outer diameter less than the inner diameter of the outer sheath; a distal tip attached to the distal end of the delivery shaft; and a balloon attached to the delivery shaft, the balloon having a proximal section extending distally from a proximal end of the balloon, a distal section extending proximally from a distal end of the balloon, and a working section between the proximal section and the distal section. A replacement heart valve positioned distally from the balloon between the distal tip and the distal end of the balloon, the replacement heart valve having a proximal end and a distal end and a frame extending from the proximal end to the distal end, the replacement heart valve having a frame retention feature at the proximal end that is removably engaged with the distal end of the retention sheath. The replacement heart valve is engaged with the distal end of the retention sheath in a loaded state such that when the retention sheath moves axially in a proximal direction away from the distal tip, the replacement heart valve is moved over the working section of the balloon into a deployable state. In the loaded state, the distal end of the replacement heart valve abuts the distal tip. The balloon may be a pleated balloon. The replacement heart valve comprises a valve construct attached to the frame. The valve construct may be a single-piece valve construct. The single-piece valve construct may comprise at least two leaflets. The valve construct may comprise a single piece of biomaterial, which may be a polymer, bovine tissue (such as bovine pericardium), or porcine tissue (such as porcine pericardium).

[010] In some embodiments, a delivery system for transcatheter repair of a native valve comprises a handle; an outer sheath having an outer diameter and an inner diameter; a delivery shaft having a distal end and an outer diameter less than the inner diameter of the outer sheath; a distal tip attached to the distal end of the delivery shaft; a balloon attached to the delivery shaft, the balloon having a proximal end and a distal end, the balloon having a puffed portion at the distal end of the balloon, the puffed portion being inflatable from a first diameter to a second diameter in a loaded configuration, and from a second diameter to a third diameter in a deployment configuration, the puffed portion having a proximal end and a distal end; and a replacement heart valve positioned between the puffed portion and the proximal end of the balloon, the replacement heart valve having a proximal end and a distal end and a frame extending from the proximal end to the distal end. In the loaded configuration, the distal end of the replacement heart valve abuts a proximal end of the puffed portion to maintain position of the valve relative to the balloon. In at least one embodiment, a proximal end of the frame is captured by the outer sheath, where the outer sheath may be a steerable catheter.

[Oil] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the various embodiments of the present disclosure are capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[012] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter that is regarded as forming the various embodiments of the present disclosure, it is believed that the disclosure will be better understood from the following description taken in conjunction with the accompanying Figures, in which: [013] FIG. 1 is a side view of the delivery system, according to one embodiment, with the valve crimped relative to the delivery shaft in a position distal from the balloon and proximal from the nose cone, the valve engaged with the retention shaft.

[014] FIG. 2 is a side view of the delivery system shown in FIG. 1 with the crimped valve pulled over the balloon.

[015] FIG. 3 is a side view of the delivery system shown in FIG. 1 with the retention shaft disengaged from the crimped valve.

[016] FIG. 4 is a side view of the delivery system shown in FIG. 1 with the retention shaft being withdrawn.

[017] FIG. 5 is a side view of the delivery system shown in FIG. 1 with the valve in the loaded configuration on the balloon.

[018] FIG. 6 is a side view of the delivery system shown in FIG. 1 with the balloon expanded to expand the balloon expandable frame of the valve such that the valve is in an expanded state.

[019] FIG. 7 is a plan view of the delivery system shown in FIG. 1 with the balloon expanded to expand the balloon expandable frame of the valve such that the valve is in an expanded state.

[020] FIG. 8 shows a cross-sectional view of a delivery system, according to another embodiment of the disclosure.

[021] FIG. 9 shows a cross-sectional view of the handle of the delivery system of FIG. 8. [022] FIG. 10 shows a schematic view of the catheter assembly of the delivery system of FIG. 8 in a loaded configuration.

[023] FIG. 11 shows a side view of the delivery system of FIG. 8 with the valve prosthesis loaded onto the catheter assembly shown in FIG. 10 in the loaded configuration.

[024] FIG. 12 shows a side view of the delivery system of FIG. 8 and FIG. 11 in the deployed configuration, with the balloon of the expanded and ready for withdrawal from the valve prosthesis.

Detailed Description

[025] The present disclosure describes novel and advantageous systems and methods for positioning a valve, in particular a balloon expandable valve, onto a catheter for delivery and maintaining its position relative to the catheter during deployment into the patient’s native heart valve to repair or replace the patient’s heart valve. Although the disclosure below is discussed with respect to balloon expandable valves, the embodiments and features described below may also be applicable to positioning, and maintaining position, of a self- expanding valve during deployment.

[026] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of some embodiments. However, it will be understood by persons of ordinary skill in the art that some embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, and/or components have not been described in detail so as not to obscure the discussion.

[027] In at least some embodiments of the present disclosure, a valve construct may be mounted to an expandable frame of the transcatheter valve prosthesis on an external surface of the frame, rather than the typical interior surface of the frame. In such embodiments, in the expanded state of the valve prosthesis, the valve construct may have a diameter that is larger than the diameter of the frame.

[028] FIGS. 1-6 each show one embodiment of a delivery system 100 during delivery of a balloon expandable valve 102 to a patient’s native heart valve, or in some embodiments as part of a valve-in-valve repair procedure. The delivery system 100 comprises a valve 102 and a catheter assembly 103. The balloon expandable valve 102 comprises a valve construct 104 attached to a balloon expandable frame 106. The valve construct 104 may comprise a biomaterial, ^' . The biomaterial may comprise one or more of a tissue material(such as but not limited to bovine pericardium or porcine pericardium), artificial tissue, polymers, plastics, silk, fibrous materials, fabrics, or other woven materials. In some embodiments, the tissue material may be a cross-linked collagen-based biomaterial that comprises acellular or cellular tissue selected from the group consisting of cardiovascular tissue, heart tissue, heart valve, aortic roots, aortic wall, aortic leaflets, pericardial tissue, connective tissue, dura mater, dermal tissue, vascular tissue, cartilage, pericardium, ligament, tendon, blood vessels, umbilical tissue, bone tissue, fasciae, and submucosal tissue and skin. In at least one embodiment, the valve construct 104 may be a single- piece valve construct comprising multiple leaflets and formed from a single sheet of material as described in co-pending and commonly owned application U.S. Application No. 16/129,235 entitled “Replacement Heart Valve with Reduced Suturing,” incorporated herein by reference in its entirety. In at least one embodiment, the valve construct 104 may be treated with an anti-calcification treatment. In some embodiments, the valve construct may be formed using a mold, may be die cut, or may be constructed using additive manufacturing, including but not limited to melt electrowriting or similar methods.

[029] The balloon expandable frame 106 has a proximal end 108 and a distal end 110. The balloon expandable frame 106 may have a plurality of interconnected struts 112, each strut 112 joined to an adjacent strut at a node 113. In some embodiments, the balloon expandable frame 106 may comprise one or more commissural posts 114. The valve construct 104 may be attached to the commissural posts 114, in at leasat one embodiment. [030] In some embodiments, the proximal end 108 of the balloon expandable frame 106 may have one or more retention features 116. The retention features 116 may be configured to engage with features on the delivery system 100. In at least one embodiment, the retention features 116 may be on one or more of the commissural posts 114. In other embodiments, at least one retention feature 116 may be a hole, slot, or other opening at a node 113 of the device other than the commissural posts. In still other embodiments, at least one retention feature 116 may be formed by a retaining pin which could extending proximally from a node 113, radially inward from a node 113, or radially outward from a node 113. It is within the scope of this disclosure that one or more nodes 113 of the balloon expandable frame 106 may have one or more retention features 116 each comprising a hole, slot, opening, pin, or other protrusion.

[031] The delivery system 100 has a distal end 122 and a proximal end, shown generally at 124. The delivery system 100 comprises a guidewire 128, a distal tip 130, an outer sheath 132 or steerable catheter, a retention sheath 134 with frame retention features 136 that may be engaged to the retention features on the valve, a delivery shaft 138, and a balloon 140 mounted onto the delivery shaft 138. A handle 150, shown in FIG. 7, may be operably connected to the retention sheath 134 in one embodiment. In some embodiments, the handle 150 may also be operably connected to at least one of the outer sheath 132 and the delivery shaft 138. The delivery system 100, according to the embodiment shown in FIGS. 1-7, allows the balloon expandable valve 102 to traverse the vasculature in a crimped state, to be loaded onto the balloon 140 such that the valve 102 is then in a deployable state, to then expand the balloon 140 from the deployable state into an expanded state, and finally to leave the valve 102 in a functioning, expanded state by withdrawing the delivery system 100 from the vasculature. In at least one embodiment, the valve can be loaded onto the balloon after the valve has crossed the patient’s arch. In some embodiments, the valve can be loaded onto the balloon in the descending aorta. In still further embodiments, the valve can be loaded onto the balloon within the valve annulus of the patient’s existing valve. By loading the valve at any time after the valve has crossed the patient’s arch, this allows the valve to be maneuvered through the patient’s vasculature with a low profile.

[032] The guidewire 128 extends distally from the distal tip 130 to guide delivery of the catheter to the deployment location through the patient’s vasculature. The distal tip 130 or nosecone has a distal end 162 and a proximal end 164 with a nosecone profile shown generally at 165 that extends between the distal end 162 and the proximal end 164. The nosecone profile 165 has a distal portion 166, a transition portion 167, a middle portion 168, and a proximal portion 169, as shown at least in FIG. 2. The distal portion 166 has a smaller diameter than the middle portion 168 and the proximal portion 169. The transition portion 167 has an increasing diameter from the distal portion 166 to the middle portion 168. The middle portion 168 has a larger diameter than the distal portion 166 and the proximal portion 169. The proximal portion 169 has a diameter that is less than the diameter of the middle portion 168 but greater than the diameter of the distal portion 166. The middle portion 168 steps down to the proximal portion 169 at relief 170.

[033] The outer sheath 132 may be a retractable sheath that has a diameter greater than the retention sheath.

[034] In some embodiments, the balloon 140 may be a pleated balloon, which may further reduce the diameter profile of the delivery catheter system.

[035] In some embodiments, a handle 150 (shown in FIG. 7) is provided. The handle 150 controls at least the inflation of the balloon 140, the advancement of the distal tip 122 to the deployment site, and the retraction of the outer sheath 132 and the retention sheath 134 to load and deploy the valve 102. The handle 150 may be in mechanical communication with at least the outer sheath 132 and the retention sheath 134. The handle may also be in fluid communication with the balloon 140 to control its inflation and therefore the expansion and deployment of the balloon 140. The handle 150 may comprise one or more actuators 152. The handle 150 may have a proximal end 156 and a distal end 158. In one embodiment, the actuator 152 near the proximal end 156 may control position of the delivery shaft 138 relative to the outer sheath 132 and an actuator 152 near the distal end 154 may control deflection of the outer sheath 132. In other embodiments, an actuator 152 may control rotation of the delivery shaft 138. In still other embodiments, one or more of the actuators may have a locking mechanism. In still further embodiments, a locking mechanism may be engaged or disengaged with a switch or other mechanism independent of any one of the actuators 152.

[036] As shown in the embodiment displayed in FIG. 1-6, the valve 102 may initially be crimped onto at least the proximal portion 169 of the distal tip 130. In such embodiments, the distal end of the valve 102 abuts the relief 170 of the distal tip 130 and a portion of the inner surface of the valve 102 abuts the distal tip.

[037] In some embodiments, the valve prosthesis 102 may be loaded onto the balloon prior to the delivery system entering the access point, and in other embodiments the valve may be loaded onto the balloon during delivery. In one method of loading the valve 102 onto the balloon 140 during delivery, the valve 102may be pulled proximally over the balloon 140 by retracting the retention sheath 134 in a proximal direction, the retention sheath 134 remaining engaged with the valve 102. To retract the retention sheath 134 in the proximal direction, in one embodiment where the retention sheath 134 is rotatably connected to the handle 150, an actuator of the handle 150 can be rotated in a first direction to move the retention sheath 134 proximally, like a worm screw, until the valve is loaded onto the balloon over the working section of the balloon. In some embodiments, the handle

150 may be in axial communication with the retention sheath, whereby moving an actuator on the handle in an axial direction from a first position to a second position, the retention sheath moves proximally from the distal tip and thereby moves the valve from a first crimped position proximally over the balloon to a known second deployable position such that the valve is loaded onto the balloon over the working section of the balloon. In further embodiments, the delivery shaft 138 is rotatably connected to the handle 150, an actuator of the handle 150 can be rotated in a first direction to move the delivery shaft 138 distally until the proximal end of the balloon passes through the valve lumen to load the valve onto the balloon over the working section of the balloon. In still other embodiments, the handle

150 may be in axial communication with the delivery shaft 138, whereby moving an actuator on the handle in an axial direction from a first position to a second position, the delivery shaft moves distally and thereby moves the balloon within the valve lumen to load the valve onto the balloon over the working section of the balloon.

[038] Once the valve 102 is in position on the working section of the balloon in any embodiment, the retention features of the valve 102 can be released from the retention sheath 134 and the retention sheath can be withdrawn. FIG. 4 shows the valve 102 in the loaded configuration with the retention sheath withdrawn. The balloon 140 can then be expanded, such as shown in FIG. 5, to deploy the valve 102 at the delivery site.

[039] In some embodiments the balloon expandable valve 102 can be deployed supra- annularly as described in co-pending and commonly owned application PCT/US21/40592 entitled “Expandable Frame for Improved Hemodynamic Performance of Transcatheter Replacement Heart Valve” which is incorporated by reference in its entirety herein.

[040] In some embodiments, the catheter assembly may further comprise an actuator ring attached to the distal end of the retention sheath 134 to engage with the retention features on the valve. In another embodiment, rather than a retention sheath as described in other embodiments herein, the catheter assembly may comprise a retention assembly that comprises a first retention cuff, a second retention cuff and a plurality of linkage members extending between the first retention cuff and the second retention cuff.

[041] In another embodiment, the catheter assembly may comprise one or more retention wires. Each retention wire is connected at a first end to the retention features on the valve and at a second end to a retention actuator on the handle. The retention actuator can apply tension to the retention wire in order to pull the crimped valve over the working section of the balloon. In at least one embodiment, the retention actuator or a separate cutter mechanism on the handle may be used to disengage the retention wire from the handle. In some embodiments, the retention wire may be a bioabsorbable material. In other embodiments, expansion of the balloon may disengage the retention wire from the handle or the valve.

[042] In one or more embodiments, as shown generally in FIGS. 1-7, the valve prosthesis 102 may be loaded onto the balloon 140 during the delivery of the valve prosthesis through the patient’s vasculature. By delivering the valve prosthesis 102, the delivery system 100 may have a reduced delivery profile because the stacking of balloon, valve, and various sheaths is not all in the same position during delivery. From an alternative viewpoint, the valve prosthesis 102 is not overlapping the working section of the balloon during the entire delivery method. [043] FIGS. 8-12 show another embodiment of systems and methods for positioning, and maintaining position of, a valve on a delivery system 800 having valve prosthesis 802 and catheter assembly 803. In at least one embodiment, the valve prosthesis 802 is loaded onto the catheter assembly 803 prior to traversing the arch. In at least one embodiment, the valve prosthesis 802 is loaded onto the catheter assembly 803 prior to entry of the delivery system 800 through the access site on the patient. FIG. 8 shows another embodiment of a catheter assembly 803 having a distal end 804 and a proximal end 805. The catheter assembly 803 comprises a nosecone 806, a balloon 810, an inner shaft 812, an outer shaft 814, a handle 818, and a fluid port 820 in communication with the balloon 810 for expanding and deflating the balloon using fluids or gases. The nosecone 806 has a distal end 822 and a proximal end 824. In some embodiments, the nosecone 806 is solid and in other embodiments, the nosecone 806 may be expandable or inflatable. The nosecone 806 may comprise, in some embodiments, a polymer, rubber, plastic, elastomer, or other material. The proximal end 824 of the nosecone 806 may be connected to a distal end 825 of the inner shaft 812. The inner shaft 812 may have one or more marker bands or radiopaque markers between the nose cone 806 and the handle 818 as described further below. The balloon 810 has a distal end 826 and a proximal end 828, where the distal end 826 in at least one embodiment abuts the proximal end 824 of the nosecone 806. The outer shaft 814 may be a steerable shaft, a retractable shaft, or an intermediate shaft. The outer shaft 814 has a greater diameter than the inner shaft 812. The outer shaft 814 may have a distal end 832 and a proximal end 834. In some embodiments, the outer shaft 814 may have a flare 836 at the distal end 832, where the flare 836 has a diameter greater than a nominal diameter of the outer shaft. The flare 836, in some embodiments, may cover or restrain the proximal end of the valve prosthesis 802 in the loaded configuration to keep the valve prosthesis in a desired radial and axial position during delivery of the valve prosthesis to the deployment site (the patient’s native valve or failing replacement valve). [044] As shown in FIG. 8 and FIGS. 10-11, the balloon 810 may, in some embodiments, comprise a puffed portion 840 extending from the distal end 826 towards a working portion 842 of the balloon 810 between the distal end 826 and the proximal end 828. In some embodiments, the balloon 810 may further comprise a distal transition portion 841 extending proximally from the distal end 826 towards the puffed portion 840. In some embodiments, the balloon 810 may further comprise one or more proximal transition portions 843, 845 extending from the working portion 842 towards the proximal end 828. FIGS. 10-11 show the balloon 810 in a loaded configuration both without the valve prosthesis 802 and with the valve prosthesis 802, respectively. As best shown in FIG. 10, the puffed portion 840 has a larger diameter in the loaded configuration than the working portion 842. The puffed portion 840 may, in the loaded configuration, be inflated with water, saline, air, or some other fluid or gas. As shown in FIG. 12, in the deployed configuration, the puffed portion 840 has a smaller diameter than the working portion 842 when the balloon is expanded to the deployed configuration. The puffed portion 840 maintains the location of the crimped valve prosthesis 802 on the balloon 810, preventing the valve prosthesis 802 from slipping distally over the nosecone 806 or away from the working portion 842. In some embodiments, the puffed portion 840 also may act a protective physical barrier between the sharp edges of the crimped frame of the valve prosthesis 802 and surrounding vasculature susceptible to damage during procedure. In some embodiments, balloon 810 may comprise a single balloon with the puffed portion 840 or may comprise at least two balloons with independent inflation channels engaged with one or more fluid ports. The two balloons may each have a proximal end and a distal end and be arranged such that the first balloon is distally from the second balloon. In some embodiments, the distal end of the second balloon may overlap at least a proximal portion of the first balloon. The first balloon may have a puffed portion, and may inflate or deflate independently of the second balloon. In some embodiments, the second balloon may have a puffed portion at a proximal end of the second balloon for retaining the proximal end of the valve prosthesis in a desired axial or radial position relative to the inner shaft.

[045] FIG. 8-9 show the handle 818 having a distal end 846 and a proximal end 848. The handle 818 may comprise a housing 850 and an actuator 852. In some embodiments, the actuator 852 may be near the distal end 846, and in other embodiments the actuator 852 may be located elsewhere along the housing 850. In some embodiments, the actuator 852 may be used to advance the inner shaft or the outer shaft, or to rotate the inner shaft for commissural alignment of the valve prosthesis as discussed in co-pending and co-owned application entitled “Systems and Methods for Predictable Commissural Alignment of a Replacement Heart Valve” filed on the same day as this application and incorporated herein by reference. In some embodiments, the handle 818 may further comprise a pull wire ring assembly 854 for deflecting comprising a pull wire 856 engaged with the outer shaft or the steerable shaft at one end and a ring 857 at the other end. In addition to the pull wire ring assembly 854, or in an alternative to the pull wire ring assembly 854, the handle 818 may comprise rack and pinion gear assembly 858 for deflection of the outer shaft or the steerable shaft. In some embodiments, the handle 818 may further comprise a lock 870 comprising a locking collet 872 and a lock switch 874.

[046] FIGS. 10-12 show the delivery system 800 in the loaded configuration and the deployed configuration. More specifically, FIG. 10 shows the catheter assembly in the loaded configuration and FIG. 11 shows the delivery system 800 with the valve prosthesis 802 loaded onto the balloon 810 of the catheter assembly 803. FIG. 11 shows the valve prosthesis 802 with frame 880 and valve construct 882 attached to the frame 880. The valve prosthesis 802 has a proximal end 884 and a distal end 886. The distal end 886 abuts the puffed portion 840 of the balloon in the loaded configuration as shown in FIG. 11. As shown in FIG. 12, in the deployed configuration, the balloon 810 is expanded and thereby expands the valve prosthesis 802 to the deployed configuration. The balloon 810 can then be deflated leaving the expanded valve prosthesis 802 in the deployed configuration, and the catheter assembly 803 can be withdrawn from the lumen of the valve prosthesis 802 and thereafter from the patient’s body, leaving the valve prosthesis 802 in the deployed configuration at the deployment site.

[047] In some embodiments, the delivery system may comprise a pusher on the steerable catheter or outer shaft to retain the position of the valve prosthesis relative to the catheter when crimped. The pusher may, in some embodiments, secure the crimped valve onto the balloon during advancement through the vasculature, preventing the valve from slipping proximally during the procedure. In still other embodiments, to retain the valve with a desired delivery profile, retaining members may be used to maintain the proximal end of the crimped valve in a desired axial and/or radial position. Such retaining members may include, but are not limited to, a knob, nub, rod, or other protrusion extending radially from the inner shaft that may, in some embodiments, be retractable upon deployment of the valve. In other embodiments, such retaining members may comprise one or more fingers, grabbers, or gripping members that releasably engage with the proximal end of the valve prosthesis to maintain the proximal end of the crimped valve in a desired axial and/or radial position. In some embodiments, a releasable retention wire may be used to keep the valve in position. In still other embodiments, a combination of retaining features on the outer shaft that releasably engage with mating features on the inner shaft, such as a pin and slot or a hole and peg, may maintain the proximal end of the crimped valve in a desired axial and/or radial position.

[048] In one embodiment, the valve prosthesis 802 is in a loaded configuration or crimped configuration proximal to the puffed section of the balloon. The proximal end of the valve prosthesis 802 is held within the flared portion of the steerable catheter. More specifically, in one embodiment, the proximal outflow crowns of the frame at proximal end 894 are held within the flared portion of the steerable catheter. At this stage, the physician likely has one hand on the steerable catheter or outer sheath to control the access site and inserts the delivery system through the sheath by advancing it over the guidewire, holding onto the shaft at the steerable catheter. The delivery system may be advanced by the practitioner from the access site to the top of the descending thoracic aorta, in an aortic valve repair procedure. The delivery system may then be advanced around the aortic arch, again in an aortic valve repair procedure. Articulation of the steerable catheter, using one or more actuators on the handle may be used to deflect or steer the delivery system through the vasculature atraumatically. While advancing under fluoroscopic visualization, the practitioner may turn one or more of the actuators in a first or second direction to deflect or steer the delivery system through the vasculature. When the practitioner is ready, the steerable catheter may be pulled proximally to expose the remainder of the balloon and to release the proximal end (or the proximal outflow crowns) from the flared portion of the steerable catheter. In at least one embodiment, a proximal-most radiopaque marker band on the inner shaft 812 indicates to the practitioner how far in the proximal direction the steerable catheter should be pulled. If the practitioner desires to align the valve with the existing commissures (either native or in the failing replacement device previously delivered), the practitioner may do so according to one or more steps or embodiments as described in co-pending and co-owned application entitled “Systems and Methods for Predictable Commissural Alignment of a Replacement Heart Valve” filed on the same day as this application and incorporated herein by reference. The balloon is advanced until an annular marker band on the balloon is aligned with the native annulus. Small deflections of the catheter assembly may be applied as necessary by the practitioner to center the valve prosthesis within the native aortic valve or failing replacement valve. Once centered or in a position desired by the practitioner, and in some embodiments once aligned with the commissures, any further minor adjustments may be made by moving the catheter assembly proximally or distally relative to the guidewire. The balloon can then be expanded as shown in FIG. 5 or FIG. 12, pushing aside the native aortic leaflets and/or the failing replacement valve’s leaflets and engaging with the patient’s current annulus. The balloon may then be deflated, as shown best in FIG. 6, by releasing fluid, gas, or air pressure. The valve prosthesis begins to function.

[049] In another embodiment, the valve prosthesis 802 is in a loaded configuration or crimped configuration proximal to the puffed section of the balloon. The proximal end of the valve prosthesis 802 is held within the flared portion of the steerable catheter. More specifically, in one embodiment, the proximal outflow crowns at proximal end 894 are held within the flared portion of the steerable catheter. The handle may have a locking mechanism comprising, for example, a lock switch and collet. The practitioner advances the delivery system around the aortic arch, again in an aortic valve repair procedure (although the systems and methods described throughout this disclosure may be suitable for other valve repairs). Articulation of the steerable catheter, using one or more actuators on the handle may be used to deflect or steer the delivery system through the vasculature atraumatically. The delivery system is advanced until an annular marker band on the balloon or the balloon shaft is aligned with the patient’ s current annulus (whether its native aortic valve annulus of an annulus of the failing replacement valve in a valve-in-valve procedure). In some embodiments, as the practitioner advances the delivery system around the arch and to the annulus, the balloon shaft and the steerable catheter shaft are locked via the locking mechanism. Once at the annulus, the locking mechanism may be released or moved into an unlocked position, which permits the steerable catheter to be pulled proximally to expose the balloon and release the proximal end of the valve prosthesis (or, more particularly, the proximal outflow crowns of the valve) from the steerable catheter or outer sleeve. A proximal-most marker band on the balloon catheter indicates to a practitioner where to pull the steerable catheter. In some embodiments, when in the unlocked position, the practitioner may move the balloon catheter distally relative to the steerable catheter or handle by moving the proximal end of the balloon catheter from a position proximal to the handle. Once positioned relative to the annulus, the practitioner may activate the locking system again by switching the locking mechanism into a locked position or the locking mechanism may remain in an unlocked position. Again, in the locked position, axial movement of the balloon catheter is restricted. Small deflections of the catheter assembly may be applied as necessary by the practitioner to center the valve prosthesis within the native aortic valve or failing replacement valve. Once centered or in a position desired by the practitioner, and in some embodiments once aligned with the commissures, any further minor adjustments may, in some embodiments, be made by moving the catheter assembly proximally or distally relative to the guidewire. The balloon can then be expanded as shown in FIG. 5 or FIG. 12, pushing aside the native aortic leaflets and/or the failing replacement valve’s leaflets and engaging with the patient’s current annulus. High rate pacing can be initiated, in some embodiments, prior to expansion of the balloon. The balloon may then be deflated, as shown best in FIG. 6, by releasing fluid, gas, or air pressure. The valve prosthesis begins to function. In some embodiments, the locking mechanism can then be unlocked and the balloon catheter can be pulled proximally back into the steerable catheter, the locking mechanism can then be locked again to lock the balloon catheter in relative axial position to the steerable catheter, and the catheter assembly can be withdrawn. In at least one embodiment, the balloon catheter is pulled proximally back into the steerable catheter until the puffed portion of the balloon catheter contacts the distal end of the steerable catheter. In other embodiments, the balloon catheter may not be re-sheathed into the steerable catheter or outer sheath, and the balloon catheter and other sheaths or steerable catheters are removed separately.

[050] As used herein, the terms “substantially” or “generally” refer to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is “substantially” or “generally” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking, the nearness of completion will be so as to have generally the same overall result as if absolute and total completion were obtained. The use of “substantially” or “generally” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, an element, combination, embodiment, or composition that is “substantially free of’ or “generally free of’ an ingredient or element may still actually contain such item as long as there is generally no measurable effect thereof. [051] As used herein any reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

[052] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[053] In addition, use of the "a" or "an" are employed to describe elements and components of the embodiments herein. This is done merely for convenience and to give a general sense of the description. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise. [054] Still further, the figures depict preferred embodiments for purposes of illustration only. One skilled in the art will readily recognize from the discussion herein that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein.

[055] While particular embodiments and applications have been illustrated and described, it is to be understood that the disclosed embodiments are not limited to the precise construction and components disclosed herein. Various modifications, changes and variations, which will be apparent to those skilled in the art, may be made in the arrangement, operation and details of the method and apparatus disclosed herein without departing from the spirit and scope defined in the appended claims.

[056] While the systems and methods described herein have been described in reference to some exemplary embodiments, these embodiments are not limiting and are not necessarily exclusive of each other, and it is contemplated that particular features of various embodiments may be omitted or combined for use with features of other embodiments while remaining within the scope of the invention.