Systems and methods for predictable commissure alignment of replacement heart valves - Patents.com

Abstract

The replacement heart valve prosthesis is loaded onto a balloon mounted on a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on a handle of the catheter system. Rotating the actuator a first amount in a first direction can rotate the heart valve prosthesis a known amount during the procedure to predictably achieve alignment of the commissures of the replacement valve with the commissures of the existing valve.

Description

[Technical field]

[0001] The present disclosure relates to novel and advantageous systems and methods for assisting a practitioner in aligning the commissure posts of a prosthetic valve with the existing commissures of the patient's current valve (which may be a native valve or a previously replaced valve) during deployment. [Background technology]

[0002] The discussion of the background art provided herein is intended to provide a general context for the present disclosure, and the inventors' work, to the extent described in this background art section, is not admitted expressly or impliedly as prior art to the present disclosure, as are aspects of the description that would not have been admitted as prior art at the time of filing.

[0003] Transcatheter valve replacement (TVR) is a minimally invasive cardiac procedure for repairing or replacing the heart's valves by using an implantable prosthetic valve delivered via catheter to the patient's native valve. The implantable prosthetic valve is typically an expandable frame with valve leaflets attached inside the expandable frame. The prosthetic leaflets are intended to mimic the action of the healthier native valve leaflets. Transcatheter valve replacement prostheses have been developed for the aortic, mitral, and tricuspid valves. A TVR procedure typically involves the introduction of a transfemoral catheter into the patient's vasculature, and the prosthetic valve is loaded into the catheter and advanced through the patient's vasculature to the native valve.

[0004] Prior to the development of these minimally invasive transcatheter valve replacement procedures, the options for most patients needing heart valve repair were limited to highly invasive surgical replacement procedures. However, for many patients needing heart valve repair, surgical repair carried relatively high risks or the patient was not a good candidate for surgery. With regard to the aortic valve, the transcatheter aortic valve replacement (TAVR) procedure has been widely adopted by clinicians around the world as an alternative to surgical replacement procedures to treat these high-risk patients with severe aortic stenosis or similar conditions. With many procedures over the decades, TAVR has been shown to improve the long-term survival rate of these patients. In addition, in recent years, several studies involving both balloon-expandable and self-expandable TAVR prostheses have demonstrated that the TAVR procedure is effective for patients with low surgical risk, and in 2019, the U.S. Food and Drug Administration expanded the indications for TAVR to include these low-risk patients.

[0005] The development of TAVR prostheses and related prior art has focused heavily on mechanisms and methods for delivering the prosthesis to the native valve, including positioning or repositioning the prosthesis relative to the valve annulus. However, one of the challenges that practitioners often face during deployment is the ability to align the valve with the commissures of the existing valve to create a more natural function of the replacement valve that can return the patient to a pre-disease state. Aligning the commissures in a surgical repair procedure is much easier to achieve than in a minimally invasive transcatheter procedure, where the practitioner is very far from the actual deployment site to guide the valve through the patient's vasculature (typically transfemorally) and relies on images to position the valve. Even with the use of images, the ability to align the commissures can vary greatly depending on the practitioner's skill, the duration of the procedure, and any other complications, as well as the capabilities of the handle, which is the practitioner's only means of controlling the position of the replacement valve during the procedure. This may be an even more pronounced concern in valve-in-valve replacement processes where a second replacement valve is inserted into an existing damaged or weakened replacement valve, and it would be desirable to align the commissures of the second valve with the commissures of the first valve to improve outcomes. There is a need for a more predictable commissure alignment procedure that simplifies the process and improves practitioner control. Summary of the Invention

[0006] 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 not intended to identify key or critical elements of all embodiments or to delineate the scope of any or all embodiments.

[0007] The present disclosure relates to novel and advantageous systems and methods for transcatheter delivery and commissure alignment of a replacement valve during deployment of the replacement valve within a patient's native or existing valve.

[0008] In at least one embodiment, the transcatheter delivery system includes a catheter assembly including a balloon shaft on which a balloon is mounted. The balloon is in fluid communication with a fluid source for expanding the balloon from a delivery diameter to a deployed diameter. A prosthetic valve, which may include a valve component mounted on an expandable frame, is loaded onto the balloon in a loading configuration of the prosthetic valve. The prosthetic valve is expandable from the loading configuration to the deployed configuration by expanding the balloon from the delivery diameter to the deployed diameter. The catheter assembly further includes a handle having at least one actuator, the actuator rotatably engaged with the balloon shaft. In other words, rotation of the actuator rotates the balloon shaft. Rotating the actuator in at least a first direction by an actuator rotation amount rotates the prosthetic valve in the first direction by a valve rotation amount proportional to the actuator rotation amount. Thus, the prosthetic valve can be rotated predictably by the practitioner. In other embodiments, valve rotation can be achieved by rotation of a proximal end of the balloon shaft protruding from a proximal side of the handle, rather than via an actuator. In some embodiments, a locking mechanism may lock the balloon catheter in at least an axial position relative to the outer shaft or steerable catheter, such that when in the locked position, axial movement of the balloon catheter is prevented during commissure alignment or other desired rotation of the balloon catheter. In the unlocked position, axial movement of the balloon catheter relative to the outer shaft or steerable catheter is permitted. In some embodiments, a locking mechanism may lock the balloon catheter in at least an axial position relative to the handle.

[0009] In some embodiments, the balloon shaft is a braided shaft. In some embodiments, the balloon shaft has a polymeric coating, an elastomeric coating, or a combination thereof. In at least one embodiment, the balloon shaft is coated with a thermoplastic elastomer, such as a polyether block amide, known under the trade name Pebax®.

[0010] The ratio of the amount of actuator rotation to the amount of valve rotation may be any desired amount of known rotation. In at least one embodiment, the ratio of the amount of actuator rotation to the amount of valve rotation is a 1:1 ratio. In another embodiment, the ratio of the amount of actuator rotation to the amount of valve rotation is a 10:8 ratio. In some embodiments, the amount of valve rotation may be approximately 70-100% of the amount of actuator rotation relative to itself. In other words, the radial movement of the actuator causes 70-100% radial movement of the valve. In some embodiments, the amount of valve rotation may be approximately 50-100% of the amount of actuator rotation relative to itself. In other words, the radial movement of the actuator causes 50-100% radial movement of the valve.

[0011] The prosthetic valve comprises at least a valve component having one or more leaflets and an expandable frame. In some embodiments, the valve component may comprise one or more separate leaflets individually attached to the expandable frame. In some embodiments, the valve component of the prosthetic valve comprises a sutureless single-piece three-dimensional structure having multiple leaflets. In one embodiment, the sutureless single-piece three-dimensional structure may be made from a single sheet of acellular crosslinked biomaterial, but in other embodiments may be made from other suitable materials. In some embodiments, the expandable frame, which is composed of multiple interconnected struts connected to each other at nodes and may further include commissure posts, may have a radiopaque marker to aid in the placement of the prosthetic valve relative to the existing commissures. In some embodiments, the radiopaque marker may be located on one of the commissure posts. In other embodiments, the radiopaque marker may be located on at least one strut or at least one node of the expandable frame.

[0012] The actuator may be rotatable in a first direction, but also in a second direction opposite the first direction. In some embodiments, the handle may further include at least one actuator stop that may help control rotation to prevent over- and under-rotation of the prosthetic valve or to prevent rotation in one of the directions. In yet other embodiments, the handle may further include a locking member, where when the locking member is engaged with the actuator, the balloon shaft cannot rotate.

[0013] In some embodiments, a method of transcatheter delivery of a replacement valve is provided to provide commissure alignment with the commissures of a patient's existing valve using a catheter handle. The method, in at least one embodiment, includes loading the replacement valve onto a balloon attached to a balloon shaft, the balloon shaft rotatably engaged with an actuator of the catheter handle. The balloon shaft may be a braided shaft. The balloon shaft may also be coated with an elastomeric coating. The method further includes delivering the replacement valve to a delivery position, rotating the replacement valve a valve rotation amount to position the replacement valve in the alignment position by rotating the actuator an actuator rotation amount, the actuator rotation amount being proportional to the valve rotation amount, and deploying the replacement valve by expanding the balloon from a delivery diameter to a deployment diameter. In one embodiment, the ratio of the actuator rotation amount to the valve rotation amount is 1:1. In addition to or instead of rotating in a first direction, the actuator may be rotatable in a second direction opposite the first direction. In some embodiments, the method may further include locking the balloon shaft or inner shaft to prevent axial movement in a locked position while allowing rotation of the balloon shaft or inner shaft about the longitudinal axis. In an unlocked position, the balloon shaft or inner shaft may move axially proximally and distally and may rotate about the longitudinal axis. In other embodiments, the method may further include locking the actuator in a locked position to prevent further rotation of the replacement valve when the replacement valve is in the aligned position.

[0014] In some embodiments, the transcatheter delivery system includes a catheter assembly having an inner shaft, an outer shaft, and a lock having a locked position and an unlocked position. The prosthetic valve may be loaded onto the inner shaft. Rotating the inner shaft at least a first amount of shaft rotation causes the prosthetic valve to predictably rotate in the first direction a valve rotation amount proportional to the amount of shaft rotation. The lock has a locked position and an unlocked position, and in the locked position, axial movement of the inner shaft relative to the outer shaft is prevented. In some embodiments, in the locked position, the inner shaft can rotate in the first direction or in a second direction opposite the first direction. In the unlocked position, the inner shaft can move axially relative to the outer shaft and the inner shaft can rotate in at least the first direction. In some embodiments, the transcatheter delivery system further includes a handle having a lock switch that engages the lock to the locked position and disengages the lock from the locked position to the unlocked position. The inner shaft may be a braided shaft. The prosthetic valve may have at least one alignment marker. In one embodiment, the prosthetic valve has alignment markers for alignment therein. In such an embodiment, the alignment markers may be spaced 120 degrees apart, while in other embodiments, the alignment markers may be spaced equally apart. At least one alignment marker comprises two overlapping serpentine struts that may form a figure eight shape or a figure "8" shape or a "figure eight" shape that may have two openings. The handle may further comprise at least one actuator, and in some embodiments, may have at least one actuator stop that prevents the actuator from rotating or moving.

[0015] In some embodiments, a method is provided for transcatheter delivery of a replacement valve using a catheter handle to provide commissure alignment with the commissures of a patient's existing valve, the method including: loading the replacement valve onto the inner shaft, delivering the replacement valve to a delivery position by advancing the inner shaft within the outer shaft, where the inner shaft may be or is in a locked position relative to the outer shaft, with a lock engaged in the locked position, disengaging the lock from the locked position to an unlocked position to allow axial movement of the outer shaft relative to the inner shaft, moving the outer shaft proximally relative to the inner shaft, engaging the lock in the locked position to prevent axial movement of the inner shaft relative to the outer shaft, rotating the replacement valve a valve rotation amount by rotating the inner shaft a shaft rotation amount to position the replacement valve in the alignment position, where the shaft rotation amount is relative to the valve rotation amount, and deploying the replacement valve.

[0016] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following Detailed Description, which shows and describes exemplary embodiments of the present disclosure. As will be appreciated, the various embodiments of the present disclosure can be modified in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Thus, the drawings and Detailed Description should be considered as illustrative in nature and not restrictive. For the avoidance of doubt, one or more distinctive features on the frame, including those shown in the drawings and elsewhere, may be desirable for valve alignment as alignment markers, as may be further discussed below. [Brief description of the drawings]

[0017] While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming various embodiments of the disclosure, it is believed that the disclosure will be better understood from the following description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 shows a schematic diagram of a transcatheter delivery system in accordance with at least one embodiment of the present disclosure. [Diagram 2] 2 shows a cross-sectional view of the handle of the transcatheter delivery system shown in FIG. 1. [Figure 3A] 3B shows the prosthetic valve loaded onto the transcatheter delivery system shown in FIG. 1 rotated from a first position shown in FIG. 3A to a second position shown in FIG. 3B. [Figure 3B] 3B shows the prosthetic valve loaded onto the transcatheter delivery system shown in FIG. 1 rotated from a first position shown in FIG. 3A to a second position shown in FIG. 3B. [Figure 4A] 3A-3B is shown expanded to an expanded state for deployment, in accordance with at least one embodiment of the present disclosure. [Figure 4B] 4B shows the prosthetic valve of FIG. 4A in a deployed state with the balloon deflated and the delivery system ready to be withdrawn. [Diagram 5] FIG. 1 is a cross-sectional view of another embodiment of a catheter assembly of a transcatheter delivery system in accordance with at least one embodiment of the present disclosure. [Figure 6] FIG. 6 is a cross-sectional view of the handle shown in FIG. 5. [Figure 7] FIG. 1 is a schematic diagram of another embodiment of a transcatheter delivery system in which the prosthetic valve is a self-expanding valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present disclosure describes a novel and advantageous prosthetic valve having a frame for mounting a valve component, and a method for mounting the valve component to the frame. Although the embodiments and techniques described below may be discussed or illustrated with respect to aortic valve replacement, it is within the scope of the present disclosure that the disclosed invention may be suitable for use in other valve repair or replacement, such as mitral and tricuspid valves. Furthermore, although the figures and embodiments described below may describe an aortic valve that typically has three leaflets, it is within the scope of the present disclosure that the disclosed invention may be suitable for prostheses used with bicuspid aortic valves.

[0019] 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 those skilled 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 shown in detail in order not to obscure an understanding of this description.

[0020] 1-4B illustrate one embodiment of the presently disclosed transcatheter delivery system 100 for delivering a prosthetic valve 102 to a patient's native valve or an already-delivered replacement valve using a catheter assembly 103.

[0021] The prosthetic valve 102 may be a self-expanding prosthetic valve or a balloon-expandable prosthetic valve. The prosthetic valve 102 may be designed for either supranulus or intraannulus placement. The prosthetic valve 102 may comprise an expandable frame 104 and a valve component 106 attached to the expandable frame. In at least one embodiment, the expandable frame may comprise one or more features of an expandable frame as described in commonly owned, co-pending application PCT / US2021 / 040592 entitled "Expandable Frame for Improved Hemodynamic Performance of Transcatheter Replacement Heart Valve," which is incorporated herein by reference in its entirety, or commonly owned, co-pending application PCT / US2021 / 040596 entitled "Exteriorly Mounted Tissue on Expandable Frame for Improved Hemodynamic Performance," which is incorporated herein by reference in its entirety.

[0022] The valve component 106 may include a biomaterial. The biomaterial may include one or more of tissue materials, artificial tissues, 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 includes acellular or cellular tissue selected from the group consisting of cardiovascular tissue, heart tissue, heart valves, aortic root, aortic wall, aortic valve cusps, pericardial tissue, connective tissue, dura mater, skin tissue, vascular tissue, cartilage, pericardium, ligament, tendon, blood vessel, umbilical cord tissue, bone tissue, fascia, and submucosa and skin. In some embodiments, the tissue material is an implantable biomaterial, such as the biomaterials described in the disclosure of commonly owned U.S. Patent No. 9,205,172, entitled "Implantable Biomaterial and Method of Producing Same," filed December 21, 2005, which is incorporated herein by reference in its entirety. In some embodiments, the cross-linked collagen-based biomaterial is processed by the ADAPT® processing process. This process is an anti-calcification treatment process for biomaterials with over 10 years of clinical data demonstrating zero residual DNA and no detectable levels of calcification when used in cardiac surgery. In some embodiments, the tissue material may be an artificial tissue. In some embodiments, the artificial tissue may include a polymer molded or formed in a single piece. In some embodiments, the artificial tissue may include polytetrafluoroethylene, polyethylene terephthalate, other polymers, and other polymer coatings. In some embodiments, the valve component 106 is a single piece three-dimensional valve component constructed from a single piece of tissue material, such as the valve described in the disclosure of commonly owned and co-pending U.S. patent application Ser. No. 16 / 129,235, entitled "Replacement Heart Valve with Reduced Suturing," which is incorporated herein by reference in its entirety. In other embodiments, the valve component may comprise one or more separate leaflets or a monolithic structure.In some embodiments, the valve components may be formed using a mold, die cut, or constructed using additive manufacturing, including but not limited to fused electrowriting or similar methods.

[0023] As shown in FIGS. 1-4B, the prosthetic valve 102 is a balloon-expandable prosthetic valve, and the catheter assembly 103 may include a balloon 110, a balloon shaft 112, a nosecone 114, an outer sheath 116, and a handle 118 having at least one actuator 120 and at least one fluid port 122. The catheter assembly 103 has a distal end 124 and a proximal end 126. The nosecone 114 is generally at the distal end of the catheter assembly, and the handle 118 is located near the proximal end 126. For purposes of this disclosure, moving "proximally" means moving in a direction toward the proximal end 126, and moving "distally" means moving in a direction toward the distal end 124.

[0024] The balloon shaft 112 may extend proximally from the nosecone 114 to at least a handle 118. The balloon 110 is mounted on the balloon shaft 112, which is in fluid communication with the handle 118 to allow fluid or gas from a fluid port 122 to expand the balloon 110 during deployment of the prosthetic valve 102. Additionally, in some embodiments, the balloon shaft 112 may be rotatably engaged with at least one actuator 120. In other embodiments, the balloon shaft 112 may extend proximally from the handle 118 and be rotatable by rotating a portion of the balloon shaft 112 that extends proximally from the handle, rather than via an actuator. In at least one embodiment, the balloon shaft 112 is a braided shaft. In some embodiments, the balloon shaft 112 may be a diamond braided shaft. The balloon shaft 112 may be coated with a polymeric coating, an elastomeric coating, or a combination thereof. In at least one embodiment, the balloon shaft is coated with a thermoplastic elastomer, such as, but not limited to, a polyether block amide known under the trade name Pebax®. In some embodiments, the balloon shaft may be at least partially covered with a fabric, knit, or other material. In at least one embodiment, the balloon shaft may be at least partially covered with nylon. In some embodiments, the balloon shaft may have an overjacket comprising a polymer, elastomer, fabric, knit, or other material.

[0025] The outer sheath 116 may be a retractable sheath. In at least one embodiment, the outer sheath 116 may be a steerable outer sheath or a steerable outer catheter. In some embodiments, the outer sheath 116 may extend from the handle 118, over the balloon shaft 112, the balloon 110, and the prosthetic valve 102, and abut the proximal end of the nose cone 114 while the prosthetic valve 102 is delivered through the vasculature to the valve annulus for repair or replacement. The outer sheath 116 engages with at least one actuator 120 on the handle 118 to retract the outer sheath 116 to expose the prosthetic valve 102 and allow expansion of the prosthetic valve 102 at the delivery site. The outer sheath 116 may be slidably engaged with one actuator 120, and the sheath 11 may be moved proximally or distally by either rotation of the actuator 120 or by a sliding motion of the actuator 120. In a preferred embodiment, the actuator 120 used to advance and retract the retractable outer sheath 116 is not the same actuator used for commissure alignment. The balloon shaft 112 is a loose fit relative to the outer sheath (or intermediate catheter shaft in some embodiments), allowing for low friction between the balloon shaft 112 and the outer sheath (or intermediate catheter shaft) and helping to prevent or reduce the effects of balloon shaft 112 curling up.

[0026] As shown in FIG. 1, the prosthetic valve 102 is positioned in a loaded configuration relative to the catheter assembly 103. The prosthetic valve 102 may be loaded onto the balloon 104 in the loaded configuration prior to deployment, or may be loaded onto the balloon during the delivery procedure, for example, as described in a co-pending and commonly owned PCT application entitled "Systems and Methods for Positioning a Valve onto a Catheter During Deployment and Maintaining Such Position," filed on even date herewith, and incorporated herein by reference. In at least one embodiment, in the loaded configuration, the prosthetic valve 102 is positioned onto the working section of the balloon 104. In some embodiments, the working section of the balloon 104 is the area of ​​maximum expansion capability of the balloon. Once the prosthetic valve is loaded onto the balloon and positioned in a desired location within a patient's native or failing replacement valve in need of repair, the prosthetic valve 102 is ready to expand. In the loaded configuration, the prosthetic valve 102 can be rotated by rotation of the balloon shaft 112 for commissure alignment. In some embodiments, the prosthetic valve 102 can be loaded onto the balloon 104 with a known circumferential orientation relative to the handle 118.

[0027] FIG. 2 shows a cross-sectional view of one embodiment of a handle 118 having at least one actuator 120 rotatably engaged with the balloon shaft 112. In some embodiments, rotation of the actuator 120 may enable rotation of the balloon shaft 112, thereby enabling the prosthetic valve 102 to rotate about the longitudinal axis of the balloon shaft 112. The actuator 120 may be at or near the proximal end of the handle, in the middle of the handle, or at or near the distal end of the handle. The actuator 120 may be a rotating wheel, knob, or switch. If the actuator 120 is a switch, the switch may have two or more positions. In some embodiments where the actuator is a switch, the switch may have three positions, and in one embodiment, the switch is a rotary switch with three positions that may be spaced 120 degrees apart from one another. In some embodiments, the switch may have four or more positions. In some embodiments, the actuator 120 may only enable incremental, predetermined rotation. In some embodiments, the actuator 120 is only capable of rotating in one direction. In some embodiments, the actuator 120 can rotate in a first direction and a second direction. In some embodiments, the actuator 120 can have an actuator stop that prevents the actuator 120 from rotating completely so that the balloon shaft, and therefore the prosthetic valve, can only rotate a certain number of degrees. This limited sweep angle can be 60 degrees, 90 degrees, 120 degrees, or 180 degrees. In some embodiments, the rotation of the actuator 120 causes the balloon shaft 112 to rotate, and thus the prosthetic valve 102. Although this paragraph describes using an actuator to rotate the balloon shaft, the balloon shaft can also be rotated by hand by the practitioner. In other words, the balloon shaft can be rotatable relative to the outer shaft or steerable catheter, or rotatable relative to the inner lumen of the handle.More specifically, a balloon shaft may extend proximally from the proximal end of the handle, and this portion of the balloon shaft may be rotatable to rotate the prosthetic valve 102.

[0028] In some embodiments, the handle may further comprise one or more deflection actuators that rotatably engage pull wires in the steerable catheter shaft to deflect the catheter during delivery of the valve to a patient's native valve or a failing replacement valve in need of repair.

[0029] In some embodiments, as shown in FIG. 2, the handle 118 may further comprise at least one actuator lock 130 configured to prevent rotation of the actuator 120 (and thus rotation of the balloon shaft 112) in some embodiments, or at least one actuator lock 130 configured to prevent axial movement of the balloon shaft 112 relative to the steerable catheter 116 during delivery. In other words, the handle 118 may comprise a rotational lock and / or an axial lock. In some preferred embodiments, actuator lock engagement of at least one of the locks 130 may, in some embodiments, prevent axial movement of the steerable catheter relative to the balloon catheter. Disengagement of at least one of the locks 130 may, in some embodiments, allow the steerable catheter to be withdrawn proximally relative to the balloon catheter and prosthetic valve. In some embodiments where a lock prevents axial movement, rotation of the balloon catheter and prosthetic valve may still be possible regardless of whether such an axial lock is engaged or disengaged. FIG. 2 shows one embodiment of a lock 130 comprising a lock switch 132 and a collet 134 to allow or prevent at least one of axial movement of the balloon catheter relative to the steerable catheter or handle or rotation of the balloon catheter of the delivery device. In some other embodiments, the lock may comprise one or more of a physical snap, screw, hard stop, pull or push locking mechanism contained within the handle. In some embodiments, the lock may include mating components on both the handle and the balloon catheter. In such embodiments, the lock may comprise a handle locking component and a balloon catheter locking component. The handle locking component may interact with the balloon catheter locking component via a mechanical stop, seal, O-ring, bladder, collet, or similar mechanism for locking and unlocking rotation.Thus, when the handle locking component engages the balloon catheter locking component, axial movement of the balloon catheter can be allowed or prevented.

[0030] In some embodiments having at least one rotation lock, the rotation lock can be engaged to prevent rotational movement of the balloon shaft and disengaged to allow rotational movement of the balloon shaft. Once the practitioner is confident that commissure alignment has been achieved, the rotation lock can be re-engaged to prevent further rotation during delivery. In at least one embodiment, the rotation lock must be engaged prior to inflation of the balloon.

[0031] In some embodiments, the lock may comprise a physical snap, screw, hard stop, pull or push locking mechanism contained within the catheter handle. In some embodiments, the lock may comprise interactive components on both the handle and the balloon catheter. The catheter lock may interact with the balloon catheter via a mechanical stop, seal, O-ring, bladder, collet, or similar mechanism for locking and unlocking rotation. In some embodiments, the actuator locking mechanism may comprise a physical snap, screw, hard stop, pull or push locking mechanism contained within the catheter handle. In some embodiments, the actuator locking mechanism may comprise interactive components on both the handle and the balloon catheter. The catheter handle locking mechanism may interact with the balloon catheter via a mechanical stop, seal, O-ring, bladder, collet, or similar mechanism for locking and unlocking rotation.

[0032] In some embodiments, the handle may further comprise one or more deflection actuators that rotatably engage pull wires in the steerable catheter shaft to deflect the catheter during delivery of the valve to a patient's native valve or a failing replacement valve in need of repair.

[0033] In some embodiments, the rotation of the valve is controlled by the catheter handle. In one embodiment, the handle interacts with the balloon catheter to translate rotation and achieve valve alignment. This interaction can introduce motion via a button, switch, rotary dial, rotary wheel, or any other means that translates manual adjustment to valve rotation. In some embodiments, the balloon catheter and handle can engage and disengage with one another to achieve valve rotation. The engagement between the components can include physical snap, screw, hard stop, pull or push locking mechanisms contained within the catheter handle. The catheter handle locking mechanism can interact with the balloon catheter via mechanical stops, seals, O-rings, bladders, collets, or similar mechanisms to lock and unlock rotation.

[0034] Rotating the commissure alignment actuator 120 in a first direction an actuator rotation amount causes the prosthetic valve to predictably rotate in the first direction an amount of valve rotation proportional to or related to the amount of actuator rotation. The ratio of the actuator rotation amount to the amount of valve rotation may be any desired amount of known rotation. In at least one embodiment, the ratio of the actuator rotation amount to the amount of valve rotation is a 1:1 ratio. In another embodiment, the ratio of the actuator rotation amount to the amount of valve rotation is a 10:8 ratio. In some embodiments, the valve rotation amount may be approximately 70-100% of the actuator rotation amount relative to the amount of valve rotation. In other words, radial movement of the actuator causes 70-100% radial movement of the valve. In one embodiment, the valve rotation is introduced by rotation of a handle spin wheel, knob, or switch. In one embodiment, the valve rotation is introduced by rotating a balloon catheter via the proximal end. Figures 3A-3B show this rotation according to one embodiment.

[0035] As shown in Figures 3A-3B, the frame 104 of the prosthetic valve has at least one alignment marker 150. In some embodiments, the alignment marker may be disposed on a commissure post of the frame. As shown in Figures 3A-3B, the alignment marker 150 comprises two overlapping serpentine struts 153, 154 that may form an "8" shape with two openings. In some embodiments, the alignment marker 150 may further comprise a radiopaque marker that may be disposed within the holes or openings of the alignment marker or around the struts or commissure posts 155 of the frame. In some embodiments, the radiopaque marker may be disposed on the commissure posts of the frame. In other embodiments, the alignment marker may comprise a series of slits in a pattern within one or more of the struts or posts of the frame. For example, the slits may form a lowercase letter "d" in one of the struts or posts of the frame, but the pattern may also form an uppercase letter "D" or any other suitable or desired configuration. In other embodiments, the alignment markers may include holes, disks, slots, or other alignment features. In some embodiments, the prosthetic valve 102 has a single alignment marker 150. In some embodiments, the prosthetic valve 102 may have more than one alignment marker. The prosthetic valve 102 may have three alignment markers, each equally spaced around the circumference of the prosthetic valve 102. In some embodiments, the alignment markers may be identical, while in other embodiments, the alignment markers may differ in shape from circumferentially adjacent markers. The alignment markers 150 may be visually identifiable by the practitioner during the delivery procedure so that the practitioner can rotate the actuator a known amount to achieve valve commissure alignment.

[0036] In some embodiments, the practitioner can use a particular image view to align the registration marker 150 with the commissures of the patient's native or failing replacement valve. Imaging can include x-ray, computed tomography, fluoroscopy, or other suitable imaging techniques. If the registration marker comprises overlapping serpentine struts 153, 154 that can form a figure "8" shape with two openings, and when performing an aortic valve repair, the registration marker 150 can be aligned with the base of each aortic valve cusp or what is commonly referred to as the belly of the valve cusp. Aligning with the base of the cusp ensures that the commissure pillars of the prosthetic valve are aligned with the commissures of the native aortic valve cusp (or the repair cusp of the failing repair valve in the case of a failing repair valve during valve-in-valve repair). To assist with the alignment, the patient may undergo a pre-procedure computed tomography (CT) scan. Analysis of this CT scan provides the implanting practitioner with a fluoroscopy angle aligned with the annular plane. The annular plane is defined by the three bases of the aortic valve cusp. Generally, there are two commonly used views: a three-cusp view and a cusp overlap view. In a three-cusp view, the alignment marker 150 can be located in the center of the image so that it is aligned with, for example, the base of the right coronary cusp. When a properly oriented prosthetic valve is viewed in a cusp overlap view, two of the alignment markers 150 overlap or overlap each other, typically near the right and left coronary ostia. The third alignment marker 150, which is located 120 degrees from the other alignment markers and is associated with a non-coronary cusp, is difficult to view because it is 90 degrees from the viewing plane. This is particularly true when the alignment markers comprise overlapping serpentine struts 153, 154 that may form an "8" shape with two openings, but may also be true for other alignment marker configurations. Although this paragraph discusses imaging and positioning for an aortic valve repair or replacement procedure, it is within the scope of the present invention to apply similar techniques to the alignment of prosthetic valves in mitral or tricuspid valve repair or replacement procedures.

[0037] Once the valve is in the desired position, the prosthetic valve can then be expanded from the loaded configuration to an expanded configuration by expanding the balloon, as shown in Figures 4A-4B. The balloon can then be deflated and the transcatheter delivery system can be withdrawn from the vasculature.

[0038] In some embodiments, such as those shown in FIGS. 1-4B, the transcatheter delivery system 100 is initiated or introduced into the body with the prosthetic valve in a loaded configuration between the nosecone and the proximal end of the balloon (in other words, the prosthetic valve is crimped onto the balloon). In at least one embodiment, the distal portion (including the distal end) of the steerable catheter covers at least the proximal end of the prosthetic valve in the loaded configuration. At this point in the procedure, at least one of the actuator locks on the handle may be engaged, and in particular, the axial actuator lock may be engaged. Additionally, in some embodiments, the proximal end of the prosthetic valve, and more specifically, the proximal apex or end of the crimped prosthetic valve, is engaged with a retention feature on the distal end of the steerable catheter in the loaded configuration. The retention feature may be a ridge, protrusion, post, finger, rod, or other similar structure that engages with an opening between the struts at or near the proximal end of the prosthetic valve, or in other embodiments, a slot, hole, or opening that mates with one or more struts at or near the proximal end of the prosthetic valve. In some embodiments, the distal end of the shortened valve may be held, captured, or covered by the proximal portion or end of the nose cone. In at least one embodiment, the distal apex or end of the shortened valve may be held, captured, or covered by the proximal portion or end of the nose cone. At least one of the actuator locks may be engaged while the prosthetic valve is in the loaded configuration and during delivery of the prosthetic valve. For example, in one embodiment, the axial actuator lock may be engaged, in another embodiment, the rotational actuator lock may be engaged, or in yet another embodiment, both the axial actuator lock and the rotational actuator lock may be engaged. The prosthetic valve remains in the loaded configuration during delivery, including navigation around the aortic arch and across the native aortic valve or incomplete replacement device, and the user may apply deflection to the steerable catheter as needed for navigation. Once the distal end of the catheter assembly has traversed the valve, the axial lock may be disengaged and the balloon catheter shaft may be advanced. The retention mechanism holds the prosthesis in place relative to the steerable catheter.The balloon is advanced until the prosthesis reaches the mid-section or working section of the balloon. Once this position is reached, the retention mechanism is disengaged and the steerable catheter is separated from the prosthesis. The steerable catheter may then be withdrawn, exposing the proximal end of the inflated balloon. The axial lock is then re-engaged and commissure alignment is performed by rotation of the balloon catheter. Once rotational (commissure) alignment is achieved and the valve is positioned at the correct implantation depth, the device is ready for deployment. High rate pacing is initiated and the balloon is expanded, securing the prosthesis within the native aortic valve. The balloon is then deflated and high rate pacing is turned off. The catheter assembly is then withdrawn from the body, leaving the prosthetic valve in place.

[0039] FIG. 5 illustrates a cross-sectional view of a transcatheter delivery system 500 in accordance with one or more embodiments of the claimed invention, and FIG. 6 illustrates a cross-sectional view of one embodiment of a handle 518 of the transcatheter delivery system 500 illustrated in FIG. The transcatheter delivery system 500 comprises: In at least one embodiment, the transcatheter delivery system 500 is initiated or introduced into the body with the prosthetic valve in a loaded configuration; In the loaded configuration, the prosthetic valve is crimped or otherwise loaded onto a balloon, and in some embodiments, the distal end of the steerable catheter may cover the proximal end of the prosthetic valve; In some embodiments, the prosthetic valve is crimped onto the balloon proximal to the nose cone, and in still other embodiments, the prosthetic valve is crimped proximal to the inflated portion of the balloon; In the loaded configuration, an axial lock on the handle may be engaged; The transcatheter delivery system is maintained in this loaded configuration during delivery navigation around the aortic arch and across the native aortic valve, and the user may apply bias to the system as needed for navigation. Once the valve has been traversed and the desired axial position for deployment has been reached, the axial lock is disengaged and the steerable catheter is withdrawn, exposing the proximal end of the inflated balloon. The axial lock is then reengaged and commissure alignment is performed by rotation of the balloon catheter. Once rotational (commissure) alignment has been achieved and the valve is located at the correct implantation depth, the device is ready for deployment. High rate pacing may then be initiated and the balloon expanded, thereby expanding the prosthetic valve. The expansion of the balloon may allow for fixation of the prosthesis to the patient's native valve or within a failing replacement valve in need of repair. The balloon is then deflated and high rate pacing, if used, may then be turned off. The delivery system device may then be withdrawn from the body, leaving the prosthetic valve in place at its delivery location within the native or failing replacement valve.

[0040] The transcatheter delivery system of FIG. 5 includes a catheter assembly 503 having a distal end 504 and a proximal end 505. The catheter assembly 503 includes a nose cone 506, a balloon 510, an inner shaft 512, an outer shaft 514, a handle 518, and a fluid port 520 in communication with the balloon 510 for inflating and deflating the balloon with a fluid or gas. The nose cone 506 has a distal end 522 and a proximal end 524. In some embodiments, the nose cone 506 is solid, and in other embodiments, the nose cone 506 may be expandable or inflatable. The nose cone 506 may include a polymer, rubber, plastic, elastomer, or other material in some embodiments. The proximal end 524 of the nose cone 506 may be connected to the distal end 525 of the inner shaft 512. The inner shaft 512 may have one or more marker bands or radiopaque markers between the nosecone 506 and the handle 518, as described further below. The balloon 510 has a distal end 526 and a proximal end 528, with the distal end 526 abutting the proximal end 524 of the nosecone 506 in at least one embodiment. The balloon 510 may have a bulged portion 540 near the distal end 526. The outer shaft 514 may be a steerable shaft, a retractable shaft, or an intermediate shaft. The outer shaft 514 has a larger diameter than the inner shaft 512. The outer shaft 514 may have a distal end 532 and a proximal end 534. In some embodiments, the outer shaft 514 may have a radiopaque marker at the distal end 532. The handle 518 has a distal end 546 and a proximal end 548. As shown in Figure 5, the inner shaft 512 may itself extend proximally or rotatably from a proximal end 548 of the handle 518. Figure 6 shows one embodiment of the handle 518, which may include a housing 550 and, in at least one embodiment, an actuator 552. In some embodiments, the actuator 552 may be near the distal end 546, while in other embodiments, the actuator 552 may be located elsewhere along the housing 550.The actuator may be used for deflection of the outer sheath or, in some embodiments, for rotation of the inner shaft. In some embodiments, the handle 518 may further comprise a pull wire ring assembly 554 for deflection, comprising a pull wire 556 engaged with the outer or steerable shaft at one end and a ring 558 at the other end. The pull wire ring assembly 554 may be engaged with the actuator 552. In addition to or instead of the pull wire ring assembly 554, the handle 518 may comprise a rack and pinion gear assembly 558 for deflection of the outer or steerable shaft. In some embodiments, the handle 518 may further comprise a lock 570, comprising a locking collet 572 and a locking switch 574, for allowing or preventing at least one of axial movement of the balloon catheter relative to the steerable catheter or handle or rotation of the balloon catheter of the delivery device. In some embodiments, the lock switch 574 may be activated, engaged, or disengaged by rotating the switch from a first position to a second position to place the lock 570 in the locked or unlocked position. In other embodiments, the lock switch 574 may be activated, engaged, or disengaged by pulling the lock switch proximally (or pushing it distally) to place the lock 570 in the locked or unlocked position.

[0041] Although the above disclosure is described with respect to balloon-expandable valves, the concepts and features are equally applicable to self-expanding valves. In some embodiments, the deployment means for balloon-expandable valves and self-expanding valves are different, so modifications to the systems and methods described above with respect to balloon-expandable valves may be necessary for self-expanding valves. For example, self-expanding valves generally do not require a balloon for expansion of the prosthetic valve.

[0042] 7 shows a schematic diagram of one embodiment of a transcatheter delivery system 700 including a self-expanding prosthetic valve 702 and a catheter assembly 703 for aligning the self-expanding prosthetic valve 702 at its commissures during deployment and delivery. The prosthetic valve 702 is similar to the prosthetic valves described above and includes a frame 705 and a valve component 706 attached to the frame 705. The catheter assembly 703 has a proximal end 704 and a distal end 707, and includes at least a handle 708 near the proximal end 704, a nosecone 709 near the distal end 707, a steerable outer shaft 710 and an inner shaft 712 extending between the distal tip 709 and the handle 708. The steerable outer shaft 710 has a distal end 713. In some embodiments, the catheter assembly 703 further includes a retractable sheath 714 between the inner shaft 712 and the steerable outer shaft 710. In some embodiments, the retractable sheath 714 may extend distally from the distal end 713 of the steerable outer shaft 710 to cover the prosthetic valve 702 in the loaded configuration. In other embodiments, the retractable sheath 714 may extend proximally from the nosecone 709 to cover the prosthetic valve 702 in the loaded configuration. In yet another embodiment, the retractable sheath may comprise a split sheath having elements on both the steerable outer shaft and the inner shaft to cover the valve in the loaded configuration.

[0043] In some embodiments, the inner shaft 712 has one or more valve retention features 716, such as pegs, protrusions, tabs, rods, fingers, or extensions, that releasably engage the prosthetic valve 702 and hold the prosthetic valve 702 in an axial and / or rotational position relative to the inner shaft 712. In some embodiments, a control mechanism in the handle may be connected to the valve retention feature to rotate or advance or retract the valve retention feature to release the valve. In other embodiments, the prosthetic valve 702 may be released from the valve retention feature 716 upon expansion of the prosthetic valve. The valve retention feature 716 may also be configured to allow a desired expansion profile of the prosthetic valve 702 and / or a desired delivery profile of the prosthetic valve 702 during navigation around the aortic arch.

[0044] In some embodiments, the steerable outer shaft 710 may have a sheath retaining feature 718 at or near the distal end of the steerable outer shaft 710. The sheath retaining feature 718 allows for rotation of the inner shaft 712 relative to the steerable outer shaft 710.

[0045] The prosthetic valve 702 in the loaded configuration is disposed about the inner shaft 712 and is covered by either the steerable outer shaft 710 or the retractable sheath 714, which covers the prosthetic valve 702 to prevent expansion. The system 700 remains in this covered configuration while being navigated around the aortic arch during delivery and while traversing the native or failing replacement valve, and the practitioner can apply deflection to the system as needed for such navigation, including by using a deflection actuator on the handle as described above. Once the patient's native or failing replacement valve has been traversed and the practitioner is ready to deploy the prosthetic valve, the inner shaft 712 can be rotated to align the prosthetic valve 702 with the commissures of the native or failing replacement valve, as with the balloon shaft described above. More specifically, the inner shaft 712 can be rotated to align the commissure posts of the prosthetic valve 702 with the commissures of the native or failing replacement valve. Once the valve is aligned in position for deployment, the steerable outer shaft 710 and / or retractable sheath 714 may be withdrawn, causing the self-expanding frame of the prosthetic valve 702 to expand outward as the sheath 714, securing the prosthetic valve 702 within its native anatomy or within a failing replacement valve. The prosthetic valve 702 may be released from one or more valve retention features 716 on the inner shaft 712, which may be accomplished by mechanical expansion of the prosthetic valve 702 or by release of a control mechanism on a handle that retracts the valve retention features 716 within the inner shaft 712. Once the prosthetic valve 702 is fully deployed within the patient's native or failing replacement valve, the catheter assembly 703 may then be removed from the patient's body.

[0046] In at least one embodiment, the prosthetic valve, whether a balloon-expandable or self-expandable prosthetic valve, is initially in a loaded or contracted configuration on the inner shaft. In an aortic valve repair procedure, the inner shaft can be locked in position relative to the outer shaft to prevent axial movement of the inner shaft relative to the outer shaft when beginning advancement from the access site to the top of the descending thoracic aorta. Also in an aortic valve repair procedure, the delivery system may then be advanced around the aortic arch. Articulation of the steerable catheter using one or more actuators on the handle may be used to atraumatically deflect or steer the delivery system through the vasculature. During advancement under fluoroscopic visualization, the practitioner may rotate 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 inner shaft may be unlocked relative to the outer shaft, allowing the steerable catheter to be pulled proximally, exposing the remainder of the balloon and releasing the proximal end (or proximal outflow apex) from the flared portion of the steerable catheter. To unlock the inner shaft relative to the outer shaft, a lock switch may be turned from a locked position to an unlocked position to disengage the lock, or in some embodiments, a lock near the proximal end of the handle may be pulled proximally (or pushed distally in other embodiments) to disengage the lock and allow axial movement of the inner shaft relative to the outer shaft. In at least one embodiment, a proximal-most radiopaque marker band on the inner shaft indicates to the practitioner how far the steerable catheter or outer shaft should be pulled proximally. Once the steerable catheter or outer shaft reaches the desired position, the lock can be re-engaged to prevent axial movement of the inner shaft relative to the outer shaft. The practitioner can then rotate the valve by rotating the inner shaft, either manually or with an actuator on a handle, to align the commissures of the prosthetic valve with the patient's native or failing replacement valve.Once centered or in the location desired by the practitioner, and in some embodiments aligned with the commissures, any further fine-tuning may be performed by moving the catheter assembly proximally or distally relative to the guidewire, or by applying a small deflection to the catheter assembly. The prosthetic valve may then be expanded, pushing aside the native aortic valve leaflets and / or the leaflets of the incompetent replacement valve, and engaging the patient's current annulus. If the prosthetic valve is a balloon-expandable valve, the balloon may then be deflated by releasing fluid, gas, or air pressure. The prosthetic valve begins to function. In some embodiments, the lock may be disengaged again, and the inner shaft may be retracted proximally into the outer shaft or steerable catheter. The lock may then be reengaged to prevent relative axial movement of the shafts, and the inner and outer shafts or steerable catheters may be withdrawn simultaneously. In other embodiments, the outer shaft or steerable catheter may be withdrawn from the patient's vasculature separately from the inner shaft.

[0047] As used herein, the term "substantially" or "generally" refers to the complete or nearly complete extent or degree of an action, feature, characteristic, state, structure, item, or result. For example, an object that is "substantially" or "generally" enclosed means that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may depend on the particular context, in some cases. Generally speaking, however, close to completeness is such that it would generally have the same result as if absolute and total completeness were obtained. The use of "substantially" or "generally" is equally applicable when used in the negative sense to refer to the complete or nearly complete absence of an action, feature, characteristic, state, structure, item, or result. For example, an element, combination, embodiment, or composition that is "substantially free" or "generally free" of a component or element may still actually contain such item, so long as there is generally no measurable effect of it.

[0048] As used herein, a reference to "one embodiment" or "an embodiment" means that a particular element, feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification do not necessarily all refer to the same embodiment.

[0049] As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," or any other variations thereof, are intended to include non-exclusive inclusions. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to only those elements and may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Furthermore, unless expressly stated to the contrary, "or" refers to an inclusive "or" and not an exclusive "or." For example, condition A or condition B is satisfied by any one of the following: A is true (or present) and B is false (or absent), A is false (or absent) and B is true (or present), and both A and B are true (or present).

[0050] Furthermore, the use of "a" or "an" is 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 clear that it is meant otherwise.

[0051] Moreover, the drawings depict preferred embodiments for purposes of illustration only: those skilled in the art will readily recognize from the description herein that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles described herein.

[0052] 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 structure and components disclosed herein. Various modifications, changes, and variations apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and apparatus disclosed herein without departing from the spirit and scope as defined by the appended claims.

[0053] While the systems and methods described herein are described with reference to certain exemplary embodiments, it is contemplated that these embodiments are not limiting and are not necessarily mutually exclusive, and that certain features of various embodiments can be omitted or combined for use with features of other embodiments while remaining within the scope of the invention.

Claims

1. 1. A transcatheter prosthetic heart valve delivery system, comprising: A balloon shaft; a balloon mounted on the balloon shaft and having a delivery diameter, the balloon in fluid communication with a fluid source for expanding the balloon from the delivery diameter to a deployed diameter; a handle having an actuator engaged with the balloon shaft; a prosthetic valve loaded onto a balloon in a loaded configuration of the prosthetic valve, the prosthetic valve being expandable from the loaded configuration to the deployed configuration by expanding the balloon from a delivery diameter to a deployed diameter; Equipped with A transcatheter prosthetic heart valve delivery system, wherein rotating the actuator in at least a first direction by an actuator rotation amount causes the prosthetic valve to predictably rotate in the first direction by a balloon rotation amount that is proportional to the actuator rotation amount.

2. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the balloon shaft is a braided shaft.

3. 3. The transcatheter prosthetic heart valve delivery system of claim 2, A transcatheter prosthetic heart valve delivery system, wherein the braided shaft includes a radiopaque marker.

4. 3. The transcatheter prosthetic heart valve delivery system of claim 2, A transcatheter prosthetic heart valve delivery system, wherein the balloon shaft has a polymeric coating.

5. 3. The transcatheter prosthetic heart valve delivery system of claim 2, A transcatheter prosthetic heart valve delivery system, wherein the balloon shaft has an elastomeric coating.

6. 6. The transcatheter prosthetic heart valve delivery system of claim 5, The transcatheter prosthetic heart valve delivery system, wherein the elastomeric coating comprises a thermoplastic elastomer.

7. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the amount of balloon rotation is approximately 70-100% of the amount of actuator rotation relative to the amount of balloon rotation.

8. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the ratio of the amount of actuator rotation to the amount of balloon rotation is 1:

1.

9. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the ratio of actuator amount to balloon rotation amount is 10:

8.

10. 10. The transcatheter prosthetic heart valve delivery system of claim 1, The artificial valve comprises: Expandable frame and a valve component attached to the frame.

11. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the valve component comprises a sutureless, single-piece, three-dimensional structure having three valve leaflets molded into the sutureless, single-piece, three-dimensional structure.

12. 11. The transcatheter prosthetic heart valve delivery system of claim 10, The frame is a radiopaque marker. A transcatheter prosthetic heart valve delivery system.

13. 13. The transcatheter prosthetic heart valve delivery system of claim 12, A transcatheter prosthetic heart valve delivery system, wherein radiopaque markers are positioned on the commissure posts of the frame.

14. 13. The transcatheter prosthetic heart valve delivery system of claim 12, A transcatheter prosthetic heart valve delivery system, wherein the radiopaque marker is disposed on at least one strut adjacent to a commissure post or at least one node.

15. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the handle includes at least one actuator stop.

16. 10. The transcatheter prosthetic heart valve delivery system of claim 1, The handle further includes a locking member. A transcatheter prosthetic heart valve delivery system, wherein when the locking member is engaged with the actuator, the balloon shaft cannot rotate.

17. 10. The transcatheter prosthetic heart valve delivery system of claim 1, A transcatheter prosthetic heart valve delivery system, wherein the actuator is rotatable in a first direction and in a second direction opposite the first direction.

18. 1. A transcatheter prosthetic heart valve delivery system, comprising: An inner shaft; a balloon coupled to a distal end of the inner shaft; An outer shaft; a lock having a locked position and an unlocked position; a prosthetic valve loaded onto a balloon in a loaded configuration of the prosthetic valve, the prosthetic valve being expandable from the loaded configuration to the deployed configuration by expanding the balloon from a delivery diameter to a deployed diameter; Equipped with rotating the inner shaft in a first direction by an amount of shaft rotation causes the prosthetic valve to predictably rotate in the first direction by an amount of balloon rotation that is proportional to the amount of shaft rotation; A transcatheter prosthetic heart valve delivery system, wherein when the lock is in a locked position, movement of the inner shaft and the balloon relative to the outer shaft is prevented.

19. 20. The transcatheter prosthetic heart valve delivery system of claim 18, further comprising: A transcatheter prosthetic heart valve delivery system comprising a lock switch for engaging a lock in a locked position.

20. 20. The transcatheter prosthetic heart valve delivery system of claim 19, The lock switch disengages the lock from a locked position to an unlocked position.

21. 20. The transcatheter prosthetic heart valve delivery system of claim 18, A transcatheter prosthetic heart valve delivery system, wherein in the locked position, the inner shaft is capable of rotating in a first direction.

22. 22. The transcatheter prosthetic heart valve delivery system of claim 21, In the locked position, the inner shaft can rotate in a second direction.

23. 20. The transcatheter prosthetic heart valve delivery system of claim 18, A transcatheter prosthetic heart valve delivery system, wherein in an unlocked position, the inner shaft can move axially relative to the outer shaft and the inner shaft can rotate in at least a first direction.

24. 22. The transcatheter prosthetic heart valve delivery system of claim 21, A transcatheter prosthetic heart valve delivery system, wherein the balloon shaft is a braided shaft.

25. 22. The transcatheter prosthetic heart valve delivery system of claim 21, A transcatheter prosthetic heart valve delivery system, wherein the prosthetic valve has at least one alignment marker.

26. 26. The transcatheter prosthetic heart valve delivery system of claim 25, A transcatheter prosthetic heart valve delivery system, wherein the prosthetic valve has three alignment markers.

27. 26. The transcatheter prosthetic heart valve delivery system of claim 25, A transcatheter prosthetic heart valve delivery system, wherein the at least one alignment marker comprises two overlapping serpentine struts forming a figure eight shape.

28. 26. The transcatheter prosthetic heart valve delivery system of claim 25, The figure 8 shape has two openings; a transcatheter prosthetic heart valve delivery system.

29. 22. The transcatheter prosthetic heart valve delivery system of claim 21, The handle further comprises at least one actuator.

30. 30. The transcatheter prosthetic heart valve delivery system of claim 29, The handle further comprises at least one actuator stop.

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