Artificial heart valve delivery system

Abstract

To provide a system for delivering a valve prosthesis.SOLUTION: A delivery system includes: a sheath having a valve prosthesis housed in the sheath in a compacted state, the valve prosthesis including a valve anchor including base portions and anchor fixing legs interconnected with the base portions and interleaved between the base portions, the anchor fixing legs having proximal ends joined to the base portions and distal ends having a connection aperture; and a pin assembly including a pin extending proximally through the connection aperture to engage with the anchor fixing legs and an annular component disposed in a cavity in a reciprocating manner, the annular component being reciprocable between an engaged configuration at a proximal position in the cavity and a disengaged configuration at a distal position in the cavity.SELECTED DRAWING: Figure 7A

Description

[Technical Field]

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 614,488, filed January 7, 2018, the entire contents of which are incorporated herein by reference.

[0002] The subject matter described herein relates to prosthetic heart valve delivery systems and methods for transcatheter delivery of valves through the venous system. [Background technology]

[0003] Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrates, the heart is a muscular organ with four pumping chambers: the left atrium, right atrium, left ventricle, and right ventricle, each with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid, and pulmonary valves. Although prosthetic heart valves can be used to replace any of these naturally occurring valves, repair or replacement of the aortic or mitral valve is more common because they are located on the left side of the heart where pressure is greatest.

[0004] Traditional heart valve replacement surgery involves accessing the heart within a patient's thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcibly spreading apart the two opposing halves of the rib cage, allowing access to the thoracic cavity and the heart therein. The patient is then placed on cardiopulmonary bypass, which involves stopping the heart to allow access to the internal chambers. Such open-heart surgery is particularly invasive and involves a lengthy and difficult recovery period.

[0005] Percutaneous delivery of aortic valves has recently emerged as a promising alternative to surgical valve replacement. Currently, transcatheter implantation is achieved via a transfemoral route with retrograde access to the native aortic valve. This minimally invasive aortic valve replacement has resulted in reduced hospital stays, fewer sternal wound complications, less surgical trauma, and improved cosmesis. Despite the success of transcatheter delivery through the femoral artery, significant drawbacks exist, especially in the elderly population, who would greatly benefit from minimally invasive procedures.

[0006] In some patients, the arterial diameter is too small to safely accommodate passage of a delivery system due to plaque buildup and the presence of previously implanted stents. Dislodging plaque material during a transcatheter procedure can result in the development of emboli that pose a risk of stroke. Therefore, it is desirable to devise additional systems to enable transcatheter delivery of valve prostheses through the venous system, which generally have a larger inner diameter to better accommodate a compact delivery system.

[0007] The foregoing examples of the related art and limitations associated therewith are intended to be illustrative and not exhaustive. Other limitations of the related art will become apparent to those skilled in the art upon reading the specification and studying the drawings. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent Application No. 62 / 614,488 [Patent Document 2] International Application No. [Patent Document 3] International Application No. [Patent Document 4] U.S. Patent Application No. 62 / 614,489 [Patent Document 5] U.S. Patent Application No. 62 / 756,556 [Patent Document 6] U.S. Patent Application No. 62 / 781,537 Summary of the Invention [Problem to be solved by the invention]

[0009] The following aspects and certain examples thereof, as described and illustrated below, are meant to be exemplary and illustrative, and not limiting in scope.

[0010] Transcatheter delivery of valvular prostheses to the heart traditionally involves delivery through the vena cava and through the chambers of the heart. Due to the anatomy of the heart, such delivery requires that the system catheter be able to navigate sharp turns without damaging the surrounding tissue or the system itself. Described below are prosthetic valve delivery systems, valvular prostheses, and methods for using the same, which provide increased flexibility for such transcatheter delivery in addition to reduced diameters, which allows for transcatheter delivery. Furthermore, such systems, valvular prostheses, and methods allow clinicians to more easily control the inflation, deployment, and release of the valvular prosthesis. Furthermore, some embodiments provide systems and valvular prostheses that can be delivered in a radially compact delivery configuration, which, as described herein, achieves numerous advantages over conventional systems and devices. [Means for solving the problem]

[0011] Some embodiments disclosed herein provide a delivery system for delivering a valve prosthesis. The valve prosthesis can include a radially expandable valve anchor, a support frame positionable within the valve anchor, and a plurality of valve leaflets coupled to the support frame. The delivery system can include a core member and an engagement mechanism for releasably engaging the valve anchor. The engagement mechanism can optionally be slidably coupled to the core member. The engagement mechanism can engage with a locking component, which can optionally be slidably coupled along the core member. Thus, in some embodiments, the engagement mechanism can be displaced or moved relative to the core member to releasably engage one or more features of the valve prosthesis. The engagement mechanism can allow one or more features of the valve anchor to radially expand while radially restricting or engaging one or more adjacent features of the support frame.

[0012] For example, in some embodiments, the delivery system can engage one or more anchoring legs of the valve anchor via an engagement mechanism while being released from one or more U-shaped members, anchoring members, valve claspers, sinus locators, valve positioners, or valve hangers of the valve anchor. The U-shaped members can each include a base portion, which can be used to engage with a particular aspect of the native valve structure, such as the aortic sinuses of the native aortic valve (including the posterior aortic sinus, left aortic sinus, and / or right aortic sinus). The base portion can have a rounded or atraumatic shape that allows the base portion to expand and fit into each sinus of the valve. Thus, in some embodiments, the delivery system is capable of engaging one or more anchoring legs of the valve anchor while the base portion of the U-shaped member is expanded against the one or more anchoring legs, thereby allowing the clinician to manipulate or move the base portion relative to the native valve structure to properly seat the valve anchor against the native valve structure.

[0013] In some embodiments, the base portion and anchoring legs can extend longitudinally along the valve anchor. For example, the valve anchor can include three base portions and three anchoring legs. Each of the anchoring legs can be interconnected with a respective base portion and can be interleaved between the respective base portions. The first end sections of the anchoring legs can be interconnected with the respective first end sections of the base portions. Furthermore, the second end sections of the anchoring legs can be releasably connectable to a delivery system using an engagement mechanism, while the second end sections of the U-shaped member (or base portion) can move independently from the second end sections of the anchoring legs (i.e., the second end sections of the anchoring legs can be connected to a delivery system, and the base portions of the U-shaped member can expand relative to the engaged second end sections of the anchoring legs).

[0014] Optionally, in some embodiments, the second end section or base portion of the U-shaped member can be maintained in a compressed configuration using a sheath. For example, the sheath can be slidably positioned over the valve anchor and retractable to allow the U-shaped member of the valve anchor to expand against the anchoring legs. The clinician can then manipulate the base portion of the U-shaped member into the appropriate position relative to the native valve structure. Once the base portion is properly positioned relative to the native valve structure (e.g., in the desired final position), the anchoring legs can be released, thereby allowing the valve anchor to fully expand and be released from the delivery system. Once the valve anchor is seated or positioned relative to the native valve structure, the support frame can be positioned longitudinally within the lumen of the valve anchor, inflated, and released into engagement with the valve anchor. Other features and steps of delivery systems, valve anchors, and methods of assembling and delivering a valve prosthesis are further discussed herein.

[0015] According to some embodiments, the engagement mechanism can include a pin assembly. The pin assembly can include (i) a tubular component having a proximal section and a distal section, and (ii) at least one pin coupled to the distal section. The pin can extend proximally from the distal section toward the proximal section and can be radially spaced apart from the tubular component.

[0016] In some embodiments, the locking component can (i) include at least one locking aperture proximal to the tubular component distal section and (ii) be configured to allow at least one pin to extend therethrough.

[0017] Optionally, the valve anchor can include at least one anchoring leg. The anchoring leg can have a coupling portion with a connecting aperture disposed through the coupling portion to allow the engagement mechanism to engage the anchoring leg.

[0018] For example, in the engaged configuration, the tubular component distal section can be axially spaced a first distance from the locking component, with at least one pin extending through the anchoring leg connection aperture and the locking component lock aperture to interconnect the valve anchor leg with the engagement mechanism. Thus, in the engaged position, the anchoring leg can be engaged with the pin and interposed between the tubular component distal section and the locking component. In the released configuration, the tubular component distal section can be axially spaced a second distance greater than the first distance from the locking component, with at least one pin positioned or released outside the locking aperture to allow the anchoring leg to disengage from the at least one pin.

[0019] According to some embodiments, a method for delivering a valve prosthesis to a target location within a blood vessel of a subject can include introducing a delivery system into the blood vessel and positioning a valve anchor at the target location. A sheath of the delivery system can be retracted proximally, allowing a U-shaped member of the valve anchor to expand at the target location to position the valve anchor relative to the native valve structure. Once the base portions of the U-shaped members are engaged or seated within the respective valve sinuses, for example, anchoring legs of the valve anchor can be released, allowing the valve anchor to fully expand into the native valve structure. Thereafter, a support frame of the valve prosthesis can be positioned within the lumen of the valve anchor, inflated, and engaged with the valve anchor. The delivery system can then be removed from the patient.

[0020] Optionally, the valve anchor can be released by disengaging an engagement mechanism of the delivery system. For example, the engagement mechanism can include a pin assembly that engages with one or more anchoring legs of the valve anchor. The pin assembly can include a locking pin carrier, which is coupled to a plurality of pins. To disengage the engagement mechanism, the locking pin carrier can be contacted by a lock activator, which moves the locking pin carrier relative to the anchoring legs and slides the pins out of engagement with the anchoring legs. The locking pin carrier can slide along and relative to the core member of the delivery system.

[0021] In some embodiments, the delivery system can include a nose cone having an engagement area and a plurality of apertures, and the pin can extend through the plurality of apertures to allow the anchoring legs of the valve anchor to engage and be restrained within the engagement area.

[0022] Optionally, a lock pin carrier can be at least partially disposed within a cavity in the nose cone and slidable therein to move the pin into or out of the engagement area. For example, when a lock activator contacts the lock pin carrier, the lock pin carrier can be advanced distally relative to the engagement area of ​​the nose cone, thereby withdrawing the pin from the engagement area and releasing the pin from the anchoring leg of the valve anchor.

[0023] Thus, various embodiments may be provided in which movement of the engagement mechanism can cause the delivery system to disengage from the anchoring legs of the valve anchor, thereby allowing release of the valve anchor from the delivery system.

[0024] Additional embodiments of the present devices, methods, and the like will become apparent from the following description, drawings, examples, and claims. As can be recognized from the foregoing and following description, each and every feature described herein, and each and every combination of two or more such features, is included within the scope of the present disclosure, provided that the features included in such combinations are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded or omitted from any embodiment of the present disclosure. Additional aspects and advantages of the present disclosure are set forth in the following description and claims, particularly when considered in conjunction with the accompanying examples and drawings.

[0025] Additional features and advantages of the subject technology will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and obtained by, among other things, the structures pointed out in the written description and examples thereof, as well as the accompanying drawings.

[0026] Certain features of the valve prostheses, delivery devices, actuation handles, other devices, systems, and methods that may be implemented in conjunction with the valve prostheses, delivery devices, actuation handles, other devices, systems, and methods discussed in this disclosure are described, for example, in International Application No. 122271-5044, entitled "HEART VALVE PROSTHESIS," filed January 4, 2019, by Ji Zhang, Brandon G. Walsh, Cheng Yong Yang, Jinhua Zhu, and Dennis Michael McMahon, and International Application No. 122271-5044, entitled "PROSTHETIC HEART VALVE DELIVERY SYSTEM," filed January 4, 2019, by Ji Zhang, Brandon G. Walsh, and Cheng Yong Yang, and Other features of the valve prostheses, delivery devices, actuation handles, and other devices, systems, and methods described in the patent application Ser. No. 122271-5048, each of which is incorporated herein by reference in its entirety, may be implemented and / or used in combination with the valve prostheses, delivery devices, actuation handles, and other devices, systems, and methods described in the patent application Ser. No. 122271-5048, each of which is incorporated herein by reference in its entirety.

[0027] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

[0028] The following figures are included to illustrate certain aspects of the present disclosure and should not be viewed as exclusive examples. The disclosed subject matter is capable of considerable modification, substitution, combination, and equivalents in form and function without departing from the scope of the present disclosure. [Brief explanation of the drawings]

[0029] [Figure 1] 1 is a cross-sectional view of a human heart and, inter alia, illustrates the implantation of an aortic valve prosthesis into the heart's native valve structure, according to some embodiments. [Figure 2]A figure illustrating a delivery system in a delivery configuration for delivering a valvular prosthesis including a radially expandable valve anchor and a support frame using an engagement mechanism for releasably engaging the expandable valve anchor, according to some embodiments. [Figure 3A] 3 is an illustration of a nose cone of the valve anchor of the delivery system of FIG. 2, according to some embodiments. [Figure 3B] FIG. 4 is a cross-sectional view of a nose cone of the valve of FIG. 3, according to some embodiments. [Figure 4A] FIG. 3 illustrates a pin assembly of the delivery system of FIG. 2, according to some embodiments. [Figure 4B] 10A-10C illustrate alternative pin assemblies according to some embodiments. [Figure 5A] FIG. 3 illustrates a pusher component of the delivery system of FIG. 2, according to some embodiments. [Figure 5B] 10A-10C illustrate alternative pusher components according to some embodiments. [Figure 6A] 3 illustrates a support frame and valve anchor compactly housed within a sheath of the delivery system of FIG. 2, according to some embodiments. [Figure 6B] 10A-10C illustrate a valve anchor in an expanded configuration partially released from a sheath and engaged with an engagement mechanism in a pre-release configuration, according to some embodiments. [Figure 6C] 10A-10C illustrate distal advancement of the support frame and pusher components of the engagement mechanism to initiate release of the valve anchor from the engagement device, according to some embodiments. [Figure 6D] 10A-10C illustrate the valve anchor and engagement mechanism in a released configuration, prior to release of the support frame from the sheath of the delivery system, in accordance with some embodiments. [Figure 6E]10A-10C illustrate the sheath being retracted proximally to allow the valve prosthesis to begin expanding, according to some embodiments. [Figure 6F] 1A-1C illustrate a valve prosthesis fully expanded within a valve anchor, according to some embodiments. [Figure 7A] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. [Figure 7B] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. [Figure 7C] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. [Figure 7D] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. [Figure 7E] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. [Figure 7F] 1A-1C illustrate steps in a method for delivering a valve prosthesis through the aorta to the native aortic valve using a valve prosthesis delivery system, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0030] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It should be understood that the subject technology can be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0031] Furthermore, while the present disclosure describes specific details of various embodiments, it will be recognized that the description is for illustrative purposes only and should not be construed as limiting in any way. Additionally, while particular embodiments of the present disclosure are disclosed or illustrated in the context of a mitral valve prosthesis, it is contemplated that such embodiments may also be used in other cardiac valve prosthesis applications. Moreover, various uses of such embodiments and modifications thereto (which may occur to those skilled in the art) are encompassed by the general concepts described herein.

[0032] Like all heart valves, a healthy aortic valve opens to allow blood flow and closes to prevent backflow. However, valve disease and dysfunction can result in backflow or reduced blood flow. In such cases, a replacement valve prosthesis must be used to perform the function of a healthy aortic valve.

[0033] However, numerous challenges exist in providing replacement valve prostheses. For example, to overcome problems of regurgitation or reduced blood flow, a suitable replacement valve prosthesis must provide an acceptable seal and anchoring to the native valve tissue when positioned and released relative to the native valve structure, such as the native valve annulus. Furthermore, the architecture of the aortic valve annulus also creates challenges in the design of aortic valve prostheses. Indeed, the aortic valve prosthesis must conform to the unique anatomical structure of the aortic valve and remain anchored in the presence of continuous contractions of a functioning heart.

[0034] The present disclosure describes systems, devices, and methods for implanting an aortic valve prosthesis using minimally invasive surgical techniques. The systems accommodate the complex anatomy of the aortic valve and ensure that the implanted valve prosthesis is properly positioned and securely maintained in the appropriate location after implantation. Additionally, some embodiments provide an aortic valve prosthesis delivery system that can also include the aortic valve prosthesis.

[0035] The valve prosthesis can include an expandable valve anchor, a support frame that can be coupled to the valve anchor, and multiple valve leaflets coupled to the support frame. The implant can have multiple artificial valve leaflets attached to its interior surface, which can mimic the function of a native aortic valve. The implant and valve anchor can have a compact configuration for delivery to the diseased valve and an unfolded or expanded configuration for release and implantation into the diseased valve annulus. Moreover, in some embodiments, the implant and valve anchor can be positioned relative to one another to minimize the diameter of the valve components during delivery.

[0036] Additionally, in some embodiments, the implant can be fixedly coupled to the valve anchor to provide efficient positioning of both the valve anchor and the implant. For example, the implant and valve anchor can be connected by a flexible element such that the implant and valve anchor can be longitudinally or rotationally displaced relative to one another prior to releasing and expanding the valve component into the heart or native valve structure. Additionally, the implant and valve anchor can be expandable from a compact state to an expanded state, and in some embodiments, can expand independently of one another.

[0037] FIG. 1 illustrates a cross-sectional view of a human heart in which an aortic valve prosthesis is implanted within the heart's natural valve structure. The heart 10 may include a right atrium 12, a right ventricle 14, a left ventricle 16, and a left atrium 18. Oxygen-depleted blood enters the right atrium 12 through the superior vena cava 20 and the inferior vena cava 22. The oxygen-depleted blood is pumped from the right atrium through the tricuspid valve 24 (which separates the right atrium 12 from the right ventricle 14) into the right ventricle 14. The right ventricle 14 then pumps the oxygen-depleted blood through the pulmonary valve 26 into the pulmonary artery 28, which directs the oxygen-depleted blood to the lungs for oxygen transfer. Oxygen-rich blood is then transported from the lungs to the left atrium 18 through the pulmonary vein 30. Oxygen-rich blood is pumped from the left atrium 18 through the mitral valve 32 into the left ventricle 16. The left ventricle 16 then pumps the oxygen-rich blood through the aortic valve 34 into the aorta 36. The aorta carries the oxygen-rich blood to a series of arteries, which transport blood to various organs in the body.

[0038] Implantation of a prosthetic aortic valve via a minimally invasive transcatheter approach can be achieved, for example, through the femoral artery and aortic arch into the left atrium or through the femoral vein and inferior vena cava by transseptal punch. The aortic valve, located between the left atrium and left ventricle, can be the most challenging valve to repair percutaneously because it can be difficult to reach. While the aortic valve can be reached through the left ventricle and mitral valve, maneuvering the catheter, which must make two approximately 180° turns, is cumbersome. However, as discussed herein, various embodiments are provided that allow clinicians to overcome these disadvantages and effectively deliver a prosthetic valve to the target location within the heart.

[0039] Delivery system for a valve prosthesis The present disclosure provides devices, systems, and methods for valve replacement, preferably using minimally invasive surgical techniques. While the systems and methods have application in several different blood vessels in various parts of the body, they are particularly well suited for replacing incompetent heart valves, and aortic valves in particular. The systems and methods also have application in other incompetent heart valves, such as the pulmonary valve or mitral valve.

[0040] The systems and methods disclosed herein may be particularly advantageous in their ability to provide a more flexible prosthetic heart valve delivery system, ensure accurate and precise placement of an artificial heart valve or valve prosthesis with reduced reliance on imaging, and provide additional anchoring of the valve prosthesis, reducing the incidence of valve migration.

[0041] Another advantage of the systems and methods disclosed herein is the ability to deliver and implant a valvular prosthesis through the aorta, which has a smaller diameter than the inferior vena cava, through which surgeons typically gain access to the heart.

[0042] The present disclosure also provides improved systems and methods for implanting a prosthetic heart valve. In particular, improved minimally invasive methods and systems are provided for retrograde implantation of an expandable prosthetic heart valve into or adjacent to a valved anatomical site in the heart. In particular, the improved prosthetic heart valve delivery systems and methods of the present disclosure offer more flexibility in valve replacement procedures, ensure accurate and precise placement of the prosthetic heart valve with reduced reliance on imaging, provide additional anchoring of the prosthetic valve, and reduce the incidence of valve migration or misalignment.

[0043] Various embodiments of the present disclosure relate to a delivery system capable of maneuvering sharp turns, the delivery system including a compactly configured valve prosthesis, which may include a valve anchor, a support frame that may be coupled to the valve anchor, and an engagement mechanism for releasably engaging the valve anchor. In the configuration of delivery system 100, the valve anchor and support frame are delivered to a target location serially (or longitudinally spaced apart from one another) in a folded configuration, rather than being positioned concentrically with respect to one another, thereby minimizing the outer profile or diameter of the valve prosthesis and the delivery system during delivery.

[0044] Various embodiments will now be described more fully hereinafter. However, such embodiments may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art. Thus, one or more features shown or otherwise disclosed in an embodiment of this specification may be used interchangeably or incorporated into other embodiments that may not explicitly show or disclose such features. Furthermore, one or more features shown or otherwise disclosed with respect to an embodiment of this specification may be excluded from such embodiment, unless explicitly indicated otherwise, using the skill of one of ordinary skill in the art.

[0045] Thus, the valvular prosthesis delivery systems described herein facilitate delivery of a valvular prosthesis to the heart while minimizing trauma or damage to the patient's blood vessels and tissue. The various embodiments described herein provide means for both pushing and pulling the valvular prosthesis delivery system through the sharp turns presented by the ventricles. It is noted that for purposes of describing the disclosed systems and methods, the term "proximal" refers to a relative position closer to the control unit, while the term "distal" refers to a relative position farther away from the control unit.

[0046] 2 illustrates a valve prosthesis delivery system 100 capable of supporting and delivering a valve prosthesis 105. As shown, the valve prosthesis 105 can include a support frame 107 and a valve anchor 120. According to some embodiments, the delivery system 100 can include a core member 110 and an engagement mechanism 115, which can be configured to releasably engage the valve anchor 120 to the core member 110. Additionally, the delivery system 100 can also include a sheath 150, which can extend distally to cover the support frame 107 and the valve anchor 120. The sheath 150 can maintain the support frame 107 and the valve anchor 120 in a compressed configuration during delivery of the system 100 to a target location. When positioned at the target location, the clinician can retract the sheath 150 proximally to allow the support frame 107 to begin to expand. Thereafter, additional actuation of the engagement mechanism 115 and further proximal retraction of the sheath 150 can allow the clinician to release the valvular prosthesis 105 at the target location.

[0047] In some embodiments, engagement mechanism 115 can include pin assembly 125, which is slidably coupled to core member 110 and locking component 140. Together, pin assembly 125 and locking component 140 can engage one or more structures of valve anchor 120 and, when released by the clinician, can disengage from valve anchor 120, allowing valve anchor 120 to fully expand or be released at the target location. In this manner, the clinician can precisely control the release of valve anchor 120 from delivery system 100.

[0048] 2, valve anchors 120 can be positioned inline with support frame 107 of valvular prosthesis 105. Both support frame 107 and valve anchors 120 can be made of shape memory materials such that they can be compressed to a radius that allows for delivery through arteries and veins, for example, and then expanded as needed for expansion and placement of valvular prosthesis 105 in the desired location.

[0049] Thus, although support frame 107 and / or valve anchor 120 may optionally be balloon expandable or further expandable using a balloon, the embodiment illustrated in FIG. 2 is configured such that support frame 107 or valve anchor 120 self-expands when sheath 150 is retracted proximally to a position where sheath 150 does not longitudinally overlap one of frames 107 or valve anchors 120, respectively.

[0050] For example, support frame 107 and / or valve anchor 120 can include a braided frame, a wire frame, or a laser-cut frame, as shown in FIG. 2 . In some embodiments, support frame 107 and / or valve anchor 120 can include a shape-memory metal that can change shape at a specified temperature or temperature range or by inducing stress. Alternatively, a self-expanding frame can include a spring-biased frame. The material from which either support frame 107 and / or valve anchor 120 are fabricated can enable support frame 107 and / or valve anchor 120 to automatically expand to its functional size and shape when deployed, but also enable support frame 107 and / or valve anchor 120 to be radially compressed to a smaller profile for delivery through the patient's vasculature. Examples of suitable materials for the self-expanding components described herein (e.g., support frame, valve anchor, locking element) include, but are not limited to, medical-grade stainless steel, titanium, nickel-titanium alloy, tantalum, platinum alloy, niobium alloy, cobalt alloy, alginate, or combinations thereof. A shape-memory alloy (commonly known as Nitinol), which has superelastic properties and is typically made from a ratio of nickel and titanium, is a suitable material. In some embodiments, the self-expanding components described herein can include materials that are inert in the body, including, but not limited to, shape-memory plastics, polymers, and thermoplastic materials. In alternative embodiments, either the support frame 107 and / or the valve anchor 120 are not self-expanding and can be expanded, for example, using a balloon catheter, as is well known in the art.

[0051] In some embodiments, the valve anchor 120 can be movably coupled to the support frame 107 such that the valve anchor 120 can be moved from a concentric position with the support frame 107 to a proximal or distal position from the support frame 107. It is advantageous to position the valve anchor 120 inline from the support frame 107 during delivery of the valvular prosthesis 105. This allows the radius of the system to be minimized, thus enabling the system to be advanced through small diameter vessels, e.g., arteries and veins. The distance the valve anchor 120 can be displaced inline from the support frame 107 is variable, allowing the valve anchor 120 to be adjacent to the support frame 107 or potentially several inches away from the support frame 107 during the delivery procedure. In some embodiments, the valve anchor 120 is physically secured to the support frame, for example, by welding or other adhesive methods.

[0052] The delivery system 100 can be configured so that the components of the heart valve prosthesis are advanced serially while still being movably connected, movably attached, fixedly connected, displaceably connected, linked, or coupled to one another, thereby minimizing the transit profile or cross-section of the delivery system. The interconnections of the components of the heart valve prosthesis can allow for different degrees of motion and can be set into engaged or held positions that provide a limited range of motion. In some embodiments, the engaged position can provide a preset relative positioning of the components of the heart valve prosthesis, facilitating proper placement and release of the heart valve prosthesis. Additionally, some embodiments can provide a high degree of control to the clinician, enhancing maneuverability of the heart valve prosthesis when implanting it at a target location.

[0053] In some embodiments, valve anchor 120 can be coupled to support frame 107 when support frame 107 is in a compact configuration prior to delivery and inflation. In some embodiments, valve anchor 120 is not secured to support frame 107. Furthermore, valve anchor 120 can be separate from support frame 107 or can be formed separately from support frame 107 and later coupled to support frame 107. Thus, at least a portion of the valve anchor, e.g., an anchoring leg, can be in contact with or otherwise reversibly attached or connected to the support frame, but no portion of the valve anchor is secured to the support frame, e.g., welded or otherwise irreversibly bonded. Alternatively, the valve anchor can be in contact with or otherwise reversibly attached to the support frame, and the valve anchor is not irreversibly secured to the support frame.

[0054] Furthermore, upon reaching the target location, the valve anchor 120 may be movably coupled to the support frame 107 in a manner that prevents the entire valve anchor 120 from being radially displaced from the support frame 107 when the valve anchor 120 is initially expanded. For example, a portion of the valve anchor 120 may be radially displaced from the support frame during the initial “landing” of the valve anchor 120 against the native valve structure at the target location. In some embodiments, the support frame 107 may be deployed or expanded into the native heart valve structure, and the valve anchor 120 may become sandwiched between the support frame and the native valve tissue and become at least partially (and in some cases, completely) immobilized (e.g., as shown in FIGS. 7E and 7F ). The valve anchor 120 may function to hold the expanded support frame 107 in place within the native valve structure.

[0055] In some embodiments, valve anchor 120 can include at least one U-shaped member, anchoring member, valve clasper, sinus locator, valve positioner, or valve hanger 126 and at least one anchoring leg 122. U-shaped member 126 and anchoring leg 122 can extend along a longitudinal axis of valve anchor 120. As illustrated in FIG. 2, valve anchor 120 can include multiple U-shaped members 126, such as three U-shaped members 126, although fewer or more are also possible.

[0056] U-shaped members 126 may be connected to anchoring legs 122 at peak portions or apexes 128 of valve anchor 120. Additionally, adjacent U-shaped members 126 may be connected to each other at their respective apexes 128. U-shaped members 126 may include first and second legs 146, 148, respectively, which meet or join at their base portions 144. Base portions 144 of U-shaped members 126 may be configured to engage with or fit within the posterior, left, and right aortic sinuses of the native aortic valve. The first and second legs 146, 148 of adjacent U-shaped members 126 may be interconnected at their peak portions 128.

[0057] 2 and 6A-6F, valve anchor 120 can include at least one anchoring leg 122. Anchoring leg 122 can include a coupling portion 124 having a connector or connecting aperture 127. The connector can include structure such as a slot or hole extending through coupling portion 124.

[0058] In some embodiments, anchoring legs 122 of valve anchor 120 are positioned approximately parallel to the longitudinal axis of support frame 107 and are attached to U-shaped members 126 at apexes 128. As used herein, apex 128 can be the apex where U-shaped members 126 join anchoring legs 122. In some embodiments, two U-shaped members 126 can be curved to join anchoring legs 122 at the apex or apex 128. In some embodiments, the apex of valve anchor 120 can be configured such that two anchoring legs 122 extend approximately parallel to one another. In some embodiments, valve anchor 120 includes at least two U-shaped members 126 and two anchoring legs 122.

[0059] Each of the first or proximal ends of the two anchoring legs 122 may be joined to a U-shaped member 126. In an additional embodiment, as shown in FIG. 2, the second or distal end of one or more of the anchoring legs 122 terminates in a coupling portion 124. That is, the coupling portion 124 of the valve anchor 120 is positioned at the end portion of the valve anchor anchoring leg 122. The coupling portion 124 may be made of a shape memory alloy, such as Nitinol. For some applications, the coupling portion 124 may be oriented parallel to the longitudinal axis of the valvular prosthesis 105, while for other applications, the coupling portion 124 may be oriented at an angle relative to the longitudinal axis.

[0060] For example, coupling portion 124 can be approximately parallel to the longitudinal axis of support frame 107 in the compact position and / or when valvular prosthesis 105 is encased in sheath 150. Alternatively, as shown in FIG. 2, coupling portion 124 can form a predetermined angle with respect to the longitudinal axis of valvular prosthesis 105 or anchoring legs 122 when valvular prosthesis 105 is in an expanded condition. The detents can help secure valve anchors 120 to support frame 107 after valvular prosthesis 105 is expanded into the native valve.

[0061] It will be recognized by those skilled in the art that the shape of the base portion 144 joining the two anchoring legs 122 of the U-shaped member 126 is not limited to being U-shaped or rounded. The base portion 144 can have other shapes, including, but not limited to, rectangular, square, diamond, triangular, oval, circular, or combinations of these shapes. The base portion 144 can be of any shape that allows it to engage and / or rest adjacent to the commissures of the native valve leaflets 190.

[0062] In some embodiments, the valve anchor 120 can include multiple U-shaped members 126 coupled to the support frame 107. That is, the delivery system 100 can include, without limitation, two, three, four, five, or more U-shaped members 126 to accommodate different valve replacement procedures or according to the anatomy of the native valve to be replaced. In various embodiments disclosed in the figures, the number of U-shaped members 126 in the valve prosthesis is three.

[0063] Additionally, according to some embodiments, valve prosthesis 105 can be configured such that support frame 107 is coupled to valve anchor 120. For example, valve prosthesis 105 can include at least one suture 170, which couples support frame 107 to the valve anchor. In some embodiments, a distal end portion of support frame 107 can be coupled to valve anchor 120 via suture 170. The portion of suture 170 attached to valve anchor 120 can be coupled to anchoring leg 122 of valve anchor 120. According to some embodiments, anchoring leg 122 can include longitudinal slot 123 extending along the length of the anchoring leg. Suture 170 can be looped into slot 123 and coupled to anchoring leg 122. This can allow the suture 170 to slide along the length of the slot 123 during expansion of the valvular prosthesis 105, as discussed further herein.

[0064] 3A and 3B are perspective and cross-sectional illustrations of an embodiment of nose cone 156 of valve anchor delivery system 100 of FIG. 2. As shown in FIGS. 2, 3A, and 3B, delivery system 100 can include nose cone 156 at its distal end. Nose cone 156 can have a substantially tubular and / or conical profile that tapers toward the distal end of nose cone 156. Additionally, nose cone 156 can include locking component 140 and cavity 141. In some embodiments, nose cone 156 can interact as part of engagement mechanism 115, allowing locking component 140 and pin assembly 125 to engage valve anchor 120.

[0065] According to some embodiments, the nose cone 156 can be configured to couple to or mate with the distal end of the valve sheath 150, reducing any seams along the outer surface of the delivery system 100 between the nose cone 156 and the sheath 150. The mating engagement between the nose cone 156 and the sheath 150 can thereby provide a smooth, continuous outer surface of the delivery system 100.

[0066] For example, the nose cone 156 can include a radial recess 154 against which the distal end of the valve sheath 150 can be positioned in the delivery configuration. The radial recess 154 can allow at least a portion of the nose cone 156 (including the locking component 140) to be inserted into the lumen 152 of the valve sheath 150, removably coupling the nose cone 156 to the valve sheath 150. Although the radial recess 154 is illustrated as having a generally conical profile, the radial recess 154 can also include a stepped profile in which the outer diameter of the nose cone 156 tapers from a diameter approximately equal to the outer diameter of the sheath 150 to a diameter approximately equal to the inner diameter of the sheath 150. In this manner, the nosecone 156 can fit inside the sheath lumen and can engage with the sheath 150, with both having a common or approximately equal outer diameter.

[0067] In some embodiments, locking component 140 may be integrally formed with nose cone 156. However, in some embodiments, as shown in Figures 3A and 3B, nose cone 156 may be an assembly of components including distal cone component 157 and locking component 140. Locking component 140 may include aperture 158 through which the pin assembly may be engaged or moved by a pusher component, as discussed below.

[0068] 3B, the proximal end portion of the distal cone component 157 can be coupled to the distal end portion of the locking component 140 by welding, frictional engagement, or other adhesive means. Additionally, the distal cone component 157 and the locking component 140 can collectively form a cavity 141. In some embodiments, both the distal cone component 157 and the locking component 140 can include internal cavities that combine to form the cavity 141 when the distal cone component 157 and the locking component 140 are coupled together. As discussed further herein, the cavity 141 can provide a predetermined volume within which the engagement mechanism pin assembly 125 can reciprocate.

[0069] Nose cone 156 can further include a channel or passageway 155 extending centrally along the longitudinal axis of the nose cone. Channel 155 can be configured to receive core member 110 as it reciprocates proximally and distally along the longitudinal axis to cause corresponding movement of support frame 107 and valve anchor 120.

[0070] According to some embodiments, lock component 140 can include at least one lock aperture 145. Lock aperture 145 can be disposed proximal to cavity 141. In some embodiments, pin assembly 125 can include multiple pins 135, and lock component 140 can include multiple lock apertures 145, each corresponding to one of the multiple pins 135.

[0071] Further, as shown, locking component 140 can include an engagement region 143 interposed between proximal flange 147 and distal flange 149. Locking aperture 145 can extend through both proximal flange 147 and distal flange 149. Locking aperture 145 extending through distal flange 149 can extend into cavity 141. Thus, a pin extending from pin assembly 125 can pass through distal flange 149, extend across engagement region 143, and pass through proximal flange 147. Thus, as further shown and discussed herein, the pin of pin assembly 125 can be radially constrained by locking aperture 145 extending through distal flange 149 and proximal flange 147 and can engage with a portion of valve anchor 120 extending into engagement region 143.

[0072] For example, as shown in FIGS. 6A-6F , pin assembly 125 can reciprocate within cavity 141 between an engaged configuration (shown in FIGS. 6A-6C ) and a released configuration (shown in FIGS. 6D-6F ). As pin assembly 125 moves from the engaged configuration to the released configuration, pin 135 of pin assembly 125 can slide out of engagement with locking aperture 145 of locking component 140. As such, pin 135 can be advanced distally out of engagement region 143 and received into cavity 141 and distal flange 149, thus releasing valve anchor 120 and allowing valve anchor 120 to expand out of engagement region 143.

[0073] 6A-6C, pin assembly 125 and locking component 140 can engage valve anchor 120 in an engaged configuration. Thus, valve anchor 120 remains engaged with delivery system 100 after sheath 150 is withdrawn proximally to allow the U-shaped member of valve anchor 120 to radially expand, thereby allowing the clinician to rotate, reposition, or otherwise manipulate the U-shaped member of valve anchor 120 to a desired position relative to the native valve structure.

[0074] 4A and 4B illustrate a pin assembly 125 and an alternative pin assembly 125′, according to several embodiments, either of which may be used with the delivery system 100 of FIG. 2. As illustrated in the embodiment shown in FIG. 4A, the pin assembly 125 can include a tubular component 130 having a proximal section 132 and a distal section 134. Additionally, both pin assemblies 125, 125′ can include an annular component, such as a piston member 136, and at least one pin 135 coupled to the annular component or the piston member 136. The annular component can have a disk, cylinder, torus, or other shape that can be coupled to and at least partially surround the core member 110. Additionally, the pin assembly 125 can be configured such that the distal section 134 of the tubular component 130 is coupled to the piston member 136. The alternative pin assembly 125' can be identical in all respects to the pin assembly 125 of FIG. 4A, except that the tubular component 130 is absent.

[0075] The pin assemblies 125, 125′ can slide along the core member 110 of the delivery system 100. For example, the core member 110 can be configured to extend through the lumen 133 of the pin assembly 125. The lumen 133 can extend through both the tubular component 130 and the piston member 136.

[0076] An advantage of pin assembly 125 may be the presence of tubular component 130, which can help maintain axial alignment of piston member 136 and pin 135 relative to the longitudinal axis of delivery system 100 during use. However, in either embodiment of the pin assembly, the longitudinal extension of lumen 133 through piston member 136 can be of sufficient length to prevent misalignment or wobble of piston member 136 relative to core member 110. Thus, both pin assemblies 125, 125′ can advantageously maintain pin 135 in approximately parallel alignment relative to core member 110. In this manner, pin 135 can smoothly slide out of engagement with locking aperture 145 of locking component 140. Furthermore, the proximal end of pin 135 can be advanced distally enough through engagement region 143 to allow valve anchor 120 to release therefrom. Thus, in some embodiments, pin 135 may continue to extend into engagement region 143, but valve anchor 120 may be able to release therefrom. However, in some embodiments, the proximal end of pin 135 may be fully received within locking aperture 145, such that pin 135 does not extend into engagement region 143 in the released configuration.

[0077] Although only one or two pins 135 may be used, the illustrated embodiment provides for three pins 135 to be used. The pins 135 extend proximally from the piston member 136 and may be radially spaced apart from the tubular component 130.

[0078] Optionally, in some embodiments, piston member 136 can include two plates or discs coupled to one another. In such embodiments, pin 135 can be positioned to extend through the proximal plate, with a distal end portion of pin 135 sandwiched between the proximal and distal plates of piston member 136, thereby engaging the distal end portion of pin 135 therebetween.

[0079] For example, the distal end portion of pin 135 may be bent at an angle, as shown in Figures 6A-6F, and at least one of the two piston members 136 may have a groove formed therein to receive and hold the bent distal end portion of pin 135 in a fixed position relative to pin assembly 125 when the proximal and distal plates of piston member 136 are coupled together. However, alternatively, the pin may be welded, mechanically fastened, or otherwise adhesively coupled to piston member 136. Thus, piston member 136 and pin 135 may slide as a unit along core member 110 between engaged and disengaged positions, as discussed herein.

[0080] 5A and 5B illustrate a pusher component 165 and an alternative pusher component 165′ according to some embodiments, either of which may be used with the delivery system 100 of FIG. 2. In some embodiments, the pusher component 165 may be used in combination with the pin assembly 125 shown in FIG. 4A.

[0081] Pusher component 165' can be used in combination with pin assembly 125' shown in FIG. 4B. In the illustrated embodiment, pusher component 165 does not include an elongated shaft component that contacts against pin assembly 125; instead, pusher component 165' can vary from pusher component 165 by including a shaft component 167 that can extend through aperture 158 in locking component 140 of nose cone 156. When used with pin assembly 125', shaft component 167 of pusher component 165' can extend through or into aperture 158 to facilitate movement and release of pin assembly 125'. However, these components 125, 125', 165, 165' can be interchanged or modified within any of the embodiments disclosed herein. Thus, in some embodiments, pusher component 165 may be brought into contact with tubular component 130 of pusher component 165, which extends through aperture 158 of lock component 140. However, in some embodiments, shaft component 167 of pusher component 165' may extend through aperture 158 of lock component 140 and come into contact with pin assembly 125'.

[0082] 5A and 5B, pusher component 165 and pusher component 165′ can each include a lumen 166 through which core member 110 can pass, thereby allowing pusher component 165 and pusher component 165′ to be slidably disposed along core member 110. As illustrated in the system diagrams of FIGS. 6A-6F, pusher component 165 (whether pusher component 165 or pusher component 165′) can be disposed distally relative to support frame 107. Finally, as discussed below, pusher component 165 can be brought into contact with tubular component 130 of pusher component 165, which extends through aperture 158 of locking component 140.

[0083] According to some embodiments, pusher component 165 can have an outer diameter or profile approximately equal to the compressed diameter of support frame 107. Thus, pusher component 165 and support frame 107 can be received within a lumen of sheath 150. Additionally, a distal end portion of support frame 107 can abut or contact proximal surface 172 of pusher component 165. As discussed further herein, some embodiments can allow support frame 107 to be forced distally against proximal surface 172 of pusher component 165, exerting a distally directed force on pusher component 165, which can then cause pusher component 165 to contact pin assembly 125 and cause release of pin 135 from valve anchor 120.

[0084] In some embodiments, pusher component 165 includes flange 175. As shown in FIG. 5A , flange 175 can be a radial flange defining proximal surface 172. Additionally, pusher component 165 can include distal surface 174, which has a generally sloped or conical profile. The conical profile of distal surface 174 can tend to allow pusher component 165 to capture or otherwise avoid engaging valve anchor 120 during distal advancement of pusher component 165 through valve anchor 120, as discussed below.

[0085] While various mechanisms may be used, in some embodiments, distal advancement of pusher component 165 may be achieved by contacting a distal end of support frame 107 against proximal face 172 of pusher component 165. For example, with reference to FIG. 6A , delivery system 100 may include a pushing block 178 coupled to a pusher tube 179. Pusher tube 179 and pushing block 178 may each include a lumen through which core member 110 may pass. Pusher tube 179 and pushing block 178 may be slidably positioned along core member 110. During a procedure, when sheath 150 is retracted proximally to the position approximately shown in FIGURE 6B, pusher tube 179 and pushing block 178 may be advanced distally along sheath 150 by the clinician, which may exert a distal force against support frame 107 and pusher component 165. This distally directed force may urge pusher component 165 toward proximal contact surface or area 137 of pin assembly 125, 125', as shown for illustrative purposes by the movement shown from FIGURE 6B to FIGURE 6C.

[0086] Thus, in some embodiments, distal surface 174 of pusher component 165, 165′ can contact proximal contact surface 137 of pin assembly 125, 125′, urging pin assembly 125, 125′ distally relative to locking component 140. In some embodiments, the tubular section can be coupled to either the pusher component or the pin assembly, or can be coupled to both. Distal movement of pin assembly 125, 125′ results in engagement mechanism 115 shifting from an engaged configuration (shown in FIG. 6C ) to a disengaged configuration (shown in FIG. 6D ).

[0087] According to some embodiments, the pusher tube 179 and the pushing block 178 can be actuated via a control unit (not shown) that can be operated by a clinician. The control unit can be communicatively coupled to the core member 110 and the pusher tube 179 and allow the clinician to actuate or move the core member 110 relative to the pusher tube 179. In this manner, the pusher tube 179 can be advanced distally over the core member 110, causing the pusher component 165 to contact the pin assembly 125 and causing the pin assembly 125 to move through the cavity 141 of the nose cone 156, thereby advancing the pin 135 distally through the engagement region 143.

[0088] In some embodiments, the control unit is communicatively coupled to the pusher component 165 and is capable of selectively actuating the pusher component 165 without requiring interaction from the pusher block 178 and the support frame 107. For example, the pusher component 165 may be directly coupled to the pusher tube 179 to directly actuate the pusher component 165 to contact the pin assembly 125 and urge the pin assembly 125 distally relative to the lock component 140. Similar to the embodiment illustrated in the figures, such an embodiment is capable of moving the engagement mechanism 115 from an engaged configuration to a disengaged configuration.

[0089] In some embodiments, lumen 166 of pusher component 165 can have an inner diameter that is smaller than the inner diameter of tubular component 130 or lumen 133 of pin assembly 125. Accordingly, such embodiments can enable pusher component 165 to have a sufficient cross-sectional profile to allow pusher component 165 to advance distally, contact pin assembly 125, and ultimately urge or push pin assembly 125 distally.

[0090] 6A-6C illustrate valve anchor 120 of delivery system 100 in an engaged configuration. This is referred to as the engaged configuration (see FIGS. 6A-6C ) when legs 122 of valve anchor 120 are inserted into engagement region 143 and locked in place via engagement mechanism 115. In the engaged configuration, pin 135 is positioned to extend from cavity 141 of nose cone 156, through connecting aperture 126 of valve anchor leg 122, and into and through locking aperture 145 of locking component 140 of nose cone 156. As such, in the engaged configuration, at least one leg 122 of valve anchor 120 is engaged and locked in position between locking component 140 of nose cone 156 and the remainder of nose cone 156.

[0091] 6A further illustrates the valve prosthesis 105 and valve anchor 120 housed in a compact state within the sheath 150 of the delivery system 100, according to some embodiments. When the delivery system 100 is initially introduced into the target location of the defective valve, the delivery system 100 is delivered in a compact state, as illustrated in FIG.

[0092] 6B illustrates valve anchor 120 in an engaged configuration, but released from sheath 150 of delivery system 100 of FIG. 2, according to some embodiments. Once delivery system 100 approaches the target location, sheath 150 of delivery system 100 is retracted proximally relative to core member 110, e.g., via a control unit including at least one controller or processor. Retraction of sheath 150 from over valve anchor 120 allows valve anchor 120 to radially expand. U-shaped member 126 can then be guided and steered to a desired position relative to the surrounding native valve structure, as discussed herein.

[0093] After U-shaped member 126 is in the desired position relative to the surrounding native valve structure, the remainder of valve anchor 120 can be released. FIG. 6C illustrates the first step and releasing valve anchor 120. As shown, in some embodiments, pusher block 178, sheath 150, and support frame 107 can be urged distally, thereby advancing pusher component 165 distally toward pin assembly 125 of delivery system 100. This distal movement of pusher component 165 into the lumen of valve anchor 120 is possible because valve anchor 120 has already been radially expanded despite being locked in the engaged configuration by engagement mechanism 115. In the partially expanded position shown in FIG. 6C, at least one U-shaped member 126 of the valve anchor 120 can extend radially from the longitudinal axis of the anchoring leg 122 of the valve anchor 120 and the support frame 107.

[0094] 6C , in the engaged configuration, the proximal surface of tubular component distal section 134 or piston member 136 is axially spaced a first distance D1 from the proximal surface of locking component 140. First distance D1 is sufficient to allow pin 135 to extend from cavity 141 through locking aperture 145 and engagement region 143. As such, pin 135 can extend through leg connecting aperture 127 of valve anchor 120 and locking component locking aperture 145 to interconnect valve anchor anchor fixation leg 122 and engagement mechanism 115. For example, the first distance D1 can be between about 1 mm and about 20 mm, between about 2 mm and about 15 mm, between about 4 mm and about 12 mm, between about 6 mm and about 10 mm, between about 8 mm and about 10 mm, or about 2 mm, about 2 mm, about 4 mm, about 6 mm, about 8 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 22 mm, about 24 mm, about 26 mm, about 28 mm, about 30 mm, about 35 mm, or about 40 mm.

[0095] As pusher component 165 is urged distally, it contacts pin assembly 125 and begins to urge pin assembly 125 distally through cavity 141. As this occurs, pin 135 slides distally through engagement region 143, eventually allowing anchoring legs 122 to disengage from pin 135 and allowing valve anchor 120 to assume the released configuration. Figure 6D is an illustration of valve anchor 120 in the released configuration.

[0096] 6D , in the released configuration, the proximal surface of the tubular component distal section 134 or piston member 136 can be axially spaced a second distance D2 from the proximal surface of the locking component 140, the second distance D2 being greater than the first distance D1. The second distance D2 is sufficient to position the pin 135 outside the locking aperture 145 and allow the valve anchor leg 122 to disengage from the pin 135 of the pin assembly 135. For example, the second distance D2 can be between about 1 mm and about 20 mm, between about 2 mm and about 15 mm, between about 4 mm and about 12 mm, between about 6 mm and about 10 mm, between about 8 mm and about 10 mm, or about 2 mm, about 2 mm, about 4 mm, about 6 mm, about 8 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18 mm, about 20 mm, about 22 mm, about 24 mm, about 26 mm, about 28 mm, about 30 mm, about 35 mm, or about 40 mm.

[0097] In operation, when pin assembly 125 is advanced distally, pin 135 is displaced a distance corresponding to the difference between D2 and D1, thereby releasing valve anchor 120 from engagement with pin assembly 125 and allowing valve anchor 120 to expand radially in preparation for positioning support frame 107 therein.

[0098] As shown in FIG. 6D , after the valve anchor 120 is released from the delivery system 100, the support frame 107 remains housed within the sheath 150 of the delivery system 100. However, after the longitudinal or axial position of the support frame 107 is adjusted so that it is centered or otherwise properly positioned within the lumen of the valve anchor 120, the clinician can then initiate the release and expansion of the support frame 107 within the lumen of the valve anchor 120. As part of this adjustment for the positioning process, the clinician can advance the support frame 107 distally. In some implementations of the method, the clinician can advance the support frame 107 to a position longitudinally distal to the valve anchor 120 and then retract the support frame 107 proximally. Such movement can ensure that the native valve leaflets are drawn upward into the space between the valve anchor 120 and the support frame 107. Thereafter, expansion and release of the support frame 107 can be initiated by the clinician, as discussed further below.

[0099] Expansion and release of support frame 107 can be initiated as illustrated in FIG. 6E , which illustrates sheath 150 being retracted proximally to expose support frame 107 and allow for initial expansion of support frame 107. FIG. 6F illustrates sheath 150 being further retracted to allow support frame 107 to fully expand within valve anchor 120. In some embodiments, further retraction of sheath 150 causes valvular prosthesis 105 to be fully exposed, thereby allowing the valvular prosthesis to expand radially within valve anchor 120. However, in some embodiments, the outward force of the self-expanding support frame 107 can cause support frame 107 to spring open after sheath 150 is partially withdrawn proximally (i.e., reaching a position distal to that illustrated in FIG. 6F ).

[0100] Methods for operating and manufacturing a valve prosthesis delivery system The method for implanting an aortic valve prosthesis using the delivery system described herein involves the non-surgical delivery and implantation of an aortic valve prosthesis, wherein a self-expandable implant with artificial valve leaflets is fixedly coupled to a valve anchor, and the support frame and valve anchor are delivered in a compact condition.

[0101] Regardless of the route of administration or access, the delivery systems disclosed herein can be operated to release the valve anchors prior to expansion of the support frame. Moreover, the valve anchors can be manipulated and repositioned after expansion to ensure proper placement before expanding or releasing the support frame. Optionally, the systems can be operated using any of a variety of imaging techniques, including ultrasound, fluoroscopy, or pulsatile feedback, such as electrical or ultrasonic pulses. Thus, the valve anchors can be positioned using imaging techniques, if desired.

[0102] In some embodiments, the clinician can determine or feel via tactile pressure that the valve anchor is properly seated or engaged with the native valve structure, confirming proper positioning of the valve anchor relative to the native valve structure. After proper placement of the valve anchor, the support frame can be moved distally along the longitudinal axis toward the valve anchor until it is positioned approximately concentrically with the valve anchor. At this point, the support frame can be released and the delivery system can be removed from the patient. The support frame can be implanted over the existing native valve leaflets.

[0103] 7A-7F illustrate a method for operating a valve prosthesis delivery system. The delivery system can be advanced through the aorta to the native aortic valve using a delivery system such as the embodiment described above in FIGS. 6A-6F. As shown in FIG. 7A, in some embodiments, a guiding mechanism, e.g., a guidewire 180, can be advanced toward the target location and fed through the core member 110, allowing the delivery system 100 to advance along the guidewire 180 toward the target location. Entry of the delivery system 100 into the vascular system can occur through a variety of routes. However, as described herein, the guidewire 180 can be introduced into the aorta and advanced toward the aortic arch. The delivery system 100 can then be advanced along the guidewire 180 until it reaches the target location, e.g., the aortic valve of the heart.

[0104] 7A illustrates the delivery system 100 after reaching the aortic valve. As discussed above with respect to FIGS. 6A-6F, the delivery system 100 is delivered to the target location in the delivery configuration (FIG. 6A) and can thereafter be manipulated to allow expansion of the various components of the valvular prosthesis 105.

[0105] As described above, FIG. 6A illustrates the delivery system 100 as it is configured prior to insertion into a patient and during advancement of the delivery system through the patient's vasculature toward a target location. The valvular prosthesis 105 is packed within the delivery system 100 in a compact configuration, such that the support frame 107 and valve anchor 120 of the valvular prosthesis 105 are packed serially within the sheath 150. As is common practice, a guidewire is first introduced into the patient, e.g., into the femoral artery or, if using a transapical technique, into the left ventricle, and advanced into the appropriate chamber, past or beyond the native heart valve requiring repair. Although not shown in the figures, the present disclosure also provides for transapical delivery of the valvular prosthesis 105.

[0106] A method for delivering a valve prosthesis to a target location having a damaged or defective valve includes advancing a delivery system 100 into a blood vessel (e.g., the aorta) and positioning a valve anchor 120 at the target location. In some embodiments, the target location is adjacent to the aortic valve of a patient's heart. Notably, the target location can be a location immediately above the native aortic valve cusps 190, as illustrated in FIG. 7A. Advancing the delivery system 100 can be accomplished by advancing its distal end to the target location in a direction opposite to the direction of blood flow.

[0107] As the delivery system is advanced into the blood vessel, the clinician can control delivery system 100 by actuating one or more actuators on a control unit. In some embodiments, the actuators can be, but are not limited to, knobs, levers, triggers, sliders, buttons, and / or handles on the control unit. Actuation of the actuators can cause sheath 150 to retract proximally and reveal at least a portion of valve anchor 120 at the target location (as shown in FIGS. 6A-6B and 7A ). Proximal retraction of sheath 150 allows U-shaped members 126 of valve anchor 120 to expand at the target location to position valve anchor 120 in a desired orientation. When portions of U-shaped members 126 are exposed, they will attempt to expand radially away from the central axis (or guidewire axis). The radial expansion of U-shaped member 126 can allow a clinician to at least initially align, position, and / or rotate delivery system 100 into proper alignment within the native valve. In some circumstances, advancement of delivery system 100 through the native vasculature may tend to cause U-shaped member to bend backward or evert in a direction opposite to that shown in FIG. 7A . In such a situation, if sheath 150 is only partially retracted from over valve anchor 120, sheath 150 can be advanced distally relative to valve anchor 120 to push or urge the U-shaped member into a forward-facing or non-everted orientation, as shown in FIG. 7A .

[0108] 7A illustrates placement of the distal end of delivery system 100, including nose cone 156, within the aorta past the native aortic valve. The distal end section of delivery system 100 (including nose cone 156) can be advanced and positioned into the aorta past the native aortic valve cusps 190. As shown in FIGS. 7A and 7B, after valve sheath 150 (which houses valve prosthesis 105) is properly positioned within the aorta, valve sheath 150 can be pulled proximally to uncover valve anchor 120. This allows base portion 144 of U-shaped member 126 of valve anchor 120 to expand radially toward the interior wall of the aorta.

[0109] In some embodiments, as discussed herein, base portion 144 of valve anchor 120 functions as a "feeler" that allows a clinician to properly place valve anchor 120 and support frame 107 within the native valve structure with minimal or no imaging during inflation time (see FIGS. 7A and 7B). Valve anchor 120, as discussed herein, can be made from, but is not limited to, a shape memory material or metal, such as, for example, nitinol.

[0110] In some embodiments, delivery system 100 is further advanced distally and / or rotated until valve anchor 120 gently seats within the native aortic structures (e.g., the annulus or sinuses) at the target location. While valve anchor 120 is advanced distally, it can rotate and self-align according to the anatomical orientation of the native aortic valve cusps 190, as shown in FIG. 7B.

[0111] After valve anchor 120 is properly seated or positioned relative to the native valve structure, the clinician can distally advance pusher component 165 to contact pin assembly 125 and distally advance pin assembly 125 relative to locking component 140. In some embodiments, distal advancement of pusher component 165 includes distally advancing pusher block 178 to contact support frame 107 and pusher component 165, displacing them distally until they contact pin assembly 135. This causes an increase in the axial spacing between locking component 140 and piston member 136 (not shown), as illustrated by distances D1 and D2 in FIGS. 6C and 6D , thereby distally advancing pin 135 out of engagement region 143.

[0112] 7C and 7D , in some embodiments, distally advancing pusher component 165 includes advancing pusher block 178 and sheath 150 relative to core member 110, thereby distally advancing support frame 107 in a collapsed state to contact proximal surface 172 of radial flange 175 (not shown, but see FIGS. 6B-6D ) of pusher component 165 and displace it distally relative to core member 110. Distal advancement of pin assembly 125 relative to locking component 140 causes pin 135 of pin assembly 125 to disengage from locking aperture 145 of the locking component, thereby permitting release of valve anchor 120 from delivery system 100.

[0113] After releasing anchoring legs 122 of valve anchor 120 to fully release valve anchor 120, delivery system 100 may optionally be advanced distally through valve anchor 120 to position support frame 107 at a desired longitudinal position within the lumen of valve anchor 120. Thereafter, valve sheath 150 (which at this point extends over or continues to cover support frame 107) may be retracted distally relative to core member 110 toward locking component 140, as illustrated in Figures 7E and 7F.

[0114] According to some embodiments, delivery system 100 may also be configured to advantageously position portions of valve anchor 120 on opposite sides of the native valve leaflets. Such capability may allow delivery system 100 to create a more secure engagement between valve anchor 120 and the native valve structure. Such configurations and advantages may be achieved through the use of an engagement mechanism that can restrain portions of the anchoring legs of the valve anchor. Furthermore, other embodiments may provide additional features that facilitate engagement on opposite sides of the native valve leaflets.

[0115] For example, as shown in FIG. 7B , support frame 107 can be slidably coupled to anchoring legs 122 of valve anchor 120 via sutures 170, which can create a radial restraint on the expansion of a proximal portion of valve anchor 120. As support frame 107 is moved distally toward locking component 140, sutures 170 are accordingly moved distally along anchoring legs 122 of valve anchor 120 toward locking component 140 (see FIGS. 7B-7D ). The reduced radial restraint created by sutures 170 thereby allows a proximal end portion of valve anchor 120 to expand radially outward while holding the distal end of valve anchor 120 stationary along its longitudinal axis as valve anchor 120 radially expands. Thus, the anchoring legs 122 of the valve anchor 120 can be positioned radially inward or at the center of the valve leaflet, and the base portion 144 of the U-shaped member 126 can be positioned radially outward of the valve leaflet or around the periphery of the valve leaflet in direct contact with the aortic wall (e.g., in the valve sinus).

[0116] Sheath 150 and support frame 107 are then advanced distally in this manner until the distal ends of sheath 150 and support frame 107 are positioned just above locking component 140. FIG. 7D illustrates the positioning of support frame 107 in its final pre-release position. Distal advancement of sheath 150 and support frame 107 to a position just above locking component 140 also positions support frame 107 in a pre-release position, which can be adjusted as needed after releasing valve anchor 120. In some embodiments, the pre-release position is a position in which support frame 107 is longitudinally disposed within sheath 105 and within the passageway of valve anchor 120.

[0117] When support frame 107 has reached its final pre-release position, the clinician can then further advance pusher component 165 to distally advance pin assembly 125, thereby releasing valve anchor 120 from engagement with pin assembly 125. That is, anchoring legs 122 can be released from being locked or engaged in engagement region 143 between locking aperture 145 of locking component 140 and connecting aperture 127 of pin assembly 125, as shown in FIG. 7E.

[0118] 7E also illustrates support frame 107 in a partially expanded configuration. After anchoring legs 122 of valve anchor 120 are released from their locked state between locking component 140 and pin assembly 125, control unit 110 is then activated to proximally retract sheath 150 along core member 110, exposing or revealing support frame 107 and allowing support frame 107 to begin expanding. As support frame 107 begins to expand, support frame 107 can be circumferentially constrained (i.e., rotationally oriented) relative to valve anchor 120 via sutures 170. Thus, in some embodiments, sutures 170 can cause the expansion of support frame 107 to be automatically guided and secured in place by valve anchor 120.

[0119] 7F, the valve prosthesis 105 can include a plurality of artificial valve leaflets 109 coupled to a support frame 107. The leaflets 109 can have surfaces that form reversibly sealable openings for unidirectional fluid flow through the valve prosthesis 105. The valve prosthesis 105 can include three leaflets 109 for a three-leaflet configuration. As will be appreciated, single-leaflet, two-leaflet, and / or multi-leaflet configurations are also possible.

[0120] For example, the leaflets 109 may be coupled to the support frame 107 to expand and control fluid flow through the lumen of the valve prosthesis 105. Additionally, in some embodiments, the valve prosthesis 105 may include a membrane or sealing layer 108 coupled to the support frame 107 and the valve leaflets 109. The membrane 108 may ensure that blood flows through a central aperture or lumen of the valve prosthesis 105. Valve prostheses as described herein may be used in various embodiments of the implantation systems described herein or may be used in any method or system known by one of skill in the art for implanting a valve prosthesis into a subject.

[0121] Additionally, sealing and anchoring of the valvular prosthesis 105 to the surrounding native valve structure is facilitated through the interposition of the native heart valve leaflets 190 between the valve anchors 120 and the support frame 107. This positioning of the leaflets 190 facilitates anchoring of the valvular prosthesis 105 into the native valve structure and may be applicable to all coronary valves (i.e., aortic, pulmonary, tricuspid, and mitral). In some embodiments, the number of valve anchors 120 may be equal to the number of native valve leaflets 190 of the native valve being treated.

[0122] 7F illustrates support frame 107 in a fully expanded, relaxed configuration. As illustrated in FIG. 7F, support frame 107 may be properly seated within the native valve anatomy when base portion 144 of U-shaped member 126 of valve anchor 120 is approximately adjacent to the distal end of support frame 107. Furthermore, support frame 107 may be properly seated within the native valve anatomy when expansion of support frame 107 results in sandwiching native aortic valve cusps 190 between the expanded support frame 107 and valve anchor 120.

[0123] In some embodiments, after support frame 107 has expanded and released into the native valve structure, the control unit can be actuated to retract the remaining portions of delivery system 100 other than support frame 107 and valve anchor 120. For example, sheath 150 can be advanced distally over core member 110 to engage radial recess 154 of nose cone 156 against the distal end of sheath 150. In this manner, delivery system 100 can assume a delivery configuration in which delivery system 100 has a generally smooth outer profile that avoids catching or otherwise damaging the vasculature during removal. Delivery system 100 can then be removed from the patient.

[0124] Additional Aspects of the Valve Prosthesis 7F, when inflated and released, the support frame 107 can include a first end portion 210 and a second end portion 212. When the prosthesis 105 is released into the native valve structure, the first end portion 210 can be positioned upstream of the second end portion 212.

[0125] As shown in FIG. 7F, the first end portion 210 of the support frame 107 may be shaped as a generally flat end of a cylinder, where the first apex 214 of the support frame 107 generally lies in a common plane, and the common plane may be oriented substantially perpendicular to the longitudinal axis of the prosthesis 105.

[0126] Optionally, the second end portion 212 may be shaped to include a series of peaks 230 and valleys 232, where the second apexes 236 of the support frame 107 collectively define the contours of the peaks 230 and valleys 232. The peaks 230 and valleys 232 of the second end portion 212 may be positioned downstream of the first end portion 210 when the prosthesis is seated within the native valve annulus. According to some embodiments, the artificial leaflets 109 may be coupled to the support frame 107 at locations circumferentially aligned with the peaks 230 of the second end portion 212, as shown in FIG. 7F . This unique configuration advantageously allows the prosthesis 100 to more fully approximate the native valve structure, permitting more natural blood flow without restricting or constraining the movement of the leaflets 109, and allowing for more seamless integration with the surrounding heart architecture.

[0127] In some embodiments, the axial ends of membrane 108 at second end portion 212 can be shaped to cover major peaks 230 and valley floors 232 of second end portion 212. In some embodiments, membrane 108 can be shaped to cover second apexes or minor peaks 236 in valley floors 232 between major peaks 230. Advantageously, the configuration of minor peaks 236 between major peaks 230 can allow improved access to and prevent ostial obstruction compared to prior art valve prostheses.

[0128] Prior art valve prostheses implanted in the aorta may block or occlude coronary ostia disposed a predetermined distance away from the annulus due to the geometry of the valve frame and membrane, as discussed in Applicant's co-pending patent applications, U.S. Patent Application Nos. 62 / 614,488 (122271-5025), filed January 7, 2018; 62 / 614,489 (122271-5040), filed January 7, 2018; 62 / 756,556 (122271-5127), filed November 6, 2018; and 62 / 781,537 (122271-5129), filed December 18, 2018, the entire contents of which are incorporated herein by reference.

[0129] Referring to FIG. 7F , the height difference between the major peak 230 and the minor peak 236 facilitates access to the coronary ostia while allowing for desired operation of the valvular prosthesis 105. In some embodiments, the minor peaks 236 are configured to be low enough to allow for various sizes and locations of the coronary ostia with respect to the patient's native annular location. Advantageously, in some embodiments, the minor peaks 236 allow access to ostia with coronary ostial heights of less than 10 mm, less than 8 mm, or less than 6 mm (which are typically excluded by conventionally available prostheses). Ostial height may be measured as the perpendicular distance between the inferior edge of the coronary ostia and the aortic annular plane. Furthermore, in some embodiments, the minor peaks 236 allow access to ostia disposed at a lower axial distance (or ostial height) relative to the annulus. Moreover, in some embodiments, the valvular prosthesis 105 may be positioned lower in the annulus to allow for greater access to the ostia. By providing minor peaks 236 between the major peaks 230, and optionally used in conjunction with one or more other features discussed herein, access to the coronary artery ostium is preserved, allowing for future procedures that may require access to the ostium (e.g., coronary stenting, etc.).

[0130] According to some embodiments, the axial length of the support frame 107 can vary between the major peaks 230, minor peaks 236, and valleys 232.

[0131] For example, the axial length of the support frame 107 measured at the major peak 230 can be about 10% to about 50%, about 20% to about 40%, about 25% to about 35%, or about 33% greater than the axial length measured at the minor peak 236.

[0132] Additionally, in some embodiments, the axial length of the support frame 107 measured at the major peak 230 can be about 50% to about 150%, about 70% to about 130%, about 90% to about 110%, or about 100% greater than the axial length measured at the valley base 232.

[0133] Additionally, in some embodiments, while membrane 108 is shown as following major peak 230 and minor peak 236 along second end portion 212 of support frame 107, membrane 108 can also extend along individual struts or frame members of support frame 107. Thus, the individual struts forming support frame 107 can roughly define the boundaries of membrane 108.

[0134] Additional aspects of the support frame 107, membrane 108, and valve anchor 120 may be configured as discussed and illustrated in some of the applicant's co-pending applications identified above, the entire contents of which are incorporated herein by reference.

[0135] For example, in some embodiments, the membrane 108 can be formed or manufactured by cutting the membrane 108 from a woven or mesh fabric. The membrane fabric can be a fabric formed from woven fibers, such as woven polyester. As discussed and illustrated in some of the applicant's co-pending applications mentioned above, the membrane fabric can be woven with warp and weft fibers oriented transversely to one another, and in some cases perpendicularly to one another. In some embodiments, the fabric can resist stretch in the warp and weft directions while allowing stretch and compliance in directions oblique to or biased from the warp and weft directions. The membrane 108 and frame 107 can be configured as also disclosed in some of the applicant's co-pending applications mentioned above.

[0136] Optionally, one or more membranes 108 can be cut from the membrane fabric using a template generally in the shape of the membrane. The template or templates can be placed over the membrane fabric to cut out the membranes. The template can be oriented at an angle relative to the membrane fabric so that, when the membrane is coupled to the support frame 107, it defines a bias angle between the warp or weft direction of the membrane fibers and the longitudinal axis of the support frame 107. The bias angle can be from about 30 degrees to about 60 degrees, such as about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, or about 55 degrees.

[0137] In some embodiments, the warp and weft yarns of the woven membrane 108 can be oriented at a bias angle between 0 and 90 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at a bias angle between about 15 and about 75 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at a bias angle between about 30 and about 60 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at a bias angle of about 45 degrees relative to the longitudinal axis.

[0138] By orienting the template at a predetermined bias angle relative to the membrane fabric, the resulting membrane 108 can be cut on bias with a bias angle relative to the warp and weft directions of the membrane fabric. In some embodiments, the membrane 108 can be cut at a bias angle by spiral wrapping the membrane fabric over the support frame 107 and cutting the membrane fabric.

[0139] Through implementation of a bias orientation of the fibers of membrane 108 on support frame 107, membrane 108 can more easily compress radially and elongate axially in cooperation with support frame 107, thus, in some embodiments, allowing membrane 108 and support frame 107 to operate as a single unit. Similarly, in some embodiments, by orienting membrane 108 along a bias angle, membrane 108 can more easily elongate along the longitudinal axis and acquire a smaller cross-sectional profile, which can prevent flaring, bunching, or pleating, thereby minimizing the cross-sectional profile of valvular prosthesis 105 in the compressed configuration.

[0140] Illustration of subject technology as clauses Various examples of aspects of the present disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Figure and reference numeral identification is provided below merely as an example and for illustrative purposes, and the clauses are not limited by those identifications.

[0141] Clause 1. A valve prosthesis including a valve anchor, the valve anchor having a longitudinal axis and proximal and distal end portions, the valve anchor including a plurality of U-shaped members and a plurality of anchoring legs, each of the plurality of U-shaped members having a rounded base portion disposed at the distal end portion of the valve anchor and first and second legs extending proximally from the rounded base portion toward the proximal end portion of the valve anchor, the first leg of the first U-shaped member and the second leg of the second U-shaped member being configured to support the valve. A valve prosthesis, wherein the anchor is connected at its proximal end portion to the proximal end portion of one of a plurality of anchor fixing legs, each of the plurality of anchor fixing legs including a connecting aperture at its distal end portion and a longitudinal slot extending along the length of the anchor fixing leg, the plurality of anchor fixing legs and the plurality of U-shaped members being capable of radially expanding in stages, allowing the natural valve structure to be interposed therebetween to anchor the valve prosthesis to the natural valve structure.

[0142] Clause 2. The valvular prosthesis of claim 1, wherein the plurality of U-shaped members includes three U-shaped members and the plurality of anchoring legs includes three anchoring legs.

[0143] Clause 3. The valve prosthesis of claim 1, wherein the connecting apertures each include a hole extending through a distal end portion of a respective anchoring leg.

[0144] Clause 4. The valve prosthesis of claim 1, further comprising a support frame, the support frame being connected to the valve anchor via at least one suture, the at least one suture being connected to the anchor fixation leg along the longitudinal slot.

[0145] Clause 5. The valvular prosthesis of claim 4, wherein the support frame includes a first end portion and a second end portion, the first end portion including a plurality of apexes extending in a first plane, and the second end portion including a plurality of peaks and valleys, the peaks being formed by a plurality of major apexes and the valleys being formed between the major apexes.

[0146] Clause 6. The valvular prosthesis of claim 5, wherein the second end portion further includes a plurality of micro-apexes, the micro-apexes being positioned intermediate the major apexes around the periphery of the second end portion, and each valley base being interposed between a micro-apex and a major apex.

[0147] Clause 7. The valve prosthesis of claim 6, wherein the support frame is connected to the valve anchor via at least one suture, the at least one suture being connected to at least one of the anchor fixation legs along at least one of the longitudinal slots and also connected to at least one of the apexes extending in the first plane.

[0148] Clause 8. The valve prosthesis of claim 5, further comprising a membrane coupled to the support frame along an interior of the support frame, the membrane extending along a second end portion of the support frame, and the height of the membrane varying between the peak and valley of the support frame.

[0149] Clause 9. The valvular prosthesis of claim 8, wherein the membrane comprises a woven fabric having warp fibers and weft fibers, the warp fibers extending transversely to the longitudinal axis of the prosthesis and the weft fibers extending transversely to the longitudinal axis of the prosthesis.

[0150] Clause 10. The valvular prosthesis of claim 1, wherein the stages include a first stage and a second stage, wherein in the first stage, the rounded base portion of each of the plurality of U-shaped members is configured to expand radially while the distal end portion of each of the plurality of anchoring legs is radially constrained via the connecting aperture, and in the second stage, the distal end portion of each of the anchoring legs is configured to expand radially following the radial expansion of the rounded base portion.

[0151] Clause 11. The valve prosthesis of claim 1, wherein the valve anchor is made from a shape memory material.

[0152] Clause 12. The valve prosthesis of claim 11, wherein the shape memory material is nitinol.

[0153] Clause 13. The valve anchor is made from a self-expanding nitinol frame, the plurality of U-shaped members includes three U-shaped members, the plurality of anchoring legs includes three anchoring legs, the connecting apertures each include a hole extending through a distal end portion of a respective anchoring leg, the prosthesis further includes a support frame, the support frame is coupled to the valve anchor via three sutures, the three sutures are coupled to the three anchoring legs along longitudinal slots in each of the three anchoring legs, the support frame includes a first end portion and a second end portion, and the first 10. The valve prosthesis of claim 1, wherein the end portion includes a plurality of apexes extending in a first plane, and the second end portion includes a plurality of peaks and valleys, the peaks being formed by a plurality of major apexes and the valleys being formed between the major apexes, and the second end portion further includes a plurality of micro-apexes, the micro-apexes being positioned intermediate the major apexes around the periphery of the second portion, each valley being interposed between a micro-apex and a major apex, and the support frame is connected to the valve anchor via at least one suture, and three sutures are further connected to three of the apexes extending in the first plane.

[0154] Clause 14. A delivery system for delivering a valvular prosthesis, the system comprising: a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions; an engagement mechanism coupled to the distal end portion of the core member for releasably engaging the valvular prosthesis, the engagement mechanism comprising a pin assembly coupled to the core member and movable along the core member, the pin assembly including an annular component and at least one pin, the at least one pin coupled to the annular component and extending away from the distal end portion, the at least one pin being radially spaced from the core member; and a locking component coupled to the core member proximal to the annular component, the locking component a lock component including at least one lock aperture configured to allow at least one pin to extend therethrough, the lock component and the pin assembly collectively forming an engagement area between the lock component and the pin assembly for engaging a portion of the valve prosthesis, the pin assembly being slidable distally relative to the core member and the lock component and an engagement mechanism for advancing the at least one pin distally out of the engagement area and releasing the pin assembly from the portion of the valve prosthesis; and a sheath having a lumen configured to house the pin assembly and the valve prosthesis therein in an engaged configuration.

[0155] Clause 15. The system of claim 14, wherein the annular component of the pin assembly includes a cylindrically shaped piston member.

[0156] Clause 16. The system of claim 14, wherein the system further includes a pusher component proximal to the pin assembly and the locking component, the pusher component coupled to the core member and slidable along the core member, the pusher component configured to contact and engage the pin assembly to advance the at least one pin distally relative to the locking component to advance the at least one pin distally out of the engagement region to release a portion of the valve prosthesis.

[0157] Clause 17. The system of claim 16, wherein the sheath is configured to house the pusher component in an engaged configuration.

[0158] Clause 18. The system of claim 16, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher component, the pusher component configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0159] Clause 19. The system of claim 16, further comprising a pusher block coupled to the pusher tube, the pusher tube being slidable along the core member to advance the pusher block distally.

[0160] Clause 20. The system of claim 19, wherein the pusher block is positioned proximal to the pusher component, the pusher block being spaced apart from the pusher component to allow placement of a support frame for the valve prosthesis therein.

[0161] Clause 21. The system of claim 20, wherein the sheath is configured to house the pusher block in an engaged configuration.

[0162] Clause 22. The system of claim 14, wherein the system further includes a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0163] Clause 23. The system of claim 14, further comprising a distal cone component coupled to the locking component, the distal cone component fixedly coupled to the core member and coupling the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the distal cone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member and allowing the pin assembly to extend therebetween when in an engaged configuration.

[0164] Clause 24. The system of claim 23, wherein the locking component and the distal cone component, when coupled together, collectively form a cavity, and the pin assembly is at least partially disposed within the cavity.

[0165] Clause 25. The system of claim 24, wherein the locking component includes a first cavity region and the distal cone component includes a second cavity region, the first and second cavity regions collectively forming a cavity when the locking component and the distal cone component are coupled together.

[0166] Clause 26. The system of claim 23, wherein the sheath has a distal end configured to abut a radial recess in the distal cone.

[0167] Clause 27. The system of claim 14, wherein the valve prosthesis includes a valve anchor having at least one anchoring leg, the at least one anchoring leg including a connecting aperture disposed therethrough for engaging the at least one pin.

[0168] Clause 28. The system of claim 14, wherein the pin assembly includes a plurality of pins, and the locking component includes a plurality of locking apertures each corresponding to one of the plurality of pins.

[0169] Clause 29. A delivery system for delivering a valve prosthesis, the system comprising: a valve prosthesis including a support frame coupled to a valve anchor, the support frame having a plurality of valve leaflets coupled thereto, the valve anchor having three anchor fixation legs, each anchor fixation leg including a connecting aperture disposed therethrough; a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions; an engagement mechanism coupled to the distal end portion of the core member for releasably engaging a valve anchor of the valve prosthesis, the engagement mechanism being a nose cone having a cavity formed therein and a locking component coupled thereto; and a pin assembly coupled to the core member and movable along the core member within the cavity, the pin assembly the assembly is disposed radially outward of the core member, the pin assembly including an annular component and three pins, the three pins coupled to the annular component and extending away from the distal end portion, the three pins being radially spaced apart from the core member; the locking component is positioned proximal to the annular component, the locking component including three locking apertures each corresponding to one of the three pins, the three locking apertures configured to allow the three pins to extend therethrough, the locking component and the pin assembly collectively forming an engagement region between the locking component and the pin assembly for engaging a portion of the valve anchor therein in an engaged configuration, and an engagement mechanism that allows release of the portion of the valve anchor upon movement of the three pins outward from the engagement region;a sheath having a lumen configured to receive the pin assembly, the valve anchor, and the support frame therein in an engaged configuration, the sheath having a distal end configured to abut a radial recess in the nosecone;

[0170] Clause 30. The system of claim 29, further comprising a pusher component proximal to the pin assembly and locking component, the pusher component coupled to the core member and slidable along the core member, the pusher component configured to contact and engage the pin assembly to distally advance the three pins relative to the locking component to distally advance the three pins out of the engagement region to release a portion of the valve prosthesis.

[0171] Clause 31. The system of claim 30, wherein the sheath is configured to house the pusher component in an engaged configuration.

[0172] Clause 32. The system of claim 30, further comprising a pusher block coupled to the pusher tube, the pusher tube being slidable along the core member to advance the pusher block distally.

[0173] Clause 33. The system of claim 32, wherein the pusher block is positioned proximal to the pusher component, the pusher block being spaced apart from the pusher component to allow placement of a support frame for the valve prosthesis therein.

[0174] Clause 34. The system of claim 33, wherein the sheath is configured to house the pusher block in an engaged configuration.

[0175] Clause 35. The system of claim 30, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher component, the pusher component configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0176] Clause 36. The system of claim 29, wherein the sheath is configured to extend over at least a portion of the locking component.

[0177] Clause 37. The system of claim 29, wherein the radial recess is configured to allow a proximal end portion of the locking component to be inserted into the lumen of the sheath to removably couple the locking component to the sheath.

[0178] Clause 38. The system of claim 29, wherein the annular component of the pin assembly includes a cylindrically shaped piston member.

[0179] Clause 39. The system of claim 38, wherein the piston member includes opposing proximal and distal plates, the proximal plate including three apertures, and three pins extending through the three apertures, portions of the three pins being interposed and engaged between the proximal and distal plates.

[0180] Clause 40. The system of claim 29, wherein the system further includes a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0181] Clause 41. The system of claim 29, wherein the system further includes a tubular component extending proximally through the locking component to a location proximal to the locking component.

[0182] Clause 42. The system of claim 29, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component, allowing three pins to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance, allowing the three pins to advance distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0183] Clause 43. The system of claim 42, wherein in the released configuration, the three pins are positioned outside the engagement region.

[0184] Clause 44. A delivery system for delivering a valvular prosthesis, the system comprising: a core member; a nose cone coupled to the core member, the nose cone having a nose cone component, a locking component proximal to and coupled to the nose cone component, and a cavity formed therein, the nose cone component positioned distal to the locking component, the locking component forming an engagement area with which a portion of the valvular prosthesis can be engaged; and a pin assembly coupled to the core member and movable along the core member within the cavity, the pin assembly including an annular component and at least one pin, the at least one pin being coupled to the annular component. a pin assembly coupled to the core member and extending through the locking component out of the cavity, the pin assembly being slidable relative to the core member and the locking component to move at least one pin out of the engagement region and release the pin assembly from a portion of the valvular prosthesis; and a pusher member coupled to the core member and slidable along the core member, the pusher member disposed proximal to the pin assembly and the locking component, the pusher member configured to contact and engage the pin assembly to move the at least one pin relative to the locking component to move the at least one pin out of the engagement region to release the portion of the valvular prosthesis.

[0185] Clause 45. The system of claim 44, wherein the pin assembly is slidable distally relative to the core member and locking component to advance at least one pin distally out of the engagement region and release the pin assembly from a portion of the valve prosthesis.

[0186] Clause 46. The system of claim 44, wherein the locking component includes a proximal flange and a distal flange, the proximal flange and the distal flange collectively forming an engagement region therebetween.

[0187] Clause 47. The system of claim 44, wherein the system further includes a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0188] Clause 48. The system of claim 44, further comprising a pusher member coupled to the core member and slidable along the core member, the pusher member configured to contact the pin assembly to slide the pin assembly to move the at least one pin out of the engagement region.

[0189] Clause 49. The system of claim 48, wherein a pusher member is disposed proximal to the pin assembly and the locking component, the pusher member configured to contact and engage the pin assembly to distally advance the at least one pin relative to the locking component to distally advance the at least one pin out of the engagement region to release a portion of the valvular prosthesis.

[0190] Clause 50. The system of claim 49, wherein the pusher member includes a conical shape having a proximal flat surface and a conical distal surface, the conical distal surface configured to contact the pin assembly.

[0191] Clause 51. The system of claim 49, wherein the pusher component includes a tubular portion and a flange extending from the tubular portion.

[0192] Clause 52. The system of claim 49, wherein the pusher component includes a radial flange having a proximal surface extending adjacent a distal end portion of the support frame of the valve prosthesis, and wherein in the collapsed state, the support frame operates to contact the pusher component proximal surface and advance the pusher component distally relative to the core member.

[0193] Clause 53. The system of claim 52, further comprising a pusher block coupled to the pusher tube, the pusher tube slidable along the core member to advance the pusher block distally, the pusher block being spaced apart from the pusher component to permit placement of a support frame of the valvular prosthesis therein.

[0194] Clause 54. The system of claim 53, further comprising a sheath configured to house the pusher block and support frame within its lumen, the sheath, support frame, and pusher block configured to contact a proximal flat surface of the pusher component and apply a distal force to the pusher component to move the pusher component relative to the core member toward the pin assembly.

[0195] Clause 55. The system of claim 44, wherein the nose component is fixedly coupled to the core member and couples the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the nosecone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to allow the pin assembly to extend therebetween when in an engaged configuration.

[0196] Clause 56. The system of claim 55, wherein the lock component and the nose cone component collectively form a cavity when coupled together, the lock component including a first cavity area and the nose cone component including a second cavity area, the first and second cavity areas collectively forming the cavity when the lock component and the nose cone component are coupled together.

[0197] Clause 57. The system of claim 44, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component to allow at least one pin to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance to advance at least one pin distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0198] Clause 58. The system of claim 57, wherein in the released configuration, at least one pin is positioned outside the engagement region.

[0199] Clause 59. A delivery system for delivering a valvular prosthesis, the system comprising: a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal end portion and the distal end portion; a nose cone coupled to the core member, the nose cone having a nose cone component and a locking component coupled to the nose cone component, the locking component forming an engagement area with which a portion of the valvular prosthesis can be engaged; and a pin assembly coupled to the core member and movable along the core member, the pin assembly including an annular component and three pins, the three pins coupled to the annular component, and the locking component. a pin assembly extending through the core member, the pin assembly being slidable relative to the core member and the locking component to move three pins out of the engagement region and release the pin assembly from the portion of the valvular prosthesis; and a pusher member coupled to the core member and slidable along the core member, the pusher member disposed proximal to the pin assembly and the locking component, the pusher member configured to contact and engage the pin assembly to advance the three pins distally relative to the locking component to advance the three pins distally out of the engagement region to release the portion of the valvular prosthesis.

[0200] Clause 60. The system of claim 59, wherein the pin assembly is slidable distally relative to the core member and locking component to distally advance the three pins out of the engagement region and release the pin assembly from a portion of the valve prosthesis.

[0201] Clause 61. The system of claim 59, wherein the locking component includes a proximal flange and a distal flange, the proximal flange and the distal flange collectively forming an engagement region therebetween.

[0202] Clause 62. The system of claim 59, wherein the system further includes a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0203] Clause 63. The system of claim 59, further comprising a pusher member coupled to the core member and slidable along the core member, the pusher member configured to contact the pin assembly to slide the pin assembly to move the three pins out of the engagement region.

[0204] Clause 64. The system of claim 63, wherein a pusher member is disposed proximal to the pin assembly and the locking component, the pusher member configured to contact and engage the pin assembly to distally advance the three pins relative to the locking component to distally advance the three pins out of the engagement region to release a portion of the valvular prosthesis.

[0205] Clause 65. The system of claim 64, wherein the pusher member includes a conical shape having a proximal flat surface and a conical distal surface, the conical distal surface configured to contact the pin assembly.

[0206] Clause 66. The system of claim 65, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher member, the pusher member configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0207] Clause 67. The system of claim 66, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0208] Clause 68. The system of claim 67, wherein the nosecone component is fixedly coupled to the core member, and the locking component has a distal portion and a proximal portion, the distal portion coupled to the nosecone component and the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to permit the tubular component to extend therebetween when in an engaged configuration.

[0209] Clause 69. The system of claim 68, wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0210] Clause 70. The system of claim 64, wherein the pusher component includes a tubular portion and a flange extending from the tubular portion.

[0211] Clause 71. The system of claim 64, wherein the pusher component includes a radial flange having a proximal surface extending adjacent a distal end portion of the support frame of the valve prosthesis, and wherein in the collapsed state, the support frame operates to contact the pusher component proximal surface and advance the pusher component distally relative to the core member.

[0212] Clause 72. The system of claim 59, wherein the nose component is fixedly coupled to the core member and couples the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the nosecone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to allow the pin assembly to extend therebetween when in an engaged configuration.

[0213] Clause 73. The system of claim 59, wherein the valve prosthesis includes a valve anchor having at least one anchor fixation leg, the at least one anchor fixation leg including connection apertures disposed therethrough for engaging the three pins.

[0214] Clause 74. A delivery system for delivering a valvular prosthesis, the system comprising: a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal end portion and the distal end portion; a nose cone coupled to the core member, the nose cone having a cavity formed therein and a locking component extending from the nose cone, the locking component forming an engagement area with which a portion of the valvular prosthesis can be engaged; and a pin assembly coupled to the core member and movable along the core member within the cavity, the pin assembly including an annular component, a tubular component extending from the annular component, and at least one pin coupled to the annular component and adapted to move the locking component out of the cavity. a pin assembly extending through the core member, the pin assembly slidable distally relative to the core member and the locking component to distally advance at least one pin out of the engagement region and release the pin assembly from a portion of the valvular prosthesis; and a pusher member coupled to the core member and slidable along the core member, the pusher member disposed proximal to the pin assembly and the locking component, the pusher member including a conical shape having a proximal flat surface and a conical distal surface, the conical distal surface configured to contact and engage a proximal end portion of the tubular component of the pin assembly to distally advance the at least one pin relative to the locking component to distally advance the at least one pin out of the engagement region to release the portion of the valvular prosthesis;a pushing block coupled to a pusher tube, the pusher tube slidable along the core member to advance the pushing block distally, the pushing block positioned proximally of the pusher component, the pushing block spaced apart from the pusher component to permit placement of a support frame of the valvular prosthesis therein;

[0215] Clause 75. The system of claim 74, wherein the locking component is disposed proximal to the annular component, the locking component including at least one locking aperture, the at least one locking aperture configured to allow at least one pin to extend therethrough.

[0216] Clause 76. The system of claim 74, wherein the locking component includes a proximal flange and a distal flange, the proximal flange and the distal flange collectively forming an engagement region therebetween.

[0217] Clause 77. The system of claim 74, wherein the annular component of the pin assembly includes a cylindrical piston member slidable within the cavity.

[0218] Clause 78. The system of claim 77, wherein the piston member includes opposing proximal and distal plates, the proximal plate including at least one aperture, and the at least one pin extending through the at least one aperture, a portion of the at least one pin being interposed and engaged between the proximal and distal plates.

[0219] Clause 79. The system of claim 74, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0220] Clause 80. The system of claim 79, wherein the locking component has a distal portion and a proximal portion, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to permit the tubular component to extend therebetween when in an engaged configuration.

[0221] Clause 81. The system of claim 80, wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0222] Clause 82. The system of claim 74, wherein the pusher component includes a tubular portion and a flange extending from the tubular portion.

[0223] Clause 83. The system of claim 74, wherein the pusher component includes a radial flange having a proximal surface extending adjacent a distal end portion of the support frame of the valve prosthesis, and wherein in the collapsed state, the support frame operates to contact the pusher component proximal surface and advance the pusher component distally relative to the core member.

[0224] Clause 84. The system of claim 74, further comprising a sheath configured to house the pushing block and support frame within its lumen, the sheath, support frame, and pushing block configured to contact a proximal flat surface of the pusher component and apply a distal force to the pusher component to move the pusher component relative to the core member toward the pin assembly.

[0225] Clause 85. The system of claim 74, wherein the valve prosthesis includes a valve anchor having at least one anchoring leg, the at least one anchoring leg including a connecting aperture disposed therethrough for engaging the at least one pin.

[0226] Clause 86. The system of claim 85, wherein the valve anchor includes three anchoring legs, and the pin assembly includes three pins for engaging respective anchoring legs of the valve anchor.

[0227] Clause 87. The system of claim 74, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component to allow at least one pin to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance to advance at least one pin distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0228] Clause 88. The system of claim 87, wherein in the released configuration, at least one pin is positioned outside the engagement region.

[0229] Clause 89. A delivery system for delivering a valve prosthesis, the system comprising: a core member; a nose cone coupled to the core member, the nose cone having a nose cone component; a locking component proximal to the nose cone component and coupled to the nose cone component; and a cavity formed therein, the nose cone component positioned distal to the locking component, the locking component forming an engagement area with which a portion of the valve prosthesis can be engaged; a pin assembly coupled to the core member and movable along the core member within the cavity, the pin assembly including an annular component and at least one pin, the at least one pin coupled to the annular component and extending through the locking component out of the cavity, the pin assembly being slidable relative to the core member and the locking component to move the at least one pin out of the engagement area and release the pin assembly from the portion of the valvular prosthesis.

[0230] Clause 90. The system of claim 89, wherein the pin assembly is slidable distally relative to the core member and locking component to advance at least one pin distally out of the engagement region and release the pin assembly from a portion of the valve prosthesis.

[0231] Clause 91. The system of claim 89, wherein the nose cone is coupled to a distal end portion of the core member.

[0232] Clause 92. The system of claim 89, wherein the locking component is disposed proximal to the annular component, the locking component including at least one locking aperture, the at least one locking aperture configured to allow at least one pin to extend therethrough.

[0233] Clause 93. The system of claim 89, wherein the locking component includes a proximal flange and a distal flange, the proximal flange and the distal flange collectively forming an engagement region therebetween.

[0234] Clause 94. The system of claim 89, wherein the nose component is fixedly coupled to the core member and couples the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the nosecone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to allow the pin assembly to extend therebetween when in an engaged configuration.

[0235] Clause 95. The system of claim 89, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component to allow at least one pin to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance to advance at least one pin distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0236] Clause 96. The system of claim 95, wherein in the released configuration, at least one pin is positioned outside the engagement region.

[0237] Clause 97. The system of claim 89, wherein the system further includes a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0238] Clause 98. The system of claim 97, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0239] Clause 99. The system of claim 98, wherein the nosecone component is fixedly coupled to the core member, and the locking component has a distal portion and a proximal portion, the distal portion coupled to the nosecone component and the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to permit the tubular component to extend therebetween when in an engaged configuration.

[0240] Clause 100. The system of claim 99, wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0241] Clause 101. The system of claim 89, wherein the nose component is fixedly coupled to the core member and couples a locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the nosecone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to allow the pin assembly to extend therebetween when in an engaged configuration.

[0242] Clause 102. The system of claim 89, wherein the lock component and the nose cone component collectively form a cavity when coupled together.

[0243] Clause 103. The system of claim 102, wherein the lock component includes a first cavity area and the nose cone component includes a second cavity area, the first and second cavity areas collectively forming a cavity when the lock component and the nose cone component are coupled together.

[0244] Clause 104. A delivery system for delivering a valvular prosthesis, the system including: a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions; a nose cone coupled to the core member, the nose cone having a nose cone component and a locking component coupled to the nose cone component, the locking component forming an engagement area with which a portion of the valvular prosthesis can be engaged; and a pin assembly coupled to the core member and movable along the core member, the pin assembly including an annular component and three pins, the three pins coupled to the annular component and extending through the locking component, the pin assembly slidable relative to the core member and the locking component to move the three pins out of the engagement area and release the pin assembly from the portion of the valvular prosthesis.

[0245] Clause 105. The system of claim 104, wherein the pin assembly is slidable distally relative to the core member and locking component to distally advance the three pins out of the engagement region and release the pin assembly from a portion of the valve prosthesis.

[0246] Clause 106. The system of claim 104, wherein the locking component is disposed proximal to the annular component, the locking component including at least one locking aperture, the at least one locking aperture configured to allow three pins to extend therethrough.

[0247] Clause 107. The system of claim 104, wherein the locking component includes a proximal flange and a distal flange, the proximal flange and the distal flange collectively forming an engagement region therebetween.

[0248] Clause 108. The system of claim 104, further comprising a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0249] Clause 109. The system of claim 108, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0250] Clause 110. The system of claim 109, wherein the nosecone component is fixedly coupled to the core member, and the locking component has a distal portion and a proximal portion, the distal portion coupled to the nosecone component and the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to permit the tubular component to extend therebetween when in an engaged configuration.

[0251] Clause 111. The system of claim 110, wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0252] Clause 112. The system of claim 104, wherein the nose component is fixedly coupled to the core member and couples the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the nosecone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to allow the pin assembly to extend therebetween when in an engaged configuration.

[0253] Clause 113. The system of claim 104, wherein the valve prosthesis includes a valve anchor having at least one anchor fixation leg, the at least one anchor fixation leg including connection apertures disposed therethrough for engaging the three pins.

[0254] Clause 114. The system of claim 104, wherein the system further includes a sheath extending along the core member and configured to house the valve prosthesis in a compressed configuration.

[0255] Clause 115. The system of claim 114, wherein the sheath is configured to extend over at least a portion of the locking component.

[0256] Clause 116. The system of claim 115, wherein the proximal end portion of the locking component includes a radial recess configured to abut the distal end of the sheath.

[0257] Clause 117. The system of claim 116, wherein the radial recess is configured to allow the locking component proximal end portion to be inserted into the lumen of the sheath to removably couple the locking component to the sheath.

[0258] Clause 118. The system of claim 104, wherein the pin assembly includes a plurality of pins, and the locking component includes a plurality of locking apertures each corresponding to one of the plurality of pins.

[0259] Clause 119. A method of assembling a valve prosthesis onto a delivery system, the method comprising the steps of: housing the valve prosthesis in a compacted state within a sheath of the delivery system, the valve prosthesis including a valve anchor and a support frame coupled to the valve anchor, the valve anchor including a plurality of anchor fixation legs having a plurality of connecting apertures; slidably coupling the pin assembly about a core member such that the pin assembly is longitudinally slidable along the core member; and inserting a plurality of pins of the pin assembly through the plurality of connecting apertures of the valve anchor and the plurality of locking apertures of the delivery system to engage the plurality of anchor fixation legs of the valve anchor.

[0260] Clause 120. The method of claim 119, further comprising the step of positioning the plurality of connection apertures of the valve anchor between the first flange and the second flange, wherein the lock aperture extends through both the first flange and the second flange.

[0261] Clause 121. The method of claim 119, further comprising the step of positioning an annular component of the pin assembly within a cavity of the delivery system such that the pin assembly reciprocates within the cavity between an engaged configuration and a disengaged configuration, a plurality of pins extending longitudinally from the annular component.

[0262] Clause 122. The method of claim 119, further comprising slidably coupling the pusher component about the core member such that the pusher component is longitudinally slidable along the core member.

[0263] Clause 123. The method of claim 122, further comprising the step of positioning the tubular component of the pin assembly to extend along the core member toward the pusher component such that the pusher component can contact an end of the tubular component.

[0264] Clause 124. The method of claim 122, further comprising positioning the tubular component of the pusher component to extend along the core member toward the pin assembly such that the tubular component can contact the pin assembly.

[0265] Clause 125. The method of claim 122, further comprising positioning a pusher component on a first end of the support frame such that the first end of the support frame can contact the pusher component.

[0266] Clause 126. The method of claim 125, further comprising positioning a pushing block at a second end of the support frame opposite the first end of the support frame so that the second end can contact the support frame.

[0267] Clause 127. The method of claim 119, further comprising the step of coupling the valve anchor to the support frame via at least one suture slidably coupled along a plurality of longitudinal slots extending along the length of the plurality of anchoring legs.

[0268] Clause 128. The method of claim 119, further comprising the step of positioning the valve anchor and a support frame serially coupled to the valve anchor within the sheath.

[0269] 129. A delivery system comprising: a sheath having a valve prosthesis, the valve prosthesis housed within the sheath in a compacted state, the valve prosthesis including a valve anchor and a support frame, the support frame movably coupled to the valve anchor, the valve anchor including a plurality of anchoring legs having a plurality of connecting apertures; a longitudinally extending core member; a locking component including a plurality of locking apertures; and a pin assembly slidably coupled to the core member such that the pin assembly is longitudinally slidable along the core member, the pin assembly including a plurality of pins extending longitudinally through the plurality of connecting apertures and through the plurality of locking apertures and engaging the plurality of anchoring legs of the valve anchor.

[0270] Clause 130. The delivery system of claim 129, further comprising positioning the plurality of connection apertures of the valve anchor between the first flange and the second flange, wherein the lock aperture extends through both the first flange and the second flange.

[0271] Clause 131. The delivery system of claim 129, wherein the pin assembly further includes an annular component reciprocally disposed within the cavity, and wherein the plurality of pins extend longitudinally from the annular component.

[0272] Clause 132. The delivery system of claim 129, further comprising a pusher component, the pusher component slidably coupled to the core member such that the pusher component is longitudinally slidable along the core member.

[0273] Clause 133. The delivery system of claim 132, wherein the pin assembly includes a tubular component extending along the core member toward the pusher component, the pusher component configured to contact an end of the tubular component.

[0274] Clause 134. The delivery system of claim 132, wherein the pusher component includes a tubular component extending along the core member toward the pin assembly, an end of the tubular component configured to contact the pin assembly.

[0275] Clause 135. The delivery system of claim 132, wherein the support frame has a first end positioned to contact the pusher component.

[0276] Clause 136. The delivery system of claim 135, further comprising a pushing block configured to contact a second end of the support frame opposite the first end of the support frame.

[0277] Clause 137. The delivery system of claim 129, further comprising at least one suture coupled to the support frame and slidably coupled along a plurality of longitudinal slots extending along the length of the plurality of anchoring legs.

[0278] Clause 138. The delivery system of claim 129, wherein the valve anchor and the support frame coupled to the valve anchor are positioned inline within the sheath.

[0279] Article 139. A sheath having a valve prosthesis, the valve prosthesis being housed in the sheath in a compacted state, the valve prosthesis including a valve anchor and a support frame, the support frame being movably coupled to the valve anchor, the valve anchor including a plurality of rounded base portions and a plurality of anchoring legs, the plurality of anchoring legs being interconnected with the plurality of rounded base portions and alternately spaced between the plurality of rounded base portions, each of the anchoring legs having a proximal end joined to the rounded base portion, and a sheath having a distal end with a connecting aperture; a longitudinally extending core member; a locking component including a plurality of locking apertures; and a pin assembly positioned distally of the support frame and slidably coupled to the core member, the pin assembly including a plurality of pins extending proximally through the plurality of connecting apertures and through the plurality of locking apertures and engaging a plurality of anchor fixation legs of the valve anchor.

[0280] Clause 140. The delivery system of claim 139, further comprising positioning a connection aperture of the valve anchor between the distal flange and the proximal flange, the lock aperture extending through both the distal flange and the proximal flange.

[0281] Clause 141. The delivery system of claim 139, wherein the pin assembly further includes an annular component, the annular component reciprocally disposed within the cavity, the pin assembly reciprocating between an engaged configuration at a proximal position within the cavity and a disengaged configuration at a distal position within the cavity, and the plurality of pins extending proximally from a proximal face of the annular component.

[0282] Clause 142. The delivery system of claim 139, further comprising a pusher component, the pusher component slidably coupled to the core member such that the pusher component is longitudinally slidable along the core member.

[0283] Clause 143. The delivery system of claim 142, wherein the pin assembly includes a tubular component extending proximally along the core member toward the pusher component, the pusher component configured to contact a distal surface of the tubular component.

[0284] Clause 144. The delivery system of claim 142, wherein the pusher component includes a tubular component extending distally along the core member toward the pin assembly, an end of the tubular component configured to contact a proximal face of the pin assembly.

[0285] Clause 145. The delivery system of claim 142, wherein the support frame has a distal end positioned to contact a proximal surface of the pusher component.

[0286] Clause 146. The delivery system of claim 145, further comprising a pushing block configured to contact a proximal end of the support frame opposite the distal end of the support frame.

[0287] Clause 147. The delivery system of claim 139, further comprising at least one suture coupled to the support frame and slidably coupled along a plurality of longitudinal slots extending along the length of the plurality of anchoring legs.

[0288] Clause 148. The delivery system of claim 139, wherein the valve anchor and the support frame coupled to the valve anchor are positioned in series within the outer sheath such that the valve anchor is disposed distal to the support frame.

[0289] Clause 149. A method for delivering a valve prosthesis to a target location within a blood vessel of a subject, the method comprising: introducing a delivery system into the blood vessel and positioning a valve anchor at the target location; retracting a sheath of the delivery system proximally to allow an anchoring member of the valve anchor to expand to anchor the valve anchor at the target location while maintaining engagement between an anchoring leg of the valve anchor and an engagement mechanism of the delivery system, the engagement mechanism including a pusher component, a pin assembly, and a locking component; and advancing the pusher component distally relative to a core member of the delivery system to contact the pin assembly, and advancing the pin assembly distally relative to the locking component to release the pin assembly from the locking component, thereby allowing release of the anchoring leg of the valve anchor from the delivery system.

[0290] Clause 150. The method of claim 149, wherein the anchoring members include U-shaped members, the method further comprising the step of advancing the anchoring members into the respective valve structures at the target locations.

[0291] Clause 151. The method of claim 150, wherein the target location includes an aortic valve and the valve structure includes an aortic valve sinus.

[0292] Clause 152. The method of claim 149, wherein the method further comprises the step of distally advancing the anchoring member into the target location.

[0293] Clause 153. The method of claim 149, wherein the method further comprises rotating the anchoring member at the target location.

[0294] Clause 154. The method of claim 149, further comprising the step of proximally withdrawing the anchoring member at the target location.

[0295] Clause 155. The method of claim 149, wherein the pin assembly includes a pin, the pin extending in an engaged configuration through the engagement region and the locking aperture of the locking component and engaging the anchoring leg in the engagement region, and wherein the distally advancing step includes advancing the pin of the pin assembly through the locking aperture and through the engagement region to permit release of the anchoring leg.

[0296] Clause 156. The method of claim 149, wherein the pin assembly includes a tubular component extending proximally from the pin assembly along the core member, and the step of distally advancing includes contacting a distal surface of the pusher component against a proximal surface of the tubular component.

[0297] Clause 157. The method of claim 149, wherein the pin assembly includes a piston member and the locking component includes a cavity, and the distally advancing step includes causing the piston member to move distally within the cavity.

[0298] Clause 158. The method of claim 149, wherein the introducing step includes the step of positioning the valve anchor adjacent an aortic valve of the patient's heart.

[0299] Clause 159. The method of claim 158, wherein the proximally retracting step allows the anchoring member to expand into the annulus of the aortic valve.

[0300] Clause 160. The method of claim 149, further comprising the step of expanding a support frame of the valvular prosthesis within the lumen of the valve anchor after the valve anchor is released.

[0301] Clause 161. The method of claim 160, wherein the expanding step includes the step of proximally retracting a sheath from over the support frame and allowing the support frame to self-expand within the valve anchor.

[0302] Clause 162. The method of claim 149, wherein the distal end portion of the delivery system is advanced to the defective valve at the target location in a direction opposite to the direction of blood flow.

[0303] Clause 163. The method of claim 149, wherein the proximal retraction of the sheath is performed while holding the support frame of the valvular prosthesis stationary along the longitudinal axis of the valvular prosthesis until the support frame radially expands.

[0304] Clause 164. A method of assembly for delivery of a valve prosthesis, the method comprising the steps of: coupling at least one suture to a support frame; and looping the at least one suture through an anchoring leg of a valve anchor such that the at least one suture is slidable along the anchoring leg.

[0305] Clause 165. The method of claim 164, further comprising the steps of compacting the support frame and valve anchor, and enclosing the compacted support frame and compacted valve anchor within a sheath, with the support frame connected to the valve anchor via at least one suture.

[0306] Clause 166. The method of claim 164, further comprising the step of inserting a pin through a connecting aperture in the anchoring leg to restrain a portion of the anchoring leg.

[0307] Clause 167. The method of claim 166, further comprising the step of sliding a pin through the connection aperture and the lock aperture.

[0308] Clause 168. The method of claim 166, further comprising the step of positioning a portion of the anchoring leg between the first flange and the second flange.

[0309] Clause 169. A method of assembly for delivery of a valvular prosthesis, the method comprising the steps of: coupling a plurality of sutures to ends of a support frame; looping the plurality of sutures around a plurality of anchoring legs of a valve anchor such that the plurality of sutures are slidable along the plurality of anchoring legs, each of the anchoring legs being interconnected between a pair of U-shaped members of the valve anchor, and each of the plurality of sutures being looped into a respective longitudinal slot extending along the length of the respective anchoring leg; compacting the support frame and valve anchor; and enclosing the compacted valve anchor and the compacted support frame slidably coupled to the compacted valve anchor within an outer sheath.

[0310] Clause 170. The method of claim 169, further comprising the step of serially disposing the compacted valve anchor and the compacted support frame within the outer sheath.

[0311] Clause 171. The method of claim 169, further comprising the step of inserting a plurality of pins of a pin assembly through a plurality of connecting apertures of a plurality of anchoring legs to radially constrain respective ends of the anchoring legs.

[0312] Clause 172. The method of claim 171, further comprising the step of sliding a plurality of pins through a plurality of connecting apertures and a plurality of locking apertures.

[0313] Clause 173. The method of claim 171, further comprising the step of positioning each end of the anchoring leg between the first flange and the second flange.

[0314] Clause 174. A system for delivering a valve prosthesis, comprising: a support frame; a valve anchor including anchoring legs and a plurality of U-shaped members; and sutures, the sutures coupled to the support frame and slidably coupled to the anchoring legs.

[0315] Clause 175. The system of claim 174, wherein the anchoring leg includes a longitudinal slot extending along the length of the anchoring leg, and the suture is slidably coupled along the longitudinal slot.

[0316] Clause 176. The system of claim 174, wherein the system further includes a pin, the anchoring leg including a connecting aperture, the pin extending through the connecting aperture and restraining a portion of the anchoring leg.

[0317] Clause 177. The system of claim 176, wherein the system further includes a lock component including a lock aperture, the pin further extending through the lock aperture.

[0318] Clause 178. The system of claim 177, wherein the locking component includes a first flange portion, a second flange portion, and an engagement region interposed between the first flange portion and the second flange portion, the locking aperture extending through the first flange portion and the second flange portion, and a portion of the anchoring leg disposed within the engagement region.

[0319] Clause 179. The system of claim 176, wherein the connecting aperture comprises a hole at the end of the anchoring leg.

[0320] Clause 180. The system of claim 174, wherein the support frame has a first end portion and a second end portion opposite the first end portion, the suture is connected to the first end portion, and the second end portion has a plurality of major peaks and valleys and a plurality of minor peaks between the plurality of major peaks.

[0321] Clause 181. The system of claim 180, further comprising a membrane shaped to cover the micropeaks.

[0322] Clause 182. The system of claim 174, wherein the valve anchor and support frame are compacted within the outer sheath.

[0323] Clause 183. The system of claim 182, wherein the valve anchor and the support frame coupled to the valve anchor are positioned inline within the outer sheath.

[0324] Clause 184. A system for delivering a valvular prosthesis, comprising: a support frame; a valve anchor including three anchoring legs and three U-shaped members interconnected between the three anchoring legs, each of the anchoring legs having a proximal end attached to the U-shaped member, a distal end having a connecting aperture, and a longitudinal slot extending along the length of the anchoring leg, such that the three anchoring legs have three connecting apertures and three longitudinal slots; and three suture loops coupled to the support frame and slidably coupled to the three anchoring legs along the three longitudinal slots.

[0325] Clause 185. The system of claim 184, further comprising a pin assembly having an annular component and three pins extending proximally from a proximal surface of the annular component, the three pins extending through the three connecting apertures and radially restraining the distal ends of the three anchoring legs.

[0326] Clause 186. The system of claim 185, wherein the system further includes a lock component including three lock apertures, and wherein the three pins further extend through the three lock apertures.

[0327] Clause 187. The system of claim 186, wherein the locking component includes a distal flange portion, a proximal flange portion, and an engagement region interposed between the distal and proximal flange portions, the three locking apertures extending through the distal and proximal flange portions, and the distal ends of the three anchoring legs disposed within the engagement region.

[0328] Clause 188. The system of claim 184, wherein the three connecting apertures include three holes extending through the distal ends of the three anchoring legs.

[0329] Clause 189. The system of claim 184, wherein the support frame has a distal end portion and a proximal end portion, the three suture loops are connected to the distal end portion, and the proximal end portion has a plurality of major peaks and valleys and a plurality of minor peaks between the plurality of major peaks.

[0330] Clause 190. The system of claim 189, further comprising a membrane covering the minor peaks.

[0331] Clause 191. The system of claim 184, wherein the valve anchor and support frame are compacted within the outer sheath.

[0332] Clause 192. The system of claim 191, wherein the valve anchor and the support frame coupled to the valve anchor are positioned inline within the outer sheath, with the valve anchor disposed distal to the support frame.

[0333] Clause 193. The system of claim 184, wherein each of the valve anchor and the support frame is a self-expanding component.

[0334] Clause 194. The system of claim 193, wherein each of the valve anchor and the support frame is fabricated from nitinol.

[0335] Clause 195. The system of claim 184, further comprising: a pin assembly having an annular component and three pins extending proximally from a proximal surface of the annular component; and a locking component including a distal flange portion, a proximal flange portion, an engagement region interposed between the distal flange portion and the proximal flange portion, and three locking apertures extending through the distal flange portion and the proximal flange portion, the three pins extending through the three connecting apertures and the three locking apertures with distal ends of the three anchoring legs disposed in the engagement region to radially restrain the distal ends of the three anchoring legs, and each of the valve anchor and support frame is a self-expanding component.

[0336] Clause 196. A method for delivering a valvular prosthesis to a target location within a blood vessel of a subject, the method comprising the steps of: introducing a delivery system into the blood vessel and positioning a valve anchor of the valvular prosthesis at the target location; retracting a sheath of the delivery system proximally to allow an anchoring member of the valve anchor to expand to anchor the valve anchor at the target location; advancing a support frame of the valvular prosthesis distally within the valve anchor while sliding a suture coupled to the support frame distally along an anchoring leg of the valve anchor; and expanding the support frame within the valve anchor.

[0337] Clause 197. The method of claim 196, wherein the step of sliding the suture distally includes moving the suture from a proximal position to a distal position, wherein at the proximal position the suture provides a radial restraint on the proximal portion of the valve anchor and at the distal position the radial restraint is relaxed, thereby permitting radial expansion of the proximal portion of the valve anchor.

[0338] Clause 198. The method of claim 197, further comprising the steps of: radially constraining a distal portion of the anchoring leg with a pin extending through a connection aperture of the anchoring leg when the suture is in a proximal position; and releasing the pin from the connection aperture to permit radial expansion of the distal portion of the anchoring leg when the suture is in a distal position.

[0339] Clause 199. The method of claim 196, wherein the step of sliding the suture distally includes the step of sliding the suture along a longitudinal slot extending along the length of the anchoring leg.

[0340] Clause 200. The method of claim 196, further comprising the step of radially constraining a distal portion of the anchoring leg with an engagement mechanism while sliding the suture distally.

[0341] Clause 201. The method of claim 196, wherein the step of expanding the support frame includes the step of proximally retracting a sheath from over the support frame and allowing the support frame to self-expand within the valve anchor.

[0342] Clause 202. The method of claim 196, wherein the target location includes an aortic valve, the anchoring members each include a U-shaped member, and the method further includes the step of advancing the U-shaped member into a respective aortic sinus of the aortic valve.

[0343] Clause 203. A delivery system for delivering a valvular prosthesis, the system including: a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions; and an engagement mechanism coupled to the distal end portion of the core member for releasably engaging the valvular prosthesis, the engagement mechanism including a pin assembly coupled to the core member and movable along the core member, the pin assembly including an annular component and at least one pin, the at least one pin coupled to the annular component and extending away from the distal end portion, the at least one pin being radially spaced from the core member; and a locking component coupled to the core member proximal to the valve prosthesis, the locking component including at least one locking aperture configured to allow at least one pin to extend therethrough, the locking component and the pin assembly collectively forming an engagement area between the locking component and the pin assembly for engaging a portion of the valve prosthesis, the pin assembly being slidable distally relative to the core member and the locking component to distally advance the at least one pin out of the engagement area and release the pin assembly from the portion of the valve prosthesis.

[0344] Clause 204. The system of claim 203, wherein the annular component of the pin assembly includes a cylindrically shaped piston member.

[0345] Clause 205. The system of claim 204, wherein the piston member includes opposing proximal and distal plates, the proximal plate including at least one aperture, the at least one pin extending through the at least one aperture, and a portion of the at least one pin interposed and engaged between the proximal and distal plates.

[0346] Clause 206. The system of claim 203, further comprising a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0347] Clause 207. The system of claim 203, further comprising a pusher member proximal to the pin assembly and the locking component, the pusher member coupled to the core member and slidable along the core member, the pusher member configured to contact and engage the pin assembly to distally advance the at least one pin relative to the locking component to distally advance the at least one pin out of the engagement region to release a portion of the valvular prosthesis.

[0348] Clause 208. The system of claim 207, wherein the pusher member includes a conical shape having a proximal flat surface and a conical distal surface, the conical distal surface configured to contact the pin assembly.

[0349] Clause 209. The system of claim 207, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher member, the pusher member configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0350] Clause 210. The system of claim 209, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0351] Clause 211. The system of claim 210, further comprising a distal cone component coupled to the locking component, the distal cone component fixedly coupled to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the distal cone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member to permit the tubular component to extend therebetween when in an engaged configuration.

[0352] Clause 212. The system of claim 203, further comprising a distal cone component coupled to the locking component, the distal cone component fixedly coupled to the core member and coupling the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the distal cone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member and allowing the pin assembly to extend therebetween when in an engaged configuration.

[0353] Clause 213. The system of claim 212, wherein the locking component and the distal cone component, when coupled together, collectively form a cavity, and the pin assembly is at least partially disposed within the cavity.

[0354] Clause 214. The system of claim 213, wherein the locking component includes a first cavity region and the distal cone component includes a second cavity region, the first and second cavity regions collectively forming a cavity when the locking component and the distal cone component are coupled together.

[0355] Clause 215. The system of claim 203, wherein the valve prosthesis includes a valve anchor having at least one anchor fixation leg, the at least one anchor fixation leg including a connection aperture disposed therethrough for engaging the at least one pin.

[0356] Clause 216. The system of claim 215, wherein the valve anchor includes three anchoring legs, and the pin assembly includes three pins for engaging respective anchoring legs of the valve anchor.

[0357] Clause 217. The system of claim 203, wherein the pin assembly includes a plurality of pins, and the locking component includes a plurality of locking apertures, each corresponding to one of the plurality of pins.

[0358] 218. A delivery system for delivering a valvular prosthesis, the system comprising: a support frame coupled to a valve anchor, the support frame having a plurality of valve leaflets coupled thereto, the valve anchor having at least one anchoring leg, the at least one anchoring leg including a connecting aperture disposed therethrough; a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal and distal end portions; and a pin assembly coupled to the core member and movable along the core member, the pin assembly including an annular component and at least one pin, the at least one pin coupled to the annular component and extending away from the distal end portion, the annular component having a cylindrical piston. a pin assembly including a core member, the at least one pin being radially spaced from the core member; and a locking component coupled to the core member proximal to the annular component, the locking component including at least one locking aperture configured to allow the at least one pin to extend therethrough, the locking component and the pin assembly collectively forming an engagement region between the locking component and the pin assembly for engaging a portion of a valvular prosthesis, the pin assembly being slidable distally relative to the core member and the locking component to distally advance the at least one pin out of the engagement region and release the pin assembly from the portion of the valvular prosthesis.

[0359] Clause 219. The system of claim 218, wherein the piston member includes opposing proximal and distal plates, the proximal plate including at least one aperture, the at least one pin extending through the at least one aperture, and a portion of the at least one pin interposed and engaged between the proximal and distal plates.

[0360] Clause 220. The system of claim 218, further comprising a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0361] Clause 221. The system of claim 218, further comprising a pusher member proximal to the pin assembly and the locking component, the pusher member coupled to the core member and slidable along the core member, the pusher member configured to contact and engage the pin assembly to distally advance the at least one pin relative to the locking component to distally advance the at least one pin out of the engagement region to release a portion of the valvular prosthesis.

[0362] Clause 222. The system of claim 221, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher member, the pusher member configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0363] Clause 223. The system of claim 222, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0364] Clause 224. The system of claim 218, wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0365] Clause 225. The system of claim 218, further comprising a distal cone component coupled to the locking component, the distal cone component fixedly coupled to the core member and coupling the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the distal cone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member and allowing the pin assembly to extend therebetween when in an engaged configuration.

[0366] Clause 226. The system of claim 225, wherein the locking component and the distal cone component, when coupled together, collectively form a cavity, and the pin assembly is at least partially disposed within the cavity.

[0367] Clause 227. The system of claim 226, wherein the locking component includes a first cavity region and the distal cone component includes a second cavity region, the first and second cavity regions collectively forming a cavity when the locking component and the distal cone component are coupled together.

[0368] Clause 228. The system of claim 226, wherein the cavity is configured to allow longitudinal travel of the pin assembly therein.

[0369] Clause 229. The system of claim 228, wherein the pin assembly annular component includes a piston member disposed within the cavity.

[0370] Clause 230. The system of claim 218, wherein the valve prosthesis includes a valve anchor having at least one anchor fixation leg, the at least one anchor fixation leg including a connection aperture disposed therethrough for engaging the at least one pin.

[0371] Clause 231. The system of claim 230, wherein the valve anchor includes three anchoring legs, and the pin assembly includes three pins for engaging respective anchoring legs of the valve anchor.

[0372] Clause 232. The system of claim 218, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component to allow at least one pin to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance to advance at least one pin distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0373] 233. A delivery system for delivering a valve prosthesis, the system including: a valve prosthesis including a support frame coupled to a valve anchor, the support frame having a plurality of valve leaflets coupled thereto, the valve anchor having three anchor fixation legs, each anchor fixation leg including a connecting aperture disposed therethrough; a core member having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal end portion and the distal end portion; and an engagement mechanism coupled to the distal end portion of the core member for releasably engaging the valve anchor of the valve prosthesis, the engagement mechanism including a pin assembly coupled to the core member and movable along the core member, the pin assembly disposed radially outward of the core member, the pin assembly including an annular component and three pins, the three pins engaging the annular component. and a locking component coupled to the core member proximal to the annular component, the locking component including three locking apertures each corresponding to one of the three pins, the three locking apertures configured to allow the three pins to extend therethrough, the locking component and the pin assembly collectively forming an engagement region between the locking component and the pin assembly for engaging a portion of the valvular prosthesis, the pin assembly being slidable distally relative to the core member and the locking component to distally advance the three pins out of the engagement region and release the pin assembly from the portion of the valvular prosthesis.

[0374] Clause 234. The system of claim 233, wherein the annular component of the pin assembly includes a cylindrically shaped piston member.

[0375] Clause 235. The system of claim 234, wherein the piston member includes opposing proximal and distal plates, the proximal plate including three apertures, and three pins extending through the three apertures, portions of the three pins being interposed and engaged between the proximal and distal plates.

[0376] Clause 236. The system of claim 233, further comprising a tubular component having a proximal section and a distal section, the distal section of the tubular component being coupled to the annular component of the pin assembly.

[0377] Clause 237. The system of claim 233, further comprising a pusher member proximal to the pin assembly and the locking component, the pusher member coupled to the core member and slidable along the core member, the pusher member configured to contact and engage the pin assembly to distally advance the three pins relative to the locking component to distally advance the three pins out of the engagement region to release a portion of the valvular prosthesis.

[0378] Clause 238. The system of claim 237, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and a pusher member, the pusher member configured to contact a proximal end portion of the tubular component to urge the pin assembly distally.

[0379] Clause 239. The system of claim 238, wherein the tubular component extends proximally through the locking component to a location proximal to the locking component.

[0380] Clause 240. The system of claim 233, wherein the pin assembly includes a tubular component coupled to the pin assembly and extending proximally between the pin assembly and the pusher member, and wherein a proximal portion of the locking component radially overlaps the tubular component in the engaged configuration.

[0381] Clause 241. The system of claim 233, further comprising a distal cone component coupled to the locking component, the distal cone component fixedly coupled to the core member and coupling the locking component to the core member, the locking component having a distal portion and a proximal portion, the distal portion coupled to the distal cone component, the proximal portion defining a lumen extending therethrough, the lumen of the proximal portion having a cross-sectional profile greater than an outer profile of the core member and allowing the pin assembly to extend therebetween when in an engaged configuration.

[0382] Clause 242. The system of claim 241, wherein the locking component and the distal cone component, when coupled together, collectively form a cavity, and the pin assembly is at least partially disposed within the cavity.

[0383] Clause 243. The system of claim 242, wherein the locking component includes a first cavity region and the distal cone component includes a second cavity region, the first and second cavity regions collectively forming a cavity when the locking component and the distal cone component are coupled together.

[0384] Clause 244. The system of claim 242, wherein the cavity is configured to allow longitudinal travel of the pin assembly therein.

[0385] Clause 245. The system of claim 244, wherein the pin assembly annular component includes a piston member disposed within the cavity.

[0386] Clause 246. The system of claim 233, wherein: (a) in an engaged configuration, the annular component of the pin assembly is axially spaced a first distance from the locking component to allow three pins to extend through the engagement region to engage a portion of the valvular prosthesis; and (b) in a released configuration, the annular component is axially spaced a second distance from the locking component that is greater than the first distance to advance the three pins distally through the engagement region to release the pin assembly from the portion of the valvular prosthesis.

[0387] Clause 247. The system of claim 246, wherein in the released configuration, the three pins are positioned outside the engagement region.

[0388] Article 248. A valve prosthesis including a valve anchor, the valve anchor having a longitudinal axis and proximal and distal end portions, the valve anchor including a plurality of U-shaped members and a plurality of anchor fixation legs, each of the plurality of U-shaped members having a rounded base portion disposed at the distal end portion of the valve anchor and first and second legs extending proximally from the rounded base portion toward the proximal end portion of the valve anchor, the first leg of the first U-shaped member and the second leg of the second U-shaped member being fixed to the plurality of anchors at the proximal end portion of the valve anchor. a plurality of anchoring legs connected to a proximal end portion of one of the anchoring legs, each of the plurality of anchoring legs including a connecting aperture at its distal end portion and a longitudinal slot extending along the length of the anchoring leg, the plurality of anchoring legs and the plurality of U-shaped members being capable of radially expanding in stages to allow the native valve structure to be interposed therebetween to anchor the valve prosthesis to the native valve structure, and the valve prosthesis including a plurality of valve leaflets configured to be connected to the valve anchors.

[0389] Clause 249. The valve prosthesis of Clause 248, further comprising a support frame, the support frame coupled to the valve anchor via at least one suture, the at least one suture coupled to the anchor fixation leg along a longitudinal slot, the support frame configured to support a plurality of valve leaflets.

[0390] Clause 250. The valve prosthesis of Clause 248, further comprising any of the features described herein.

[0391] Further considerations In some embodiments, any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses. In some embodiments, any of the clauses (e.g., dependent clauses or independent clauses) may be combined with any one or more other clauses (e.g., dependent clauses or independent clauses). In some embodiments, a claim may include some or all of the terms (e.g., steps, actions, means, or components) recited in a clause, sentence, phrase, or paragraph. In some embodiments, a claim may include some or all of the terms recited in one or more clauses, sentences, phrases, or paragraphs. In some embodiments, some of the terms in each clause, sentence, phrase, or paragraph may be removed. In some embodiments, additional terms or elements may be added to a clause, sentence, phrase, or paragraph. In some embodiments, the subject technology may be implemented without utilizing some of the components, elements, functions, or operations described herein. In some embodiments, the subject technology may be implemented using additional components, elements, functions, or operations.

[0392] The foregoing description is provided to enable one skilled in the art to practice the various configurations described herein. While the subject technology has been described with reference to, among other things, various diagrams and configurations, it should be understood that these are for illustrative purposes only and should not be taken as limiting the scope of the subject technology.

[0393] There may be many other ways to implement the subject technology. The various functions and elements described herein may be partitioned differently than shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other configurations. Accordingly, many changes and modifications may be made to the subject technology by those skilled in the art without departing from the scope of the subject technology.

[0394] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of example approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0395] As used herein, the term "distal" can refer to a location or direction that is away from a point of interest, such as a control unit or region of a delivery system that will be used to deliver a valvular prosthesis to a native valve annulus. Additionally, the term "proximal" can refer to a location or direction that is closer to a point of interest, such as a control unit or region of a delivery system that will be used to deliver a valvular prosthesis.

[0396] As used herein, the phrase "at least one of" preceding a list of items, followed by the term "and" or "or" separating any of the items, modifies the list as a whole, rather than each member (i.e., each item) of the list. The phrase "at least one of" does not require the selection of at least one of each listed item. Rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, and C" or "at least one of A, B, or C" refers to A alone, B alone, or C alone, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0397] Terms such as "top," "bottom," "front," and "rear," etc., as used in this disclosure, should be understood to refer to any frame of reference rather than the usual gravitational frame of reference. Thus, top, bottom, front, and rear surfaces can extend upward, downward, diagonally, or horizontally in the gravitational frame of reference.

[0398] Moreover, to the extent that terms such as "include" or "having" are used in the description or claims, such terms are intended to be inclusive in the same manner as the term "comprise" is interpreted when used as a transitional phrase in a claim.

[0399] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0400] Reference to an element in the singular is intended to mean "one or more," not "one and only one," unless otherwise specified. Masculine pronouns (e.g., his) include the feminine and neuter genders (e.g., her and its), and vice versa. The term "some" denotes one or more. Underlined and / or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with interpreting the description of the subject technology. All structural and functional equivalents to the elements of the various structures described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly set forth in the description above.

[0401] While the detailed description contains many details, these should not be construed as limiting the scope of the subject technology, but merely as illustrating different examples and aspects of the subject technology. It should be recognized that the scope of the subject technology includes other embodiments not discussed in detail above. Various other modifications, changes, and alterations may be made to the arrangement, operation, and details of the methods and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise expressly stated, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more," unless expressly specified otherwise. In addition, it is not necessary for a device or method to address every problem that can be solved (or possess every advantage that can be realized) by different embodiments of the present disclosure to be encompassed within the scope of the present disclosure. The use of "possible" and its derivatives herein is to be understood to mean "possibly" or "optionally," as opposed to categorical possibility.

Claims

1. a sheath having a valve prosthesis, the valve prosthesis being housed in the sheath in a compacted state, the valve prosthesis including a valve anchor and a support frame, the support frame being movably coupled to the valve anchor, the valve anchor including a plurality of rounded base portions and a plurality of anchoring legs, the plurality of anchoring legs being interconnected with the plurality of rounded base portions and alternately spaced between the plurality of rounded base portions, each of the anchoring legs having a proximal end joined to one of the plurality of rounded base portions and a distal end having a connecting aperture; a longitudinally extending core member; a lock component including a plurality of lock apertures; a pin assembly positioned distally of the support frame and slidably coupled to the core member, the pin assembly including a plurality of pins extending proximally through the plurality of connecting apertures and through the plurality of locking apertures to engage the plurality of anchoring legs of the valve anchor and an annular component reciprocally disposed within a cavity, the annular component reciprocating between an engaged configuration at a proximal position within the cavity and a disengaged configuration at a distal position within the cavity, the plurality of pins extending proximally from a proximal surface of the annular component; a pusher component slidable along the core member and relative to the locking component; A delivery system comprising:

2. The delivery system of claim 1 , wherein the pusher component is longitudinally slidable along the core member.

3. 2. The delivery system of claim 1, wherein the pin assembly includes a tubular component extending proximally along the core member toward the pusher component, the pusher component configured to contact a distal surface of the tubular component.

4. 2. The delivery system of claim 1, wherein the pusher component includes a tubular component extending distally along the core member toward the pin assembly, an end of the tubular component configured to contact a proximal face of the pin assembly.

5. a core member for carrying a valve prosthesis along said core member; a locking component fixedly coupled to the core member and including a plurality of locking apertures; a pusher component slidable relative to the core member and the locking component to contact a pin assembly; the pin assembly positioned distally of the pusher component and slidably coupled to the core member, the pin assembly including a plurality of pins extending proximally through a plurality of locking apertures to engage the valvular prosthesis with the plurality of locking apertures, the pin assembly being movable along the core member in response to contact from the pusher component so that the plurality of pins exit the locking apertures and disengage the valvular prosthesis, the locking component being coupled to a nose cone fixedly coupled to the core member, the nose cone including a cavity, the pin assembly being disposed within and movable within the cavity; A delivery system comprising:

6. The delivery system of claim 5 , further comprising a sheath extending proximally of the pusher component.

7. The delivery system of claim 5 , wherein the pusher component is longitudinally slidable along the core member.

8. 6. The delivery system of claim 5, wherein the pin assembly includes a tubular component extending proximally along the core member toward the pusher component, the pusher component configured to contact a distal surface of the tubular component.

9. 6. The delivery system of claim 5, wherein the pusher component includes a tubular component extending distally along the core member toward the pin assembly, an end of the tubular component configured to contact a proximal face of the pin assembly.

10. a sheath having a valve prosthesis, the valve prosthesis housed in the sheath in a compacted state, the valve prosthesis including a valve anchor and a support frame, the support frame movably coupled to the valve anchor, the valve anchor including a plurality of anchoring legs, each anchoring leg having a connecting aperture; a longitudinally extending core member; a lock component including a plurality of lock apertures; a pin assembly positioned distally of the support frame and slidably coupled to the core member, the pin assembly including a plurality of pins extending proximally through the plurality of connecting apertures and through the plurality of locking apertures to engage the plurality of anchoring legs of the valve anchor; and a pusher component slidable longitudinally along the core member and relative to the locking component to contact a proximal surface of the pin assembly; A delivery system comprising:

11. 11. The delivery system of claim 10, wherein the pin assembly includes a tubular component extending proximally along the core member toward the pusher component, the pusher component configured to contact a distal surface of the tubular component.

12. 11. The delivery system of claim 10, wherein the pusher component includes a tubular component extending distally along the core member toward the pin assembly, an end of the tubular component configured to contact a proximal face of the pin assembly.

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