Heart valve prosthesis

Abstract

The present disclosure relates to a heart valve prosthesis comprising: a support frame comprising a plurality of grid cells arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one sub-peak portion disposed in the longitudinal direction intermediate the edge portion and the plurality of main peak portions.

Description

[0001] This application is a divisional application of the patent application with application number 2019100075922, application date January 4, 2019, and invention name “Heart Valve Prosthesis”. Technical Field

[0002] The present disclosure relates to devices and methods for percutaneous delivery and implantation of heart valve prostheses. The valve prosthesis can be delivered to a defective native valve in a compressed state within a sheath and released in situ. Background Art

[0003] Artificial 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 of which is provided with its own one-way valve. The native heart valves are identified as the aortic valve, mitral valve (or mitral valve), tricuspid valve, and pulmonary valve. Although 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), artificial heart valves can be used to replace any of these naturally occurring valves.

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

[0005] The foregoing examples of the prior art and their associated limitations are for illustrative purposes and are not comprehensive. Other limitations of the prior art will become apparent to those skilled in the art after reading this specification and studying the accompanying drawings. Summary of the Invention

[0006] The present disclosure relates to heart valve prostheses, and delivery devices and actuation handles that can facilitate delivery of heart valve prostheses to a patient's defective native valve structure (eg, aortic valve). In some embodiments, delivery can be performed using a transcatheter approach.

[0007] The delivery device and actuation handle can enable clinicians to more easily manipulate and advance the delivery device through blood vessels leading to the heart and through the tortuosity of these vessels using a transvascular approach (e.g., a transfemoral approach). Indeed, some embodiments disclosed herein enable components of a heart valve prosthesis to be advanced serially as axially displaceable units (with partial, complete, or no overlap between components) while remaining movably connected, movably attached, flexibly connected, displaceably connected, coupled, or linked to one another, thereby minimizing the delivery device's transit profile or cross-section. Optionally, the distance over which components of the heart valve prosthesis can be continuously displaced can be variable, such that various components can be adjacent or potentially separated by inches or feet. Furthermore, the interconnection of components of the heart valve prosthesis can allow for varying degrees of movement and can be configured to provide engaged or retained positions with limited ranges of movement. In some embodiments, the engaged positions can also provide a predetermined relative positioning of the components of the heart valve prosthesis to facilitate proper placement and release of the heart valve prosthesis. Furthermore, some embodiments can provide clinicians with a high degree of control and enhance the maneuverability of the heart valve prosthesis when implanting it in a target location.

[0008] According to some embodiments, a procedure for transcatheter aortic valve implantation (TAVI) and / or transcatheter aortic valve replacement (TAVR) is provided. For example, in a TAVI procedure, a clinician can anchor an anchoring member of a heart valve prosthesis relative to the aortic valve annulus to guide the placement of an artificial valve leaflet structure. The valve prosthesis may include an artificial valve leaflet, an anchoring member, a valve frame member, and a tethering member that allows the anchoring member and the frame member to be placed in series in a delivery device to reduce the overall cross-section of the delivery device. The tethering member can be coupled to the anchoring member and the frame member to allow a range of movement and, in some embodiments, restrict other movement. The tethering member can slide relative to the anchoring member between a release position and a retaining position. In the retaining position, the tethering member can allow relative movement of the valve frame member and a preset or predetermined position of the valve frame member for optimal positioning relative to the anchoring member, which can facilitate the placement and release of the valve prosthesis.

[0009] For example, in some embodiments, the interconnection can be achieved using a novel approach of wrapping the tethering member around a "U-shaped" portion of the anchoring member. The tethering member can be slid along the anchoring member until it reaches the end of its travel on the anchoring member. The clinician can apply tension to the tethering member until the tethering member is seated in the engagement area. This action can loosen the tethering member and engage it to the engagement area of ​​the anchoring member. Thereafter, based solely on the clinician's placement of the anchoring member into the aortic sinus region (which the clinician can see and "feel" by fluoroscopy), the tethering member establishes a fixed range of longitudinal travel of the valve frame member relative to the anchoring member, and subsequently establishes the proper position of the valve frame member in the anatomy.

[0010] Thus, some embodiments disclosed herein advantageously provide a delivery device with a reduced pass profile or cross-section, thereby enabling the delivery of a heart valve prosthesis in a safer and less invasive manner than conventional methods. Thus, open-heart surgery can be avoided because the heart valve prosthesis can be advanced to the heart using a catheter via an access point in a blood vessel (e.g., the femoral artery). This provides significant benefits to the patient, including, for example, less trauma to the patient, easier recovery, and potentially lower surgical risks.

[0011] Furthermore, while the serial arrangement of the anchoring member and the valve carrier member overcomes the challenge of creating a low-profile delivery device, the advantageous arrangement of the interconnections overcomes another key challenge: how to optimally position the valve prosthesis within the native valve structure and reliably anchor it in place. Indeed, some embodiments disclosed herein address this challenge and teach structures and methods for operably coupling the anchoring member to the valve carrier member using a tethering member in a delivery device.

[0012] The delivery device can include a proximal sheath that can accommodate at least a portion of the anchoring member and a distal carrier assembly that can accommodate at least a portion of the valve support member. When the valve prosthesis is loaded onto the delivery device, the tethering member can extend between the anchoring member and the valve support member. The valve prosthesis can be released from the delivery device in a component-by-component manner, allowing the clinician to manipulate and position the anchoring member first, followed by the valve support member.

[0013] In some embodiments, the anchoring member can be coupled to an engagement feature or grasper of the delivery device that allows the clinician to push or pull the anchoring member. When the anchoring member is properly positioned relative to the native annulus, the grasper can be released from engagement with the anchoring member.

[0014] Additionally, in some embodiments, the distal carrier assembly of the delivery device may include two components or what is referred to as a two-piece cephalad assembly. According to some embodiments, it is recognized that if a single tubular member or cephalad is used to protect the majority of the valve support member, various problems may arise due to the expansion forces and corresponding compression forces required to maintain the valve support member in its compressed configuration during delivery to the target valve structure. Because the delivery device can be very long (e.g., in some embodiments, up to approximately 4 to 6 feet or more, although the length can be less than 4 feet, 3 feet, or 2 feet), these forces can create a stiffer distal portion of the delivery device. Furthermore, these forces may require a high degree of longitudinal force to release the valve support member due to the high friction forces caused by the radial forces of valve implantation.

[0015] Thus, the radial forces and friction of such a construction can cause problems with actuation of the mating handles and make precise positioning of the distal end of the delivery device very difficult. For example, the friction tends to be variable friction, which makes it difficult for the clinician to position the components of the valve prosthesis relative to each other, which can lead to unpredictable and / or imprecise component positioning or deployment. Accordingly, some embodiments herein include implementations whereby by separating the distal carrier or cephalad assembly into two components (e.g., a proximal housing and a distal housing), the components can cover a smaller surface area of ​​the valve carrier component, thereby reducing the radial forces applied to the individual components and the resulting friction that needs to be overcome in order to actuate or release the valve carrier component. Thus, the problems associated with a single tubular component are more manageable.

[0016] Additionally, in some embodiments, the two-piece distal carrier assembly may also enable the clinician to release the valve carrier members in a favorable sequence. For example, during testing and development of the valve prostheses, deployment systems, and handle actuators disclosed herein, some embodiments demonstrated favorable properties by allowing the distal portion of the valve carrier member to open first before the proximal portion of the valve carrier member is released. In some embodiments, the valve carrier member may have one or more anchors at its distal portion that supplement the outward expansion force (due to the self-expansion of the valve carrier member) and the frictional engagement it creates. By opening the distal portion first (by actuation of the distal head vertebra or housing), the distal portion can open like a flower and engage with the native valve structure to secure the longitudinal position of the valve carrier member relative to the native valve structure. Thereafter, the radially outward force of the self-expansion of the valve carrier member can cause the proximal portion of the valve carrier member to become disengaged from the proximal head vertebra or housing and released.

[0017] Some embodiments may also provide self-aligning features to allow components of the delivery assembly to move from a released state (in which components of the valve prosthesis are released from engagement with the delivery assembly) to a nested or stowed state (in which the outer surfaces of multiple portions of the delivery assembly are aligned or in abutment at a seam.) Such alignment, abutment, or positioning may provide a smoother outer profile, which may reduce the likelihood of the delivery assembly snagging or becoming entangled with the prosthetic valve after release, or reducing the likelihood of entanglement with other vasculature when the delivery assembly is retrieved from the patient's vasculature.

[0018] For example, in some embodiments, the distal carrier or head cone assembly may include an internal plunger or piston mechanism. When the valve carrier member is loaded into the delivery device, the plunger mechanism may be compressed. When the valve carrier member is released, the plunger mechanism's spring may push the plunger head to a predetermined position relative to the distal carrier assembly. According to some embodiments, in the predetermined position, the plunger head may be partially exposed from the distal housing and configured to engage with the proximal housing so that the proximal and distal housings are aligned in an abutting relationship relative to each other. Thus, the plunger head may engage with the proximal and distal housings to reduce the possibility of the delivery device becoming stuck or snagging on the prosthetic valve or other vasculature during retrieval of the delivery device. These features may also facilitate proximal retraction of the delivery device into the introducer sheath. Furthermore, the plunger head may provide a proximal surface that can contact the distal portion of the valve carrier member without engaging or snagging on the complex network of the valve carrier member, thereby ensuring that the valve carrier member can open like a flower without becoming stuck on the delivery device. Thus, some embodiments may include one or more of these advantageous features that address the problem of valve prostheses and / or delivery devices getting caught or hooked on each other or around anatomical structures.

[0019] Furthermore, due to the reduced cross-sectional profile of the delivery device, retrograde delivery of the valve prosthesis through a blood vessel (e.g., the femoral artery in a retrograde transfemoral approach) can be achieved with reduced risk of trauma to the surrounding vasculature. For example, retrograde delivery of valve prostheses through the femoral artery has been associated with aortofemoral artery injury and / or rupture, and a potential risk of stroke when delivery involves traversing the aortic arch. However, the various features and advantages achieved using some embodiments disclosed herein provide valve prostheses and delivery devices that minimize trauma along the delivery path of the device while also minimizing the invasive nature of the implantation procedure.

[0020] Other embodiments of the present apparatus and methods, etc., will become apparent from the following description, drawings, examples, and claims. It will be appreciated from the foregoing and following description that each and every feature described herein, and each and every combination of two or more of these features, is included within the scope of the present disclosure, provided that the features included in such combination are not mutually inconsistent. In addition, any embodiment of the present disclosure may not specifically include any feature or combination of these features. Other 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.

[0021] Additional features and advantages of the subject technology will be set forth in the following description and in part will be apparent from the description or may be learned by practicing the subject technology. The advantages of the subject technology will be realized and obtained through the structures particularly pointed out in the written description and its embodiments as well as the accompanying drawings.

[0022] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Various features of illustrative embodiments of the present disclosure are described below with reference to the accompanying drawings. The illustrated embodiments are intended to illustrate the present disclosure rather than to limit the present disclosure. The drawings include the following figures:

[0024] Figure 1 Delivery of a valve prosthesis using a valve delivery device in a transfemoral retrograde approach is shown, according to some embodiments.

[0025] Figure 2 A valve prosthesis according to some embodiments is shown.

[0026] Figure 3 is loaded onto a valve delivery device according to some embodiments Figure 2 Side cross-sectional view of a valve prosthesis.

[0027] Figure 4 According to some embodiments Figure 3 A perspective view of a valve delivery device of FIG. 1 is shown showing a grasping mechanism for engaging a valve anchor.

[0028] Figure 5A and Figure 5B FIG. 1 is a diagram showing a head vertebra protector according to some embodiments. Figure 3 Side cross-sectional view of the operation of the distal carrier assembly of the valve delivery device.

[0029] Figure 6 A frame component of a valve prosthesis is shown, according to some embodiments.

[0030] Figure 7AA prior art valve prosthesis and typical obstruction of its coronary ostium are shown.

[0031] Figure 7B Shown is a diagram positioned relative to a native valve structure according to some embodiments. Figure 6 A valve prosthesis is provided that advantageously allows blood to flow through one or more coronary artery ostia.

[0032] Figure 8 Aspects of a method of forming a membrane of a valve prosthesis according to some embodiments are shown.

[0033] Figure 9 yes Figure 8 An enlarged view of a portion of the membrane fabric.

[0034] Figure 10 According to some embodiments Figure 6 The membrane of the valve prosthesis.

[0035] Figure 11 According to some embodiments Figure 10 A magnified view of a portion of the membrane. DETAILED DESCRIPTION

[0036] In the following detailed description, many specific details are enumerated to provide a comprehensive understanding of the subject technology. It should be understood that the subject technology can be implemented under the situation that there is not a part in these specific details. In other cases, well-known structures and technologies are not shown in detail to prevent affecting the understanding of the subject technology.

[0037] Furthermore, while the present disclosure lists specific details of various embodiments, it should be understood that this description is merely illustrative and should not be construed as limiting in any way. Furthermore, it is contemplated that while specific embodiments of the present disclosure may be disclosed or illustrated in the context of an aortic valve prosthesis, such embodiments may also be used in other heart valve prosthesis applications. Furthermore, various applications of such embodiments and variations thereof that may be conceived by those skilled in the art are also encompassed by the basic concepts described herein.

[0038] Various embodiments will now be described more fully below. However, these embodiments may be embodied in a variety of different forms and should not be construed as being limited to the embodiments listed herein; rather, these embodiments are provided to make this disclosure complete and comprehensive and to fully convey the scope of this disclosure to those skilled in the art. Therefore, one or more features shown or otherwise disclosed in an embodiment herein may be used interchangeably or incorporated into another embodiment in which this feature(s) may not be explicitly shown or disclosed. In addition, unless expressly indicated, one or more features shown or otherwise disclosed for an embodiment herein may be excluded from that embodiment using the techniques of the art.

[0039] Like all heart valves, a healthy aortic valve will open to allow blood to flow through and close to prevent blood from flowing back. However, disease or malfunction of the valve can cause backflow or reduced blood flow (stenosis). In these cases, a replacement aortic valve prosthesis must be used to perform the function of a healthy aortic valve.

[0040] Minimally invasive surgical techniques are developing in which valve prostheses can be introduced into a patient using a catheter introduced through a small incision that provides access to, for example, the femoral artery or directly into the heart. These implantation techniques have shown promising results for providing treatment options for patients who are not suitable for open surgery. However, challenges remain with such catheter-based delivery of artificial valves.

[0041] For example, according to one aspect of at least one embodiment disclosed herein, it is recognized that conventional conduit delivery devices place stress on the vessel wall as they advance through the vessel and risk damaging the vessel wall. Furthermore, according to one aspect of at least one embodiment disclosed herein, it is recognized that transcatheter prosthetic valves may not be able to treat patients with aortic regurgitation (aortic insufficiency). Additionally, according to one aspect of at least one embodiment disclosed herein, it is recognized that conventional prosthetic valves may be difficult to position, may require rapid prosthetic ventricular pacing, and may have limited expansion. Consequently, the implantation and use of conventional prosthetic valves may result in complications such as vascular injury, moderate to severe paravalvular leakage, valve thrombosis / displacement, coronary artery obstruction, and excessive stress due to excessive radial forces.

[0042] The present disclosure describes various aspects of a heart valve prosthesis that can be delivered to a patient's defective heart valve. The valve prosthesis may include at least one valve anchor or clasper that is movably connected to, movably attached to, flexibly connected to, displaceably connected to, coupled to, or connected to a radially expandable valve support or valve frame. The valve frame may include artificial leaflets (valve leaflets) or cusps and provide the function of a native heart valve. Certain features of the valve prosthesis that can be achieved by the prostheses discussed in the present disclosure are further described in, for example, U.S. Patent No. 8,366,768, the entire contents of which are incorporated herein by reference.

[0043] Thus, the present disclosure provides a variety of features that may be incorporated into or excluded from any embodiment explicitly discussed or illustrated herein. Variations and combinations of these features may be implemented by those skilled in the art to achieve the advantages and benefits discussed herein. Furthermore, while some variations or combinations may be indicated or suggested herein, it is contemplated that those skilled in the art may implement or exclude certain aspects or features disclosed herein when developing appropriate embodiments or implementing these teachings. Advantageously, the various embodiments described herein allow for the treatment of patients suffering from aortic regurgitation, allow for precise axial, angular, and radial positioning of valve prostheses, minimize valve displacement and paravalvular leak, while avoiding damage to the annulus, minimize the need for a pacemaker, and reduce the likelihood of obstruction of the coronary arteries.

[0044] exist Figure 1 Some of these features and benefits of a heart valve prosthesis are illustrated in FIG. 5 . Figure 1 The delivery device 200 is shown being used in a human heart 300. The heart 300 may include an aorta 301 having an aortic arch 302 and an aortic valve 304. The aortic valve 304 may include a plurality of native leaflets 306 and may separate the aorta 301 from the left ventricle 310. According to some embodiments, the delivery device 200 may be passed retrograde through the aorta 301 until it reaches and is positioned by the native leaflets 306 of the aortic valve 304.

[0045] refer to Figure 1 and Figure 2During delivery of the valve prosthesis 100 to the native valve site, the valve anchor 104 and the support frame 102 can be arranged in tandem as a unit that is axially displaced along the longitudinal axis of the delivery device 200 (with or without partial or complete overlap between the anchor and the frame). Compared to a concentric arrangement, this configuration allows for a more radially compact configuration of the components of the valve prosthesis 100, resulting in a smaller cross-section and facilitating catheter-based delivery. This can increase the flexibility of the delivery device 200, enabling the delivery device 200 to travel over a guidewire through the tortuous geometry of the circulatory system, particularly the aortic arch 302. In fact, even with a delivery device guided by a guidewire, the aortic arch 302 presents a difficult obstacle due to its abrupt and high curvature. Typically, this is a limiting constraint for some surgeries or delivery devices. However, according to the various benefits and advantages of some embodiments disclosed herein, such as Figure 1 As shown, the delivery device 200 can be advanced through the aortic arch 302 to a target location in the area of ​​the aortic valve 304 .

[0046] like Figure 1 As shown, once the valve anchor 104 is in the desired position, the support frame 102 can be released from the distal carrier assembly and expanded into apposition with the native valve leaflets 306 and the internal aspects of the valve anchor 104, thereby sandwiching the native valve leaflets 306 between the support frame 102 and the valve anchor 104. Advantageously, by sandwiching the native valve leaflets 306 between the support frame and the valve anchor, the valve prosthesis 100 can reduce its reliance on radial force retention. In addition, by sandwiching the native valve leaflets 306 between the support frame and the valve anchor, the likelihood of the native valve leaflets 306 blocking the coronary ostia is reduced, which can benefit patients with a shorter coronary ostia distance and patients who already have a valve prosthesis but may need a new valve prosthesis within the existing valve prosthesis (a "valve-in-valve" application). Thus, the support frame and valve anchor can expand into contact with the aortic valve 304, applying a chronic outward force to the native leaflets 306 and aortic annulus 320. Thereafter, the artificial leaflets of the prosthesis 100 can begin to function in the desired manner and provide the same operation as a native valve.

[0047] According to some embodiments, the present disclosure also provides a handle actuator that can be used to control the operation of the delivery devices disclosed herein and allow a clinician to reliably and precisely control the delivery of a valve prosthesis. Figure 1 Features and operation of a handle actuator are shown for delivering a valve prosthesis using handle actuator 500 , according to some embodiments.

[0048] Figure 1 A handle actuator 500 is shown that can control one or more functions of a delivery device (e.g., the delivery device 200 discussed herein) for delivery of a valve prosthesis (e.g., the heart valve prosthesis 100 discussed herein). The handle actuator 500 can include a plurality of actuators or movable elements, such as knobs or buttons. The movable elements can allow a clinician to control one or more operations of the delivery device 200. The handle actuator 500 can include a control handle 510 having a longitudinal axis 512. The handle actuator 500 can also be referred to as a control unit. In some embodiments, the handle actuator 500 can be coupled to the second core component 222 (e.g., in a position where the second core component 222 is located). Figure 3 5 and 5 ). A control handle 510 may support the actuator and be held by the clinician during surgery.

[0049] In some embodiments, as Figure 1 As shown, the handle actuator 500 may include a first movable element 520, a second movable element 522, a third movable element 524, and a fourth movable element 526. The first movable element 520 may be used to steer the delivery device 200, the second movable element 522 may be used to release the valve anchor, the third movable element 524 may be used to release the nose cone or valve frame, and the fourth movable element 526 may be used as a nose cone toggle lock. The first movable element 520, the second movable element 522, the third movable element 524, and the fourth movable element 526 may also be referred to as a first control element 520, a second control element 522, a third control element 524, and a fourth control element 526.

[0050] Optionally, in some embodiments, one or more of the movable elements (e.g., the second movable element 522 and / or the third movable element 524) may include a button or slider safety switch 529 for preventing unintentional rotation of the movable element. The safety switch 529 can be constructed as a resilient button or slider mechanism that can be actuated to release a locking member that provides resistance to rotational or translational motion of each movable element. In some embodiments, the movable element may have a raised feature that provides a visual indication of rotation and facilitates tactile engagement and actuation by a clinician. Other features of the handle actuator 500 and a method of operating the handle actuator 500 are discussed and illustrated in Figures 13A to 13H of U.S. patent application No. 62 / 781,537, filed on December 18, 2018, the entire text of which is incorporated herein by reference.

[0051] Now refer to Figure 2, which shows a valve prosthesis 100 and its components in various configurations. Valve prosthesis 100 can be delivered to a patient using a suitable delivery device, including the delivery devices described herein. Valve prosthesis 100 may include: a support frame 102; and an anchoring member or valve anchor 104 to which support frame 102 is movably connected, movably attached, flexibly connected, displaceably connected, coupled, or connected.

[0052] The valve prosthesis 100 can be configured such that the components of the valve prosthesis 100 are advanced in series (advanced inserts) while the components remain movably connected, movably attached, flexibly connected, displaceably connected, coupled, or linked to each other, thereby minimizing the pass-through profile or cross-section of the delivery system. The interconnections between the components of the valve prosthesis 100 can allow for varying degrees of movement and can be set in engagement or retention positions that provide a limited range of movement. In some embodiments, the engagement position can also provide a preset relative positioning of the components of the valve prosthesis 100 to facilitate the correct placement and release of the valve prosthesis 100. In addition, some embodiments can provide the clinician with a high degree of control and enhance the maneuverability of the valve prosthesis 100 when implanting the valve prosthesis 100 in the target location.

[0053] In some embodiments, the valve anchor 104 can be coupled to the support frame 102 when the support frame 102 is in a compact configuration prior to delivery and deployment. In some embodiments, the valve anchor 104 is not fixed to the support frame 102. Furthermore, the valve anchor 104 can be separate from the support frame 102, or can be formed separately from the support frame 102 and subsequently coupled to the support frame 102. Thus, while at least a portion of the valve anchor 104 (e.g., the anchoring legs) can contact the support frame 102 or otherwise be reversibly attached or connected to the support frame 102, no portion of the valve anchor 104 is fixed (e.g., welded or otherwise irreversibly bonded) to the support frame 102. In other words, the valve anchor 104 can contact or otherwise be reversibly attached or connected to the support frame 102, rather than being irreversibly fixed to the support frame 102.

[0054] In addition, once the target location is reached, the valve anchor 104 can be movably coupled to the support frame 102 in a manner that prevents the entire valve anchor 104 from being radially displaced from the support frame 102 during initial expansion. For example, during the initial "landing" of the valve anchor 104 onto the native valve structure at the target location, a portion of the valve anchor 104 can be radially displaced from the support frame. In some embodiments, the support frame 102 can be deployed or expanded within the native heart valve structure, and the valve anchor 104 can become interposed between the support frame and the native valve tissue, becoming at least partially, and possibly completely, immobilized. The valve anchor 104 can be used to hold the expanded support frame 102 in place within the native valve structure.

[0055] Alternatively, the support frame 102 may be referred to as a valve frame or a valve support frame. Figure 2 The support frame 102 is shown aligned with and expanded within the valve anchor 104 in the configuration achieved when the prosthesis 100 is released and expanded within the native valve structure. The native valve structure includes the annulus or leaflets. The expanded configuration is used to secure the valve prosthesis 100 within the native valve annulus by engaging the native valve structure. In some embodiments, the expanded configuration of the valve prosthesis 100 can reduce reliance on radial forces applied by the support frame 102 and the valve anchor 104 to secure the valve prosthesis 100 by clamping or compressing the native leaflets between the support frame 102 and the valve anchor 104 of the valve prosthesis 100. In addition, as further discussed herein, during implantation of the valve prosthesis 100, the support frame 102 and the valve anchor 104 can move relative to each other in the expanded and / or compressed states to facilitate proper positioning of the prosthesis 100 relative to the native valve annulus and its surrounding structures. Indeed, the various advantages achieved by the prosthesis 100 and delivery devices disclosed herein allow the clinician to achieve greater precision in placing the prosthesis 100, as well as making such increased precision more readily achievable.

[0056] refer to Figure 2, the support frame 102 may include an outer surface (or exterior surface) and define a central perforation about a longitudinal axis 120. The longitudinal axis 120 corresponds to the inflow-outflow axis of the prosthesis 100. In some embodiments, the valve prosthesis 100 also includes a plurality of artificial leaflets or cusps 106 coupled to the support frame 102. The support frame 102 may provide structural support for the leaflets 106. The leaflets 106 may have a surface defining a reversibly sealable opening for unidirectional flow of fluid through the prosthesis 100. The prosthesis 100 may include three leaflets 106 for a tri-leaflet configuration. It will be appreciated that single-leaflet, double-leaflet and / or multi-leaflet configurations are also possible. For example, the leaflets may be coupled to the support frame 102 to span the fluid and control the flow of fluid through the lumen of the prosthesis 100. The artificial valve leaflet 106 may comprise one or more synthetic materials, engineered biological tissue, biological leaflet tissue, pericardial tissue, cross-linked pericardial tissue, aortic root tissue, chemically or biologically processed / treated tissue, or combinations thereof. In some embodiments, the pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissue, or combinations thereof.

[0057] Furthermore, in some embodiments, valve prosthesis 100 can include a sealing member or membrane 108 that can be attached to the inner side, outer side, and / or surround support frame 102 (e.g., by being laminated to the inner and outer surfaces of support frame 102). Thus, leaflets 106 can be coupled to support frame 102 and / or membrane 108. In some embodiments, membrane 108 can restrict blood flow in the area surrounding leaflets 106 so that blood flow occurs only between leaflets 106 and through the lumen of prosthesis 100, as in a healthy native heart valve.

[0058] like Figure 2As shown, the support frame 102 and / or valve anchor 104 may include a braided frame, a wire frame, or a laser-cut frame (e.g., a laser-cut tubular mesh). In some embodiments, the support frame 102 and / or valve anchor 104 may include a shape memory metal that can change shape at a specified temperature or temperature range, or change shape by inducing stress. Alternatively, the self-expanding frame may include a frame with a spring biasing member. The material of the support frame 102 and / or valve anchor 104 can allow the support frame 102 and / or valve anchor 104 to automatically expand to its functional size and shape when deployed, and also allow the support frame 102 and / or valve anchor 104 to be radially compressed to a smaller profile so that it can be delivered through the patient's vascular system. Examples of suitable materials for the self-expanding members described herein (e.g., support frame, valve anchor, locking component) include, but are not limited to, medical-grade nickel-titanium alloy, tantalum, platinum alloy, niobium alloy, cobalt alloy, alginate, or a combination thereof. A superelastic shape memory alloy made substantially of nickel and titanium in proportion, commonly known as Nitinol, is a preferred material. In some embodiments, the self-expanding members described herein may comprise materials including, but not limited to, thermoplastics, shape memory plastics, and polymers that are inert within the human body. In alternative embodiments, the support frame 102 and / or valve anchor 104 are not self-expanding, but may be expanded, for example, using a balloon catheter as is known in the art. Examples of suitable materials for the members described herein include, but are not limited to, stainless steel and titanium. Optionally, the support frame 102 and / or valve anchor 104 may comprise a radiopaque material to allow visualization under fluoroscopy or other imaging techniques.

[0059] Optionally, the support frame 102 may include one or more hooks 109 that can engage the native valve annulus, aortic root, or any other portion of the native valve when the support frame 102 is expanded within the native valve annulus. The hooks 109 can engage the native valve annulus to secure the prosthesis 100 during surgery and reduce any downstream or antegrade displacement of the prosthesis 100.

[0060] The support frame 102 may include a first end 110 and a second end 112. When the prosthesis 100 is released within the native valve annulus, the first end 110 may be located upstream of the second end 112. Figure 2As shown, the first end 110 of the support frame 102 can be shaped as a generally flat end of a cylinder, where the apices 114 of the support frame 102 are substantially in a common plane, which can be oriented generally perpendicular to the longitudinal axis 120 of the prosthesis 100. Further, the second end 112 can be shaped to include a series of peaks 130 and valleys 132, where the second apices or sub-peaks 136 of the support frame 102 collectively form the profile of the peaks 130 and valleys 132. The peaks 130 and valleys 132 of the second end 112 can be located downstream of the first end 110 when the prosthesis is in place within the native annulus.

[0061] According to some embodiments, as Figure 2 As shown, the artificial leaflets 106 can be coupled relative to the support frame 102 at locations that are circumferentially aligned with the peaks 130 of the second end 112. In some embodiments, the artificial leaflets 106 can be connected to the membrane 108 using ultra-high molecular weight polyethylene sutures. This unique configuration can advantageously enable the prosthesis 100 to more fully access the native valve structure, allowing for more natural blood flow without limiting or otherwise constraining the movement of the leaflets 106, and enabling the prosthesis 100 to more seamlessly integrate with the surrounding structures of the heart. In some embodiments, the artificial leaflets 106 can include features including, but not limited to, planar features, flat features, three-dimensional features, Bezier curves, or other suitable shapes. Alternatively, the artificial leaflets 106 can be shaped by being fixed on a lobe-shaped mandrel.

[0062] The valve anchor 104 can include at least one U-shaped member, a valve clasp, an atrioventricular (AV) node locator, a valve locator, or a valve hook 140 extending around a longitudinal axis of the valve anchor 104. As Figure 2 As shown, the valve anchor 104 can include a plurality of lobes or U-shaped members 140, for example including three U-shaped members 140, but can also include fewer or more U-shaped members 140. In some embodiments, the U-shaped members 140 can be configured to engage with, or fit within, the posterior aortic sinus, the left aortic sinus, and the right aortic sinus of the native aortic valve. Each U-shaped member 140 can have a peak portion 142 and a base portion 144. Each U-shaped member 140 can include a first leg 146 and a second leg 148. The first leg 146 and the second leg 148 of adjacent U-shaped members 140 can be interconnected at their peak portions 142. Further, the U-shaped members 140 can include shapes other than U-shaped, such as wave-shaped, V-shaped, W-shaped, or zig-zag shaped, among others. Alternatively, a plurality of valve anchors 104 can each include one or more U-shaped members 140, where the plurality of valve anchors 104 cooperatively engage with the aortic sinuses in order to anchor the valve prosthesis described herein.

[0063] Valve prosthesis 100 can include a coupling mechanism that interconnects support frame 102 and valve anchor 104. The coupling mechanism can include a single continuous strand of material or multiple separate strands of material that interconnect support frame 102 and valve anchor 104. Furthermore, the coupling mechanism can be attached to one or more locations on support frame 102 and / or valve anchor 104 in a sliding, engaging, or fixed manner.

[0064] According to some embodiments, the valve anchor 104 optionally defines one or more engagement regions in one or more portions of the valve anchor 104 , wherein a coupling mechanism can engage with the one or more engagement regions to limit relative movement between the support frame 102 and the valve anchor 104 .

[0065] For example, at the interconnection of the various peaks, the valve anchor 104 can define a coaptation region 150. The coaptation region 150 can also be referred to as a peak coaptation region.

[0066] like Figure 2 As shown, the support frame 102 can be flexibly coupled to the valve anchor 104 via one or more tethering members or coupling mechanisms 160. The coupling mechanism 160 can be coupled to the support frame 102 and the valve anchor 104 to allow relative movement between the support frame 102 and the valve anchor 104. However, the coupling mechanism 160 can be configured to limit relative movement between the support frame 102 and the valve anchor 104. In some embodiments, as discussed herein, when the coupling mechanism 160 is engaged in the engagement region 150, the engagement region 150 of the valve anchor 104 can serve to further limit relative movement of the support frame 102 relative to the valve anchor 104.

[0067] Accordingly, the valve anchor 104 can be coupled to the support frame 102 to allow the valve anchor 104 to move axially or longitudinally relative to the support frame 102 while still remaining coupled to the support frame 102. This advantageous feature of some embodiments can allow the clinician to independently position the valve anchor 104 relative to the support frame 102. For example, in a transcatheter aortic valve replacement, the clinician can independently position the valve anchor 104 in order to fit the base portion 144 of the valve anchor 104 into the aortic sinus. Portions of the aortic sinus can include the posterior aortic sinus, the left aortic sinus, and / or the right aortic sinus of the native aortic valve. In some embodiments, the valve anchor 104 can be rotated to align in the respective aortic sinus. In some embodiments, the interconnection of the valve anchor 104 with the support frame 102 can allow the valve anchor 104 to spin to align in the aortic sinus. Thereafter, with the valve anchor 104“landed” in the respective aortic sinus, the interconnection of the valve anchor 104 with the support frame 102 further enables the support frame 102 to be translated along the longitudinal axis 120 of the valve prosthesis 100. In some embodiments, during the delivery procedure, the valve anchor 104 can be moved at least axially from a proximal position relative to the support frame 102 to a distal position relative to the support frame 102, or from either of these positions to a position in which the support frame 102 at least partially overlaps the valve anchor 104 longitudinally or in which the support frame 102 is concentric with the valve anchor 104. For example, the ranges of various positions are shown in FIGS. A through F of U.S. Patent Application No. 62 / 781,537, filed December 18, 2018, the entirety of which is incorporated by reference herein. Figure 11 A to Figure 11 The ranges of various positions are shown in FIGS. A through F of U.S. Patent Application No. 62 / 781,537, filed December 18, 2018, the entirety of which is incorporated by reference herein.

[0068] For example, as Figure 2As shown, when the support frame 102 is nested within the valve anchor 104, the base portion 144 of the valve anchor 104 can be longitudinally spaced apart from the first end 110 of the support frame 102 along the longitudinal axis 120 by a distance of about 10% to about 100%, about 25% to about 75%, about 33% to about 100%, about 33% to about 66%, about 25% to about 75%, about 50% to about 75%, or about 60% to about 70% of the length of the support frame 102. In some embodiments, the support frame 102 can be contained within the valve anchor 104 or completely overlap the valve anchor 104. In some embodiments, the support frame 102 can have minimal or no overlap with the valve anchor 104. The support frame 102 can be moved along the longitudinal axis 120 to overlap the valve anchor 104 by about 10% to about 100%, about 25% to about 75%, about 33% to about 100%, about 33% to about 66%, about 25% to about 75%, or about 50% to about 75% of the length of the support frame 102. According to some embodiments, the U-shaped member 140 of the valve anchor 104 can be in a nested position within the aortic sinus, and the base portion 144 of the valve anchor 104 can be longitudinally adjacent to, coplanar with, or spaced apart from the first end 110 of the support frame 102. For example, the valve anchor 104 can be in the nested position when at least one base portion 144 of the valve anchor 104 is in contact with or adjacent to a basal attachment of a native aortic valve leaflet. Furthermore, the first end 110 of the support frame 102 can be longitudinally adjacent to, coplanar with, or spaced apart from the native valve structure (or the virtual ring formed by the underlying connections of the native aortic valve leaflets) or the ventricle-aorta junction.

[0069] The coupling mechanism 160 can allow for rotational and longitudinal movement of the valve anchor 104 relative to the support frame 102. Thus, despite the presence of the coupling mechanism 160, the valve anchor 104 can also be rotationally moved relative to the support frame 102. Furthermore, in some embodiments, the coupling mechanism 160 can be fixedly attached or coupled to the support frame 102 and fixedly or slidably attached to the valve anchor 104. As the support frame 102 moves relative to the valve anchor 104, the coupling mechanism 160 can slide along the U-shaped member 140. In some embodiments, the U-shaped member 140 has a generally arcuate or convex shape (e.g., Figure 2140 ), which allows coupling mechanism 160 to move unrestricted along the geometry of first leg 146 and second leg 148 of U-shaped member 140. When coupling mechanism 160 is allowed to slide along first leg 146 and second leg 148 of U-shaped member 140, valve prosthesis 100 may be in a position referred to as a "slidable" state. In the slidable state, the range of longitudinal and / or rotational movement of support frame 102 relative to valve anchor 104 is variable and may be at its maximum because coupling mechanism 160 can move along first leg 146 and second leg 148 of U-shaped member 140.

[0070] In some embodiments, the coupling mechanism 160 can be fixedly attached or coupled to the support frame 102 and fixedly attached to the valve anchor 104. The coupling mechanism 160 can elastically and / or plastically stretch, bend, or deform as the support frame 102 moves relative to the valve anchor 104. When the coupling mechanism 160 deforms, the range of longitudinal and / or rotational movement of the support frame 102 relative to the valve anchor 104 is variable, as permitted by the deformation of the coupling mechanism 160.

[0071] In some embodiments, the coupling mechanism 160 can have a plurality of coupling members, wherein each coupling member is coupled to the circumference of the support frame 102 and is intermittently spaced along the circumference of the support frame 102. Each coupling member can be slidably coupled to a corresponding one of the U-shaped members 140. Furthermore, the coupling mechanism 160 can have a plurality of coupling members coupled together in an end-to-end manner. Furthermore, the coupling mechanism 160 can have a plurality of coupling members that are individually coupled to the support frame 102 at one end and individually coupled to the valve anchor 104 at the other end. Each coupling member can be slidable along the valve anchor 104, as similarly disclosed herein, and will not be described again here for the sake of brevity.

[0072] However, as noted above, the valve anchor 104 can also include an engagement region 150 that can engage with the coupling mechanism 160 to limit relative movement between the support frame 102 and the valve anchor 104. The engagement region 150 can include one or more localized concavities or other geometric shapes that can engage or capture the coupling mechanism 160 once the coupling mechanism 160 enters the engagement region 150. Various embodiments of the engagement region 150 (such as those described in the aforementioned U.S. Patent Application No. 62 / 781,537) may be used to define a plurality of coupling mechanisms. Figure 2 A to Figure 2 G) can be used to allow the slidable coupling mechanism 160 to enter the engagement area 150, but restrict the coupling mechanism 160 from leaving the engagement area 150.

[0073] Now refer to Figure 3 , which provides a side cross-sectional view of valve prosthesis 100 loaded onto delivery device 200, according to some embodiments. Figure 3 Among the many features shown in Figure 3 The proximal enclosure 210 of the delivery device 200 is shown to extend over both the valve anchor 104 and the support frame 102. Thus, according to some embodiments, Figure 3 In the compression or delivery configuration shown, a coupling mechanism (not shown) can extend between the valve anchor 104 and the support frame 102 and be at least partially enclosed within the proximal housing 210 (depending on the connection point of the coupling mechanism to the support frame 102 and the longitudinal extent of the proximal housing 210).

[0074] in addition, Figure 3 It is shown that the valve anchor 104 can include a coupling travel limiter 240. The coupling travel limiter 240 can provide an enlarged outline of the wireframe structure of the valve anchor 104 to limit or prevent movement of the coupling mechanism as it slides along the U-shaped portion of the valve anchor 104.

[0075] In alternative embodiments of the delivery device 200, both the valve anchor 104 and the support frame 102 can be enclosed within the proximal sheath member 204 before and during release of the valve anchor 104. For example, in some embodiments, the valve anchor 104 can be distal to the support frame 102, wherein the valve anchor 104 is near the distal end of the proximal sheath member 204, and the support frame 102 can be generally adjacent to the valve anchor 104 (in a tandem configuration) and proximal to the valve anchor 104. In some embodiments of the delivery device 200, both the valve anchor 104 and the support frame 102 can be enclosed within the proximal sheath member 204, wherein the support frame 102 is near the distal end of the proximal sheath member 204, and the valve anchor 104 is generally adjacent to and proximal to the support frame 102.

[0076] Furthermore, in alternative embodiments of delivery device 200, valve anchor 104 can be enclosed within distal carrier assembly 206, and support frame 102 can be enclosed within proximal sheath member 204 prior to and during delivery of the valve prosthesis. For example, in some embodiments of delivery device 200, both valve anchor 104 and support frame 102 can be enclosed within distal carrier assembly 206, and support frame 102 can be enclosed within proximal sheath member 204 prior to and during delivery of the valve prosthesis. In this configuration, valve anchor 104 and support frame 102 can be substantially adjacent to each other (in a tandem configuration), and valve anchor 104 can be positioned proximal to support frame 102. Additional details of the delivery device and prosthesis are provided in the above-referenced U.S. Patent Application No. 62 / 781,537, which is incorporated herein by reference.

[0077] also, Figure 3 Anchor retention member 170 is shown as being operable to engage coaptation region 150 of valve anchor 104 with control member or grasper 224 to facilitate movement and control of the positioning of valve anchor 104 during delivery. As discussed with respect to FIG. 7G through FIG. 7I of the aforementioned U.S. Patent Application No. 62 / 781,537, such engagement can maintain coaptation region 150 in a common plane 152 that is oriented generally perpendicularly relative to the longitudinal axis of delivery device 200.

[0078] Figure 4 Various aspects of a delivery device 200a according to at least one embodiment are shown. These figures do not illustrate all components that may be incorporated into a delivery device in an embodiment. However, the features shown in these figures may be incorporated into embodiments of a delivery device to facilitate engagement with a valve anchor and / or facilitate delivery and control of the valve anchor during implantation and deployment at a target location.

[0079] For example, Figure 4 An embodiment of a delivery device 200a including a grasping mechanism is shown. The grasping mechanism can be used to securely connect a portion of the valve anchor to the delivery device to allow a clinician to control the movement, operation, and deployment of the valve anchor. The grasping mechanism can engage one or more portions or structures of the valve anchor using various coupling mechanisms, including attachment devices such as mechanical coupling, dissolvable structures, chemically reactive degradable structures, electrolytically degradable structures, and the like.

[0080] In some embodiments, the gripping mechanism may be a tubular gripping mechanism. Figure 4 The delivery device 200a shown may include a grasper 224a that can engage with and control the longitudinal position of the valve anchor 104a. The grasper 224a of the delivery device 200a may include an engagement wire that can move within the lumen of the tubular housing. The valve anchor 104a may be configured to include a clasper tang extending from the engagement region 150d or 150d' of the valve anchor 104a. The engagement wire may include a distal portion that includes a pin, ridge, or protrusion that can be coupled to an engagement structure of the clasper tang at the engagement region of the valve anchor 104a. When engaged together, the engagement wire and the clasper tang can be drawn proximally into the lumen of the tubular housing, which secures the engagement wire and the clasper tang relative to each other in radial and longitudinal directions. However, as the line of coaptation and the fastener tang move out of the lumen of the tubular housing, the line of coaptation and the fastener tang can disengage as the valve anchor 104a and the fastener tang radially expand, thereby disengaging the fastener tang from the line of coaptation. These and other features are discussed in the above-referenced U.S. Patent Application No. 62 / 781,537, which is incorporated herein by reference.

[0081] During use, after the valve anchor has been released from the proximal sheath and the valve anchor and valve frame have been released from the delivery device, the delivery device can be configured to be compactly reassembled and withdrawn into the introducer sheath to minimize any damage to the vessel through which the delivery device was advanced.

[0082] For example, in at least one embodiment, Figure 5A As shown, the proximal housing 210 can include a proximal portion 250 to facilitate realignment (eg, radial realignment) of the distal end portion 208 of the proximal sheath member 204 with the proximal housing 210 .

[0083] like Figure 5A As shown, the proximal portion 250 can be coupled to the core component 220. Furthermore, the proximal portion 250 can optionally be tapered or tapered in the proximal direction, and / or the proximal portion 250 can have a circumferential node 252 and / or a circumferential lumen 254, which can facilitate realignment of the proximal sheath member 204 relative to the proximal housing 210 along the longitudinal axis of the delivery device 200. The tapering of the proximal portion 250 can allow the distal portion 208 of the proximal sheath member 204 to be smoothly advanced distally over the proximal portion 250, and the circumferential node 252 can contact the inner surface of the distal portion 208 of the proximal sheath member 204 as the distal portion 208 approaches the proximal abutment surface 214.

[0084] For example, Figure 5A As shown, the circumferential protrusion 252 can taper in the proximal direction from the proximal abutment surface 214. With such a configuration, when the proximal sheath member 204 slides distally toward the proximal housing 210, the circumferential protrusion 252 can advantageously guide the distal end portion 208 of the proximal sheath member 204 distally toward the proximal abutment surface 214 of the proximal housing 210, such that the outer surface of the proximal sheath member 204 is aligned with the outer surface of the proximal housing 210. Thus, the outer surface of the proximal housing 210 and the outer surface of the proximal sheath member 204 can provide the delivery device 200 with a smooth outer profile, which can advantageously reduce the likelihood of the delivery device 200 getting stuck or otherwise damaging tissue within the body cavity as the delivery device 200 moves within the body cavity.

[0085] Optionally, the proximal portion 250 can include three circumferential protrusions 252 and three circumferential cavities 254. The circumferential protrusions 252 can extend proximally from the proximal abutment surface 214. The three circumferential cavities 254 can correspond to the number of U-shaped components of the valve anchor that are received within the proximal sheath member 204 between the proximal sheath member 204 and the proximal portion 250 of the proximal housing 210.

[0086] This advantageous feature of some embodiments may allow the distal housing 212 to be properly positioned along the delivery device 200 to ensure that the distal housing 212 does not snag or become caught on any structure during retrieval of the delivery device 200 .

[0087] Also like Figure 5A and Figure 5B As shown, the proximal housing 210 and the distal housing 212 can collectively house the support frame 102. The first core member 220 and the second core member 222 can be actuated to separate the proximal housing 210 and the distal housing 212, thereby allowing the support frame 102 to self-expand while in place within the valve anchor 104.

[0088] For example, by pushing or pulling first core component 220, second core component 222 and / or proximal sheath member 204 relative to each other along the longitudinal axis of delivery device 200, the clinician can control the longitudinal movement of each of these components to allow release of support frame 102 and valve anchor 104 of valve prosthesis 100.

[0089] Furthermore, in some embodiments, in order to facilitate delivery of the delivery device 200 to the target location, such as Figure 5A and 5B As shown, the second core component 222 may include a lumen 218 to allow the delivery device 200 to be moved along a guidewire that may extend through the lumen 218 of the second core component 222 .

[0090] Figure 5A and 5B Further shown are the positions of the proximal housing 210 and the distal housing 212 during release of the support frame 102. Figure 5A The positions shown in the figure are separated into Figure 5B After the position shown in FIG. 1 , the first end 110 of the support frame 102 can begin to expand from the compressed configuration to the expanded configuration. In some embodiments, the support frame 102 can have one or more anchors 109 at its first end 110 (see also FIG. Figure 2), when the anchor 109 engages the native valve structure, the anchor 109 can supplement the outward expansion force (due to the self-expansion of the support frame 102) and the resulting frictional engagement to mitigate downstream movement of the support frame 102 relative to the native valve structure. Thus, by first opening the first end 110 (before the second end 112, and via relative movement of the proximal housing 210 and the distal housing 212), the first end 110 can be opened like a flower to facilitate release of the support frame and / or engagement with the native anatomical structure (e.g., the valve structure itself) to secure the longitudinal position of the support frame 102 relative to the native valve structure. Thereafter, the second end 112 of the support frame 102 can be controlled and released to disengage and release the second end 112 from the proximal housing 210.

[0091] In some embodiments, the first end 110 and the second end 112 can open simultaneously at the same or different rates. For example, in some embodiments, the first end 110 and the second end 112 can open simultaneously, but the first end 110 opens at a faster rate than the second end 112.

[0092] Advantageously, the use of the proximal housing 210 and the distal housing 212 allows for greater control and enhanced operation of the frame 102. For example, by controlling the position and rate of separation of the proximal housing 210 and the distal housing 212, the opening of the support frame 102 at the first end 110 and the second end 112 can be controlled. Furthermore, by controlling the movement of the distal housing 212, the timing and rate of opening of the first end 110 can be controlled relative to the timing and rate of opening of the second end 112 (which can be controlled by movement of the proximal housing 210).

[0093] Additionally and advantageously, by having separate proximal and distal housings 210, 212, the frictional forces experienced by the delivery device 200 may be reduced and the travel of the housings 210, 212 relative to the support frame 102 may be minimized.

[0094] In particular, according to some embodiments, the distal carrier assembly 206 can include a plunger mechanism 260 that can facilitate expansion of the support frame 102. The plunger mechanism 260 can be moved from a compressed state (e.g., Figure 5A ) is expanded to an extended state (as shown Figure 5B ). The plunger mechanism 260 can be biased by a spring or other device so as to automatically move from the compressed state to the expanded state. However, in some embodiments, the plunger mechanism 260 can also be manually actuated by a clinician.

[0095] As shown, the plunger mechanism 260 can include a plunger head 262 and a biasing device 264. The plunger head 262 can include a conical or tapered proximal portion 286. The tapered proximal portion 286 can be configured to not only contact the first end of the support frame 102 during delivery, but also help center the distal portion 290 of the tubular portion 282 of the proximal housing 210 relative to the longitudinal axis of the delivery device 200 and help align the distal portion 290 with the proximal portion 292 of the tubular portion 272 of the distal housing 212. The plunger head 262 can also include an outer peripheral surface 294 that can not only contact an inner surface 296 of the tubular portion 272, but can also contact an inner surface 298 of the tubular portion 282 as the tubular portion 282 is advanced distally over the tapered proximal portion 286 of the plunger head 262.

[0096] In addition, the plunger mechanism 260 can be housed within the distal lumen 270 of the tubular portion 272 of the distal housing 212. For example, the biasing device 264 can be a spring. The biasing device 264 can be inserted between an internal structure or wall 274 of the distal lumen 270 and a distal surface or structure 276 of the plunger head 262. The plunger head 262 can move proximally within the distal lumen 270 to continue to apply a proximally oriented force to the first end 110 of the support frame 102 until the support frame 102 exits the distal lumen 270. Thereafter, according to some embodiments, the support frame 102 can self-expand until the second end 112 is pulled out of the proximal lumen 280 of the tubular portion 282 of the proximal housing 210 as the support frame 102 continues to expand. The expanded state of the support frame 102 is discussed above. Figure 1 and Figure 2 Shown in.

[0097] According to some embodiments, the present disclosure optionally provides a membrane that can be used with the valve prostheses disclosed herein to reduce the diameter of a support frame in a compressed configuration. Figures 6 to 11 Aspects of the film 608 described herein are shown.

[0098] Figure 6 6 shows support frame 102 coupled to membrane 608 of valve prosthesis 600 according to some embodiments. Figure 6 In the illustrated embodiment, the membrane 608 is positioned or disposed within the lumen or against the inner surface of the expanded support frame 102. As previously described, in some embodiments, the membrane 608 can function as a sealing member and can be attached to the inner side, outer side, and / or surrounding the support frame 102.

[0099] In some embodiments, the membrane 608 may be secured or otherwise attached to the support frame 102 via a plurality of sutures 604. The sutures 604 may attach the membrane 608 to the wire structure of the support frame 102 by passing through the membrane 608 and wrapping around portions of the support frame 102. Figure 6 In the illustrated embodiment, the stitches 604 can be closely spaced (e.g., 2 to 4 stitches 604 on each side of a parallelogram cell or diamond cell of the support frame 102) to create a tight seal between the membrane 608 and the support frame 102.

[0100] In some embodiments, the two lateral ends of the membrane 608 may be connected at the seam 602 to form a generally cylindrical shape. Figure 6 As shown, the axial ends of the membrane 608 can wrap around the ends of the support frame 102 at the first end 110 and / or the second end 112. In some embodiments, the axial ends of the membrane 608 can wrap around the first end 110 and / or the second end 112 to at least partially cover the inner and outer surfaces of the support frame 102. For example, the peak 606 of the membrane 608 can wrap around the peak 130 of the second end 112 of the support frame 102. Advantageously, by wrapping the axial ends of the membrane 608 around the first end 110 and / or the second end 112, the valve prosthesis 600 can be better sealed to the native heart valve. In addition, the sutures 604 can be arranged at closer intervals along the axial ends of the membrane 608 than in the middle of the axial ends of the membrane 608, where the membrane 608 is connected to the support frame 102.

[0101] As previously described, the leaflets can be coupled to membrane 608. In some embodiments, membrane 608 can restrict blood flow in the area surrounding the leaflets so that blood flow occurs only between the leaflets, through the lumen of prosthesis 600, as in a healthy native heart valve.

[0102] In some embodiments, at second end portion 112, an axial end of membrane 608 may be shaped to cover primary peaks 130 and valleys 132 of second end 112. In some embodiments, membrane 608 may be shaped to cover secondary apexes or secondary peaks 136 located within valleys 132 between primary peaks 130. Advantageously, the configuration of secondary peaks 136 between primary peaks 130 may allow for improved access to the coronary ostia and prevent occlusion of the coronary ostia compared to prior art valve prostheses.

[0103] For example, reference Figure 7A, a prior art valve prosthesis 600' is shown within the aorta 696'. A support frame 602' is disposed within the aortic valve annulus 692'. As shown, due to the geometry of the support frame 602' and the membrane 608', the support frame 602' and the membrane 608' may block or obstruct the coronary artery ostia 694', which is located a distance 693' from the valve annulus 692'.

[0104] In contrast, Figure 7B An embodiment of a valve prosthesis 600 is shown that advantageously allows blood to flow to the adjacent coronary ostia 694. As discussed above and as Figure 7B As shown, the height difference between primary peak 130 and secondary peak 136 of valve prosthesis 600 facilitates access to coronary ostia 694 while allowing for desired operation of valve prosthesis 600 .

[0105] In some embodiments, the secondary peaks 136 of the valve prosthesis 600 can be sufficiently low to allow for (and adapt to) a variety of sizes and positions of the coronary ostia 694 relative to the position of the patient's native annulus 692. Advantageously, in some embodiments, the secondary peaks 136 of the valve prosthesis 600 allow access to the coronary ostia 694 at a coronary ostia height of less than 10 mm, less than 8 mm, or less than 6 mm, which is typically not permitted by conventionally available prostheses. In some embodiments, the secondary peaks 136, optionally in conjunction with one or more other features described herein, allow access to the coronary ostia 694 that is disposed at a small axial distance 693 from the annulus 692. For example, the secondary peaks 136 can allow access to the coronary ostia 694 that is disposed at a coronary ostia height of less than 6 mm, or where the lower edge of the coronary ostia 694 is at a small axial distance 693 of less than 6 mm from the plane of the aortic annulus. Furthermore, in some embodiments, valve prosthesis 600 can be positioned lower within annulus 692 to allow for smoother access to coronary ostia 694. By providing secondary peaks 136 between primary peaks 130 of valve prosthesis 600, and optionally by one or more other features described herein, access to coronary ostia 694 is preserved, allowing for future procedures that may require access to coronary ostia 694, such as coronary stent implantation.

[0106] Figure 8 A method of forming or manufacturing a membrane for use with a valve prosthesis is shown, which can be part of a method of forming a valve prosthesis. In some embodiments, one or more membranes 608 can be cut from a membrane fabric 601. The membrane fabric 601 can be a fabric formed from a woven fiber such as woven polyester. Figure 9As shown, the membrane fabric 601 is formed by weaving fibers in a warp direction 608a and a weft direction 608b, with the warp direction 608a and the weft direction 608 being oriented transversely relative to each other, and in some cases, the warp direction 608a and the weft direction 608 being oriented perpendicularly relative to each other. In some embodiments, the fabric can resist stretching in the warp direction 608a and the weft direction 608b while allowing and accommodating stretching in a direction oblique to or offset from the warp direction 608a and the weft direction 608b.

[0107] Reference again Figure 8 One or more membranes can be cut from the membrane fabric 601 using a template that substantially has the shape of the membrane 608. One or more templates can be placed on the membrane fabric 601 to cut the membrane 608. Figure 8 The middle membrane 608 is shown in a planar orientation, but the support frame 102 and the longitudinal axis 120 projected therefrom are also shown for reference.

[0108] The template can be oriented at an angle (diagonally) relative to the membrane fabric 601. A skew angle 608c can be defined between an edge of the membrane fabric 601 and the projected longitudinal axis 120. For reference, the skew angle 608c is shown between the edge of the membrane fabric 601 and an offset axis 120' parallel to the longitudinal axis 120. As discussed further below, the skew angle 608c can be between about 30° and about 60°, such as about 35°, about 40°, about 45°, about 50°, or about 55°.

[0109] By orienting the template at an offset angle 608c relative to the membrane fabric 601, the resulting membrane 608 is cut obliquely at an offset angle 608c relative to the warp 608a and weft 608b of the membrane fabric. In some embodiments, the membrane 608 can be cut at an offset angle 608c by spirally winding the membrane fabric onto a support frame and cutting the membrane fabric 601.

[0110] Figure 10 Shown using Figure 8 and Figure 9608 is a finished film made by the process shown in . In the embodiment shown, the warp and weft of the fabric of the membrane 608 are oriented in a direction that is biased to the longitudinal axis of the prosthesis or at an angle relative to the longitudinal axis of the prosthesis. In some embodiments, the bias angle of the membrane 608 can be substantially oriented so that the warp or weft of the material is aligned with the expandable elements (e.g., grid cells, parallelogram grid cells, diamond grid cells) of the support frame 102. Advantageously, in some embodiments, the membrane 608 can have improved conformability and can not resist the movement or expansion of the support frame 102, thereby reducing the stress and bunching of the membrane 608 when the membrane 608 and the prosthesis are in a compressed configuration. In some embodiments, the reduction in stress of both the membrane 608 and the support frame 102 also facilitates the assembly and loading of the valve prosthesis.

[0111] Indeed, development of some embodiments of the prosthesis has shown that the unique orientation and configuration of membrane 608 described herein can allow membrane 608 to more easily compress radially and extend axially with support frame 102, thereby, in some embodiments, allowing membrane 608 and support frame 102 to operate as a single unit. Similarly, in some embodiments, by orienting membrane 608 along an offset angle, membrane 608 can more easily extend along longitudinal axis 120 to achieve a smaller cross-sectional profile, which can prevent flaring, bulging, or puckery, thereby minimizing the cross-sectional profile of the valve prosthesis in the compressed configuration.

[0112] Figure 11 6 is a plan view of the warp threads 608a and weft threads 608b of the membrane 608 relative to the longitudinal axis 120 of the support frame 102. In some embodiments, the warp threads 608a and weft threads 608b of the woven membrane 608 can be oriented at an offset angle 608c between 0 and 90 degrees relative to the longitudinal axis 120. In some embodiments, the woven membrane 608 can be oriented at an offset angle 608c between 15 and 75 degrees relative to the longitudinal axis 120. In some embodiments, the woven membrane 608 can be oriented at an offset angle 608c between 30 and 60 degrees relative to the longitudinal axis 120. In some embodiments, the woven membrane 608 can be oriented at an offset angle 608c of approximately 45 degrees relative to the longitudinal axis 120.

[0113] In some embodiments, the warp and weft threads of the woven membrane 108 can be oriented at an offset angle of between 0 and 90 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at an offset angle of between about 15 and 75 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at an offset angle of between about 30 and 60 degrees relative to the longitudinal axis. In some embodiments, the woven membrane 108 can be oriented at an offset angle of about 45 degrees relative to the longitudinal axis.

[0114] Itemized description of the subject technology

[0115] For convenience, various examples of aspects of the present disclosure are described as groups of clauses with numbered clauses (1, 2, 3, etc.). These clauses are provided as examples and do not limit the subject technology. The figures and the designations of the reference numerals are provided below only as examples and for illustrative purposes, and the clauses are not limited to these designations.

[0116] Item 1. A valve prosthesis comprising: a support frame comprising a plurality of grid units, the plurality of grid units being arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite to the bottom edge; and at least one secondary peak portion longitudinally disposed between the edge portion and the plurality of main peak portions.

[0117] Clause 2. The valve prosthesis of clause 1, wherein the at least one secondary peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

[0118] Clause 3. The valve prosthesis of any preceding clause, wherein the plurality of mesh cells define a wire structure.

[0119] Clause 4. The valve prosthesis of any preceding clause, wherein the at least one secondary peak portion lies in a common plane.

[0120] Clause 5. The valve prosthesis of any preceding clause, wherein each of the plurality of grid cells comprises a parallelogram-shaped grid cell.

[0121] Clause 6. The valve prosthesis of any preceding clause, wherein each of the plurality of mesh cells comprises a diamond-shaped mesh cell.

[0122] Clause 7. The valve prosthesis of any preceding clause, wherein the at least one secondary peak portion is configured to provide access to a coronary ostium of the patient.

[0123] Clause 8. The valve prosthesis of Clause 7, wherein the coronary ostium has a coronary ostium height of less than 10 mm.

[0124] Clause 9. The valve prosthesis of any preceding clause, wherein the support frame defines a central through-hole.

[0125] Clause 10. The valve prosthesis of any preceding clause, wherein the support frame comprises a braided frame.

[0126] Clause 11. The valve prosthesis of any preceding clause, wherein the support frame comprises a wire frame.

[0127] Clause 12. The valve prosthesis of any preceding clause, wherein the support frame comprises a laser-cut frame.

[0128] Clause 13. The valve prosthesis of any preceding clause, wherein the support frame comprises a shape memory metal.

[0129] Clause 14. The valve prosthesis of any preceding clause, wherein the support frame comprises a self-expanding material.

[0130] Clause 15. The valve prosthesis of any preceding clause, wherein the support frame comprises one or more hooks.

[0131] Item 16. The valve prosthesis of any preceding item, further comprising: a valve anchor having at least one U-shaped member extending around a longitudinal axis of the valve anchor; and a coupling mechanism interconnecting the valve anchor with the support frame.

[0132] Item 17. A valve prosthesis comprising: a support frame comprising a plurality of grid cells arranged to define: a bottom edge of the support frame; a plurality of first vertices disposed on a common plane; and a plurality of second vertices collectively defining a plurality of peaks and a plurality of valleys.

[0133] Clause 18. The valve prosthesis of Clause 17, wherein the common plane is oriented generally perpendicularly relative to a longitudinal axis of the valve prosthesis.

[0134] Clause 19. The valve prosthesis of clause 17 or 18, wherein the plurality of peaks and the plurality of valleys are disposed downstream of the bottom edge.

[0135] Clause 20. The valve prosthesis of clauses 17 to 19, wherein the plurality of first apices are disposed at a smaller axial distance from the bottom edge than the plurality of second apices.

[0136] Clause 21. The valve prosthesis of clauses 17 to 20, wherein the plurality of valleys are disposed longitudinally intermediate the bottom edge and the plurality of peaks.

[0137] Clause 22. The valve prosthesis of clauses 17 to 21, wherein the plurality of mesh cells define a wire structure.

[0138] Clause 23. The valve prosthesis of clauses 17 to 22, wherein each of the plurality of grid cells comprises a parallelogram-shaped grid cell.

[0139] Clause 24. The valve prosthesis of clauses 17 to 23, wherein each of the plurality of mesh cells comprises a diamond-shaped mesh cell.

[0140] Clause 25. The valve prosthesis of clauses 17 to 24, wherein the plurality of valleys are configured to provide access to a coronary ostium of the patient.

[0141] Clause 26. The valve prosthesis of Clause 25, wherein the coronary ostium has a coronary ostium height of less than 10 mm.

[0142] Clause 27. The valve prosthesis of clauses 17 to 25, wherein the support frame defines a central perforation.

[0143] Clause 28. The valve prosthesis of clauses 17 to 26, wherein the support frame comprises a braided frame.

[0144] Clause 29. The valve prosthesis of clauses 17 to 27, wherein the support frame comprises a wire frame.

[0145] Clause 30. The valve prosthesis of clauses 17 to 28, wherein the support frame comprises a laser cut frame.

[0146] Clause 31. The valve prosthesis of clauses 17 to 29, wherein the support frame comprises a shape memory metal.

[0147] Item 32. A valve prosthesis, comprising: a support frame comprising a plurality of grid units, the plurality of grid units being arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed between the edge portion and the plurality of main peak portions, wherein the plurality of secondary peak portions are also radially disposed between the plurality of main peak portions.

[0148] Clause 33. The valve prosthesis of clause 32, wherein the plurality of main peak portions comprises three main peak portions.

[0149] Clause 34. The valve prosthesis of clause 32 or 33, wherein the plurality of sub-peak portions comprises three sub-peak portions.

[0150] Clause 35. The valve prosthesis of clauses 32 to 34, wherein the plurality of secondary peak portions are disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

[0151] Clause 36. The valve prosthesis of clauses 32 to 35, wherein the plurality of mesh cells define a wire structure.

[0152] Clause 37. The valve prosthesis of clauses 32 to 36, wherein the plurality of secondary peak portions lie in a common plane.

[0153] Clause 38. The valve prosthesis of clauses 32 to 37, wherein each of the plurality of grid cells comprises a parallelogram-shaped grid cell.

[0154] Clause 39. The valve prosthesis of clauses 32 to 38, wherein each of the plurality of mesh cells comprises a diamond-shaped mesh cell.

[0155] Clause 40. The valve prosthesis of clauses 32 to 39, wherein the at least one secondary peak portion is configured to provide access to a coronary ostium of the patient.

[0156] Clause 41. The valve prosthesis of Clause 40, wherein the coronary ostium has a coronary ostium height of less than 10 mm.

[0157] Clause 42. The valve prosthesis of clauses 32 to 41, wherein the support frame comprises a wire frame.

[0158] Clause 43. The valve prosthesis of clauses 32 to 42, wherein the support frame comprises a laser cut frame.

[0159] Clause 44. The valve prosthesis of clauses 32 to 43, wherein the support frame comprises a shape memory metal.

[0160] Clause 45. The valve prosthesis of clauses 32 to 44, wherein the support frame comprises a self-expanding material.

[0161] Clause 46. The valve prosthesis of clauses 32 to 45, wherein the support frame comprises one or more hooks.

[0162] Item 47. A valve prosthesis comprising: a support frame comprising a plurality of grid units arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed intermediate the edge portion and the plurality of main peak portions; and a membrane attached to the support frame.

[0163] Item 48. A valve prosthesis according to Item 47, wherein the membrane includes: a first end portion corresponding to the bottom edge of the support frame; a plurality of membrane main peak portions corresponding to the plurality of main peak portions of the support frame; and at least one membrane secondary peak portion corresponding to the at least one secondary peak portion of the support frame.

[0164] Clause 49. The valve prosthesis of clause 47 or 48, wherein the membrane is attached to the support frame via a plurality of sutures.

[0165] Clause 50. The valve prosthesis of Clause 49, wherein the plurality of sutures pass through the membrane and wrap around portions of the support frame.

[0166] Item 51. A valve prosthesis according to Item 49, wherein a first group of sutures among the plurality of sutures are arranged at closer intervals than a second group of sutures among the plurality of sutures, the first group of sutures being along a plurality of top portions corresponding to the plurality of main peak portions and the at least one secondary peak portion of the support frame, and the second group of sutures being connected to a portion of the support frame located between the plurality of top portions and the plurality of base portions.

[0167] Clause 52. The valve prosthesis of clauses 47 to 51, wherein the membrane fabric of the membrane is formed from woven fibers.

[0168] Clause 53. The valve prosthesis of Clause 52, wherein the membrane fabric is formed by weaving fibers in warp and weft directions, the warp and weft directions being oriented transversely relative to each other.

[0169] Clause 54. The valve prosthesis of Clause 53, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0170] Clause 55. The valve prosthesis of Clause 53, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0171] Item 56. A method of manufacturing a membrane for a support frame of a valve prosthesis, the method comprising: generating a template on a membrane fabric in the shape of one or more membranes to be attached to the support frame of the valve prosthesis; orienting the template at an oblique angle relative to the membrane fabric; and generating one or more membranes from the membrane fabric using the template.

[0172] Clause 57. The method of clause 56, wherein the membrane fabric is formed from woven fibers.

[0173] Clause 58. The method of clause 57, wherein the membrane fabric is formed by weaving fibers in a warp direction and a weft direction, the warp direction and the weft direction being oriented transversely relative to each other.

[0174] Clause 59. The method of clause 58, wherein the membrane fabric resists stretching in the warp and weft directions of the fibers.

[0175] Clause 60. The method of Clause 58, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0176] Clause 61. The method of clauses 56 to 60, wherein the deflection angle is about 30 degrees to about 60 degrees.

[0177] Item 62. A valve prosthesis comprising: a support frame comprising a plurality of grid units arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed intermediate the edge portion and the plurality of main peak portions; and a membrane attached to the support frame.

[0178] Item 63. A valve prosthesis according to Item 62, wherein the membrane includes: a first end portion corresponding to the bottom edge of the support frame; a plurality of membrane main peak portions corresponding to the plurality of main peak portions of the support frame; and at least one membrane secondary peak portion corresponding to the at least one secondary peak portion of the support frame.

[0179] Item 64. A valve prosthesis according to Item 63, wherein one or more membrane main peak portions of the multiple membrane main peak portions surround corresponding one or more main peak portions of the multiple main peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more main peak portions of the support frame.

[0180] Item 65. A valve prosthesis according to Item 64, wherein one or more of the at least one membrane sub-peak portions surround a corresponding one or more of the at least one sub-peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more sub-peak portions of the support frame.

[0181] Clause 66. The valve prosthesis of clauses 62 to 65, wherein the at least one secondary peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

[0182] Clause 67. The valve prosthesis of clauses 62 to 66, wherein the membrane surrounds the support frame, the support frame having one or more openings along a longitudinal axis of the support frame.

[0183] Clause 68. The valve prosthesis of clauses 62 to 67, wherein the membrane is disposed within the lumen of the support frame so as to be attached to an inner surface of the support frame.

[0184] Clause 69. The valve prosthesis of clauses 62 to 68, wherein the membrane is laminated to an inner surface and an outer surface of the support frame.

[0185] Clause 70. The valve prosthesis of clauses 62 to 69, wherein the membrane fabric of the membrane is formed from woven fibers.

[0186] Clause 71. The valve prosthesis of clause 70, wherein the membrane fabric is formed by weaving fibers in warp and weft directions, the warp and weft directions being oriented transversely relative to each other.

[0187] Clause 72. The valve prosthesis of clause 71, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0188] Clause 73. The valve prosthesis of clause 71, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0189] Clause 74. The valve prosthesis of clauses 62 to 73, further comprising a plurality of leaflets coupled to the membrane.

[0190] Clause 75. The valve prosthesis of clause 74, wherein the membrane is coupled to the leaflets to restrict fluid flow around the leaflets and to direct the fluid flow to areas between the leaflets.

[0191] Item 76. A valve prosthesis comprising: a support frame comprising a plurality of grid units arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed between the edge portion and the plurality of main peak portions; and a membrane attached to the support frame, wherein the membrane fabric of the membrane is formed by woven fibers formed by weaving the fibers along a warp and a weft direction, the warp and the weft directions being oriented transversely relative to each other, and the membrane comprising a first end corresponding to the bottom edge of the support frame, the first end of the membrane wrapping around the bottom edge of the support frame.

[0192] Item 77. A valve prosthesis according to Item 76, wherein the membrane includes: a plurality of membrane main peak portions, which correspond to the plurality of main peak portions of the support frame; and at least one membrane secondary peak portion, which corresponds to the at least one secondary peak portion of the support frame.

[0193] Item 78. A valve prosthesis according to Item 77, wherein one or more membrane main peak portions of the multiple membrane main peak portions surround corresponding one or more main peak portions of the multiple main peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more main peak portions of the support frame.

[0194] Item 79. A valve prosthesis according to Item 78, wherein one or more of the at least one membrane sub-peak portions surround a corresponding one or more of the at least one sub-peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more sub-peak portions of the support frame.

[0195] Clause 80. The valve prosthesis of clauses 76 to 79, wherein the at least one secondary peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

[0196] Clause 81. The valve prosthesis of clauses 76 to 80, wherein the membrane surrounds the support frame, the support frame having one or more openings along a longitudinal axis of the support frame.

[0197] Clause 82. The valve prosthesis of clauses 76 to 81, wherein the membrane is disposed within the lumen of the support frame so as to be attached to an inner surface of the support frame.

[0198] Clause 83. The valve prosthesis of clauses 76 to 82, wherein the membrane is laminated to an inner surface and an outer surface of the support frame.

[0199] Clause 84. The valve prosthesis of clauses 76 to 83, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0200] Clause 85. The valve prosthesis of clauses 76 to 84, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0201] Clause 86. The valve prosthesis of clauses 76 to 85, further comprising a plurality of leaflets coupled to the membrane.

[0202] Clause 87. The valve prosthesis of clause 86, wherein the membrane is coupled to the leaflets to restrict fluid flow around the leaflets and to direct the fluid flow to areas between the leaflets.

[0203] Item 88. A valve prosthesis comprising: a support frame comprising a plurality of grid units arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed intermediate the edge portion and the plurality of main peak portions; and a membrane attached to the support frame, wherein the membrane is attached to the support frame via a plurality of sutures.

[0204] Item 89. A valve prosthesis according to Item 88, wherein the membrane includes: a first end portion corresponding to the bottom edge of the support frame; a plurality of membrane main peak portions corresponding to the plurality of main peak portions of the support frame; and at least one membrane secondary peak portion corresponding to the at least one secondary peak portion of the support frame.

[0205] Item 90. A valve prosthesis according to Item 89, wherein one or more membrane main peak portions of the plurality of membrane main peak portions surround a corresponding one or more main peak portions of the plurality of main peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more main peak portions of the support frame.

[0206] Item 91. A valve prosthesis according to Item 90, wherein one or more of the at least one membrane sub-peak portions surround a corresponding one or more of the at least one sub-peak portions of the support frame so as to cover a portion of the inner surface of the support frame and a portion of the outer surface of the support frame at the corresponding one or more sub-peak portions of the support frame.

[0207] Clause 92. The valve prosthesis of clauses 88 to 91, wherein the at least one secondary peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

[0208] Clause 93. The valve prosthesis of clauses 88 to 92, wherein the membrane surrounds the support frame, the support frame having one or more openings along a longitudinal axis of the support frame.

[0209] Clause 94. The valve prosthesis of clauses 88 to 93, wherein the membrane is disposed within the lumen of the support frame so as to be attached to an inner surface of the support frame.

[0210] Clause 95. The valve prosthesis of clauses 88 to 94, wherein the membrane is laminated to an inner surface and an outer surface of the support frame.

[0211] Clause 96. The valve prosthesis of clauses 88 to 95, wherein at least two of the plurality of sutures pass through one of the plurality of lattice cells of the support frame.

[0212] Item 97. A valve prosthesis according to items 88 to 96, wherein a first group of sutures among the plurality of sutures are arranged at closer intervals than a second group of sutures among the plurality of sutures, the first group of sutures being along a plurality of top portions corresponding to the plurality of main peak portions and the at least one secondary peak portion of the support frame, and the second group of sutures being connected to a portion of the support frame located between the plurality of top portions and the plurality of base portions.

[0213] Clause 98. The valve prosthesis of clauses 88 to 97, wherein the membrane fabric of the membrane is formed from woven fibers.

[0214] Clause 99. The valve prosthesis of clause 98, wherein the membrane fabric is formed by weaving fibers in warp and weft directions, the warp and weft directions being oriented transversely relative to each other.

[0215] Clause 100. The valve prosthesis of clause 99, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0216] Clause 101. The valve prosthesis of clause 99, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0217] Item 102. A valve prosthesis comprising: a support frame comprising a plurality of grid cells arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite the bottom edge; and at least one secondary peak portion longitudinally disposed intermediate the edge portion and the plurality of main peak portions; and a membrane attached to the support frame, wherein the membrane is attached to the support frame via a plurality of sutures, wherein the plurality of sutures pass through the membrane and wrap around portions of the support frame.

[0218] Item 103. A valve prosthesis according to Item 102, wherein the membrane includes: a first end portion corresponding to the bottom edge of the support frame; a plurality of membrane main peak portions corresponding to the plurality of main peak portions of the support frame; and at least one membrane secondary peak portion corresponding to the at least one secondary peak portion of the support frame.

[0219] Clause 104. The valve prosthesis of clause 103, wherein one or more of the plurality of membrane major peak portions encases a respective one or more of the plurality of major peak portions of the support frame so as to cover a portion of an inner surface of the support frame and a portion of an outer surface of the support frame at the respective one or more major peak portions of the support frame.

[0220] Clause 105. The valve prosthesis of clause 104, wherein one or more of the at least one membrane minor peak portion encases a respective one or more of the at least one minor peak portion of the support frame so as to cover a portion of an inner surface of the support frame and a portion of an outer surface of the support frame at the respective one or more minor peak portions of the support frame.

[0221] Clause 106. The valve prosthesis of clauses 102-105, wherein the at least one minor peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of major peak portions.

[0222] Clause 107. The valve prosthesis of clauses 102-106, wherein the membrane encases the support frame, the support frame having one or more openings along a longitudinal axis of the support frame.

[0223] Clause 108. The valve prosthesis of clauses 107, wherein the membrane is disposed within a lumen of the support frame so as to be attached to an inner surface of the support frame.

[0224] Clause 109. The valve prosthesis of clauses 102-108, wherein the membrane is layered on an inner surface and an outer surface of the support frame.

[0225] Clause 110. The valve prosthesis of clauses 102-109, wherein a first set of the plurality of sutures is arranged at a tighter spacing than a second set of the plurality of sutures, the first set of sutures being coupled to the support frame along a plurality of apical portions corresponding to the plurality of major peak portions and the at least one minor peak portion of the support frame, the second set of sutures being coupled to the support frame at portions of the support frame intermediate the plurality of apical portions and a plurality of basal portions.

[0226] Clause 111. The valve prosthesis of clauses 102-110, wherein a membrane fabric of the membrane is formed from woven fibers.

[0227] Clause 112. The valve prosthesis of clause 111, wherein the membrane fabric is formed by weaving fibers along a warp direction and a weft direction, the warp direction and the weft direction being oriented transversely with respect to one another.

[0228] Clause 113. The valve prosthesis of clause 112, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0229] Clause 114. The valve prosthesis of clause 112, wherein the membrane fabric is stretchable in one or more directions oblique to the warp or weft directions of the fibers.

[0230] Clause 115. A valve prosthesis comprising: a support frame having a longitudinal axis; and a membrane attached to the support frame, the membrane comprising a membrane fabric having woven fibers oriented at an oblique angle relative to the longitudinal axis of the support frame.

[0231] Clause 116. The valve prosthesis of clause 115, wherein the membrane fabric comprises a first plurality of fibers along a warp direction and a second plurality of fibers along a weft direction, wherein the first plurality of fibers and the second plurality of fibers are oriented transversely relative to each other.

[0232] Clause 117. The valve prosthesis of clause 116, wherein the membrane fabric resists stretching along the warp direction of the first plurality of fibers and the weft direction of the second plurality of fibers.

[0233] Clause 118. The valve prosthesis of clause 116, wherein the membrane fabric is stretchable in one or more directions oblique to the warp direction of the first plurality of fibers or the weft direction of the second plurality of fibers.

[0234] Clause 119. The valve prosthesis of clause 116, wherein the membrane fabric resists stretching along the warp and weft directions of the fibers.

[0235] Clause 120. The valve prosthesis of clause 116, wherein the longitudinal direction and the latitudinal direction are aligned with expandable elements of the support frame, the expandable elements being capable of expanding during transition between a compressed configuration and an expanded configuration of the support frame.

[0236] Clause 121. The valve prosthesis of clauses 115 to 120, wherein the deflection angle is about 30 degrees to about 60 degrees.

[0237] Clause 122. The valve prosthesis of clause 121, wherein the membrane comprises a first end, a plurality of membrane main peak portions, and at least one membrane secondary peak portion.

[0238] Clause 123. The valve prosthesis of clause 121, wherein the membrane is attached to the support frame via a plurality of sutures.

[0239] Clause 124. The valve prosthesis of clause 123, wherein the plurality of sutures pass through the membrane and wrap around portions of the support frame.

[0240] Clause 125. The valve prosthesis of clause 123, wherein the plurality of sutures permit movement of the membrane relative to the support frame when the membrane is attached to the support frame.

[0241] Clause 126. The valve prosthesis of clause 123, wherein the support frame is made of a wire structure and the membrane is attached to the support frame by passing the plurality of sutures through the membrane and around portions of the wire structure of the support frame.

[0242] Item 127. A valve prosthesis according to items 115 to 126, wherein the support frame includes one or more peak portions and one or more base portions, and the membrane includes one or more membrane peak portions corresponding to the one or more peak portions of the support frame and one or more membrane base portions corresponding to the one or more base portions of the support frame.

[0243] Clause 128. The valve prosthesis of clause 127, wherein the one or more membrane peak portions respectively wrap around the one or more peak portions of the support frame.

[0244] Clause 129. The valve prosthesis of clauses 115 to 128, wherein the membrane comprises a cylindrical shape formed by connecting one lateral end of the membrane to another lateral end of the membrane, the cylindrical shape corresponding to the shape of the support frame.

[0245] Item 130. A valve prosthesis comprising: a support frame having a longitudinal axis; and a membrane attached to the support frame, the membrane comprising: a plurality of first fibers arranged along a warp direction; and a plurality of second fibers arranged along a weft direction transverse to the warp direction, the plurality of first fibers and the plurality of second fibers being woven together, the warp direction and the weft direction being inclined relative to the longitudinal axis of the support frame.

[0246] Clause 131. The valve prosthesis of clause 130, wherein the membrane is attached to the support frame via a plurality of sutures that permit movement of the membrane relative to the support frame when the membrane is attached to the support frame.

[0247] Clause 132. The valve prosthesis of clause 131 , wherein the support frame is made of a wire structure and the membrane is attached to the support frame by passing the plurality of sutures through the membrane and around portions of the wire structure of the support frame.

[0248] Item 133. A valve prosthesis according to items 130 to 132, wherein the support frame includes one or more peak portions and one or more base portions, and the membrane includes one or more membrane peak portions corresponding to the one or more peak portions of the support frame and one or more membrane base portions corresponding to the one or more base portions of the support frame.

[0249] Clause 134. The valve prosthesis of clause 133, wherein the one or more membrane peak portions respectively wrap around the one or more peak portions of the support frame.

[0250] Clause 135. The valve prosthesis of clauses 130 to 134, wherein the membrane comprises a cylindrical shape formed by connecting one lateral end of the membrane to another lateral end of the membrane, the cylindrical shape corresponding to the shape of the support frame.

[0251] Clause 136. The valve prosthesis of clauses 130 to 135, wherein the longitudinal direction and the latitudinal direction are aligned with expandable elements of the support frame, the expandable elements being capable of expanding during transition between a compressed configuration and an expanded configuration of the support frame.

[0252] Clause 137. The valve prosthesis of clauses 130 to 136, wherein the membrane comprises a first end, a plurality of membrane main peak portions, and at least one membrane secondary peak portion.

[0253] Clause 138. The valve prosthesis of clauses 130 to 137, wherein the membrane is attached to the support frame via a plurality of sutures.

[0254] Clause 139. The valve prosthesis of clause 138, wherein the plurality of sutures pass through the membrane and wrap around portions of the support frame.

[0255] Clause 140. The valve prosthesis of clauses 130 to 139, wherein the membrane resists stretching along the warp direction of the first plurality of fibers and the weft direction of the second plurality of fibers.

[0256] Clause 141. The valve prosthesis of clauses 130 to 140, wherein the membrane is stretchable in one or more directions oblique to the warp direction of the first plurality of fibers or the weft direction of the second plurality of fibers.

[0257] Further plans

[0258] In some embodiments, any clause herein can depend on any one of the independent clauses or any one of the dependent clauses. In some embodiments, any clause (e.g., dependent clause or independent clause) can be combined with any other one or more clauses (e.g., dependent clause or independent clause). In some embodiments, the claim may include some or all of the words (e.g., steps, operations, devices, or components) described in the clause, sentence, phrase, or paragraph. In some embodiments, the claim may include some or all of the words described in one or more clauses, sentences, phrases, or paragraphs. In some embodiments, some words in each clause, sentence, phrase, or paragraph can be removed. In some embodiments, other words or elements can be added to the clause, sentence, phrase, or paragraph. In some embodiments, the present subject technology can be implemented without utilizing some components, elements, functions, or operations described herein. In some embodiments, the present subject technology can be implemented with other components, elements, functions, or operations.

[0259] The foregoing description is provided to enable those skilled in the art to implement the various configurations described herein. Although the subject technology has been described in detail with reference to the various drawings and configurations, it should be understood that these drawings and configurations are for illustrative purposes only and should not be considered as limiting the scope of the subject technology.

[0260] Many other ways can also exist to realize the subject technology.Without departing from the subject technology and scope, the division of various functions and elements described herein may be different from (function and element) shown.It is apparent to those skilled in the art that various modifications to these structures, and the general principles defined herein can be applied to other structures.Therefore, without departing from the scope of the subject technology, those of ordinary skill in the art can make many modifications and modifications to the subject technology.

[0261] It should be understood that the specific order or hierarchy of steps in the disclosed process is for illustrative purposes. It should be understood that the specific order or hierarchy of steps in the process may be rearranged based on design choices. Certain steps may be performed simultaneously. The accompanying method claims present elements of the various steps in an exemplary order and are not limited to the specific order or hierarchy presented.

[0262] As used herein, the term "distal" can refer to a location or direction that is farther from a target point, such as a control unit or region of a delivery system, where a delivery device is used to deliver a valve prosthesis to a native valve annulus. Additionally, the term "proximal" can refer to a location or direction that is closer to a target point, such as a control unit or region of a delivery system, where a delivery device is used to deliver a valve prosthesis.

[0263] As used herein, the phrase "at least one", preceding a series of items, with the term "and" or "or" separating any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase "at least one" does not require at least one of each item; rather, the phrase allows for the selection of at least one of any one or more of the items, and / or the selection of at least one of each individual item. For example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" each permit for the selection of only A, only B, or only C; any combination of A, B, and C; and / or at least one of each of A, B, and C.

[0264] Terms, such as "top", "bottom", "front", "back", and the like, used herein should be understood in reference to any frame of reference, and not in reference to a common gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a back surface can extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

[0265] In addition, the use of the terms "including", "containing", and the like, in the detailed description and in the claims, are used broadly and encompass the terms "consisting of", to the same extent as the term "consisting of" is interpreted under 35 U.S.C. § 112.

[0266] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations.

[0267] The reference to the singular form of an element is not meant to limit the element to "one and only one", but rather "one or more". The masculine pronoun, e.g., "his", includes the feminine and neuter, e.g., "her" and "its", and vice versa. The term "some" refers to one or more. The use of underlined and / or italicized headings and subheadings are used in this document for convenience and do not limit the subject technology. The explanations of the descriptions of the subject technology are not limited to the explanations of the drawings. Throughout this document, all constructions of elements known or to be known to those of ordinary skill in the art are expressly incorporated by reference and are included within the scope of the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.

[0268] Although the detailed description contains many details, these details should not be interpreted as limiting the scope of the subject technology, but should only be interpreted as illustrating different examples and aspects of the subject technology. It should be understood that the scope of the subject technology includes other embodiments not discussed in detail above. Without departing from the scope of the present disclosure, various other modifications, changes and variations can be made to the arrangement, operation and details of the method and device of the subject technology disclosed herein. Unless otherwise indicated, reference to an element in the singular is not intended to mean "one and only one", but to "one or more". In addition, a device or method does not need to solve each problem solvable by the different embodiments of the present disclosure (or have each advantage that can be realized) in order to be included in the scope of the present disclosure. The use of "can" and its derivatives herein should be understood as meaning "possibly" or "optionally" relative to an affirmative meaning.

Claims

1. A valve prosthesis, comprising: a support frame comprising a plurality of grid cells arranged to define: a bottom edge of the support frame; a plurality of main peak portions opposite to the bottom edge; and at least one secondary peak portion disposed longitudinally intermediate the edge portion and the plurality of primary peak portions.

2. The valve prosthesis according to claim 1, wherein: The at least one secondary peak portion is disposed at a smaller axial distance from the bottom edge than the plurality of primary peak portions.

3. The valve prosthesis according to claim 1, wherein: The plurality of grid cells defines a line structure.

4. The valve prosthesis according to claim 1, wherein: The at least one secondary peak portion lies in a common plane.

5. The valve prosthesis according to claim 1, wherein: Each of the plurality of grid cells comprises a parallelogram grid cell. The valve prosthesis according to claim 1 , wherein: Each of the plurality of grid cells comprises a diamond-shaped grid cell.

7. The valve prosthesis according to claim 1, wherein: The at least one secondary peak portion is configured to provide access to a coronary ostium of a patient.

8. The valve prosthesis according to claim 7, wherein: The coronary ostium has a coronary ostium height of less than 10 mm.

9. The valve prosthesis according to claim 1, wherein: The support frame defines a central aperture.

10. The valve prosthesis according to claim 1, wherein: The support frame comprises a braided frame.

11. The valve prosthesis according to claim 1, wherein: The support frame comprises a wire frame.

12. The valve prosthesis according to claim 1, wherein: The support frame comprises a laser cut frame.

13. The valve prosthesis according to claim 1, wherein: The support frame comprises a shape memory metal.

14. The valve prosthesis according to claim 1, wherein: The support frame comprises a self-expanding material.

15. The valve prosthesis according to claim 1, wherein The support frame includes one or more hooks.

16. The valve prosthesis according to claim 1, further comprising: a valve anchor having at least one U-shaped member extending about a longitudinal axis of the valve anchor; as well as A coupling mechanism interconnects the valve anchor and the support frame.

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