Patent ID: 12220314

DETAILED DESCRIPTION

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

Further, while the present disclosure sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting. Additionally, it is contemplated that although particular embodiments of the present disclosure may be disclosed or shown in the context of aortic valve prostheses, such embodiments may be used in other cardiac valve prosthesis applications. Furthermore, various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.

Various embodiments will now be described more fully hereinafter. Such embodiments may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art. Thus, one or more features shown or otherwise disclosed in an embodiment herein may be interchangeably used or incorporated into another embodiment that may not expressly show or disclose such feature(s). Further, one or more features shown or otherwise disclosed for an embodiment herein may be excluded from such embodiment, unless expressly indicated, using skill in the art.

As with all cardiac valves, a healthy aortic valve will open to allow blood flow and close to prevent backflow of blood. However, disease and dysfunction of the valve can result in regurgitation or decreased blood flow (stenosis). In such cases, a replacement aortic valve prosthesis must be used to perform the functions of a healthy aortic valve.

Minimally invasive surgical techniques are evolving, where a valve prosthesis can be introduced into a patient using a catheter that is introduced via a small incision that provides access to, for example, a femoral artery or directly to the heart. These implantation techniques have shown promising results in providing treatment options for patients who are poor open surgical candidates. Nevertheless, challenges still remain in such catheter-based delivery of prosthetic valves.

For example, in according with an aspect of at least one embodiment disclosed herein is the realization that advancing a conventional tubular delivery device through a vessel exerts stress against the vessel walls and carries the risk of damaging the vessel walls. Further, in according with an aspect of at least one embodiment disclosed herein is the realization that transcatheter prosthetic valves may not be able to treat patients with aortic regurgitation. Additionally, in according with an aspect of at least one embodiment disclosed herein is the realization that conventional prosthetic valves may be difficult to position, may require rapid ventricular pacing, and may have limited expansion. Accordingly, implantation and use of conventional prosthetic valves may result in complications, such as vascular damage, moderate to severe paravalvular leakage, valve thrombosis/migration, coronary artery blockage, and excessive stress due to excessive radial force.

The present disclosure describes various aspects of heart valve prostheses that can be delivered to a defective heart valve in a patient. The valve prostheses can comprise at least one valve anchor or clasper, which is movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to a radially-expandable valve support or frame. The valve frame can comprise prosthetic valve leaflets or cusps and provide the functionality of the native heart valve. Certain features of valve prostheses, which can be implemented with the prostheses discussed in the present disclosure, are also further described for example, in U.S. Pat. No. 8,366,768, the entirety of which is incorporated herein by reference.

Thus, the present disclosure provides a variety of features that can be optionally incorporated or excluded from any of the embodiments explicitly discussed or illustrated herein. These modifications and combinations of features can be performed by a person of skill to achieve advantages and benefits discussed herein. Further, certain modifications or combinations are indicated or suggested herein, but it is contemplated that a person skill can implement or exclude certain aspects or features disclosed herein in developing a suitable embodiment or implementation of these teachings. Advantageously, various embodiments described herein allow for treating patients with aortic regurgitation, permit precise axial, angular, and radial positioning of the valve prosthesis, minimize valve migration and paravalvular leakage while avoiding damage to the valve annulus, minimize the need for a pacemaker, and decrease the likelihood of blocking the coronary artery.

Some of these features and benefits of the heart valve prosthesis are illustrated with respect toFIGS.1-5.FIG.1illustrates the use of the delivery device200in a human heart300. The heart300can comprise an aorta301having an aortic arch302and an aortic valve304. The aorta valve304can comprise a plurality of native valve leaflets306and separate the aorta301from the left ventricle310. In accordance with some embodiments, the delivery device200can be advanced retrograde through the aorta301until reaching and being positioned through the native valve leaflets306of the aortic valve304.

With reference toFIGS.1and2, during delivery of the valve prosthesis100to the native valve site, the valve anchor104and the support frame102can be positioned in tandem, as an axially displaced unit (with or without partial or full overlapping between the anchor and the frame) along the longitudinal axis of the delivery device200. This configuration, as opposed to a concentric arrangement, can allow a more radially compact configuration of the components of the valve prosthesis100, creating a much smaller cross-section and facilitating a catheter-based delivery. This can improve the flexibility of the delivery device200, enabling the delivery device200to be advanced over a guidewire through the tortuous geometries of the circulatory system, and in particular, the aortic arch302. Indeed, even with guidewire-directed delivery devices, the aortic arch302represents a difficult obstacle due to its sudden and high-degree of curvature. Often, this is a limiting constraint for some surgeries or delivery devices. However, in accordance with the various benefits and advantages of some embodiments disclosed herein, as illustrated inFIG.1, the delivery device200can be advanced over the aortic arch302to a target location in the region of the aortic valve304.

As shown inFIG.1, once the valve anchor104is in the desired position, the support frame102can be released from the distal carrier assembly and expanded into apposition with the native valve leaflets306and the internal aspects of the valve anchor104, thus sandwiching the native valve leaflets306between the support frame102and the valve anchor104. Advantageously, by sandwiching the native valve leaflets306between the support frame and the valve anchor, the valve prosthesis100can have reduced reliance on radial force retention. Further, by sandwiching the native valve leaflets306between the support frame and the valve anchor, the likelihood of the native valve leaflets306blocking the opening of the coronary artery is reduced, which may be beneficial for patients with low coronary ostia distance, and in patients with an existing valve prosthesis, who may need a new valve prosthesis inside the existing valve prosthesis (valve-in-valve application). The support frame and the valve anchor can thus expand into contact with the aortic valve304, exerting a chronic outward force against the native valve leaflets306and aortic valve annulus320. Thereafter, the prosthetic valve leaflets of the prosthesis100can begin to function in the manner desired and provide the same operation as a native valve.

According to some embodiments, the present disclosure also provides a handle actuator that can be used to control the operation of the presently disclosed delivery device and allow a clinician to reliably and accurately control the delivery of the valve prosthesis.FIG.1illustrates features and operation of the handle actuator, according to some embodiments, for delivering a valve prosthesis using a handle actuator500.

FIG.1illustrates the handle actuator500, which can control one or more functions of a delivery device (e.g., the delivery device200discussed herein) for delivering of a valve prosthesis (e.g., the heart valve prosthesis100discussed herein). The handle actuator500can comprise a plurality of actuators or movable elements, such as knobs or buttons. The movable elements can permit a clinician to control one or more operations of the delivery device200. The handle actuator500can comprise a control handle510having a longitudinal axis512. The handle actuator500may be also referred to as a control unit. In some embodiments, the handle actuator500may be coupled to the second core member222(shown, e.g., inFIGS.3and5). The control handle510can support the actuators and be held by the clinician during the procedure.

In some embodiments, as illustrated inFIG.1, the handle actuator500can comprise a first movable element520, a second movable element522, a third movable element524, and a fourth movable element526. The first movable element520can be used to steer the delivery device200, the second movable element522can be used to release the valve anchor, the third movable element524can be used to release nosecone or valve frame, and the fourth movable element526can be used as a nose cone toggle lock. The first movable element520, the second movable element522, the third movable element524, and the fourth movable element526may be also referred to as the first control element520, the second control element522, the third control element524, and the fourth control element526.

Optionally, in some embodiments, one or more of the movable elements, such as the second movable element522and/or the third movable element524, can include a button or slider safety switch529that prevent the unintentional rotation of the moveable elements. The safety switch529can be configured as resilient button or slider mechanisms that can be actuated to release a lock that provides resistance to rotational or translational movement of the respective movable element. In some embodiments, the movable elements can have a raised feature that provides a visual indication of rotation and facilitates tactile engagement and actuation by the clinician. Other features of the handle actuator500and methods for operating the handle actuator500are discussed and illustrated in FIGS. 13A-13H of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, the entirety of which is incorporated herein by reference.

Referring now toFIG.2, a valve prosthesis100and components thereof are shown in various configurations. The valve prosthesis100can be delivered to a patient using a suitable delivery device, including embodiments of the delivery devices disclosed herein. The valve prosthesis100can comprise a support frame102and an anchoring component or valve anchor104to which the support frame102is movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled.

The valve prosthesis100can be configured such that components of the valve prosthesis100to be advanced in series while still being movably connected, movably attached, flexibly connected, displaceably connected, linked, or coupled to each other, thereby minimizing a passing profile or cross section of the delivery system. The interconnection of components of the valve prosthesis100can allow different degrees of motion and can be set into an engaged or retained position that provides a limited range of motion. In some embodiments, the engaged position can also provide a preset relative positioning of the components of the valve prosthesis100to facilitate proper placement and release of the valve prosthesis100. Additionally, some embodiments can provide a clinician with a high degree of control and enhance the maneuverability of the valve prosthesis100when implanting the valve prosthesis100at the target location.

In some embodiments, the valve anchor104can be coupled to the support frame102when the support frame102is in the compact configuration prior to delivery and expansion. In some embodiments, the valve anchor104is not fixed to the support frame102. Further, the valve anchor104can be separate from the support frame102or formed separately from and later coupled to the support frame102. Thus, although a least a portion of the valve anchor104, e.g., the anchoring leg, may be in contact with or otherwise reversibly attached or connected to the support frame102, no part of the valve anchor104is fixed, e.g., welded or otherwise irreversibly adhered, to the support frame102. Alternatively stated, the valve anchor104, which may be in contact with or otherwise reversibly attached to the support frame102, is not irreversibly fixed to the support frame102.

Further, upon reaching the target location, the valve anchor104can be movably coupled to the support frame102in a manner that prevents the entire valve anchor104from being radially displaced from the support frame102when the valve anchor104is initially expanded. For example, portions of the valve anchor104can be radially displaced from the support frame during initial “landing” of the valve anchor104against the native valve structure at the target location. In some embodiments, the support frame102can be deployed or expanded within the native heart valve structure, and the valve anchor104can become sandwiched between the support frame and the native valve tissue, becoming at least partially, and possibly fully, immobilized. The valve anchor104can function to hold the expanded support frame102in place within the native valve structure.

Optionally, the support frame102may be referred to as a valve frame or valve support frame.FIG.2illustrates the support frame102aligned with and expanded within the valve anchor104, in a configuration that is achieved when the prosthesis100is released and expanded within the native valve structure. The native valve structure includes the valve annulus or leaflets. This expanded configuration, serves to secure the valve prosthesis100within the native valve annulus by engaging the native valve structure. In some embodiments, the expanded configuration of the valve prosthesis100may reduce reliance on securing the valve prosthesis100with radial force exerted by the support frame102and the valve anchor104via the sandwiching or compression of the native valve leaflets between the support frame102and the valve anchor104of the valve prosthesis100. Further, as discussed further herein, during implantation of the valve prosthesis100, the support frame102and the valve anchor104can be movable relative to each other in expanded and/or compressed states in order to facilitate proper positioning of the prosthesis100relative to the native valve annulus and surrounding structures. Indeed, various advantages made possible by the prosthesis100and delivery device disclosed herein allow a clinician to achieve a higher degree of precision in placing the prosthesis100, as well as making such increased precision easier to achieve.

Referring toFIG.2, the support frame102can comprise an outer or external surface and defines a central orifice about a longitudinal axis120. The longitudinal axis120corresponds to an inflow-outflow axis of the prosthesis100. In some embodiments, the valve prosthesis100further comprises a plurality of prosthetic valve leaflets or cusps106that are coupled to the support frame102. The support frame102can provide a structural support for the valve leaflets106. The valve leaflets106can have surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the prosthesis100. The prosthesis100can include three valve leaflets106for a tri-leaflet configuration. As appreciated, mono-leaflet, bi-leaflet, and/or multi-leaflet configurations are also possible. For example, the valve leaflets can be coupled to the support frame102to span and control fluid flow through the lumen of the prosthesis100. The prosthetic leaflets106can comprise one or more synthetic materials, engineered biological tissues, biological valvular leaflet tissues, pericardial tissues, cross-linked pericardial tissues, 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, human tissue, or combinations thereof.

Furthermore, in some embodiments, the valve prosthesis100can comprise a sealing component or membrane108that can be attached to an inside surface, an outside surface, and/or enclose the support frame102, such as by being laminated onto inner and outer surfaces of the support frame102. Thus, the valve leaflets106can be coupled to the support frame102and/or the membrane108. In some embodiments, the membrane108can restrict blood flow in areas around the valve leaflets106so that blood flow occurs only between the valve leaflets106through the lumen of the prosthesis100, as in a healthy native heart valve.

The support frame102and/or the valve anchor104can comprise a braided frame, a wire frame, or a laser-cut frame (e.g., laser-cut tubular mesh), as shown inFIG.2. In some embodiments, the support frame102and/or the valve anchor104can comprise a shape-memory metal, which can change shape at a designated temperature or temperature range or by inducing stress. Alternatively, the self-expanding frames can include those having a spring-bias. The material from which either the support frame102and/or the valve anchor104is fabricated can allow the support frame102and/or the valve anchor104to automatically expand to its functional size and shape when deployed but also allows the support frame102and/or the valve anchor104to be radially compressed to a smaller profile for delivery through the patient's vasculature. Examples of suitable materials for self-expanding components described herein (e.g., support frames, valve anchors, locking members) include, but are not limited to, medical grade nickel titanium alloys, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, or combinations thereof. Shape memory alloys having superelastic properties generally made from ratios of nickel and titanium, commonly known as Nitinol, are preferred materials. In some embodiments, self-expanding components described herein can include materials including, but not limited to shape memory plastics, polymers, and thermoplastic materials which are inert in the body. In an alternative embodiment, either the support frame102and/or the valve anchor104is not self-expanding, and may be expanded, for example, using a balloon catheter as is well known in the art. Examples of suitable materials for components described herein include, but are not limited to, stainless steel and titanium. Optionally, either the support frame102and/or the valve anchor104can comprise radiopaque materials to allow visualization under fluoroscopy or other imaging techniques.

Optionally, the support frame102can comprise one or more hooks109that can engage with tissue of the native valve annulus, the aortic root, or any other portion of the native valve when the support frame102is expanded within the native valve annulus. The hooks109can be engaged with the native valve annulus to secure the prosthesis100and mitigate any downstream or antegrade migration of the prosthesis100during operation.

The support frame102can comprise a first end portion110and a second end portion112. The first end portion110can be positioned upstream of the second end portion112when the prosthesis100is released within the native valve annulus. As illustrated inFIG.2, the first end portion110of the support frame102can be shaped as a generally flat end of a cylinder, where first apices114of the support frame102lie generally in a common plane, which can be oriented substantially perpendicular relative to a longitudinal axis120of the prosthesis100. Further, the second end portion112can be shaped to include a series of peaks130and valleys132, where second apices or minor peaks136of the support frame102collectively form contours of the peaks130and valleys132. The peaks130and valleys132of the second end portion112can be positioned downstream of the first end portion110when the prosthesis is seated within the native valve annulus.

In accordance with some embodiments, the prosthetic leaflets106can be coupled relative to the support frame102at locations circumferentially aligned with the peaks130of the second end portion112, as shown inFIG.2. In some embodiments, the prosthetic leaflets106can be coupled to the membrane108using ultra-high molecular weight polyethylene sutures. This unique configuration can advantageously enable the prosthesis100to more fully approximate the native valve structures, permit a more natural blood flow without limiting or otherwise constraining movement of the valve leaflets106, and more seamlessly integrate with surrounding architecture of the heart. In some embodiments, the prosthetic leaflets106can comprise features, including, but not limited to, planar features, flat features, three-dimensional features, Bézier curves, or other suitable shapes. Optionally, the prosthetic leaflets106can be shaped through fixation on a leaflet-shaped mandrel.

The valve anchor104can comprise at least one U-shaped member, valve clasper, sinus locator, valve positioner, or valve hanger140that extends about a longitudinal axis of the valve anchor104. As illustrated inFIG.2, the valve anchor104can comprise a plurality of lobes or U-shaped members140, such as three U-shaped members140, but can have fewer or more. In some embodiments, U-shaped members140can be configured to engage with or fit inside the posterior aortic sinus, the left aortic sinus, and the right aortic sinus of a native aortic valve. The U-shaped members140can each have a peak portion142and a base portion144. The U-shaped members140can each comprise first and second legs146,148. The first and second legs146,148of the adjacent U-shaped members140can be interconnected at the peak portions142thereof. Further, the U-shaped members140can comprise shapes other than a U-shape, such as a wave-shape, V-shape, W-shape, or zig-zag. Optionally, multiple valve anchors104can each comprise one or more U-shaped members140, wherein the multiple valve anchors104cooperatively engage with the aortic sinus to anchor the valve prosthesis as described herein.

The valve prosthesis100can include a link mechanism that interconnects the support frame102to the valve anchor104. The link mechanism can comprise a single, continuous strand of material or multiple, independent strands of material that interconnects the support frame102to the valve anchor104. Further, the link mechanism can attach in a sliding, engaged, or fixed manner to one or more locations on the support frame102and/or on the valve anchor104.

In accordance with some embodiments, the valve anchor104may optionally define one or more engagement areas in one or more portions of the valve anchor104, where a link mechanism may engage with the one or more engagement areas to restrict relative motion between the support frame102and the valve anchor104.

For example, at the interconnection of the respective peak portions, the valve anchor104can define an engagement area150. The engagement area150may also be referred to as a peak portion engagement area.

As illustrated inFIG.2, the support frame102can be flexibly coupled to the valve anchor104via one or more tethering components or link mechanisms160. The link mechanism160can be coupled to the support frame102and to the valve anchor104, permitting relative movement between the support frame102and the valve anchor104. However, the link mechanism160can be configured to limit relative movement between the support frame102and to the valve anchor104. In some embodiments, the engagement area150of the valve anchor104can be used to further restrict relative motion of the support frame102with respect to the valve anchor104when the link mechanism160is engaged in the engagement area150, as discussed herein.

The valve anchor104can thus be coupled to the support frame102to permit the valve anchor104to be moved axially or longitudinally relative to the support frame102while still remaining coupled to the support frame102. This advantageous feature of some embodiments can allow a clinician to independently position the valve anchor104relative to the support frame102. For example, in a transcatheter aortic valve replacement, the clinician can independently position the valve anchor104in order to fit the base portions144of the valve anchor104into the aortic sinus. Portions of the of aortic sinus may include the posterior aortic sinus, the left aortic sinus, and/or the right aortic sinus, of a native aortic valve. In some embodiments, the valve anchor104can rotate to be aligned in the respective aortic sinuses. In some embodiments, the interconnection of the valve anchor104to the support frame102can allow the valve anchor104to self-rotate to be aligned in the aortic sinus. Thereafter, with the valve anchor104“landed” in the respective aortic sinuses, the interconnection of the valve anchor104to the support frame102further enables the support frame102to translated along the longitudinal axis120of the valve prosthesis100. In some embodiments, during the delivery procedure, the valve anchor104can be moved at least axially from a proximal position relative to the support frame102, to a distal position relative to the support frame102, or from either of such positions to a position in which the support frame102at least partially longitudinally overlaps with or is concentric within the valve anchor104. A range of various positions are illustrated, for example, in FIGS. 11A-11F of U.S. Patent Application No. 62/781,537, filed on Dec. 18, 2018, the entirety of which is incorporated herein by reference.

For example, when the support frame102is nested within the valve anchor104, as shown inFIG.2, the base portions144of the valve anchor104can be longitudinally spaced apart from first end portion110of the support frame102along the longitudinal axis120at a distance which is 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 a length of the support frame102. In some embodiments, the support frame102can be contained or otherwise fully overlapping the valve anchor104. In some embodiments, the support frame102can have minimal or no overlap with the valve anchor104. The support frame102can move along the longitudinal axis120to overlap the valve anchor104by 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 frame102. In accordance with some embodiments, the U-shaped members140of the valve anchor104can be in nested positions within the aortic sinuses, and the base portions144of the valve anchor104can be about longitudinally adjacent to, coplanar with, or spaced apart from the first end portion110of the support frame102. For example, the valve anchor104can be in a nested position when at least one base portion144of the valve anchor104is in contact with or adjacent to the basal attachments of the native aortic valvar leaflets. Further, the first end portion110of the support frame102can be longitudinally adjacent to, coplanar with, or spaced apart from the native valve structure (or a virtual ring formed by the basal attachments of the native aortic valvar leaflets) or with the ventriculo-aortic junction.

The link mechanism160can allow rotational and longitudinal movement of the valve anchor104relative to the support frame102. Thus, despite the presence of the link mechanism160, the valve anchor104can move rotationally with respect to the support frame102. Further, in some embodiments, the link mechanism160can be fixedly attached or coupled to the support frame102and fixedly or slidably attached to the valve anchor104. When the support frame102is moved relative to the valve anchor104, the link mechanism160can slide along the U-shaped members140. In some embodiments, the U-shaped members140have a generally arcuate or convex shape (as illustrated with the U-shaped members ofFIG.2) that allows unrestricted movement of the link mechanism160along the geometry of the first and second legs146,148of the U-shaped members140. When the link mechanism160is allowed to slide along the first and second legs146,148of the U-shaped members140, the valve prosthesis100can be in a position referred to as a “slidable” state. In the slidable state, the range of longitudinal and/or rotational movement of the support frame102relative to the valve anchor104is variable and may be its greatest because the link mechanism160can move along the first and second legs146,148of the U-shaped members140.

In some embodiments, the link mechanism160can be fixedly attached or coupled to the support frame102and fixedly attached to the valve anchor104. When the support frame102is moved relative to the valve anchor104, the link mechanism160can stretch, flex, deform elastically and/or plastically. As the link mechanism160deforms, the range of longitudinal and/or rotational movement of the support frame102relative to the valve anchor104is variable as allowed by the deformation of the link mechanism160.

In some embodiments, the link mechanism160can have multiple link members, where each link member is coupled to and intermittently spaced about a circumference of the support frame102. Each link member may be slidably coupled to a respective one of the U-shaped members140. Further, the link mechanism160can have multiple link members that are coupled together in an end-to-end manner. Moreover, the link mechanism160can have multiple link members that are individually coupled at one and to the support frame102and at another and to the valve anchor104. Each of the link members can be slidable along the valve anchor104, as disclosed similarly herein and not described again herein for brevity.

As noted above, however, the valve anchor104can also comprise engagement areas150that can engage with the link mechanism160in order to restrict relative motion between the support frame102and the valve anchor104. The engagement areas150can include one or more local concavities or other geometric shapes that can engage or trap the link mechanism160once the link mechanism160passes into the engagement area150. Various embodiments of engagement areas150can be used to permit the slidable link mechanism160to enter into the engagement area150, but restrict the link mechanism160from exiting the engagement area150, such as those disclosed in FIGS. 2A-2G of U.S. Patent Application No. 62/781,537, noted above.

Referring now toFIG.3, a side cross-sectional view is provided of the valve prosthesis100loaded onto the delivery device200, according to some embodiments. Among the many features illustrated inFIG.3,FIG.3shows that a proximal enclosure210of delivery device200can extend over both the valve anchor104and the support frame102. Thus, in accordance with some embodiments, in the compressed or delivery configuration shown inFIG.3, the link mechanism (not shown) can extend between the valve anchor104and the support frame102and be at least partially enclosed within the proximal enclosure210(depending on the attachment point of the link mechanism with the support frame102and the longitudinal extent of the proximal enclosure210).

In addition,FIG.3illustrates that the valve anchor104can comprise a link motion limiter240. The link motion limiter240can provide an enlarged profile of the wireframe structure of the valve anchor104so as to restrict or prevent motion of the link mechanism as the link mechanism slides along the U-shaped member of the valve anchor104.

In alternative embodiments of the delivery device200, the valve anchor104and the support frame102can both be enclosed within the proximal sheath component204prior to and during delivery prior to releasing the valve anchor104. For example, in some embodiments, the valve anchor104can be distal to the support frame102wherein the valve anchor104is near the distal end of the proximal sheath component204and the support frame102can be approximately adjacent to the valve anchor104(in a serial configuration) and is proximal to the valve anchor104. In some embodiments of the delivery device200, the valve anchor104and the support frame102can both be enclosed within the proximal sheath component204, with the support frame102near the distal end of the proximal sheath component204and the valve anchor104being approximately adjacent to the support frame102and proximal to the support frame102.

Further, in alternative embodiments of the delivery device200, the valve anchor104can be enclosed within the distal carrier assembly206and the support frame102can be enclosed within the proximal sheath component204prior to and during delivery of the valve prosthesis. For example, in some embodiments of the delivery device200, both the valve anchor104and the support frame102can be enclosed within the distal carrier assembly206and the support frame102can be enclosed within the proximal sheath component204prior to and during delivery of the valve prosthesis. In this configuration, the valve anchor104and the support frame102can be approximately adjacent to one another (in a serial configuration) and the valve anchor104can be positioned proximal to the support frame102. Other details of delivery devices and prostheses are provided in U.S. Patent Application No. 62/781,537, noted above and incorporated herein by reference.

In addition,FIG.3illustrates that an anchor retention component170can be used to engage the engagement areas150of the valve anchor104with the control member or a grasper224to facilitate movement and control of the positioning of the valve anchor104during delivery. As discussed with regard to FIGS. 7G-7I of U.S. Patent Application No. 62/781,537, noted above, this engagement can maintain the engagement areas150in a common plane152, oriented generally perpendicular relative to the longitudinal axis of the delivery device200.

FIG.4illustrates aspects of the delivery device200a, according to at least one embodiment. These figures do not illustrate all of the components of the delivery device that can be incorporated into an embodiment. However, the features illustrated in these figures can be incorporated into embodiments of the delivery device to facilitate engagement with the valve anchor and/or facilitate delivery and control of the valve anchor during implantation and release of the valve anchor at the target location.

For example,FIG.4illustrates an embodiment of a delivery device200athat comprises a grasper mechanism. The grasper mechanism can be used to securely couple a portion of the valve anchor with the delivery device to permit the clinician to control movement, operation, and deployment of the valve anchor. The grasper mechanism can engage one or more portions or structures of the valve anchor using a variety of coupling mechanisms, which can use attachment means including mechanical engagement, dissolvable structures, chemically reactive degradable structures, electrolytically degradable structures, and the like.

In some embodiments, the grasper mechanism can be a tubular grasper mechanism. The delivery device200a, shown inFIG.4, can comprise a grasper224athat can engage with and control the longitudinal position of the valve anchor104a. The grasper224aof the delivery device200acan comprise an engagement wire that is movable within a lumen of a tubular enclosure. The valve anchor104acan be configured to comprise a clasper tang extending from an engagement area150dor150d′ of the valve anchor104a. The engagement wire can comprise a distal end portion that includes pins, ridges, or protrusions that can be coupled to the engagement structure of the clasper tang at the engagement area of the valve anchor104a. When engaged together, the engagement wire and the clasper tang can be proximally drawn into the lumen of the tubular enclosure, which secures the engagement wire and the clasper tang relative to each other in both radial and longitudinal directions. However, when the engagement wire and the clasper tang are moved outside of the lumen of the tubular enclosure, the engagement wire and the clasper tang can be disengaged as the valve anchor104aand the clasper tang expand radially, thereby disengaging the clasper tang from the engagement wire. These and other features are discussed in U.S. Patent Application No. 62/781,537, noted above and incorporated herein by reference.

During use, after the valve anchor has been released from within the proximal sheath and after the valve anchor and the 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 in order to minimize any damage to the blood vessel through which the delivery device was advanced.

For example, in at least one embodiment, as illustrated inFIG.5A, the proximal enclosure210can comprise a proximal section250to facilitate realignment (e.g., radial realignment) of the distal end portion208of the proximal sheath component204with the proximal enclosure210.

As illustrated inFIG.5A, the proximal section250can be coupled to the core member220. Further, the proximal section250can optionally be conical or tapered in a proximal direction and/or have circumferential nodes252and/or circumferential cavities254that can facilitate realignment of the proximal sheath component204relative to the proximal enclosure210along a longitudinal axis of the delivery device200. The tapering of the proximal section250can allow the distal end portion208of the proximal sheath component204to smoothly advance distally over the proximal section250, and the circumferential nodes252can contact an inner surface of the distal end portion208of the proximal sheath component204as the distal end portion208approaches the proximal abutment surface214.

For example, as illustrated inFIG.5A, the circumferential nodes252may gradually taper from the proximal abutment surface214in the proximal direction. With such a configuration, as the proximal sheath component204slides distally toward the proximal enclosure210, the circumferential nodes252can advantageously guide the distal end portion208of the proximal sheath component204distally toward the proximal abutment surface214of the proximal enclosure210so that the outer surface of the proximal sheath component204is aligned with an outer surface of the proximal enclosure210. Thus, the outer surfaces of the proximal enclosure210and the proximal sheath component204can provide a smooth outer profile for the delivery device200that can advantageously reduce the likelihood that the delivery device200catches or otherwise damages tissue within a body lumen as the delivery device200is moved therewithin.

Optionally, the proximal section250can comprise three circumferential nodes252and three circumferential cavities254. The circumferential nodes252may extend proximally from the proximal abutment surface214. The three circumferential cavities254can correspond to the number of U-shaped members of the valve anchor that are housed within the proximal sheath component204between the proximal sheath component204and the proximal section250of the proximal enclosure210.

This advantageous feature of some embodiments can allow the distal enclosure212to be properly positioned along the delivery device200in order to ensure that distal enclosure212does not snag or become caught on any structure during retrieval of the delivery device200.

As also shown inFIGS.5A and5B, the proximal and distal enclosures210,212can collectively house the support frame102. The first and second core members220,222can be actuated to separate the proximal and distal enclosures210,212, thereby permitting the support frame102to self-expand when in position within the valve anchor104.

For example, by pushing or pulling the first core member220, the second core member222, and/or the proximal sheath component204relative to each other along the longitudinal axis of the delivery device200, a clinician can control longitudinal movement of each of these components to permit the release of the support frame102and the valve anchor104of the valve prosthesis100.

Further, in some embodiments, to facilitate delivery of the delivery device200to the target location, as shown inFIGS.5A and5B, the second core member222can include a lumen218to permit the delivery device200to move along a guidewire, which can extend through the lumen218of the second core member222.

FIGS.5A and5Bfurther illustrate positions of the proximal and distal enclosures210,212during the release of the support frame102. After separating the proximal and distal enclosures210,212from the position illustrated inFIG.5Ato the position illustrated inFIG.5A, the first end portion110of the support frame102can begin to expand from the compressed configuration to an expanded configuration. In some embodiments, the support frame102can have one or more anchors109(see alsoFIG.2) at its first end portion110that, when engaged with the native valve structure can supplement the outward expansive force (due to self-expansion of the support frame102) and its resultant frictional engagement, to mitigate downstream migration of the support frame102relative to the native valve structure. Thus, by opening the first end portion110first (before the second end portion112, and via relative movement of the proximal and distal enclosures210,212), the first end portion110can “flower” out to facilitate release of the support frame and/or to engage with the native anatomy, such as the valve structure itself, to secure a longitudinal position of the support frame102relative to the native valve structure. Thereafter, the second end portion112of the support frame102can be controlled and released to become disengaged and released from the proximal enclosure210.

In some embodiments, the first end portion110and the second end portion112can open simultaneously, at the same or different rates. For example, in some embodiments, the first end portion110and the second end portion112can open simultaneously, but with the first end portion110opening at a faster rate than the second end portion112.

Advantageously, the use of the proximal enclosure210and the distal enclosure212allows for greater control and enhanced operation of the support frame102. For example, by controlling the position and rate of separation of the proximal enclosure210and the distal enclosure212, the opening of the support frame102at both the first end portion110and the second end portion112can be controlled. Further, by controlling the movement of the distal enclosure212, the timing and rate of opening of the first end portion110can be controlled relative to the timing and rate of opening of the second end portion112(which may be controlled by the movement of the proximal enclosure210).

Additionally and advantageously, by having separate proximal and distal enclosures210,212, the delivery device200may experience reduced frictional forces and minimize travel of the enclosures210,212relative to the support frame102.

In particular, in accordance with some embodiments, the distal carrier assembly206can comprise a plunger mechanism260that can facilitate expansion of the support frame102. The plunger mechanism260can expand from a compressed state (shown inFIG.5A) to an extended state (shown inFIG.5A). The plunger mechanism260can be biased by a spring or other device in order to move automatically from the compressed state to the extended state. However, the plunger mechanism260can also be manually actuated by the clinician in some embodiments.

As illustrated, the plunger mechanism260can comprise a plunger head262and a biasing means264. The plunger head262can comprise a conical or tapered proximal portion286. The conical proximal portion286can be configured to not contact only the first end portion of the support frame102during delivery, but can also help center a distal end portion290of the tubular portion282of the proximal enclosure210relative to a longitudinal axis of the delivery device200and help align the distal end portion290with a proximal end portion292of the tubular portion272of the distal enclosure212. The plunger head262can also comprise an outer circumferential surface294that can contact not only an inner surface296of the tubular portion272, but can also contact an inner surface298of the tubular portion282when the tubular portion282is distally advanced over the conical proximal portion286of the plunger head262.

Further, the plunger mechanism260can be housed within a distal lumen270of a tubular portion272of the distal enclosure212. For example, the biasing means264may be a spring. The biasing means264can be interposed between an interior structure or wall274of the distal lumen270and a distal surface or structure276of the plunger head262. The plunger head262can move proximally within the distal lumen270in order to continue to exert a proximally oriented force on the first end portion110of the support frame102until the support frame102exits the distal lumen270. Thereafter, in accordance with some embodiments, the support frame102can self-expand until the second end portion112is pulled out of a proximal lumen280of a tubular portion282of the proximal enclosure210as the support frame102continues to expand. The expanded state of the support frame102is illustrated inFIGS.1and2, discussed above.

According to some embodiments, the present disclosure optionally provides a membrane that can be used with the presently disclosed valve prosthesis to reduce the diameter of the support frame in a compressed configuration.FIGS.6-11illustrate aspects of the membrane608described herein.

FIG.6illustrates a support frame102of a valve prosthesis600with a membrane608coupled thereto, according to some embodiments. In the embodiment shown inFIG.6, the membrane608is positioned or disposed within a lumen or against an inner surface of the expanded support frame102. As previously described, in some embodiments, the membrane608can serve as a sealing component and can be attached to the inside surface, the outside surface, and/or enclose the support frame102.

In some embodiments, the membrane608can be affixed or otherwise attached to the support frame102via a plurality of sutures604. The sutures604can attach the membrane608to the wire structure of the support frame102by passing through the membrane608and wrapping around portions of the support frame102. In the illustrated embodiment ofFIG.6, the sutures604can be closely spaced (e.g., 2-4 sutures604per side of a parallelogram cell or diamond-shaped cell of the support frame102) to create a tight seal between the membrane608and the support frame102.

In some embodiments, the lateral ends of the membrane608can be attached at a seam602to form a generally cylindrical shape. As illustrated inFIG.6, axial ends of the membrane608can be wrapped around the ends of the support frame102at the first end portion110and/or the second end portion112. In some embodiments, the axial ends of the membrane608can wrap around the first end portion110and/or the second end portion112to at least partially cover both the inside surface and the outside surface of the support frame102. For example, the peaks606of the membrane608can be wrapped over the peaks130of the second end112of the support frame102. Advantageously, by wrapping the axial ends of the membrane608around the first and/or second ends110,112, the valve prosthesis600can be better sealed against the native heart valve. Further, the sutures604can be more densely spaced along the axial ends of the membrane608than where the membrane608is coupled to the support frame102intermediate the axial ends of the membrane608.

As previously described, valve leaflets can be coupled to the membrane608. In some embodiments, the membrane608can restrict blood flow in areas around the valve leaflets so that blood flow occurs only between the valve leaflets through the lumen of the prosthesis600, as in a healthy native heart valve.

In some embodiments, at the second end portion112, an axial end of the membrane608can be shaped to cover the major peaks130and valleys132of the second end112. In some embodiments, the membrane608can be shaped to cover the second apices or minor peaks136within the valleys132between the major peaks130. Advantageously, the configuration of the minor peaks136between the major peaks130can allow improved access to and prevent obstructions of the coronary ostia compared to prior art valve prostheses.

For example, referring toFIG.7A, a prior art valve prosthesis600′ is shown within an aorta696′. The support frame602′ is disposed within the aortic valve annulus692′. As shown, the support frame602′ and membrane608′ may block or obstruct the coronary ostia694′ disposed a distance693′ away from the valve annulus692′ due to the geometry of the support frame602′ and the membrane608′.

In contrast,FIG.7Bshows an embodiment of the valve prosthesis600that advantageously permits blood flow to adjacent coronary ostia694. As discussed above, and as shown inFIG.7B, the difference in height between the major peaks130and the minor peaks136of the valve prosthesis600facilitates access to the coronary ostia694while allowing for desired operation of the valve prosthesis600.

In some embodiments, the minor peaks136of the valve prosthesis600can be low enough to allow a variety of sizes and locations of the coronary ostia694with respect to the native valve annulus692location of a patient. Advantageously, in some embodiments, the minor peaks136of the valve prosthesis600allow for access to coronary ostia694that are less than 10 mm, less than 8 mm, or less than 6 mm in coronary ostia height, which are typically excluded by conventional available prostheses. In some embodiments, the minor peaks136, and optionally along with one or more other features described herein, allow for access to coronary ostia694that are disposed at a lower axial distance693relative to the valve annulus692. For example, the minor peaks136can allow for access to coronary ostia694disposed at a coronary ostia height or lower axial distance693of less than 6 mm between the inferior edge of the coronary artery ostium694and the aortic annular plane. Furthermore, in some embodiments, the valve prosthesis600can be arranged to be disposed lower in the valve annulus692to allow greater access to the coronary ostia694. By providing minor peaks136between the major peaks130of the valve prosthesis600, and optionally used with one or more other features discussed herein, access to the coronary ostia694is preserved allowing for future procedures that may require access to the coronary ostia694, such as coronary stenting.

FIG.8illustrates a method of forming or manufacturing the membrane for use with the valve prosthesis, which may be a portion of the method of forming the valve prosthesis. In some embodiments, one or more membranes608can be cut from a membrane fabric601. The membrane fabric601can be a fabric formed from woven fiber, such as woven polyester. As shown inFIG.9, the membrane fabric601is woven together with fibers in a warp direction608aand a weft direction608bthat are oriented transverse, and in some cases, perpendicular, relative to each other. In some embodiments, a fabric may resist stretching in the warp and weft directions608a,608bwhile allowing stretching and compliance in directions oblique to or biased from the warp and weft directions608a,608b.

Referring back toFIG.8, one or more membranes608can be cut from the membrane fabric601using templates that are generally in the shape of the membranes608. One or more templates can be placed on the membrane fabric601to cut out the membranes608. While the membrane608is shown in a flat orientation inFIG.8, the support frame102and the projected longitudinal axis120thereof is shown for reference.

The templates can be oriented at an angle relative to the membrane fabric601. A bias angle608ccan be defined between the edge of the membrane fabric601and the projected longitudinal axis120. For reference, the bias angle608cis shown between the edge of the membrane fabric601and an offset axis120′ that is parallel to the longitudinal axis120. As discussed further below, the bias angle608ccan be from about 30 degrees to about 60 degrees, such as about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, or about 55 degrees.

By orientating the templates at a bias angle608crelative to the membrane fabric601, the resulting membrane608is cut on the bias with the bias angle608cwith respect to the warp and weft directions608a,608bof the membrane fabric601. In some embodiments, the membrane608can be cut at the bias angle608cby spiral wrapping the membrane fabric onto the support frame and cutting the membrane fabric601.

FIG.10illustrates a resultant membrane608manufactured using the process shown inFIGS.8and9. In the depicted embodiment, the warp and weft of the fabric of the membrane608is oriented at a bias or diagonal with respect to the direction of a longitudinal axis of the prosthesis. In some embodiments, the bias angle of the membrane608can be generally oriented such that the warp or the weft of the material is aligned with expandable elements (e.g., the cells, parallelogram cells, or diamond-shaped cells) of the support frame102. Advantageously, in some embodiments, the membrane608may have increased conformability and may not resist movement or expansion of the support frame102, thereby reducing stress and bunching of the membrane608when the membrane608and prosthesis are in a compressed configuration. In some embodiments, the reduction of stress on both the membrane608and the support frame102can facilitate both assembly and loading of the valve prosthesis.

Indeed, development of some embodiments of the prosthesis has shown that the unique orientation and configuration of the membrane608described herein can permit the membrane608to more easily radially compress and axially elongate in tandem with the support frame102, thus permitting the membrane608and the support frame102to operate as a single unit, in some embodiments. Similarly, in some embodiments, by orientating the membrane608along a bias angle, the membrane608can more readily elongate along longitudinal axis120to obtain a smaller cross-sectional profile, which can prevent flaring, bunching, or pleating, thereby minimizing the cross-sectional profile of the valve prosthesis in a compressed configuration.

FIG.11is a plan view of the warp608aand the weft608bof the membrane608relative to the longitudinal axis120of the support frame102. In some embodiments, the warp608aand weft608bof the woven membrane608can be oriented relative to the longitudinal axis120at a bias angle608cbetween 0 and 90 degrees. In some embodiments, the woven membrane608can be oriented at a bias angle608cbetween 15 and 75 degrees relative to the longitudinal axis120. In some embodiments, the woven membrane608can be oriented at a bias angle608cbetween 30 and 60 degrees relative to the longitudinal axis120. In some embodiments, the woven membrane608can be oriented at a bias angle608cof approximately 45 degrees relative to the longitudinal axis120.

In some embodiments, the warp and weft of the woven membrane108can be oriented relative to the longitudinal axis at a bias angle between 0 and 90 degrees. In some embodiments, the woven membrane108can be oriented at a bias angle between about 15 and about 75 degrees relative to the longitudinal axis. In some embodiments, the woven membrane108can be oriented at a bias angle between about 30 degrees and about 60 degrees relative to the longitudinal axis. In some embodiments, the woven membrane108can be oriented at a bias angle of about 45 degrees relative to the longitudinal axis.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as clause sets having numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples, and do not limit the subject technology. Identifications of the figures and reference numbers are provided below merely as examples and for illustrative purposes, and the clauses are not limited by those identifications.

Clause 1. A valve prosthesis comprising: a support frame comprising a plurality of cells arranged to define a bottom edge of the support frame, a plurality of major peak portions opposite the bottom edge, and at least one minor peak portion disposed longitudinally intermediate the bottom edge and the plurality of major peak portions; and a membrane attached to the support frame.

Clause 2. The valve prosthesis of Clause 1, wherein the membrane comprises a first end portion corresponding to the bottom edge of the support frame, a plurality of membrane major peak portions corresponding to the plurality major peak portions of the support frame, and at least one membrane minor peak portion corresponding to the at least one minor peak portion of the support frame.

Clause 3. The valve prosthesis of Clause 2, wherein one or more membrane major peak portions of the plurality of membrane major peak portions are wrapped around corresponding one or more major peak portions of the plurality of major peak portions of the support frame to cover a part of an inner surface and a part of an outer surface of the support frame at the corresponding one or more major peak portions of the support frame.

Clause 4. The valve prosthesis of Clause 3, wherein one or more membrane minor peak portions of the at least one membrane minor peak portion are wrapped around corresponding one or more minor peak portions of the at least one minor peak portion of the support frame to cover a part of an inner surface and a part of an outer surface of the support frame at the corresponding one or more minor peak portions of the support frame.

Clause 5. The valve prosthesis of any preceding Clause, wherein the at least one minor peak portion is disposed at a lower axial distance from the bottom edge compared to the plurality of major peak portions.

Clause 6. The valve prosthesis of any preceding Clause, wherein the membrane encloses the support frame with one or more openings along a longitudinal axis of the support frame.

Clause 7. The valve prosthesis of any preceding Clause, wherein the membrane is disposed within a lumen of the support frame to be attached to an inner surface of the support frame.

Clause 8. The valve prosthesis of any preceding Clause, wherein the membrane is laminated onto inner and outer surfaces of the support frame.

Clause 9. The valve prosthesis of any preceding Clause, wherein the membrane is attached to the support frame via a plurality of sutures.

Clause 10. The valve prosthesis of Clause 9, wherein the plurality of sutures are passed through the membrane and are wrapped around a plurality of portions of the support frame.

Clause 11. The valve prosthesis of Clause 9, wherein a first set of the plurality of sutures along a plurality of top portions corresponding to the plurality of major peak portions and the at least one minor peak portion of the support frame is more densely spaced than a second set of the plurality of sutures coupled to portions of the support frame intermediate the plurality of top portions and a plurality of base portions.

Clause 12. The valve prosthesis of any preceding Clause, wherein membrane fabric of the membrane is formed from woven fiber.

Clause 13. The valve prosthesis of Clause 12, wherein the membrane fabric is formed by weaving fibers in a warp direction and a weft direction that are oriented transverse relative to each other.

Clause 14. The valve prosthesis of Clause 13, wherein the membrane fabric resists stretching in the warp direction and the weft direction of the fibers.

Clause 15. The valve prosthesis of Clause 13, wherein the membrane fabric stretches in one or more directions oblique to the warp direction or the weft direction of the fibers.

Clause 16. The valve prosthesis of any preceding Clause, further comprising: a plurality of valve leaflets coupled to the membrane.

Clause 17. The valve prosthesis of Clause 16, wherein the membrane is coupled to the plurality of valve leaflets to restrict fluid flow around the plurality of valve leaflets and to direct the fluid flow to an area between the plurality of valve leaflets.

Clause 18. A method of manufacturing a membrane for a support frame of a valve prosthesis, the method comprising: creating a template on a membrane fabric in a shape of one or more membranes to be attached to a support frame of a valve prosthesis; orientating the template at a bias angle relative to the membrane fabric; and generating one or more membranes from the membrane fabric using the template.

Clause 19. The method of Clause 18, wherein the membrane fabric is formed from woven fiber.

Clause 20. The method of Clause 19, wherein the membrane fabric is formed by weaving fibers in a warp direction and a weft direction that are oriented transverse relative to each other.

Clause 21. The method of Clause 20, wherein the membrane fabric resists stretching in the warp direction and the weft direction of the fibers.

Clause 22. The method of Clause 20, wherein the membrane fabric stretches in one or more directions oblique to the warp direction or the weft direction of the fibers.

Clause 23. The method of Clause 18-22, wherein the bias angle is about 30 degrees to about 60 degrees.

Clause 24. A valve prosthesis, comprising: a support frame having a longitudinal axis; and a membrane coupled to the support frame, the membrane comprising: a plurality of first fibers arranged in a warp direction, and a plurality of second fibers arranged in a weft direction that is transverse relative to the warp direction, the plurality of first fibers and the plurality of second fibers being woven together, the warp and weft directions being oblique relative to the longitudinal axis of the support frame.

Clause 25. The valve prosthesis of Clause 24, wherein the warp and weft directions are aligned with expandable elements of the support frame, the expandable elements being expandable during a transition between a compressed configuration and an expanded configuration of the support frame.

Clause 26. A method of manufacturing a valve prosthesis, the method comprising: aligning a membrane along a support frame having a longitudinal axis, the membrane comprising: a plurality of first fibers arranged in a warp direction, and a plurality of second fibers arranged in a weft direction that is transverse relative to the warp direction, the plurality of first fibers and the plurality of second fibers being woven together, the warp and weft directions being oblique relative to the longitudinal axis of the support frame; and attaching the membrane to the support frame.

Clause 27. The method of Clause 26, wherein the membrane is attached to the support frame via a plurality of sutures, the plurality of sutures permitting movement of the membrane relative to the support frame when the membrane is attached to the support frame.

Clause 28. The method of Clause 27, wherein the support frame is made of a wire structure, and wherein the membrane is attached to the support frame by passing the plurality of sutures through the membrane and wrapping around a plurality of portions of the wire structure of the support frame.

Clause 29. The method of Clause 26-28, 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 the one or more membrane base portions corresponding to the one or more base portions of the support frame.

Clause 30. The method of Clause 29, further comprising: wrapping the one or more membrane peak portions over the one or more peak portions of the support frame, respectively.

Clause 31. The method of Clause 26, further comprising: forming a cylindrical shape with the membrane by attaching one lateral end of the membrane to another lateral end of the membrane, the cylindrical shape corresponding to a shape of the support frame.

Clause 32. The method of Clause 26, wherein the warp and weft directions are aligned with expandable elements of the support frame, the expandable elements being expandable during a transition between a compressed configuration and an expanded configuration of the support frame.

Clause 33. A method for delivering a prosthetic heart valve prosthesis to a native valve structure of a patient at an implantation site, the method comprising: introducing the valve prosthesis into the patient at the implantation site, the valve prosthesis including a valve anchor and an expandable valve frame comprising a bottom edge, a plurality of major peak portions, and at least one minor peak portion disposed longitudinally intermediate the bottom edge and the plurality of major peak portions; permitting expansion of the valve anchor; distally urging a portion of the valve anchor into engagement with a native valve structure; permitting the valve anchor to expand against the native valve structure; rotating the valve frame to rotationally align the minor peak portion with an ostia at the implantation site; and permitting expansion of the valve frame within a lumen of the valve anchor.

Clause 34. The method of Clause 33, wherein the minor peak portion is disposed at a lower axial distance relative to the ostia.

Clause 35. The method of Clause 34, wherein the distally advancing the valve frame into the valve anchor comprises distally advancing the valve frame until further distal movement of the valve frame relative to the valve anchor is restricted by a link mechanism.

Clause 36. The method of Clause 33-35, wherein prior to the permitting expansion of the valve frame, the method further comprises distally advancing the valve frame into the valve anchor.

FURTHER CONSIDERATIONS

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

The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.

There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.

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

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

As used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate 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 of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to 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.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

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

A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these should not be construed as limiting the scope of the subject technology but merely as illustrating different examples and aspects of the subject technology. It should be appreciated that the scope of the subject technology includes other embodiments not discussed in detail above. Various other modifications, changes and variations may be made in the arrangement, operation and details of the method and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise expressed, reference to an element in the singular is not intended to mean “one and only one” unless explicitly stated, but rather is meant to mean “one or more.” In addition, it is not necessary for a device or method to address every problem that is solvable (or possess every advantage that is achievable) by different embodiments of the disclosure in order to be encompassed within the scope of the disclosure. The use herein of “can” and derivatives thereof shall be understood in the sense of “possibly” or “optionally” as opposed to an affirmative capability.