PROSTHETIC VALVE WITH SUPPORT ARMS

Prosthetic valves that include support arms extending from support posts thereof, and methods for utilizing such prosthetic valves, are disclosed herein. As one example, a prosthetic valve can include an annular frame movable between a radially compressed state and a radially expanded state, and at least one support arm. The frame can include a plurality of support posts, each extending between a post inflow end and an opposite post outflow end. The support arm can extend from a corresponding support post, and terminate at a free-ended tip which is biased radially away from the corresponding support post.

FIELD

The present disclosure relates to mechanically expandable prosthetic valves that include support arms extending from support posts thereof.

BACKGROUND

Native heart valves, such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system. Various valvular diseases can render the valves ineffective and require replacement with artificial valves. Surgical procedures can be performed to repair or replace a heart valve. Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

Different types of prosthetic valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves. Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve. One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, toward the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.

One of the challenges associated with the above-mentioned procedures relates to the ability of the prosthetic valves to be adequately secured relative to the native annulus, in an atraumatic manner. This may be of particular importance in specific pathologies, such as aortic insufficiency or aortic regurgitation, in which the native anatomy may lack calcified deposits that could otherwise support prosthetic valves configured to exert outwardly directed radial forces to retain them in position. Thus, a need exists for improving fixation of prosthetic valve implanted within native anatomical orifices.

SUMMARY

The present disclosure is directed toward mechanically expandable prosthetic valves that include at least one support arm extending from a vertical support post thereof, configured to resist undesirable axial displacement of the prosthetic valve, relative to the native annulus, after implantation.

According to some aspects of the disclosure, a prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state. The frame comprises a plurality of support posts, a plurality of angled struts extending circumferentially between and interconnected with the support posts, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm extending at least one of the support posts.

In some aspects, the at least one support arm extends from the post outflow end or the post inflow end of at least one of the support posts.

In some aspects, the support arm terminates at a free-ended tip which is biased radially away from the corresponding support post.

In some aspects, the width of the support post from which the support arm extends is greater than the width of any of the angled struts.

In some aspects, each of the plurality of support posts extends between a post inflow end and an opposite post outflow end.

In some aspects, the plurality of support posts includes a plurality of commissure support posts, wherein each commissure support post includes a commissure window and a plurality of non-commissural support posts, wherein each non-commissural support post is devoid of a commissure window.

In some aspects, the support arm is circumferentially deflected relative to the frame, such that the tip is circumferentially offset from the corresponding support post.

In some aspects, the support arm is twisted.

In some aspects, the support arm comprises a first arm portion extending from a base of the support arm at the end of the corresponding support posts, and a second arm portion continuously extending from the first arm portion to the tip.

In some aspects, the plurality of support arms comprises at least one outflow support arm extending from the post outflow end of at least one of the support posts, and at least one inflow support arm extending from the post inflow end of at least one of the support posts.

In some aspects, the at least one outflow support arm comprises a plurality of outflow support arms.

In some aspects, the at least one inflow support arm comprises a plurality of inflow support arms.

In some aspects, the prosthetic valve further comprises an outer skirt mounted on the frame.

In some aspects, the skirt further comprises a sealing ring extending radially away from the frame.

In some aspects, the sealing ring is compressible.

According to some aspects of the disclosure, a prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state. The frame comprises a plurality of support posts, wherein each support post extends between a post inflow end and an opposite post outflow end, a plurality of angled struts extending circumferentially between and interconnected with the support posts, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm.

In some aspects, the at least one support arm extends from the opening outflow end or the opening inflow end.

In some aspects, the support arm terminates at a free-ended tip which is biased radially away from the corresponding support post.

In some aspects, the width of the support post from which the support arm extends is greater than the width of any of the angled struts.

In some aspects, at least one of the support posts comprises a post opening extending between an opening outflow end which is distal to the post outflow end, and an opening inflow end which is proximal to the post inflow end.

In some aspects, the plurality of support posts comprises a plurality of commissure support posts, wherein each commissure support post comprises a commissure window and a plurality of non-commissural support posts, wherein each non-commissural support post is devoid of a commissure window.

In some aspects, the support arm is integrally formed with the corresponding support post it extends from.

In some aspects, the at least one support arm comprises a plurality of support arms.

In some aspects, the plurality of support arms comprises inflow support arms extending from the opening inflow ends of corresponding post openings of the support posts.

In some aspects, the plurality of support arms comprises at least one outflow support arm extending from the opening outflow end of the post opening of at least one of the non-commissural support posts, and at least one inflow support arm extending from the opening inflow end of the post opening of at least one of the support posts.

According to one aspect of the disclosure, a method of delivering a prosthetic valve comprises advancing the prosthetic valve in a radially compressed state toward a native heart valve, partially expanding the prosthetic valve at a position in which the outflow end of the prosthetic valve is proximal to native leaflets of the native heart valve, angularly orienting the prosthetic valve such that commissures of the prosthetic valve are aligned with native commissures of the native leaflets, and further expanding the prosthetic valve within a native annulus of the native heart valve.

In some aspects, the prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state.

In some aspects, the frame comprises a plurality of vertical posts comprising a plurality of support posts, a plurality of angled struts extending circumferentially between and interconnected with the vertical posts, and at least one support arm extending from at least one of the vertical posts.

In some aspects, each of the plurality of support posts extends between a post inflow end and an opposite post outflow end.

In some aspects, the plurality of support posts comprises a plurality of commissure support posts, wherein each commissure support post comprises a commissure window, and a plurality of non-commissural support posts, wherein each non-commissural support post is devoid of a commissure window.

In some aspects, the support arm terminates at a free-ended tip which is biased radially away from the corresponding vertical post.

In some aspects, the method further comprises distally advancing the prosthetic valve, after partially expanding it and prior to fully expanding it, until the tips contact an abutment surface of the native heart valve.

In some aspects, fully expanding the prosthetic valve comprises clamping native leaflets of the native heart valve between the frame and the at least one support arm.

In some aspects, advancing a prosthetic valve in a radially compressed state comprises retaining the prosthetic valve in a capsule of a delivery apparatus coupled to the prosthetic valve.

In some aspects, the method further comprises moving the capsule axially relative to the prosthetic valve to expose the prosthetic valve from the capsule, prior to partially expanding the prosthetic valve.

According to some aspects of the disclosure, there is provided a prosthetic valve comprising an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises one or more pairs of actuation posts, a plurality of support posts, a plurality of angled struts extending circumferentially between adjacent actuation posts and support posts and interconnecting the actuation posts and the support posts, and one or more actuators coupled to the actuation posts. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The one or more actuators configured to adjust the frame between the radially compressed state and the radially expanded state. The at least one support arm extends from the post outflow end or the post inflow end of at least one of the support posts, and terminates at a free-ended tip which is biased radially away from the corresponding support post.

According to some aspects of the disclosure, there is provided a prosthetic valve comprising an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of support posts, and a plurality of angled struts extending circumferentially between and interconnected with the support posts. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The at least one support arm extends from the post outflow end or the post inflow end of at least one of the support posts, and terminates at a free-ended tip which is biased radially away from the corresponding support post. The width of the support post from which the support arm extends is greater than the width of any of the angled struts.

According to some aspects of the disclosure, there is provided a delivery assembly comprising a prosthetic valve and a delivery apparatus. The prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises one or more pairs of actuation posts, a plurality of support posts, a plurality of angled struts extending circumferentially between adjacent actuation posts and support posts and interconnecting the actuation posts and the support posts, and one or more actuators coupled to the actuation posts. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The one or more actuators configured to adjust the frame between the radially compressed state and the radially expanded state. The at least one support arm extends from the post outflow end or the post inflow end of at least one of the support posts, and terminates at a free-ended tip which is biased radially away from the corresponding support post.

In some examples, the delivery assembly comprises at least one actuator assembly releasably coupled to the actuator and configured to rotate the actuator to adjust the frame between the radially compressed state and the radially expanded state, a handle comprising one or more control mechanisms, and an outer shaft extending from the handle. At least one of the control mechanisms is configured, upon actuation thereof, to rotate the actuator assembly and the actuator of the prosthetic valve to adjust the frame between the radially compressed state and the radially expanded state. The actuator assembly is disposed within the outer shaft.

According to some aspects of the disclosure, there is provided a prosthetic valve comprising an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of vertical posts, a plurality of angled struts, and one or more actuators. The vertical posts comprise one or more pairs of actuation posts, a plurality of support posts, and at least one post opening comprised in at least one of the vertical posts. Each pair of actuation posts comprises an upper post member and a lower post member. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The post opening extends between an opening outflow end and an opening inflow end. The angled struts extend circumferentially between adjacent actuation posts and support posts and interconnect the actuation posts and the support posts. The one or more actuators is coupled to the actuation posts and configured to adjust the frame between the radially compressed state and the radially expanded state. The at least one support arm extends from the opening outflow end or the opening inflow end, wherein the support arm terminates at a free-ended tip which is biased radially away from the corresponding vertical post.

According to some aspects of the disclosure, there is provided a prosthetic valve comprising an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of support posts, and a plurality of angled struts extending circumferentially between and interconnected with the support posts. Each support post extends between a post inflow end and an opposite post outflow end. At least one of the support posts comprises a post opening extending between an opening outflow end which is distal to the post outflow end, and an opening inflow end which is proximal to the post inflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The at least one support arm extends from the opening outflow end or the opening inflow end, wherein the support arm terminates at a free-ended tip which is biased radially away from the corresponding vertical post. The width of the support post from which the support arm extends is greater than the width of any of the angled struts.

According to some aspects of the disclosure, there is provided a delivery assembly comprising a prosthetic valve and a delivery apparatus. The prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of support posts, and a plurality of angled struts extending circumferentially between and interconnected with the support posts. Each support post extends between a post inflow end and an opposite post outflow end. At least one of the support posts comprises a post opening extending between an opening outflow end which is distal to the post outflow end, and an opening inflow end which is proximal to the post inflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The at least one support arm extends from the opening outflow end or the opening inflow end, wherein the support arm terminates at a free-ended tip which is biased radially away from the corresponding vertical post. The width of the support post from which the support arm extends is greater than the width of any of the angled struts.

In some examples, the delivery assembly comprises at least one actuator assembly releasably coupled to the actuator and configured to rotate the actuator to adjust the frame between the radially compressed state and the radially expanded state, a handle comprising one or more control mechanisms, and an outer shaft extending from the handle. At least one of the control mechanisms is configured, upon actuation thereof, to rotate the actuator assembly and the actuator of the prosthetic valve to adjust the frame between the radially compressed state and the radially expanded state. The actuator assembly is disposed within the outer shaft.

According to some aspects of the disclosure, there is provided a prosthetic assembly comprising a docking station and a prosthetic valve. The prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of vertical posts that comprise a plurality of support posts, and a plurality of angled struts extending circumferentially between and interconnected with the vertical posts. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The at least one support arm extends from at least one of the vertical posts, and terminates at a free-ended tip which is biased radially away from the corresponding vertical post, defining a radial gap between the tip and the vertical post.

In some examples, the docking station comprises a radially collapsible and expandable docking frame comprising an inflow end portion and an outflow end portion, a sealing member disposed on the outflow end portion, and a valve seat extending from the outflow end portion and defining a diameter which is less than the diameter of a main body of the docking frame. The scaling member is configured to form a seal between the docking station and a body lumen, and defines a sealing member inflow end and a sealing member outflow end. The scaling member is retained between the annular frame of the prosthetic valve, in the radially expanded state, and the at least one support arm, such that the annular frame is positioned radially inward to the sealing member, and the tip is positioned radially outward to the sealing member.

According to some aspects of the disclosure, there is provided a method comprising: advancing a prosthetic valve in a radially compressed state toward a native heart valve; partially expanding the prosthetic valve; angularly orienting the prosthetic valve; and further expanding the prosthetic valve within a native annulus of the native heart valve. The prosthetic valve comprises an annular frame movable between a radially compressed state and a radially expanded state, a valvular structure mounted within the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, and at least one support arm. The frame comprises a plurality of vertical posts that comprise a plurality of support posts, and a plurality of angled struts extending circumferentially between and interconnected with the vertical posts. Each support post extends between a post inflow end and an opposite post outflow end. The support posts comprise a plurality of commissure support posts and a plurality of non-commissural support posts. Each commissure support post comprises a commissure window. Each non-commissural support post is devoid of a commissure window. The at least one support arm extends from at least one of the vertical posts, and terminates at a free-ended tip which is biased radially away from the corresponding vertical post, defining a radial gap between the tip and the vertical post. Partially expanding the prosthetic valve is performed at a position in which the outflow end of the prosthetic valve is proximal to native leaflets of the native heart valve. Angularly orienting the prosthetic valve is performed such that commissures of the prosthetic valve are aligned with native commissures of the native leaflets.

The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the terms “have” or “includes” means “comprises”. Further, the terms “coupled”, “connected”, and “attached”, as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, “and/or” means “and” or “or”, as well as “and” and “or”.

Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner,” “outer,” “upper,” “lower,” “inside,” “outside,”, “top,” “bottom,” “interior,” “exterior,” “left,” right,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

The term “plurality” or “plural” when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

The terms “proximal” and “distal” are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient's body) is the distal end. The term “proximal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term “distal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms “longitudinal” and “axial” are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

It should be understood that the disclosed examples can be adapted to deliver and implant prosthetic devices in any of the native annuluses of the heart (e.g., the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

FIG.1shows a sectional view of a healthy human heart. The heart has a four-chambered conical structure that includes the left atrium12, the right atrium14, the left ventricle16and the right ventricle18. The wall separating between the left and right sides of the heart is referred to as the septum20. The native mitral valve30is positioned between the left atrium12and the left ventricle16. The native tricuspid valve60is positioned between the right atrium14and the right ventricle18. The native aortic valve40is positioned between the left ventricle16and the aorta50. The initial portion of the aorta50extending from the native aortic valve40is the aortic root52, and the adjoining part of the left ventricle16is the left ventricular outflow tract (LVOT)22.

During the diastolic phase, or diastole, deoxygenated blood flows from the right atrium14into the right ventricle18through the tricuspid valve60. During systole, leaflets of a normally functioning tricuspid valve60close to prevent the venous blood from regurgitating back into the right atrium14. When the tricuspid valve60does not operate normally, blood can backflow or regurgitate into the right atrium14.

The native mitral valve30comprises a mitral annulus32and a pair of mitral leaflets34extending downward from the annulus32. When operating properly, the leaflets34function together to allow blood flow only from the left atrium12to the left ventricle16. Specifically, during diastole, when the muscles of the left atrium12and the left ventricle16dilate, oxygenated blood flows from the left atrium12, through the mitral valve30, into the left ventricle16. During systole, when the muscles of the left atrium12relax and the left ventricle16contacts, the blood pressure within the left ventricle16increases so as to urge to two mitral leaflets34to coapt, thereby preventing blood flow from the left ventricle16back to the left atrium12.

The native aortic valve40comprises an aortic annulus42and three aortic leaflets44extending upward (toward the aortic root52) from the annulus42. During systole, blood is expelled from the left ventricle16, through the aortic valve40, into the aorta80. In addition, as illustrated for example inFIG.15, the native pulmonary valve62separates the right ventricle18from the pulmonary artery64. During systole, the right ventricle18contracts to force the blood collected in the right ventricle18through the pulmonary valve62and pulmonary artery64into the lungs. When either the native tricuspid valve60, native mitral valve30, native pulmonary valve62, or native aortic valve40, fails to function properly, a prosthetic replacement valve100can help restore functionality.

FIGS.2A-2Dillustrate a prosthetic valve100, according to one example. The prosthetic valve100can be configured to replace a native heart valve (e.g., aortic, mitral, pulmonary, and/or tricuspid valves). The prosthetic valve100is illustrated as a mechanically expandable prosthetic valve that can be radially compressed for delivery to an implantation location within a patient's body and then radially expanded to a working diameter at the implantation location. The prosthetic valve100can include a frame104having an annular shape. The prosthetic valve100can further include a valvular structure108supported within and coupled to the frame104.FIG.2Ashows a perspective view of a prosthetic valve100including a skirt146and a valvular structure108thereof.FIG.2Bshows the prosthetic valve100ofFIG.2Awith the skirt146removed from view.FIG.2Bshows the frame104of the prosthetic valve100ofFIGS.2A-2Bwithout any soft components, such as a skirt or a valvular structure.FIG.2Dshows a top view of the frame104ofFIG.2C.

In the example, the valvular structure108includes one or more leaflets112made of flexible material and configured to open and close to regulate blood flow. In one example, the valvular structure108can have three leaflets112, which can be arranged to collapse in a tricuspid arrangement. The leaflets112can be made in whole or in part from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials.

As illustrated, the frame104has an inflow end116, an outflow end120, and a central longitudinal axis C extending in a direction from the inflow end116to the outflow end120. The frame104can include a plurality of vertical posts122aligned with the central longitudinal axis C. The vertical posts122can include support posts124and actuation posts128spaced along a circumference of the frame104. In one example, the support posts124and actuation posts128can be arranged in an alternating manner along the circumference of the frame104. The frame104can further include a plurality of angled struts132extending circumferentially between adjacent support posts124and actuation posts128and interconnecting the support posts124and actuation posts128. The angled struts132, support posts124, and actuation posts128, define cells136of the frame104. As illustrated, the angled struts132can have a curved shape.

One or more commissure windows140can be formed in one or more of the support posts124. Commissures144can be formed at the commissure windows140to couple the leaflets112to the frame104. Support posts124can include commissure support posts125, which are support posts124that include commissure windows140, and non-commissural support posts126, which are support posts124devoid of commissure windows. The commissure support posts125and non-commissural support posts126can be arranged in an alternating manner along the circumference of the frame104. In the illustrated example, frame104includes a total of six support posts124, three of which are commissure support posts125and three of which are non-commissural support posts126.

One or more of the support posts124can further include cantilevered struts134extending from the corresponding post inflow ends180. In some examples, the cantilevered struts134can extend such that distal ends of the cantilevered struts134align with or substantially align with the inflow end116of the frame104.

The prosthetic valve100can further include one or more skirts or sealing members. For example, the prosthetic valve100can include an inner skirt (not shown), mounted on the radially inner surface of the frame104. The inner skirt can function as a scaling member to prevent or decrease perivalvular leakage, to anchor the leaflets112to the frame104, and/or to protect the leaflets112against damage caused by contact with the frame104during crimping and during working cycles of the prosthetic valve100. The prosthetic valve100can further include an outer skirt146mounted on the outer surface of the frame104. The outer skirt146can function as a scaling member for the prosthetic valve100by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve100. The inner and outer skirts can be formed from any of various suitable biocompatible materials, including any of various synthetic materials, including fabrics (e.g., polyethylene terephthalate fabric) or natural tissue (e.g., pericardial tissue). Further details regarding the use of skirts or sealing members in prosthetic valves can be found, for example, in U.S. Patent Application No. 62/854,702 and PCT Patent Application No. US2020/024559, each of which is incorporated by reference herein.

In some cases, as shown in the example illustrated inFIG.2B, inflow edge portions of the leaflets112can be attached to the cantilevered struts134and/or to selected struts132of the frame104. Alternatively or additionally, cantilevered struts134can prevent or mitigate portions of an outer skirt146from extending radially inwardly and thereby prevent or mitigate any obstruction of flow through the inflow end116of the frame104caused by the outer skirt146. The cantilevered struts134can further serve as supports to which portions of the inner and/or outer skirts can be coupled, as shown inFIG.2A. For example, sutures used to connect the inner and/or outer skirts can be wrapped around the cantilevered struts134and/or can extend through apertures formed at end portions of the cantilevered struts134.

In some implementations, leaflets112can be sutured directly to angled struts132of the frame104. In other implementation, inflow edge portions of the leaflets can be sutured to an inner skirt generally along the scallop line. The inner skirt can in turn be sutured, via one or more sutures, for example, to adjacent angled struts132of the frame104.

Each support post124, including any commissure support posts125or non-commissural support post126, extends between a post inflow end180which is closer to the inflow end116of the valve100, and a post outflow end182which is closer to the outflow end120of the valve100. Two angled struts132intersect with each support post124at a post inflow end180, which is circumferentially disposed between two adjacent inflow apices114, such that a corresponding cantilevered strut134can extend distally from the post inflow end180. Similarly, two angled struts132intersect with each support post124at a post outflow end182, which is circumferentially disposed between two adjacent outflow apices118.

As further shown, each commissure support post125and each non-commissural support post126also intersects, at a middle portion thereof, with four additional angled struts132extending from adjacent upper post members160and lower post members164on both sides, resulting in each support posts124, and specifically, each commissure support post125and each non-commissural support post126, intersecting with a total of at least eight curved struts extending from adjacent actuation posts128.

In one example, the frame104can be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting the angled struts132. In one example, the frame104(e.g., the posts and struts) can be made of biocompatible plastically-expandable materials that will allow the frame104to be adjusted between the radially expanded configuration and radially compressed configuration. Suitable examples of plastically-expandable materials that can be used in forming the frame104include, but are not limited to, stainless steel, cobalt chromium alloy, and/or nickel titanium alloy (which can also be referred to as “NiTi” or “nitinol”).

In some examples, one or more actuators170can be coupled to the actuation posts128, and used to adjust the frame104between the radially expanded configuration and the radially compressed configuration. In one example, each actuation post128can include an upper post member160and a lower post member164(the terms “upper” and “lower” are relative to the orientation of the prosthetic valve100inFIGS.2A-2C) aligned with the longitudinal axis C and having opposing ends separated by a gap. The respective actuator170can be coupled to the post members160,164and operable to increase or decrease the gap therebetween in order to radially compress or expand the frame104. Angled struts132can converge with upper post members160to define outflow apices118at the outflow end120. Angled struts132can similarly converge with lower post members164to define inflow apices114at the inflow end116.

In one example, the actuator170can include an actuator rod172with an attached actuator head. In the example illustrated inFIGS.2A-2C, the actuator rod172extends through or into the post members160,164and across the gap therebetween. In the example illustrated inFIGS.2A-2C, the actuator rod172is inserted into the upper post member160from the outflow end120, and the actuator head (hidden from view inFIGS.2A-2C) can be disposed or retained at the outflow apex118of the upper post member160.

In some examples, the actuator rod172is externally threaded. As illustrated inFIGS.2A-2C, the lower post member164can include a nut176with an internal thread to threadedly engage the actuator rod172. In this case, the actuator rod172can be axially translated by rotating the actuator rod172relative to the nut176. In some examples, the actuator rod172can be freely slidable relative to the upper post member160. In other examples, the actuator rod172can threadedly engage the upper post member160. The term “axially translated”, as used herein, refers to translation along an axis coinciding with or parallel to the central longitudinal axis C.

In one scenario, the actuator rod172can be rotated in a first direction to move the upper post member160towards the lower post member164and thereby decrease the size of the gap therebetween, which can have the effect of radially expanding the frame104. In another scenario, the lower post member164may be held steady while the actuator rod172is rotated in a second direction to move the upper post member160away from the lower post member164and thereby increase the size of the gap therebetween, which can have the effect of radially compressing the frame104.

The actuator rod172also can include a stopper178(e.g., in the form of a nut, washer or flange) disposed thereon. The stopper178can be disposed on actuator rod172such that it sits within the gap therebetween. Further, the stopper178can be integrally formed on or fixedly coupled to the actuator rod172such that it does not move relative to the actuator rod172. Thus, the stopper178can remain in a fixed axial position on the actuator rod172such that it moves in lockstep with the actuator rod172.

When the actuator rod172is rotated in a direction configured to collapse the prosthetic valve, the stopper178moves toward the outflow end120of the frame until the stopper178abuts the inflow end of the upper post member160. Upon further rotation of the actuator rod172, the stopper178can apply a proximally directed force to the upper post member160to radially compress the frame104. Specifically, during crimping/radial compression of the prosthetic valve100, the actuator rod172can be rotated in a direction that causes the stopper178to push against (i.e., provide a proximally directed force to) the inflow end of the upper post member160, thereby causing the upper post member160to move away from the lower post member164, and thereby axially elongating and radially compressing the prosthetic valve100.

In an alternative implementation, some of the actuator rods172can be rotated in one direction while the other actuator rods172are rotated in an opposite direction simultaneously to either radially expand the frame or radially compress the frame. This counter-rotation of the actuator rods can be used to help reduce the likelihood of the entire frame104rotating about the central longitudinal axis C during rotation of the actuator rods172about their respective axes (e.g., when radially expanding the frame104).

Additional examples of mechanically expandable valves can be found in International Application No. PCT/US2021/052745 and U.S. Provisional Applications Nos. 63/209,904 and 63/282,463, which are incorporated by reference herein.

A prosthetic valve100can further include support arms150extending from a support post124. In the examples illustrated inFIGS.2A-2C, three support arms150are shown to extend from non-commissural support posts126, and more specifically, from post outflow ends182of the non-commissural support posts126. While three support arms150are shown in the illustrated example, it is to be understood that any other number of support arms is contemplated, such as a single support arms, two support arms, or more than three support arms.

As shown, the actuation posts128are arranged in pairs, each pair including an upper post member160and a lower post member164which can be axially aligned with each other, and each pair of actuation posts128can be connected, such as via angled struts132, to a commissure support post125on one side thereof, and to a non-commissural support post126on the other side. As shown, support posts124disposed between angled struts132can have a width, in the circumferential direction, that is greater than the width of other curved or angled struts132of the frame104, so as to improve structural stability to the frame104. This unique feature of increased width can be taken advantage of, to offer better support to the support arms150extending from ends thereof.

Each support arm150can extend from a base151at which it is attached to the support post124, such as to a post outflow end182as illustrated inFIGS.2A-2C, or a post inflow end180(as shown, for example, inFIG.10), to a tip156which is biased radially away from the frame104, and more specifically, from the corresponding support post124, such that the tips156of corresponding support arms150are spaced away from the frame104in a free state of the support arms150, referring to a state in which the support arms150are free to assume a pre-shaped configuration in the absence of external forces acting there-against. The support arms150can be formed from any suitable shape-memory material (e.g., Nitinol) such that the support arms resiliently extend radially away from the frame104when they are not constrained by an outer shaft208or a capsule210, as will be further explained below.

In some examples, the support arm150can include a first arm portion152extending from the base151, and a second arm portion154continuously extending from the first arm portion152and terminating at the tip156. In a free state of the support arms150, they extend generally radially outwardly from the frame104such that their tips156are generally spaced away from the rest of the frame104. In one example, a support arm150acan have a C-shaped first arm portion152a(seeFIG.2C), while the second arm portion154acan be a linear or slightly curved portion of the arm (but with a curvature which is significantly less than the curvature of the first arm portion152a). The first arm portion152acan generally extend radially away from the corresponding support post124, while the second arm portion154acan extend in the axial direction, toward the opposite end of the corresponding post124. For example, for a support arm150aextending from the post outflow ends182, the second arm portion154acan extend toward the post inflow end180.

In some examples, as shown inFIG.2D, any support arm150can be further circumferentially angled, meaning that in addition to being pre-shaped to deflect radially outwardly such that the tip156is spaced radially away from the rest of the frame104, it can also deflect circumferentially such that the tip156is circumferentially offset from the corresponding base151and/or the corresponding support post124. In some examples, as shown inFIG.3, any support arm150can be further twisted. The support arms150can be twisted in a wide variety of different ways and can be twisted along their full length or just a portion of their length. The twists158aid in crimping or compressing of the prosthetic valve100. In the illustrated example, a first twist158ais included at or near (e.g., adjacent) the base151and a second twist158bis included at or near (e.g., adjacent) the tip156. While two twists158are shown in the example illustrated inFIG.3, it is to be understood that any other number is contemplated, including a single twist, or more than two twists. In the illustrated example, the twists158are ninety degree twists, forming one-hundred-eighty total degrees of twist along a support arm150that include two twists.

Each angled strut132can have a thickness T1in the radial direction, and a width W1in the lateral or circumferential direction. Each support post124can have a thickness T2in the radial direction, and a width W2in the lateral or circumferential direction. Each support arm150can have a thickness T3and a width W3. Since the support arm150can twist along its length, it is to be understood that the thickness T3is defined in the radial direction and the width W3is defined in the lateral or circumferential direction at least at or adjacent to the base151.

In some implementations, as illustrated, the width W2of the support posts is greater than the width W1of the angled struts. Specifically, the thickness T1and width W1of the angled struts132is selected to allow them to change their angular orientation (in the lateral or circumferential direction) to allow the frame104to move between compressed and expanded configurations, while the axially-oriented vertical support posts124remain in the same orientation, and are usually wider to provide adequate support to the angled struts132. Moreover, since some of the support posts124are commissure support posts125, their width W2can be selected to accommodate commissure windows140therein. Thus, in such prosthetic valves100, the width W2of the support posts124is greater than the width W1of the angled struts132, while the thickness T2can be similar or equal to the thickness T1, especially if the frame104is manufactured by cutting (e.g., laser cutting) a tubular member having a uniform thickness. In some examples, the width W2is at least two times greater than the width W1. In some examples, the width W2is at least three times greater than the width W1.

The width W3of the support arms150can be, in some implementations, less than the width W2of the support posts124they extend from, to allow the support arms150to properly deflect away from the rest of the frame104. While the thickness T3can be similar to that of the thickness T2and/or the thickness T1, especially if the support arms150are also cut (e.g., by laser cutting) from the same tube member as the rest of the frame104, in other implementations, the thickness T3can be less than the thickness T2. After being cut (e.g., laser cut from a tubular member), the support arms150can be heat-formed to a predefined shape, such as the shape of support arms150adescribed above, or other shapes as will be further described below. In some examples, the width W3can be 70% or less than the width W2. In some examples, the width W3can be 60% or less than the width W2. In some examples, the width W3can be 50% or less than the width W2. In some examples, the width W3can be 40% or less than the width W2. In some examples, the width W3can be 30% or less than the width W2. In such implementations, the greater width W2of the support arms150can provided improved structural to support arms150.

In some examples, the support arms150can have a rectangular cross-section, such that the width W3is greater than the thickness T3. In some examples, the thickness T3can be 90% or less of the width W3, the thickness T3can be 80% or less of the width W3, thickness T3can be 70% or less of the width W3, thickness T3can be 60% or less of the width W3, thickness T3can be half or less of the width W3, thickness T3can be 40% or less of the width W3, thickness T3can be 30% or less of the width W3, thickness T3can be ¼ or less of the width W3, or the thickness T3can be 20% or less of the width W3.

The support arms150are configured to extend radially outwardly upon deployment of the prosthetic valve100, and contact, abut or rest on an upper and/or lower abutment surfaces of the native annulus. For example, for a prosthetic valve100configured to be implanted within a native aortic valve40, the tips156of support arms150extending from post outflow ends182can rest on aortic root abutment surface46, which is the surface of the aortic annulus42facing the aortic root52. Likewise, the tips156of support arms150extending from post inflow ends180can contact the LVOT abutment surface48, which is the surface of the aortic annulus42facing the LVOT22. Similarly, for a prosthetic valve100configured to be implanted within a native mitral valve30, the tips156of support arms150extending from post outflow ends182can rest on mitral ventricular abutment surface38, which is the surface of the mitral annulus32or native mitral leaflets34facing the left ventricle16. Likewise, the tips156of support arms150extending from post inflow ends180can contact the mitral atrial abutment surface36, which is the surface of the mitral annulus32or native mitral leaflets34facing the left atrium12. Thus, the tips156can be atraumatic to avoid damaging the abutment surfaces they are configured to contact or rest on. For example, the tips156may have smooth contact surfaces that may be flattened or curved and are not configured to penetrate the tissue they contact and/or rest on. The tips156can be covered in some implementations. In some examples, the tips156can be configured to be flexible to allow for reduction of possible trauma to the tissue upon contact.

FIG.4illustrates a delivery assembly200, which can include a prosthetic valve260and a delivery apparatus202, according to some examples. The delivery apparatus2—can be used to deliver a mechanically expandable prosthetic valve260described herein (e.g., prosthetic valve100or500). The prosthetic valve260can be releasably coupled to the delivery apparatus202. It should be understood that the delivery apparatus202can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

The delivery apparatus202in the illustrated example generally includes a handle204, an outer elongated shaft208extending distally from the handle204and at least one actuator assembly220extending distally through the outer shaft208. The delivery apparatus202can also include an elongated nosecone shaft232extending distally from the handle204through the outer shaft208. A nosecone240can be connected to the distal end of the nosecone shaft232. The at least one actuator assembly220can be configured to radially expand and/or radially collapse the prosthetic valve260when actuated.

As illustrated, one actuator assembly220can be provided for each actuator (e.g., actuator170or570) on the prosthetic valve260. For example, six actuator assemblies220can be provided for a prosthetic valve260having six actuators. In other configurations, however, any greater or fewer number of actuator assemblies can be present.

The distal end portion of the shaft208can be sized and shaped to house the prosthetic valve260in a radially compressed, delivery state during delivery of the prosthetic valve through, for example, the vasculature of a patient. In this way, the distal end portion of shaft208functions as a delivery sheath or capsule for the prosthetic valve during delivery.

The actuator assemblies220can be releasably coupled to the prosthetic valve260. For example, in the illustrated configuration, each actuator assembly220can be coupled to a respective actuator of the prosthetic valve260. Each actuator assembly220can comprise a support tube224, an actuator member226(hidden within support tube224inFIG.4, exposed inFIG.9A), and optionally a locking tool. When actuated, the actuator assembly can transmit pushing and/or pulling forces to portions of the prosthetic valve to radially expand and collapse the prosthetic valve as previously described. The actuator assemblies220can be at least partially disposed radially within, and extend axially through, one or more lumens of the outer shaft208. For instance, the actuator assemblies220can extend through a central lumen of the shaft208or through separate respective lumens formed in the shaft208.

The terms “releasably coupled” or “releasably attached”, as used herein, are interchangeable, and refer to two components coupled in such a way that they are coupled together and can be separated without plastically deforming either of the components.

Although not illustrated, the delivery apparatus202can include, in some implementations, a multi-lumen delivery shaft212extending through the lumen of the outer shaft and having a plurality of lumens therein. Any of the nosecone shaft232and/or actuation assemblies220can extend through lumens of the multi-lumen delivery shaft212.

The actuator member226of each actuator assembly220can be releasably coupled to a respective actuator of the prosthetic valve (e.g., actuator170). The support tube224of each actuator assembly220can abut an adjacent portion of the frame of the prosthetic valve, such as an outflow apex (e.g., apex118). In this manner, during valve expansion, the support tubes224can prevent movement of the outflow end of the prosthetic valve relative to the delivery apparatus while the actuator members of the actuator assemblies220can actuate the actuators of the prosthetic valve and cause the inflow end of the prosthetic valve to move toward the outflow end of the prosthetic valve.

The handle204of the delivery apparatus202can include one or more control mechanisms (e.g., knobs206or other actuating mechanisms) for controlling different components of the delivery apparatus202in order to expand and/or deploy the prosthetic valve260. For instance, in the illustrated example, the handle204comprises first, second, and third knobs206a,206b, and206c.

The first knob206acan be a rotatable knob configured to produce axial movement of the outer shaft208relative to the prosthetic valve260in the distal and/or proximal directions in order deploy the prosthetic valve from the delivery sheath once the prosthetic valve has been advanced to a location at or adjacent the desired site of implantation within a patient. For instance, rotation of the first knob206ain a first direction (e.g., clockwise) can retract the outer shaft208proximally relative to the prosthetic valve260and rotation of the first knob206ain a second direction (e.g., counterclockwise) can advance the outer shaft208distally. In other configurations, the first knob206acan actuated by sliding or moving the knob206aaxially, such as puling and/or pushing the knob. In still further configurations, actuations of the first knob206a, such as by rotation or sliding the first knob206a, can produce axial movement of the actuator assemblies220and thereby the prosthetic valve260relative to the delivery sheath to advance the prosthetic valve distally from the sheath.

In one example, a capsule210can be attached to a distal end of the outer shaft208. Axial movement of the outer shaft208in a distal direction relative to the other shafts and prosthetic valve can move the capsule210over the distal end portions of the actuation assemblies220and the prosthetic valve260(i.e., when the prosthetic valve260, such as prosthetic valve100or500, is in the radially compressed configuration) such that the prosthetic valve260is enclosed within the capsule210. Axial movement of the outer shaft208in a proximal direction relative to the other shafts and the prosthetic valve can retract the capsule210from the prosthetic valve260, exposing the prosthetic valve, for example, for deployment at an implantation location.

The second knob206bcan be a rotatable knob configured to produce radial expansion and/or contraction of the prosthetic valve260. For instance, rotation of the second knob306bcan move the actuator members and the support tubes224of actuator assemblies220axially relative to one another. The actuator members or drivers of actuator assemblies220in turn cause corresponding movement of the actuators (e.g., actuators170or570) of the prosthetic valve. Rotation of the second knob206bin a first direction (e.g., clockwise) can radially expand the prosthetic valve260and rotation of the second knob206bin a second direction (e.g., counterclockwise) can radially collapse the prosthetic valve260. In other configurations, the second knob206bcan be actuated by sliding or moving the knob206baxially, such as pulling and/or pushing the knob.

The third knob206ccan be a rotatable knob configured to retain the prosthetic valve260in an expanded state. For instance, the third knob206ccan be operatively connected to a proximal end portion of the locking tool of each actuator assembly220. Rotation of the third knob206cin a first direction (e.g., clockwise) can rotate each locking tool to advance the locking nuts to their distal positions to resist radial compression of the frame of the prosthetic valve. Rotation of the knob206cin the opposite direction (e.g., counterclockwise) can rotate each locking tool in the opposite direction to decouple each locking tool from the prosthetic valve260. In other configurations, the third knob206ccan be actuated by sliding or moving the third knob206caxially, such as pulling and/or pushing the knob. In some embodiments, the prosthetic valve can be self-locking, in which case a locking tool is not required. For example, the frame of the prosthetic valve can include locking features that automatically engage the actuator members of the prosthetic valve to resist radial compression of the prosthetic valve after it is expanded, such as disclosed in U.S. Application Nos. 63/085,947, 63/138,599, and 63/179,766.

Although not shown, the handle204can include a fourth rotatable knob operative connected to a proximal end portion of each actuator member. The fourth knob can be configured to rotate each actuator member, upon rotation of the knob, to unscrew each actuator member226from the proximal portion of a respective actuator. As described above, once the locking tools and the actuator members are uncoupled from the prosthetic valve260, they can be removed from the patient.

In particular implementations, the delivery assembly202including the delivery apparatus202with the prosthetic valve260assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve260and the delivery apparatus202, respectively, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

FIGS.5-6shows various configurations by which a prosthetic valve100with self-expandable support arms150can be retained in an undeployed state within a capsule210or a sheath of the delivery apparatus202during delivery to the site of implantation. For simplicity, soft components, such as a valvular structure108or a skirt146, are not shown. While the prosthetic valve100is illustrated to be retained in a crimped state within a capsule210inFIGS.5-6, it is to be understood that the same configurations apply to a delivery apparatus that does not necessarily include a capsule, in which case the valve100can be similarly retained within a distal portion of a shaft of the delivery apparatus, such as the outer shaft208. The actuator assemblies220, which can be coupled to the prosthetic valve100during delivery, as well as actuators170and soft components of the valve100, are removed from view inFIGS.5-6for clarity.

FIG.5illustrates one exemplary configuration with “flipping” support arms. During delivery, the support arms150can be partially or completely straightened, as shown, in their undeployed state. The support arms150can be restrained from radially expanding outward by the constrictive force of the capsule210. Depending on the length of the support arms150, this configuration can result in the tips156disposed proximal to the outflow apices118of the frame104if for support arms150that extend from post outflow ends182, or disposed distal to the inflow apices114of the frame104if for support arms150that extend from post inflow ends180. When the support arms150are freed from the capsule210during deployment of the prosthetic valve100, they spring back to their pre-formed shape, as shown inFIGS.2A-2D.

FIG.6illustrates another exemplary configuration in which the support arms150are compressed, in their undeployed folded configuration, between the rest of the frame104and the inner walls of the capsule210. The support arms150can be restrained from deployment by the capsule210. Depending on the length of the support arms150, this configuration can result in the tips156disposed between the inflow end116and the outflow end120of the valve. When the support arms150are freed from the capsule210during deployment of the prosthetic valve100, they spring outwardly to their pre-formed shape, as shown inFIGS.2A-2D.

FIGS.7-8show additional optional shapes of the support arms150in their free, deployed state.FIG.7shows an exemplary support arm150bthat includes a U-shaped or L-shaped first arm portion152b, and a relatively linear second arm portion154bextending axially therefrom.FIG.8shows an exemplary support arm150cthat includes a relatively linear first arm portion152cextending radially away from the base151c, and a relatively linear second arm portion154cextending axially therefrom. It is to be understood that other pre-formed shapes are contemplated, configured to deflect the support arms150radially outwardly to the rest of the frame104.

FIG.9A-9Bshow stages of an exemplary method for implantation of a prosthetic valve100within a native aortic annulus42. For simplicity, soft components, such as a valvular structure108or a skirt146, are not shown. The prosthetic valve100can be coupled to a delivery apparatus202, which can be used to deliver, position, and secure the prosthetic valve100in a native heart valve annulus. In the illustrated implantation procedure, the prosthetic valve100is implanted in a native aortic annulus42using a transfemoral delivery approach. In other examples, the prosthetic valve100can be implanted at other locations (e.g., a mitral valve, a tricuspid valve, and/or a pulmonary valve), within previously-implanted prosthetic valve, and/or using other delivery approaches (e.g., transapical, transaortic, transseptal, etc.).

The prosthetic valve100can be releasably coupled, as described above, to the actuator assemblies220of delivery apparatus202, and advanced in a compressed state through the patient's vasculature toward the site of implantation (e.g., the aortic annulus). Upon reaching the site of implantation, the prosthetic valve100can be deployed by pushing it distally out of the capsule210and/or outer shaft208, or by proximally pulling the capsule210and/or outer shaft208relative to the prosthetic valve100, which allows the support arms150to spring out radially away from the rest of the frame104as described above with respect toFIGS.5-6, for example. The actuation assemblies220can then be utilized, as described above, to radially expand the prosthetic valve100, at least to a partially expanded diameter, as shown inFIG.9A.

A significant advantage of mechanically expandable prosthetic valves is that the expansion mechanism allows them to be controllably and gradually expanded, as opposed to balloon expandable valves or self-expandable valves, which are conventionally expanded to their final functional diameter in a relatively rapid manner with limited control over the expansion process. This can be taken advantage of for properly positioning the support arms in a desired orientation, relative to the native anatomy. For example, as shown inFIG.9A, actuator assemblies220can be utilized to partially expand the prosthetic valve100to a partially expanded diameter, which is greater than the crimped diameter but less than the final functional diameter, such that the frame104, and optionally even the support arms150, are not yet immovably pressed within the native annulus. This allows the prosthetic valve100to be angularly oriented to a desired angular orientation, for example with respect to the aortic leaflets44.

As shown inFIG.9A, when the prosthetic valve100is deployed within the native aortic valve40, the support arms150can be positioned over and/or around the aortic leaflets44. As shown inFIGS.2A-2D, a prosthetic valve100can include a total of six support posts124, three of which are commissure support posts125to which commissures144are coupled, and three of which are non-commissural support posts126disposed between the commissure support posts125. In one configuration, the prosthetic valve100can include one or more (e.g., three as in the illustrated examples) support arms150extending from the post outflow ends182of the non-commissural support posts126, while the commissure support posts125remain devoid of support arms. When implanted in a native aortic valve40, it may be desired to position the support arms150over the native aortic leaflets44between the native commissures, such that the tips156can abut aortic root abutment surface46instead of contacting the native commissures.

The prosthetic valve100can be deployed out of the capsule at a position which is proximal to the native aortic leaflets44, allowing the support arms150to spring radially outwards, after which the prosthetic valve100can be distally advanced to position the native aortic leaflets44between the frame104and the support arms150. Partial expansion of the prosthetic valve100can be performed upon deployment, prior to axial advancement, and/or during and/or after axial advancement of the valve100. In the partially expanded diameter of the prosthetic valve100, shown inFIG.9A, it can be angularly reoriented, if needed, to align the commissures144of the prosthetic valve100with the native commissures between the native aortic leaflets44.

Further expansion of the prosthetic valve100to the functional size, which can be optionally accompanied by further axial displacement relative to the native aortic annulus42, serves to anchor the prosthetic valve100in position, wherein the support arms150may press against the native annulus for migration resistance. For example, the tips156can rest over the aortic root abutment surface46, so as to resist unintentional distally oriented migration of the prosthetic valve100toward the left ventricle16.

In some cases, the support arms150can extend around native leaflets and potentially grasp the native leaflets, as shown inFIG.9B. For example, when the prosthetic valve100is further expanded by the actuator assemblies220from the partially expanded diameter shown inFIG.9Ato the desired functional diameter shown inFIG.9B, the support arms150can be pressed between the surrounding aortic wall and the expanded frame104, grasping portions of the native aortic leaflets44between the support arms150and the frame104. The frame104and at least some portion of the support arms150, such as the tips156, can approximate each other in such procedures, optionally pinching the native leaflets44therebetween. In some cases, the native leaflets44can be bunched up between the support arms150and the rest of the frame104. This can provide for greater securement of the prosthetic valve100to the leaflets44, which may be specifically advantageous in some pathologies, such as Aortic Insufficiency, in which the native leaflets44do not include sufficient internal calcifications to warrant proper retaining force of a prosthetic valve pressed there-against. In alternative implementations, the support arms150do not necessarily hook the native leaflets.

While optional angular orientation of the prosthetic valve100is described above, in a partially expanded state thereof, it is to be understood that in alternative implementations, active angular orientation may not be required, relying on the natural tendency of the support arms150to slip along the native leaflets44to a position between the native commissures, during continuous expansion of the valve100. In such implementations, the mechanical expansion mechanism of a mechanically expandable prosthetic valve100is still advantageous in that it allows sequential controlled expansion of the valve100at a rate that will allow the support arms150to be self-oriented to the proper positions along the native aortic leaflets44, whereas abrupt expansion of conventional self-expandable valves, for example, may result in a less desirable outcome with respect to the position of the support arms150relative to the native anatomy.

Utilization of support arms150engaged with portions of the native tissue, such as annular abutment surfaces and/or native leaflets, can advantageously prevent or reduce the prevalence of axial movement of the prosthetic valve100in a direction opposite to the side the arms150extend from, and can also help ensure that the prosthetic valve100is perpendicular to the annulus and prevents undesirable “rocking” or tilting of the frame. By engaging the native annulus, and optionally the native leaflets, the support arm can assist in more evenly distributing the load to achieve equilibrium, thus providing a more robust implantation.

In some implementations, the gap formed between the tips156and the frame104is configured to allow the support arms150to cover the native aortic leaflets44during gradual controlled expansion of the prosthetic valve100. When further utilized to accommodate native aortic leaflets44therein, the native leaflets can be folded, for example by first arm portions152of the support arms150, toward the native aortic annulus42, distancing them away from the coronary arteries24to avoid obstruction of the ostia of the coronary arteries24. Native leaflets bunched up within support arms150can also improve PVL sealing around the frame104.

After reaching the final functional expanded diameter, the actuator assemblies220can be uncoupled from the actuators170and the delivery apparatus202can then be withdrawn from the patient's body, leaving the prosthetic valve100within the aortic annulus42to regulate blood flow from the left ventricle16into the aorta50. While illustrated for use in a native aortic valve40inFIGS.9A-9B, it is to be understood that a mechanically expandable prosthetic valve100with support arms150can be similarly implanted within a native tricuspid valve60, a native mitral valve30valve, or any other orifice.

As mentioned, a prosthetic valve100can include any number of support arms150. Thus, the plural use of the term “support arms150” is not meant to be limiting, and may refer to implementation in which a single support arm150is included. For example, a prosthetic valve100configured for deployment within a native valve, such as the native aortic valve40described above with respect toFIGS.9A-9B, can include any number of support arms, such as three support arms as shown inFIGS.2A-2D, more or less than three arms, or even a single support arm150that can extend, for example, from a post outflow end182of one of the non-commissural support posts126.

Support arms150can include outflow support arms150′, extending from post outflow ends182, as well as inflow support arms150″, extending from post inflow ends180.FIG.10shows another exemplary configuration of a mechanically expandable prosthetic valve100dthat includes both outflow support arms150′ and inflow support arms150″. While three outflow support arms150′ and three inflow support arms150″ are illustrated, it is to be understood that any other number of any type of support post(s) is contemplated.

In some examples, a prosthetic valve100can include an equal number of outflow support arms150′ and inflow support arms150″, as illustrated inFIG.10. In alternative configurations, the number of outflow support arms150′ can be different from the number of inflow support arms150″. In some examples, the prosthetic valve100can include one or more inflow support arms150″ without any outflow support arms.

In some examples, the outflow support arms150′ and the inflow support arms150″ can be aligned, extending from opposite sides of the same support posts124, as shown inFIG.10. In other examples, the outflow support arms150′ and inflow support arms150″ can be arrange in any other non-aligned arrangement, including in a staggered arrangement relative to each other. While the support arms150′ and150″ are shown to extend from post outflow ends182and post inflow ends180of non-commissural support posts126, it is to be understood that in alternative implementations, support arms150of any type can extend from post outflow ends182and/or post inflow ends180of commissure support posts125.

When implanted within a native aortic valve40for example, as described above with respect toFIGS.9A-9B, inflow support arms150″ of the type shown for prosthetic valve100d, for example, can atraumatically engage with the LVOT abutment surface, to prevent undesirable axial movement of the prosthetic valve in the proximal direction, toward the aorta50. Since it may be desired to avoid outflow support arms150′ from being aligned with native commissures of an aortic valve40, prosthetic valves100for such implantations can include outflow support arms150′ that extend solely from non-commissural support posts126, with no outflow arms extending from commissure support posts125. However, since the ventricular side of the aortic valve40does not include native leaflets or commissures, such that prosthetic valve100for such implantations can include inflow support arms150″ that extend from any support posts124, including commissure support posts125. Thus, prosthetic valve100can include a first number of outflow support arms150′ (e.g., three), and a second number of inflow support arms150″ (e.g., six).

FIG.11shows another exemplary configuration of a mechanically expandable prosthetic valve100ethat includes outflow support arms150′ and inflow support arms150″ extending from all of the support posts124, resulting, for example, in a total of six inflow support arms150″ and six outflow support arms150′, though any other number is contemplated.

When a mechanically expandable prosthetic valve100includes inflow support arms150″, they can be formed to extend from the corresponding support posts124instead of cantilevered struts134, and can be shaped and designed to support portions of inner and or outer skirts that can be coupled thereto, in a similar manner described above with respect to the cantilevers struts134. For example, skirts and/or leaflets of the prosthetic valve100can be coupled (e.g., sutured) to first arm portions152of selected or all inflow support arms150″. In some examples, as illustrated inFIG.10for prosthetic valve100d, both inflow support arms150″ and cantilevered struts134can be included. Exemplary prosthetic valve100dis shown to include three inflow support arms150″, and three cantilevers struts134intermittently disposed therebetween, together configured to support skirts and/or leaflets that can be coupled thereto.FIG.11illustrates another configuration of a prosthetic valve100ethat includes inflow support arms150″ without any cantilevered struts134, wherein some or all of the inflow support arms150″ can be configured to support skirts and/or leaflets that can be coupled thereto.

FIG.12shows a mechanically expandable prosthetic valve100that can be implanted within the mitral valve. The prosthetic valve illustrated inFIG.12is of the type of prosthetic valve100eillustrated inFIG.11, including both outflow support arms150′ and inflow support arms150″, optionally extending from all support posts124, though any other configuration is contemplated. A prosthetic valve100that includes both outflow and inflow support arms150′,150″ can be supported at opposing sides of the native valve, such as the mitral valve30. The opposing support arms150are disposed on opposite sides of the mitral annulus32, wherein the tips156of the outflow support arms150′ can atraumatically engage with the mitral ventricular abutment surface38, and the tips156of the inflow support arms150″ can atraumatically engage with the mitral atrial abutment surface36, as shown. This configuration allows the prosthetic valve100to be held securely in position without requiring a substantial radial force against the native annulus, resisting axial migration of the valve100in both directions, as the mitral annulus32is grasped between the outflow support arms150′ and the inflow support arms150″.

Conventional prosthetic valves may be appropriately sized for placement inside many native cardiac valves or orifices, such as within a native aortic annulus40. However, with larger native valves (e.g., a native tricuspid valve60or a native mitral valve30), a conventional prosthetic valve might be too small to secure into the larger annulus. In this case, the prosthetic valve may not be large enough to sufficiently expand inside and properly seal against the native the native annulus. Support arms150extending from opposing sides of the support posts124can securely grasp the native mitral annulus32, for example, between their opposingly directed tips156, such that the frame104need not rely on a pressure fit, or friction fit, between the outer surface of the valve100and the inner surface of the mitral annulus32for adequate prosthetic valve retention.

FIG.13shows another exemplary prosthetic valve100′, which can be similar to other types of prosthetic valves100described above, except that it includes an outer skirt146″ that comprises a scaling ring147. The sealing ring147desirably is sized such that when the prosthetic valve100′ is implanted in the native annulus, it completely covers any gap that may exist between the frame104and the native annulus.

The outer skirt146′ can further include a flat base layer disposed around the frame104(in a similar manner to outer skirt146ª illustrated inFIG.2A) to which the sealing ring147is attached, or can be comprised solely of the sealing ring147without including a flattened base layer. The sealing ring147can be coupled (e.g., sutured) to the frame104and/or to an inner skirt of the prosthetic valve. In some implementations, as shown, the scaling ring147can be disposed around the valve inflow end116.

The prosthetic valve100ffurther includes outflow support arms150′, such as six support arms150′ shown in the illustrated example, though any other number is contemplated. The prosthetic valve100fcan be devoid of inflow support arms150″, the role of which can be replaced by the scaling ring147.

FIG.14depicts a prosthetic valve100fimplanted in a native mitral valve30. The prosthetic valve100fis particularly suitable for deployment in a larger native annulus, such as that of the native mitral valve30, which can in some instances lack the sufficient anatomical structure to retain a typical prosthetic valve in place. This is because the outflow support arms150′ abut the mitral ventricular abutment surface38to prevent migration of the prosthetic valve100toward the left atrium12, while the sealing ring147abuts the mitral atrial abutment surface36to prevent migration of the prosthetic valve100toward the left ventricle16. Furthermore, the increased diameter of the sealing ring147can provide adequate PVL sealing, even if the prosthetic valve100fis implanted in a range of native annuluses that can be greater in size than the prosthetic valve100fdiameter.

In some implementation, such as in the illustrated example, the sealing ring147can be configured to abut the mitral atrial abutment surface36, in a manner that allows the scaling ring147to completely cover any gaps or opening between the mitral valve30and the frame104. The sealing ring147is preferably impervious to the flow of blood, allowing it to effectively block blood from flowing back into the left atrium12between outer surfaces of the prosthetic valve100′ and the native tissue, ensuring that all, or substantially all, of the blood passes through the valvular structure108from the left atrium12to the left ventricle16. In this manner, the sealing ring147can serve to better retain the prosthetic valve100′ in place against migration toward the left ventricle16, as mentioned above.

Alternatively, or additionally, the sealing ring147can be made of a relatively compressible or squeezable material, configured to have at least a portion thereof squeezed within the native annulus (e.g., the mitral annulus32), such that the sealing ring's147outer surface can conform to irregularities around the native annulus and seal it.

In some implementations, the sealing ring147includes a textured outer surface, configured to promote tissue overgrowth or thrombosis, such that over time, such tissue overgrowth can improve PVL sealing against the native tissue.

In some examples, the sealing ring147can extend radially away from the frame104to a distance of at least 2 mm, or at least 5 mm, in a free or un-squeezed state thereof. In some examples, the scaling ring147can include a compressible or squeezable insert149and a cloth cover148. For example, the squeezable insert149can be made of a silicone-based material, although other compressible materials can be used. The cloth cover148can be formed of any biocompatible fabric, such as, for example, polyethylene terephthalate or polyester fabric. In other implementations, the sealing ring147can be formed by rolling a flat sheet of cloth material to form a cylinder-like member.

While illustrated for use in a native mitral valve30inFIGS.12and14, it is to be understood that the prosthetic valve100, such as valve100eand/or100f, respectively, can be similarly implanted within a native tricuspid valve60, a dilated aortic valve, or any other enlarged orifice. Utilization of the proposed prosthetic valve100(such as valve100eand/or100f) for implantation in such enlarged native valves or orifices can advantageously provide adequate anchoring against the native tissue, as well as improved PVL sealing when including a sealing ring147, without requiring the aid of additional devices such as docking stations that can be alternatively used in such scenarios, thus simplifying the implantation procedure.

As mentioned above, conventional prosthetic valve may be appropriately sized for placement inside many native cardiac valves or orifices. However, with larger native valves, blood vessels (e.g., an enlarged aorta), grafts, etc., conventional prosthetic valves might be too small to secure into the larger implantation or deployment site. In this case, the prosthetic valve may not be large enough to sufficiently expand inside the native valve or other implantation or deployment site or the implantation/deployment site may not provide a good seat for the prosthetic valve to be secured in place.

FIG.15shows a cutaway view of a human heart with an exemplary docking station90positioned in the inferior vena cava70. A docking station90that includes a valve seat94in which a prosthetic valve96is placed, can be generally used to supplement the function of a defective tricuspid valve60and/or to prevent too much pressure from building up in the right atrium14. During systole, the leaflets of a normally functioning tricuspid valve60close to prevent the venous blood from regurgitating back into the right atrium14. When the tricuspid valve60does not operate normally, blood can backflow or regurgitate into the right atrium14, the inferior vena cava70, the superior vena cava72, and/or other vessels in the systolic phase. Blood regurgitating backward into the right atrium14increases the volume of blood in the atrium and the blood vessels that direct blood to the heart. This can cause the right atrium14to enlarge and cause blood pressure to increase in the right atrium14and blood vessels, which can cause damage to and/or swelling of the liver, kidneys, legs, other organs, etc. A prosthetic valve implanted in the inferior vena cava70and/or the superior vena cava72can prevent or inhibit blood from backflowing into the inferior vena cava70and/or the superior vena cava72during the systolic phase.

An exemplary docking station90illustrated inFIG.15can include a valve seat94and one or more retaining portions92. The valve seat94provides a supporting surface for implanting or deploying a prosthetic valve96in the docking station90after the docking station90is implanted in the circulatory system. The retaining portion92helps retain the docking station90and the valve96at the implantation position or deployment site in the circulatory system. The retaining portion92can take a wide variety of different forms. In one exemplary implementation, the retaining portion92includes friction enhancing features that reduce or eliminate migration of the docking station90. The friction enhancing features can take a wide variety of different forms. For example, the friction enhancing features can comprise barbs, spikes, texturing, adhesive, and/or a cloth or polymer cover with high friction properties on the retaining portions92.

FIG.15illustrates one example of a docking station90and prosthetic valve96deployed in the inferior vena cava70. However, it is to be understood that the docking station90and valve96can be deployed in any interior surface within the heart or a lumen of the body. When the heart is in the diastolic phase, as shown inFIG.15, the prosthetic valve96opens. Blood flows from the inferior vena cava70and the superior vena cava72, into the right atrium14. The blood that flows from the inferior vena cava70flows through the docking station90and valve96. Also, while in the diastolic phase, blood in the right atrium14flows through the tricuspid valve60, and into the right ventricle18.

FIG.16illustrates an example of a radially collapsible and expandable docking frame302of a docking station300configured for implantation in a body lumen, such as in the inferior vena cava70or the superior vena cava72of the human heart. Only half of the total circumference of the frame is illustrated inFIG.16for clarity. The docking frame302can comprise an inflow end portion304and an outflow end portion306. The docking frame302can comprise a plurality of longitudinal strut members308circumferentially spaced apart from each other around the docking frame302. The docking frame can further comprise a plurality of rows of angled struts310arranged alternatingly in a zig-zag pattern. The rows of angled struts310can be axially spaced apart from each other along a longitudinal axis of the frame.

The angled struts310are arranged such that first end portions314of the struts are coupled to longitudinal strut members308at junctions320, and second end portions316of the struts are coupled to second end portions of adjacent struts310to form “free” apices318. The apices318can be arranged in circumferential rows, each row spaced apart from the preceding and succeeding rows along the longitudinal axis C. In the illustrated example, the free apices318are oriented in the direction of the outflow end portion306, but the apices can also be oriented toward the inflow end portion304. When oriented in the downstream/outflow direction, the apices318of the struts310can engage the tissue of the inferior vena cava70and reduce or prevent downstream displacement or migration of the docking frame302post-implantation. In certain embodiments, the orientation of the apices318in the downstream direction (and the lack of apices oriented in the upstream direction) can also facilitate proximal/upstream motion of the frame through the inferior vena cava70, allowing recapture of the frame and/or retrieval/removal of the docking station from the patient in certain implementations.

As noted above, the docking station300can be radially collapsed to a collapsed or crimped configuration for delivery to the treatment site through a patient's vasculature. In certain implementations, the docking frame302can be made of a shape memory material, such as the nickel titanium alloy (Nitinol), Elgiloy, stainless steel, or combinations thereof, that allows the frame to be compressed to a reduced diameter for delivery in a delivery apparatus and then causes the frame to expand to its functional size inside the patient's body when deployed from the delivery apparatus. In certain examples, the docking frame302can be configured as a plastically-expandable or balloon-expandable frame adapted to be crimped onto an inflatable balloon or other expansion mechanism of a delivery apparatus and expanded to their functional size by. Such plastically expandable or ductile materials include nickel-chromium alloys, stainless steel, etc.

The outflow end portion306can comprise a plurality of struts322coupled to junctions320of an outflow row of struts312. The struts322that can extend in a downstream direction, and can be angled radially inwardly toward the longitudinal axis C. More particularly, the struts322can comprise first portions324coupled to the junctions320and angled inwardly toward the longitudinal axis, and second portions326extending from the first portions324parallel, or substantially parallel, to the longitudinal axis C. The second portions326of the struts322can thereby define a valve-receiving portion or valve seat generally indicated at328, which can be coaxial with the docking frame302and configured to receive a prosthetic valve. The valve seat328can have a diameter which is less than the diameter of the main body of the docking frame302. The second portions326of the struts322can further comprise one or a plurality of apertures or openings, such as openings330and332spaced apart along the portions326. In certain examples, the free end portions (e.g., at332) of the struts322can define a downstream-most end of the frame.

In some examples, the struts310of the outflow row312can further comprise struts334extending from apices318and curving radially inwardly. The end portions of the struts334can comprise openings335, and can define a diameter that is less than the diameter of the main body of the docking frame302and greater than the diameter of the valve seat328.

In certain examples, a scaling member can be disposed on the outflow end portion306, such as the representative sealing member336shown inFIG.17. In certain examples, the scaling member336can cover at least a portion of the exterior surfaces of struts322, the struts310of the outflow row312, and the struts334. In certain examples, the sealing member336can comprise an inner portion disposed radially inwardly of the struts322and coupled to the struts322(e.g., by suturing), an outer portion covering outer surfaces of the struts322, the struts310of the outflow row312, and the struts334, and an intermediate portion extending between the inner portion and the outer portion, although the scaling member may have any configuration that facilitates sealing between a prosthetic valve and the valve seat328, and/or between the outer surface of the docking frame302and the surrounding anatomy at the outflow end portion of the frame. The sealing member336can be coupled/secured/attached to the docking frame302for example, by suturing through the various strut openings319,335,330,332, and/or the openings in apices318of the struts of the outflow row312.

In certain examples, various components of the sealing member336can be made from any of various materials, such as woven or non-woven fabrics, polymeric laminate materials, composite materials, etc. For instance, the various portions364-370of the sealing member can comprise, for example, woven fabrics comprising any of a variety of synthetic/polymeric and/or natural fiber materials, such as polyethylene terephthalate (PET) fabric (e.g., DACRON®), polyester fabric, polyamide fabric, Nylon, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), ultra-high molecular weight polyethylene (UHMWPE) (e.g., DYNEEMA®), polypropylene, cotton, combinations thereof, etc. In certain examples, any or all of the portions of the sealing member436can also comprise a film including any of a variety of crystalline or semi-crystalline polymeric materials, such as polytetrafluorcthylene (PTFE), PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc. In this manner, the scaling member336can be relatively thin and yet strong enough to allow it to be sutured to the frame302, and to allow a prosthetic valve to be expanded against it, without tearing.

The first portion364can be positioned within the outflow end portion306of the frame302. The central portion366can be positioned within the valve seat328defined by the strut members322. The scaling member336can be folded over the outer aspect of the frame302such that the sealing member extends over or covers the struts322, the struts334, the valve seat328, and covers the outflow row312of struts310. Thus, the fourth portion370can be positioned against the radially outward surface of the frame302, terminating at a scaling member inflow end388defined by the outer portion (i.e., fourth portion370) of the scaling member, opposite to an outflow end390of the sealing member, defined as the portion of the scaling member disposed over the outflow end portion306of the frame302.

Previously disclosed docking stations, including docking station300of the type described above with respect toFIGS.15-17, include a valve seat (e.g., valve seat328) defining an inner diameter configured to provide retention force when a prosthetic valve is deployed therein. Additional examples of docking stations can be found in International Application No. PCT/US2021/046207 and U.S. Publication No. 2019/0000615, which are incorporated by reference herein.

FIG.18shows an exemplary prosthetic valve100gthat includes outflow support arms150′ and inflow support arms150″. A radial gap G can be defined as the radial distance between the tip156and the frame104, and in particular, the tip156and the base151of the corresponding arm150, in a free (i.e., unconstrained) state of the arm. In some implementations, the prosthetic valve100gincludes differently sized outflow support arms150gand inflow support arms150h. The outflow support arms1508defined a radial gap G1, while the inflow support arms150hdefine a gap G2that is greater than G1.

FIG.19shows a prosthetic assembly400that includes the prosthetic valve100gmounted in the docking station300. While the valve seat diameter is configured to accommodate deployment of the frame104therein, the gaps G1are sized to allow the outflow support arms1508to abut or rest over the sealing member outflow end390, for example such that the first portions1528are disposed over the outflow end390while the tips156gcan be disposed distal to the sealing member outflow end390, over an outer surface of the sealing member336. The greater gaps G2are sized to allow the inflow support arms150fto abut or rest over the inflow end388of the sealing member336, for example such that the first portions152hare disposed over the inflow end388while the tips156hcan be disposed proximal to the inflow end388, over an outer surface of the scaling member336. This configuration advantageously prevents spontaneous or otherwise undesired axial displacement of the prosthetic valve100within the valve seat328of the docking station300, thus providing additional retention force to the valve100within the docking station300.

FIGS.20A-20Billustrate another example of a prosthetic valve500, which can be similar to prosthetic valve100described above with respect toFIGS.2A-2D, with like numbers referring to like components, except that prosthetic valve500includes support arms550that extend from an end of corresponding openings590formed within a vertical posts522, such as non-commissural support posts526. Specifically, a mechanically expandable prosthetic valve500can include an annular frame504and a valvular structure108supported within and coupled to the frame504, as shown inFIG.20A. Though not illustrated with the skirt for sake of clarity, it is to be understood that a prosthetic valve500can further include any of the skirts described above, including skirt146adescribed above in conjunction withFIG.2A, or skirt146fdescribed above in conjunction withFIGS.13-14.

The frame504has an inflow end516and an outflow end520, and includes a plurality of support posts524and actuation posts528that can be arranged in an alternating manner along the circumference of the frame504. The frame504further includes angled struts532extending circumferentially between adjacent vertical posts522. Specifically, angled struts532circumferentially extend between support posts524and actuation posts528and interconnect the support posts524and actuation posts528. The angled struts532, support posts524, and actuation posts528, define cells536of the frame504. As illustrated, the angled struts532can have a curved shape. As shown, the actuation posts528are arranged in pairs, each pair including an upper post member560and a lower post member564which can be axially aligned with each other, and each pair of actuation posts528can be connected, such as via angled struts532, to a commissure support post525on one side thereof, and to a non-commissural support post526on the other side.

Support posts524can include commissure support posts525, which include commissure windows540configured to support commissures144attached thereto, and non-commissural support posts526, which include post openings590. The commissure support posts525and non-commissural support posts526can be arranged in an alternating manner along the circumference of the frame504. In the illustrated example, frame504includes a total of six support posts524, three of which are commissure support posts525and three of which are non-commissural support posts526.

One or more of the support posts524can further include cantilevered struts534extending to the inflow end516of the frame504. In some examples, the cantilevered struts534can extend such that distal ends of the cantilevered struts534align with or substantially align with the inflow end516of the frame504.

Each support post524, including any commissure support posts525or non-commissural support post526, extends between a post inflow end580which is closer to the inflow end516of the valve500, and a post outflow end582which is closer to the outflow end520of the valve500. Two angled struts532intersect with each support post524at a post inflow end580, which is circumferentially disposed between two adjacent inflow apices514, such that a corresponding cantilevered strut534can extend distally from the post inflow end580. Similarly, two angled struts532intersect with each support post524at a post outflow end582, which is circumferentially disposed between two adjacent outflow apices518.

As further shown, each commissure support post525and each non-commissural support post526also intersects, at a middle portion thereof, with four additional angled struts532extending from adjacent upper post members560and lower post members564on both sides, resulting in each support posts524, and specifically, each commissure support post525and each non-commissural support post526, intersecting with a total of at least eight curved struts extending from adjacent actuation posts528.

In one example, the frame504can be adjusted between a radially expanded configuration and a radially compressed configuration by deflecting the angled struts532. In one example, the frame504(e.g., the posts and struts) can be made of biocompatible plastically-expandable materials that will allow the frame504to be adjusted between the radially expanded configuration and radially compressed configuration. Suitable examples of plastically-expandable materials that can be used in forming the frame504include, but are not limited to, stainless steel, cobalt chromium alloy, and/or nickel titanium alloy (which can also be referred to as “NiTi” or “nitinol”).

In some examples, one or more actuators570can be coupled to the actuation posts528, and used to adjust the frame504between the radially expanded configuration and the radially compressed configuration. In one example, each actuation post528can include an upper post member560and a lower post member564(the terms “upper” and “lower” are relative to the orientation of the prosthetic valve500inFIGS.20A-20B) aligned with the longitudinal axis of the valve and having opposing ends separated by a gap. The respective actuator570can be coupled to the post members560,564and operable to increase or decrease the gap therebetween in order to radially compress or expand the frame504. Angled struts532can converge with upper post members560to define outflow apices518at the outflow end520. Angled struts532can similarly converge with lower post members564to define inflow apices514at the inflow end516.

In one example, the actuator570can include an actuator rod572with an attached actuator head. In the example illustrated inFIGS.20A-20B, the actuator rod572extends through or into the post members560,564and across the gap therebetween. In the example illustrated inFIGS.20A-20B, the actuator rod572is inserted into the upper post member560from the outflow end520, and the actuator head (hidden from view inFIGS.20A-20B) can be disposed or retained at the outflow apex518of the upper post member560.

In some examples, the actuator rod572is externally threaded. As illustrated inFIGS.20A-20B, the lower post member564can include a nut576with an internal thread to threadedly engage the actuator rod572. In this case, the actuator rod572can be axially translated by rotating the actuator rod572relative to the nut576. In some examples, the actuator rod572can be freely slidable relative to the upper post member560. In other examples, the actuator rod572can threadedly engage the upper post member560.

In one scenario, the actuator rod572can be rotated in a first direction to move the upper post member560towards the lower post member564and thereby decrease the size of the gap therebetween, which can have the effect of radially expanding the frame504. In another scenario, the lower post member564may be held steady while the actuator rod572is rotated in a second direction to move the upper post member560away from the lower post member564and thereby increase the size of the gap therebetween, which can have the effect of radially compressing the frame504.

The actuator rod572also can include a stopper578(e.g., in the form of a nut, washer or flange) disposed thereon. The stopper578can be disposed on actuator rod572such that it sits within the gap therebetween. Further, the stopper578can be integrally formed on or fixedly coupled to the actuator rod572such that it does not move relative to the actuator rod572. Thus, the stopper578can remain in a fixed axial position on the actuator rod572such that it moves in lockstep with the actuator rod572.

When the actuator rod572is rotated in a direction configured to collapse the prosthetic valve, the stopper578moves toward the outflow end520of the frame until the stopper578abuts the inflow end of the upper post member560. Upon further rotation of the actuator rod572, the stopper578can apply a proximally directed force to the upper post member560to radially compress the frame504. Specifically, during crimping/radial compression of the prosthetic valve500, the actuator rod572can be rotated in a direction that causes the stopper578to push against (i.e., provide a proximally directed force to) the inflow end of the upper post member560, thereby causing the upper post member560to move away from the lower post member564, and thereby axially elongating and radially compressing the prosthetic valve500.

In an alternative implementation, some of the actuator rods572can be rotated in one direction while the other actuator rods572are rotated in an opposite direction simultaneously to cither radially expand the frame or radially compress the frame. This counter-rotation of the actuator rods can be used to help reduce the likelihood of the entire frame504rotating about its central longitudinal axis during rotation of the actuator rods572about their respective axes (e.g., when radially expanding the frame504).

Each angled strut532can have a width W1in the lateral or circumferential direction, which is less than the width of any of the vertical posts. Specifically, each support post524can have a width W2, which is greater than the width W1of the angled struts. Since commissure support posts525can include commissure window540, and non-commissural support posts526can include post openings590, the width W2can be selected to accommodate commissure windows540and post openings590in the respective support posts524. The actuation posts528, including any upper post member560and lower post member564, define a width W7, which can be similar to, or different from, the width W2, but will also be greater than the width W1of the angled struts. Actuation posts528will be relatively wider than angled struts as they include bores through which actuation rods572can extend. One or more of the actuation posts528can also include a post opening590, in which case the width W7can be selected to accommodate post openings590in the respective actuation posts528.

Each post opening590can extend from an opening inflow end592, which is the end closer to the post inflow end580, and an opening outflow end594, which is closer to the post outflow end582. The post opening590can define a width W4in the lateral or circumferential direction, which is less than the width W2, such that the difference between W2and W4defines the width of the sidewalls of a post opening590comprised in a support post524. In some examples, the width W2is greater than the width W4by at least 10%. In some examples, the width W2is greater than the width W4by at least 20%. In some examples, the width W2is greater than the width W4by at least 30%. In some examples, the width W2is greater than the width W4by at least 50%. In some examples, the width W2is greater than the width W4by at least 70%. In some examples, the width W2is at least two times greater than the width W4.

In a similar manner, the width W4can be less than the width W7, such that the difference between W7and W4defines the width of the sidewalls of a post opening590comprised in an actuation post528. In some examples, the width W7is greater than the width W4by at least 10%. In some examples, the width W7is greater than the width W4by at least 20%. In some examples, the width W7is greater than the width W4by at least 30%. In some examples, the width W7is greater than the width W4by at least 50%. In some examples, the width W7is greater than the width W4by at least 70%. In some examples, the width W7is at least two times greater than the width W4.

A prosthetic valve500further includes one or more support arms550extending from vertical posts522, such as support posts524and/or actuation posts528. Unlike support arms150of prosthetic valve100described above, a support arm550does not extend from an end of a support post, such as a post outflow end or a post inflow end, but rather from an end of a post opening590. In the examples illustrated inFIGS.20A-20B, a prosthetic valve500ª is shown to include three support arms550ª extending from opening outflow ends594of post opening590formed in outflow portions of non-commissural support posts526. While three support arms550are shown in the illustrated example, it is to be understood that any other number of support arms is contemplated, such as a single support arm, two support arms, or more than three support arms.

A support arm550can be cut from a corresponding vertical post522, wherein the cutting edges form the resulting post opening590. Specifically, a support arm550can be formed by cutting an appropriate longitudinal portion (e.g., laser cutting) through the thickness of the vertical post522along a circumference that spans three sides the arm550, while leaving one side of the arm uncut or intact. The uncut end of the arm550forms the base551of the arm550, at which it integrally extends from the corresponding uncut end of the post opening590. In the illustrated example, an uncut base551of the arm550is shown at the opening outflow end594, such that the support arm550distally extends from the opening outflow end594toward the opening inflow end592, terminating with a free-ended cut tip556in the vicinity of the opening inflow end592.

Since the support arm550is cut from the vertical post522, it is aligned with the respective resulting post opening590, such that the length of the arm550(defined between the base551and tip556) is equal to or shorter than the length of the post opening590(defined between the opening inflow end592and opening outflow end594). The arm can define a width W5, which can be similar to or less than the width W4of the post opening590it is cut from. As described above with respect to tips156of support arms150, the tip556is preferably atraumatic to avoid damaging abutment surfaces it is configured to contact or rest on. For example, the tip556may have a smooth contact surface that may be flattened or curved and is not configured to penetrate the tissue it is configured to contact and/or rest on. The tip556can be covered in some implementations. In some examples, the tips556can be configured to be flexible to allow for reduction of possible trauma to the tissue upon contact. In the illustrated example, the tip556is shown to be rounded, optionally formed to define a diameter or width W6which can be slightly greater than the width W5of the rest of the arm550. However, since any portion of the support arm550is cut from the respective support post, even for a wider tip556, the width W6will be similar to or less than the width W4or the corresponding post opening590. It is to be understood that any of the support arms150disclosed hereinabove, can be optionally equipped with similarly formed wider tips156.

After being cut from the respective vertical post, the support arm550can be shape-set (e.g., heat set) to deflect at an angle radially away from the rest of the frame504, resulting in the tip556being biased radially away and spaced away from the frame504(or from the respective post opening590) in a free state of the support arm550, as shown inFIG.20Bfor example.

As mentioned, a prosthetic valve500can include any number of support arms550. Thus, the plural use of the term “support arms550” is not meant to be limiting, and may refer to implementation in which a single support arm550is included. For example, a prosthetic valve500can include any number of support arms, such as three support arms as shown inFIGS.20A-20B, more or less than three arms, or even a single support arm550that can extend, for example, from an opening outflow end594of one of the non-commissural support posts526.FIG.21shows exemplary support arms550that can extend from post openings590formed in various vertical posts522.

Support arms550can extend from support posts524, as shown for support arms550aand550bextending from non-commissural support post525and support arms550cextending from commissure support posts525. Support arms550can similarly extend from actuation posts528, as shown for support arms550cextending from upper post members560and support arms550dextending from lower post members564.

As shown inFIG.21, a prosthetic valve500can include outflow support arms550′ outflow support arms550′ extending downwardly from post openings590formed in upper portions of vertical posts522(i.e., toward the inflow end516), and inflow support arms550″ extending upwardly from post openings590formed in lower portions of vertical posts522(i.e., toward the outflow end520). Upper post openings590are formed closer to respective post outflow ends582, as shown for post openings550a, or closer to respective outflow apices518, as shown for post opening590c, in which case the support arms550integrally extend from the respective opening outflow ends594. Lower post openings590are formed closer to respective post inflow ends580, as shown for post openings550band550c, or closer to respective inflow apices516, as shown for post opening590d, in which case the support arms550integrally extend from the respective opening inflow ends592.

Outflow support arms550′ will generally extend only from non-commissural support posts526or lower post members564, since commissure support posts525include commissure windows540at this level of the frame504. However, inflow support arms550″ can extend from either type of vertical posts, including lower post members564, non-commissural support posts526, and/or commissure support posts525. Any combination of outflow support arms and/or inflow support arms described above with respect to prosthetic valve100, can be implemented in prosthetic valve500, with the exception of outflow support arms550′ that cannot extend from commissure support posts525. It is to be understood that the various types and positions of support arms550a,550b,550c,550dand550eare illustrated together inFIG.21for the sake of illustration and not limitation, and that any type and position of support arms can be used alone or in combination with any other type or position of the arms.

FIG.22shows a prosthetic valve500ofFIGS.20A-20Bwith self-expandable support arms550retained in an undeployed state within a capsule210. While illustrated to be retained in a crimped state within a capsule210, it is to be understood that the same configuration applies to a delivery apparatus that does not necessarily include a capsule, in which case the valve500can be similarly retained within a distal portion of a shaft of the delivery apparatus, such as the outer shaft208. The actuator assemblies220, which can be coupled to the prosthetic valve500during delivery, as well as actuators570and soft components of the valve500, are removed from view inFIG.22for clarity.

As shown, during delivery, the support arms550can be pressed radially inward into their respective post opening590. This configuration can be advantageous over other types of arms which are folded in a crimped configuration between the frame and the capsule, since the arms550can be completely flush with the outer surface of the rest of the frame504(and in particular, an outer surface of the respective support post), without affecting overall crimped profile of the valve during delivery. When the support arms550are freed from the capsule210during deployment of the prosthetic valve500, they spring outwardly to their pre-formed shape, as shown inFIG.20B.

FIG.23A-23Bshow stages of an exemplary method for implantation of a prosthetic valve500aof the type shown inFIGS.20A-20Bwithin a native aortic annulus42. For simplicity, soft components, such as a valvular structure or a skirt, are not shown. The prosthetic valve500can be coupled to a delivery apparatus202, which can be used to deliver, position, and secure the prosthetic valve500in a native heart valve annulus. In the illustrated implantation procedure, the prosthetic valve500is implanted in a native aortic annulus42using a transfemoral delivery approach. In other examples, the prosthetic valve500can be implanted at other locations (e.g., a mitral valve, a tricuspid valve, and/or a pulmonary valve), within previously-implanted prosthetic valve, and/or using other delivery approaches (e.g., transapical, transaortic, transseptal, etc.).

The prosthetic valve500can be releasably coupled, as described above, to the actuator assemblies220of delivery apparatus202, and advanced in a compressed state through the patient's vasculature toward the site of implantation (e.g., the aortic annulus). Upon reaching the site of implantation, the prosthetic valve500can be deployed by pushing it distally out of the capsule210and/or outer shaft208, or by proximally pulling the capsule210and/or outer shaft208relative to the prosthetic valve500, which allows the support arms550to spring out radially outward, distancing the tips556from the corresponding post opening590and the rest of the frame504as described above with respect toFIG.22, for example. The actuation assemblies220can then be utilized, as described above, to radially expand the prosthetic valve500, at least to a partially expanded diameter, as shown inFIG.23A.

As mentioned above with respect to mechanically expandable valve100, the feasible controlled gradual expansion of a mechanically expandable prosthetic valve500can be taken advantage of for properly positioning the support arms550in a desired orientation, relative to the native anatomy. For example, as shown inFIG.23A, actuator assemblies220can be utilized to partially expand the prosthetic valve500to a partially expanded diameter, which is greater than the crimped diameter but less than the final functional diameter, such that the frame504, and optionally even the support arms550, are not yet immovably pressed within the native annulus. This allows the prosthetic valve500to be angularly oriented to a desired angular orientation, for example with respect to the aortic leaflets44.

As shown inFIG.23A, when the prosthetic valve500is deployed within the native aortic valve40, the support arms550can be positioned over and/or around the aortic leaflets44. As shown inFIGS.20A-20B, a prosthetic valve500can include a total of six support posts524, three of which are commissure support posts525to which commissures144are coupled, and three of which are non-commissural support posts526disposed between the commissure support posts525. In one configuration, the prosthetic valve500can include one or more (e.g., three as in the illustrated examples) support arms550integrally formed with non-commissural support posts526and extending from opening outflow ends594of corresponding post opening590, while the commissure support posts525remain devoid of support arms. When implanted in a native aortic valve40, it may be desired to position the support arms550over the native aortic leaflets44between the native commissures, such that the tips556can abut aortic root abutment surface46instead of contacting the native commissures.

The term “integral” or “integrally formed”, as used herein, refers to a construction of a component that does not include any welds, fasteners, adhesives or other means for securing separately formed pieces of material to each other. For example, an integrally formed support arm550is formed directly as a partially cut portion of a vertical post522, rather than being separately formed and subsequently attached to the support post.

The prosthetic valve500can be deployed out of the capsule at a position which is proximal to the native aortic leaflets44, allowing the support arms550to spring radially outwards, after which the prosthetic valve500can be distally advanced to position the native aortic leaflets44between the frame504and the support arms550. Partial expansion of the prosthetic valve500can be performed upon deployment, prior to axial advancement, and/or during and/or after axial advancement of the valve500. In the partially expanded diameter of the prosthetic valve500, shown inFIG.22A, it can be angularly reoriented, if needed, to align the commissures144of the prosthetic valve500with the native commissures between the native aortic leaflets44.

Further expansion of the prosthetic valve500to the functional size, which can be optionally accompanied by further axial displacement relative to the native aortic annulus42, serves to anchor the prosthetic valve500in position, wherein the support arms550may press against the native annulus for migration resistance. For example, the tips556can rest over the aortic root abutment surface46, so as to resist unintentional distally oriented migration of the prosthetic valve500toward the left ventricle16.

In some cases, the support arms550can extend around native leaflets and potentially grasp the native leaflets, as shown inFIG.23B. For example, when the prosthetic valve100is further expanded by the actuator assemblies220from the partially expanded diameter shown inFIG.23Ato the desired functional diameter shown inFIG.23B, the support arms550can be pressed between the surrounding aortic wall and the expanded frame504, grasping portions of the native aortic leaflets44between the support arms550and the frame504. The frame504and at least some portion of the support arms550, such as the tips556, can approximate each other in such procedures, optionally pinching the native leaflets44therebetween. Since the support arms550are aligned with corresponding post opening590, portion of the native leaflet tissue can be pressed by the arms550into the post opening590, which can improve securement of the prosthetic valve500to the leaflets44. In some cases, the native leaflets44can be bunched up between the support arms550and the rest of the frame504. This can also provide for greater securement of the prosthetic valve500to the leaflets44, which may be specifically advantageous in some pathologies, such as Aortic Insufficiency, in which the native leaflets44do not include sufficient internal calcifications to warrant proper retaining force of a prosthetic valve pressed there-against. In alternative implementations, the support arms550do not necessarily hook the native leaflets.

While optional angular orientation of the prosthetic valve500is described above, in a partially expanded state thereof, it is to be understood that in alternative implementations, as described with respect to prosthetic valve100, active angular orientation may not be required, relying on the natural tendency of the support arms550to slip along the native leaflets44to a position between the native commissures, during continuous expansion of the valve500. In such implementations, the mechanical expansion mechanism of a mechanically expandable prosthetic valve500is still advantageous in that it allows sequential controlled expansion of the valve500at a rate that will allow the support arms550to be self-oriented to the proper positions along the native aortic leaflets44, whereas abrupt expansion of conventional self-expandable valves, for example, may result in a less desirable outcome with respect to the position of the support arms550relative to the native anatomy.

Utilization of support arms550engaged with portions of the native tissue, such as annular abutment surfaces and/or native leaflets, can advantageously prevent or reduce the prevalence of axial movement of the prosthetic valve500in a direction opposite to the side the arms550extend from, and can also help ensure that the prosthetic valve500is perpendicular to the annulus and prevents undesirable “rocking” or tilting of the frame. By engaging the native annulus, and optionally the native leaflets, the support arm can assist in more evenly distributing the load to achieve equilibrium, thus providing a more robust implantation.

In some implementations, the radial gap formed between the tips556and the post opening590is configured to allow the support arms550to cover the native aortic leaflets44during gradual controlled expansion of the prosthetic valve500. When further utilized to accommodate native aortic leaflets44therein, the native leaflets can be folded, for example by first arm portions552of the support arms550, toward the native aortic annulus42, distancing them away from the coronary arteries24to avoid obstruction of the ostia of the coronary arteries24. Native leaflets bunched up within support arms550can also improve PVL scaling around the frame504.

After reaching the final functional expanded diameter, the actuator assemblies220can be uncoupled from the actuators570and the delivery apparatus202can then be withdrawn from the patient's body, leaving the prosthetic valve500within the aortic annulus42to regulate blood flow from the left ventricle16into the aorta50. While illustrated for use in a native aortic valve40inFIGS.23A-23B, it is to be understood that a mechanically expandable prosthetic valve500with support arms550can be similarly implanted within a native tricuspid valve60, a native mitral valve30valve, or any other orifice.

FIG.24illustrates another exemplary prosthetic valve500b, which can be similar to prosthetic valve500a, except for including support arms550bthat extend from opening outflow ends594of post opening590formed in inflow portion of vertical posts522, such as non-commissural support posts526.FIGS.25A-25Bshow stages of an exemplary method for implantation of a prosthetic valve500bof the type shown inFIG.24within a native aortic annulus42, which can be similar to the method described above in conjunction withFIG.23A-23B, except that the lower (i.e., more distal) position of the support arms550bis adapted to allow better positioning of a prosthetic valve500hin a higher position relative to the annulus42(such as for supra-annular implantation procedures).

While support arms550aare shown to extend from post opening590formed at the outflow portion of vertical posts522, and support arms550bare shown to extend from post opening590formed at the inflow portion of vertical posts522, it is to be understood that the position in which post openings590are formed, with corresponding support arms550extending therefrom, can be along any other portion of the vertical post522, including at a mid-portion of the vertical post. Moreover, while three support arms550bextending in a distal direction from opening outflow ends594of post opening590formed in inflow portions of non-commissural support posts526are illustrated, it is to be understood that any number of distally-oriented support arms550can extend from opening outflow ends594of post openings formed in any other type of vertical posts, such as location similar to those illustrated inFIG.21for posts openings590band590ealong inflow portions of lower posts members564and commissure support posts525, respectively.

WhileFIGS.20A-20Billustrate an exemplary prosthetic valve500awith distally-extending support arms550aextending solely from opening outflow ends594of post opening590formed in outflow portions of vertical posts522, andFIG.24illustrates an exemplary prosthetic valve500bwith distally-extending support arms550bextending solely from opening outflow ends594of post opening590formed in inflow portions of vertical posts522, it is to be understood that any vertical posts522can include more than one distally extending support arm550, each extending from an opening outflow end594of post openings formed at different axial positions along the vertical posts. For example, at least one non-commissural support post526can include one support arm550adistally extending from an opening outflow end594of a post opening590formed in its outflow portion, and another support arm550bdistally extending from an opening outflow end594of a post opening590formed in its inflow portion. Such a combination can allow the prosthetic valve500to be axially positioned at any suitable position within the patient's annulus, depending on patient-specific native anatomy, with the appropriate set of support arms disposed over the native leaflets and clamped thereover.

While some types of a prosthetic valves500is illustrated inFIGS.23A-23B and25A-25Bfor implantation in an aortic annulus, it is to be understood that prosthetic valve500can be implanted in any other native orifice or annulus, including according to the implantation procedures and configurations described above in conjunction with any ofFIGS.12and14, and can be mounted within a docking station300in a similar manner to that described above in conjunction withFIGS.18-19, mutatis mutandis.

Some Examples of the Disclosed Technology

It is appreciated that certain features of the disclosed technology, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosed technology, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosed technology. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.