Patent Publication Number: US-2023157823-A1

Title: Implantable device and delivery system for reshaping a heart valve annulus

Description:
RELATED APPLICATIONS 
     This application is a continuation application of U.S. Serial No. 16/546,737, filed Aug. 21, 2019, which is a continuation of U.S. Serial No. 15/352,288, filed on Nov. 15, 2016, which claims the benefit of priority under 35 U.S.C. § 119(e) to 62/256,660, filed Nov. 17, 2015, the entire disclosures of which are hereby incorporated by reference in their entireties. 
     INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
     Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. For example, this application claims the benefit of priority under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 62/256,660 entitled “MITRAL VALVE” and filed on Nov. 17, 2015, the entire disclosure of which is incorporated herein by reference for all purposes and forms a part of this specification. 
     BACKGROUND 
     Field 
     In general, features related to implantable medical devices are described. For example, heart valve medical devices and delivery and positioning systems for implanting various devices are described. 
     Description of the Related Art 
     Heart valve incompetency is a serious problem. For example, heart disease can cause the chambers of the heart to expand and weaken. With specific reference to the mitral valve, as a result of aging or disease, the left ventricle dilates and the papillary muscles are displaced. Consequently, the annulus of the mitral heart valve dilates excessively. In this state of dilation, valve leaflets no longer effectively close, or coapt, during systolic contraction. Consequently, regurgitation (i.e. retrograde flow back across the valve that should be closed) of blood occurs during ventricular contraction. Cardiac output is thus decreased. 
     This condition is typically addressed by the surgical implantation of an annuloplasty ring. A surgeon positions the annuloplasty ring proximate the valve annulus and sutures it in place thereby restoring the valve annulus to approximately its native configuration. The valve leaflets can now function normally again. 
     This procedure is invasive as it is performed open chest and is also time consuming. In open heart surgery, the patient is put on cardiopulmonary bypass with its associated risks of morbidity and mortality due to stroke, thrombosis, heart attack and extended recovery time. 
     There is, therefore, a need for less invasive and more efficient solutions to these problems that avoid the aforementioned drawbacks. 
     SUMMARY 
     The embodiments disclosed herein each have several aspects no single one of which is solely responsible for the disclosure’s desirable attributes. Without limiting the scope of this disclosure, its more prominent features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the embodiments described herein provide advantages over existing systems, devices and methods. 
     The following disclosure describes non-limiting examples of some embodiments. For instance, other embodiments of the disclosed systems and methods may or may not include the features described herein. Moreover, disclosed advantages and benefits can apply only to certain embodiments of the invention and should not be used to limit the disclosure. 
     Systems, devices and methods for a heart valve implant and related delivery systems are described. The implant is intended to be delivered in a minimally invasive percutaneous manner, such as transfemorally, transeptally, or transapically. The implant may instead be implanted surgically, in that it should reduce the duration of the procedure and, more particularly, the duration that the patient is on bypass. The development can be directed to mitral valve or tricuspid valve procedures. 
     The development relates to the implant and delivery systems, and associated methods of use of each. The implant contracts to a first configuration, such as a delivery configuration, having a first diameter for delivery via a delivery catheter. The implant is capable of expanding out to a second configuration, such as a tissue engaging configuration (and/or anchored configuration), having a second diameter larger than the first diameter to match the width of a dilated annulus of a heart valve. The implant engages the tissue of the heart valve annulus and then contracts to a third configuration, such as an annulus remodeling diameter, having a third diameter that is smaller than the second diameter, thus gathering and cinching in the dilated annulus to decrease the width of the dilated annulus. 
     The implant includes a tubular frame with moveable struts, where pairs of adjacent struts form apices. The apices have collars at least partially surrounding the apex. After engaging heart valve annulus tissue with the implant, the collars can be moved along the apex, e.g. downward or upward along the apex, to decrease the angle between the adjacent struts, causing the tubular frame to contract in width. This pulls the tissue of the heart valve annulus closer together. The implant thus reconfigures the valve annulus down to a smaller diameter, reducing and/or eliminating problems associate with the valve, such as regurgitation. 
     A delivery system and associated methods are also disclosed that comprise a catheter and imaging and positioning features to maneuver the distal end of the catheter and the device into the desired position above and proximate the heart valve annulus. Transeptal delivery may be used, for example, with procedures involving the mitral valve. The delivery system can be used with the implant described herein as well as other implantable devices. 
     Moreover, the development also provides an artificial heart valve with a modified ring-like structure that not only provides for reduction of the heart valve annulus, but also displaces or replaces one or more defective heart valve leaflets. The artificial valve may include the various implant devices described herein having the one or more leaflets attached thereto. 
     In particular, in one aspect, an implant for reducing heart valve regurgitation is described. The implant comprises a frame, a plurality of anchoring members and a plurality of collars. The frame has upper crowns, lower crowns and struts between the upper and lower crowns. The frame has a tissue engaging configuration having a tissue engaging diameter, and an annulus remodeling configuration where the frame has an annulus remodeling diameter that is less than the tissue engaging diameter. The plurality of anchoring members are coupled with the lower crowns of the frame for engaging cardiac tissue proximate the heart valve annulus. The plurality of collars are coupled with the upper crowns of the frame, wherein when force is applied to the collars, the collars slide along the upper crowns and the struts to move the frame from the tissue engaging configuration towards the annulus remodeling configuration. 
     In some embodiments, the plurality of anchoring members are helically wound anchoring members and the lower crowns of the frame are adapted to threadingly receive the helically wound anchoring members. The helically wound anchoring members may further include anchoring heads for engagement with actuators to rotationally advance the helically wound anchoring members in the cardiac tissue to anchor the frame into the cardiac tissue. The implant may further comprise abutments on each of the anchor heads to engage with the struts and the lower crowns to limit travel of the helically wound anchoring members. The helically wound anchoring members may have sharpened tips to facilitate penetration of the helically wound anchor members into the cardiac tissue. 
     The implant may further comprise at least one tab on each of the collars, with the tabs inwardly biased to engage with the upper crowns when the collars are slid over the upper crowns and struts. The implant may further comprise a groove formed on an outwardly facing side of the upper crowns and at least one tab on each of the collars with the tabs inwardly biased to engage with the groove. Each of the collars may comprise a plurality of the tabs, and the plurality of tabs can be advanced over the upper crowns and struts to selectively vary the annulus remodeling diameter of the frame. The plurality of tabs may be vertically disposed on an outwardly facing portion of the collars and comprise a lowermost tab, with the lowermost tab initially disposed and engaged with an underside of the upper crown. 
     The implant may further comprise a plurality of pusher members that engage with the plurality of collars to forcibly advance the collars over the upper crowns and struts to reduce the diameter of the frame. 
     The implant may further comprise flex sections on the collars to facilitate advancement of the collars over the upper crowns and struts. 
     The frame may define a longitudinal axis, and the lower crowns and anchoring members received in the lower crowns may be inclined outwardly in a distal direction at an angle between about 30° to about 60° with respect to a portion of the axis that extends distally below the implant. 
     In another aspect, a delivery system for delivering an implant for reducing heart valve regurgitation is described. The delivery system comprises the implant, a delivery catheter, and an imaging catheter. The implant comprises a frame, a plurality of anchoring members and a plurality of collars. The frame has upper crowns, lower crowns and struts between the upper and lower crowns, and a tissue engaging configuration with a tissue engaging diameter and an annulus remodeling configuration where the frame has an annulus remodeling diameter less than the tissue engaging diameter. The plurality of anchoring members are coupled with the lower crowns of the frame for engaging cardiac tissue proximate the heart valve annulus. The plurality of collars are coupled with the upper crowns of the frame, and when force is applied to the collars, the collars slide on the upper crowns and the struts to move the frame from the tissue engaging configuration towards the annulus remodeling configuration. The delivery catheter is releasably attached to the implant and is configured to deliver the implant to a position proximate the heart valve annulus. The imaging catheter comprises a distal end configured to extend proximate the heart valve annulus and to capture one or more images therein of the position of the implant relative to the heart valve annulus. 
     In some embodiments, the delivery system further comprises a plurality of actuating members for engaging corresponding anchoring members of the implant to cause the anchoring members to penetrate and advance into the cardiac tissue to anchor the frame in position proximate the heart valve annulus. The delivery system may further comprise a plurality of pusher members for engaging corresponding collars of the implant to forcibly advance each collar over its respective upper crown and struts thereby reducing the diameter of the frame and the valve annulus. The delivery system may further comprise means for centering the imaging catheter with respect to the implant. The distal end of the imaging catheter may comprise longitudinally disposed and circumferentially disposed ultrasound transducers. The frame may define a longitudinal axis, and the lower crowns and anchoring members received in the lower crowns may be inclined outwardly in a distal direction at an angle of approximately 45° with respect to a portion of the axis that extends distally below the implant. 
     In some embodiments, the delivery system may further comprise a loop encircling the frame proximate its lower crowns, and a constricting actuator to constrict the loop to facilitate collapse and loading of the implant into the delivery system. Each of the collars may comprise a plurality of tabs that are inwardly biased to engage with corresponding undersides of the upper crowns when the collars are slid over the upper crowns and struts by the pusher members. After the frame has been anchored into the cardiac tissue, the loop may be constricted to determine the desired reduction in diameter of the frame prior to advancing the collars and tabs over the respective upper crowns and struts. 
     In another aspect, a method of reducing the size of an enlarged heart valve annulus is described. The method comprises the steps of delivering an implant in a delivery system to a site above and proximate the enlarged heart valve annulus, the implant having a proximal end and a distal end; releasing the implant from the delivery system to allow the implant to take on a tissue engaging diameter; anchoring the distal end of the implant into cardiac tissue proximate and above the enlarged heart valve annulus; translating a plurality of collars over corresponding upper crowns of the proximal end of the implant to reduce the tissue engaging diameter to an annulus remodeling diameter, thereby reducing the size of the enlarged heart valve annulus; and disengaging the anchored and reduced diameter implant from the delivery system. 
     In another aspect, a heart valve replacement implant is described. The heart valve replacement implant comprises a replacement valve, a tubular valve housing, a cinch frame, a plurality of anchoring members and a plurality of collars. The replacement valve has a plurality of replacement valve leaflets. The tubular valve housing is fixedly attached to the replacement valve leaflets. The cinch frame is connected to and circumferentially surrounds the tubular valve housing. The cinch frame has upper crowns, lower crowns and struts between the upper and lower crowns, and is configurable between a tissue engaging configuration with opposing upper crowns separated by a tissue engaging diameter and an annulus remodeling configuration with opposing upper crowns separated by an annulus remodeling diameter that is less than the tissue engaging diameter. The plurality of anchoring members are coupled with the upper crowns of the cinch frame for engaging cardiac tissue proximate the heart valve annulus. The plurality of collars are coupled with the lower crowns of the cinch frame. When force is applied to the collars, the collars slide on the lower crowns and the struts to reconfigure the cinch frame from the tissue engaging configuration towards the annulus remodeling configuration. 
     In some embodiments, the heart valve replacement implant further comprises a sealing flange on the cinch frame that is disposed on the atrial side of the heart valve when the heart valve replacement system is implanted. 
     In another aspect, a heart valve replacement implant is described. The heart valve replacement implant comprises a replacement valve, a tubular valve, a cinch frame, a plurality of anchoring members and a plurality of collars. The replacement valve has a plurality of replacement valve leaflets. The tubular valve housing is fixedly attached to the replacement valve leaflets. The cinch frame is connected to and circumferentially surrounds the tubular valve housing. The cinch frame has upper crowns, lower crowns and struts between the upper and lower crowns, and is configurable between a tissue engaging configuration with opposing lower crowns separated by a tissue engaging diameter and an annulus remodeling configuration with opposing lower crowns separated by an annulus remodeling diameter that is less than the tissue engaging diameter. The plurality of anchoring members are coupled with the lower crowns of the cinch frame for engaging cardiac tissue proximate the heart valve annulus. The plurality of collars are coupled with the upper crowns of the cinch frame. When force is applied to the collars, the collars slide on the upper crowns and the struts to reconfigure the cinch frame from the tissue engaging configuration towards the annulus remodeling configuration. 
     In some embodiments, the tubular valve housing has a proximal end and a distal end, and the upper crowns of the cinch frame have extensions adapted to be received in openings in the proximal end of the valve housing such that the upper crowns and the cinch frame pivot about the proximal end of the valve housing. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the drawing, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure. 
         FIG.  1    is a perspective view of an embodiment of an implant, having a frame, collars and anchors, for reshaping a heart valve annulus. 
         FIG.  2    is a perspective view of the implant of  FIG.  1    shown in an unconstrained state. 
         FIG.  3    is a perspective view of the implant of  FIG.  1    shown in an anchored state. 
         FIG.  4    is a perspective view of the implant of  FIG.  1    shown in a cinched state. 
         FIGS.  5 A- 5 E  are various views of embodiments of a collar and frame that may be used with the implant of  FIG.  1   . 
         FIGS.  6 A and  6 B  are side views of embodiments of a collar and frame that may be used with the implant of  FIG.  1    shown, respectively, in an expanded and a cinched state. 
         FIGS.  7 A through  7 D  show, respectively, a circumferentially outward facing view, a side view, a circumferentially inward facing view, and a perspective view of an embodiment of a collar having locking tabs. 
         FIGS.  8 A through  8 C  are various views of an embodiment of a collar having cutouts that may be used with the implant of  FIG.  1   . 
         FIG.  9    is a perspective view of an embodiment of a collar with locking tabs. 
         FIGS.  10  and  11    are perspective views of an embodiment of an implant having collars with locking tabs shown, respectively, in an expanded and a cinched state. 
         FIGS.  12  and  13    are perspective views of an embodiment of an implant having collars with cutouts shown, respectively, in an expanded and a cinched state. 
         FIGS.  14  and  15    are perspective views of an embodiment of an implant having collars with locking tabs shown, respectively, in an expanded and a cinched state. 
         FIGS.  16  and  17    are partial side views of an embodiment of an implant having a rotational member and filament for cinching adjacent struts of the implant. 
         FIGS.  18  and  19    are partial side views of an embodiment of an implant having two strings for cinching adjacent struts of the implant. 
         FIG.  20    is a partial side of an embodiment of an implant having an axially displaceable circumferential filament for cinching the frame of the implant. 
         FIGS.  21 A through  21 D  are partial sequential side views of an embodiment of a frame showing sequential cinching of adjacent struts using a string member and tabs. 
         FIGS.  22 A through  22 E  are perspective views of various embodiments of delivery systems having positioning and imaging capabilities that may be used to deliver the various implants described herein. 
         FIG.  23    is a side view of an embodiment of an intravascular cardiac echography (ICE) catheter for delivering, e.g. aligning and positioning, the various implants described herein, and having a guidewire entering and exiting the catheter. 
         FIGS.  24 A through  24 D  are perspective views of another embodiment of an ICE catheter and delivery system for delivering, e.g. aligning and positioning, the various implants described herein and having a circular array of sensors at the tip of the catheter, e.g. for radial and/or circumferential echo views. 
         FIGS.  25 A through  25 E  are sequential perspective views of an embodiment of a delivery system with imaging capability showing an embodiment of a method for the delivery, positioning and anchoring of the various implants described herein for resizing the native valve annulus. 
         FIG.  26    is a side view of an embodiment of an implant having a constricting loop and is shown interacting with a delivery system for advancing the collars. 
         FIGS.  27 A and  27 B  are side and detail views, respectively, of an embodiment of an implant having a cinch loop and is shown interacting with a delivery system for advancing the anchors. 
         FIG.  28    is a perspective view of an embodiment of a delivery system having an implant attached thereto for delivery and securement of the implant to a heart valve annulus. 
         FIG.  29    is a cross section view taken along line 29-29 of  FIG.  28    showing the internal features of a portion of the delivery system of  FIG.  28   . 
         FIGS.  30 A through  30 C  are perspective views of a replacement heart valve implant with anchors coupled to upper crowns and collars coupled with lower crowns and having a sealing atrial flange and shown, respectively, in a unconstrained state, an anchored state, and a cinched state. 
         FIG.  31    is a cross-section view of a heart showing the replacement heart valve implant of  FIGS.  30 A through  30 C  deployed across a native mitral valve of the heart. 
         FIGS.  32 A and  32 B  are perspective views of an embodiment of a replacement heart valve implant with anchors coupled to upper crowns and shown, respectively, in an anchored state and a cinched state. 
         FIGS.  33 A and  33 B  are perspective and side views of an embodiment of a replacement heart valve implant having a cinch frame and a housing and shown, respectively, in a deployed, unconstrained state and in an anchored, cinched and locked state. 
         FIGS.  34 A and  34 B  are side views of an embodiment of a distal section of a steerable catheter shown in straight and flexed states, respectively, that may be used to deliver the various implants described herein. 
         FIGS.  35 A and  35 B  are side views of an embodiment of a distal section of a steerable catheter having a spine that may be used to deliver the various implants described herein. 
         FIGS.  36 A and  36 B  are side views of another embodiment of a distal section of a steerable catheter having a thin film that may be to deliver the various implants described herein. 
         FIG.  37    is a side view of another embodiment of a distal section of a steerable catheter having nesting elements that may be used to deliver the various implants described herein. 
     
    
    
     DETAILED DESCRIPTION 
     The following detailed description is directed to certain specific embodiments of the development. In this description, reference is made to the drawings wherein like parts or steps may be designated with like numerals throughout for clarity. Reference in this specification to “one embodiment,” “an embodiment,” or “in some embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrases “one embodiment,” “an embodiment,” or “in some embodiments” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but may not be requirements for other embodiments. 
       FIGS.  1  through  4    are perspective views of an embodiment of an implant  1 . The implant  1  is intended to be delivered proximate to, above and/or or within, the cardiac valve annulus. Unless otherwise stated, “valve” as used herein may refer to any of a variety of valves, including the tricuspid or mitral valve of the heart. The implant  1  may be subsequently implanted in the annular cardiac tissue just above the plane of the valve orifice. In some embodiments, the implant may be a heart valve replacement including valve leaflets, which can be implanted in annular cardiac tissue and extend into the valve annulus, as further described herein. 
     Particular features for various embodiments of an implant, of a delivery system, and of related systems and methods of use of the implant and delivery system (either together or separately), are described herein. The implant, delivery system, and related systems and methods of use may have the same or similar features and/or functionalities as other implants, delivery systems, and related systems and methods of use as described, for example, in U.S. Pat. Application 14/861,877 entitled “ADJUSTABLE ENDOLUMENAL IMPLANT FOR RESHAPING MITRAL VALVE ANNULUS and filed on Sep. 22, 2015, as described, for example, in U.S. Provisional Application No. 62/234,592 entitled “HEART VALVE DELIVERY SYSTEM WITH INTRAVASCULAR ULTRASOUND IMAGING CAPABILITY” and filed on Sep. 29, 2015, and/or as described, for example, in U.S. Pat. Application No. 15/280,004 entitled “METHODS FOR DELIVERY OF HEART VALVE DEVICES USING INTRAVASCULAR ULTRASOUND IMAGING” and filed on Sep. 29, 2016, the entire disclosure of each of which is incorporated herein by reference for all purposes and forms a part of this specification. Thus, the description of particular features and functionalities herein is not meant to exclude other features and functionalities, such as those described in the references incorporated herein by reference or others within the scope of the development. 
     With reference to  FIG.  1   , the implant  1  is an implantable device. The implant  1  forms an opening  3  extending through the implant  1 . For sake of description, a geometric reference longitudinal axis is indicated. The implant  1  may be described with reference to the axis. An “axial” direction refers to movement generally parallel to the axis in either an upward or downward direction, unless otherwise indicated. The opening  3  extends axially between an upper portion  2  of the implant  1  and a lower portion  4  of the implant  1 . The upper and lower portions  2 ,  4  may include various features of the implant  1 . The terms “upper,” “upward,” and the like refer to directions generally toward the upper portion  2 , and the terms “lower,” “downward,” and the like refer to directions generally toward the lower portion  4 , unless otherwise indicated. “Proximal” refers to a direction in the upward direction, and “distal” refers to a direction in the downward direction. The terms “inner,” “inward,” and the like refer to directions generally toward the axis, and terms “outer,” “outward,” and the like refer to directions generally away from the axis, unless otherwise indicated. 
     The implant  1  includes a frame  10 . The frame  10  extends around and partially along the axis. The axis may be defined by the frame  10 . The frame  10  is generally symmetric with respect to the axis. However, the frame  10  need not be symmetric with respect to the axis. The frame  10  has a generally tubular shape. “Tubular” includes circular as well as other rounded or otherwise closed shapes. The frame  10  is generally circular about the axis. The frame  10  may be circular, rounded, ellipsoidal, segmented, other shapes, or combinations thereof. The frame  10  may change shape, size, configuration, etc. The frame  10  may have various shapes, sizes, configurations etc. at various phases of use, e.g. pre-delivery, during delivery, after engagement with tissue, after contracting the annulus, post-contraction, during the lifetime of use while implanted, etc. 
     The implant  1  includes one or more struts  12 . The struts  12  are part of the frame  10 . The struts  12  are elongated structural members. The struts  12  and/or other parts of the frame  10  are formed of a metal alloy. The struts  12  and/or other parts of the frame  10  may be formed of an alloy of nickel titanium. In some embodiments, the struts  12  and/or other parts of the frame  10  are formed of other metals, metal alloys, plastics, polymers, composites, other suitable materials, or combinations thereof. There are sixteen struts  12 . In some embodiments, there may be fewer or more than sixteen struts  12 . In some embodiments, there may be at least two, four, six, eight, ten, twelve, fourteen, eighteen, twenty, twenty-two, twenty-four, twenty-six, twenty-eight, thirty, or more struts  12 . 
     The struts  12  may be part of the same, monolithic piece of material (e.g. tube stock). Thus the struts  12  may refer to different portions of the same, extensive component. The struts  12  may be formed from the same piece of material. The struts  12  may be formed separately and attached permanently together, e.g. by welding, etc. In some embodiments, the struts  12  may be separate components that are detachably coupled together by other components of the implant  1 . For example, the struts  12  may be held together via various components described herein, such as collars  18 , anchors  20 , other features, or combinations thereof. In some embodiments, separate strut units may include two or more struts permanently attached together such as at an apex, and the separate units may each be coupled together, either permanently or detachably, to form the frame  10 . In some embodiments, the struts  12  may be attached by hinges, pins, or other suitable means. 
     The elongated, middle portions of the struts  12  have a generally rectangular cross-section but can vary in circumferential width and radial thickness to allow for different beam characteristics and forces applied as the collars are advanced. The long ends of the rectangular cross-section of the struts  12  extend along the circumference of the frame  10 . “Circumference” as used herein generally refers to a perimeter or boundary and can refer to a circular or other rounded or non-rounded path lying in a plane substantially transverse to the axis, unless otherwise stated. The short ends of the rectangular cross-section of the struts  12  extend transversely to the circumference of the frame  10 . In some embodiments, other configurations and/or cross-sectional shapes of the struts  12  may be implemented. 
     The struts  12  extend around the axis to form the various shapes of the frame  10 . The struts  12  are arranged such that the wall pattern of the frame  10  may be approximately sinusoidally or zig-zag shaped. In some embodiments, the wall pattern may have other suitable shapes, sinusoidal or otherwise. The vertices of the sinusoidal shaped frame  10  may be pointed or rounded. 
     Pairs of adjacent struts  12  meet at an apex. At least a first pair of adjacent struts  12  meets at an upper apex or crown  14  at the upper portion  2  of the implant  1 . At least a second pair of adjacent struts  12  meets at a lower apex or crown  16  at the lower portion  4  of the implant  1 . The terms “apex,” apices,” and the like may be used interchangeably with terms “crown,” “crowns,” and the like, as used herein and as used in any reference incorporated by reference herein, unless otherwise stated. The upper and lower crowns  14 ,  16  are spaced sequentially along the circumference of the frame  10 , with one of the upper crowns  14  followed by one of the lower crowns  16 , followed by another one of the upper crowns  14 , etc. In the illustrated embodiment, there are eight upper crowns  14  and eight lower crowns  16 . In some embodiments, there may be no more than about six or four or fewer or more than eight or ten or twelve upper and lower crowns  14 ,  16 , depending on the number of struts  12  and the resulting number of apices. 
     The upper crowns  14  are each configured to have a restraint such as a collar  18  fitted over and/or around the upper crown  14 . Thus, the upper crowns  14  may include various features, dimensions, etc. as described herein for coupling with the collar  18 , as further described. The upper crowns  14  are shown partially covered by the collars  18  in  FIG.  1   . The upper ends of the upper crowns  14  are more clearly seen in  FIG.  4   , where the collars  18  have been moved distally toward the lower portion  4  of the implant  1  relative to their position in  FIG.  1   . In some embodiments, one or more of the upper crowns  14  may not have the collar  18 . In some embodiments, fewer than all of the upper crowns  14  are configured to receive the collar  18 . In some embodiments, all of the upper crowns  14  may be configured to receive the collar  18  but when implanted only some of the upper crowns  14  may actually include the collar  18 . 
     At least two and optimally at least four or six or all of the lower crowns  16  are configured for coupling with an anchor  20 . The anchor  20  is moveably coupled with the lower crown  16 . The anchor  20  engages with tissue of the heart, for example the annulus, to secure the implant  1  to the tissue, as further described herein. Movement of the anchor  20  relative to the lower crowns  16  causes the anchor  20  to penetrate the tissue. The lower crowns  16  may include a variety of engagement features to allow such movement of the anchors  20 , such as flanges and/or the openings  17 . The lower crowns  16  each include a series of the openings  17  extending through the lower crowns  16 . The openings  17  extend in two spaced columns in the axial direction along the lower crown  16 . The openings  17  in each column are alternately located in the axial direction, as shown, to accommodate receipt of the anchor  20  therein. Other configurations and/or spacings of the openings  17  may be implemented. For clarity, only some of the openings  17  are labeled in  FIG.  1   . The openings  17  are shown as circular holes. Other shaped openings  17  may be implemented. 
     The openings  17  of the lower crown  16  are configured to rotatably receive a helical segment of the corresponding anchor  20  such that the anchor extends sequentially through the openings  17 , both while the anchor  20  moves relative to the struts  12  and while the anchor  20  is stationary relative to the struts  12 , as further described herein. In some embodiments, features alternative to or in addition to the openings  17  may be used to couple the anchor  20  with the corresponding lower crown  16 . In some embodiments, fewer than all of the lower crowns  16  may be configured for coupling with the anchor  20 . Thus one or more of the lower crowns  16  may not have the openings  17  and/or other features for coupling with the anchor  20 . In some embodiments, all of the lower crowns  16  may be configured for coupling with the anchor  20 , but when implanted only some of the lower crowns  16  may actually include the anchor  20 . 
     The struts  12  are reconfigurable about the upper and lower crowns  14 ,  16 . Pairs of adjacent struts  12  that meet at the upper and lower crowns  14 ,  16  can move angularly relative to each other. Such movement may be described as a rotation or pivot of the adjacent struts  12  about the corresponding upper or lower crown  14 ,  16 . For example, two adjacent struts  12  forming the upper crown  14  may be moved such that the struts  12  effectively rotate relative to each other about the upper crown  14 . For example, two adjacent struts  12  forming the lower crown  16  may be moved such that the struts  12  effectively rotate relative to each other about the lower crown  16 . “Rotation” of the struts  12  as described includes pinching together of the struts  12 , for example with the collar  18  as described herein. Thus, adjacent struts  12  may not include an actual rotatable hinge, pin, or other rotation features. Movement of the struts  12  closer together to decrease the angle therebetween is described as a “closing” of the struts  12 . Movement of the struts  12  farther apart to increase the angle therebetween is described as an “opening” of the struts  12 . 
     The struts  12  may be biased to an enlarged cross-sectional configuration in the absence of an external force applied to the struts  12 . Application of an external circumferentially compressive force to the struts  12 , for example with the collar  18 , causes the struts  12  to move angularly, for example to close. Movement of the struts  12  in this closing manner also causes the implant  1  to decrease its circumference( e.g. diameter) in the case of a circular implant  1 . In its free, unconstrained state, the frame  10  may be in an enlarged configuration. Application of the compressive circumferential force causes the circumference of the frame  10  to reduce. Removal or lessening of the circumferential force allows the frame  10  to open. The circumferential force may be increased or decreased by moving the collar  18  farther downward or upward, respectively, in the axial direction, as further described herein. The collar  18  may lock in place after translating axially down the upper crown  14  to secure the implant  1  at a particular width. 
     The implant  1  includes one or more restraints such as the sliders or collars  18 . The terms “collar,” collars,” and the like may be used interchangeably with the terms “slider,” “sliders,” “sliding members,” and the like, as used herein and as used in any reference incorporated by reference herein, unless otherwise stated. As shown in  FIGS.  1 - 4   , the implant  1  includes eight collars  18 . In some embodiments, there may be fewer or more than eight collars  18 . The number of collars  18  may correspond to the number of upper crowns  14 . In some embodiments, there may be fewer collars  18  than upper crowns  14 . Thus, in some embodiments, some upper crowns  14  of the frame  10  may not include the collar  18 . 
     The collar  18  couples with the corresponding upper crown  14 . The collar  18  may be fitted over the upper crown  14 . The collar  18  forms an inner opening at least partially therethrough and into which the upper crown  14  is received as the collar  18  fits over the upper crown  14 . The collar  18  may have a rectangular profile as shown. In some embodiments, the collar  18  may have other profiles, e.g. rounded, segmented, polygonal, other suitable shapes, or combinations thereof. The profile of the collar  18  may be a closed shape, as shown, or it may be an open shape such as a “C” shape. The collar  18  thus at least partially surrounds the corresponding upper crown  14 . As shown, the collar  18  completely surrounds the corresponding upper crown  14 . In some embodiments the collar  18  may not completely surround the upper crown  14 . The collar  18  engages with the upper crown  14 . 
     The collar  18  may engage with circumferentially opposed sides of the upper crown  14  and/or adjacent struts  12 . The collar  18  engages with and may be advanced downward over the upper crown  14  to angularly move the corresponding pair of adjacent struts  12  towards each other. The collar  18  may apply a compressive circumferential force to the struts  12  to cause the struts  12  to decrease the angle between the struts  12 . The circumferential force may be applied inwardly to the struts  12  and towards the upper crown  14 . Thus, a vertical force applied to the collars  18  may be translated into a circumferential force on the struts  12 . By “circumferential” it is meant that the direction of the forces is along the outer perimeter or boundary of the frame  10  as viewed from the top or bottom of the frame  10 , and is not meant to limit the shape of the frame  10  to a circle. Movement of the collar  18  over the struts  12  moves, e.g. rotates, the struts  12  such that the angle between the adjacent struts  12  decreases. A first circumferential force may be applied to one of the struts  12  by the collar  18  and a second circumferential force that is opposite in direction to the first circumferential force may be applied to the adjacent strut  12  by that same collar  18 . The farther the collar  18  is moved down over the struts  12 , the more the struts  12  move and the more the angle decreases, causing the frame  10  to decrease in width, e.g. diameter. The struts  12  thus move relative to each other about the upper crown  14  due to movement of the collar  18 . The collar  18  may lock in place, for example with a locking tab  19 . 
     The collar  18  may include the locking tab  19 . The locking tab  19  provides an engagement feature for the collar  18  to engage with the struts  12 . The locking tab  19  locks the collar  18  in place on the upper crown  14  after movement of the collar  18  over the upper crown  14 . The locking tab  19  is biased toward the inner opening formed by the collar  18 . The locking tab  19  may be shape set to take on an inwardly oriented bias. The collar  18  and/or features thereof such as the locking tab  19  are formed of a nickel titanium alloy such as Nitinol. In some embodiments, the collar  18  and/or features thereof such as the locking tab  19  are formed of other materials, such as metals, other metal alloys, plastics, polymers, composites, other suitable materials, or combinations thereof. Further details of various embodiments of the collar  18 , and features thereof such as the locking tab  19 , are described herein. 
     The collars  18  may thus provide one or more functions for the implant  1 . In some embodiments, the collars  18  may cinch the frame  10 , as described. In some embodiments, the frame  10  may be cinched by features in addition to or alternatively to the collars  18 , and the collars  18  may restrain the frame  10  in the cinched state. In some embodiments, the collars  18  may thus not cinch the frame  10  but only restrain the frame  10  in the cinched state. In some embodiments, the collars  18  may cinch the frame  10  as well as restrain the frame  10  in the cinched state. 
     The implant  1  includes one or more anchors  20 . Referring to  FIG.  1   , the anchors  20  have anchor heads  22  attached at their upper or proximal ends. As shown, each anchor head  22  comprises an abutment  24  and an engagement structure such as a hook  26 . The abutment  24  may be a cap portion on an upper end of the anchor  20 . The abutment may be cylindrical. The abutment  24  may have a width sized to limit axial advance of the anchor  20 , as described herein. The hooks  26  are elongated, over-hanging members. The hooks  26  may provide an engagement for a delivery tool. The hooks  26  may interact with a delivery tool to rotate and axially advance the anchors  20 , as described herein. In some embodiments, features other than the hooks  26  may be used, for example eye bolts. 
     The anchors  20  are made of a suitable biocompatible metal alloy such as stainless steel, cobalt chromium, platinum iridium, nickel titanium, other suitable materials, or combinations thereof. Each anchor  20  is sharpened at its distal point, or leading turn, so as to facilitate penetration into the cardiac tissue. Each anchor  20  may be from about ten to about fifteen millimeters (mm) in total axial length. In some embodiments, the anchors  20  may be shorter or longer than ten to fifteen millimeters (mm) in total axial length. By “total” axial length it is meant the axial length of the anchor  20  from the end of the distal penetrating tip to the opposite, proximal end of the head  22 . The helical portion of the anchor  20  may be from about six to about twelve millimeters (mm) in axial length, i.e. in an axial direction. In some embodiments, the helical portion of the anchor  20  may be shorter or longer than six to twelve millimeters (mm) in axial length. The anchor head  22  and/or other non-helical portions of the anchor  20  may be from about three to about four millimeters (mm) in axial length. In some embodiments, the anchor head  22  and/or other non-helical portions may be shorter or longer than three to four millimeters (mm) in axial length. The anchors  20  are capable of extending from about four to about seven millimeters (mm) axially beyond the corresponding lower crown  16 . For example, the helical portions of the anchors  20  may extend from four to seven millimeters (mm) into the cardiac tissue. As mentioned, the frame  10  is shown with eight upper crowns  14  and eight lower crowns  16  and anchors  20 , but this number of apices is shown for illustration purposes and may be varied, for example four upper and lower apices, sixteen upper and lower apices, etc. In some embodiments, regardless of the number of apices, each upper crown  14  is fitted with a collar  18  and each lower crown  16  has a respective anchor  20  threadingly received through the openings  17  of the anchor  20 . 
     The anchors  20  couple with the lower crowns  16 . The anchors  20  may be in the general shape of a helix. As shown, the openings  17  receive helically wound anchors  20 . The openings  17  are spaced to accommodate the pitch of the helical anchors  20 , for example the spacing between the turns in the helix of the anchor  20 . There may be a gap between the inner diameter of the openings  17  and the outer diameter of the anchor  20  to allow for free movement of the anchor  20  through the openings  17 . There may be a small gap between the inner diameter of the openings  17  and the outer diameter of the anchor  20 . In some embodiments, there may be an interference fit between the openings  17  and the anchor  20  or a varying pitch to provide interference between the anchor and frame. 
       FIGS.  2  through  4    illustrate the implant  1  in various stages of delivery and deployment. In  FIG.  2   , the implant has been expelled from a delivery catheter and is in its unconstrained state above and proximate the cardiac valve annulus. This unconstrained state may be a tissue engaging configuration of the implant  1  having a tissue engaging diameter and a tissue engaging height. In this unconstrained state, the frame  10  may have an overall axial height in the range of 15 to 20 millimeters (mm). This height or range of height will vary even further from this 15 to 20 mm range, depending on the number of apices and anchors  20 . More specifically, the height is smaller with more apices and anchors  20  and is greater with fewer apices and anchors  20 . In the embodiment shown in  FIG.  2   , the frame has a height of approximately 17 millimeters. Other heights in the unconstrained state are possible, and this particular embodiment is not limiting of the scope of the present disclosure. 
       FIG.  3    depicts the implant after it has been anchored into the cardiac tissue. This anchored state may be an anchored configuration, which may or may not be similar to the tissue engaging configuration, of the implant  1  having an anchored diameter and an anchored height. The anchored diameter of the implant  1  may be less than, equal to, or greater than the tissue engaging diameter of the implant  1  in the tissue engaging configuration. The anchored height of the implant  1  may be less than, equal to, or greater than the tissue engaging height of the implant  1  in the first configuration. Thus, the implant  1  when engaged with and anchored into the tissue may be in the tissue engaging configuration. The anchors  20  have been rotationally advanced through the lower crowns  16  and the tissue piercing end has rotationally advanced into the cardiac tissue. The abutments  24  function as a depth control for the anchors  20 , limiting the extent of axial travel of the helical anchors  20  into the cardiac tissue as the abutments  24  seat in the valley bounded by the lower ends of the adjacent struts  12 . 
       FIG.  4    shows the implant  1  in its contracted or cinched state. This cinched state may be an annulus remodeling configuration of the implant  1  having an annulus remodeling diameter and an annulus remodeling height. The annulus remodeling diameter of the implant  1  is less than the tissue engaging diameter of the implant  1  in the tissue engaging configuration. The annulus remodeling height of the implant  1  may be greater than the tissue engaging height of the implant  1  in the tissue engaging configuration. In the cinched state, the collars  18  have been moved downwardly over the upper crowns  14  until inwardly biased locking tabs  19  engage with the gap or valley bounded by the upper portions of adjacent struts  12 , below the underside of the upper crowns  14 . This engagement of the locking tabs  19  to the valley under the upper crowns  14  locks the implant into its cinched position. In an alternate embodiment, cut-outs may be formed on the upper crowns  14  to accept the locking tabs  19 . 
     The implant  1  in it cinched state has a reduced circumference. Thus the cinched implant  1  has a reduced length perimeter or boundary relative to the unconstrained state. The reduction in circumference need not result in the same general shape of the implant as before the cinching. For example, before cinching, the implant  1  may be in a generally elliptical, oval or other shape, and after cinching the implant  1  may be in a general “D” shape or other shape (and with a relatively reduced circumference). Thus, the implant  1  may be in a variety of shapes before or after cinching, as well as during cinching. For instance, restraints such as the collars  18  may be advanced individually, i.e. not simultaneously. The implant  1  may thus have an irregular shape while being cinched. In some embodiments, even in the cinched state not all of the collars  18  are advanced, and/or are not all advanced the same amount, such that in the cinched state the angular displacements among different pairs of adjacent struts may not be the same. The implant  1  may thus be cinched in a custom manner depending on the particular patient’s needs. In some embodiments, about half of the implant  1  may be cinched, for example to bring the anterior native leaflet closer to the posterior native leaflet, or vice versa. Thus, the “cinched” state of the implant  1  is not limited to only those particular shapes shown and described herein, but includes a multitude of possible shapes, sizes, etc. and which may be chosen based on needs of the patient. 
       FIGS.  5 A through  5 D  are various views of an embodiment of a collar  50  that may be used with the implant  1 . The collar  50  is shown coupled with the struts  12  at the upper crown  14 .  FIGS.  5 A and  5 B  are front views of a portion of the implant  1 , showing the collar  50  coupled with the upper crown  14  at different axial locations.  FIG.  5 A  shows the implant  1  in a unconstrained state.  FIG.  5 B  shows the collar  50  advanced distally relative to the position of the collar  50  shown in  FIG.  5 A  to reconfigure the implant  1  in a cinched state.  FIG.  5 C  is a cross section view of the implant  1  taken along line  5 C- 5 C of  FIG.  5 B .  FIG.  5 D  is a front view of the implant  1  showing a portion of a delivery tool engaging the implant  1 . 
     The collar  50  has multiple locking tabs  54 . The locking tabs  54  may have the same or similar features and/or functionalities as other locking tabs described herein, for example the locking tabs  19 , and vice versa. The locking tabs  54  may be projections or cutouts of the collar  50 . The locking tabs  54  are biased toward the upper crown  14 . The locking tabs  54  may therefore contact the upper crown  14 . The upper crown  14  may include openings which can receive the ends of the locking tabs  54  therein. The upper crown  14  may define a gap in between adjacent struts  12  at a valley, as described, which may receive the end of the locking tabs  54  therein. While two such locking tabs  54  are shown, it should be understood that three or more locking tabs  54  could be employed. The plurality of locking tabs  54  allows the physician/user of the implant  1  to adjust the degree of cinch of the implant  1 . Increased cinch, resulting in a smaller width of the implant  1  due to contraction, will tend to further reduce the width of the heart valve annulus. 
       FIGS.  5 B and  5 C  depict the collar  50  advanced distally. The collar  50  as shown may be in its fully advanced state, thus reconfiguring the implant  1  to a state of maximum cinch. The uppermost locking tab  54  is engaging the underside of the upper crown  14 . As stated with reference to  FIGS.  1 - 4   , rather than engaging the underside or upper crown  14 , cut-outs in the upper crown  14  itself can provide the locking engagement with tabs  54 . Additionally, as best seen in  FIG.  5 D , the collar  50  has a modified or cut out upper section to more readily receive a driver tube  56 . A string member  58 , which could take the form of a wire, cable, thread, suture or the like, is used to apply tension to the upper crown  14  as the driver tube  56  advances the collar  50 . The driver tube  56  may be an elongated tube configured to contact and the collar  50  and to apply a downward pressure to the collar  50  to advance the collar  50  along the frame  10 . The string member  58  extends through an opening in the upper crown  14  to counteract the downward force applied by the driver tube  56 . This allows the frame  10  to remain stationary axially while the collar  50  advances distally to reconfigure the struts  12  and cinch the implant  1 . 
       FIG.  5 E  is a partial side view of the frame  10  coupled with a frequency generator  11 . The frequency generator  11  may be used with the various implants described herein, for example the implant  1 , etc. The frame  10  is shown with a slider or collar  50 ′, a pull wire  58 ′ and a pusher tube  56 ′. The collar  50 ′, pull wire  58 ′ and/or pusher tube  56 ′ may be analogous to the collar  50 , the pull wire  58  and/or the driver tube  56 , respectively. To advance the collar  50 ′ over the frame  10  a high-frequency vibration can be added by the frequency generator  11  to assist the movement of the collar  50 ′. For example, relative vibrational movement between the collar  50 ′ and the frame  10  may produce dynamic movement that facilitates overcoming a static friction between the collar  50 ′ and the frame  10 . The vibration could be transmitted through the pull-wire  58 ′ and/or the pusher tube  56 ′. Vibration of either or both the pull-wire  58 ′ or the pusher tube  56 ′ will transmit the force to the frame  10  and collar  50 ′ vibrating the frame  10  and collar  50 ′ at a frequency to allow an easier movement between the frame  10  and collar  50 ′. An additional tensioning of the pull-wire  58 ′ during the advancement will provide a force to the frame  10 , changing the frame  10  upper apex shape from a wide angle to a more acute angle thus lessening the force required to advance the collar  50 ′. This combination of pull-force and vibration will lower the push-pull forces required to advance the collar  50 ′ over the frame  10 . The frequency transmitted through the tensioning wire and/or pusher tube  56 ′ will lower these forces and could be coupled through each connection. A variety of suitable frequency generator tools could be used as the frequency generator  11  to transmit these vibrational frequencies, such as a CUSA system (Integra® CUSA® EXcel+ Ultrasonic Tissue Ablation System). The frequency may be, for example, from 1 to 100 KHz. The frequency can be varied during the procedure, tailored during the procedure or provided at a fixed defined frequency. 
       FIGS.  6 A and  6 B  depict an alternate embodiment of the frame  10  and the frame/collar interaction. In addition to the struts  12 , the frame  10  is further provided with mid-struts  64 . The mid-struts  64  have crowns  68  and bridge the gap between lower apices  16 . Locking tabs  62 , of collars  60 , engage with mid-strut crown  68  as collar  60  is advanced by operations of wire  58  and driver tube  66 . The mid-strut crown  68  may be pulled proximally by the wire  58  to engage the locking tabs  62 . The locking tabs  62  engage with the underside of mid-strut crowns  68  reducing the diameter of the frame  10  and cinching and locking the implant as shown in  FIG.  6 B . The collars  60  have sections removed along their sides from proximate mid collar to the collar distal end to accommodate movement of struts  12  as the collar is advanced over the mid-strut crown  68 . Also, it is understood that rather than engaging with the underside of mid-strut crown  68 , cut-outs could be provided in the surface of the mid-strut crowns  68 . A driver tube  66  may act to drive the collar  60 . The collar  60 , locking tabs  62  and driver tube  66  may have the same or similar features and/or functionalities as, respectively, the collar  50 , the locking tabs  54 , and the driver tube  56 , and vice versa. 
       FIGS.  7 A through  7 D  are various views of another embodiment of a collar  70  that may be used with the various devices, systems and methods described herein. The collar  70  may have the same or similar features and/or functionalities as the other collars described herein, and vice versa.  FIGS.  7 A,  7 B,  7 C and  7 D  show, respectively, a circumferentially outward facing view, a side view, a circumferentially inward facing view, and a perspective view of the collar  70 . The collar  70  includes locking tabs  72 ,  74 . Here the locking tabs  72 ,  74  are on opposing sides of the collar  70 . Two cut-outs  76  are located proximate the midsection of the sides of the collar  70 . There may be only one or more than two cut-outs  76 . Flex sections  78  are provided on either of the lower sides of the collar  70 . There are numerous advantages of these features on the collar  70 . For example, the lower tab  74  acts as a safety tab. As part of the assembly process, the lower tab  74  is positioned into engagement with a cut out in the upper crown  14 , or, alternatively, the underside of the upper crown  14 , of the implant  1 . This may, for example, keep the collar  70  engaged with the upper crown  14  during the rigors of packaging and shipping and during the surgical procedure itself. As further example, both tabs  72 ,  74  can act as safety tabs by having multiple cut outs on either side of the upper crowns  14 . In some embodiments, the cut outs  76  are created for preferential forming of the collar  70 . For example, a starting material of a round hypotube may be crushed or swaged into an oval shape to slide the collar  70  over the upper crowns  14 . Further, the flex sections  78  may reduce friction when the collar  70  is being advanced over the struts  12 . The flex sections  78  may also minimize scraping of the collar  70  against the struts  12  of the frame  10  when the collar  70  is advanced. Additionally, as best seen with reference to  FIG.  7 D , when the collar  70  is advanced such that the upper locking tab  72  is engaged with the underside of an upper crown  14 , the lower, inwardly biased tab  74  will help support upper tab  72  when it is advanced into locking engagement with the upper crown  14 . 
       FIGS.  8 A through  8 C  illustrate another embodiment of a collar  80  that may be used with the various devices, systems and methods described herein. The collar  80 , also referred to as a “slider,” may have the same or similar features and/or functionalities as the other collars described herein, and vice versa.  FIG.  8 A  is a front view of the slider or collar  80 ,  FIG.  8 B  is a side view of the collar  80 , and  FIG.  8 C  is a perspective view of the collar  80 . This variation of the collar  80  is also provided with preferential forming cut outs  86  and flex sections  88 , which may be similar or the same as the cutouts  76  and flex sections  78  as described with reference to the collar  70  in  FIGS.  7 A through  7 D . In this embodiment, however, locking tabs are not provided on the collar  80 . Rather, tabs are instead provided on the upper crown  14  (not shown) for locking engagement with cut outs  82  on the collar  80 . These tabs would extend outwardly from the upper crown  14  and be downwardly biased. 
       FIG.  9    is a perspective view of another embodiment of a slider or collar  90 . The collar  90  is provided with radial locking tabs  92 . Locking tabs  92  are located on the sides of the collar  90  and are inwardly biased to engage with grooves (not shown) on the sides of the upper crowns  14  of the frame  10 . Multiple levels of such grooves may be formed on the upper crown  14 , and in addition or alternatively can be provided on the upper portions of the struts  12 . Such grooves in either or both locations allow for more varied degrees of cinching of the implant  1 . 
       FIGS.  10  through  15    are perspective views of various embodiments of implants that may be used with the various systems and methods described herein. In  FIGS.  10  through  15   , only some of the same features may be labeled for clarity. For example, only some of the struts  12  may be labeled in the figures, etc.  FIGS.  10  and  11    are perspective views of an embodiment of an implant  100 . The implant  100  may have the same or similar features and/or functionalities as other implants described herein, for example the implant  1 , and vice versa. The implant  100  is shown in an embodiment of an unconstrained state in  FIG.  10   . The implant  100  is shown in an embodiment of an anchored, cinched and locked state in  FIG.  11   . The implant  100  includes a frame  100  having struts  112 , upper crowns  114 , lower crowns  116  and anchors  120 . These may be analogous to, for example, the frame  10 , the struts  12 , the upper crowns  14 , the lower crowns  16 , and the anchors  20 , respectively. By “analogous” it is meant these features may have the same or similar features and/or functionalities as each other. The implant  100  has lower crowns  116  that are inclined at an angle with respect to the struts  112 . The lower crowns  116  may be inclined downward and outward, or distally and outward, relative to the struts  112  and/or relative to the axis (shown in  FIG.  10   ). In this manner, the anchors  120  may be directed more in a direction into the annular tissue above and proximate the heart valve, and less in a downward direction toward the valve leaflets. The angle may be measured between the direction the lower crowns  116  extend and a portion of the axis extending underneath the implant  100 . The angle may also be measured between the direction the lower crowns  116  extend and the direction that the struts  112  extend downward. This angle may be between thirty to sixty degrees. In some embodiments, this angle is approximately forty-five degrees. The anchors  120  are formed as one piece. A variety of different types of anchors may be used with the implant  100 . For example, other anchors described herein may be used, for example the anchor  20  having the anchor head  22  and anchor abutment  24 , as described with respect to  FIGS.  1  through  4   . The implant  100  in  FIGS.  10  and  11    includes opposing tab sliders or collars  118 . The collars  118  may be analogous to the collars  70 , described with respect to  FIGS.  7 A through  7 D . 
       FIGS.  12  and  13    are perspective views of an embodiment of an implant  101 . The implant  101  may have the same or similar features and/or functionalities as the implant  100 , and vice versa. The implant  101  is shown in an embodiment of an unconstrained state in  FIG.  12   . The implant  101  is shown in an embodiment of an anchored, cinched and locked state in  FIG.  13   . The implant  101  has upper crowns  124  having locking tabs  130 . The implant  101  also includes indexed sliders or collars  128 . The collars  128  may be analogous to the collars  80  described with respect to  FIGS.  8 A through  8 C . The tabs  130  are provided on the upper crowns  124  for locking engagement with the grooves formed in the collar  128 . Such grooves may be similar to the grooves  82  of the collar  80 . 
       FIGS.  14  and  15    are perspective views of an embodiment of an implant  102 . The implant  102  may have the same or similar features and/or functionalities as the implant  100  and/or  101 , and vice versa. The implant  102  is shown in an embodiment of an unconstrained state in  FIG.  14   . The implant  102  is shown in an embodiment of an anchored, cinched and locked state in  FIG.  15   . The implant  102  includes radial locking collars  148 . The collars  148  may be analogous to the collars  90 , described with respect to  FIG.  9   . Radially inwardly biased locking tabs  149  on the collars  148  engage with grooves  150  cut into the outer sides of the upper crowns  144 . The pitch of the helically wound anchors  120  can be varied. The pitch of the last turn of the anchors  120  may also be varied, for example to self-lock the anchors  120  into the lower crowns  116 . Moreover, the last or most distal turn of the helical anchors  120  may be swaged from a circular cross section to a more oval cross section to prevent backing out of the anchors  120  from the lower crown  116 , for example to prevent backing out after engagement or anchoring in the heart tissue. Rather than swaging, pitch of the most distal turn of the helical anchors could be varied to prevent backing out. 
       FIGS.  16  and  17    are side views of a portion of an implant  103  in an uncinched and cinched state, respectively. The views indicate an embodiment of a method for cinching the implant  103  after anchoring. The implant  103  may be analogous to the various implants described herein, for example the implant  1 , etc. The implant  103  includes a frame  160 . The frame  160  may be analogous to other frames described herein, for example the frame  10 , etc. The frame  160  has lower apices  166  which include eyelets  168 . A string  172  is attached to or fed through the eyelets  168 . Alternatively, the string  172  can carry enlargements, knots, and the like at its ends to prevent the ends from passing through the eyelets  168  as the frame  160  is cinched. String  172  can be made of wire, cable, suture, thread, or the like. Rotational member  170  is either fixedly attached to string  172  or string  172  is passed through a tunnel formed in the end of rotational member  170 .  FIG.  16    shows frame  160  in an unconstrained state.  FIG.  17    shows the frame in its implanted state. After anchoring, the rotational member  170  is rotated thereby winding string  172  about the member  170 . This action causes the gap between lower apices  166  to shorten thereby cinching, or reducing the diameter, of the frame  160 . 
       FIGS.  18  and  19    show a variation of the implant  103  of  FIGS.  16  and  17   . In  FIGS.  18  and  19   , rather than have a rotational member cause the cinching, a string  180  is provided. The string  180  can take the form of a thread, suture, or the like. The string  180  is attached to a string  182  by way of loop or knot  188 . The string  182  is similar to the string  172  shown in  FIGS.  16  and  17   .  FIG.  18    shows the frame  160  in an unconstrained state, while  FIG.  19    shows the frame  160  being brought towards a cinched state. As the proximal end of the string  180  is pulled by the operator to cause cinching of the frame  160 , the knots  184  will click, one by one, through an eyelet  186  in the upper crowns  187 . The knots  184  are sized so to be able to be pulled through the eyelet  186 , but cannot reverse back through the eyelet  186 . In this manner, the knots  184  provide a locking function and multiple degrees of cinch of the frame  160 . After the desired degree of cinching has been achieved, the proximal ends of the string  180  are secured to maintain tension and then cut and the ends removed from the system. 
       FIG.  20    is a partial side view of another embodiment of an implant  104 . The implant  104  may be analogous to the other implants described herein, for example the implant  1 , etc. The implant  104  includes features for cinching the frame  160 . A string-like member  202  is passed through multiple eyelets  204  disposed on the lower apices  166 . The string-like member  202  extends circumferentially about the lower section of the frame  160 . A driver unit (not shown) can be used to grab and gather the string-like member  202  until the desired amount of reduction in the diameter of the frame  160 , or cinching, is achieved. In some embodiments, other features described herein may be used with the string-like member  202  to cinch the string-like member  202 , for example the string  180  or the rotational member  170 . 
       FIGS.  21 A through  21 D  are partial side views of an embodiment of a frame  210  that may be used with the various implants described herein, for example the implant  1 , etc. The views sequentially show a technique for cinching the frame  210 . As shown in  FIG.  21 A , the frame  210  has struts  212 , upper crowns  214  and lower crowns  216 , which may be analogous, respectively, to other struts, upper crowns and lower crowns described herein. A central projection  218  extends downwardly from the upper crown  214  into the gap or valley bounded by adjacent struts  212 . The central projection  218  includes three tabs  220 . There may be fewer or greater than three tabs  220 . The tabs  220  extend in an upwardly oriented and angled direction, e.g. outward, from the central projection  218 . With reference to  FIG.  21 B , a string member  222  spans the distance between adjacent lower apices  216 . The string member  222  may be between one, some or all distances between pairs of adjacent lower apices  216 . The string member  222  can take the form of a wire, cable, suture, thread, or the like. The string member  222  is passed through one or more holes  224  in the lower crowns  216 . The holes  224  are sized and positioned so as not to interfere with the rotation of helical anchors  232  as they are threadingly advanced through the holes  234  (see  FIG.  21 C ). The anchors  232  may be analogous to other anchors described herein, for example the anchors  20 , etc. The ends of the string members  222  may be knotted, for example for thread or suture string members  222 . The ends of the string members  222  may be provided with a weld ball, collar, etc. crimped onto its ends, for example if the string members  222  are wire or cable. Such end features may prevent the ends of the string members  222  from being pulled through the holes  224  when tension is applied. As shown in  FIG.  21 C , a driver tube  226  is operated to apply tension to pull wire  230 . For ease of operation, an alignment feature  228  can be provided to align pull wire  230  with central projection  218  and its tabs  220 . Either by pulling or rotating driver tube  226 , the operator applies tension to pull wire  230  which is hooked around string member  222 . The operator can then apply varying degrees of cinching to frame  210  by ratcheting string member  222  up and into engagement with tabs  220 .  FIG.  21 D  shows the frame in one particular state of cinch. The string member  222  may be engaged with any of the tabs  220  to provide more or less cinching to the frame  210 . 
       FIGS.  22 A and  22 B  are perspective views of an embodiment of a distal end of a delivery catheter  40  being used to deliver an implant  1 A. The delivery catheter  40  has various positioning and imaging capabilities. The distal end of the delivery catheter  40  is maneuvered into position above the heart valve annulus. The delivery catheter  40  may be used to deliver the various implants described herein, for example the implant  1 , etc. The implant  1 A shown being delivered in  FIGS.  22 A- 22 B  is for resizing the heart valve annulus. It is understood that a variety of different implants may be delivered with the delivery system and methods described herein. The implant  1 A may be analogous to the other implants described herein, such as the implant  1 . By “analogous” as used herein it is meant the implant  1 A may have the same or similar features and/or functionalities as the implant  1 , and vice versa. As shown, this particular implant  1 A includes a frame  250 . The frame  250  has anchors  20  attached to a lower or distal portion of the frame  250  and extending distally therefrom. The frame  250  has an upper or proximal portion with collars  252  extending over upper crowns  251  of the frame  250 . Only some of the collars  252 , upper crowns  251  and anchors 20 are labelled for clarity. The collars  252  may be moved, e.g. distally, along the frame  250  by driver tubes  260  to resize the frame  250 . The frame  250 , upper crowns  251  and collars  252  may be analogous to the various frames, upper crown and collars described herein, such as the frame  10 , upper crowns  14  and collars  18 , and vice versa. 
     The frame  250 , one or more driver tubes  260 , and an intravascular cardiac echography (or “ICE”) catheter  270  may be extended from the distal end of the delivery catheter 40. The frame  250  and driver tubes  260  may be analogous to the various frames and driver tubes described herein. The driver tubes  260  are shown engaging corresponding upper crowns  252  of the frame  250 . A centering frame  280  maintains concentric positioning of the ICE catheter  270  relative to the frame  250  during deployment, alignment and positioning of the frame  250  above and proximate to the target heart valve annulus tissue. The centering frame  280  maintains a generally centered position of the catheter  270  relative to the frame  250 . By centering the ICE catheter within the frame  250 , the operator need only rotate the ICE catheter  270  to view each anchor 20 and placement of the anchors 20. Further, the ICE catheter  270  could be used to view various other individual features of the implant  1 A, such as the collars  252 , for instance to view the extent to which each collar  252  is advanced down and over upper crowns  251  of the frame  250 , to more precisely adjust the size of the frame  250 . The ICE catheter  270  could also provide significant benefit to an embodiment where a singular cinching mechanism or driver tube needs to be landed on each crown  251  of the frame  250  to adjust the sizing of the frame  250 . An indexing feature (not shown) may also be provided on the ICE catheter  270 , for example, such that actuation of the indexing feature by the operator causes the ICE catheter  270  to automatically move, or rotate, to the next anchor 20 position. 
       FIGS.  22 C and  22 D  are perspective views of an embodiment of an implant  1 B being delivered and implanted by the delivery catheter  40 . The implant  1 B may be analogous to the various implants described herein, such as the implants  100 ,  101 ,  102 , and vice versa. As shown in  FIGS.  1 C and  1 D , the implant  1 B includes a frame  10  with struts  12  forming upper apices or crowns  14  and lower apices or crowns  16 . The lower crowns  16  have openings  17 , such as holes, aligned to receive the anchors  20  there through. For clarity, only some of the upper crowns  14 , lower crowns  16 , struts  12  and anchors  20  are labelled in  FIGS.  1 C and  1 D . The anchors  20  may be rotated to move distally through the openings  17 . The implant  1 B is intended to be delivered proximate to and above a cardiac valve (tricuspid, mitral) annulus, and subsequently implanted in the annular cardiac tissue just above the plane of the valve orifice. 
     Driver tubes  22 ′, having proximal portions  22 ″ extending out of the delivery catheter  40 , are provided for rotationally engaging the anchors  20 . Manipulation, for example rotation, of the driver tubes  22 ′ by the operator causes the anchors  20  to advance towards, engage with and penetrate cardiac tissue to secure frame  10  into the annulus approximate and above the valve. The anchors  20  may be advanced individually one at a time, some advanced together, or all advanced together. In some embodiments, the driver tube  22 ′ may rotate relative to the proximal portion  22 ″. In some embodiments, the driver tube  22 ′ and proximal portion  22 ″ are part of the same, continuous driver tube and/or the entire tube  22 ′ and proximal portion  22 ″ may rotate together. 
     An embodiment of an ultrasound catheter  30 , such as the Acuson IPX8 AcuNav catheter, is shown contained within and advanced down a central lumen of the delivery catheter  40 . The ultrasound catheter  30  may be analogous to the ICE catheter  270 . In some embodiments, by rotating the ultrasound catheter  30  around the inside of the valve annulus, the relative position of the frame  10 , and of any valve leaflets, will be seen for accurate positioning of the anchors  20  around and above the valve annulus. 
     In some embodiments, the ultrasound catheter  30  is contained within and advanced down an offset, non-central lumen of the delivery catheter  40 . In this manner, the ultrasound catheter  30  would not interfere with the frame  10 , its attachments or other featues, and the driver components. In some embodiments, the ultrasound catheter  30  may be located and steered to the side of the annulus to image, allowing for less rotation to more quickly view the anchor points of the frame  10 . An offset lumen could exit more proximally with regard to the distal end of the delivery catheter  40 . This more proximal exit would reduce the overall profile or diameter of the distal end of the delivery catheter  40 . In addition, this more proximal exit port would enable a view of the valve annulus from above. The offset lumen could also be compressible allowing for an even smaller profile until the ultrasound catheter  40  is advanced through the offset lumen. 
     While the ultrasound catheter  30  is shown integrated into the same delivery system as the delivery catheter  40 , in some embodiments the ultrasound catheter  30  could otherwise be introduced secondarily through another entry site, such as through the aortic valve, and placed near or inside the implant for imaging and placement of the anchors  20 . 
       FIG.  22 E  is a perspective view of an embodiment of a centering frame  32  coupled to the ultrasound catheter  30  and to an implant  1 C. The implant  1 C may be analogous to other implants described herein, such as the implants 1,  1 A,  1 B, and vice versa. The centering frame  32  has centering arms  34  connected to a centering hub  36  that is mounted on the ultrasound catheter  30 . As the distal end of the delivery catheter  40  is maneuvered into position above the heart valve annulus, the centering frame  32  maintains concentric positioning of the ultrasound catheter  30  relative to the frame  10  during deployment, alignment and positioning of the frame  10  above and proximate to the target heart valve annulus tissue. The centering aspect is desirable, for example, because if the ultrasound catheter  30  remains centered within the frame  10 , the operator such as a surgeon or technician need only rotate the ultrasound catheter  30  to view each anchor  20  and placement the of each anchor  20 . There may also be an indexing feature (not shown) on the ultrasound catheter  30  such that actuation of the indexing feature by the operator causes the ultrasound catheter  30  to automatically move, or rotate, to the next anchor position. The centering frame  32  may be used with delivery of the various implants described herein, such as the annulus resizing implants and/or the heart valve replacement implants. 
       FIG.  23    is a side view of an embodiment of an ICE catheter  270 . The ICE catheter  270  as shown includes a guidewire entry port  292  and a guidewire exit port  294  which together accept the guidewire  296 . This embodiment allows the ICE catheter  270  to be delivered separately from the frame  10  thereby reducing the overall diameter of the delivery catheter  40  (e.g. as shown in  FIGS.  22 A and  22 B ). An ICE handle may be located at a proximal end of the catheter  270 . An ICE array may be located at the distal end of the catheter  270 . 
     In some embodiments, a separately delivered ultrasound catheter  270  could be functionally linked to the distal end of the delivery catheter  40  and to the inside of the frame  10 . The delivery catheter  40  could have mechanical docking and radiopaque features to aid in delivery and stability of the ultrasound catheter  270  relative to the delivery catheter  40 . 
       FIGS.  24 A,  24 B,  24 C and  24 D  depict an embodiment of an ICE catheter  300  that may be used with the various implants and delivery devices, systems and methods described herein. The ICE catheter  300  has radial ultrasonic transducers  302 , circumferential ultrasonic transducers  304  and guidewire  306  passing centrally therethrough. A guidewire lumen  303  extends out from a delivery catheter  240 . The delivery catheter  240  may be analogous to the delivery catheter  40 . The ICE catheter  300  extends out through the guidewire lumen  303 .  FIGS.  24 B and  24 C  show the implant  1  deployed with the ICE catheter  300  tip. The other implants described herein may be delivered with the ICE catheter  300 , such as the implants 1,  1 A,  1 B,  1 C, and the implants  500 ,  520 ,  530  described below, etc.  FIG.  24 C  further shows the relationship of the ICE catheter  300  to the delivery catheter  240  while it is taking a radial echo view to properly position the anchor  20  for insertion into heart valve annulus tissue.  FIG.  24 C  shows the ICE catheter  300  capturing a circumferential echo image for properly positioning the frame  10  in a plane above the heart valve and its leaflets. The features shown and described in  FIGS.  24 A- 24 D  may be used to deliver various other implants, such as other resizing devices or heart valve replacement valves. 
     In some embodiments, software or electronic controls can be effective to cycle through the radial cross sectional images around the valve annulus perimeter, relieving the need to physically move, via rotation, translation or deflection, the ICE catheter  300 . A larger circumferential transducer array could also be placed distal of the annulus to not interfere with space limitations of the delivery catheter  240 , further decreasing the profile of the delivery catheter  240 . In another embodiment, the transducers of the ICE catheter  300   could generate a three dimensional image of the annulus of frame  10 . The user could then more readily see the relative alignment of the annulus, valve leaflets and the implant  1 . 
       FIGS.  25 A through  25 E  are sequential perspective views of an embodiment of a delivery system  401  with imaging capability showing an embodiment of a method for the delivery, positioning and anchoring of the various implants described herein for resizing the native valve annulus. While  FIGS.  25 A through  25 E  depict delivery of the implant  1  for resizing the annulus, it is understood that implants for replacing the valve may also be delivered with the system  401 . The implant  1  may be delivered, positioned and anchored to reshape the valve annulus. The implant  1  may be inserted using the delivery system  401  via access to the vasculature of the leg, in particular the femoral vein or the iliac vein. The system  401  may include the various implants, catheters and other features described herein, for example the implant  1 , the delivery catheter  240 , the ICE catheter  300 , the guidewire  306 , etc. The system  401  may include any of the implants described herein, for example implants including valve annulus reshaping devices or valve replacements that include valve leaflets. 
     As shown in  FIG.  25 A , the system  401  is then advanced across the septum separating the upper chambers of the heart. The ICE catheter  300  is advanced to a position above the heart valve annulus, for example, the mitral valve annulus, as shown in  FIG.  25 B .  FIG.  25 C  shows the implant  1  expelled from the distal end of the delivery system  401  above and proximate to the mitral valve annulus. A series of radial images are taken to properly position the anchors  20  for insertion into the mitral valve annulus tissue, as shown in  FIG.  25 D . Subsequently, a circumferential image is captured, as shown in  FIG.  25 E , to confirm that all anchors  20  are appropriately placed and anchored in the mitral valve annulus tissue above the mitral valve leaflets. If one or more anchors  20  are not positioned or anchored properly, they can be rotationally retracted, repositioned and re-anchored prior to removal of the driver tubes. In addition, a circumferential image can be taken prior to anchoring to confirm location of the lower crowns  16  of the frame  10  of the implant  1 . It should also be understood that treatment of the tricuspid valve could involve insertion of the system  401  for access through the jugular vein whereby the system is then advanced down the superior vena cava and into the right atrium proximate and above the tricuspid valve annulus. 
       FIG.  26    is a perspective view of an embodiment of an implant  100  having a constricting loop  320 . The implant  100  is shown interacting with a delivery system for advancing the collars  60 . The constricting loop  320  may be used with other embodiments of the implant described herein, for example the implants  101 ,  102 , etc. As shown in  FIG.  26   , the constricting loop  320  is provided. The constricting loop  320  encircles the frame  110  proximate the lower crowns  16 . The constricting loop may encircle upper portions of the lower crowns  16  as shown, or other portions. A constricting loop actuator  330  may be provided to act on and constrict the constricting loop  320 . For example, the actuator  330  may include a wire with a loop through which the constricting loop  320  extends, and where pulling the wire proximally will constrict and tighten the constricting loop  320  about the frame  110 . In operation, the constricting loop  320  may be actuated first, allowing the operator to first predetermine the desired diameter of the frame  110 . The collars  60  may then be advanced, cinching the frame  110  and locking it in the desired diametric dimension. In some embodiments, other collars described herein may be implemented. The constricting loop  320  is then removed. Constricting the frame  110  also reduces resistance to advancement of the collars  60 . Furthermore, the constricting loop  320  assists in collapsing the frame  110  into the distal portion of the delivery catheter. Moreover, the constricting loop  320  helps reduce friction between the flared lower crowns  16  and the inner diameter of the delivery catheter. Additionally, a proximal loop can be utilized to restrict the proximal portion of the frame  110  to change the angle at which the anchors address the valve annulus. 
       FIG.  27 A  is a perspective view of an embodiment of an implant  105  having a cinch loop  340 . In this variation, the implant  105  does not include collars and the cinch loop  340  is provided to cinch and lock the frame of the implant  105  in the target heart valve annulus tissue. After anchoring, the cinch loop  340  is tightened down by operation of a cinch loop driver  350 .  FIG.  27 B  is a detail view showing a close up view of the driver  350  interacting with the loop  430 . The driver  350  may include an inner tube or member  351  extending therethrough to or near a distal opening of the driver  350 . A distal member  352 , such as a wedge, may be attached to the distal end of the inner tube  351 . The distal member  352  removably attaches to an element  353 , for example by threaded engagement, friction fit, or other suitable engagement means. The loop  340  extends through or is otherwise attached to the element  353 , locking the loop  340  in place. Pulling the element  353  in the proximal direction, for example by moving the driver  350  proximally, and/or pulling the inner tube  351  proximally, the loop  340  reduces in circumference around the implant  105 , cinching the frame to a smaller diameter. The ends can then be snipped and driver  350  and inner tube  351  withdrawn. Once the operator has achieved the desired reduction in diameter of the anchored frame, the cinch loop  340  is locked in place and the cinch loop driver  350  is removed. In some embodiments, the cinch loop  340  may engage with the frame  110 , for example with the lower crowns  16 , to lock in place. Such engagement may be by friction fit, openings in the lower crowns  16  that allow for unidirectional movement of the loop  340 , or other suitable means. 
       FIG.  28    is a perspective view of a delivery system  400  that may be used to deliver the various implants described herein. The delivery system  400  comprises a steerable sheath  402 , a sheath steering nob  404 , cinch knobs  406 , anchor knobs  408 , the implant  100  which may be any implant described herein, the ICE probe  270 , all supported and secured to a base  410 . The cinch knobs  406  and anchor knobs  408  are all spring loaded to maintain tension. Rotation of the anchor knobs  408  rotationally advance the helically wound anchors  20  into the annular tissue above the target heart valve. Cinch knobs  406  are manipulated by the operator to advance the collars and lock the frame of the implant  100  into a cinched position. 
       FIG.  29    is a cross section taken along line 29-29 of  FIG.  28   . The pull wires  412  are attached to the sheath steering knob  404  to deflect the distal end of the sheath  402 . The sheath  402  may be a steerable outer sheath  402 , for example made of braided polymer or metal such as Nitinol or stainless steel. The ICE catheter shaft  270  may be centrally located with the guidewire lumen  303  located within the ICE catheter lumen  271 . There are eight anchor driver wires  403 , for example nitinol, circumferentially located within the sheath  402 . The anchor driver wires  403  are located within anchor driver sheaths, for example laser cut hypotubes. There are eight pusher tubes  56 ′, which may be braided, located around the ICE catheter shaft  270 . The pusher tubes  56 ′ may include a cinch retaining tube  404 , for example a laser cut hypotube and a cinch retaining wire  407 , for example nitinol. 
       FIGS.  30 A- 30 C  are perspective views of an embodiment of an expandable replacement valve implant  500  shown in various states, i.e. configurations.  FIG.  30 A  shows the replacement valve implant  500  in an unconstrained state.  FIG.  30 B  shows the replacement valve implant  500  in a deployed and anchored state.  FIG.  30 C  shows the replacement valve implant  500  in an anchored and cinched state. 
     The replacement valve implant  500  may be delivered with the various delivery systems and methods described herein. The replacement valve implant  500  may include an associated cinching structure. The replacement valve implant  500  is thus suited to treat multiple disease conditions. For example, the replacement valve implant  500  can treat mitral regurgitation developed as a consequence of cardiomyopathy and attendant dilation of the mitral valve annulus. Moreover, the replacement valve implant  500  and cinching structure can treat failed or defective heart valve leaflets by replacing the native valve apparatus. Additionally, the replacement valve implant  500  and cinching structure can treat both mitral regurgitation and those patients with concomitant defects in the valve leaflets themselves. 
     The replacement valve implant  500  includes one or more non-native valve leaflets  502 . The leaflets  502  may be mechanical or tissue-based such as porcine or bovine. The leaflets  502  replace the function of the defective heart valves by providing normal or otherwise acceptable blood flow regulation. The leaflets  502  may be configured to mimic the natural configuration of native leaflets. As shown, there are three leaflets  502 . In some embodiments, there may be one, two, three or more leaflets  502 . The leaflets  502  are coupled with housing and/or other features of the replacement valve implant  500 , as described herein. 
     The replacement valve implant  500  includes an inner valve housing  510 . The valve housing  510  may be a support for various features of the implant  500 , such as the leaflets  502 , one or more frames, struts, etc. The valve housing  532  is configured to extend into the valve annulus and contain the leaflets  502  therein. The leaflets  502  may be mechanically attached to the inner valve housing  510  by a variety of suitable means, including sutures, fasteners, adhesives, crimping, other means, or combinations thereof. The valve housing  510  forms an inner portion of the replacement valve implant  500  that connects with an outer portion, as described herein. The valve housing  510  may include an inner frame  508  and/or an inner barrier  519 , as described herein. 
     The inner frame  508  may be analogous to other frames described herein, such as the frame  10 , and thus be a structural member, include a tubular shape, have sinusoidal struts, etc. The inner frame  508  may be a variety of suitable materials, such as metal, preferably nitinol. After deployment from a delivery catheter and expansion to the unconstrained shape, the inner frame  508  may or may not change shape, size, etc. The inner frame  508  may be coupled with an outer frame  512 , as described herein. Lower apices of the inner frame  508  may be coupled with lower apices of an outer frame  512 . The inner frame  508  may be a portion of the outer frame  512 . For example, the inner frame  508  may be part of the same continuous structure as the frame  512  and form an inner portion thereof. 
     The inner frame  508  may be coupled to or otherwise carry the inner barrier  519  to form the valve housing  510 . The inner barrier  519  is a membrane-like material extending around the circumference of the valve housing  510 . The inner barrier  519  is configured to extend into the valve annulus to contain the leaflets  502  within the annulus. The inner barrier  519  also acts to prevent leakage of blood flow around the replacement valve implant  500 . The inner barrier  519  may comprise any of a variety of suitable materials, including ePTFE or a polyester material, such as Dacron. The inner barrier  519  may be coupled with the inner frame  508 . The inner barrier  519  may be coupled with the inner frame  508  with a variety of suitable means, for example with sutures, mechanical attachments, embedding, other suitable features, or combinations thereof. 
     The inner barrier  519  may be carried by the radially inwardly or outwardly facing surfaces of the inner frame  508 . As shown, separate segments of the inner barrier  519  may be coupled with the inner frame  508  in between struts of the inner frame  508 . In some embodiments, the inner barrier  519  may be a single, continuous tubular membrane. For example, the inner barrier  519  may be provided entirely or mostly on the inside or internal diameter of the valve housing  510 . In some embodiments, the inner barrier  519  may be provided entirely or mostly on the outside or external diameter of the valve housing  510 . In some embodiments, there may be multiple barriers  519 , such as an internal and an external inner barrier  519  each on opposite sides of the inner frame  508 . 
     The illustrated replacement valve implant  500  includes an outer cinch frame  512 . The outer frame  512  is coupled with one or more anchors  516  and one or more restraints such as collars  518 . The outer frame  512 , anchors  516  and collars  518  may be analogous to any of the other frames, anchors and collars described herein, for example the frame  10 , anchors  20  and collars  18 , respectively. The outer frame  512  may thus include a tubular shape, having a sidewall comprising sinusoidal or zigzag struts, with restraints, etc. The outer frame  512  may be coupled with the inner frame  508 , for example at lower crowns  521  as shown. In some embodiments, the outer frame  512  may be coupled with the inner frame  508  in other manners, such as at upper crowns, etc. In some embodiments, the inner and outer frames  508 ,  512  may be part of the same monolithic material, for example different portions of a single, continuous wire or laser cut frame, etc. The outer frame  512  may compress for delivery within a delivery catheter, expand upon deployment from the catheter, and contract upon advancement of collars  518 , as described herein. Contraction of the outer frame  512  may resize and/or re-shape the valve annulus. Activation of the restraints and/or manipulation of a control such as a pull wire advances the proximal end of the outer frame  512  radially inwardly toward the axis to reduce the inner diameter of the native valve annulus. 
     The anchors  516  may be located along a proximal end of the outer frame  512 , as shown. In some embodiments, the anchors  516  may be in other locations along the circumference of the implant  500 , for example located farther distally, located along the distal end of the implant  500 , etc. The anchors  516  are inclined radially outward in the distal direction as deployed from the head of the anchors to the tissue-penetrating tips of the anchors. In some embodiments, the anchors  516  may have other orientations, for example substantially parallel to the axis, radially outward substantially transverse to the axis, inclined in the proximal or distal directions, or combinations thereof. The anchors  516  may engage either the inner frame  508  or the outer frame  512  of the implant  500 , such as at a strut or apex of the outer frame  512 . The anchors  516  act to secure the replacement valve implant  500  to tissue such that the replacement valve implant  500  extends through the native annulus and across the native valve. The anchors  516  may be helical as described herein and rotatably engage the tissue. The anchors  516  are shown retracted or pre-anchored in  FIG.  30 A . In  FIG.  30 B , the anchors  516  have been advanced into a tissue engagement orientation. In  FIG.  30 C , the outer frame  512  has been cinched such that the anchors  516  have now pulled the valve annulus inward to reduce the circumference of the annulus to conform to the implant  500  and reduce or eliminate the perivalvular space. 
     The collars  518  may be advanced along the outer frame  512  to adjust the circumference of the outer frame  512 . The collars  518  may be advanced along upper or lower crowns of the outer frame  512 . As shown, the collars  518  are coupled with the lower crowns  521 . The collars  518  may be advanced along the lower crowns  521  similarly as described herein, for example, with respect to the implant  1  of  FIGS.  1 - 4   , etc. 
     The replacement valve implant  500  may include an outer barrier  517 , which may be analogous to the inner barrier  519  of the valve housing  510 . Thus, the outer barrier  517  of the frame  512  may be a material such as ePTFE or polyester, and may be selected to encourage or inhibit endothelial ingrowth. The outer barrier  517  may be elastic such that it can stretch and/or contract to reduce or prevent bunching or wrinkling of the material during and after delivery, deployment and cinching of the outer frame  512 . The outer barrier  517  may be carried on the radially inwardly or outwardly surface of the outer frame  512 . As shown, separate segments of the outer barrier  517  may be coupled with the frame  512  in between struts of the outer frame  512 . In some embodiments, the outer barrier  517  may be a single, continuous membrane. For example, the outer barrier  517  may be provided on the inside or internal diameter of the outer frame  512 . In some embodiments, the outer barrier  517  may be provided on the outside or external diameter of the outer frame  512 . In some embodiments, there may be multiple barriers  517 , such as an internal and external outer barrier  517 . In some embodiments, there may not be any barrier  517 . 
     The outer frame  512  and/or barrier  517  may form a generally frustoconical shape in the unconstrained state, as shown in  FIG.  30 A . Thus, the struts of the outer frame  512  and the barrier  517  are inclined outward in the proximal direction relative to the longitudinal axis of the replacement valve implant  500 . The proximal edge of the barrier  517  is located radially farther outward relative to the distal edge of the barrier  517  in the unconstrained state. The outer frame  512  and/or outer barrier  517  may contact various portions of the native heart anatomy after deployment from the delivery catheter, such as the annulus wall. After the anchors  516  have engaged the tissue but before cinching the outer frame  512 , the outer frame  512  and/or outer barrier  517  may still be in a generally frustoconical shape, as shown in  FIG.  30 B , leaving a perivalvular annular space but blocking perivalvular blood flow by the outer barrier  517  and/or inner barrier  519 . After cinching the outer frame  512 , the outer frame  512  and/or outer barrier  517  may form a generally cylindrical shape, as shown in  FIG.  30 C . In some embodiments, after cinching the outer frame  512 , the outer frame  512  and/or outer barrier  517  may form other shapes, such as a generally frustoconical shape, other non-cylindrical shapes, etc. 
     The replacement valve implant  500  shown in  FIGS.  30 A- 30 B  includes an annular atrial skirt or flange  514 . The atrial flange  514  may be an extension of the barrier  517  in the radial or generally radial direction for at least about 2 mm, or about 5 mm, or more. The atrial flange  514  extends outward from a proximal edge of the outer frame  512 . In some embodiments, the atrial flange  514  may instead extend outward from a distal edge of the outer frame  512 , for example forming a “ventricular” flange situated inside the annulus and/or within the left ventricle (for a mitral valve implant). Such “ventricular” flange may be analogous to the atrial flange  514  as described herein. The atrial flange  514  and/or other flanges may further reduce and/or prevent of leakage of blood flow around the replacement valve implant  500 , e.g. leakage in between the replacement valve implant 500and the surrounding valve annulus. The atrial flange  514  may be a variety of suitable materials, such as ePTFE or a polyester material, for example Dacron. The atrial flange  514  may thus be a similar material as the outer barrier  517 . In some embodiments, the atrial flange  514  may also include an extension of the outer frame  512  in the outward direction and providing support for the barrier material, such as the polyester material. 
       FIG.  30 B  shows the replacement valve implant  500  in its deployed and anchored state. As shown, the anchors  516  have been advanced through and engage the frame  508  and through the flange  514  and into tissue. Holes  503  are provided in or adjacent to the atrial flange  514  to allow the helically wound anchors  516  to pass therethrough and anchor into the annular tissue above the heart valve. The anchors  516  may also fixedly engage the flange  514 . The anchors  516  may engage the atrial flange  514  such that a fixed connection is provided between the flange  514  and the respective anchor  516  before and/or after advancement of the anchors  516  therethrough. The flange  514  has a generally annular shape around the circumference of the implant  500 . The flange  514  may be generally circular, or other rounded or non-rounded shapes. The flange  514  maybe symmetric or asymmetric with respect to the axis or with a plane that includes the axis 
     The replacement valve implant  500  may have a variety of suitable dimensions. In the deployed and anchored state, and/or the deployed and unanchored state, and/or in the anchored and uncinched state, and/or in the anchored and cinched state, the valve housing  510  may have a height measured along the axis  513  in the range of about twenty millimeters to about thirty millimeters, although such height can vary. In some embodiments, in these various states the valve housing  510  may have a height in the range of about ten millimeters to about fifty millimeters. Referring to  FIGS.  30 A- 30 B , the inner diameter  511  of the valve housing  510  may be within the range of about twenty-five millimeters to about thirty millimeters, although such diameter can be varied. In some embodiments, the inner diameter  511  of the valve housing  510  may be within the range of about fifteen millimeters to about sixty millimeters. Referring to  FIG.  30 B , the atrial flange  514  may have a radial width  515  between about five millimeters and about thirty millimeters. In some embodiments, the atrial flange  514  may have a width  515  between about ten millimeters and about twenty millimeters wide. Referring to  FIG.  30 C , depending on the disease state(s), the cinch frame  512  can have an outer diameter  523  from about forty millimeters to about eighty millimeters. Larger diameters may be implemented, for example, if the disease state is or includes a dilated heart valve annulus as incidence of the patient’s cardiomyopathy. The inner diameter  525  of the cinch frame  512 , which may be measured in some embodiments from anchor  516  head to opposite anchor  516  head, may range from about thirty millimeters to about sixty millimeters, or in some embodiments from about fifteen millimeters to about one hundred millimeters, in the cinched orientation. 
     After the replacement valve implant  500  is anchored in place, it is cinched as shown in  FIG.  30 C . Cinching may be accomplished by a cinching mechanism on the deployment catheter, followed by advancing the collars  518  to achieve retention. Alternatively, cinching may be accomplished by manipulation and movement of collars  518 . The various cinching techniques described herein may be employed. The replacement valve implant  500  may encourage tissue ingrowth after implantation. For example, the inner our outer frame  508 ,  512 , the inner barrier  519 , the outer barrier  517 , other features of the implant  500 , or combinations thereof, may be configured to facilitate tissue ingrowth and further securement of the implant  500  within the heart. 
       FIG.  31    illustrates the replacement valve implant  500  positioned, anchored, cinched and implanted in the annular tissue above and proximate the target heart valve. For illustration purposes, the replacement valve implant  500  has been deployed across the native mitral valve, with the atrial flange  514  blocking or at least substantially blocking paravalvular leakage around the replacement valve implant  500 . The replacement valve implant  500  is in sealing engagement with the atrial wall surrounding the native valve, which in some embodiments may be due in part to atrial blood pressure. 
     While the atrial flange  514  provides additional sealing in the atrium, in some embodiments such additional sealing may not be included.  FIGS.  32 A and  32 B  are perspective views of embodiments of heart valve replacements  520  and  520 ′ without the additional sealing or atrial flange  514  and shown, respectively, in an unconstrained state and in a cinched state. Further, the heart valve replacement  520  includes the outer barrier  517  located on the outside of the outer frame  512 , while the heart valve replacement  520 ′ includes the outer barrier  517  located on the inside of the outer frame  512 . The heart valve replacements  520  and  520 ′ may otherwise be analogous to the heart valve replacement  500 . Like reference numerals with respect to  FIGS.  30 A through  30 C  thus represent like elements in  FIGS.  32 A and  32 B . After being anchored in position as shown in  FIG.  32 A , the collars are actuated, in a manner similar to that of  FIG.  30 C , to cinch the replacement valve  520  as shown in  FIG.  32 B . While nine anchors  516  have been shown with respect to the replacement valve embodiments of  FIGS.  30  through  32   , it is understood that the number of such anchors  516  can be varied. In some embodiments, such variance of the number of anchors  516  can range from three to eighteen. In some embodiments, the number of anchors  516  can vary in multiples of three. 
     Another embodiment of a replacement valve implant  530  is depicted in  FIGS.  33 A and  33 B .  FIG.  33 A  shows the replacement valve implant  530  in an unconstrained and unanchored state and  FIG.  33 B  shows the replacement valve implant  530  in an anchored, cinched and locked state. The replacement valve implant  530  may include features analogous to features described with respect to other implants herein, for example the implant  1 ,  500 ,  520 ,  520 ′, etc. 
     The replacement valve implant  530  includes an inner valve housing  532  and an outer frame  536 . The valve housing  532  may be analogous to the valve housing  510 . The valve housing  532  may include one or more leaflets  502 , which may be analogous to the leaflets  502  as described with respect to the replacement valve implant  500 . The valve housing  532  may include an inner frame  535  as shown, which may be formed of nitinol. The inner frame  535  may thus have proximal, generally diamond-shaped segments that are adjacent distal, irregular hexagonal-shaped segments extending circumferentially in a generally tubular shape about an axis, as indicated in  FIG.  33 B . The valve housing  532  has a series of upper crowns  542  with openings therethrough. The openings may be circular or other shapes. The openings in the upper crowns  542  may engage with one or more features of an outer cinch frame  536 , such as extensions  540  that extend from upper crowns of the outer frame  536 . 
     The outer frame  536  may be analogous to other frames or outer frames described herein, for example, the frames  10 ,  512 , etc. The outer frame  536  is coupled with one or more anchors  516  and one or more restraints such as collars  518 . The outer frame  536  may be coupled with the valve housing  532 , for example the inner frame  535 , at the upper (proximal) crowns  542 , as described. In some embodiments, the outer frame  536  may be coupled with the inner frame  535  in other manners, such as at lower crowns, etc. In some embodiments, the inner and outer frames  535 ,  536  may be part of the same monolithic material, for example different portions of a single, continuous frame, etc. 
     The outer frame  536  may compress for delivery within a delivery catheter, expand upon deployment from the catheter, and contract upon advancement of collars  518 , as described herein. The outer frame  536  in an unconstrained state, as shown in  FIG.  33 A , inclines radially outward in a distal direction from a proximal end of the valve housing  532 . Contraction of the outer frame  536  to a cinched state, as shown in  FIG.  33 B , may resize and/or re-shape the native valve annulus. The outer frame  536  may advance radially inwardly toward the axis to reduce the inner diameter of the native valve annulus into conformance with the inner frame  535 . The outer frame  536  may include collars  538  at the upper crowns  534 . The collars  538  may be advanced distally to cinch the implant  530  to cause the outer frame  536  to advance radially inward. The collars  538  may interact with the outer frame  536  to cinch the outer frame  536  as described herein with respect to other collars and frames, such as the collars  18  and the frame  10 , etc. 
     The extensions  540  include perpendicularly disposed tabs generally forming T-Bar extensions on the upper crowns  534  of the outer frame  536 . The extensions  540  engage with the openings in the upper crowns  542  of the valve housing  532  to pivotally secure the outer frame  536  to the valve housing  532 . The extensions  540  may be inserted into the openings during assembly of the replacement valve implant  530 . The anchors  516  are moveably engaged with lower crowns  521  that are located in between upper crowns  542  of the valve housing  532 . The anchors  516  may engage with the lower crowns as described herein with respect to other anchors and crowns, such as the anchors  20  and lower crowns  16 , etc. After the anchors  516  have been rotationally advanced into the annular heart valve tissue, cinching of the outer frame  536  as shown in  FIG.  33 B  will draw the annular tissue or portions thereof toward the valve housing  532 . Further, in the cinched state shown in  FIG.  33 B , portions of the native annulus tissue may be drawn radially inward and/or upward (proximally) in between the outer frame  536  and the valve housing  532 . This action will reduce the potential for paravalvular leaking and migration of the replacement valve implant  530 . In some embodiments, the valve housing  532  may be tapered, for example having a smaller diameter on the atrial side of the valve orifice and a larger diameter on the ventricular side to facilitate blood flow through and across the replacement heart valve  530 . 
     Relatively large diameter catheter shafts are described herein that may be used to deliver the re-sizing implants, such as the implant  1  and others, or valve replacements, such as the valve  500  and others, as described herein. These large diameter catheter shafts may include features that mitigate or eliminate the tendency to kink, wrinkle or tear when attempting a sharp bend radius.  FIG.  34 A  through  37  show various embodiments of sections of steerable catheters that may be used with the various implants described herein. The features of the steerable catheters improve the catheter’s ability to maneuver tight bends to a position above and proximate and/or into the mitral valve annulus or tricuspid valve annulus. 
       FIGS.  34 A and  34 B  are side views of an embodiment of a distal section  600  of a steerable catheter  602  shown in straight and flexed states, respectively, that may be used to deliver the various implants described herein. The steerable catheter  602  may be used in the various delivery systems and methods described herein. The steerable catheter  602  has a distal end  604  and intermediate section  606 . The distal end  604  may be a deflectable section, as described herein. The distal end  604  may include a length of the catheter  602  extending from the distal tip. For example, the deflectable section of the distal end  604  may include a length of five or ten or fifteen centimeters, or more or less, of the catheter  602  as measured from the distal tip in a proximal direction. The intermediate section  606  may take the form of a shaft section reinforced with a braid or slotted tubing. The catheter  602  may include a proximal end opposite the distal end  604 . Only a portion of the catheter  602  is shown for clarity. The proximal end of the catheter  602  may be coupled with a proximal manifold having a deflection control. The catheter  602  and/or features thereof may be implemented with the various catheters and delivery systems described herein, for example those shown in and/or described with respect to  FIGS.  22 A- 25 E , or others. 
       FIGS.  35 A and  35 B  depict an embodiment of the distal section  604  that may be used with the steerable catheter  602 , shown in straight and flexed states, respectively. The distal section  604  has a single spine  608  running along its outer curve, and a series of support ribs  610  formed or cut into the inner curve. The distal section  604  may be formed of a flexible metal tube, such as nitinol. The distal section  604  may incorporate pull wires for control of the delivery system. Alternatively, the pull wire may be looped around the distal section’s distal tip and back toward the proximal part of the catheter  602 . The support ribs  610 , with voids therebetween, allow the distal section  604  to achieve a tight bend radius. This flexed state of the distal section  604  is realized with minimal protrusion of the support ribs  610  into the inner diameter or outer diameter of the distal section  604 . Moreover, the spine  608  provides a smooth surface on the outer curve of the distal section  604  minimizing friction or interference with heart tissue during delivery and positioning of the catheter and implant. 
       FIGS.  36 A and  36 B  illustrate another embodiment of a distal section  614  that may be used with the steerable catheter  602 . Here, the distal section  614  may be a flexible metal tube that is wrapped or encased in a thin film  612  or polymeric material such as Teflon, pTfe, nylon or other thin material. This thin film  612  encapsulation does not restrict the flexibility of the distal section  614  but does provide for smoother delivery and transition into and out of a guide catheter. The thin film  612  may be stretchable or designed to fold in on itself, somewhat similar to an accordion, when flexed as shown in  FIG.  36 B . 
       FIG.  37    shows another embodiment of a distal section  624  that may be used with the steerable catheter  602 . Here, distal section  624  comprises a series of larger elements  626  and smaller elements  628 . The smaller elements  628  nest within the larger elements  626 . All elements may slide over one another. When the distal section  624  is in a straight state, the metal elements are most overlapped. As the distal section  624  is actuated towards the flexed state, as shown for example in  FIG.  37   , there may be progressively less overlap of the elements particularly on the outer curve of the distal section  624 . 
     The embodiments of the distal and intermediate sections of the catheter  602  are intended for use in the delivery and implant of both the ring-like embodiments and the replacement valve embodiments described herein. In treating the mitral valve, for example, once the catheter is passed through the septum separating the right and left atria, it is guided slightly upwardly towards the upper reaches of the left atrial chamber. It is then bent significantly in a direction downward towards the mitral annulus, aligning the distal end and the implant with the mitral annulus. The devices, systems and methods described herein allow such bending to occur without kinking or wrinkling which would otherwise impede delivery of the implant. 
     Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein, but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word “example” is used exclusively herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “example” is not necessarily to be construed as preferred or advantageous over other implementations, unless otherwise stated. 
     Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination. 
     Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. 
     It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”