Patent Publication Number: US-2021169642-A1

Title: Suture guard for a prosthetic valve

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. application Ser. No. 16/170,795, filed Oct. 25, 2018, which claims the benefit of Provisional Application No. 62/579,761, filed Oct. 31, 2017, which are incorporated herein by reference in their entireties for all purposes. 
    
    
     FIELD 
     The present disclosure relates generally to prosthetic valves and more specifically suture guards and holders for flexible leaflet-type prosthetic heart valve devices. 
     BACKGROUND 
     Prosthetic heart valves have been developed that attempt to mimic the function and performance of a native valve. Prosthetic valves with flexible leaflets typically require some means for securing the leaflets to a support structure, such as a leaflet frame. Leaflet(s) may be secured to the frame, for example, by suturing or adhesive/thermal bonding. In addition, the prosthetic valve is typically attached to a human heart with sutures, through a sewing cuff arranged with the frame, or some other mechanical attachment means (e.g., staples). 
     Prosthetic heart valve delivery may be difficult due to various aspects of the prosthetic valve and the anatomy to which the prosthetic valve is inserted. Accordingly, it would be desirable to ease implantation and protect the prosthetic valve during delivery of the prosthetic valve and attachment of the prosthetic valve to the heart. 
     SUMMARY 
     According to one example (“Example 1”), a system includes a heart valve including a first commissure post, and a delivery apparatus coupled to the heart valve, wherein the delivery apparatus includes a base including an inflow end and an outflow end, the outflow end being distal to the inflow end, and a suture guard that is selectively deployable and that extends through the base, the suture guard configured to transition from initial configuration to a deployed configuration, wherein in the initial configuration the suture guard is in a collapsed configuration such that the suture guard is situated radially inwardly of an interior surface of an outflow end of the first commissure post, and wherein in the deployed configuration the suture guard extends radially outwardly of the interior surface of the outflow end distal to the outflow end of the first commissure post. 
     According to another example (“Example 2”) further to Example 1, the suture guard includes a frame element that is shape set such that when the suture guard is transitioned to the deployed configuration the frame element is configured to cause the suture guard to naturally adopt the deployed configuration. 
     According to another example (“Example 3”) further to Example 2, frame element is defined by a first strut and a second strut, the first and second struts being configured to separate from one another as the suture guard is transitioned to the deployed configuration due to the shape set of the frame element such that the first strut extends radially outwardly of the interior surface of the outflow distal to the outflow end of the first commissure post, and such that the second strut extends radially outwardly of an interior surface of an outflow end of a second commissure post and distally of the outflow end of the second commissure post. 
     According to another example (“Example 4”) further to Example 3, the first strut defines a first looped portion of the frame element and the second strut defines a second looped portion of the frame element, and wherein a bend region defines a transition between the first looped portion and the second looped portion, wherein an angle of the bend region in the deployed configuration is greater than an angle of the bend region in the initial configuration. 
     According to another example (“Example 5”) further to Example 4, the bend region stores potential energy in the initial configuration that is convertible to kinetic energy to cause the frame element to adopt the deployed configuration. 
     According to another example (“Example 6”) further any of Examples 2 to 5, the first and second struts are the same strut. 
     According to another example (“Example 7”) further to any of Examples 4 to 6, the first and second looped portions collectively define a first frame element, the suture guard including a second frame element substantially similar to the first frame element and angularly offset relative to the first frame element such that the first looped portion of the first frame element is adjacent a second looped portion of the second frame element, wherein the first looped portion of the first frame element and the second looped portion of the second frame element collectively define a first petal of the suture guard, and wherein the first petal of the suture guard is configured to extend radially outwardly of the interior surface of the outflow distal to the outflow end of the first commissure post in the deployed state. 
     According to another example (“Example 8”) further to any of Examples 4 to 7, the first looped portion of the first frame element and the second looped portion of the second frame element are coupled together by a biocompatible film. 
     According to another example (“Example 9”) further to Example 8, the biocompatible film includes a polymer. 
     According to another example (“Example 10”) further to Example 8, the polymer includes ePTFE. 
     According to another example (“Example 11”) further to any of Examples 4 to 10, the suture guard includes a same number of petals as the heart valve includes commissure posts. 
     According to another example (“Example 12”) further to any of Examples 7 to 11, the suture guard includes a third frame element substantially similar to the first and second frame elements and angularly offset relative thereto such that the suture guard includes three petals. 
     According to another example (“Example 13”) further to any of the preceding Examples, when in the initial configuration the suture guard is in a non-everted configuration, and when in the deployed configuration the suture guard is everted such that a portion of the suture guard that extends radially outwardly of the interior surface of the outflow end of the first commissure post extends toward the inflow end of the base. 
     According to another example (“Example 14”) further to any of the preceding Examples, the suture guard is advanceable relative to the base to cause the suture guard to transition to the deployed configuration, and wherein the suture guard is retractable relative to the base to cause the suture guard to transition to the initial configuration. 
     According to another example (“Example 15”) further to any of the preceding Examples, when in the initial configuration an outflow end of the first commissure post is exposed, and when in the deployed configuration the suture guard covers the outflow end of the first commissure post. 
     According to another example (“Example 16”) further to any of the preceding Examples, the frame element includes nitinol or a shape memory polymer 
     According to another example (“Example 17”) further to any of the preceding Examples, the suture guard is configured to deflect suture line from becoming entangled with the first commissure post. 
     According to another example (“Example 18”) further to any of the preceding Examples, the suture guard is configured to deflect suture line from becoming looped around the first commissure post. 
     According to another example (“Example 19”) further to any of the preceding Examples, the delivery apparatus further includes a shaft extending through the base, the shaft including an inflow end and an outflow end, and the suture guard extending through a lumen of the shaft, wherein an application of linear motion of the shaft in the outflow direction relative to the base causes the suture guard to transition to the deployed configuration. 
     According to another example (“Example 20”) further to Example 19, with the suture guard in the deployed configuration, an application of linear motion of the shaft in the inflow direction relative to the base causes the suture guard to transition to the initial configuration. 
     According to another example (“Example 21”) further to any of the preceding Examples, the system further includes a delivery handle configured to control the transition of the suture guard between the initial and deployed configurations. 
     According to another example (“Example 22”) a delivery apparatus for a prosthetic valve includes a base configured to engage the prosthetic valve, the base including an inflow end and an outflow end, the outflow end being more distal than the inflow end, and a suture guard configured to transition from initial configuration to a deployed configuration, the suture guard including an end and an intermediate portion, wherein in the initial configuration the suture guard is collapsed within the base in a non-everted configuration such that the end is distal to the intermediate portion, and wherein in the deployed configuration the suture guard is deployed from the outflow end of the base such that a portion of the suture guard is everted such that the end extends toward the inflow end of the base proximal to the intermediate region, wherein the suture guard is configured to deflect suture line from becoming entangled with a first commissure post of the prosthetic valve during an implantation procedure. 
     According to another example (“Example 23”) a delivery apparatus for a prosthetic valve includes a base configured to engage the prosthetic valve, the base including an inflow end and an outflow end, and a suture guard, the suture guard extending through the base and including an end that is configured to extend from the outflow end of the base, the suture guard further configured to evert such that the end of the suture guard extends toward the inflow end of the base, wherein the suture guard is configured to deflect suture line from becoming entangled with a first commissure post of the prosthetic valve during an implantation procedure. 
     According to another example (“Example 24”) a method of delivering a prosthetic valve including a first commissure post includes providing a delivery apparatus secured to the prosthetic valve, the delivery apparatus including a base including an inflow end and an outflow end, the outflow end being distal to the inflow end, and a suture guard that is selectively deployable and that extends through the base, the suture guard being situated radially inwardly of an interior surface of an outflow end of the first commissure post, and advancing the suture guard relative to the base such that the suture guard extends radially outwardly of the interior surface of the outflow end distal to the outflow end of the first commissure post to deflect suture line from looping around the first commissure post. 
     According to another example (“Example 25”) further to Example 24, the method further includes retracting the suture guard relative to the base such that the suture guard is withdrawn into an interior of the base such that the suture guard is in a collapsed and non-everted configuration. 
     According to another example (“Example 26”) a delivery apparatus for a prosthetic valve includes a suture guard configured to move one or more valve posts of the prosthetic valve inwardly toward a longitudinal axis of the prosthetic valve upon application of a linear motion to shorten a length of the suture guard. 
     According to another example (“Example 27”) further to Example 26, the suture guard is configured to protect at least one of the valve posts and one or more leaflets of the prosthetic valve from becoming entangled with sutures during implantation of the prosthetic valve to a target location. 
     According to another example (“Example 28”) further to any of Examples 26-27, the suture guard includes one or more fiber lines arranged between the one or more valve posts. 
     According to another example (“Example 29”) further to Example 28, upon application of linear motion the one or more fiber lines are configured to apply tension to move one or more valve posts of the prosthetic valve inwardly toward a longitudinal axis of the prosthetic valve. 
     According to another example (“Example 30”) further to Example 29, the suture guard includes a linear motion mechanism configured to apply the tension to the one or more fiber lines and withdraws the one or more fiber lines inwardly toward the suture guard. 
     According to another example (“Example 31”) further to any of Examples 28-30, the suture guard includes an upper portion and a lower portion, and the lower portion is configured to interface with the prosthetic valve, and the lower portion is configured to apply the tension to the one or more fiber lines. 
     According to another example (“Example 32”) further to any of Examples 26-31, the apparatus further includes an atraumatic dome arranged with an outflow portion of the prosthetic valve and configured to protect against injury to a portion of a heart and to create a ramp for sutures to slide over and past the commissure posts. 
     According to another example (“Example 33”) further to Example 26, the suture guard includes an everted tube configured to cover the valve posts and move the one or more valve posts of the prosthetic valve inwardly toward a longitudinal axis of the prosthetic valve. 
     According to another example (“Example 34”) further to Example 26, the suture guard includes one or more arms configured to bend the one or more valve posts of the prosthetic valve inwardly toward a longitudinal axis of the prosthetic valve 
     According to another example (“Example 35”) further to any of Examples 26-34, the suture guard is configured to protect valve during surgery, protect tissue during insertion, and prevent strut wrap. 
     According to another example (“Example 36”) further to any of Example 36-35, the apparatus further includes a delivery handle configured to control the suture guard. 
     According to another example (“Example 37”) further to Example 36, the handle is pre-attached to the suture guard for implantation of the prosthetic valve. 
     According to another example (“Example 38”) further to any of Examples 36-37, upon application of linear motion, the one or more fiber lines are configured to apply tension to move the one or more valve posts of the prosthetic valve inwardly toward a longitudinal axis of the prosthetic valve, and further including a release fiber coupled to the handle and configured to releasably lock the one or more fiber lines with the suture guard, and wherein a portion of the handle is configured to actuate and release the release fiber to unlock the one or more fiber lines. 
     The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure. 
         FIG. 1A  is an outflow side perspective view of an example prosthetic heart valve in accordance with an embodiment; 
         FIG. 1B  is an inflow side perspective view of the embodiment of the valve of  FIG. 1A ; 
         FIG. 2A  is a perspective top and bottom views of an example suture guard in accordance with an embodiment; 
         FIG. 2B  is a first and second side view of the suture guard, shown in  FIG. 2A , with a prosthetic heart valve; 
         FIG. 2C  is a bottom view of the suture guard and the prosthetic heart valve, shown in  FIGS. 2A-B , with a fiber; 
         FIG. 2D  is a first and second side view of the suture guard, the prosthetic heart valve, and the fiber, as shown in  FIGS. 2A-C ; 
         FIG. 2E  is top view of the suture guard, the prosthetic heart valve, and the fiber, as shown in  FIGS. 2A-D ; 
         FIG. 2F  is a partial cross-sectional first view and second side view of the suture guard, the prosthetic heart valve, and the fiber as shown in  FIGS. 2A-E ; 
         FIG. 2G  is a partial cross-sectional first view and top view of the suture guard, the prosthetic heart valve, and the fiber as shown in  FIGS. 2A-F ; 
         FIG. 3A  is an exploded view of an example suture guard and a prosthetic heart valve, in accordance with an embodiment; 
         FIG. 3B  is another view of the suture guard and the prosthetic heart valve, as shown in  FIG. 3A ; 
         FIG. 3C  is a bottom view of the suture guard and the prosthetic heart valve, as shown in  FIGS. 3A-B ; 
         FIG. 4A  is a partial cross-sectional view of an example suture guard, a prosthetic heart valve, and a delivery handle, in accordance with an embodiment; 
         FIG. 4B  is a partial cross-sectional view of the suture guard, the prosthetic heart valve, and the delivery handle, as shown in  FIG. 4A , in another configuration; 
         FIG. 5  is a partial cross-sectional view of an example suture guard, a prosthetic heart valve, and another delivery handle, in accordance with an embodiment; 
         FIG. 6  is an illustration of an example suture guard and a prosthetic heart valve, in accordance with an embodiment; 
         FIG. 7  is an illustration of another example suture guard and a prosthetic heart valve, in accordance with an embodiment; 
         FIG. 8  is an illustration of example fiber wrapping pathway, in accordance with an embodiment; 
         FIG. 9  is an illustration of example fiber wrapping pathway, in accordance with an embodiment; 
         FIG. 10  is an exploded view of the example suture guard shown in  FIGS. 3A-C ; 
         FIG. 11  is another exploded view of the example suture guard shown in  FIGS. 3A-C ; 
         FIG. 12  is an illustration of portions of the example suture guard shown  FIGS. 10-11 ; 
         FIG. 13  is an illustration of portions of the example suture guard shown  FIGS. 10-11 ; 
         FIGS. 14-17  are exploded views of delivery handles and suture guards shown in  FIGS. 4-5 ; 
         FIG. 18  is an exploded view of the everted suture guard shown in  FIG. 6 ; 
         FIG. 19  is another exploded view of the everted suture guard shown in  FIG. 6 , showing a cross section of a portion of the suture guard; 
         FIG. 20  is another view of the everted suture guard shown in  FIG. 6  and  FIGS. 18-19 ; 
         FIG. 21  is an exploded view of suture guard shown in  FIG. 7 ; 
         FIG. 22  is another view of the everted suture guard shown in  FIG. 7  and  FIG. 21 ; 
         FIG. 23  is an illustration of an example handle, in accordance with an embodiment; 
         FIG. 24  is a schematic illustration of the various components of the suture guard shown in  FIGS. 2A-G , in the configuration shown in  FIG. 2F ; 
         FIG. 25  is a schematic illustration of the various components of the suture guard shown in  FIGS. 2A-G , in the configuration shown in  FIG. 2G ; 
         FIG. 26  is a schematic exploded illustration of the various components of the suture guard shown in  FIGS. 2A-G ; 
         FIG. 27  is a schematic illustration of the first portion of the suture guard shown in  FIGS. 2A-G ; 
         FIG. 28  is a schematic illustration of the second portion of the suture guard shown in  FIGS. 2A-G ; 
         FIGS. 29A-29E  are schematic illustrations of an example suture guard shown in a deployed configuration in combination with a heart valve, in accordance with an embodiment; 
         FIGS. 30A-30B  are schematic illustrations of the example suture guard shown in  FIG. 29A  with the heart valve removed for clarity, in accordance with an embodiment; 
         FIGS. 31A-31B  are schematic illustrations of the example suture guard shown in  FIG. 30A  in a non-deployed configuration, in accordance with an embodiment; 
         FIG. 32  is a schematic illustration of the example suture guard shown in  FIG. 29A  during an implantation procedure, in accordance with an embodiment; 
         FIG. 33A-1  is a cross-sectional view of the example suture guard shown in the deployed configuration in  FIG. 29B , taken along line  33 - 33 , in accordance with an embodiment; 
         FIG. 33A-2  is a detail view of a portion of  FIG. 33A-1 , showing a portion of the suture guard overlapping a portion of a valve frame, as indicated; and 
         FIG. 33B  is a cross-sectional view of the example suture guard shown in  FIG. 33A-1  in a non-deployed configuration and with the heart valve removed for clarity, in accordance with an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. 
     Although the embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in connection with prosthetic valves, more specifically cardiac prosthetic valves. However, embodiments within the scope of this disclosure can be applied toward any valve or mechanism of similar structure and/or function. Furthermore, embodiments within the scope of this disclosure can be applied in non-cardiac applications. 
     Aspects of the present disclosure are directed toward heart suture guards. The heart suture guards are configured to facilitate implantation of the heart valve. The heart suture guards discussed herein facilitate placement and suturing of the heart valve into the native annulus, and, in certain embodiments, help prevent damage to the heart valve from mishandling of the heart valve during an implantation procedure. For example, the heart suture guards (also referred to herein as suture guards) discussed herein are configured to help prevent sutures from looping over or otherwise becoming entangled with the valve posts (also referred to herein as suture looping, shunt wrapping, and/or strut wrapping) during implantation. When suture is inadvertently looped around one or more valve posts and subsequently tightened, the looped suture can damage one or more portions of the valve structure, damage one or more valve leaflets, negatively impact the functionality of the valve and/or the leaflets inside the posts. The heart suture guard designs, consistent with various aspects of the present disclosure, are configured to lessen the opportunity for suture looping. 
     In some embodiments, the suture guards are configured to engage the valve posts to deflect the valve posts radially inward toward a longitudinal axis of the prosthetic valve  100 . In some examples, this mechanism of deflecting the valve posts radially inward helps prepare the valve for insertion into the annulus. Moreover, in some examples, a deflection of the valve posts radially inward helps reduce a radial profile of the valve posts, which help reduce the likelihood of a suture becoming entangled with the valve post. In various embodiments, the suture guard may also operate to cover or at least extend over an outflow end of the valve post, as illustrated and described below. A suture guard that extends over an outflow end of the valve post can operate to deflect suture line running along an exterior of the valve from migrating to a position interior to a valve post. 
     In some embodiments, the heart suture guards include ramping features that are configured to deflect suture away from the valve posts. In some examples, the suture guards help the suture land safely on a suture ring or sewing cuff on the prosthetic valve without getting entangled with the valve posts. 
       FIGS. 1A and 1B  are outflow and inflow, respectfully, perspective views of a valve  100  in the form of a prosthetic heart valve, in accordance with an embodiment. The components of the valve  100  that are visible in  FIGS. 1A and 1B  include three flexible leaflets  310 , a leaflet frame  200  including three valve (commissure) posts  210  that has been covered with material, a base frame  500  that has been covered with material, and a sewing cuff  600 . The leaflet free edges  312  of the leaflets  310  come together at a coaptation region  316  in a Y-shaped pattern (when viewed from above) to close the valve  100 . The valve  100  closes in this fashion when the pressure of the blood on the outflow side (as viewed in  FIG. 1A ) is greater than the pressure of the blood on the inflow side of the valve (as viewed in  FIG. 1B ). The leaflet free edges  312  of the leaflets  310  move apart to open the valve  100  and to let blood flow through the valve  100  from the inflow side as viewed in  FIG. 1B  when the pressure of the blood on the inflow side of the valve  100  is greater than the pressure on the outflow side of the valve  100 . For purposes of this disclosure, it is to be understood that the inflow side or end of the heart valve  100  is considered “proximal” to the outflow side or end of the heart valve  100 , while the outflow side or end of the heart valve  100  is considered “distal” to the inflow side or end of the heart valve  100 . 
     The leaflets  310  generally flex about the leaflet base  325  of the U-shaped portion as the leaflets  310  open and close. In an embodiment, when the valve  100  is closed, generally about half of each leaflet free edge  312  abuts an adjacent half of a leaflet free edge  312  of an adjacent leaflet  310 , as shown in  FIG. 1A . The three leaflets  310  of the embodiment of  FIG. 1A  meet at a triple point  348 . The valve orifice  150  is occluded when the leaflets  310  are in the closed position stopping fluid flow during reverse flow. 
     In accordance with other embodiments of the valve  100 , each leaflet  310  includes a central region  329  and two side regions  328  on opposite sides of the central region  329 . The central region  329  is defined by a shape substantially that of an isosceles trapezoid defined by two central region sides  327 , the leaflet base  325  and the leaflet free edge  312 . Each of the side regions  328  has a shape substantially that of a triangle and each are defined by one of the central region sides  327 , one of the leaflet sides  323 , and the leaflet free edge  312 . 
       FIG. 2A  is a side-by-side illustration of a suture guard  202  in accordance with an embodiment. The suture guard  202  includes a first (upper) portion  204  and a second (lower) portion  206 . The first portion  204  is configured to interface with a prosthetic heart valve  100  (as shown in further detail in  FIGS. 2B-G ). The first portion  204  includes supports  208  that may be equal to a number of valve (commissure) posts  210 , shown in  FIGS. 1A-B . The supports  208  may interface with an internal portion of the valve (commissure) posts  210 . As described in further detail below, the supports  208  act as a surface to structurally support the valve (commissure) posts  210  when moved inwardly for delivery. More specifically, the suture guard  202  is configured to move, which may be by bending, one or more valve (commissure) posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . 
     In addition, the first portion  204  may also include tapered surfaces  211  that are carved out of the first portion  204  to avoid interference with the leaflets  310 . The first portion  204  may be arranged within an inflow side of the valve  100 . The first portion  204  of the suture guard  202  also includes fiber holding portions  212  that are arranged at a perimeter of the first portion  204  of the suture guard  202 . The fiber holding portions  212  include openings that a suture or fiber may be thread through in order to move the one or more valve (commissure) posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . 
     The second portion  206  of the suture guard  202  is arranged below or under the first portion  204 . The second portion  206  may be configured to apply the force used to move the one or more valve (commissure) posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . The second portion  206 , for example, can apply tension via a linear motion to the fiber or suture. The second portion  206  withdraws the one or more fiber lines inwardly toward the second portion  206  of the suture guard  202  to move the one or more valve (commissure) posts  210 . In addition, this mechanism shortens the length of the suture guard  202  and the one or more valve (commissure) posts  210  as opposed to lengthening the assembly. As shown in detail with reference to  FIGS. 2C-G , the second portion  206  may interface with a suture or fiber such that the suture or fiber slides inside the second portion  206 , which pulls the suture or fiber. This action by the second portion  206  applies the force used to move the one or more valve (commissure) posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . 
       FIG. 2B  is a first and second side view of the suture guard  202 , shown in  FIG. 2A , with a prosthetic heart valve  100 . The suture guard  202  is shown with the prosthetic heart valve  100 . The suture guard  202  does not alter the shape or otherwise move the prosthetic heart valve  100  at this point. The suture guard  202  is arranged within the inflow portion of the prosthetic heart valve  100  and may support the leaflets  310  during implantation. 
     The suture guard  202  is shown in an initial (e.g., not tensioned) position. The suture guard  202  has not applied to tension to or otherwise altered the shape of the prosthetic heart valve  100  in the position shown in  FIG. 2B . To connect the first portion  204  and the second portion  206 , the second portion  206  is pressed into the first portion  204 . In certain embodiments, the second portion  206  connects by using a click-tight mechanism or pawl mechanism. The second portion  206  connects with the first portion  204  with one click, in certain embodiments. 
     To align the suture guard  202  with the prosthetic valve  100 , the fiber holding portions  212  (or tabs) are aligned with the valve (commissure) posts  210 . The fiber holding portions  212  may be seated against the base of the prosthetic valve  100 , which may be facilitated by the tapered surfaces  211  of the first portion  204  of the suture guard  202 . 
       FIG. 2C  is a bottom view of the suture guard  202  and the prosthetic heart valve  100 , shown in  FIGS. 2A-B , with a fiber  214 . One end of the fiber  214  is wrapped through openings in the fiber holding portion  212 . The fiber  214  may be knotted at the through openings in the fiber holding portion  212  to tie the fiber  214  to the suture guard  202 . In certain embodiments, another fiber  214  is similarly routed through each of the fiber holding portions  212 . In other embodiments, a single fiber  214  is used. In certain embodiments, the fiber holding portions  212  are equal to the number of supports  208  in the first portion  204  of the suture guard  202 , which may be equal to a number of valve (commissure) posts  210 . The other end of the first fiber  214  is fed through the right hole in the fiber holding portions  212 , and through a sewing cuff  600  of the prosthetic heart valve  100 , in certain embodiments. The fibers  214  may be arranged from through a sewing cuff  600  to weave the fibers  214  between the inflow side and the outflow side of the prosthetic heart valve  100 . 
       FIG. 2D  is a first and second side view of the suture guard  202 , the prosthetic heart valve  100 , and the fiber  214 , as shown in  FIGS. 2A-C . After passing the fiber  214  through the sewing cuff (not shown), the fiber  214  is then passed through the valve (commissure) post  210 . The fiber  214  is routed along a side of the valve (commissure) posts  210  (e.g., a right side of the valve (commissure) posts  210  as shown on the left portion of  FIG. 2D ). The fiber  214  remains on an outer diameter of the prosthetic heart valve  100  and does not pass through the inner diameter of the prosthetic heart valve  100  at any point. The fiber  214  is passed through the valve (commissure) posts  210  to the left (as shown right portion of  FIG. 2D ) and engages with the prosthetic heart valve  100  in the same manner as the other valve (commissure) posts  210  but mirrored. 
       FIG. 2E  is top view (from the outflow side) of the suture guard  202 , the prosthetic heart valve  100 , and the fiber  214 , as shown in  FIGS. 2A-D . After arranging the fiber  214  as described with reference to  FIG. 2D , the fiber  214  may then be passed through the prosthetic heart valve  100  (e.g., through the sewing cuff) and through the left opening in the fiber holding portion  212 . The other two fibers  214  are then fed through their respective openings in the fiber holding portions (obstructed in  FIG. 2E ) through the prosthetic heart valve  100  (e.g., through the sewing cuff), and through their respective valve (commissure) posts  210 , as described with reference to the first fiber  214 . In this embodiment, the three fibers  214  are fed through the prosthetic heart valve  100  and suture guard  202 . The fibers  214  each span two valve (commissure) posts  210  with one end of the fibers  214  attached to the fiber holding portions  212  of the suture guard  202 . 
     Although the prosthetic heart valve  100  is shown as a tricuspid valve (e.g., three leaflets  310 ), the prosthetic heart valve  100  may include any number of leaflets (e.g., one, two, four, five, six, and so on). In embodiments where the prosthetic heart valve  100  includes a different number of leaflets  310 , the number of leaflets  310  may correspond to an equal number of aspects on the suture guard  202  such as an equal number of fibers  214 , fiber holding portions  212 , supports  208 , and valve (commissure) posts  210 . 
       FIG. 2F  is a partial cross-sectional first view and second side view of the suture guard  202 , the prosthetic heart valve  100 , and the fiber(s)  214  as shown in  FIGS. 2A-E . The free end of each fiber  214  is then fed inside the suture guard  202 . More specifically, the fiber  214  may be fed into the second portion  206  of the suture guard  202  between cone shaped members  216  of the second portion  206 . The fibers  214  may enter the second portion through openings  218 . 
     As shown in  FIG. 2F , the second portion  206  is shown engaged with the first portion  204  of the suture guard  202 . As compared to  FIG. 2G , the second portion  206  is outwardly extended from the first portion  204 . The second portion  206  may be threadedly engaged or engaged via a snap-fit (click-fit or pawl mechanism) connection to the first portion  204 . The second portion  206  is moved inwardly within the first portion  204  to adjust tension on the fibers  214  as shown in  FIG. 2G . The prosthetic valve  100  and suture guard  202  are packaged together and delivered to a physician for implantation in the configuration shown in  FIG. 2F . The physician engages the suture guard  202  by pressing (e.g., linearly actuating) the first portion  204  into the second portion  206 , which in turn, tensions the fiber(s)  214  causing the valve (commissure) posts  210  to deflect inward preparing the prosthetic valve  100  for insertion into the annulus. 
       FIG. 2G  is a partial cross-sectional first view and top view of the suture guard  202 , the prosthetic heart valve  100 , and the fiber(s)  214  as shown in  FIGS. 2A-F . The prosthetic valve  100  and the suture guard  202  are shown in an engaged state for implantation. With all the fibers  214  secured to the second portion  206  (e.g., inside cone shaped members  216 ), the prosthetic heart valve  100  is ready for implantation (e.g., after packaging and sterilization). When a surgeon is ready to implant the prosthetic heart valve  100 , a handle (e.g., as shown in  FIGS. 4-5 ) is attached to the second portion  206 , then the second portion  206  is pressed into the first portion  204  pulling the three fibers  214  with it as shown by the arrows in  FIG. 2G . The length of the fibers  214  are fixed from end-to-end, thus, the tension resulting from pressing the second portion  206  into the first portion  204  (e.g., linear motion mechanism) deflects or moves, which may be by bending, the valve (commissure) posts  210  inwards. The fibers  214  may be arranged from through the sewing cuff  600  to weave the fibers  214  between the inflow side and the outflow side of the prosthetic heart valve  100 . 
     To remove the suture guard  202 , the surgeon cuts each of the three fibers  214  in a designated area  220  (e.g., a cut slot as also shown in  FIG. 2C ) which releases the tension in the fibers  214  allowing the valve (commissure) posts  210  held inward by the fibers  214  to return to the initial position when the suture guard  202  is released from the prosthetic valve  100 . The suture guard  202  is removed from the prosthetic heart valve  100  by pulling the suture guard  202  out and away from the prosthetic heart valve  100 . The handle may be removed prior to removing the suture guard  202  or the handle may be reattached to facilitate removal of the suture guard  202 . As the ends of each of the fibers  214  remain attached to the suture guard  202  after being cut, the cut ends of each fiber  214  unwind back through the prosthetic heart valve  100  as the suture guard  202  is retracted away from the heart valve  100 . Thus, removing the suture guard  202  also removes the fibers  214  from the prosthetic heart valve  100 . 
     The suture guard  202  acts as a delivery tool to aide in the surgical process. As noted above, the suture guard  202  lessens the chance that sutures are entangled with for the valve (commissure) posts  210  and/or lessens the chance of suture wrapping around one or more of the leaflets  310  (shunt wrapping) during implantation of the prosthetic valve  100  at the target location. As discussed in detail above, the suture guard  202  is configured to ease of implantation, protect the anatomy, and prevent strut wrap. 
       FIG. 3A  is an exploded view of an example suture guard  202  and a prosthetic heart valve  100 , in accordance with an embodiment. The suture guard  202  includes a first (upper) portion  204  and a second (lower) portion  206 . The first portion  204  is configured to interface with a prosthetic heart valve  100 , as shown in further detail in  FIG. 3B . The suture guard  202  may also include an atraumatic dome  320 . The atraumatic dome  320  interfaces with the first portion  204  of the suture guard  202 . The first portion  204  may be arranged within the inflow section of the prosthetic heart valve  100  and the atraumatic dome  320  may be arranged within the outflow portion of the prosthetic heart valve  100 . The atraumatic dome  320  is configured to protect against injury to a portion of a heart. In addition, the atraumatic dome  320  is configured to create a ramp for sutures (used to attach the prosthetic valve  100  at an implant location) to slide over and past the valve (commissure) posts  210  of the prosthetic valve  100  to avoid suture entanglement with one or more leaflets of the valve (commissure) posts  210 . 
     As shown in  FIG. 3A , the second portion  206  may be separable from the first portion  204 . In addition, the suture guard  202  includes a fiber  214  routed through the suture guard  202 . One end of the fiber  214  is routed through an opening in the first portion  204  (e.g., as shown above in  FIGS. 2A-G ). The fiber  214  may be defined by one or more knotted portions  322 . In certain embodiments, the fiber  214  is routed through the valve (commissure) posts  210  of the prosthetic valve  100  as shown in  FIG. 3A . The valve (commissure) posts  210  may include an opening. 
     The second portion  206  of the suture guard  202  is arranged below or under the first portion  204  of the suture guard  202 . The second portion  206  may be configured to apply the force used to move the one or more valve (commissure) posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . The second portion  206 , for example, can apply a linear motion to the fiber  214  or fibers  214 . The second portion  206  withdraws the one or more fiber lines inwardly toward the second portion  206  of the suture guard  202  to move the one or more valve (commissure) posts  210 . In addition, this mechanism shortens the length of the suture guard  202  and the one or more valve (commissure) posts  210  as opposed to lengthening the assembly. 
     As shown in  FIG. 3A , the second portion  206  includes one or more prong structures  324  that interface with the first portion  204 . The one or more prong structures  324  force the fiber  214  into the first portion  204 . This action by the second portion  206  applies the tension to the fiber  214  as shown in further detail with reference to  FIG. 3B . 
     The second portion  206  can include a screw mechanism  326  configured to secure the second portion  206  to the first portion  204 . The screw mechanism  326  rotates relative to the second portion  206 . The screw mechanism  326  may facilitate applying tension to the fiber  214  and maintaining tension on the fiber  214  during delivery and implantation of the prosthetic valve  100 . 
       FIG. 3B  is another view of the suture guard  202  and the prosthetic heart valve  100 , as shown in  FIG. 3A  with the second portion  206  coupled with the first portion, and with portions removed for ease of understanding. As shown in  FIG. 3B , the prong structures  324  force the fiber  214  into the first portion  204  thereby applying tension to the fiber  214 . The fiber  214  is crimped up into the first portion  204  by the prong structures  324 . Because the fiber  214  is coupled to at least one of the one or more valve (commissure) posts  210  of the prosthetic valve  100 , the tension moves the valve (commissure) posts  210  inwardly toward a longitudinal axis of the prosthetic valve  100 . 
     In certain embodiments, the fiber  214  is secured to each of the valve (commissure) posts  210 . In other embodiments, the suture guard  202  may include multiple fibers  214  (e.g., as described with reference to  FIGS. 2A-G ). When a surgeon is ready to implant the prosthetic heart valve  100 , a handle (e.g., portions of which are shown in  FIGS. 4-5 ) is attached to the second portion  206  at the screw mechanism  326 . The handle may be used to actuate the screw mechanism  326  to apply tension to the fiber  214 . The atraumatic dome  320  and the screw mechanism  326  can include oppositely threaded portion such that the screw mechanism  326  can fix the first portion  204  and the second portion  206  of the suture guard  202  together. In addition, the handle can include oppositely threaded portions relative to the screw mechanism  326  in order to tighten the screw mechanism  326  and tension the fiber  214 . 
     To remove the suture guard  202 , the surgeon cuts the fiber  214  in a designated area which releases the tension in the fiber  214  lines allowing the valve (commissure) posts  210  inwards to return to intended position. The suture guard  202  is removed from the prosthetic heart valve  100  by pulling the suture guard  202  out and away from the prosthetic heart valve  100 . The handle may be removed prior to removing the suture guard  202 , in other instances, the handle may be reattached to facilitate removal of the suture guard  202 .  FIG. 3C  is a bottom view of the suture guard  202  and the prosthetic heart valve  100 , as shown in  FIGS. 3A-B , without the atraumatic dome  320   
       FIG. 4A  is a partial cross-sectional view of an example suture guard  202 , a prosthetic heart valve  100 , and a delivery handle  410 , in accordance with an embodiment. The suture guard  202  shown in  FIG. 4A  includes an atraumatic dome  320  having an internally threaded portion  402 . The atraumatic dome  320  includes deflection lobes  404  that are configured to interface and couple the atraumatic dome  320  to another portion of the suture guard  202 .  FIG. 4A  also shows a sleeve  400  that is used to facilitate use of the delivery handle  410 . 
     The sleeve  400  shown in  FIG. 4A  includes an externally threaded portion  406  that is configured to thread into the internally threaded portion  402  of the atraumatic dome  320 . The externally threaded portion  406  is configured to interface with one or more fibers  214  that are arranged with one or more of the valve (commissure) posts  210  of the prosthetic valve  100 . The delivery handle  410  is configured to apply tension to the one or more fibers  214 . The externally threaded portion  406  rotates relative to the internally threaded portion  402  and applies tension to the fiber  214  due the externally threaded portion  406  and the internally threaded portion  402  moving apart. This maintains tension on the fiber  214  during implantation of the prosthetic valve  100 . Because the fiber  214  is coupled to at least one of the one or more valve (commissure) posts  210  of the prosthetic valve  100 , the handle  410  applies tension and moves the valve (commissure) posts  210  inwardly toward a longitudinal axis of the prosthetic valve  100 . 
     The sleeve  400  includes tabs  408  that interface with the suture guard  202 . In addition, the delivery handle  410  that is configured to move relative to the sleeve  400  to apply tension to the fiber  214 . The delivery handle  410  is coupled to the externally threaded portion  406 .  FIG. 4 -B show a portion of the delivery handle  410 . The delivery handle  410  is accessible to an operating physician and extends outside the body. In certain instances, the delivery handle  410  portion shown attaches to another handle. The delivery handle  410  shown may be disposable. 
       FIG. 4B  is a partial cross-sectional view of the suture guard  202 , the prosthetic heart valve  100 , and the sleeve  400 , as shown in  FIG. 4A , in another configuration. The sleeve  400  is separated from the suture guard  202  in the configuration shown in  FIG. 4B . As shown in  FIG. 4B , the illustrative valve (commissure) post  210  is moved inwardly compared to the configuration shown in  FIG. 4A . To facilitate release of the sleeve  400  from the suture guard  202 , the delivery handle  410  is dovetailed at the point of interface with the externally threaded portion  406 . As a result, the externally threaded portion  410  may be slid perpendicular to the externally threaded portion  406  to release from the externally threaded portion  406 . Thus, the delivery handle  410  and the sleeve  400  are uncoupled and released from the suture guard  202 . 
       FIG. 5  is a partial cross-sectional view of an example valve holding  200  device, a prosthetic heart valve  100 , and another delivery handle  505 , in accordance with an embodiment. The suture guard  202  shown in  FIG. 5  includes an atraumatic dome  320  having an internally threaded portion  402 . The delivery handle  505  is accessible to an operating physician and extends outside the body. In certain instances, the delivery handle  505  portion shown attaches to another handle. The delivery handle  505  shown may be disposable. 
     The delivery handle  505  shown in  FIG. 5  includes an externally threaded portion  406  that is configured to thread into the internally threaded portion  402  of the atraumatic dome  320 . The externally threaded portion  406  is configured to interface with one or more fibers  214  that are arranged with one or more of the valve (commissure) posts  210  of the prosthetic valve  100 . The delivery handle  505  is configured to control the suture guard  202  and apply tension to the one or more fibers  214 . The externally threaded portion  406  rotates relative to the internally threaded portion  402  and applies tension to the fiber  214  and maintains tension on the fiber  214  during delivery and implantation of the prosthetic valve  100 . Because the fiber  214  is coupled to at least one of the one or more valve (commissure) posts  210  of the prosthetic valve  100 , the handle  505  applies tension and moves the valve (commissure) posts  210  inwardly toward a longitudinal axis of the prosthetic valve  100  as shown in  FIG. 5 . 
     The delivery handle  505  configured to separate from the suture guard  202  by applying pressure at area  506  as indicated by the arrows. Applying pressure at the area  506  opens the delivery handle  505  at area  508  as indicated by the arrows. As a result, the delivery handle  505  releases the externally threaded portion  406 . Thus, the delivery handle  505  is uncoupled from the suture guard  202 . 
       FIG. 6  is an illustration of an example suture guard  202  and a prosthetic heart valve  100 , in accordance with an embodiment. The holding device  200  shown in  FIG. 6  is an everted tube. The everted tube holding device  200  is arranged through the inflow portion of the prosthetic valve  100  and folded over the valve (commissure) posts (for further detail regarding the everted tube holding device  200 , reference may be made to  FIGS. 18-20 ). The everted tube holding device  200  is secured in place by a fiber that is arranged through the prosthetic valve  100  in accordance with the examples discussed above. As shown, the everted tube holding device  200  is configured to cover the valve (commissure) posts to help minimize the potential for suture looping. For example, the everted tube holding device  200  operates to deflect suture line extending along and exterior of the valve from becoming entangled with one or more of the covered valve (commissure) posts during the implantation procedure. 
     In some examples, the everted tube holding device  200  may be configured to engage the valve (commissure) posts to move the one or more valve (commissure) posts of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . For instance, to move the valve (commissure) posts inwardly, the everted tube holding device  200  may be configured to create a surface on which the fiber  214  or fibers  214  (as noted above, the number of fibers may be equal to the number of valve (commissure) posts) slide, as they are tensioned in relation to the valve (commissure) posts, which causes the valve (commissure) posts to be moved inward. Additionally or alternatively, the everted tube holding device  200  may provide cushioning to the valve (commissure) posts to further reduce likelihood of trauma during implantation. 
     The everted tube holding device  200  may be removed from the prosthetic heart valve  100  by releasing the fiber  214  or fibers  214 , which releasing tension on the everted tube holding device  200  and the valve (commissure) posts. The everted tube holding device  200  may then be slid through the prosthetic valve  100 . Additional examples of suture guards that operate to cover one or more of the valve (commissure) posts are illustrated and described further below with regard to  FIGS. 29A-33B . 
       FIG. 7  is an illustration of another example suture guard  202  and a prosthetic heart valve  100 , in accordance with an embodiment. The suture guard  202  includes one or more retractable arms  700  that cover valve (commissure) posts of the prosthetic heart valve  100 . The retractable arms  700  provide a soft barrier between the valve (commissure) posts of the prosthetic heart valve  100  and anatomical features, such as the interior walls of the heart, thereby reducing the likelihood of trauma. These arms also provide a ramping surface for fiber loops  214  to slide past the valve (commissure) posts of the prosthetic heart valve  100 . The retractable arms  700  can be retractable allowing for the prosthetic heart valve  100  to be removed from the upstream side of the prosthetic heart valve  100 . 
     The suture guards discussed herein are configured to protect prosthetic heart valves during surgery, protect tissue during insertion, and provide room for suture placement and tying as discussed in detail above. The suture guards  200  are also configured to connect and disconnect to a delivery handle, and attach/detach from prosthetic heart valves  100  from the inflow direction. 
       FIG. 8  is an illustration of example fiber pathway, in accordance with an embodiment. The fiber  214  may be routed across a surface  800  and through a trough  802 . The fiber  214  includes a non-adjustable direction  804  and an adjustable direction  806 . As shown in  FIG. 8 , the fiber  214  is routed underneath itself resulting in the fiber  214  arranged in the trough  802  when the non-adjustable direction  804  is placed under tension. 
     The surface  800  includes an area  808  on the back of the surface  800 , which can be a device as discussed herein, to facilitate removal of the fiber  214  by cutting the fiber  214 . The routing of the fiber  214  allows for one of the fiber to slip when pulled (in the adjustable direction  806 ) while not allowing the other end of the fiber  214  to slip (in the non-adjustable direction  804 ). 
     The surface  800  may be a portion of the suture guard  202  shown and discussed herein. The surface  800  and corresponding features shown in  FIG. 8 , for example, may be arranged at the perimeter of the suture guard  202  for the fiber  214 . Anywhere the fibers  214  are anchored (e.g., fiber holding portions shown in  FIGS. 2A-G  or knotted portions  322  shown in  FIGS. 3A-B ) may utilize the aspects of  FIG. 8 . 
       FIG. 9  is an illustration of example fiber wrapping pathway, in accordance with an embodiment. The fiber  214  may be routed through a device  900 . The device includes pathways  902  through which the fiber  214  may be routed. The fiber  214  includes a non-adjustable direction  804  and an adjustable direction  806 . As shown in  FIG. 9 , the fiber  214  is routed onto itself. The pathways  902  are large enough to fit two fibers  214  as shown in the left portion of  FIG. 9 , but not for three fibers  214 . In certain embodiments, a release fiber  904  may be used to release the fiber  214 . The release fiber  904  acts as lock loop that can release the fiber  214  when pulled in a release direction  906 . As shown in the right portion of  FIG. 9 , the pathways  902  are large enough for 3 fibers but not for 4 fibers. 
     The routing of the fiber  214  allows for one of the fiber to slip when pulled (in the adjustable direction  806 ) while not allowing the other end of the fiber  214  to slip (in the non-adjustable direction  804 ). 
     The device  900  may be a portion of the suture guard  202  shown and discussed herein. The device  900  and corresponding features shown in  FIG. 9 , for example, may be arranged at the perimeter of the suture guard  202  for the fiber  214 . Anywhere the fibers  214  are anchored (e.g., fiber holding portions shown in  FIGS. 2A-G  or knotted portions  322  shown in  FIGS. 3A-B ) may utilize the aspects of  FIG. 9 . 
       FIG. 23  is an illustration of an example handle  2300 , in accordance with an embodiment. The handle  2300  may be disposable and remotely actuatable to release fibers  214  from the suture guards  202  discussed herein. As shown in  FIG. 23 , the handle  2300  includes a release fiber  904 . The release fiber  904  can be engaged with fibers  214  as shown in  FIG. 9 . 
     An end of the release fiber  904  may also be coupled to cap  2302 . The cap  2302  is removeable from the handle  2300  by pulling on the cap  2302  in the direction shown. In this manner, the release fiber  904  is removed through a catheter  2304  portion of the handle  2300 . As a result, the release fiber  904  unlocks the fiber  214  or fibers  214 , as shown in  FIG. 9 . 
     As noted above, upon application of linear motion by the suture guard  202 , the one or more fiber lines  214  are configured to apply tension to move one or more valve posts  210  of the prosthetic valve  100  inwardly toward a longitudinal axis of the prosthetic valve  100 . The release fiber  906  is coupled to the cap  2302  and configured to releasably lock the one or more fiber lines  214  with the suture guard  202 , as discussed with reference to  FIG. 9 . Upon actuation and removal of the cap  2302  from the handle  2300 , the release fiber  906  releases the release fiber  906  from the pattern shown in  FIG. 9  to unlock the one or more fiber lines  214 . 
       FIGS. 29A to 33B  provide illustration on an example system  1000  according to some embodiments. The system  1000  generally includes a suture guard  2000  that operates to protect one or more components of a heart valve  100  during an implantation procedure of the heart valve  100 . In various embodiments, the suture guard  2000  is configured to minimize a possibility for entanglement of suture line (or other deployment components) with one or more portions of the heart valve  100 . For instance, as mentioned above, in various implantation procedures, one or more suture lines are utilized to install or implant the prosthetic heart valve  100  into a native valve annulus. In certain implantation procedures, the heart valve  100  is translated along one or more suture lines toward the native valve annulus (see, e.g.,  FIG. 32 ). The suture guard  2000  operates to help minimize a possibility that the suture line will become entangled with one or more of the commissure posts  210  as the heart valve  100  is translated along the suture line by covering, for example, one or more commissure posts of the prosthetic heart valve  100 . It should be appreciated that the prosthetic heart valve  100  illustrated and described with reference to  FIGS. 29A-29E, 32, and 33A-1 and 33A-2  is consistent in form and function with the heart valve  100  illustrated and described above. 
     In some examples, the suture guard  2000  is configured such that it operates to deflect suture line such that the suture line does not cross from one side of a commissure post  210  to an opposing side of the commissure post radially inwardly of the commissure post  210 . For instance, in some examples, the suture guard  2000  is configured to extend over the commissure posts  210  of the heart valve  100  as shown in  FIGS. 29A-29E .  FIG. 32  also provides an illustration of the suture guard  2000  deployed over a heart valve  100  with suture line  3000  extending along the exterior of the commissure posts  210  of the heart valve  100 . While not essential, in some embodiments, the suture guard  2000  may optionally be configured such that upon deployment of the suture guard  2000 , the suture guard  2000  engages the commissure posts  210  to cause a radially inward deflection thereof. 
     It is also to be appreciated that the suture guard  2000  illustrated and described with regard to  FIGS. 29A-33B  may be optionally used in combination with the various other suture guards illustrated and described herein. For instance, after utilizing suture guard  202  (e.g.,  FIGS. 2A-2G ) to deflect the valve posts radially inward in preparing a heart valve  100  for insertion into the annulus, for example, the suture guard  2000  illustrated and described with regard to  FIGS. 29A-33B  may be utilized to cover the commissure posts  210  the heart valve  100  to help deflect suture line extending along and exterior of the heart valve  100  from becoming entangled with the commissure posts  210 . Alternatively, the suture guard  2000  illustrated and described with regard to  FIGS. 29A-33B  may be utilized in lieu of the various other suture guards illustrated and described herein, and does not require the commissure posts  210  of the heart valve  100  to be deflected radially inward. 
       FIGS. 29A-29E  provide illustration of a system  1000  including an example suture guard  2000  and a prosthetic heart valve  100 , in accordance with an embodiment. The suture guard  2000  is shown in  FIGS. 29A-29E  in a deployed configuration in combination with a heart valve  100 , where the suture guard  2000  covers one or more portions of the commissure posts  210  of the heart valve  100 .  FIGS. 30A-30C  illustrate the suture guard  2000  in the deployed configuration with the heart valve  100  removed, for clarity. Conversely,  FIGS. 31A-31B  illustrate the suture guard  2000  in the non-deployed configuration with the heart valve  100  removed, for clarity. 
     In various embodiments, the suture guard  2000  generally includes a cover member and a base. In some examples, the cover member includes a frame element, and may optionally include a film element coupled to the frame element. For example, as shown in  FIGS. 29A-31B , the suture guard  2000  includes a cover member  2100 . In various examples, the cover member  2100  includes a frame element  2200  and a film element  2306 . In some examples, the frame element  2200  and the film element  2306 , collectively, define the cover member  2100 . However, in some examples, the cover member  2100  may include the frame element  2200  without also requiring the film element  2306 . In yet further examples, similar to those discussed above with respect to  FIG. 6 , a suture guard may include a cover member without a frame element.  FIG. 29D  is a top view of the system  1000  consistent with  FIG. 29C , but with the film element  2306  highly transparent to illustrate the frame element  2200  extending into the base  2400   
     The frame element  2200  may be formed of one or more elongate members (e.g., a wire). In the exemplary embodiments depicted in  FIGS. 29A-33B , the frame element  2200  is formed of a plurality of interrelated elongate members,  2200 A,  2200 B, and  2200 C, that collectively define a cover member  2100  having a triple petal configuration. It should be understood, however, that the depicted frame element  2200  is not the only frame element configuration envisioned within the scope of the disclosure. The frame element  2200  can differ from the embodiments depicted in  FIGS. 29A-33B  in numerous ways such as, but not limited to, the number of petals, the geometries of the interrelated elongate members, including the various curvatures and angles of the interrelated elongate members, collectively, and individually, the number of elongate members forming the frame element  2200  (e.g., 1, 2, 3, elongate members, such as a single continuous elongate member, or multiple discrete yet interrelated elongate members), and/or the diameter(s) of the elongate members. 
     The elongate members  2200 A,  2200 B, and  2200 C may be formed of various materials and/or combinations of materials. In exemplary embodiments, nitinol (NiTi) is used as the material of the elongate members. However, other materials such as stainless steel, polymeric materials, polyamide, polyester, polyimide, biosorbable polymers, a cobalt, chromium, nickel alloy, or any other appropriate biocompatible material, and combinations thereof, may be used as the material of the elongate members. In various embodiments, the frame element  2200  is generally conformable, fatigue resistant, elastic, and distensible such that the frame element  2200  can transition between deployed and non-deployed configurations. In various embodiments, the frame element  2200  provides structure and shape for the cover member  2100  of the suture guard  2000 . In the embodiment depicted in  FIGS. 29A-33B , the frame element  2200  provides a supportive structural framework for the film element  2306 , which may otherwise be relatively flaccid and flexible. 
     In various embodiments, the film element  2306  may attached to or otherwise coupled with at least a portion of the frame element  2200 . In some examples, the film element  2306  is attached to the frame element  2200  with an adhesive material, such as, for example, a silicone, a polyurethane, or fluorinated ethylene propylene (FEP). Silicone, for example, may be utilized as a bonding agent to adhere the film element  2306  to the frame element  2200 . The adhesive material may be applied to portions of the frame element  2200  or to all of the frame element  2200 . 
     In some examples, some or all of the film element  2306  is disposed on both sides (e.g., a first side  2202  and a second side  2204 ) of the frame element  2200  such that the elongate members—e.g., elongate members  2200 A,  2200 B, and  2200 C—are encapsulated by the film element  2306 . In some examples, the first side  2202  of the frame element  2200  corresponds to a portion of the cover member  2100  that faces the heart valve  100  when the suture guard  2000  is in the deployed configuration. This first side  2202  of the frame element  2200  may alternatively be referred to as the portion of the cover member  2100  exposed to an interior lumen of the base  2400  of the suture guard  2000  in the non-deployed configuration (also referred to herein as the delivery configuration). In some examples, the second side  2204  of the frame element  2200  corresponds to a portion of the cover member  2100  opposite the first side  2202 , and that faces away from the heart valve  100  when the suture guard  2000  is in the deployed configuration. In the deployed configuration, the first side  2202  can be understood to face in an outflow direction of the heart valve  100 , while the second side  2204  can be understood to face in an inflow direction of the heart valve  100 . 
     In various examples, portions of the film element  2306 , such as those on opposing sides of the frame element  2200 , may be adhered to each other so as to encapsulate portions of or the entirety of the frame element  2200 . Stitching, lashing, banding, and/or clips may be alternatively used to attach the film element  2306  to the frame element  2200 . In some embodiments, a combination of techniques is used to attach the film element  2306  to the frame element  2200 . 
     In various embodiments, the film element  2306  may be formed of a membranous material that inhibits or reduces the passage of blood and/or other bodily fluids and materials through the film element  2306 . In an exemplary embodiment, the film element  2306  is a polymer material, such as, for example, a fluoropolymer material. In at least one embodiment, the film element  2306  is an expanded polytetrafluoroethylene membrane. It is to be appreciated that the film element  2306  may be formed of other materials, such as, but not limited to a silicone, a urethane, a polyester (e.g., DACRON®), and combinations thereof. 
     As shown in  FIGS. 29A-30C , when in the delivery configuration, the suture guard  2000  is configured such that the cover member  2100  extends radially outwardly from the base  2400 . As shown in  FIGS. 29A-29C , the cover member  2100  extends radially outwardly of an interior surface(s)  222  of the outflow end(s)  224  of the commissure post(s)  210 , distal to the outflow end(s)  224  of the commissure post(s)  210 . In some examples, the cover member  2100  extends radially outwardly of an exterior surface(s)  226  of the outflow end(s)  224  of the commissure post(s)  210 .  FIG. 33A-1  is a cross sectional view of the system  1000  of  FIG. 29B  taken along line  33 - 33 , with the film element  2306  removed for clarity. 
     As shown in  FIG. 33A-1 , the cover member  2100 , including the frame element  2200  extends radially outwardly of the commissure post  210  of the heart valve  100 . By extending radially outwardly of the commissure post  210  or otherwise covering the commissure post(s)  210 , the cover member  2100  operates to deflect suture line (such as suture line  3000 ) extending along and exterior of the commissure post  210  such that the suture line does not become entangled with the commissure post  210  as the heart valve  100  is advanced along (and relative to) the suture line. 
     In various embodiments, the cover member  2100  is configured to adopt a predetermined deployment shape once deployed from the base  2400 . In some example, the shape adopted by the cover member  2100  is dictated by a predetermined shape of the frame element  2200 . In some other examples, the shape adopted by the cover member  2100  is additionally or alternatively dictated by a predetermined shape of the film element  2306 . That is, in various embodiments, one or more of the materials of the cover member  2100  are configured with shape memory properties that operate to cause the cover member  2100  to adopt a predetermined deployment shape when the suture guard  2000  is transitioned to the deployed configuration. 
     In various embodiments, the cover member  2100  is configured to evert as it is deployed from the base  2400 . For instance, as shown in  FIGS. 29A-30C , in the deployed configuration, a first portion  2102  of the cover member  2100  is everted relative to second portion  2104  of the cover member  2100 , with a transition region  2106  therebetween. Conversely, as shown in  FIGS. 31A-31C  in the non-deployed configuration (e.g., the delivery configuration), the first portion  2102  of the cover member  2100  is non-everted relative to the second portion  2104  of the cover member  2100 . Thus, in some examples, in the deployed configuration, the cover member  2100  includes an everted portion (e.g., first portion  2102 ) and a non-everted portion (e.g., second portion  2104 ). As shown, in the non-deployed configuration each of the first and second portions  2102  and  2104  extend in an outflow direction with the transition region  2106  therebetween, whereas in the deployed configuration, the first portion  2102  (e.g., the everted portion) is everted such that the first portion  2102  extends from the transition region  2106  in an inflow direction towards an inflow end  2410  of the base  2400 . Thus, an axial length of the cover member  2100  measured along the longitudinal axis of the suture guard is greater in the non-deployed configuration than in the deployed configuration. Moreover, a radial profile (e.g., a diameter of the cover member  2100 ) is greater in the deployed configuration than in the non-deployed configuration. It should thus be appreciated that, when transitioning from the non-deployed configuration to the deployed configuration, a portion of the axial length of the cover member  2100  is converted into the radial dimension of the cover member  2100 . In other words, in various examples, in the non-deployed configuration the suture guard  2000  has a first axial length and a first diameter, whereas in the deployed configuration the suture guard has a second, shorter axial length and a second, greater diameter. 
     Such a deployed configuration provides that the cover member  2100  is configured to adopt a delivered profile conducive for covering one or more portions of the heart valve  100  during implantation of the heart valve  100  to help minimize a potential for suture line entanglement. With reference to  FIG. 33A-2 , it should be appreciated that, while the cover member  2100  is illustrated with the first portion  2102  of the cover member extending at an angle 0&gt;θ&gt;180 relative to a longitudinal axis of the system  1000  (e.g., angle θ is also representative of the relative angle between the longitudinal axis of the heart valve  100  and the first portion  2102 , and the relative angle between the longitudinal axis of the second portion  2104  of the cover member  2100  and the first portion  2102 ), the angle θ may be equal to zero or one hundred eighty degrees (0≥θ≥180). Put differently, the first portion  2102  and the second portion  2104  may be parallel or non-parallel provided that that the cover member  2100  extends to a position radially outwardly of the interior surface(s)  222  of the outflow end(s)  224  of the commissure post(s)  210 . 
     As mentioned above, the shape adopted by the cover member  2100  may be dictated by the properties of one or more of the frame element  2200  and the film element  2306 . For instance, in some examples, the frame element  2200  includes a plurality of elongate members (e.g.,  2200 A,  2200 B, and  2200 C), where the elongate members include shape memory properties that operate to bias the cover member  2100  such that the cover member  2100  adopts a predetermined profile when not otherwise constrained, such as by the base  2400 . 
     As shown in  FIGS. 29C and 29D , the various elongate members  2200 A,  2200 B, and  2200 C are shaped such that they collectively form a multi-petal geometry, where each petal is configured to cover or overlay a respective commissure post of a heart valve. The cover member  2100  shown in  FIGS. 29C and 29D  includes three petals,  2110 ,  2112 , and  2114 . The first petal  2110  includes elongate members  2200 A and  2200 C. The second petal  2112  includes elongate members  2200 A and  2200 B. The third petal  2114  includes elongate members  2200 B and  2200 C. 
     The elongate members  2200 A,  2200 B, and  2200 C may be bent or formed with one or more bend regions, and optionally one or more loop regions. For example, elongate member  2200 C includes a plurality of loop regions, including first loop region  2206 C and second loop region  2208 C, as well as a bend region  2210 C. As shown, the bend region  2210 C is situated between the first and second loop regions  2206 C and  2208 C. Situated between the bend region  2210 C and the first loop region  2206 C is a first length or strut  2212 C of elongate member  2200 C. Similarly, situated between the bend region  2210 C and the second loop region  2208 C is a second length or strut  2214 C of elongate member  2200 C. The elongate member  2200 C is configured such that, when the suture guard  2000  is in the non-deployed configuration, the first and second lengths  2212 C and  2214 C of the elongate member  2200 C are angled away from one another at a first angle. Conversely, when the suture guard  2000  is in the deployed configuration, the elongate member  2200 C is configured such that the first and second lengths  2212 C and  2214 C are angled away from one another at a second angle greater than the first angle. That is, an angle of the bend region  2210 C is configured to change as the suture guard is transitioned between the deployed and non-deployed configurations. 
     In particular, as the suture guard  2000  is transitioned from the non-deployed configuration to the deployed configuration, the bend region  2210 C is configured such that the angle of bend region  2210 C increases, such that the elongate member  2200 C adopts the deployed profile illustrated in  FIGS. 29C and 29D . In some examples, the angle of bend region  2210 C increases from an acute angle to an obtuse angle as the suture guard  2000  is transitioned from the non-deployed configuration to the deployed configuration. Conversely, as the suture guard  2000  is transitioned from the deployed configuration to the non-deployed configuration, the bend region  2210 C is configured such that the angle of bend region  2210 C decreases, causing the first and second lengths  2212 C and  2214 C of the elongate member  2200 C to be drawn closer to one another. In various examples, the elongate member  2200 C is shape set to adopt the deployed profile illustrated in  FIGS. 29C and 29D . The elongate members  2200 A,  2200 B, and  2200 C may be shape set according to known methods. Accordingly, in such examples, when the suture guard  2000  is situated in the non-deployed configuration, the angle of the bend region  2210 C is reduced such that the material of the bend region  2210 C stores energy. As the suture guard  2000  is transitioned from the non-deployed configuration to the deployed configuration, this energy that is stored in the bend region  2210 C is converted to kinetic energy and helps transition the suture guard  2000  to the deployed configuration (e.g., helps the cover member adopt the deployed profile). 
     In various examples, the first and second loop regions  2206 C and  2208 C of elongate member  2200 C help define, at least in part, the first and third petals  2110  and  2114 , respectively of the cover member  2100 . As shown, petal  2114  is defined, at least in part, by loop region  2208 C of elongate member  2200 C and by loop region  2208 B of elongate member  2200 C. Petals  2110  and  2112  are similarly defined, at least in part, by a plurality of loop regions of a plurality of elongate elements. While the cover member of  FIGS. 29C and 29D  is configured such that each petal includes a plurality of loop portions, such as from a plurality of elongate elements, it should be appreciated that elongate elements may alternatively be configured such that each petal of the cover member  2100  includes only one of the elongate elements. 
     In various examples, opposing loop regions of a plurality of elongate elements that collectively define a petal of the cover member  2100  may be coupled together via the film element  2306  of the cover member  2100 . For example, as shown, the film element  2306  couples together the loop regions of the elongate members  2200 A and  2200 C at petal  2110 . Likewise, the film element  2306  couples together the loop regions of the elongate members  2200 A and  2200 B at petal  2112 . Likewise, the film element  2306  couples together the loop regions of the elongate members  2200 B and  2200 C at petal  2114 . 
     It should also be appreciated that while the suture guard  2000  is illustrated in  FIG. 33A-1  in the deployed configuration with a portion of the cover member  2100  (e.g., the first portion  2102 , or a portion thereof) extending proximal to the outflow end  224  of the commissure post(s)  210 , the suture guard  2000  may alternatively be configured such that cover member  2100  does not extend proximal to the outflow end(s)  224  of the commissure post(s)  210 , but instead extends radially outwardly of the interior surface(s)  222  of the commissure post(s) distal to the outflow end(s)  224  of the commissure post(s)  210 . 
     The suture guard  2000  may configured such that the cover member  2100  is selectively deployable from the base  2400 , or may alternatively be configured such that the cover member  2100  automatically deploys from the base  2400  upon an activation of the base  2400 . That is, the cover member  2100  may deploy from the base  2400  to cover the commissure post(s) of the heart valve  100  without requiring manipulation of the cover member  2100  aside from activation of the base  2400 . For instance, in some examples, the base  2400  is comprised of a support element  2402  and a shaft element  2404 , where the shaft element  2404  is operable to translate (e.g., be advanced and/or retracted) relative to the support element  2402 . In some such examples, the support element  2402  includes a lumen  2412  through which the shaft element  2404  extends. In some examples, a cross-sectional profile of the shaft element  2404  taken transverse to a longitudinal axis of the base  2400  (referred to hereinafter as a transverse cross-sectional profile of the shaft element) is complimentary of a luminal profile of the lumen  2412 . In some examples, the shaft element  2404  includes one or more protrusions, such as protrusions  2432  extending along its longitudinal length that are complimentary to one or more features  2434  of the luminal profile of the support element  2402 , and that operate to constrain the shaft element  2404  against substantial rotational movement relative to the support element  2402 . As discussed in greater detail below, such protrusions may additionally or alternatively operate to bias or maintain the shaft element  2404  in one or more discrete positions (e.g., axial or angular) relative to the support element  2402 . 
     In various examples, as the shaft element is advanced relative to the support element  2402 , the cover member  2100  is automatically deployed from an outflow end  2406  of the shaft element  2404 . In some examples, the shaft element  2404  includes a lumen  2408  extending through the shaft element  2404  and through which the cover member  2100  extends. Thus, in various examples, one or more of the frame element  2200  (including one or more of elongate members  2200 A,  2200 B, and  2200 C) and the film element  2306  extends through and is translatable (e.g., advanceable or retractable) relative to the shaft element  2404  of the base  2400 . 
     In various examples, one or more of the frame element  2200  and the film element  2306  are operably coupled to one or more of the support element  2402  and the shaft element  2404  such that advancement of the shaft element  2404  relative to the support element  2402  causes advancement (e.g., translation in the outflow/distal direction) of the cover member  2100  relative to the shaft element  2404 , which causes the suture guard  2000  to transition to the deployed configuration, where the cover member  2100  extends radially outwardly of the lumen  2408  of the shaft element  2404 . 
     Similarly, in various examples, one or more of the frame element  2200  and the film element  2306  are operably coupled to one or more of the support element  2402  and the shaft element  2404  such that retraction of the shaft element  2404  relative to the support element  2402  causes retraction (e.g., translation in the inflow/proximal direction) of the cover member  2100  relative to the shaft element  2404 , which causes the suture guard  2000  to transition to the non-deployed (e.g., delivery) configuration. Associating the deployment and retraction of the cover member  2100  of the suture guard  2000  with the activation of the base  2400  provides for minimizing a potential for mishandling of the suture guard  2000 , including premature deployment or retraction of the cover member  2100 . 
     In addition to the discussion above, it should be appreciated that, in some examples, the suture guard  2000  is configured such that in the non-deployed (e.g., delivery) configuration the cover member  2100  is situated within the lumen  2408  of the base  2400  in a collapsed configuration. That is, in some examples, the suture guard  2000  is configured such that in the non-deployed configuration the cover member  2100 , including the frame element  2200  and/or the film element  2306 , is situated radially inwardly of the interior surface  222  of the outflow end  224  of the commissure post(s)  210 . 
     It should also be appreciated that while the examples illustrated and described above involve a base  2400  that is configured such that a shaft element  2404  is translatable relative to a support element  2402 , in various other examples, the base  2400  may be alternatively configured such that the shaft element  2404  is additionally or alternative rotatably coupled to the support element  2402 . In such examples, in addition to or as an alternative to translation of the shaft element  2404  relative to the support element  2402 , the shaft element  2404  is rotatable relative to the support element  2402 , where such rotation and/or translation operates to cause the cover member  2100  to extend radially outwardly of the interior surface  222  of the outflow end(s)  224  of the commissure post(s)  210 . 
     In some examples, one or more regions of the base  2400 , such as a wall of the lumen  2408 , operate as one or more bearing surfaces along which the cover member  2100  interacts as the cover member  2100  transitions between everted and non-everted configurations. Accordingly, in various examples, the base  2400  is configured to constrain the cover member  2100  in a collapsed configuration when the suture guard is in the non-deployed configuration. 
     In some examples where the base  2400  includes components (e.g., support element  2402  and shaft element  2404 ) that are configured to translate and/or rotate relative to one another to facilitate the extension of the cover member  2100  radially outwardly of the interior surface(s)  222  of the outflow end(s)  224  of the commissure post(s)  210 , the base  2400  may additionally include one or more features that operate to bias the shaft element  2404  into one or more discrete positions (e.g., axial or angular) relative to the support element  2402 . For example, as shown in  FIG. 33A-1 , the shaft element  2404  includes biasing members  2414 A and  2414 B, which are each configured to interface with a flange  2416  of the support element  2402 . As shown, the suture guard  2000  is in the deployed configuration with the shaft element  2404  in a distally advanced position relative to the support element  2402 , where flange  2416  is situated between biasing member  2414 A and a flange  2418  of the shaft element  2404 . With the flange  2416  so positioned, the biasing member  2414 A and the flange  2418  operate to help maintain the suture guard  2000  in the deployed position by biasing the flange  2416  between biasing member  2414 A and a flange  2418 . 
     In various examples, the biasing force of the biasing member  2414 A may be overcome by applying a proximally directed longitudinal force to the shaft element  2404  to deflect tab  2420 A radially inwardly of flange  2416  such that biasing member  2414 A can clear flange  2416  and shaft element  2404  can be proximally withdrawn relative to support element  2402 . In various examples the biasing member(s) (e.g.,  2414 A and/or  2414 B) may include one or more ramp features, such as ramp feature  2422 A, that help facilitate a deflection of the biasing member as longitudinal force is applied (e.g., proximally and/or distally) to the shaft element  2404 . Such ramp features may be configured as bearing surfaces that engage and slide along flange  2416  as the shaft element  2404  is translated relative to the support element  2402 . In some examples, one or more of the biasing members (e.g.,  2414 A and/or  2414 B) may include one or more stop features, that operates to obstruct translation of the shaft element  2404  beyond a designated axial position relative to the support element  2402 . For example, as shown in  FIG. 33B , biasing member  2414 B includes stop feature  2424 B, which is a portion of tab  2420 B, that is configured to engage flange  2416  to obstruct proximal translation of the shaft element  2404  beyond the position illustrated in  FIG. 33B , which is the position of the shaft element  2404  in the non-deployed configuration. It should be appreciated that heart valve  100  has been removed from  FIG. 33B  for clarity. Referring back to  FIG. 33A-1 , in some examples, the flange  2418  of the shaft element  2404  may operate as a stop feature that functions to obstruct distal translation of the shaft element  2404  beyond the position illustrated in  FIG. 33A-1 , which is the position of the shaft element  2404  in the deployed configuration. As shown in  FIG. 33B , the suture guard  2000  is in the non-deployed configuration with the shaft element  2404  in a proximally advanced position relative to the support element  2402 , where flange  2416  is situated between biasing member  2414 A and tab  2420 B. With the flange  2416  so positioned, the biasing member  2414 A and the tab  2420 B operate to help maintain the suture guard  2000  in the deployed position (e.g., a discrete position) by biasing the flange  2416  between biasing member  2414 A and the tab  2420 B. 
     In some examples, the base  2400  may be configured to interface with any of the delivery handles herein illustrated and described. Accordingly, one or more of the delivery handles illustrated and/or described herein may be utilized to advance the suture guard  2000 , including the heart valve  100  to a target region within a patient&#39;s heart, and/or to cause the suture guard  2000  to transition between delivery and deployed configurations. Accordingly, it is to be appreciated that one or more of the delivery handles illustrated and/or described herein may include one or more mechanisms configured to cause the shaft element  2404  to be advanced relative to the support element  2402 . 
     In some examples, the base  2400  may be configured to be coupleable to one or more regions of the heart valve  100 . For example, as shown in  FIG. 30A , the base  2400  includes a retention feature  2426 . Retention feature  2426  is a protrusion extending radially from a portion of the base  2400 , such as from a portion of the support element  2402 . In various examples, suture can be passed through the sewing cuff  600  of the heart valve  100  and looped around the retention feature  2426  to secure or otherwise couple the heart valve  100  to the suture guard  2000 . In some examples, the retention feature  2424  may include a guide  2428  that operates to retain engagement between the suture and the retention feature  2424 . For instance, as shown in  FIG. 30A , the guide  2428  includes a channel or groove, and in  FIG. 29E , a suture or fiber  3002  is shown extending within the channel or groove of guide  2428 . 
     In some examples, the base  2400  may be further configured to include a cut slot  2430 , similar to the cut slot described above with respect  FIG. 2C . To decouple the suture guard  2000  from the heart valve  100 , the surgeon cuts the suture or fiber  3002  in the designated area of cut slot  2430 , which releases the suture or fiber extending through the sewing cuff  600  and looping around the retention feature  2426 , thereby allowing the heart valve  100  to be decoupled from the suture guard  2000 . 
     While the cover member  2100  illustrated and described herein is shown with a tri-lobal or three petal configuration, it is to be appreciated that the cover member  2100  may be configured to include less than three petals, such as two petals, or alternatively more than three petals, such as four, five, six, or more than six petals. Indeed, in various examples, the cover member may comprise any number of petals provided that the cover member  2100  is operable to be deployed and retracted in accordance with the disclosure above. In some examples, in lieu of a petal or lobed design, the cover member  2100  may not include any petals, but may instead be configured as an evertable hood consistent with the profile illustrated and described above with respect to  FIG. 6 . 
     Moreover, while the cover member illustrated and described in association with  FIGS. 29A-33B  includes a frame element  2200  having discrete elongate elements  2200 A,  2200 B, and  2200 C, it should be appreciated that the frame element  2200  may include a single continuous elongate element. The single continuous elongate element may be bent into the configuration illustrated and described above with respect to  FIGS. 29A-33B , or may alternatively be formed into alternative configurations. For instance, in some examples, the frame element  2200  may be helically shaped. Additionally, while the elongate elements  2200 A,  2200 B, and  2200 C, are illustrated and described as including a bend region, such as bend region  2210 C, it should be appreciated that the elongate element(s) may include a plurality of bend regions. 
     The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.