Patent Publication Number: US-2023157820-A1

Title: Valve holder assembly with suture looping protection

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 17/806,928, filed Jun. 14, 2022, which is a continuation of International Patent Application No. PCT/US2020/064895, filed Dec. 14, 2020, which claims the benefit of U.S. Patent Application No. 62/948,744, filed Dec. 16, 2019, the entire disclosures all of which are incorporated by reference for all purposes. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally concerns medical devices and tools for delivering medical devices. More specifically, the disclosure relates to the surgical replacement of native heart valves that have malformations and/or dysfunctions with prosthetic heart valves that can be implanted through a minimally sized incision. Embodiments of the invention relate to prosthetic heart valves, and to holders for facilitating the implantation of the prosthetic heart valves at native heart valves sites, for example, for a mitral valve replacement procedure. 
     BACKGROUND 
     Referring first to  FIG.  1   , the human heart is generally separated into four pumping chambers which pump blood through the body. Each chamber is provided with its own one-way exit valve. The left atrium receives oxygenated blood from the lungs and advances the oxygenated blood to the left ventricle through the mitral (or bicuspid) valve. The left ventricle collects the oxygenated blood from the left atrium and pushes it through the aortic valve to the aorta, where the oxygenated blood is then distributed to the rest of the body. Deoxygenated blood from the body is then collected at the right atrium and advanced to the right ventricle through the tricuspid valve. The right ventricle then advances the deoxygenated blood through the pulmonary valve and the pulmonary arteries to the lungs to again supply the blood with oxygen. 
     Each of the valves associated with the chambers of the heart are one-way valves that have leaflets to control the directional flow of the blood through the heart and to prevent backflow of the blood into other chambers or blood vessels that are upstream of the particular chamber. The valves are each supported by an annulus having a dense fibrous ring attached either directly or indirectly to the atrial or ventricular muscle fibers. 
     When a valve becomes diseased or damaged, the efficiency and/or general functionality of the heart may be compromised. Diseased heart valves may be categorized as either stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and/or incompetent, wherein the valve does not close completely, causing excessive backward flow of blood through the valve when the valve is closed. Valve disease can be severely debilitating and even fatal if left untreated. 
     Various surgical techniques can be performed to replace a diseased or damaged valve. For example, the leaflets of a diseased or damaged native valve may be at least partially removed to prepare the valve annulus for receiving a prosthetic replacement valve.  FIG.  2    shows an example of one type of popular prosthetic replacement valve  1  that is a tissue-type bioprosthetic valve generally constructed with three natural-tissue valve leaflets  2 , made for example, from porcine tissue or bovine pericardium, or from synthetic or semisynthetic material, that are mounted on a surrounding cloth-covered valve stent structure or frame  3 . The shape and structure of the leaflets  2  are supported by a number of commissure posts  4  formed by the frame  3  and positioned circumferentially around the frame  3 . In these valves, a biocompatible cloth-covered suture or sewing ring  5  having an inflow side  7  can also be provided on the stent structure  3  of the valve  1 , to facilitate easier attachment to the native valve annulus. Such prosthetic valves function much like natural human heart valves, where the leaflets coapt against one another to affect the one-way flow of blood. Examples of such a prosthetic valve are described more fully in U.S. Pat. Nos. 8,986,374 and 7,776,084, both of which are incorporated herein by reference in their entireties for all purposes. 
     When implanting a tissue type prosthetic valve as described above at a native valve annulus, a number of sutures may be involved in the attachment process, many of which may be pre-installed for providing a track on which the valve is advanced, or “parachuted,” until it is properly positioned at the implant site. Additional sutures may also be applied between the prosthetic valve and the heart walls after proper placement, to securely attach or hold the valve implant in place. 
     Depending on the direction of implantation, for example with some mitral valve replacement procedures, commissure posts of the stent or frame, or other portions of the prosthetic valve, may be pointed distally and advanced on a blind side of the valve, thereby obstructing visibility of the posts or other portions during advancement and implantation. Such procedures can also require a prosthetic valve and its holder to fit through an incision of approximately 15-20 mm in its narrowest direction or dimension. Meanwhile, in some cases, the prosthetic valves are implanted through small access channels using one of various minimally invasive surgical procedures, where visibility at the implant site may be impeded or obstructed. 
     Each of the above factors may lead to tangling of the sutures with the valve prosthesis, most commonly with the commissure posts of the frame, because the commissure posts provide a protrusion on which the sutures can easily loop around and tangle. This type of entanglement of sutures with prosthetic valves is referred to as “suture looping,” which specifically refers to instances where a suture is inadvertently wrapped around one or more of the commissure post tips, where it can then migrate towards and damage the leaflets or interfere with proper leaflet coaptation or other valve operation when the sutures are tightened or secured, resulting in improper valve operation. In some cases, such tangling may not be apparent to the practitioner at the time of implantation, and will only be revealed some time later when valve operation is observed to be improper or other complications arise in the patient, in which case, it may be necessary to initiate another procedure to repair or replace the prosthetic valve. 
     Attempts have been made to resolve the issue of suture looping, some of which involve holders, which hold the prosthetic valves during delivery of the valves to the native valve annulus. Examples of replacement valve implant procedures are described in more detail in U.S. Patent Application Publication No. 2018/0116795, the contents of which are incorporated herein by reference in their entirety. In one example, a holder has a ratchet or cinching mechanism that bends or folds the commissure posts of the prosthetic valve radially inwardly during delivery, such that the ends of the commissure posts are pointed inwards to reduce the possibility of sutures catching against or looping around the commissure posts. After the valve prosthesis is delivered to the implant site, the holder is removed thereby releasing and expanding the commissure posts to their original positions. 
     An additional safety feature of the referenced publication is that the prosthetic valve is prevented from being implanted prior to activating the commissure posts, for example, via a removable activator dial, thereby reducing or eliminating mistakes caused by user error. In particular, the dial is not removed until the system is activated, and while in place, the activator dial prevents the valve from being implanted. In some embodiments, the holder includes a removable handle that cannot be connected to the system until the activator dial is removed. The holder also provides for integrated alignment features or other safety features associated with the ratchet mechanism, such that over-deployment or under-deployment of the holder is prevented. 
     In the above design, the commissure posts are urged radially inward by deployment sutures that connect the valve holder to the valve commissures at several locations. One particular set of locations requires the monofilament suture to be sewn through multiple layers of cloth at each of the commissure tips of the valve. This is ergonomically undesirable for the assemblers as they have to exert a large amount of force with their fingertips to pinch the needles and drive the monofilament suture through the layers of cloth. Suturing through the layers of cloths also leaves a lump of cloth above the monofilament suture, where this lump can potentially snare implantation sutures during valve implantation, leading to suture looping. 
     In another aspect of the prior design, the suture routing used to pull the commissure tips closer together results in the suture contacting the leaflets near their free edges, thereby creating the possibility of damaging the leaflets. In addition, early bench testing showed that the suture routing was not always effective in preventing suture looping, which is the main function of the holder system. In another design, the routing was slightly modified so that the sutures formed a triangle between the three commissures which was able to deflect possible suture loops during implantation. One drawback of this modified routing, however, was an increase in the force required to remove the holder from the valve due to the additional routing. 
     In view of the above, it is desirable to have a prosthetic heart valve implant assembly that reduces the possibility of suture looping while improving device usability during implantation. The design disclosed herein ensures a more consistent operation and improves assembly and stability while maintaining and improving safety features of previous designs. In addition, suture routing is improved to prevent contact with valve leaflets and to reduce removal forces. 
     SUMMARY 
     In one embodiment of the present invention, a prosthetic heart valve has a plurality of valve leaflets that control directional flow of blood through a heart and a stent structure having a plurality of commissure posts supporting the valve leaflets. The stent structure has a covering over the plurality of commissure posts and has a sewing ring at an inflow end of the stent structure. Each of the plurality of commissure posts has a tip and a suture loop attached to the covering at a location adjacent to or on the tip of the commissure post. Each suture loop provides a passage for a suture to pass through between the covering and the suture loop. The suture loop may be aligned with the tip of the commissure post or may be aligned perpendicular to the tip of the commissure post. 
     In another embodiment, each commissure post has an additional suture loop or loops attached to the covering at a location adjacent to or on the tip of the commissure post. The first suture loop and the additional suture loop or loops are aligned to provide a single passage for a suture to pass through between the covering and the suture loops. Alternatively, the additional suture loop may lay across the first suture loop or may be located end to end to provide two adjacent passages for a suture or sutures to pass through between the covering and the suture loops. 
     In another embodiment, a valve holder assembly includes a prosthetic heart valve as described above and a valve holder. In addition, a first deployment suture connects the valve holder to the prosthetic heart valve. The first deployment suture is attached to the valve holder, routed through the suture loop, and back to the valve holder. 
     In one embodiment, there are two commissure posts and the first deployment suture is attached to the valve holder, routed through the suture loop of a first commissure post, routed through the suture loop of a second commissure post, and back to the valve holder. Furthermore, the first deployment suture may be attached to the valve holder, routed through the sewing ring, through the suture loop of the first commissure post, through the suture loop of the second commissure post, again through the sewing ring, and back to the valve holder. 
     In another embodiment, the valve holder further includes a second deployment suture connecting the valve holder to the prosthetic heart valve. The second deployment suture is attached to the valve holder, routed through the suture loop of the second commissure post, and back to the valve holder. Further, the embodiment may include a second suture loop of the second commissure post. The first suture loop and the second suture loop are located end to end to provide two adjacent passages for a suture or sutures to pass through between the covering and the suture loops. 
     In another embodiment, a valve holder assembly includes a valve holder body to hold a prosthetic heart valve. The valve holder body has a top surface, a bottom surface, and a central axis. A rotor is insertable through the top surface and positioned in the valve holder body. When a prosthetic heart valve is coupled to the valve holder body, the rotor is rotatable around the central axis of the valve holder body to adjust the prosthetic heart valve to a delivery position. A guide body is mounted to the valve holder body and projects above the upper surface of the valve holder body. The guide body has an opening through which an activator is couplable to the rotor for rotating the rotor around the central axis of the valve holder body. A handle adapter is insertable into the opening of the guide body along the central axis. The handle adapter has an opening through which the activator is couplable to the rotor for rotating the rotor around the central axis of the valve holder body. The opening of the handle is also configured to receive a handle. 
     In a further embodiment, the valve holder body has a snap arm that flexes to engage a stop of the guide body to secure the valve holder body and the guide body together. The valve holder assembly may further include an attachment suture. The guide body has an arm extending from the front of the guide body and the arm has a recess along a bottom of the arm. The guide body may also have a stop extending from the back of the guide body and the stop has a recess along a bottom of the stop. The handle adapter may have a suture mount extending from the front of the handle adapter and the suture mount may have a recess along a top of the suture mount. In addition, the handle adapter may have a suture support extending from the back of the handle adapter and the suture support may have a recess along a top of the suture support. The attachment suture may then be secured in the recesses of the arm and the stop of the guide body and in the recesses of the suture support and the suture mount of the handle adapter. 
     In another embodiment, the handle adapter has a ledge and a gap is formed between the ledge of the handle adapter and a top surface of the guide body. The attachment suture may be located in the gap to hide the suture routing from view. 
     The valve holder body may also have a central opening and the rotor extends through the central opening below a bottom of the valve holder body. 
     In another embodiment, the guide body has a cutting well comprising two arms extending from the guide body, a top of each arm has a suture recess and the arms are spaced apart to form an opening to permit cutting of a suture across the arms of the cutting well. 
     In another embodiment, the valve holder assembly has an activator dial connectable to the rotor for rotating the rotor around the central axis of the body. The activator dial has a flange and the handle adapter has a corresponding rib. The activator dial is rotatable in one direction and stops at a location where the flange engages the rib. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings: 
         FIG.  1    shows a schematic cross-sectional view of a human heart; 
         FIG.  2    shows a schematic perspective view of an example of a prosthetic heart valve that can be used with embodiments of the invention; 
         FIG.  3    shows an exploded perspective view of a heart valve implant holder assembly according to an embodiment of the invention. 
         FIG.  4    shows a perspective view of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  5 A  shows a top perspective view of a valve holder body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  5 B  shows a bottom perspective view of the valve holder body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  5 C  shows a top view of the valve holder body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  6    shows a top perspective view of a valve holder rotor of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  7 A  shows a top perspective view of a guide body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  7 B  shows a bottom perspective view of the guide body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  7 C  shows a top view of the guide body of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  8 A  shows a top perspective view of a handle adapter of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  8 B  shows a bottom perspective view of the handle adapter of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  8 C  shows a top view of the handle adapter of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  9 A  shows a bottom perspective view of an activator dial of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  9 B  shows a side view of the activator dial of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  9 C  shows a top view of the activator dial of the heart valve implant holder assembly of  FIG.  3   . 
         FIG.  10    shows a cross-sectional view of the assembled valve holder body and valve holder rotor of  FIG.  4   . 
         FIG.  11    shows a top perspective view of the assembled guide body and valve holder body of  FIG.  4   . 
         FIG.  12 A  shows a top perspective view of an alternative embodiment of a guide body of the heart valve implant holder assembly. 
         FIG.  12 B  shows a top perspective view of the guide body of  FIG.  12 A  from the other side. 
         FIG.  12 C  shows a bottom perspective view of the guide body of  FIG.  12 A . 
         FIG.  13 A  shows a top perspective view of an alternative embodiment of a handle adapter of the heart valve implant holder assembly. 
         FIG.  13 B  shows a bottom perspective view of the handle adapter of  FIG.  13 A . 
         FIG.  14 A  shows a schematic view of a prosthetic heart valve at the outflow side with suture routing. 
         FIG.  14 B  shows a detail view of the suture routing of  FIG.  14 A . 
         FIGS.  15 A- 15 H  shows several embodiments of suture loops and suture routings. 
     
    
    
     DETAILED DESCRIPTION 
     The valve holders disclosed herein are particularly useful for avoiding suture looping and other valve damage during advancement of the prosthetic valves to the implant sites, as well as preventing damage during final suturing of the valves at the native valve annulus. In mitral valve replacement procedures, commissure posts of the prosthetic valve point distally away from practitioners, and in the direction of valve advancement, and may be more prone to suture looping or other entangling. For such procedures, valve holders can be deployed to bend or fold the commissure posts radially inward toward a center of the valve to reduce or eliminate suture looping. Such procedures can also include features that prevent valve implantation until the commissure posts are in the activated or deployed positions. The holders can also include alignment features that prevent over-deployment or under-deployment. In this fashion, the holders provide ease of use while minimizing or reducing user errors. 
     The valve holders described herein include various parts that are designed to ensure a more consistent operation of the deployment mechanism to bend the valve commissure posts prior to valve implantation, to implement hard stops to prevent over-deployment and/or to improve assembly and stability between the parts. With regard to the prosthetic heart valve, routing of the sutures to deploy the commissure posts is improved to reduce contact between the routing sutures and the valve leaflets and to reduce the force required to remove the valve holder from the prosthetic valve after implantation. 
     In another embodiment, retaining loops are attached to the covering of the commissure posts to more precisely define a location where the suture is routed through the valve. Routing the suture underneath the commissure post loops is easier than trying to do the same through multiple layers of cloth. This is more ergonomic for assemblers that have to repeat this task many times during the work day. Also, the combination of the commissure post loop and the suture presents a low profile. This allows the implantation sutures to glide over the commissure post tips more easily, without suture looping. 
     With reference to  FIGS.  3 - 4   , a heart valve implant holder assembly  10  includes a valve holder  14  and an activator dial (or actuator)  16 . The valve holder  14  includes a valve holder body  20 , a rotor  22 , a guide body  24  and a handle adapter  26 . As described further below, the sewing ring  5  of a prosthetic heart valve ( FIG.  2   ) is attached to the bottom of the valve holder body  20 . The rotor  22  is positioned in a bore of the body  20 . After attaching the guide body  24  to the valve holder body  20  and attaching the handle adapter  26  to the guide body  24 , the implant holder assembly  10  is ready to be activated. The rotor  22  is activated using the activator dial  16  to deploy the valve holder  14  and bend the commissure posts  4  of the prosthetic heart valve to a delivery position or configuration. When deployed, the occurrence of suture looping over the commissure posts  4  of the prosthetic heart valve during the surgical procedure is reduced or eliminated. 
     With reference to  FIGS.  5 A- 5 C , the valve holder body  20  has a circular platform  30  with a flat upper surface  31  and a pair of suture mounts  32  located at a periphery of the platform  30 . Each suture mount  32  forms a tunnel above the upper surface  31  of the circular platform. A hole  34  at the base of each tunnel passes through the circular platform. Between the suture mounts  32  are two additional holes  36  located between the holes  32  for receiving pins of the guide body  24 . In addition, the valve holder body  20  has three suture openings in the platform  30 . Each suture opening includes a recessed area  40  into the upper surface  31  of the platform and a pair of holes  42  at the bottom of the recessed area that pass through the circular platform. Between the holes  42  is a tie strut  44 . Each of the holes  34 ,  42  may be used for routing sutures that are used to deploy the prosthetic heart valve to a deployed position where the commissure posts are angled radially inwards toward the center of the valve to reduce or eliminate suture looping. One way of suturing the prosthetic heart valve to the valve holder to enable this feature is described in detail in U.S. Patent Application Publication No. 2018/0116795. Projecting up from the top of the circular platform  30  are rails  48  for securing the valve holder body  20  to corresponding retainers of a package (not shown) for delivery. 
     In the valve holder body  20 , a central opening  50  is provided for receiving the rotor  22 . The opening  50  is stepped to provide three abutment surfaces, namely an upper abutment surface  52 , a middle abutment surface  54 , and a lower abutment surface  56 . At the lower abutment surface  56 , the diameter of the opening  50  is smallest. 
     The upper abutment surface  52  is surrounded by a cylindrical wall  60 . At three equidistant locations around the upper abutment surface  52 , the cylindrical wall  60  has cutouts  62  forming snap arms  64 . In particular, each cutout has a base  66  spaced from the upper abutment surface  52  by an opening  67  through the valve holder body  20 . An upper surface  68  of the base  66  is above and parallel to the upper abutment surface. Extending upward from the upper surface  68  is the snap arm  64 . A free end of the snap arm has a protrusion that extends towards the center of the valve holder body opening  50 . The protrusion includes a ramped surface  72  that increasingly protrudes into the opening  50  from top to bottom. There is space between the snap arm  64  and the back of the cutout  62  to permit the snap arm to flex during assembly of the guide body  24  to the valve holder body  20 . 
     In the present embodiment, two of the snap arms  64 , i.e., the arms adjacent the suture mounts  32 , have a smaller width than the third snap arm, which is located diametrically opposite the suture mounts. Each of the snap arms has the same height. The widths and heights of the snap arms, however, may all be the same or varied as desired. A tab recess  78  in the cylindrical wall  60  may also be included to align the guide body  24  and the valve holder body  20 . 
     The middle abutment surface  54  is surrounded by a ratchet wall  80  to interact with the rotor  22 , as will be described further below. The lower abutment surface  56  is surrounded by a cylindrical wall  82  that is interrupted by three setbacks  84  that are equally spaced apart around the wall. The setbacks  84  provides spaces for passing sutures through the valve holder body  20  through openings  86 . 
     With reference to  FIG.  5 B , the bottom side of the valve holder body is tiered. The peripheral outer portion of the valve holder body is a rim  90 . Extending below the rim are three reduced diameter portions. An upper reduced diameter portion  92  has a smaller diameter than the rim  90  to provide clearance for a connected prosthetic heart valve. A middle reduced diameter portion  94  has a smaller diameter than the upper reduced diameter portion  92 . The openings  67  associated with the snap arms are formed through the upper and middle reduced diameter portions  92 ,  94 . A lower reduced diameter portion  96  has the smallest diameter of the reduced diameter portions and forms the openings  86  of the setbacks  84  and additional passages  98  from the openings  86  for the routing of sutures through the valve holder body  20  to the prosthetic heart valve from the rotor  22 . 
     In a preferred embodiment, the upper reduced diameter portion  92  has a setback  100  under the rim  90  to accommodate the passage of sutures through holes  34  and holes  42 . In particular, the setback  100  includes two recessed portions  102 , each one located to receive one of holes  34  and one of holes  42 . 
     With reference to  FIG.  6   , the rotor  22  is configured to be positioned inside of the central opening  50  of the valve holder body  20  and is rotatable with respect to the holder body  20 . As will be described later, sutures are connected to the rotor  22  for adjusting the prosthetic heart valve to the delivery position using the activator dial  16 . The rotor  22  includes a central portion  110  and a plurality of outwardly extending flexible arms  112 . The flexible arms  112  are resilient such that the arms can be deflected inwards towards the central portion  110  and then released, causing the arms  112  to spring back into a relaxed shape when no longer deflected. 
     End portions of the arms  112  have engagement portions  114  in the form of teeth or pawls to engage the corresponding ratchet wall  80  of the valve holder body  20  in the form of a plurality of notches or grooves ( FIG.  10   ). The teeth  114  of the rotor  22  engage the ratchet wall  80  of the body  20  to provide a one-way ratcheting mechanism that allows the rotor  22  to rotate in one direction relative to the body  20  (e.g., clockwise), but that prevents the rotor  22  from moving in a counter or opposite direction (e.g., counter-clockwise). 
     The central portion  110  of the rotor  22  defines a central opening  120  to receive the activator dial  16 . Extending below and inset from the central portion  110  is a lower portion  122  of the rotor  22 . The central opening  120  extends through the lower portion. A rib  124  of the lower portion ( FIG.  10   ) intersects the central opening  120 . Notably, in a preferred embodiment, the lower portion  122  of the rotor  22  protrudes below the bottom of the valve holder body  20  when assembled. In addition, the bottoms of the flexible arms  112  of the rotor may slide along the middle abutment surface  54  of the valve holder body  20  and/or a stop surface  126  of the central portion  110  of the rotor may slide along the lower abutment surface  56  of the valve holder body  20  during activation. 
     The rotor  22  additionally includes one or more holes  130  projecting through a sidewall of the central portion  110  of the rotor  22  and into the central opening  120 . The holes  130  provide attachment points for connecting end regions of the sutures to the rotor  22 . When the sutures are connected to the rotor  22 , rotation of the rotor  22  will create tension in the suture lines and further cause the sutures to be pulled in the direction of the moving rotor  22 . Because the sutures are connected to the commissure posts of the prosthetic valve, this pulling force activates or deploys the valve holder  14  to adjust the prosthetic valve to a collapsed or delivery position by transferring the force onto the commissure posts of the prosthetic valve. The commissure posts are thereby radially bent inwards toward a center of the prosthetic valve. 
     In order to actuate the rotor  22 , the central opening  120  has alignment keys  132  in the shape of longitudinally extending protrusions to mate with alignment keyways  306  of the activator dial  16 . With reference to  FIG.  3   , the activator dial  16  is used by an operator or user to rotate the rotor  22  and adjust the valve holder  14  to the deployed configuration. The activator dial  16  can be assembled with the valve holder  14  prior to use in a surgical procedure. In one embodiment, for example, the activator dial  16  can be preassembled with the valve holder  14  during an assembly process by the manufacturer of the valve holder  14 . Such an assembly step prior to use in surgical procedures can be done in order to aid in proper usage of the valve holder  14  and reduce the risk of inadvertent user error. 
     With reference to  FIGS.  9 A- 9 C , the dial  16  includes a central shaft  302  having a central axis, and an enlarged gripping portion  304  extending therefrom. The central shaft  302  is sized and configured to be received in the central opening  120  of the rotor  22 . The central shaft  302  includes alignment keyways  306  in the shape of longitudinally extending slots or recesses for coupling to the alignment keys  132  of the rotor  22 . The mating of the alignment features  132 ,  306  enables the rotor  22  to rotate together with the dial  16 . In various embodiments, the dial  16  can be turned either manually (for example, by the hands of an operator) or automatically via a motor or other means. Meanwhile, while three mating alignment features  132 ,  306  are respectively shown, the number of mating alignment features can be different in various embodiments. In one embodiment, for example, a single mating alignment feature can be used. 
     After the activator dial  16  is used to deploy the commissure posts to a collapsed position, the activator dial  16  may be removed and a handle (not shown) may be attached to the valve holder to deliver the prosthetic heart valve to the native valve site. To securely connect the handle to the valve holder body  20 , the guide body  24  and the handle adapter  26  are provided. 
     With reference to  FIGS.  7 A and  7 B , the guide body  24  has an upper tubular wall  140  and a lower tubular wall  142 . The lower wall  142  has a greater outer diameter than the upper wall  140  and fits within the upper portion of the central opening  50  of the valve holder body  20 . A ledge  144  separates the upper and lower walls. 
     The upper tubular wall  140  of the guide body  24  has a cutout  146  on one side. Projecting out from the upper wall  140  just below the cutout  146  is a suture cutting well  150 , including a first arm  152  and a second arm  154 . The top of each arm has a suture recess  158  and the arms are spaced apart to form the well  150  to permit easy cutting of sutures across the well  150 . As will be discussed later, this well receives the sutures that connect the valve holder  14  to the prosthetic heart valve. A post  160  extends downward from the free end of each arm  152 ,  154 . The posts  160  engage the holes  36  of the valve holder body  20  to prevent rotation between the guide body  24  and the valve holder body  20 . 
     The lower tubular wall  142  of the guide body  24  is recessed below the suture cutting well  150 . In this area, the arms  152 ,  154  of the cutting well  150  have recesses  156 . As will be discussed later, these recesses  156  receive a suture or sutures for holding the guide body  24  and the handle adapter  26  together. 
     Spaced equidistantly around the ledge  144  are three stops that project out from the upper and lower walls  140 ,  142 . A first stop  170  is located opposite the cutting well  150 . The first stop  170  has a flat upper surface  172  and a recess  174  extending along the bottom of the first stop to receive a suture. The two additional stops  176  are located on either side and adjacent the cutting well  150 . Each stop  176  has a flat upper surface  178  and a ramped surface  180  extending from the outer edge of the stop to the lower cylindrical wall of the guide body  142 . Notably, the three stops are configured to engage the corresponding snap arms  64  of the valve holder body  20  to secure the guide body  24  and the valve holder body  20  together. (See  FIG.  11   ). Located between one of the stops  176  and the first stop  170  is a tab  182  projecting outwardly from the top of the lower cylindrical wall  142 . The tab  182  is oriented to fit in the tab recess  78  of the valve holder body  20  for proper alignment. 
     An opening  186  extends through the guide body  24 . Midway through the guide body  24 , a platform  190  extends into the opening  186 . The platform  190  defines a central bore  192  having an alignment keyway  196 . The upper side of the platform  190  also has a ramp  198 . Preferably, the ramp  198  is located adjacent the cutting well  150  of the guide body and is spaced apart from the alignment keyway  196 . The ramp  198  and the alignment keyway  196  are configured to permit a flexible arm  310  on the activator dial  16  to pass through and back out of the central bore  192  of the guide body  24  for connecting and disconnecting the activator dial  16  to and from the rotor  22 . 
     With reference to  FIGS.  8 A and  8 B , the handle adapter  26  is a cylindrical tube having an upper tubular part  202  and a lower tubular part  204 . The lower tubular part  204  is sized to fit inside the opening  186  of the guide body  24 . A ledge  206  is arranged around the cylindrical tube between the upper part  202  and the lower part  204 . 
     Projecting up from the top of the ledge is a vertical rib  208  that will interact with a flange  338  on the activator dial  16  to prevent further rotation of the dial  16 . At the location of the vertical rib  208 , the ledge has extension portions  209  that project further away from the cylindrical tube. A suture mount  210  having a first support  212  and a second support  214  extends from the extension portions  209  and from the lower tubular part  204 . Along the top of each support  212  and  214  adjacent the ledge  206  is a recess  220  for a suture. The first and second supports are spaced apart from each other and the space is wide enough to receive a cutting instrument to cut a suture laid across the recesses  220  of the suture mount  210 . A shield  216  is mounted at the lower free ends of the supports  212 ,  214  and projects outwardly and laterally. Also, along the bottom of each support adjacent the ledge is a recess  222  for a suture. 
     On the opposite side of the adapter  26  from the suture mount  210  is a suture support  224  that projects out from the ledge  206 . The suture support  224  has a pair of back-to-back recesses  228 . The recesses  228  have through holes  230  located adjacent each other at one end of the recesses and cutouts  232  at the opposite end of the recesses. The holes  230  and cutouts  232  are for securing sutures. Inside the central bore  234  of the cylindrical tube is a screw thread  240 . Preferably, the screw thread is an ACME thread and has less than one full turn to facilitate injection molding. The thread also has a first alignment keyway  242  and a second alignment keyway  244  to facilitate insertion and removal of the activator dial  16 . 
     With reference to  FIGS.  9 A- 9 C , the activator dial  16  has a tubular central shaft  302  with a flexible arm  310 . The flexible arm  310  is spaced apart from the remainder of the central shaft  302  by gaps  320  on either side and at the bottom of the flexible arm  310  such that the flexible arm  310  is movable (e.g., bendable) relative to the remainder of the central shaft  302 . The flexible arm  320  may be bent inwards relative to the remainder of the central shaft  302  and towards a central cavity of the dial  16 . The flexible arm  320  is resilient such that the flexible arm  310  may be bent by the application of a force and will return to its original shape when the force is removed. 
     A key  322  at the free end of the flexible arm is configured to engage the ramp  198  of the guide body  24  and has a width suitable to pass through the alignment keyway  196  of the guide body  24 . Directly below the flexible arm  320  is one of the keyways  306  for coupling to the rotor  22  as mentioned previously. At the bottom of the central shaft of the dial, additional recesses  324  are provided to assist with suture routing through the rotor. 
     The gripping portion  304  of the activator dial  16  is scalloped around the periphery to better permit grasping and rotation. An upper surface  326  of the gripping portion is provided with indicia, such as arrows  328  to indicate direction of rotation, and a triangular marker  330  may be used to identify the location of the flexible arm  310  which is obscured from view by the gripping portion during assembly to the valve holder  14 . 
     A bottom surface  334  of the gripping portion has radial struts  336  to improve strength. An angled flange  338  extends down from the bottom surface  334 . The flange includes a triangular plate  340  formed as an extension from one of the radial struts  336 . A brace plate  342  extends from the triangular plate at  900  to provide strength. Extending down from the bottom of the gripping portion  304  and along the central shaft  302  are a plurality of spacers  346  to assist with aligning the central shaft  302  by engaging the central bore  234  of the handle adapter during assembly. 
     As mentioned earlier, sutures are used to deploy or activate the valve holder and place the prosthetic valve in a deployed position where the commissure posts are urged radially inward toward a center of the valve to reduce or eliminate suture looping. Another aspect of the invention is the use of a suture loop or loops that straddle across each commissure post tip to assist with suture routing for placing the commissure posts in the deployed state. With reference to  FIGS.  14 A and  14 B , suture loops  500  are attached to each commissure post  4  near the tip. The suture loops can be made of any suitable material, such as cloth or fabric, and can be stitched or otherwise attached to the commissure post. Several suture loops  500   a  may be attached adjacent each other to form a suture passage  502 . Sutures are routed under the loops and thus avoid having to be pushed through multiple layers of cloth. Suture routing from the commissure posts  4  to the valve holder body  20  will now be described in detail. 
     In one method, suture routing is performed by knotting an end of a deployment suture  250 , then taking the other end of the suture and routing it into the central opening  120  of the rotor  22  and through one of the holes  130  of the sidewall of the rotor  22  (see  FIG.  10   ). The suture is pulled taut so that the knotted end rests in the central opening  120  and stops against the inside of the sidewall at the hole  130 . The free end of the deployment suture is next fed through one of the openings  86  of the valve holder body  20 . Two other deployment sutures are also routed through the other corresponding holes  130  of the rotor and openings  86  of the valve holder body  20 . 
     Once the sutures are routed through the valve holder body  20 , the rotor  22  can be fit into the central opening  50  of the valve holder body  20 . Notably, in this position, the flexible arms  112  of the rotor have teeth  114  that engage the ratchet wall  80  of the valve holder body. This will provide a ratcheting mechanism that allows the rotor  22  to rotate in one direction and pull on the sutures. In addition, the bottom of the rotor protrudes beyond the bottom of the valve holder body to prevent suture entanglement among the sutures passing from the rotor through the valve holder body. Such entanglement could seize up the ratchet mechanism and prevent rotation and deployment. Preferably, when assembled, the rotor rib  124  is parallel to the suture mounts  32  of the valve holder body  20 . 
     After the rotor  22  is assembled to the valve holder body  20 , the guide body  24  can be snapped onto the rotor/holder body assembly. The snap arms  64  of the valve holder body  20  will deflect radially outwardly as the three stops  170 ,  176  are pressed against the snap arms  64 , and the snap arms will snap back once the stops  170 ,  176  clear the ramped surfaces  72  of the snap arms to lock the guide body  24  to the valve holder body  20  (see  FIG.  11   ). Assembly is easily performed by pushing all three stops against the snap arms at once, or by snapping in the larger first stop  170 , followed by snapping in the two additional stops  176 . Notably, the snap arms  64  point away from where the prosthetic heart valve is attached to the valve holder body reducing the possibility of damage to the new valve during assembly. If desired, the guide body may have a different color for more visible contrast and to assist in identifying the location of the cutting well  150 . 
     With reference to  FIGS.  2 ,  5 B, and  14 A , the inflow side  7  of the sewing ring  5  of the prosthetic heart valve  1  will be secured to the underside  91  of the rim  90  of the valve holder body  20 . Prior to this, the free ends of the deployment sutures  250  ( FIG.  1   ) from the rotor  22  will be routed through loops  500  on the commissure posts  4   a ,  4   b ,  4   c . Accordingly, the free end of one suture  250   a  from the rotor and opening  86   a  of the valve holder body  20  is threaded through the sewing ring  5  from the inflow side ( FIG.  14 A ). Preferably, the suture  250   a  is routed from directly under the center of the corresponding commissure posts  4   a  and threaded straight up through the sewing ring  5 . The suture  250   a  is then routed along the outside of the cloth covering of the commissure post  4   a  and threaded under the loop or loops  500   a  at or near the tip of the commissure post  4   a . A needle can be used to pass the suture  250   a  through the sewing ring and through the loops  500   a.    
     After routing the suture  250   a  up the first commissure post  4   a  and under the loops  500   a , the suture  250   a  is routed to the tip of an adjacent commissure post  4   b  and then threaded down through a corresponding loop or loops  500   b  on the adjacent commissure post  4   b . Next, the suture  250   a  is routed down along the outside of the cloth covering of the commissure post  4   b  and through the sewing ring  5  at the base of commissure post  4   b . When each of the three sutures are routed in this way, it results in pairs of sutures extending along each commissure post, i.e., sutures  250   a ,  250   b  on commissure post  4   b , sutures  250   c ,  250   a  on commissure post  4   a , etc. Preferably, the sutures of each pair are routed directly next to each other, or even touching, along the length of the commissure post and pass through the sewing ring  5  on either side of a thread forming the cloth-covering of the sewing ring. 
     Once the suture  250   a  is routed back to the inflow side of the sewing ring  5 , the suture  250   a  is routed through a hole  42   b  in the rim  90  of the valve holder body  20  ( FIG.  5   c   ). A needle can be used to route the suture  250   a  through the loops  500   b  of the commissure post  4   b , to press through the sewing ring  5  and pass through the platform hole  42   b . Preferably, the hole  42   b  selected in the recessed area  40   b  is the hole farthest from the suture mounts  32 . Similar routing is followed for sutures  250   b  and  250   c . At this point, the needle from each suture can be removed. Preferably, suture routing through the commissure posts is counterclockwise when viewed from the outflow side of the valve (see routing of suture  250   a  in  FIG.  14   a   ). 
     This type of suture routing at the commissure posts of the prosthetic heart valve has benefits over previous techniques. Previously, the sutures were routed from the valve holder through the central outflow area and extended toward the commissure tips, passing through the coaptation area between the leaflets on the way. This routing seemed to be effective in preventing suture looping, but had two main issues—suture contact with the leaflets and high holder removal force. In the routing depicted in  FIGS.  10  and  14 A , the sutures  250  are routed from the central opening  120  of the valve holder body through the openings  86  and laterally toward the sewing ring, rather than at an angle toward the commissure tips. From there, each suture passes through the sewing ring, through suture loops  500  near the commissure tip, toward the next commissure tip, and then down that commissure, back through the sewing ring, and finally through the valve holder. The new routing is no more difficult to assemble, eliminates having to pass sutures through the tissue coaptation, and, owing to fewer and less drastic turns in the routing, results in a much lower holder removal force. 
     After the last suture  250   c  has been returned to the valve holder body  20  through one of holes  42   a  of the recessed area  40   a , the suture  250   c  is routed back down through the platform rim  90  through the other hole  42   a  of the recessed area  40   a . After that, the suture  250   c  is fed back up through tunnel hole  34 , placed across the cutting well  150  of the guide body  24  using recesses  158 , then through the tunnel of the other suture mount  32  (see  FIG.  11   ). The suture  250   a  is routed in a similar way. 
     For suture  250   b  which has been fed up through hole  42   c  of the recessed area  40   c  located opposite from the cutting well  150 , the suture  250   b  is routed back down through the other hole  42   c  in the same recessed area  40   c . The suture  250   b  is then routed under the valve holder body  20  to the same hole  42   a  that suture  250   c  was routed. Suture  250   b  is then routed up through hole  42   a , back down through the other hole  42   a , then back up through tunnel hole  34 , just like suture  250   c . Suture  250   b  is then fed across the cutting well  150 . Each suture is pulled to tighten and tied off on the closest suture mount  32 . A holder fixture (not shown) that is known in the art may be used to assist in alignment of the commissure posts and suitable tightening of the sutures. 
     After the deployment sutures  250   a ,  250   b ,  250   c  have been routed and secured, a handle attachment suture  260  is used to secure the handle adapter  26  to the guide body  24 . With reference to  FIGS.  4 ,  7 A, and  8 A , the attachment suture  260  is threaded under one of the arms  152 ,  154  of the cutting well  150  of the guide body  24  at the location of the recess  156 . The length of the thread is centered at the recess  156  and knotted around the arm. The handle adapter  26  is placed into the guide body  24  with the shield  216  facing the cutting well  150  of the guide body  24 . Preferably, the lower tubular part  204  of the handle adapter rests on the platform  190  of the guide body, leaving a small gap  262  between the ledge  206  of the handle adapter and the top of the tubular wall  140  of the guide body. The gap  262  serves as a channel for attachment suture  260  in order to better hide or cover the exposed suture routing. The extension portions  209  of the ledge also assist in hiding the suture routing. 
     With the center of the suture  260  tied to one of the arms  152 ,  154  of the guide body  24 , a first end portion of the suture  260  is routed under the other arm  152 ,  154 , then routed up and back across the suture guard  210  of the handle adapter  26 . The first end portion is received in the recesses  220  of the suture guard and is then routed in the gap  262  between the ledge  206  of the handle adapter and the top of the guide body  24  to the suture support  220 . The first end portion is then routed to the other side of the suture support, up through the cutout  232 , and down through hole  230  and knotted at that location leaving a tail. The second end portion  266  of the attachment suture  260  is routed the same way in the opposite direction. In a final step, one of the suture tails is threaded under the first stop  170  of the guide body and back up through a hole  230  of the handle adapter. The tail is located in the recess  174  of the first stop  170 , is tightened, and is knotted with the other tail to the suture support  220 . This improved suture tie-down better secures the handle adapter to the guide body and prevents unintentional separation during handling and implantation. 
     When the handle adapter  26  and the guide body  24  are secured together, the shield  216  of the handle adapter  26  provides an additional safety feature against inadvertent or premature release of the prosthetic valve from the valve holder  14 . When the handle adapter  26  is coupled to the holder  14 , the shield  216  is aligned with the cutting well  150  of the guide body  24 , and is positioned over and covers the cutting well  150 , thereby preventing or reducing inadvertent or unintended cutting or breaking of the sutures connecting the valve holder  14  to the prosthetic heart valve. When the handle adapter  26  is removed, the cutting well  150  is revealed and the suture or sutures connecting the valve holder  14  to the prosthetic valve can then be cut or untied to release the valve. In addition, assembly and disassembly of the handle adapter and the guide body is easily achieved by a simple axial movement between the parts, no tilting of the parts is needed. 
     With the valve holder  14  assembled, the activator dial  16  may be attached to deploy the commissure posts to a collapsed or bent configuration. The central shaft  302  of the dial  16  is inserted into the central bore  234  of the handle adapter  26  ( FIG.  3   ). In particular, the flexible arm  310  of the dial  16  is aligned with the first alignment keyway  242  ( FIG.  8   c   ) of the handle adapter  26  and the ramp  198  of the guide body  24  ( FIG.  7   c   ). When inserted, the flexible arm  310  will pass through the first alignment keyway  242  and engage the ramp  198 . The marker  330  on the upper surface  326  of the dial  16  assists in locating the proper orientation of the flexible arm  310  of the dial for assembly, where for example, a corresponding marker or other indicia may be present on another part of the valve holder  14  or other device the dial  16  is configured to connect to, to aid in proper alignment with marker  330  on dial  16  during insertion or attachment. 
     After passing through the handle adapter  26 , the key  322  of the flexible arm  310  engages the ramp  198  of the guide body  24 . Due to the flexibility of the flexible arm  310  of the dial  16 , contact between the key  322  and the ramp  198  of the guide body  24  causes the flexible arm  310  to bend inwards into the central cavity of the dial  16  such that the key  322  may pass through the central bore  192  of the guide body  24 . The lower surface of the key  322  has an oblique or slanted shape (e.g., via a chamfer or fillet) to facilitate inward bending of the flexible arm  310 . Once the key  322  passes the central bore  192  of the guide body  24 , the flexible arm  310  returns to its original unbent shape. An upper surface of the key  322  has a flat shape that matches an underside surface of the platform  190  to prevent or hinder the flexible arm  310  from bending once the key  322  passes the central bore  192  of the guide body  24 . This is to retain the dial  16  in the guide body  24  and prevent inadvertent or unintended removal of the dial  16  before deployment of the valve holder  14  is complete. Recesses  324  at the bottom of the central shaft  302  provide accommodation space for the sutures and suture knots in the central opening  120  of the rotor  22 . The spacers  346  of the dial  16  engage the central bore  234  of the handle adapter to provide a tighter fit and increased stability. 
     Once the key  322  passes the central bore  192  of the guide body  24  and the dial  16  is connected to the rotor  22 , the dial  16  may be rotated to cause the rotor  22  to rotate and deploy the commissure posts. The sutures attached to the rotor are pulled and slide through the suture loops  500  to cause the commissure posts to fold inward. The rotor  22  has a one-way ratcheting mechanism such that the dial  16  may only be rotated in one direction, and the dial  16  is prevented from being rotated in an opposite direction. The underside of the guide body  24  has space to facilitate rotation of the dial  16  relative to guide body  24 , which provides clearance for the key  322  of the dial  16  during rotation. 
     The dial  16  has an angled flange  338  that, together with the vertical rib  208  of the handle adapter  26 , acts as a stop after the dial has been rotated to fully deploy the commissure posts. With reference to  FIG.  4   , the dial  16  is shown in a first position where the key  322  of the central shaft  302  has been aligned with the ramp  198  of the guide body  24 , and the central shaft  302  of the dial is connected to the rotor  22 . The dial marker  330  assists in locating the proper orientation. The dial  16  is then rotated clockwise (in the direction of the arrows) until the angled flange  338  stops against the vertical rib  208 . The rotational movement is less than 360 degrees such that the dial  16  is restricted to less than one full rotation in use. The stop prevents over-deployment or over-tightening of the valve. The dial  16  may be removed by removing the key  322  upwards through the keyway  196  of the guide body  24  and through the second alignment keyway  244  of the handle adapter  26 . Upon removal of the dial  16 , the valve holder  14  is in the fully deployed configuration. In addition, the keyway  196  and the one-way ratcheting mechanism prevent under-deployment of the valve. The dial  16  is prevented or hindered from being removed from the guide body  24  until the key  322  is aligned with the keyway  196 . 
     Upon removal of the dial  16 , a handle (not shown) can be attached to deliver the prosthetic heart valve to the valve site. The handle is threaded to the screw thread  240  of the handle adapter  26 . Once the prosthetic valve is secured to the valve site, the handle and the handle adapter  26  can be removed by cutting the handle attachment suture  260  at the recesses  220  of the suture mount  210  of the handle adapter. Alternatively, the handle by itself can be removed by unscrewing it. The suture  260  is tied off to the handle adapter and will be removed with the handle adapter. With the suture mount  210  of the handle adapter removed, the sutures  250  connecting the valve holder body  20  to the prosthetic valve are exposed ( FIG.  11   ). The valve holder body  20 , together with the guide body  24  and rotor  22 , can now be removed from the prosthetic valve by cutting the sutures  250  at the single cut point of the cutting well  150 . 
     Several variations to the above described assembly may be used. With reference to  FIGS.  12 A- 12 C and  13 A- 13 B , an alternative guide body  524  and handle adapter  526  may be used. The guide body  524  is similar to the guide  306  described in U.S. Patent Application Publication 2018/0116755 and can be used with the valve holder body  302  disclosed in that publication. The guide body  524  has flexible arms  530  that snap into openings  320  of the valve holder body in the publication. 
     Similar to the first embodiment, the guide body  524  has an upper tubular wall  526  and a lower tubular wall  528  and a ledge  531  that separates the upper and lower walls. Along one side, the upper tubular wall  526  has an opening  532  and opposed flanges  534  that project from the wall  526  to define the opening  532 . Two flexible arms  530   a ,  530   b  extend from the lower tubular wall  528  and are adjacent the opposed flanges, respectively. 
     On the opposite side from the opposed flanges, the guide body has a cutout  536  that extends partially into the lower tubular wall  528  and entirely through the upper tubular wall  526 . A third flexible arm  530   c  is located in the cutout  536  and is cantilevered from the lower tubular wall  528  from a location inside the cutout  536 . This results in a longer flexible arm  530   c  than the two flexible arms  530   a,b  and easier assembly to the valve holder body. Similar to the guide  306  in the aforementioned publication, the guide body  524  has a keyway  538  which provides a passage for removal of the activator dial  16  and a wall  540  which provides a stop that limits rotation of the dial, all described more fully in the publication. 
     With referenced to  FIGS.  13 A and  13 B , the handle adapter  526  is similar to the handle adapter  26  of the first embodiment. The handle adapter  526  is a cylindrical tube having an upper tubular part  542  and a lower tubular part  544 . The lower tubular part is sized to fit inside the opening of the guide body  524 . A ledge  546  is arranged around the cylindrical tube between the upper part  542  and the lower part  544 . The ledge  546  has a recess  548  and, on each side of the recess, a support  550  extends from the ledge to form a suture mount. Each support has a notch  554  for a suture. Below the suture mount is a strut  556  extending from the lower tubular part  544 . At the end of the strut  556  is a suture guard  557 . 
     Inside the bore of the handle adapter  526  is a screw thread  558 . The thread  558  has a first alignment keyway  560  and a second alignment keyway  562  to facilitate insertion and removal of the activator dial  16 . The inner wall of the cylindrical tube is also recessed at the location of the keyways  560 ,  562 . An inner wall  564  at the bottom of the lower tubular part  544  is also recessed and forms an undercut surface  566 . 
     The handle adapter  526  is assembled to the guide body  524  by inserting the lower tubular part  544  into the central opening  566  of the guide body  524 . The opening  532  between the opposed flanges  534  of the guide body  524  provides space for passage of the strut  556  of the handle adapter  526 . The second alignment keyway  562  of the handle adapter is aligned with the keyway  538  of the guide body  524 . 
     With referenced to  FIGS.  15 A- 15 H , several variations for attaching suture loops  500  to commissure posts  4  and routing sutures  250  through the suture loops are provided.  FIG.  15 A  provides a single suture loop  500  for both sutures  250   a ,  250   b .  FIG.  15 B  provides three suture loops  500   a, b, c  that provide a single passage  600  for both sutures  250   a ,  250   b .  FIG.  15 C  provides a single suture loop  500  aligned vertically and the sutures  250   a ,  250   b  cross over each other.  FIG.  15 D  provides two vertical loops  500  and crossover sutures.  FIG.  15 E  provides overlapping loops  500  and a single vertical passage  600 .  FIG.  15 F  provides multiple pairs of overlapping loops  500   a ,  500   b  and a single vertical passage. The overlapping loops may also be arranged to provide a single horizontal passage (not shown).  FIG.  15 G  provides two end-to-end horizontally arranged loops  500  with separate passages  600   a ,  600   b  for the sutures.  FIG.  15 H  provides one pair of end to end horizontally arranged suture loops  500   a  above another pair of similarly arranged loops  500   b  resulting in separate vertical passages  600   a ,  600   b  for the sutures. The arrangements in  FIGS.  15 G and  15 H  can be rotated 90 degrees to provide horizontal passages if desired. 
     In other alternative embodiments, various different features from the different embodiments discussed herein and incorporated by reference can be combined in a single modified heart valve implant holder assembly. 
     For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in anyway. Instead, the present disclosure is directed toward all features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved. 
     Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods.