Patent Publication Number: US-2023145819-A1

Title: Tension member routing elements in transcatheter stented prosthesis tensioning system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 16/911,480, filed Jun. 25, 2020, which is a continuation of U.S. application Ser. No. 15/964,438, filed Apr. 27, 2018, now U.S. Pat. No. 10,743,990, which claims the benefit of U.S. Provisional Patent Application No. 62/490,896, filed Apr. 27, 2017, the entire contents of which are incorporated herein by reference. 
    
    
     BACKGROUND 
     The disclosure relates to transcatheter stented prosthesis delivery devices or systems that utilize one or more elongate tension members to compressively retain a stented prosthesis to the delivery device. 
     A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrio-ventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semilunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or “coapt” when the valve is in a closed position. Problems that may develop with valves include stenosis in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient. 
     Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. One conventional technique involves an open-heart surgical approach that is conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. 
     More recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of the valve prosthesis on the beating heart, intending to obviate the need for the use of classical sternotomy and cardiopulmonary bypass. In general terms, an expandable valve prosthesis is compressed about or within a catheter, inserted inside a body lumen of the patient, such as the femoral artery, and delivered to a desired location in the heart where the valve prosthesis is then deployed. 
     The present disclosure addresses problems and limitations associated with the related art. 
     SUMMARY 
     The present disclosure relates to numerous delivery devices or systems for transcatheter stented prosthesis (e.g., stented prosthetic heart valve) loading, delivery and implantation. Such delivery devices can include an optional outer delivery sheath assembly, a shaft assembly and a handle assembly. The delivery device provides a loaded delivery state in which the stented prosthesis is loaded and compressed over a distal portion of the shaft assembly. Compression of the stented prosthesis can be adjusted with one or more elongate tension members, which extend around the stented prosthesis and proximately to an actuation and release assembly that can optionally be located in the handle assembly. The delivery device can be manipulated to adjust tension in the tension members to permit the stented prosthesis to self-expand, contract and ultimately release from the shaft assembly. 
     Partial or full compression of the stented prosthesis can be achieved by pulling or otherwise retracting the tension members proximally. The present inventors have observed that with some tension member routing configurations, the tension member experiences wear and damage at a location where the tension member transitions from a first orientation that is generally parallel to the distal portion (e.g., as the tension member is routed back to the handle assembly) to a second orientation that is not parallel to the distal portion (e.g., extending from the stented prosthesis) or vice versa. In order to protect the tension members from abrasion and wear as tension in the tension member is adjusted, the disclosed embodiments can include one or more transition elements that create a smooth, rounded transition surface for the tension members to travel over as they change direction. After the tension members are released from the stented prosthesis, via various methods, the delivery device can be withdrawn from the patient. 
     Various disclosed embodiments are configured so that a longitudinal and/or rotational position of at least one end of a stent frame of the stented prosthesis is locked or maintained with respect to the delivery device. By locking the longitudinal and/or rotational position of at least one end or location of the stent frame, more predictable positioning and more equal and uniform crimping of the stent frame can be achieved. By locking the rotational position of the distal portion of the delivery device to the stent frame, clocking of the stented prosthesis for anatomical rotational alignment may be achieved more efficiently with minimal backlash. Locking can be achieved, for example, with a suture, wire, or the like interconnecting one end of the stent frame to the distal portion of the delivery device. 
     Aspects of the disclosure relate to a combination of a stented prosthesis loaded to a delivery device. The combination comprises a stented prosthesis including a stent frame having a compressed arrangement and an expanded arrangement; wherein the stent frame includes a distal end and a proximal end and an aperture provided at the distal end. The combination further includes a delivery device having a distal portion on which the stented prosthesis is loaded. The delivery device includes a release member extending along the distal portion. The combination also includes a lock member threaded through the aperture and engaged with the release member; wherein the lock member restricts longitudinal and/or rotational movement of the stent frame with respect to the distal portion of the delivery device when the stent frame is in both of the compressed arrangement and the expanded arrangement until release of the lock member from the release member. 
     Aspects of the disclosure relate to a method comprising providing a combination including: a stented prosthesis including a stent frame having a compressed arrangement and an expanded arrangement; wherein the stent frame includes a distal end and a proximal end and an aperture provided at one or more ends, e.g., the distal end. The method further includes providing a delivery device including a distal portion on which the stented prosthesis is loaded in the compressed arrangement. The delivery device further includes a release member extending along the distal portion and a lock member threaded through the aperture. The method further comprises delivering the stented prosthesis to a target site and disengaging the release member from the lock member to unlock the lock member so that the stent frame can move longitudinally and rotate with respect to the distal portion of the delivery device in the compressed arrangement. In some methods, the lock also prevents rotational movement of the stented prosthesis with respect to the distal portion of the delivery device. 
     Additional embodiments include a delivery device for delivering a stented prosthesis to a target site. The delivery device comprises an elongate tension member that can compressively retain the stented prosthesis to the delivery device; and a shaft assembly having a distal portion configured to retain the stented prosthesis. The shaft assembly further including a transition element secured to the distal portion, the transition element at least partially defining a lumen; wherein the elongate tension member extends in a first direction distally along a length of the distal portion, the elongate tension member is then routed through the lumen and then extends in a second direction that is different than the first direction. The transition element provides a rounded surface over which the tension member contacts as the tension member extends from the first direction to the second direction. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a perspective view of an example of a delivery device or system for delivering a stented prosthetic heart valve. 
         FIG.  2 A  is a schematic illustration of the delivery device of  FIG.  1    having the stented prosthetic heart valve positioned over a distal portion of the delivery device with a plurality of elongate tension members in a compressed arrangement. 
         FIG.  2 B  is a partial, schematic illustration of the delivery device of  FIG.  2 A  having the stented prosthetic heart valve positioned over the distal portion; the stented prosthetic heart valve shown in an expanded arrangement. 
         FIG.  3    is a schematic illustration of how three elongate tension members can be releasably positioned around a stented prosthesis with a release pin and tension in the tension members can be adjusted with a single actuator (the stented prosthesis is omitted for ease of illustration). 
         FIG.  4 A  is a perspective view of one stented prosthetic heart valve that can be used with the delivery devices disclosed herein shown in the expanded arrangement. 
         FIG.  4 B  is a front view of the stented prosthesis of  FIG.  4 A  in the compressed arrangement. 
         FIG.  5 A  is a perspective view of a distal portion of a delivery device, such as the delivery device of  FIG.  1   . 
         FIG.  5 B  is a partial, partially-exploded view of the distal portion of  FIG.  5 A . 
         FIG.  6 A  is a partial plan view of a portion of an alternate delivery device, similar to that of  FIG.  1   . 
         FIG.  6 B  a partial, perspective view of an alternate embodiment of a transition element secured to a distal portion. 
         FIG.  6 C  is a perspective view of an alternate embodiment of a transition element. 
         FIGS.  7 A- 7 D  collectively illustrate portions of an alternate distal portion. 
         FIG.  7 E  illustrate yet another distal portion having a plurality of channels arranged in a generally spiral orientation. 
         FIG.  8 A  is a schematic illustration of a truncated distal portion having a transition element. 
         FIG.  8 B  is a perspective view of the transition element of  FIG.  8 A . 
         FIG.  9    is a schematic illustration of a truncated distal portion having an alternate transition element. 
         FIG.  10    is a perspective view of an alternate transition element. 
         FIG.  11    is a perspective view of yet another transition element. 
         FIG.  12    illustrates a series of steps for forming a transition element and assembling the transition element to a distal portion. 
         FIG.  13    is a perspective view of a distal portion having a transition element (the distal portion shown as partially transparent). 
         FIG.  14 A  is a perspective view of an alternate distal portion having a plurality of transition elements. 
         FIG.  14 B  is an enlarged section of a portion of the distal portion of  FIG.  14 A . 
         FIG.  14 C  is a perspective view of the distal portion prior to rolling the distal portion into the shape of  FIG.  14 A . 
         FIG.  15    is a perspective view of an alternate distal portion having three tiers. 
         FIG.  16    is a partial, front view of an alternate distal portion. 
         FIG.  17 A  is a perspective view of an alternate transition element. 
         FIG.  17 B  is a perspective view of a distal portion including the transition element of  FIG.  17 A . 
         FIG.  18    is a perspective view of an alternate distal portion including a plurality of transition elements. 
         FIG.  19 A  is a side view of the stented prosthesis positioned over a distal portion; wherein a tension member circumscribing the stented prosthesis is routed through a transition element. 
         FIG.  19 B  is an enlarged view of Sec.  19 B of  FIG.  19 A . 
         FIG.  19 C  is a perspective view of the transition element of  FIGS.  19 A- 19 B . 
         FIG.  20    is a partial, schematic illustration of one way in which tension members can be internally routed around a stent frame of the stented prosthesis relative to a delivery device. 
         FIG.  21    is a partial, schematic illustration of another way in which tension members can be externally routed around the stent frame relative to the delivery device. 
         FIG.  22    is a partial, schematic illustration of one way in which one end of the stent frame can be locked in longitudinal and rotational position with respect to a distal portion of a delivery device. 
         FIG.  23    is a partial, schematic illustration of another way in which one end of the stent frame can be locked in longitudinal and rotational position with respect to a distal portion of a delivery device. 
         FIG.  24    is a partial, schematic illustration of yet another way in which one end of the stent frame can be locked in longitudinal and rotational position with respect to the distal portion of the delivery device of  FIG.  23   . 
         FIG.  25    is a partial, schematic illustration of another way in which one end of the stent frame can be locked in longitudinal position with respect to the distal portion of the delivery device of  FIG.  23   . 
         FIG.  26    is a partial, schematic illustration of an additional way in which one end of the stent frame can be locked in longitudinal and rotational position with respect to a distal portion of a delivery device. 
         FIG.  27    is a partial, schematic illustration of a further way in which one end of the stent frame can be locked in longitudinal and rotational position with respect to a distal portion of a delivery device. 
         FIG.  28    is a partial, schematic illustration of a guide that can be secured to the distal portion. 
         FIG.  29    is a partial, schematic illustration of an alternate guide that can be secured to the distal portion. 
         FIG.  30    is a partial, schematic illustration of another guide that can be secured to a distal portion. 
         FIG.  31    is a partial, schematic illustration of yet another guide that can be secured to the distal portion. 
         FIG.  32    is a partial, schematic illustration of an alternate guide that can be secured to the distal portion. 
         FIG.  33    is a partial, schematic illustration of another guide that can be secured to the distal portion. 
         FIG.  34 A  a partial, cross-sectional schematic illustration of yet another guide having a ring that can be secured to the distal portion. 
         FIG.  34 B  is a side view of the ring of  FIG.  34 A  being directly secured to the distal portion. 
         FIG.  35    is a partial, schematic illustration of an alternate guide that can be secured to the distal portion. 
         FIG.  36    is a partial, schematic illustration of the stent frame having guide loops secured thereto and one end of the stent frame being longitudinally locked with respect to a distal portion. 
         FIG.  37    is a partial, perspective view of an alternate distal portion having generally spiral cut channels similar to the embodiment of  FIG.  7 E . 
         FIG.  38    is a partial, exploded view of a transition element and the distal portion of  FIG.  37   . 
         FIG.  39    is a perspective view of the assembled distal portion of  FIGS.  37 - 38   . 
         FIG.  40    is a perspective view of an alternate distal portion. 
         FIG.  41    is a perspective view of the distal portion of  FIG.  40    further including a wrap and a hub. 
         FIG.  42    is a cross-sectional view of the distal portion of  FIG.  41   . 
         FIG.  43    is a perspective view of an alternate distal portion substantially similar to those of  FIGS.  37 - 42    having an integrated hub. 
         FIGS.  44 - 47    illustrate select components of an alternate distal portion having a plurality of transition elements through which tension members can be routed. 
         FIGS.  48 - 51    illustrate select components of an alternate distal portion having a plurality of transition elements through which tension members can be routed. 
         FIGS.  52 - 54    illustrate select components an alternate distal portion having a plurality of transition elements through which tension members can be routed. 
         FIGS.  55 - 56    illustrate select components an alternate distal portion having a plurality of transition elements through which tension members can be routed. 
     
    
    
     DETAILED DESCRIPTION 
     Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” or “distally” are a position distant from or in a direction away from the clinician. “Proximal” and “proximally” are a position near or in a direction toward the clinician. 
     As described below, some aspects of the present disclosure relate to delivery devices or systems utilizing one or more tension members to compress and retain a stented prosthesis to the delivery device during transcatheter delivery to a target site. By way of background, general components of one non-limiting example of a delivery device  10  with which some aspects of the present disclosure are useful are illustrated in  FIGS.  1 - 3   . The delivery device  10  is arranged and configured for percutaneously delivering a stented prosthesis, such as a stented prosthetic heart valve  30  (schematically illustrated), to a target site. The delivery device  10  includes an optional outer sheath assembly  12  having a flexible outer sheath  14 , a flexible shaft assembly  16  and a handle assembly  18 . The shaft assembly  16  can include a distal portion  22  and define a continuous lumen  26  (referenced generally) sized to slidably receive an auxiliary component such as a guide wire  28 . In this embodiment, the outer sheath  14  is interconnected to a capsule  24  that is selectively disposed over the stented prosthesis  30  and assists in constraining the stented prosthesis  30  in the compressed arrangement. The capsule  24  can be retracted by the handle assembly  18  to expose the stented prosthesis  30  for deployment. 
     One or more tension members  20  (e.g., sutures, cords, wires or filaments) are further provided, and can be considered part of the delivery device  10  in some embodiments or as part of the stented prosthesis  30  in other embodiments. It is to be understood that the terms “tension member”, “suture”, “cord”, “wire” and filament”, as used herein, should be considered equivalent, interchangeable elements. Some examples in which the tension members  20  can be arranged are schematically illustrated in  FIGS.  2 A- 3    (the stented prosthesis and other delivery device components being omitted in  FIG.  3    for ease of illustration). One end of each of the tension members  20  can be secured proximate the handle assembly  18 , then each tension member  20  can extend distally to wrap around the stented prosthesis  30  positioned over the distal portion  22  to a release pin  50  positioned adjacent the stented prosthesis  30  and then back to the handle assembly  18  or other mechanism for maintaining and adjusting the desired level of tension in the tension members  20  either individually or in pairs or groups of tension members. Due to friction losses as the tension member  20  goes around the stent frame  32 , positioning the release pin  50  approximately 360 degrees from the distal portion  22  results in asymmetric crimping and consequently the stent frame in-folding. Therefore, in some embodiments, the release pin  50  is placed 180 degrees from the distal portion  22 , but for practical purposes is more practically placed within the distal portion  22 , or about 360 degrees from the distal portion  22 . The release pin  50  is optional, with the primary benefit being a reduced length of the tension member(s)  20  to adjust compression of the stented prosthesis  30 , and may be omitted as in the embodiments of  FIGS.  20 - 21   . Other tension member arrangements are envisioned. The delivery device  10  provides a loaded, compressed arrangement ( FIG.  2 A ) in which the stented prosthesis  30  is loaded over the shaft assembly  16  and is compressively retained on the distal portion  22  by the tension members  20 . As is schematically illustrated in  FIGS.  2 A- 2 B , compression of the stented prosthesis  30  is adjustable with the tension members  20 . In this illustrated embodiment, the tension members  20  wrap around the stented prosthesis  30  normal to an axis of the shaft assembly  16 . Alternatively, the tension members  20  can be configured to wrap around the stented prosthesis  30  at other angles with respect to the axis of the shaft assembly  16 . The present inventors have found that wrapping the tension members  20  at an angle to the distal portion  22  creates non-symmetric crimping of the stented prosthesis  30 , which causes in-folding of the stent frame  32 . In-folding of the stent frame  32  can decrease structural integrity. 
     After being loaded, compressed and optionally sheathed with the capsule  24 , the stented prosthesis  30  is delivered to the native defective heart valve. Once the stented prosthesis  30  is sheathed with the capsule  24 , tension in the tension members  20  can be released, if desired to release tension in the tension members  20  for more effective steering and a more flexible shaft assembly  16 , as the capsule  24  maintains the stented prosthesis  30  in the compressed arrangement. Once in position, the capsule  24  is retracted (if provided) and/or tension in the tension members  20  is lessened or released to permit the stented prosthesis  30  to self-expand to an expanded arrangement, partially releasing and ultimately fully deploying the stented prosthesis  30  from the shaft assembly  16  (see,  FIG.  2 B ). Then, the release pin  50  is proximally retracted to disengage from the tension members  20  so that the tension members  20  can be released from the stented prosthesis  30  and withdrawn from the patient along with the delivery device  10 . In alternate embodiments, the release pin  50  is omitted and the tension members  20  can be cut for release from the stented prosthesis  30 , as with the embodiments of  FIGS.  20 - 21   . If the stented prosthesis  30  is longitudinally and/or rotationally locked to the distal portion  22  as discussed in greater detail below, the lock may be released prior to tension member  20  release, after tension member release, simultaneous with tension member release, or if tension members are released individually, it may be unlocked at any point in the sequence. The present disclosure focuses on numerous ways to configure a delivery device, such as the delivery device  10 , to prevent wear of the tension member  20  as tension in the tension member(s) is adjusted. It is to be understood that the delivery device  10  disclosed above is provided as only one example and that aspects of the disclosure can also be used with other types of delivery devices. 
     As referred to herein, the stented prostheses and stented prosthetic heart valves or “prosthetic valves” useful with the various devices and methods of the present disclosure may assume a wide variety of configurations. The prosthetic valves can include a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic or tissue-engineered leaflets, and can be specifically configured for replacing valves of the human heart. The stented prosthesis and prosthetic valves of the present disclosure may be self-expandable, balloon expandable and/or mechanically expandable or combinations thereof. In general terms, the prosthetic valves of the present disclosure include a stent or stent frame having an internal lumen maintaining a valve structure (tissue or synthetic), with the stent frame having a normal, expanded condition or arrangement and collapsible to a compressed condition or arrangement for loading within the delivery device. For example, the stents or stent frames are support structures that comprise a number of struts or wire segments arranged relative to each other to provide a desired compressibility and strength to the prosthetic valve. The struts or wire segments are arranged such that they are capable of self-transitioning from, or being forced from, a compressed or collapsed arrangement to a normal, radially expanded arrangement. The struts or wire segments can be formed from a shape memory material, such as a nickel titanium alloy (e.g., Nitinol™). The stent frame can be laser-cut from a single piece of material, or can be assembled from a number of discrete components. 
     One non-limiting example of the stented prosthesis  30  is illustrated in detail in  FIGS.  4 A- 4 B . As a point of reference, the stented prosthesis  30  is shown in a normal or expanded arrangement in the view of  FIG.  4 A  and a compressed arrangement in  FIG.  4 B . The stented prosthesis  30  includes a stent or stent frame  32  and a valve structure  34 . The stent frame  32  can assume any of the forms mentioned above, and is generally constructed to be self-expandable from the compressed arrangement to the normal, expanded arrangement. As discussed above, compression of the stented prosthesis  30  can be achieved with one or more tension members  20 . 
     The valve structure  34  of the stented prosthesis  30  can assume a variety of forms, and can be formed, for example, from one or more biocompatible synthetic materials, synthetic polymers, autograft tissue, homograft tissue, xenograft tissue, or one or more other suitable materials. In some embodiments, the valve structure  34  can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. In some embodiments, the valve structure  34  is formed, for example, from heart valve tissue, pericardium, and/or other suitable tissue. In some embodiments, the valve structure  34  can include or form one or more leaflets  36 . For example, the valve structure  34  can be in the form of a tri-leaflet bovine pericardium valve, a bi-leaflet valve, or another suitable valve. 
     In some prosthetic valve constructions, such as that of  FIGS.  4 A- 4 B , the valve structure  34  can comprise two or three leaflets  36  that are fastened together at enlarged lateral end regions to form commissural joints, with the unattached edges forming coaptation edges of the valve structure  34 . The leaflets  36  can be fastened to a skirt that in turn is attached to the stent frame  32 . The stented prosthesis  30  includes a first end (inflow)  40  and an opposing second end (outflow)  44  of the stented prosthesis  30 . As shown, the stent frame  32  can have a lattice or cell-like structure, and optionally forms or provides posts  46  corresponding with commissures of the valve structure  34  as well as features  48  (e.g., crowns, eyelets or other shapes) at the first and second ends  40 ,  44 . If provided, the posts  46  are spaced equally around the stent frame  32  (only one post  46  is clearly visible in  FIG.  4 A ). 
     Turning now also to  FIGS.  5 A- 5 B , which illustrate one example embodiment of a distal portion  122  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. In this embodiment, the distal portion  122  includes a hollow cylindrical body  124  having a plurality of windows  126 . Within the hollow cylindrical body  124  is an insert  130  including a ridge  132 . The ridge  132  may include a plurality of notches  134  that are aligned with each of the windows  126  when the insert  130  is operatively positioned within the distal portion  122 . Positioned over each of the notches  134  is a transition element  140 . In operation, one or more tension members  20  extend around the prosthetic valve and through one window  126 , transition element  140 , and also through the notch  134  and along the insert  130  proximally to a handle assembly or the like (only one example tension member  20  is shown for ease of illustration in  FIG.  5 B ). The transition element  140  provides a smooth, rounded surface for the tension members  20  to travel over as tension in the respective tension member(s)  20  is adjusted to compress and release compression of the stented prosthesis. When tension in the tension members  20  is adjusted, the length of tension member  20  around the stented prosthesis changes. Transition surfaces along a path as the tension member(s)  20  changes direction and travels through the window  126  and the notch  134  and then along the insert  130 , within the distal portion  122  can cause damage to the tension member(s)  20 . The transition element  140  includes an aperture  142  defined by a beveled, rounded or otherwise smooth surface  144  for the tension member(s)  20  to travel over to reduce wear of the tension member(s)  20 . 
     Referring now also to  FIG.  6 A , which illustrates an alternate transition element  240  that can be used with a distal portion  222  of a delivery device, such as the delivery device  10  of  FIG.  1   . In this embodiment, the transition element  240  is a coil having a smooth, rounded outer surface  242  over which one or more transition member(s)  20  pass over as they are redirected from the stented prosthesis  30  proximally along a shaft assembly  216  to a handle assembly or the like (e.g., see also, the shaft assembly  16  and the handle assembly  18  of  FIG.  1   ). The tension members  20  can be any of the type disclosed herein. Alternatively, in the embodiment of  FIG.  6 B  the tension members (not shown) can be routed through a transition element  240 ′ being a coil forming a lumen  241 ′ that is joined to the exterior of the distal portion  222 . The coil can be a single coil  240 ′ ( FIG.  6 B ), or a pair of coils  240 ″ ( FIG.  6 C ) to keep a plurality of tension members separated. By overlapping two coils, three lumens  243   a - c  are present and each lumen  243   a - c  may be used to constrain a release pin (e.g.,  50 ) or tension member (e.g.,  20 ), as desired. 
     Referring now also to  FIGS.  7 A- 7 D , which illustrate alternate components that can be used with any of the embodiments disclosed herein. This embodiment includes a distal portion  322  (which could be substituted for distal portion  22 , for example) including a sleeve  342 , optional shield  343  and cage members  344  (generally referenced) that are welded or otherwise attached and extend around at least a portion of a circumference of the distal portion  322  on the sleeve  342 . In some embodiments, the cage members  344  extend around the entirety of the sleeve  342 . As best shown in  FIG.  7 B , the sleeve  342  defines three channels  346   a - c . The distal portion  322  extends through the first channel  346   a , a release pin  50 , as described above, can extend through the second channel  346   b  and one or more tension members (not shown, see also the prior disclosed embodiments) can be routed through the third channel  346   c . The cage members  344  are configured to provide an atraumatic surface  348  for one or more tension members  20  to travel across as they are redirected from the stented prosthesis to a location proximal the stented prosthesis through the third channel  346   c . The shield  343 , if provided, has windows (not visible) through which the tension members  20  can be routed. The shield  343  may keep blood, valve frame, or valve leaflets from interacting with the tension members  20 . The sleeve  342  can take many other configurations. 
     Referring now also to  FIG.  7 E , which illustrates yet another distal portion  322 ′ that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The distal portion  322 ′ can retain prosthesis  30  with at least one tension member  20  (only one tension member  20  is visible). The distal portion  322 ′ of this embodiment includes a plurality of channels  346 ′ (e.g., eight channels) similar to the concept shown in  FIGS.  7 A- 7 D ; however the channels  346 ′ align the individual tension members  20  arms with a similar number (eight) transition elements  340 ′ (only one is shown) having an atraumatic surface over which one or more tension members  20  can travel over as the tension member  20  changes direction. In some embodiments, as shown, the channels  346 ′ can be oriented in a generally spiral orientation on the distal portion  322 ′ with respect to a central axis of the distal portion  322 ′. In one embodiment, the tension members  20  are symmetrically spaced around a central guide wire lumen (not shown) in the distal portion  322 ′. On the distal portion  322 ′ is beneficial to redirect some of the tension members  20  close to 180 degrees from the transition element(s)  340 ′ and spiral-configured channels  346 ′ are one way of bringing the tension members  20  around an outer circumference of the distal portion  322 ′. 
     Referring now also to  FIGS.  8 A- 8 B , which illustrate a section of an alternate distal portion  422  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. In this embodiment, the distal portion  422  can include one or more apertures  424  (only one aperture is shown in a truncated section of the distal portion) through which one or more tension members  20  are routed. The aperture  424  includes a transition element  440  being a ring, made of wire or the like that has a smooth rounded surface to provide abrasion relief as the tension member(s)  20  passes over the ring  440 . In one example embodiment, the ring  440  is a C-shaped wire formed and welded to a metal laser cut hypotube forming the distal portion  422 . In the illustrated embodiment, the ring  440  is hyperbolic paraboloid shape. Any additional apertures for routing one or more tension members  20  into the distal portion  422  can be similarly configured, as desired. 
     Referring now also to  FIG.  9   , which illustrates part of an alternate distal portion  522  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. In this embodiment, the distal portion  522  can include one or more apertures  524  (only one is shown) through which one or more tension members  20  are routed. The aperture  524  includes a transition element  540  being an electroplated edge, which has a smooth, rounded surface to provide abrasion relief as the tension member(s)  20  pass over the edge  540  to change direction. Any additional apertures for routing one or more tension members into the distal portion  522  can be similarly configured, as desired. 
     Referring now also to  FIG.  10   , which discloses an alternate transition element  640  that can be inserted into any aperture of and secured coaxially with any of the distal portions disclosed herein to create a smooth, rounded surface for one or more tension members  20  to travel over as the tension members  20  pass from outside of the distal portion to within the distal portion. In this embodiment, the transition element  640  includes a generally cylindrical body  642  having one or more flanges  644  and a lip  646 . When the transition element  640  is operatively positioned within an aperture of a distal portion (see also,  FIG.  8 A  and related disclosure), the lip  646  is configured to extend from within the distal portion, through the aperture and around an edge of the aperture. The lip  646  can, in some embodiments, define an arc that extends about 180 degrees with respect to a center axis of the body  642 . As desired, the body  642  can include a plurality of features  648  to assist in maintaining the transition element  640  in place within the aperture of the distal portion. 
     Referring now also to  FIG.  11   , which illustrates an alternate transition element  740 . The transition element  740  defines an aperture  742  having a smooth, rounded edge  744 . The transition element  740  is configured to be secured and maintained within one of the apertures of the distal portion (similar to what is shown in  FIG.  8 A  or, alternatively, any distal portion disclosed herein) to effectively cover the edge of the aperture of the distal portion. In this embodiment, the transition element  740  is arranged on the distal portion so that the aperture  742  is aligned with the aperture in the distal portion. Similar to other disclosed embodiments, one or more tension members can be routed over the smooth rounded edge  744  as the one or more tension members pass from outside of the distal portion to within the distal portion. 
     Now also referring to  FIG.  12   , which illustrates an alternate transition element  840  in multiple stages of formation and assembly to a distal portion  822  (shown as truncated for ease of illustration). In this embodiment, the transition element  840  includes an aperture  842  that can be positioned to align with an aperture  824  in the distal portion  822 , which can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The transition element  840  further includes a beveled, rounded, smooth edge  844  around the aperture  842  to provide an atraumatic surface for one or more tension members  20  to travel across. The edge  844  can be coined or otherwise machined, for example, within a flat metal blank that is subsequently bent to conform to the curvature of the distal portion  822 . In various embodiments, upon assembly, the transition element  840  can have an outer diameter that is larger than an outer diameter of the distal portion  822  and the transition element  840  can have an inner diameter that is slightly smaller than an inner diameter of the distal portion  822 . 
     Referring now also to  FIG.  13   , which illustrates an alternate distal portion  922  (shown as truncated and partially transparent) configuration in which an aperture  924   a  in the distal portion  922  that receives one or more tension members  20  is manufactured to have a transition element  926  being a beveled, rounded, smooth edge that is coined or otherwise integrally formed into the distal portion  922 . The distal portion  922  can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The transition element  926  can be formed, for example, by inserting tooling through the aperture  924   a  such that the tooling is positioned about 180 degrees from the aperture  924   a . As illustrated, the distal portion  922  can include two opposing apertures  924   a ,  924   b . The second aperture  924   b  can also include a coined edge  926  or the like, as desired. One purpose of aperture  924   b  is to allow access of a laser beam, polishing element, or cutting tool to smooth the edges of the aperture  924   a.    
     Turning now also to  FIGS.  14 A- 14 C , which illustrate an alternate distal portion  1022  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The distal portion  1022  has a plurality of apertures  1024 , each having a transition element  1026 , which is a smooth, coined edge. As with prior disclosed embodiments, the transition element  1026  provides an atraumatic surface over which one or more tension members (not shown) can pass as the tension member(s) is redirected from the stented prosthesis (not shown), through the aperture  1024 , inside and along the distal portion  1022 . The distal portion  1022  of this embodiment can optionally be formed from a sheet of material as is generally illustrated in  FIG.  14 C  that is subsequently rolled and seam welded to produce the distal portion  1022  configuration shown in  FIG.  14 A . 
     Now also referring to  FIG.  15   , which illustrates an alternate distal portion  1122  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The distal portion  1122  includes three tiers  1123   a - c , each defining a lumen  1125   a - c  extending along a length of the distal portion  1122 . The first tier  1123   a  is the longest, the tier section  1123   b  shorter than the first tier  1123   a  and the third tier  1123   c  is the shortest of the three tiers  1123   a - c . As illustrated, the varying length of the tiers  1123   a - c  provides staggered points for tension members  20  to exit and enter the respective tiers  1123   a - c . In this way, the tension members  20  are spaced along a length of the stented prosthesis (omitted) positioned on the distal portion  1122 . This distal portion  1122  has a reduced diameter in a region proximate the first and second sections  1123   a - b  where a paravalvular leakage prevention wrap of the stented prosthesis, of the type frequently provided with stented prosthetic heart valves, would be positioned, if provided. 
     Referring now also to  FIG.  16   , which illustrates yet another distal portion  1222  that can be used in replacement of the distal portion  22  of  FIG.  1    or with another device. The distal portion  1222  of this embodiment routes at least one tension member  20  and the release pin  50  outside and over a cylindrical body  1223  of the distal portion  1222 . In this embodiment, the distal portion  1222  includes guides  1238   a - b  and also one or more transition elements  1240 . The first and second guides  1138   a - b  retain the release pin  50  and the transition element  1240  retains at least one tension member  20  and provides an atraumatic, rounded surface  1144  as the tension member  20  changes direction, thus reducing wear and damage to the tension member(s)  20 . The distal portion  1222  can include multiple guides  1138   a - b  and/or transition elements  1240 , similarly or differently configured, as desired, along a length or circumference of the body  1123 . 
     Turning now also to  FIGS.  17 A- 17 B , which collectively illustrate an attachment  1337  that can be operatively secured to a distal portion  1322  (or distal portion  22 , for example) to provide a guide  1338 , a transition element  1340 , as well as a receiving channel  1341  through which the distal portion  1322  is inserted. In this embodiment, a release pin (not shown, see the release pin  50  disclosed above with respect to other embodiments) can be positioned within the guide  1338  and one or more elongate tension members can be routed through apertures  1342  and/or  1338  in the transition element  1340 . As with prior disclosed embodiments, the transition element  1340  is configured to have a beveled, rounded surface or edge  1344  proximate the apertures  1342  and or  1338  so that wear of the tension member is reduced. In various embodiments, the rounded, atraumatic edge  1344  is machined into the transition element  1340  or manufactured or machined as a separate component and then welded or otherwise attached proximate the aperture  1342 . Alternatively, the atraumatic edge  1344  can be formed by stamping, coining, extruding, honing, electropolishing, acid etching, autogenous welding or the like. Optionally, the attachment  1337  can be clipped, slid or otherwise secured around a distal portion  1322  (see,  FIG.  17 B ). If the attachment  1337  is to be clipped onto the distal portion  1322 , the attachment  1337  includes a gap  1343  and is made of a material that provides sufficient flexing such that the gap  1343  can be widened to allow the distal portion  1322  to be inserted therethrough. The distal portion  1322  can include a plurality of similarly configured attachments  1337  along a length of the distal portion  1322 , as desired. In various embodiments, the distal portion  1322  includes slots (not shown) for receiving each attachment  1337  so that the profile of the delivery device is minimized by at least somewhat accommodating for the profile increase attributable to the attachment  1337 . 
     Referring now also to  FIG.  18   , which illustrates select components of a distal end of an alternate delivery device, which can be similar to that of  FIG.  1    except as explicitly stated. The device includes a distal portion  1422  (which could replace distal portion  22  of  FIG.  1   ) over which a stented prosthesis, such as those disclosed herein, can be loaded. The delivery device can further include the release pin  50  positioned within one or more guides  1438   a - b  located on a cylindrical body  1423  of the distal portion  1422 . Also provided are two transition elements  1440   a - b  that each include beveled, rounded surface  1444   a - b  over which one or more tension members (not shown) pass to change directions as the tension member(s) is routed, for example, from the stented prosthesis and along a length of the distal portion  1422 . The release pin  50  could alternatively or additionally function as a lock member, as discussed below with respect to other embodiments (see, e.g.,  FIG.  22    and related disclosure). The guides  1438   a - b  and/or transition elements  1440   a - b  can comprise a machined cylinder or ceramic disc (not visible), which can optionally additionally provide radiolucent properties. The atraumatic, rounded surface  1444   a - b  of the transition elements  1440   a - b  can be machined or formed into the respective transition element  1440   a - b , which provides abrasion relief for tension members routed therethrough (e.g., in the illustrated embodiment, for tension members positioned at ends of the stent frame). 
     A transition element  1540  can also be provided in a delivery device (e.g., such as that of  FIG.  1   ) proximate one or more tension elements  1520  wrapped around the middle or waist of the prosthetic valve as is generally shown in  FIGS.  19 A- 19 B . The tension elements  1520  are of the type as disclosed with respect to the tension elements  20  disclosed herein. The transition element  1540  is a ring that redirects and reduces wear on waist tension member  1520  at the point where the tension member  1520  is redirected from the stent frame  32  to along a distal portion  1542  of a delivery device (see also,  FIG.  1   , for example of on suitable delivery device). The transition element  1540  can include a rigid ring (shown in  FIG.  19 C ) or a flexible loop of material or the like, for example. In some embodiments, the transition element  1540  will be made of the same material as the tension members  1520 . The transition element  1540  can be provided in combination with or as a substitute for any of the transition elements disclosed herein, as desired. 
     Now also referring to  FIG.  20   , which illustrates one way in which elongate tension members  20  can be routed in which tension members  20  proximate a middle of the stent frame  32  (partially shown) are generally positioned through or interior to the stent frame  32 . A distal portion  1622  over which the stent frame  32  is positioned can include one or more transition elements  1640   a - d  having an atraumatic, rounded surface for the tension members  20  to pass over as they change direction from a direction generally parallel to the distal portion  1622  to a direction generally perpendicular to the distal portion or vice versa. The transition elements  1640   a - d  can be any of the type disclosed herein. Moreover, the distal portion  1622  can be configured substantially similar to the distal portions disclosed above and can be used with the delivery device of  FIG.  1   , for example. 
     Alternatively, the tension members  20  can be routed exterior to the stent frame  32  (partially shown) as is shown  FIG.  21   . In such embodiments, it is beneficial for the stent frame  32  to include transition elements  1640   d - e  though which waist tension members  20  can be routed in placed of the transition elements  1640   b - c  of  FIG.  20   . The transition elements  1640  can be made of a flexible material, such as the material of the tension members  20  and provide an atraumatic surface for one respective tension member  20  to pass through as the tension member  20  transitions from a direction generally parallel to the distal portion  1622  to a direction generally perpendicular to the distal portion  1622  or vice versa. 
     In addition, it can be beneficial for one end  40  (i.e. distal end) of the stent frame  32  to be longitudinally and/or rotationally locked in position relative to the distal portion  1622 . Locking one end  40  of the stent frame  32  is beneficial as the forces on the tension members  20  proximate the middle of the stent frame  32  during expansion of the stent frame  32  will pull the stent frame  32  proximally and this can result in asymmetric crimping and jamming of the second end  44  (i.e. proximal or outflow end) into the distal portion  1622 . By locking one end  40  of the stent frame  32  to the distal portion  1622  with a locking configuration of the type illustrated in  FIGS.  22 - 28    (e.g., utilizing a suture or the like  1760 ,  1850 ), the lock member and release member  1760 ,  1850  bears much of the cinching loads and prevents the distal end  40  of the stent frame  32  from moving proximally as the stent frame  32  is compressed. An added benefit is that when the stent frame  32  expands, the foreshortening of the stent frame  32  that occurs when the stent frame  32  expands is predictable. For example, if the inflow end  40  of the stent frame  32  is locked in longitudinal position, the stent frame  32  will always shorten towards or in the direction of the inflow end  40 , which improves deployment predictability. The lock position of the stent frame  32  may be at multiple location along the stent frame  32  or just at inflow and outflow ends  40 ,  44 , for example. 
     Referring now also to  FIG.  22   , which illustrates one way in which the stent frame  32  can be secured over a distal portion  1722  and locked into position with a lock member  1760  being a flexible loop of material such as a suture or the like extending between an aperture  33  formed into the stent frame  32  and around the release member  50  that is positioned within a boss  1738  having an axis parallel to that of the distal portion  1722 . If the suture  1760  is tight, rotational locking is present as well, which the user may need for torqueing the stented prosthesis into rotational alignment with a native valve, for example, to align a prosthetic valve and the native valve commissures to facilitate perfusion of the coronary arteries and to allow for future catheter access for coronary artery procedures. As can be seen, the aperture  33  is not a cell of the lattice of the stent frame  32  but the aperture  33  is formed within the material of the stent frame  32  (e.g., at a node, see also,  FIG.  25   ) which defines the lattice. In the present embodiment, the release member  50  is an elongate pin (“release pin”). When in the configuration of  FIG.  22   , the stent frame  32  is locked in longitudinal position with respect to the distal portion  1722 . When the release member  50  is proximally retracted to disengage from the lock member  1760 , the stent frame  32  is unlocked and can move longitudinally and/or rotationally with respect to the distal portion  1722 . In all other respects, the stent frame  32  and distal portion  1722  can be any of the types disclosed herein for use with delivery devices disclosed herein. The location of the suture  1760  can be positioned anywhere vertically along the stent frame  32 , including providing multiple locks or sutures  1760  in multiple locations along the stent frame  32 . 
     Similarly,  FIG.  23    illustrates the stent frame  32  secured over a distal portion  1822  and having one end (distal end)  40  locked into position with the lock member  1760  extending between the aperture  33  formed in the stent frame  32  (as described with the prior embodiment) and around the release pin  50  that is positioned within a boss  1838  arranged orthogonal to the distal portion  1822 . When in the configuration of  FIG.  23   , one end  40  of the stent frame  32  is locked in longitudinal position with respect to the distal portion  1822 . When the release pin  50  is proximally retracted to disengage from the lock member  1760 , the stent frame  32  is unlocked from the distal portion  1822  in that both ends of the stent frame  32  can move longitudinally and/or rotationally with respect to the distal portion  1822 . The stent frame  32  and distal portion  1822  can be any of the type disclosed herein for use with delivery devices disclosed herein.  FIG.  24    illustrates a substantially similar embodiment in which the release pin  50  is omitted and substituted with a release member being an elongate, flexible member (e.g., cord, suture or the like)  1850  that functions similarly to release pin  50  in that the release member  1850  is releasably engaged with the lock member  1760 . Once the release member  1850  is released from lock member  1760 , the lock member  1760  is released from the boss  1838  and the stent frame  32  can longitudinally and/or rotationally move with respect to the distal portion  1822  (i.e. transitions from being locked to unlocked). Rotational locking is also present in the locking features highlighted in  FIGS.  22 - 24   . 
     In another similar embodiment, as shown in  FIG.  25   , the lock member  1760  can be omitted. In this embodiment, the release member or suture  1850  can be routed both through aperture  1839  in the boss  1838  and the aperture  33  in the stented frame  32  to maintain the longitudinal and/or rotational position of the stent frame  32  with respect to the distal portion  1822 . To unlock the stent frame  32 , the release member  1850  can either be cut or the tension in the release member  1850  can otherwise be lessened to unlock the stent frame  32  from the distal portion  1822 . Similarly, as shown in  FIG.  26   , the boss  1838  of  FIG.  25    can be omitted and substituted with an aperture  1939  provided in a distal portion  1922 . As shown in  FIG.  27   , the stent frame  32  can be longitudinally and/or rotationally locked in position (in both the compressed and expanded arrangements) with respect to the distal portion  2022  with the release member  1850  by providing an aperture  2039  in the distal portion  2022  and wrapping the release member  1850  around a node  35  of the stent frame  32 . In these embodiments, the stent frame  32  is unlocked by releasing the release member  1850  from the stent frame  32  or otherwise sufficiently easing tension in the release member  1850  so that the stent frame  32  can move longitudinally with respect to the distal portion  1822 ,  1922 ,  2022 . In all other respects, the stent frame  32  and distal portions  1822 ,  1922  and  2022  can be any of the types disclosed herein for use with delivery devices disclosed herein. 
     Turning now also to  FIG.  28   , which illustrates the distal portion  22  having at least one guide  2140 . The guide  2140  includes a cylindrical body  2141  coaxially positioned over the distal portion  22 . The guide  2140  also includes two trapezoidal-shaped projections  2143  extending from the body  2141  that collectively define a channel  2145  through which one or more tension members  20  can be routed, as shown. The projections  2143  also include an aperture  2147  through which a pin  2150  can be inserted. Collectively, slanted edges of the projection  2143  and the pin  2150  provide an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa, for example. In an alternate embodiment, as shown in  FIG.  29   , the pin  2150  of  FIG.  28    can be replaced with a flexible member  2150 ′, which can optionally be made of the same material as the tension member(s)  20  to reduce friction between the tension member(s)  20  and the flexible member  2150 ′. 
     Referring now also to  FIG.  30   , which illustrates an alternate guide  2240  positioned over the distal portion  22 . The guide  2240  includes a boss  2243  defining a channel  2245  in which one or more tension members  20  can be routed, as shown. Similar to the projections  2143  of  FIGS.  29 - 30   , the boss  2243  has a generally trapezoidal cross-section and is configured to provide an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa. It will be understood that multiple guides  2240  can be provided on the distal portion  22 . 
     Turning now also to  FIG.  31   , which illustrates an alternate guide  2340  having an aperture  2345  through which a flexible member is threaded to form a loop  2350 . One or more of the tension members  20  can be routed through the loop  2350 , which are positioned to provide an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa, for example. It will be understood that multiple guides  234  can be provided along a length of the distal portion  22 . 
     Referring now also to  FIG.  32    which illustrates an alternate guide  2440  having two apertures  2445  through which respective flexible members are threaded to form loops  2450 . One or more of the tension members  20  can be routed through each of the loops  2450 . The loops  2450  respectively provide an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa, for example. In some embodiments, the loops  2450  are made of the same material as the tension members  20  to further reduce friction. It will be understood that multiple guides  2440  can be provided on the distal portion  22 . 
     Similarly,  FIG.  33    illustrates an alternate guide  2540  having four apertures  2545  (generally referenced) through which respective flexible members are threaded to form loops  2550 . One or more of the tension members  20  can be routed through each of the loops  2550 . The loops  2450  respectively provide an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa. In some embodiments, the loops  2550  are made of the same material as the tension members  20 . 
     Turning now also to  FIG.  34 A  which illustrates an alternate guide  2640  having a ring  2650  through which one or more tension members  20  are threaded. The ring  2650  provides an atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa, for example. Optionally, the guide  2640  can also include a support or divider  2652 . In other alternate embodiments, as shown in  FIG.  34 B , the ring  2650  can be directly welded or otherwise attached to the distal portion  22 . It will be understood that multiple guides  2640  can be provided on the distal portion  22 . 
     Referring now also to  FIG.  35   , which illustrates yet another alternate guide  2740  positioned over the distal portion  22 . The guide  2740  includes a boss  2743  defining a channel  2745  in which a loop  2750  can be secured. Through the loop  2750 , one or more tension members  20  can be routed. The loop  2750  is configured to provide a rounded, atraumatic surface over which the tension members  20  can slide as they transition from a direction generally parallel to the distal portion  22  to a direction that is generally perpendicular to the distal portion  22  or vice versa. In some embodiments, the loop  2750  is made of the same material as the tension members  20  as discussed with respect to prior embodiments. It will be understood that multiple guides  2740  can be provided on the distal portion  22 . 
     In further embodiments, as generally shown in  FIG.  36   , the guides discussed above can be replaced with transition elements  2840  that are flexible loops secured to the stent frame  32 . In this embodiment, three sets of flexible loops  2840  are provided on the stent frame  32  for tension members (not shown, see prior disclosed embodiments) to be routed through and to reduce wear on the tension members as they change direction with respect to the distal portion  22 . In this embodiment, the stent frame  32  is longitudinally and/or rotationally locked in position (in both the compressed and expanded arrangements) with any of the locking configurations of  FIGS.  22 - 27   . In the illustrated embodiment, the distal portion is configured similarly to that shown in  FIG.  26   . In this way, a distal portion  2922  is provided with an aperture  2939  through which a suture  2850  of the like is threaded to selectively release the stent frame  32  from the distal portion  2922 . 
     Turning now also to  FIGS.  37 - 39   , which collectively illustrate an alternate distal portion  2922  having a body  2924  with first and second ends  2926 ,  2928 . The distal portion  2922  can be used as a substitute for the distal portion  22  of  FIG.  1   , for example. Similar to what is shown in  FIG.  7 E , the body  2924  includes a plurality of generally spiral channels  2946  and a plurality of notches  2930  for receiving transition elements  2940 , which can be split rings or the like. The transition elements  2940  function similar to the cage members  344  of  FIGS.  7 A- 7 D  and provide for a rounded, atraumatic surface for one or more tension members (not shown) to travel over from the prosthetic heart valve (not shown) to the channels  2946 . The transition elements  2940  can be optionally be welded to the body  2924 . In alternate embodiments, the transition elements  2940  are positioned and oriented in different way (e.g., similar to the embodiments shown in  FIG.  8 A or  9   , for example). In such alternate embodiments, the transition elements  2940  can be welded or electrojoined to the body  2924 , as desired. 
     As best shown in  FIG.  38   , the first end  2926  further includes a flexible section  2932  collectively defined by a plurality of notches. The flexible section  2932  has an increased flexibility with respect to other portions of the body  2924  that can be beneficial as the distal portion  2922  navigates an aortic arch. Similarly, the second end  2928  also includes a flexible section  2948  defined by a plurality of features similar to bellows. It is envisioned that any number of flexible sections can be provided and that one or more flexible sections can be provided elsewhere on the device. The distal portion  2922  can be used as a substitute for the distal portion of  FIG.  1   , for example, or can be used with an alternate delivery device. 
     Turning now also to  FIGS.  40 - 42   , which illustrate an alternate distal portion  3022  that includes a body  3024  having two flexible sections  3032 ,  3048  similar to the flexible sections  2932 ,  2948  described above. The body  3024  further defines a lumen  3036  through which an extension member  3038  can be positioned for attachment to a hub  3042  at a second end  3028  of the body  3024 . In some embodiments, the extension member  3038  is hollow so that a guide wire (e.g., the guide wire  28  of  FIG.  1   ) can be inserted therethrough. The distal portion  3022  can be used as a substitute for the distal portion of  FIG.  1   , for example, or can be used with an alternate delivery device. 
     The distal portion  3022  can further optionally include a heat shrink wrap  3050  as generally referenced in  FIG.  42   . The heat shrink wrap  3050  is arranged and configured to generally enclose the channels  3046  and includes openings  3052  for one or more tension members (not shown). One advantage of enclosed channels  3046  is improved tension member loading as the tension members cannot cross or interact with one another. The openings  3052  can be formed via cutting or otherwise and are located proximate the tension member transition areas (i.e. where the start of each channel  3046  meets one respective transition element  3040 ). The heat shrink wrap  3050  can be made of any biocompatible material including Teflon® (PTFE) and polyester, for example. 
     Referring now also to  FIG.  43   , which illustrates a distal portion  3122  that can be substituted for the distal portion  22  of  FIG.  1   , for example. The distal portion  3122  is electroformed and can optionally include a body  3124  with an integrated hub  3142 . As illustrated, the hub  3142  can be threaded or can alternatively be snapped on to the body  3124 . The distal portion  3122  can otherwise be arranged, configured and function similar to the embodiments of  FIGS.  37 - 42    or other embodiments disclosed herein. The distal portion  3122  can be used as a substitute for the distal portion of  FIG.  1   , for example, or can be used with an alternate delivery device. 
     Referring in addition now to  FIGS.  44 - 47    which illustrate select components of an alternate distal portion  3222  that can be substituted for the distal portion  22  of  FIG.  1   , for example. A plurality of transition elements  3250  are spaced along a length of the distal portion  3222  for receiving one or more tension members  20  of the type disclosed herein for compressively retaining a stented prosthesis (not shown) to the distal portion  3222  in a manner described above with respect to other embodiments. Only one tension member  20  is partially shown in  FIG.  46    for ease of illustration, see also  FIG.  56   , which is similar in concept. In one illustrative embodiment, the distal portion  3222  can include six transition elements  3250  mounted into and positioned exterior with respect to a central lumen  3223  of the distal portion  3222 . Each transition element  3250  is generally cane shaped having a straight portion  3252  connected to a curved portion  3254  having an end  3256 . The curved portion  3254  and the distal portion  3222  collectively define a lumen  3258  (only a select few of which are referenced for ease of illustration in  FIG.  47   ) through which the one or more tension members  20  can be routed. At one of the transition elements  3250 , each tension member  20  will change direction and wrap around the transition element  3250  as discussed above with respect to other embodiments (i.e. the transition elements  3250  are positioned proximate a location where at least one tension member  20  transitions from a first orientation that is not parallel to the distal portion  3222  to a second orientation that is generally parallel to the distal portion  3222  or vice versa). For example, each tension member  20  will be routed in a distal direction parallel along the length of the distal portion  3222 , through at least one transition element  3250  and then turn to wrap around the stented prosthesis, which is loaded onto the distal portion  3222 . Once the transition element wraps around the stented prosthesis, the tension member  20  is routed through the adjacent transition element  3250  and back proximally along the length of the distal portion  3222  to the handle assembly or the like. In one embodiment, the distal portion  3222  includes apertures  3224 ,  3225  ( FIG.  45   ) for receiving and mounting each transition element  3250  via welding or the like to keep the profile of the distal portion  3222  as small as possible ( FIG.  46   ), which can reduce vascular complications. The ends  3256  can be inserted into apertures  3224  and the straight portions  3252  can be inserted within apertures  3225  on opposing sides of the distal portion  3222  (only one side aperture  3225  is shown, however, the second aperture an opposing side of the distal portion  3222  is identical to that shown in  FIG.  45   ). As with prior disclosed embodiments, the transition elements  3250  define a smooth rounded outer surface over which the tension members  20  can change direction, which reduces wear on the tension members  20 . In all other respects, the distal portion  3222  can be any of the type disclosed herein for use with delivery devices disclosed herein. 
     Referring in addition now to  FIGS.  48 - 51   , which illustrate select components of an alternate distal portion  3322  that can be substituted for the distal portion  22  of  FIG.  1   , for example. A plurality of transition elements  3350  are spaced along a length of the distal portion  3322  for receiving one or more tension members  20  of the type disclosed herein for compressively retaining a stented prosthesis (not shown) to the distal portion  3322 . Only one tension member  20  is partially shown in  FIG.  50    for ease of illustration, see also  FIG.  56   , which is similar in concept. In one illustrative embodiment, the distal portion  3322  can include six transition elements  3350  mounted generally parallel to one another. The transition elements  3350  are each positioned exterior with respect to a central lumen  3323  of the distal portion  3322 . Each transition element  3350  includes two straight portions  3354  interconnected by a curved portion  3352 . Opposite the curved portion  3352 , each straight portion  3354  can include a foot  3356  that mirrors the contour of the distal portion  3322 . The curved portion  3352  and the distal portion  3322  collectively define a lumen  3358  ( FIG.  50   ) through which the one or more transition elements  3350  can be routed. At one of the transition elements  3350 , each tension member  20  will change direction and wrap around the transition element  3350 , proximate the curved portion  3352 , similar to other disclosed embodiments (i.e. the transition elements  3350  are positioned proximate a location where at least one tension member  20  transitions from a first orientation that is not parallel to the distal portion  3322  to a second orientation that is generally parallel to the distal portion  3322  or vice versa). For example, each tension member  20  will be routed in a distal direction parallel along the length of the distal portion  3322 , then turn through one lumen  3358  to wrap around the stented prosthesis, which is loaded onto the distal portion  3322 . Once the tension member  20  wraps around the stented prosthesis, the tension member  20  is routed through the lumen  3358  of the adjacent transition element  3350  on the opposite side of the distal portion  3322  and back proximally along the distal portion  3322  to the handle assembly or the like. In one embodiment, the distal portion  3322  includes apertures  3324  ( FIG.  49   ) for receiving and mounting each transition element  3350  via welding or the like to keep the profile of the distal portion  3350  as small as possible ( FIG.  50   ), which can reduce vascular complications. As with prior disclosed embodiments, the transition elements  3350  define a smooth rounded outer surface over which the tension members  20  can change direction, which reduces wear on the tension members  20 . In all other respects, the distal portion  3322  can be any of the type disclosed herein for use with delivery devices disclosed herein. 
     For embodiments disclosed herein, a rounded, smooth surface of a transition element can be formed using a laser welder to break the edge of a hole or aperture through or over which the tension member is routed in the transition element. One example that can utilize this technique, among other disclosed herein, is shown in  FIGS.  52 - 54   . In this embodiment, only a short length of a distal portion  3422  is illustrated, however, it will be understood that the distal portion  3422  can be similar to those disclosed above, except as explicitly stated. Attached to an outer surface of the distal portion  3422  are one or more transition elements  3450  (only one is shown). Each transition element  3450  includes a semi-circular body  3451  in which two apertures  3452   a ,  3452   b  are formed. The apertures  3452   a ,  3452   b  can optionally be offset along a length of the body  3451 , as illustrated. Each aperture  3452   a ,  3254   b  includes a smooth, rounded surface  3454   a ,  3254   b  over which one or more tension members  20  can be routed and over which the tension members  20  can change direction (i.e. the transition elements  3450  are positioned proximate a location where at least one tension member  20  transitions from a first orientation that is not parallel to the distal portion  3422  to a second orientation that is generally parallel to the distal portion  3422  or vice versa). The transition element  3450  and distal portion  3422  collectively form a lumen  3456  in which one or more tension members  20  can be routed. In one illustrative embodiment, one tension member  20  is routed parallel along the length of the distal portion  3422  in a distal direction, into the lumen  3456 , out of the first aperture  3452   a , changes direction and then around the stented prosthesis (not shown) in ways disclosed above with respect to other embodiments. Once the tension member  20  wraps substantially all the way around the stented prosthesis, the tension member  20  is routed through the second aperture  3254   b , into the lumen  3456  and then proximally back to the handle assembly (not shown). Multiple tension members  20  (e.g., proximal, waist and distal tension members) can be routed in a similar fashion. When multiple tension members  20  are provided, multiple tension members  20  may be routed through lumens  3456  as they are directed to the appropriate locations along the length of the distal portion  3422 . The distal portion  3422  can be used as a substitute for the distal portion of  FIG.  1   , for example, or can be used with an alternate delivery device. 
     Referring in addition now to  FIGS.  55 - 56   , which illustrate select components of an alternate distal portion  3522  that can be substituted for the distal portion  22  of  FIG.  1   , for example. A plurality of transition elements  3550   a ,  3550   b ,  3550   c  are spaced along a length of the distal portion  3522  for receiving one or more tension members  20  ( FIG.  56   ) of the type disclosed herein for compressively retaining a stented prosthesis (not shown) to the distal portion  3522 . It is noted that  FIG.  56    conceptually illustrates one tension member routing configuration suitable for all embodiments disclosed herein for use with various optional transition elements, distal portions and delivery devices disclosed herein. For organization of a plurality of tension members  20 , a hub  3524  can be provided having a plurality of circumferentially spaced apertures  3526  (only a select few of which are referenced in  FIG.  55    for ease of illustration). In one illustrative embodiment, the distal portion  3522  can include three transition elements  3550   a ,  3550   b ,  3550   c  mounted along the length of the distal portion  3522 . The transition elements  3550   a ,  3550   b ,  3550   c  are each positioned exterior with respect to a central lumen  3523  of the distal portion  3522 . Each transition element  3550   a ,  3550   b ,  3550   c  includes a rounded outer body  3552  from which a plurality of arms  3554  (only two of which is referenced in  FIG.  55    for ease of illustration) extend radially in the direction of the distal portion  3522 . Each arm  3554  is configured to contact the distal portion  3522  so that a plurality of lumens  3556  are formed between two adjacent arms  3554 , the outer body  3552  and the distal portion  3522 . Within each lumen  3556 , one or more tension members  20  can be routed. After extending through one of the lumens  3556 , each tension member  20  will change direction and wrap around the respective transition element  3550   a ,  3550   b ,  3550   c  as discussed above with respect to other embodiments. Therefore, each lumen  3556  defines a smooth, rounded surface  3558  to prevent wear on the tension member  20  as it changes direction (i.e. the transition elements  3550   a ,  3550   b ,  3550   c  are positioned proximate a location where at least one tension member  20  transitions from a first orientation that is not parallel to the distal portion  3522  to a second orientation that is generally parallel to the distal portion  3522  or vice versa). In one example embodiment, as generally illustrated in  FIG.  56   , each tension member  20  will be routed from its own aperture  3526  in the hub  3524  parallel along the length of the distal portion  3522 , then turn after exiting one lumen  3556  of one transition element  3550   a ,  3550   b ,  3550   c  to wrap around the stented prosthesis as described with respect to other embodiments. Once the tension member  20  wraps around the stented prosthesis, the tension member  20  is routed through another lumen  3556  of the same transition element  3550   a ,  3550   b ,  3550   c  and back proximally along the distal portion  3522  to the hub  3524  and the handle assembly or the like. In one embodiment, the hub  3524  is configured to have a sufficient number of apertures  3526  so that each aperture  3526  houses, at a maximum, one length of one respective tension member  20  (e.g., if three tension members  20  are provided, the hub  3524  includes at least six apertures  3526 ). This configuration limits the opportunity for the tension members  20  to tangle and snag. As it can be seen in  FIG.  56   , the number of arms  3554 , and thus the number of lumens  3556 , for each transition element  3550   a ,  3550   b ,  3550   c  can vary as desired. In one illustrative example, the distal transition element  3550   c  includes three arms defining two lumens, the waist transition element  3550   b  includes four arms defining three lumens and the proximal transition element  3550   a  includes five arms defining four lumens. Although the lumens and apertures of the waist and distal transition elements  3350   b ,  3550   c  are not labeled, they are identically configured to those shown and described with respect to the proximal transition element  3550   a , except in number. The number of arms  3554  and lumens  3556  for all transition elements  3550   a ,  3550   b ,  3550   c , as well as the number of transition elements provided can vary, as desired. Alternatively, if multiple transition elements are provided, they can be identically configured. In all other respects, the distal portion  3522  can be any of the type disclosed herein for use with delivery devices disclosed herein. 
     For all embodiments disclosed herein, the transition element(s) can be considered part of the distal portion or can be considered a separate element. For all embodiments disclosed herein, the transition elements can be made of a material having a very fine surface finish, (e.g., less than 20 micro inch root mean square (RMS); in some embodiments less than 6 RMS). In all embodiments herein, transition elements and other smooth surfaces can be formed by laser ablation, extrude honing and tumbling, for example. 
     For many of the embodiments disclosed above, the tension members are routed along an outer surface of the distal portion. Such embodiments are believed to be beneficial because when the tension members change direction, less of a moment arm is applied to the respective transition elements, which reduces the tendency for the distal portion to buckle. 
     In view of the present disclosure, embodiments include a delivery device for delivering a stented prosthesis to a target site. The delivery device comprises an elongate tension member that can compressively retains the stented prosthesis to the delivery device and a shaft assembly having a distal portion configured to retain the stented prosthesis. The shaft assembly further including a transition element secured to the distal portion, the transition element at least partially defining a lumen; wherein the elongate tension member extends in a first direction distally along a length of the distal portion. The elongate tension member is then routed through the lumen and then extends in a second direction that is different than the first direction. The transition element provides a rounded edge over which the tension member contacts as the tension member extends from the first direction to the second direction. In some embodiments, a plurality of elongate tension members are provided and a plurality of transition elements spaced along a length of the distal portion. Some embodiments include the stented prosthesis, wherein the second direction is around the stented prosthesis. In some embodiments, the transition element has a surface finish less than 20 micro inch RMS. In some embodiments, the transition element includes a straight portion connected to a curved portion; wherein the curved portion at least partially defines the lumen. In some embodiments, the curved portion includes an end that is secured to the distal portion. In some embodiments, the delivery device includes six transition elements provided in pairs, each pair being two of the six transition elements. In some embodiments, the two transition elements of each pair are offset with respect to one another. In some embodiments, the two transition elements of each pair are parallel with respect to one another. In some embodiments, the transition element includes an outer body having a plurality of arms extending radially toward the distal portion. In some embodiments, the distal portion includes a hub having a plurality of apertures through which the tension member is routed. In some embodiments, the apertures are circumferentially spaced. In some embodiments, the tension member extends through two apertures of the hub. In some embodiments, the lumen is defined by the transition element and the distal portion. In some embodiments, the transition element extends around less than an entirety of a circumference of the distal portion. In some embodiments, the distal portion defines a plurality of apertures for receiving the transition element. Some embodiments include a plurality of transition elements that are identically shaped. In some embodiments, the lumen defines a plane that is perpendicular to the distal portion. In some embodiments, the transition element extends radially from the distal portion. 
     In view of present disclosure, embodiments include a combination of a stented prosthesis loaded to a delivery device. The combination comprises a stented prosthesis including a stent frame having a compressed arrangement and an expanded arrangement; wherein the stent frame includes a distal end and a proximal end and an aperture provided at one or more ends, e.g., at the distal end. The combination further includes a delivery device having a distal portion on which the stented prosthesis is loaded. The delivery device includes a release member extending along the distal portion. The combination also includes a lock member threaded through the aperture and engaged with the release member; wherein the lock member restricts longitudinal and/or rotational movement of the stent frame with respect to the distal portion of the delivery device when the stent frame is in both of the compressed arrangement and the expanded arrangement until release of the lock member from the release member. In some embodiments, the lock member is wrapped one or more times around the release member. The release member can be selected from the group consisting of an elongate release pin and an elongate flexible member. In some embodiments, the distal portion of the delivery device includes a boss through which the release member is slidably positioned. In some embodiments, the boss is arranged orthogonal to the distal portion. In some embodiments, the lock member is threaded around and around the release member. In some embodiments, the lock member is a flexible loop of material. In some embodiments, the lock member is threaded through the distal portion. In some embodiments, the combination further includes a plurality of elongate tension members wrapped around a circumference of the stent frame to secure the stented prosthesis to the distal portion of the delivery device. In some embodiments, one transition element having a rounded surface is provided proximate each of the tension members at a location where each of the plurality of tension members changes direction. 
     The embodiments disclosed herein can be used in a method comprising providing a combination including: a stented prosthesis including a stent frame having a compressed arrangement and an expanded arrangement; wherein the stent frame includes a distal end and a proximal end and an aperture provided at one or more ends, e.g., the distal end; providing a delivery device including a distal portion on which the stented prosthesis is loaded in the compressed arrangement; the delivery device further including a release member extending along the distal portion; and a lock member threaded through the aperture. The method further includes delivering the stented prosthesis to a target site and disengaging the release member from the lock member to unlock the lock member so that the stent frame can move longitudinally and/or rotationally with respect to the distal portion of the delivery device in the compressed arrangement. The method can further include transitioning the stent frame from the compressed arrangement to the expanded arrangement; wherein a plurality of tension members compress the stented prosthesis during the step of delivering the stented prosthesis and the step of expanding the stented prosthesis includes releasing tension in the plurality of tension members. In some embodiments, one transition element having a rounded surface is provided proximate each of the tension members at a location where each of the plurality of tension members changes direction. In some embodiments, the transition element forms a lumen exterior to the distal portion of the delivery device. In some embodiments, the distal portion of the delivery device includes a boss through which the release member is slidably positioned. In some embodiments, the boss is arranged orthogonal to the distal portion of the delivery device. In some embodiments, the lock member is wrapped around and around the release member during the step of delivering the stented prosthesis to the target site. In some embodiments, the lock member is a flexible loop of material. In some embodiments, the lock member is threaded through the distal portion of the delivery device. 
     Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.