Patent Publication Number: US-2023134344-A1

Title: Delivery device having dynamic flexible spindle

Description:
FIELD 
     The present technology is generally related to delivery devices for transcatheter delivery of a stented prosthesis. 
     BACKGROUND 
     Diseased or otherwise deficient heart valves can be repaired or replaced with an implanted prosthetic heart valve. Conventionally, heart valve replacement surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. Traditional open surgery inflicts significant patient trauma and discomfort, and exposes the patient to a number of potential risks, such as infection, stroke, renal failure, and adverse effects associated with the use of the heart-lung bypass machine, for example. 
     Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. With percutaneous transcatheter (or transluminal) techniques, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the annulus of the valve to be restored (e.g., the aortic valve annulus). 
     A delivery device must often navigate through tortuous anatomy as it is tracked through the vasculature to the treatment site within the heart. The catheter may be navigated through various anatomical turns as it travels within the vasculature, including the sharp bend of the aortic arch. 
     The present disclosure addresses problems and limitations associated with the related art. 
     SUMMARY 
     The techniques of this disclosure generally relate to transcatheter delivery devices and elements thereof. Embodiments of the disclosure include a dynamically flexible spindle that can be selectively stiffened or, alternatively, be made more flexible. In this way, the spindle can be very flexible while navigating an aortic arch and can be made more rigid during deployment of the prosthesis, which can improve prosthesis deployment accuracy. 
     In one aspect, the present disclosure provides a delivery device including an inner shaft assembly including an inner shaft having a proximal end and a distal end and one or more lumens. The inner shaft further includes a spindle connected to the distal end of the inner shaft and the spindle includes a body having one or more lumens, wherein the one or more lumens may be one or more side lumens offset with respect to a central axis of the spindle. The delivery device further includes one or more spine wires that can slide within both a lumen of the inner shaft and a lumen of the spindle. 
     In another aspect, the disclosure provides a method including providing a delivery device having an inner shaft assembly having a spindle supporting a stented prosthesis. The inner shaft assembly supports a first spine wire that can slide within a first lumen of the inner shaft assembly and the spindle includes a first lumen that can receive the first spine wire. The method includes transitioning the first spine wire from a retracted position in which a distal tip of the first spine wire is proximal with respect to the spindle to an advanced position in which the first spine wire is inserted within the first lumen of the spindle. The method may further include transitioning one or more additional spine wires from a retracted position in which a distal tip of the additional spine wires are proximal with respect to the spindle to an advanced position in which the additional spine wires are inserted within a lumen of the spindle. 
     The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG.  1    is a perspective view of a delivery device for delivering a stented prosthesis. 
         FIG.  2 A  is a partial, schematic illustration of the delivery device of  FIG.  1    having a prosthesis positioned over an inner shaft assembly; the stented prosthesis shown in an expanded state. 
         FIG.  2 B  is a schematic illustration of the delivery device of  FIG.  2 A  having a stented prosthesis positioned over the inner shaft assembly; a plurality of elongated tension members compressing the stented prosthesis into a compressed state. 
         FIG.  3    is a front view of a stented prosthesis that can be used with the delivery devices disclosed herein. 
         FIG.  4    is a partial, schematic diagram of a delivery device having the stented prosthesis of  FIG.  3    loaded thereon in which forces applied by elongated tension members to compress the stented prosthesis have deformed the flexible spindle. 
         FIG.  5 A  is a partial, schematic diagram of a delivery device having a spine wire proximally retracted from a spindle supporting the stented prosthesis of  FIG.  3    so that the spindle is flexible. 
         FIG.  5 B  is a partial, schematic diagram of the delivery device of  FIG.  5 A  in which the spine wire is distally advanced into the spindle to increase the rigidity of the spindle during compression of the stented prosthesis. 
         FIG.  6 A  is a partial, schematic diagram of a spindle of the disclosure. 
         FIG.  6 B  is a cross-sectional view of the spindle of  FIG.  6 A . 
         FIG.  7    is a cross-sectional view of an alternate spindle of the disclosure. 
         FIG.  8    is a cross-sectional view of yet another alternate spindle of the disclosure. 
         FIG.  9 A  is a cross-sectional view of an alternate spindle having two spine wires distally advanced within a body of the spindle. 
         FIG.  9 B  is a cross-sectional view of the spindle of  FIG.  9 A  having the spine wires proximally retracted from the body. 
         FIG.  10 A  is a schematic illustration of an alternate spindle of the disclosure. 
         FIG.  10 B  is a cross-sectional view of the spindle of  FIG.  10 A . 
         FIG.  11 A  is a perspective view of an alternate spindle of the disclosure. 
         FIG.  11 B  is a cross-sectional view of the spindle of  FIG.  11 A . 
         FIG.  11 C  is a cross-sectional view of an alternate spindle, similar to that of  FIG.  11 A . 
         FIG.  11 D  is a cross-sectional view of an alternate spindle, similar to that of  FIG.  11 A . 
         FIG.  12    is a partial, schematic illustration of an alternate spindle having a body that is shown as transparent for ease of illustration. 
         FIG.  13    is a perspective view of a spindle secured to a key plate. 
         FIG.  14 A  is a cross-sectional view of the spindle of  FIG.  13    interconnected to an inner shaft with a hub. 
         FIG.  14 B  is a partial, perspective view of the inner shaft of  FIG.  14 A  in which a distal end of the inner shaft is omitted for ease of illustration. 
         FIGS.  15 - 16    are a perspective views illustrating an alternate hub that can be used to interconnect a spindle to an inner shaft. 
         FIG.  17 A  is a front, distal-side view of a receiving surface of a hub. 
         FIG.  17 B  illustrates an opposing side of the receiving surface of  FIG.  17 A . 
         FIG.  18    is a flow chart illustrating example methods of the disclosure. 
     
    
    
     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 used herein with reference to a stented prosthetic heart valve, the terms “distal” and “outflow” are understood to mean downstream to the direction of blood flow, and the terms “proximal” or “inflow” are understood to mean upstream to the direction of blood flow. Although the present disclosure has been described with reference to various 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. 
     As described below, aspects of the present disclosure relate to delivery devices to deliver the stented prosthesis in a compressed state to a target site. By way of background, general components of one non-limiting example of a delivery device  1  with which the present disclosures are useful are illustrated in  FIG.  1 - 2 B . The delivery device  1  is arranged and configured for percutaneously delivering a stented prosthesis  2 , such as a prosthetic heart valve, to a patient’s defective heart valve. The delivery device  1  includes an optional outer delivery sheath assembly  3  including a capsule  8 , an inner shaft assembly  4 , and a handle assembly  5 . The inner shaft assembly  4  can include an inner shaft  10  connected to a spindle  6 . One or more elongate tension members  7   a ,  7   b ,  7   c  (schematically depicted) can optionally be provided, and can be considered part of the delivery device  1  in some embodiments or as part of the stented prosthesis  2  in other embodiments. The delivery device  1  provides a loaded delivery state in which the stented prosthesis  2  is loaded over the inner shaft assembly  4  and is compressively retained on the spindle  6  by the capsule  8  and/or the elongate tension members  7   a - 7   c . In one example, the spindle is made of stainless steel or polyamide, for example. In one embodiment as is schematically illustrated in  FIGS.  2 A- 2 B , the compression on the stented prosthesis  2  is adjustable with one or more elongated tension members (e.g., sutures, cords, wires or the like)  7   a - 7   c . Once the loaded and compressed stented prosthesis  2  is located at a target site, tension in the elongated tension members  7   a - 7   c  is lessened or released to permit the stented prosthesis  2  to self-expand, partially releasing and ultimately fully deploying the stented prosthesis  2  from the inner shaft assembly  4 . In the illustrated embodiment, the optional delivery sheath assembly  3 , where provided, can include the capsule  8  selectively disposed over the stented prosthesis  2  to assist in constraining the stented prosthesis  2  in the loaded or compressed state. The optional delivery sheath assembly  3  can be retracted by the handle assembly  5  to expose the stented prosthesis  2 . In an alternative embodiment, the capsule  8  of the delivery sheath assembly  3  is disposed over the stented prosthesis  2  to fully constrain the stented prosthesis  2  in the loaded or compressed state. The optional delivery sheath assembly  3  is then retracted by the handle assembly  5  to release the stented prosthesis  2 . The delivery device  1  can optionally be tracked over a guide wire  9  inserted through the handle assembly  5 , inner shaft assembly  4  and spindle  6 . Like reference numerals for components shown in  FIG.  1   -2B will be used herein to identify identical components/structures. 
     As referred to herein, a stented prosthesis useful with the various devices and methods of the present disclosure may assume a wide variety of configurations, such as 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. Although the stented prosthesis of the present disclosure is described mainly as being self-expandable, the stented prosthesis can also be balloon expandable and/or mechanically expandable or combinations thereof. In general terms, the stented prosthesis of the present disclosure includes 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 is 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 condition to a normal, radially expanded condition. 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 simplified, non-limiting example of a stented prosthesis  100  is illustrated in detail in  FIG.  3   . It is to be understood that stented prosthesis  2  and stented prosthesis  100 , referenced herein, are interchangeable. As a point of reference, the stented prosthesis  100  is shown in a normal or expanded state in the view of  FIG.  3   . The stented prosthesis  100  includes a stent or stent frame  102  and a valve structure  104 . The stent frame  102  can assume any of the forms mentioned above. In some embodiments, the stent frame  102  is constructed to be self-expandable from the compressed state to the normal, expanded state. In some embodiments, the stent frame  102  is constructed to be balloon expandable from the compressed state to the normal, expanded state. In some embodiments, the stent frame  102  is constructed to be mechanically expandable from the compressed state to the normal, expanded state. 
     When present, the valve structure  104  of the stented prosthesis  100  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  104  can be formed, for example, from bovine, porcine, equine, ovine and/or other suitable animal tissues. In some embodiments, the valve structure  104  can be formed, for example, from heart valve tissue, pericardium, and/or other suitable tissue. In some embodiments, the valve structure  104  can include or form one or more leaflets  106 . For example, the valve structure  104  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  FIG.  3   , the valve structure  104  can comprise two or three leaflets that are fastened together at enlarged lateral end regions to form commissural joints, with the unattached edges forming coaptation edges of the valve structure  104 . The leaflets  106  can be fastened to a skirt that in turn is attached to the stent frame  102 . Alternatively, the leaflets  106  can be fastened directly to the stent frame  102 . The stented prosthesis  100  includes an outflow portion  108  corresponding to a first or outflow end  110  (forcing out fluid) of the stented prosthesis  100 . The opposite end of the stented prosthesis  100  can define an inflow portion  112  corresponding to a second or inflow end  114  (receiving fluid). As shown, the stent frame  102  can have a lattice or cell-like structure, and optionally forms or provides posts  116  corresponding with commissures of the valve structure  104  as well as eyelets  118  (or other shapes) at the outflow and inflow ends  110 ,  114 . If provided, the posts  116  are spaced equally around frame  102  (only one post  116  is clearly visible in  FIG.  3   ). 
     With many radial frame deployment delivery device designs, distal flexibility presents an issue in at least two ways. For one, when tracking the spindle around the aortic arch, the presence of the spindle in the delivery device limits the flexibility of the distal end of the delivery device. That said, having too flexible of a spindle impairs prosthesis deployment accuracy and the ability to effectively compress the stented prosthesis on the spindle with sutures or the like prior to delivery without deforming the spindle. As shown in  FIG.  4   , for example, if the flexible spindle  6  is not supported during loading of the stented prosthesis  100 , the force exerted by sutures/elongated tension members  7   a - 7   c  used for compressively retaining the stented prosthesis  100  on the spindle  6  can cause deformation of the spindle  6 . In other words, the spindle  6  may bend and/or be forced to an angle with respect to the inner shaft  10 . Aspects of the disclosure include a spindle that can be utilized in a delivery device having a selectively variable stiffness. Delivery devices of the disclosure include one or more spine wires to provide selective rigidity to a spindle, such as spindle  6 . As shown in  FIGS.  5 A- 5 B , embodiments of the disclosure provide for a delivery device  201  having selective rigidity in that one or more spine wires  212  can be proximally retracted from spindle  206  (so that a distal tip  213  is proximal with respect to the spindle  206 ) when flexibility of the spindle  206  is desired. The spine wire  212  can be distally advanced at least partially into the spindle  206  to provide greater rigidity in the spindle  6 , when desired, such as during loading of the stented prosthesis  100 . Therefore, each spine wire  212  is made of a material that is flexible but is more rigid than a material of the spindle  206 . In some embodiments, one or more spine wires  212  are made of the same material and have the same flexibility or stiffness as the other spine wires  212 . In some embodiments, one or more spine wires  212  are made of a different material and have a different flexibility or stiffness as the other spine wires  212 . In some embodiments, one or more spine wires  212  have a different x-sectional shape and/or diameter as the other spine wires  212 . For example, different x-sectional shapes may include round, oval, triangular, square, and/or hexagonal. The spindle  206  is provided in these illustrations as an example and it is to be understood that the other spindles disclosed herein will operate in a similar manner. It should also be understood that all spine wires disclosed herein are similarly configured and operate in a similar manner. 
     Referring now in addition to  FIGS.  6 A- 6 B , which illustrate part of a spindle  306  that can be used in a delivery device, such as a replacement for spindle  6  of  FIG.  1 - 2 B , for example. In one example, the spindle  306  includes a body  308  optionally defining a central lumen  310  that can be used for tracing a guide wire  9  (see also,  FIGS.  1  and  12   ). The body  308  can further define two or more additional side lumens  314  offset with respect to a central axis of the spindle  306 . As shown, the side lumens  314  can be positioned outside of the body  308  and can be about 180 degrees (+/- 5 degrees) from each other with respect to a circumference of the body  308 . One or more side lumens  314  can be configured to each receive one spine wire  312 . Alternatively, as shown in  FIG.  7   , a spindle  406  can include a body  408  having a central lumen  410  and two side lumens  414  formed within the material of the body  408  and offset with respect to a central axis of the spindle  406 , so that both the body  408  and the spindle  406  as a whole have a uniform outer diameter. Each side lumen  414  is configured to receive one spine wire  412 . The spindle  406  of  FIG.  7    can otherwise be identically configured and operate in an identical manner to spindles disclosed above. In yet another example shown in  FIG.  8   , a spindle  506  can include a body  508  that omits the central aperture and includes side lumens  514  at least partially formed within the body  508  and open to an outer covering,. Each side lumen can be offset with respect to a central axis of the spindle  506  and is configured to receive a spine wire  512 . The spindle of  FIG.  8    can otherwise be identically configured and operate in an identical manner to spindles disclosed above. It is to be understood that spindles  406  or  506  can be used as a replacement for spindle  6  in  FIG.  1   , for example. 
     The side lumens  314 ,  414 ,  514  can each receive a respective spine wire  312 ,  412 ,  512  inserted in a distal direction within one side lumen  314 ,  414 ,  514  from a proximal position with respect to the spindle  306 ,  406 ,  506  (i.e. such that a distal tip of the spine wire is proximal to the spindle). When inserted within the side lumen of the spindle (an “advanced position”), the spine wire provides greater stiffness to the spindle. When the spine wire is proximally retracted such that the distal tip of the spine wire is proximal to the spindle, the spindle has an increased flexibility. It is envisioned that any of the disclosed spindles can include additional side lumens and spine wires, as desired. 
     Referring in addition to  FIGS.  9 A- 9 B , in some embodiments, a body of any of the disclosed spindles can include a plurality of cuts (generally referenced) extending along a length of the body around its circumference configured to provide greater flexibly of the body in two planes. For example, a spindle  606  can have a body  608  including a plurality of cuts  620  (generally referenced). The plurality of cuts  620  can include a first set of cuts  622  (generally referenced) extending longitudinally in a row on one side of the body  608  and a second set of cuts  624  (generally referenced) extending longitudinally in a row on a second side of the body  608 , 180 degrees from the first set of cuts  622 . When spine wires  612  are inserted within their respective side lumens  614  ( FIG.  9 A ), the plurality of cuts  320  restricts flexibility of the spindle  606  to one plane. As can be seen, the side lumens  614  are offset with respect to a central axis of the spindle  606 . The plurality of cuts  620  can extend through the entire thickness of the body  608  or only part of the thickness of the body  608 . The plurality of cuts  620  can be formed in many ways including laser cutting. In some embodiments, additional rows of cuts  626 ,  628  are provided. It will be understood that any of the spindle bodies disclosed herein can be configured to have a plurality of cuts  620  as disclosed with respect to  FIGS.  9 A- 9 B . To reduce the stiffness of the spindle  606 , the spine wires  612  are proximally withdrawn from the side lumens  614  as shown in  FIG.  9 B . 
     Referring in addition now to  FIGS.  10 A- 10 B , which illustrate yet another spindle  706  that can be incorporated into a delivery device, such as the delivery device of  FIG.  1 - 2 B , as a replacement for spindle  6 . The spindle  706  includes a body  708  having an optional central lumen  710  and one or more side lumens  714  offset with respect to a central axis of the spindle  706 . In the embodiment of  FIGS.  10 A- 10 B , the side lumen  714  is formed outside of the body  708 . For example, the side lumen  714  may be formed by a tube  713  bonded to the body  708 . In some embodiments, the body  708  includes a plurality of cuts  720  (generally referenced) extending along a length of the body  708  around its circumference configured to provide greater flexibly of the body  708  in two planes as disclosed above. When a spine wire  712  is inserted within the side lumen  714 , the plurality of cuts  720  restricts flexibility of the spindle  706  to one plane. The plurality of cuts  720  can extend through the entire thickness of the body  708  or only part of the thickness of the body. To reduce the stiffness of the spindle  706 , the spine wire  712  is proximally withdrawn from the side lumen  714 . 
     Any of the spindles of the present disclosure can optionally include one or more features  730  through which elongated tension members  7   a - 7   c  can be routed. In the example of  FIGS.  10 A- 10 B , a plurality of features  730  are secured on the body  708 , opposite the tube  713 . Each feature  730  can have two legs  732  defining an opening  734  through which one or more elongate tension members  7   a - 7   c  can be routed (see also  FIG.  1 - 2 B ). Opposite the body  708 , the legs  732  are interconnected with an arcuate portion  736 , such as a ball, for example. Generally, each feature  730  is configured to have rounded surfaces so that the elongated tension members are not abraded. 
     In other various embodiments, as shown in  FIGS.  11 A- 11 D , a spindle  806 , such as any of those disclosed herein, can have a body  808  having a generally triangular cross-section (i.e., the body  808  is formed by three interconnected sides  809 , 809b, 809c). The spindle  806  can have a central lumen  810  and one or more side lumens  814  formed within the body  808 , the side lumens  814  offset with respect to a central axis of the spindle  806 . As with prior disclosed embodiments, the side lumens  814  can receive a spine wire (similar to any disclosed herein) for selectively stiffening the spindle  806 , as desired, in a manner disclosed herein. 
     Referring in addition to  FIG.  12   , which illustrates an alternate spindle  906  interconnected to an inner shaft  904  with a hub  950 . It will be understood that the illustrated components can be used in a delivery device, such as that of  FIG.  1 - 2 B  as a general replacement for spindle  6  and inner shaft  10 . In this embodiment, that spindle  906  includes a central aperture  910  through which a guide wire  9  can be inserted. The spindle  906  also includes a side lumen  914  through which a spine wire  912  can be optionally inserted to adjust rigidity of the spindle  906 . In this example, the side lumen  914  is offset with respect to a central axis of the spindle  906 . The inner shaft  904  includes a corresponding first aperture  962  aligned with and in communication with the central aperture  910  so that the guide wire  9  can be directed through the first aperture  962  to the central aperture  910 . The inner shaft  904  also includes a second aperture  964  aligned with the side aperture  914  so that the spine wire  912  can be directed from the second aperture  964  to the side aperture  914 . Both the spindle  906  and the inner shaft  904  can include additional apertures to accommodate additional spine wires or other components, as desired. Optionally, the body  908  can include one or more features  730 , as discussed in more detail above. In one example, the spindle  906  and inner shaft  904  are interconnected with a hub  950 . Additional disclosure relating to various hub configurations is provided with respect to  FIG.  14 A- 16   . 
     Referring now in addition to  FIG.  13 - 14 A , which illustrate an alternate spindle  1006  that can be used with the delivery device of  FIG.  1 - 2 B  as a replacement for spindle  6 . The spindle  1006  includes a body  1008  defining a central lumen  1010 . One or more side lumens  1014  are also defined and can be configured within the body  1008 , within a separate tube  1013  bonded to the body  1008  or in any other way disclosed herein. In this example, the side lumens  1014  are offset with respect to a central axis of the spindle  1006 . The spindle  1006  further includes a key plate  1040  connected to the body  1008 . The body  1008  and/or tube  1013  can include a plurality of cuts  1020  (generally referenced) to impart flexibility in two or more planes as disclosed with respect to other embodiments. The key plate  1040  is configured to maintain alignment with an inner shaft  1004  ( FIGS.  14 A- 14 B , see also,  FIG.  1    and related disclosure). In this way, the key plate  1040  has a square or other polygon cross-section as viewed perpendicular from a longitudinal axis of the spindle  1006 . As shown in  FIG.  14 A , a hub  1050  is provided to interconnect the spindle  1006  to the inner shaft  1004 . In one example, a distal end  1060  of the inner shaft  1004  includes a plurality of angled barbs  1062  that engage respective recesses  1052  in the hub  1050  via a push fit. In one example, the inner shaft  1004  may further be secured to the hub  1050  with adhesive applied to the barbs  1062 . Other methods of fixedly securing the inner shaft  1004  to the hub  1050  are also envisioned. The hub  1050  further includes a recess  1054  configured to maintain the key plate  1040 . 
     Referring now in addition to  FIG.  14 B , which illustrates the inner shaft  1004  of  FIG.  14 B  in additional detail (the distal end  1060  of the inner shaft  1004  is omitted for ease of illustration). In this example, the inner shaft  1004  includes a first lumen  1064  and a second lumen  1066 . Additional lumens can be provided, as desired to accommodate additional spine wires  1012  or other components. The first lumen  1064  can receive a guide wire  9  and is therefore aligned with and in communication with the central lumen  1010  of the spindle  1006 . In the present example, the central lumen  1010  and the first lumen  1064  are interconnected via the hub  1050 . The second lumen  1066  of the inner shaft  1004  can receive a spine wire  1012  and is in communication with the side lumen  1014  of the spindle  1006 . In the present example, the second lumen  1066  and the side lumen  1014  are interconnected via the hub  1050 . The inner shaft assembly  1004  and hub  1050  can be used with any of the spindles disclosed herein. 
     Referring now in addition to  FIGS.  15 - 16   , which illustrate an alternate hub  1150  that can be used to interconnect any spindle and inner shaft of the disclosure. In one example, the hub  1150  includes a distal collar  1152  interconnected to a proximal collar  1154  with a plurality of supports  1156  (only a few of which are referenced for ease of illustration). The distal collar  1152  can be spot welded or otherwise fixedly secured to the body  1008  of the spindle  1006 . The proximal collar  1154  can be similarly spot welded or otherwise fixedly secured to the inner shaft  1004 . The proximal collar  1154  can include one or more windows  1158  for reflow material. The proximal collar  1154  and the distal collar  1152  include respective apertures  1170 ,  1172  arranged and sized to receive the body  1008  of the spindle  1006 . The proximal collar  1154  can include one or more additional apertures  1174  to receive addition components, such as the spine wire  1012  as is shown in  FIG.  15   . The spine wire  1012  can extend from the aperture  1174  through to the distal collar  1152  and out aperture  1172  or the distal collar  1152  can include a separate aperture for the spine wire  1012 . 
     The hub  1150  of  FIG.  16    can include a receiving surface  1176  configured to engage a key plate of the spindle  1006  (for example, see key plate  1040  and related disclosure) to maintain the orientation of the spindle  1006  with respect to the inner shaft  1004 . In the example of  FIG.  17 A , such a receiving surface  1276  includes an accepting slot  1278  corresponding in shape to a shape of the key plate of the spindle. In one example, the receiving surface  1276  can include one aperture  1280  interconnected to a second, smaller aperture  1282 . The first and second apertures  1280 ,  1282  may be joined ( FIG.  17 A ) or they may have distinct and separate boundaries (as would coordinate with the hub of  FIGS.  15 - 60   ). When the key plate (not shown) is inserted within the accepting slot  1278 , the key plate cannot rotate with respect to the hub  1150  so that the alignment of the spindle with respect to the inner shaft is maintained. An opposing side, opposite the receiving surface  1276  is shown in  FIG.  17 B . It is to be understood that any of the hubs disclosed herein are suitable for use with any of the spindles, inner shafts and delivery devices disclosed herein. 
     Methods of the disclosure are outlined in  FIG.  18   . One method  1300  of delivering a stented prosthesis includes providing a delivery device having a spindle and a spine wire  1302 . The delivery device being of the type suitable for delivering a stented prosthesis to a target site via a transcatheter procedure. The stented prosthesis being any of the type disclosed herein. The method includes compressively retaining and securing the stented prosthesis to a spindle of the delivery device  1306 . In one example, the stented prosthesis is compressively secured with one or more sutures (or alternate elongated tensioning members) while the spine wire is distally advanced within the spindle to support and provide rigidity to the spindle  1304 / 1306 . Once the stented prosthesis is compressively retained on the spindle, the spine wire can be proximally withdrawn to a position proximal the spindle  1308 . The tension in the elongate tension members can be loosened slightly, if desired. Then, the delivery sheath assembly can be positioned over the stented prosthesis. The delivery device is advanced using known techniques into a femoral artery of a patient and tracked around the patient’s aortic arch. The flexible capsule, cuts in the spindle, retracted spine wire and reduced tension in the elongated tension members provide flexibility at the stented prosthesis to provide easier navigation of the delivery device around the tortuous aortic arch. When the stented prosthesis is in position at a heart valve  1310 , ready for deployment, the spine wire can be distally advanced into the spindle  1312 , the elongated tension members can be further tensioned and the delivery catheter (which may or may not include the capsule) can be proximally retracted. Then, the tension in the elongated tension members can be released, which will allow the stented prosthesis to expand to its natural arrangement. When the stented prosthesis is in the desired position, the elongated tension members can be severed to deploy the stented prosthesis and release the stented prosthesis from the spindle  1314 . The spine wire can be proximally withdrawn, proximal to the spindle so that the spindle is flexible again  1316 . The elongated tension members are removed with the delivery device. Removal of the delivery device can include advancing the capsule to cover the spindle, retracting the spine wire and proximally withdrawing the delivery device along the path of delivery  1318 . 
     It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.