Patent Publication Number: US-2023157802-A1

Title: Transcatheter heart valve storage container and crimping mechanism

Description:
CROSS REFERENCE TO RELATED APPPLICATIONS 
     This application is a continuation U.S. Application No. 17/174,784, filed Feb. 12, 2021, which is a Continuation of U.S. Application No. 16/036,190, filed Jul. 16, 2018, entitled “Transcatheter Heart Valve Storage Container and Crimping Mechanism” (issued as U.S. Pat. No. 10,918,473) which claims the benefit of U.S. Provisional Application No. 62/534,033, filed Jul. 18, 2017, the disclosures of which are incorporated by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to medical devices and particularly to containers and methods for storing and preparing expandable heart valve prostheses for implantation. 
     BACKGROUND 
     Prosthetic heart valves are used to replace damaged or diseased heart valves. In vertebrate animals, the heart is a hollow muscular organ having four pumping chambers: the left and right atria and the left and right ventricles, each provided with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid and pulmonary valves. Prosthetic heart valves can be used to replace any of these naturally occurring valves. 
     Where replacement of a heart valve is indicated, the dysfunctional valve is typically surgically removed and replaced with either a mechanical valve or a tissue valve. Tissue valves are often preferred over mechanical valves because they typically do not require long-term treatment with anticoagulants. The most common tissue valves are constructed with whole porcine (pig) valves, or with separate leaflets obtained from bovine (cow) pericardium. Although so-called stentless valves, comprising a section of porcine aorta along with the valve, are available, the most widely used valves include some form of stent or synthetic leaflet support. Typically, a wireform having alternating arcuate cusps and upstanding commissures supports the leaflets within the valve, in combination with an annular stent and a sewing ring. The alternating cusps and commissures mimic the natural contour of leaflet attachment. 
     A conventional heart valve replacement surgery involves accessing the heart in the patient’s thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the two opposing halves of the rib cage to be spread apart, allowing access to the thoracic cavity and heart within. The patient is then placed on cardiopulmonary bypass which involves stopping the heart to permit access to the internal chambers. Such open heart surgery is particularly invasive and involves a lengthy and difficult recovery period. 
     Recently, a great amount of research has been performed to reduce the trauma and risk associated with conventional open heart valve replacement surgery. In particular, the field of minimally invasive surgery (MIS) has exploded since the early to mid-1990s, with devices now being available to enable valve replacements without opening the chest cavity. MIS heart valve replacement surgery still typically requires bypass, but the excision of the native valve and implantation of the prosthetic valve are accomplished via elongated tubes (catheters or cannulas), with the help of endoscopes and other such visualization techniques. 
     More recently, a variety of prosthetic heart valves have been developed wherein the valve structure is mounted on a stent and then delivered to the implantation site via a percutaneous catheterization technique. Such transcatheter heart valves (THV) are typically crimped to a smaller diameter or profile just prior to implantation. 
     To minimize the possibility of damage to the relatively delicate tissue type or bioprosthetic heart valves, they are packaged in jars filled with a sterilant and preservative solution for shipping and storage prior to use. In doing so, the valves are stabilized to prevent the valves from contacting the inside of the jar. Prior to implantation in a patient, residual traces of the sterilant and preservative solution are washed from the valve. Washing is accomplished by first removing the valve from the jar and then rinsing the valve in a sterile saline solution. After rinsing, the valve is crimped to reduce it to a size appropriate for transcatheter delivery and implantation. This process leaves the valve susceptible to damage if the valve contacts any surfaces while being manipulated prior to implantation. 
     There remains a need for a storage and preparation system for such valves that prevents damage to the valve, and enables a medical practitioner to easily and safely remove the valve from the storage container, prepare, and crimp the valve prior to implantation 
     SUMMARY 
     Disclosed herein is a storage container for a transcatheter heart valve that allows for the storage of the heart valve in its expanded configuration and permits easy crimping of the heart valve from a larger diameter to a smaller diameter upon removal of the valve from the storage jar prior to implantation. The storage container includes a container housing and a crimping mechanism. The container housing is sized to receive the heart valve in its expanded configuration. The crimping mechanism is incorporated into the container and engages the heart valve to convert the heart valve from its expanded configuration to its crimped or unexpanded configuration upon opening of the container and removal of the valve. 
     While the present invention is particularly well-suited for use with stented prosthetic heart valves, it can also be applied to other types of stents such as coronary stents, peripheral stents, other stented heart valves and stent grafts. 
     In some embodiments, the crimping mechanism includes a valve cover coupled to the container housing. The valve cover including a central opening in communication with an interior of the container housing where movement of the heart valve through the central opening converts the heart valve from its expanded configuration to its crimped configuration. The heart valve has a larger diameter in its expanded configuration than in its crimped configuration. 
     The valve cover can include a tapered channel extending from a bottom surface to the central opening, where movement of the heart valve through the tapered channel upon opening of the container converts the heart valve from its expanded configuration to its crimped configuration. In some embodiments, the tapered channel can define a cone-shaped passage. The size of the opening to the tapered channel at the bottom surface of the valve cover can be designed to correspond to the size of the heart valve in its expanded configuration, while the other end of the channel corresponds to the size of the valve in its crimped configuration. 
     In some embodiments, the crimping mechanism further includes a top cover coupled to the container housing having an opening axially aligned with the central opening of the valve cover. The crimping mechanism further includes a base structure having a central cavity sized and configured to receive the heart valve. The base is axially movable with respect to the valve cover for moving the heart valve through the central opening of the valve cover. The valve cover can be fixed to the container housing. And the top cover can be rotatably coupled to the container housing and the valve cover. The base includes an exterior thread for engaging a threaded opening in the top cover such that rotation of the top cover causes the threaded opening to engage the exterior threads of the base and move the base axially with respect to the top cover. 
     In some embodiments, the crimping mechanism further includes a valve stage located within a central cavity of the base, the valve stage providing axial support for the heart valve. In other embodiments, the crimping mechanism includes a valve support extending axially adjacent the heart valve and providing radial or lateral support for the heart valve. 
     Also disclosed herein is a system for storing and crimping an expandable prosthetic heart valve. The system includes an expandable prosthetic heart valve having both crimped and expanded configurations, the heart valve comprising an annular frame with a leaflet structure positioned within frame. The system also includes a container housing sized to receive the heart valve in its expanded configuration, and a crimping mechanism incorporated into the container housing and engaging the heart valve that is operable to convert the heart valve from its expanded configuration to its crimped configuration upon opening of the container and removal of the heart valve. The heart valve can be a tissue-type valve and the container housing can hold a solution suitable for preserving the leaflet structure. 
     In some embodiments, crimping mechanism includes a valve cover coupled to the container housing and including a central opening in communication with an interior of the container housing, and a base having a central cavity sized and configured to receive the heart valve. The base is axially movable with respect to the valve cover for moving the heart valve through the central opening of the valve cover. The heart valve is positioned within a central cavity of the base, and movement of the heart valve through the central opening converts the heart valve from its expanded configuration to its crimped configuration. 
     In some embodiments, the crimping mechanism includes a top cover rotatably coupled to the valve cover and the container housing, the top cover having an opening axially aligned with the central opening of the valve cover. The base includes an exterior thread for engaging a threaded opening in the top cover. The base is rotatably coupled to the top cover and rotation of the top cover causes the threaded opening to engage the exterior threads of the base thereby moving the base axially with respect to the top cover. 
     In some embodiments, the valve cover includes a tapered channel extending from a bottom surface of the valve cover to the central opening of the valve cover. The size of the opening to the tapered channel at the bottom surface corresponds to the size of the heart valve in its expanded configuration while the other end of the channel corresponds to the size of the valve in its crimped configuration. Movement of the heart valve through the tapered channel converts the heart valve from its expanded configuration to its crimped configuration. 
     Further disclosed herein is a method of storing and crimping an expandable prosthetic heart valve. The method includes providing a prosthetic heart valve having a crimped configuration sized to be delivered to a site of implantation through a catheter and an expanded configuration sized to engage a heart valve annulus. The method also includes storing the heart valve in a container in its expanded configuration and converting the heart valve from its expanded configuration to its crimped configuration as it passes through an opening in the container. The step of converting further comprises compressing the heart valve through a tapered channel provided in the container. 
     In some embodiments, the container includes a container housing, a valve cover coupled to the container housing and including a central opening in communication with an interior of the container housing, and a base having a central cavity receiving the heart valve. The base is rotatably coupled to the valve cover and axially movable with respect to the valve cover and container housing. The step of converting the heart valve from its expanded configuration to its crimped configuration further comprises axially moving the base with respect to the valve cover and advancing the heart valve from the central cavity of the base and through the central opening of the valve cover. 
     In some embodiments, a top cover is rotatably coupled to the valve cover and the container housing. The base can include an exterior thread for engaging a threaded opening in the top cover, where the threaded opening in the top cover is axially aligned with the central opening of the valve cover. The step of converting the heart valve from its expanded configuration to its crimped configuration further comprises rotating the top cover to cause the threaded opening to engage the exterior threads of the base and thereby moving the base axially with respect to the top cover. 
     In some embodiments, the step of converting the heart valve from its expanded configuration to its crimped configuration further comprises crimping the heart valve and maintaining the heart valve in its crimped state using a constraint around the heart valve. And the method further includes detaching the heart valve from the storage container after placing the constraint around the valve and mounting the valve on a delivery catheter. 
     The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims. 
    
    
     
       DESCRIPTION OF DRAWINGS 
         FIG.  1    is a perspective view of an example storage container for a transcatheter heart valve; 
         FIG.  2    is a front view of the storage container of  FIG.  1   ; 
         FIG.  3    is a top view of the storage container of  FIG.  1   ; 
         FIG.  4    is a bottom view of the storage container of  FIG.  1   ; 
         FIG.  5    is a perspective view of the storage container of  FIG.  1    including a lid; 
         FIG.  6    is a front perspective view of the storage container of  FIG.  5   ; 
         FIG.  7    is a bottom perspective view of the lid of  FIG.  5   ; 
         FIG.  8    is a front view of the storage container of  FIG.  5   ; 
         FIG.  9 A  is a section view of the storage container of  FIG.  1   ; 
         FIG.  9 B  is a section view of the storage container of  FIG.  1   ; 
         FIG.  10    is a top perspective view of an example valve cover; 
         FIG.  11    is a bottom perspective view of the valve cover of  FIG.  10   ; 
         FIG.  12    is a front view of the valve cover of  FIG.  10   ; 
         FIG.  13    is at top view of the valve cover of  FIG.  10   ; 
         FIG.  14    is a bottom view of the valve cover of  FIG.  10   ; 
         FIG.  15    is a section view of the valve cover of  FIG.  13   ; 
         FIG.  16    is a front view of an example base; 
         FIG.  17    is a side view of the base of  FIG.  16   ; 
         FIG.  18    is a perspective view of the base of  FIG.  16   ; 
         FIG.  19    is a top view of the base of  FIG.  16   ; 
         FIG.  20    is a bottom view of the base of  FIG.  16   ; 
         FIG.  21    is a perspective view of an example lower flange; 
         FIG.  22    is a bottom view of the lower flange of  FIG.  21   ; 
         FIG.  23    is a perspective view of an example valve stage; 
         FIG.  24    is a front view of the valve stage of  FIG.  23   ; 
         FIG.  25    is a top view of the valve stage of  FIG.  23   ; 
         FIG.  26    is a section view of the valve stage of  FIG.  25   ; 
         FIG.  27    is a perspective view of an example support ring; 
         FIG.  28    is a front view of the support ring of  FIG.  27   ; 
         FIG.  29    is a top view of the support ring of  FIG.  27   ; 
         FIG.  30    is a perspective view of an example valve support; 
         FIG.  31    is a front view of the valve support of  FIG.  30   ; 
         FIG.  32    is a side view of the valve support of  FIG.  30   ; 
         FIG.  33    is a top view of the valve support of  FIG.  30   ; 
         FIG.  34    is a perspective view of an example valve support ring; 
         FIG.  35    is a front view of the valve support ring of  FIG.  34   ; and 
         FIG.  36    is a top view of the valve support ring of  FIG.  34   . 
     
    
    
     Like reference symbols in the various drawings indicate like elements. 
     DETAILED DESCRIPTION 
     The following description of certain examples of the inventive concepts should not be used to limit the scope of the claims. Other examples, features, aspects, embodiments, and advantages will become apparent to those skilled in the art from the following description. As will be realized, the device and/or methods are capable of other different and obvious aspects, all without departing from the spirit of the inventive concepts. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
     For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The described methods, systems, and apparatus should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved. 
     Features, integers, characteristics, compounds, chemical moieties, or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed. 
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. 
     “Optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. 
     Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps. “Exemplary” means “an example of” and is not intended to convey an indication of a preferred or ideal aspect. “Such as” is not used in a restrictive sense, but for explanatory purposes. 
     The terms “proximal” and “distal” as used herein refer to regions of a sheath, catheter, or delivery assembly. “Proximal” means that region closest to handle of the device, while “distal” means that region farthest away from the handle of the device. 
     The term “tube” or “tubular” as used herein is not meant to limit shapes to circular cross-sections. Instead, tube or tubular can refer to any elongate structure with a closed-cross section and lumen extending axially therethrough. A tube may also have some selectively located slits or openings therein - although it still will provide enough of a closed structure to contain other components within its lumen(s). 
     Embodiments disclosed herein provide a storage container for a transcatheter heart valve that also facilitates preparation for delivery and implantation of the valve. Transcatheter heart valves come in a variety of designs, including directly radially expandable types (such as balloon expandable valves), self-expanding valves, mechanically expandable valves, and so-called “rolled” heart valves that are spirally wound into a compact configuration that can be expanded by unwinding. While a balloon expandable heart valve is represented herein, it should be understood that the principles disclosed herein are applicable to all types of expandable heart valves, stents and similar medical devices. 
     The present disclosure is directed to a container for storing, preparing, and handling an expandable prosthetic heart valve prior to implantation. Many transcatheter heart valves include flexible leaflets typically made from animal tissue or other biocompatible natural or synthetic material. The embodiment illustrated represents an expandable prosthetic heart valve having bovine pericardial leaflets. This heart valve is similar to that shown and described in U.S. Pat. No. 9,393,110, entitled “Prosthetic Heart Valve” and expressly incorporated herein by reference. Regardless of the material of the flexible leaflets, it is advantageous to store them in a relaxed state to minimize folding or compression of the leaflets. However, to deliver such expandable heart valves, the overall profile of the valve is made smaller (i.e., crimped) in order to pass through a relatively small diameter delivery catheter, thus requiring folding or compressing of the leaflets. 
     The container of the present disclosure enables the storage of a heart valve in its expanded configuration to better protect the flexible leaflets during potentially long storage times, and permits easy crimping of the heart valve upon removal from the storage jar prior to implantation. 
       FIG.  1    illustrates an assembled view of an example storage container  100  for a prosthetic heart valve  105 , the valve having both expanded and unexpanded configurations.  FIG.  2    provides a front elevation of the storage container  100 , and  FIGS.  3  and  4    provide top and bottom views, respectively. As shown, the storage container  100  includes a container housing  110  sized to receive the heart valve  105  in its expanded configuration (as shown in  FIGS.  9 A and  9 B ) and a top cover  130 . 
     The storage container  100  includes a removable lid  190  to prevent contamination of the heart valve  105  and other storage container  100  components.  FIGS.  5 ,  6  and  8    illustrate the storage container  100  of  FIG.  1    with the lid  190  coupled to the top cover  130 . The lid  190  is sized and configured to be removably press fit (interference fit) into the threaded opening  132  of the top cover  130 .  FIG.  7    provides a bottom perspective view of the lid  190  illustrating a raised annular surface  191  projecting from the bottom of the lid  190  for engaging the threaded opening  132  of the top cover  130  of the storage container  100 . It is also contemplated that the lid  190  can couple to the top cover  130  using a snap fit, a threaded connection, or using any other reversible fastener known in the art. The storage container  100  can be used for storing bioprosthetic heart valves having leaflets that require wet storage in a liquid sterilant/preservative. Therefore, when the lid  190  is coupled to the top cover  130 , the storage container  100  is desirably leak-proof. The various components of the storage container  100  can be made of a variety of corrosion resistant materials, preferably molded polymers. 
     As will be described in more detail below, a crimping mechanism  120  is incorporated into the container  100 . The crimping mechanism  120  engages the heart valve  105  and is operable to convert the heart valve  105  from a larger diameter in its expanded configuration to a smaller diameter in its crimped configuration upon opening the container and removal of the valve from the container  100 .  FIGS.  9 A and  9 B  provide cross-section views of the storage container  100  of  FIG.  1    taken along the section lines illustrated in  FIG.  3   .  FIGS.  9 A and  9 B  illustrate the various components of the crimping mechanism  120  including the top cover  130 , a base  140 , a valve cover  150 , a valve stage  160 , and a valve support  170 . 
       FIGS.  10 - 14    provide various view of an example valve cover  150 .  FIG.  15    provides a cross-section of the valve cover  150  taken along the section lines illustrated in  FIG.  13   . The valve cover  150  includes a central opening  152  in communication with the interior of the container housing  110 . As will be described in more detail below, as the heart valve  105  is pushed through valve cover  150  and out the central opening  152 , it is converted from its larger expanded configuration to its smaller unexpanded/crimped configuration. The diameter of the central opening  152  corresponds to the diameter of the heart valve  105  in the crimped configuration. As illustrated in  FIG.  15   , the valve cover  150  includes a tapered channel  154  extending from a bottom opening  158  on the bottom surface  156  of the valve cover  150  to the central opening  152 . The tapered channel  154  can define a cone-shaped passage. The tapered channel  154  can also include a cylindrically-shaped portion  155  adjacent the central opening  152 . This cylindrically-shaped portion  155  can help maintain the heart valve  105  in its crimped configuration and in a secure position for attachment to a delivery device. The dimension/diameter of the opening  158  provided on the bottom surface  156  of the valve cover  150  is sized and configured to correspond to the dimension/diameter of the heart valve  105  in the expanded configuration. The opening  158  can also have a dimension/diameter larger than the dimension/diameter of the heart valve  105  in the expanded configuration. 
     As illustrated in  FIGS.  11 ,  12  and  15   , the bottom surface  156  of the valve cover  150  includes a cylindrically-shaped projection  159 . As provided in  FIGS.  9 A and  9 B , this projection  159  is sized to extend into, and help position, the valve cover  150  with respect to the container housing  110 . 
     The valve cover  150  can be fixedly connected to the container housing  110  such that the valve cover  150  cannot move axially and/or rotationally with respect to the container housing  110 . For example, the valve cover  150  can be coupled to the container housing  110  by a number of screws positioned around the circumference of the valve cover  150 . It is contemplated that the valve cover  150  could be coupled to the container housing  110  using any suitable known fastener. As will be described in more detail below, with the valve cover  150  fixed to the container housing  110 , rotation of the top cover  130  allows the heart valve  105  (supported by base  140 ) to move axially within the storage container  100  and ultimately out through opening  152 . As such, the heart valve  105  is converted from its larger expanded configuration to its smaller crimped configuration upon removal from the container. 
       FIGS.  16 - 20    provide various views of an example base  140 . The base  140  includes a central cavity  143  sized to receive the heart valve  105 , as illustrated in  FIGS.  9 A and  9 B . The base  140  is axially movable with respect to the valve cover  150  and the top cover  130  for moving the heart valve  105  through the central opening  152  of the valve cover  150 . 
     The base  140  includes an engagement feature for mating with the top cover  130  to facilitate axial movement of the base  140 . For example, as illustrated in  FIG.  9 B , the top cover  130  includes a threaded opening  132  axially aligned with the opening  152  of the valve cover  150 . The base  140  can include an exterior thread  142  for rotatably coupling with the threaded opening  132  of the top cover  130 . 
     As illustrated in  FIG.  9 B , a portion of the base  140  extends through the valve cover  150  to threadingly engage the threaded opening  132  of the top cover  130 . For example, as provided in  FIG.  16   , the exterior thread  142  is provided on one or more arms  144  of the base  140 . The arms  144  extend up from a generally horizontal end surface  145  of the base  140 . In assembly, the arms  144  extend through openings  151  provided in the valve cover  150  (shown in  FIG.  13   ) to engage the threaded opening  132  of the top cover  130 . In an example storage container  100 , the arms  144  are sized and configured to move freely through the openings  151  in the valve cover  150  and do not engage or contact the valve cover  150  during axial movement of the base  140 .  FIGS.  13  and  14    of the valve cover  150  illustrate example arcuate shaped openings  151  for accommodating through movement of the arms  144  of the base  140 . 
     The storage container  100  includes a lower flange  134  for axially fixing the container housing  110 , valve cover  150 , and top cover  130 .  FIGS.  21  and  22    provide perspective and top views, respectively, of the lower flange  134 . As provided in  FIGS.  9 A and  9 B , the lower flange  134  is coupled to a bottom surface  136  of the top cover  130  such that the lower flange  134  is fixedly connected, axially and rotationally, with respect to the top cover  130 . The lower flange  134  can be coupled to the top cover  130  by a number of screws positioned around the circumference of the lower flange  134 . It is contemplated that the lower flange  143  can be coupled to the top cover  130  using any suitable fastener known in the art. A recessed shoulder  138  provided on the lower flange  134  can be sized to provide a gap or space  139  between the lower flange  134  and the container housing  110  and the valve cover  150 . The inclusion of this gap/spacing  139  allows the top cover  130  and lower flange  143  to rotate independently of the container housing  110  and valve cover  150  (the container housing  110  being fixedly connected to the valve cover  150 ). 
       FIGS.  23 - 25    provide various views of an example valve stage  160 .  FIG.  26    is a cross-section view of the valve stage  160  taken along the section line illustrated in  FIG.  25   . The valve stage  160  is located within the central cavity  143  of the base  140 . The heart valve  105  is positioned on the valve stage  160  such that the valve stage  160  provides axial support for the heart valve  105 . The valve stage  160  can include multiple arms  162  extending up from a base structure  166  of the valve stage  160 . As illustrated in  FIGS.  23  and  25   , the arms  162  can be equally spaced around the circumference of the valve stage  160 . The top surface  164  of the arms  162  provides the support surface for the heart valve  105 . The arms  162  can move radially. That is, the ends of the arms  162  can move radially in towards the longitudinal axis of the valve stage  160 , resulting in a radial compression of the valve stage  160  proximate the end of the arms  162 . The arms  162  are fixed to the base structure  166 , but flexure features (such as cutouts  161  illustrated in  FIG.  26   ) can be provided at the juncture between the arms  162  and the base structure  166 . The arms  162  can also be constructed from a flexible material, to allow them to flex under compressive force (i.e., the force applied by the tapered channel  154  as the valve stage  160  is moved axially along with the base  140 ). This allows the arms  162  and the distal end of the valve stage  160  to contract slightly as it is pushed into the tapered channel  154  during crimping of the heart valve  105 . It is also contemplated that the valve stage  160  can be used to limit axial movement of the base  140  and help push the heart valve  105  through the tapered channel  154 . For example, as contact between the valve arms  162  and the tapered channel  154  causes the arms  162  to move radially inward, the arms  162  will reach a point of ultimate compression thereby preventing any further axial movement of the valve stage  160  and the base  140 . As illustrated in  FIGS.  23  and  25   , the arms  162  can define a wedge-shape in cross-section. This wedge-shape allows the arms  162  to compress until the adjacent side walls  163 A and  163 B of the wedge-shape arms  162  contact. The arms  162  can also include a bend  165  along the length of the arm  162 . This bend  165  provides for further compression/radial movement of the arms  162 . 
       FIGS.  27 - 29    provide various views of an example support ring  180 . The crimping mechanism  120  can include a support ring  180  positioned at the top surface  164  of the valve stage  160  as illustrated in  FIGS.  9 A and  9 B . The support ring  180  helps position the heart valve  105  on the valve stage  160  and within the tapered channel  154 . As illustrated in  FIGS.  27  and  28   , the support ring  180  includes a tapered edge  182  that provides a contact point for the heart valve  105  and centers the heart valve  105  on the support ring  180 . 
       FIGS.  30 - 33    provide various views of an example valve support  170 . The crimping mechanism  120  includes a valve support  170  that extends axially adjacent to the heart valve  105  as illustrated in  FIG.  9 A . During axial movement of the base  140  and/or crimping of the heart valve  105 , the valve support  170  can provide radial and/or lateral support for the heart valve  105 . The valve support  170  can include axially extending arms  172  that extend from a base structure  174 . The arms  172  can define a curved inner surface  176  corresponding in size and shape to the outer surface of the heart valve  105 . 
     The valve support  170  remains fixed axially within the container housing  110  during crimping of the heart valve  105 . That is, as the base  140  moves axially towards/away from the top cover  130 , the arms  172  of the valve support  170  extend/pass through openings  146  provided in the base  140 . In an example storage container  100 , the arms  172  are sized and configured to move freely through the openings  146  in the base  140 .  FIGS.  18 - 20    illustrate arcuate-shaped openings  146  for accommodating through movement of the arms  172 . As illustrated in  FIG.  9 A , the base structure  174  is positioned under the base  140 , and between the base  140  and the container housing  110 . 
       FIGS.  34 - 36    provide various views of an example upper valve support ring  185 . The crimping mechanism  120  includes an upper valve support ring  185  positioned at the lower surface  156  of the valve cover  150  proximate the opening  158  to the tapered channel  154  as illustrated in  FIGS.  9 A and  9 B . As shown in  FIGS.  30  and  31   , the distal end of the arms  172  of the valve support  170  can include a recessed surface  178  for accommodating the upper valve support ring  185 . The upper valve support ring  185  can be positioned above the heart valve  105  and can be used to secure the heart valve  105  in the container  110  in its expanded configuration. The upper support ring  185  can also be used to guide the heart valve  105  into the tapered channel  154  and ease the transition (from the expanded configuration) into the valve cover  150  and towards the crimped configuration. 
     As mentioned above, a preferred heart valve  105  includes a stent body and a plurality of flexible leaflets. If the leaflets need to remain hydrated during storage, such as if they are made of bioprosthetic material, the entire container housing  110  is filled with a liquid sterilant/preservative solution. To facilitate preparation of the heart valve  105  prior to implantation, the container housing  110  and/or top cover  130  can include a drain hole (not shown). Alternatively, the lid  190  can be removed from the top cover  130  and unwanted fluid can be drained by tilting or inverting the storage container  100 . 
     Prior to implantation of the heart valve  105 , the preservative solution (if present) can be drained from within the container housing  110 . If desired, the lid  190  can be removed and the heart valve  105  rinsed while the heart valve  105  remains within the container housing  110 , thereby reducing the chance of damage to the valve  105 . The heart valve  105  can then be crimped by passing the heart valve  105  through the crimping mechanism  120 . The user can grasp the container housing  110  to hold it in a fixed position whiling rotating the top cover  130 . Rotation of the top cover  130  allows the exterior thread  142  on the arms  144  of the base  140  to engage the threaded opening  132  in the top cover  130 , resulting in axial movement of the base  140 . Axial movement of the base  140  results in a corresponding axial movement of the heart valve  105  toward and through the tapered channel  154  of the valve cover  150 . As the heart valve  105  is moved through the tapered channel  154 , and ultimately out through opening  152 , radial pressure provided by the tapered channel  154  compresses the heart valve  105  and the heart valve  105  is converted from its larger expanded configuration to its smaller crimped configuration. If desired, a constraint can be provided around the heart valve  105  to maintain it in the crimped configuration and/or further crimp the heart valve  105 . The heart valve  105  can then be detached from the storage container  100  and mounted to a delivery device for implantation. 
     Although the foregoing embodiments of the present disclosure have been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced within the spirit and scope of the present disclosure. It is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.