Abstract:
This invention relates to a system and apparatus for retaining a prosthetic valve in a valve pocket suspended in a sealed container to protect from damage and contamination during shipment, handling and storage. The apparatus is an easy to open container having remote fill ports for adding a sterile liquid after enclosing the valve inside. A tamper evident seal is provided having a novel configuration to detect prior opening of the container. The apparatus includes an assembly having a shelf that is provided in a variety of configurations. The shelf has a mitral valve configuration and an aortic valve configuration. The shelf is selected based on the valve configurations and size. The system is easily assembled having a single variable component to adapt to a particular prosthetic valve to be stored. The present invention provides an apparatus for eliminating the need for direct attachment of the valve serial tag to the valve.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims the benefit of U.S. provisional application No. 60/623,484, filed Oct. 29, 2004, the entire contents of which are herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a system and apparatus for packaging replacement heart valves and the like for storing and shipping after manufacturing. More particularly, the present invention relates to a heart valve retainer for holding a replacement heart valve in a controlled and sterile condition. The present invention also relates to an apparatus from which the surgical personnel can remove the prosthetic heart valve quickly and effectively for use in a patient during heart valve surgery.  
       BACKGROUND  
       [0003]     Heart valves and more specifically prosthetic aortic and mitral valves are manufactured and prepared for insertion into patients during a surgical procedure. The valves must be sterilized after manufacture and stored in a container for shipment to a hospital or surgery center. The valve is then removed from the package, rinsed and prepared for placement in a patient during surgery.  
         [0004]     The container preserves the sterile condition of the valve, protects the valve from damage and minimizes the effort needed by the surgical team to prepare and insert the valve. Sterilization is a critical and challenging in working with prosthetic devices. The devices are made in a non-sterile environment and sterilized before packaging and shipping. The valve is usually stored in a sterile solution such as a 0.2% Glutaraldehyde after sterilization. Glass jars are commonly used because glass resists reacting with the solution, is inexpensive and can withstand sterilization. A retainer holds the valve in a fixed position inside the container to keep it submerged in the solution.  
         [0005]     Prior art designs to store and ship prosthetic heart valves include U.S. Pat. No. 4,750,619 patent to Cohen assigned to Osteonics Corp entitled “PACKAGE WITH TRAY FOR SECURING AND PRESENTING A STERILE PROSTHETIC IMPLANT ELEMENT”. In the &#39;619 patent, a package for holding the prosthetic heart valve has a tray which is stored in a hinged receptacle which is sealed to protect against contamination. In all, three containers are used including the sealing cover. In the Dohm patent U.S. Pat. No. 5,720,391, entitled “PACKAGING AND HOLDER FOR HEART VALVE PROSTHESIS”, the prosthetic is mounted on a holder having a post. The holder is suspended in a plurality of trays each having a lid. The trays are heat sealed to protect the valve. In U.S. Pat. No. 5,823,342 to Caudillo for “PACKAGING FOR MITRAL OR AORTIC HEART VALVE DEVICE” a outer shell is screwed together to form a housing over a container having an interchangeable holder for an aortic or mitral valve. U.S. Pat. No. 5,960,956, entitled “STORAGE CONTAINER”, describes a container for holding a prosthetic device in a high humidity environment of sterile liquid but not submersing the device.  
         [0006]     Manufacturers are making a variety of valve designs and sizes. This variety of size and configuration demands a flexible packaging system to reduce inventory of valve containers and retainers. Accordingly, there is a need for a system or apparatus for packaging prosthetic heart valves that can be configured to different valve designs, valve sizes, and styles with minimal changes. There is also a need for a storage system that is easy to open.  
       SUMMARY  
       [0007]     This invention relates to a novel valve retainer system and apparatus that is flexible in adapting to different valve configurations and sizes. The present invention provides an apparatus for securing a prosthetic valve in a fixed position by suspending a valve pocket in a jar filled with a sterile liquid. The present invention relates to a valve retainer having a body, a shelf and a cap. The body is a generally cylindrical structure with first end in the jar and a second end adjacent the lid and a ledge supported between the first end and the second end. A shelf is selected having a valve pocket designed for a particular valve size and configuration. The shelf is attached to the body. The valve is placed in the valve pocket in the shelf. The valve and leaflets are protected against damage by being contained in the valve pocket. The cap is inserted into the second end of the body to engage and hold the valve securely in the pocket.  
         [0008]     In one embodiment, the present invention comprises an apparatus that facilitates removing the valve from the package and draining away the sterile solution without touching the valve.  
         [0009]     Preferably, the present invention comprises a container that is easy to open.  
         [0010]     In a preferred embodiment, the invention comprises an apparatus for minimizing inventory required to package prosthetic valves for shipment, sterilization and storage by a configurable storage system.  
         [0011]     In another aspect, the present invention provides a packaging system for prosthetic valves that is easy to assemble.  
         [0012]     In another aspect, the present invention comprises an apparatus that minimizes exposure to non-sterile surfaces during removal to help maintain the sterile condition of the prosthetic device.  
         [0013]     In another embodiment, the present invention is a retainer for holding a sterilized prosthetic valve that is stored in a sealed container and is conveniently removed to hold the valve for rinsing.  
         [0014]     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0015]      FIG. 1  is a top view of a closed article according to one aspect of the present invention.  
         [0016]      FIG. 2  is a side elevation of  FIG. 1 .  
         [0017]      FIG. 3  is side section view taken at approximately  3 - 3  of  FIG. 2 .  
         [0018]      FIG. 4  is a perspective view showing a tamper resistant tag.  
         [0019]      FIG. 5  is a perspective view of a body component.  
         [0020]      FIG. 6  is a perspective view of a shelf component.  
         [0021]      FIG. 6   a  is a perspective view of an alternative embodiment of a shelf component.  
         [0022]      FIG. 6   b  is a perspective view of an alternative embodiment of a shelf component.  
         [0023]      FIG. 6   c  is a perspective view of an alternative embodiment of the shelf component.  
         [0024]      FIG. 7  is a perspective view of a bottom portion of a cap.  
         [0025]      FIG. 8  is an exploded perspective view of the valve retainer with an aortic valve mounted in a holder several components.  
         [0026]      FIG. 9  is an exploded perspective view of the valve retainer with an aortica mitral valve mounted in a holder. 
     
    
       [0027]     The FIGS are not necessarily to scale.  
       DETAILED DESCRIPTION  
       [0028]     The present invention provides a solution to packaging a prosthetic device in a sterile condition for shipment and storage prior to application to a patient.  
         [0029]      FIG. 1  shows a top view of the present invention. The present apparatus  10  is a system for suspending a prosthetic valve in a sterile solution in a container to protect the valve from damage and contamination during shipment handling and storage. The container is shown as a jar  56  ( FIG. 2 ) with a removable lid  12  sealingly attached. The lid  12  has a top side  14  and a grip surface  18 . A torque enhancing shape  16  is preferably formed in the lid  12 . The torque enhancing shape  16  has a first projection  20  on the grip surface  18  defining a first flat  22  and a first point  23 . A second projection  24  is disposed on the grip surface  18  at an angular separation from the first projection  20 . The second projection  24  has a second flat  26  and a second point  27 . In the embodiment shown in  FIG. 1 , the flats  22 ,  26  are orientated at a tangent to the circular grip surface  18 . The first projection  20  and the second projection  24  enhance the application of torque, by a surgery worker (not shown), to turn and open the lid  12 . When the lid  12  is wet, aAn opening force at arrow A is easier to apply than the same force applied at Arrow B.  
         [0030]     A first fill hole  28  is formed in the lid  12  to provide access through the top  14  into the storage chamber  30  ( FIG. 3 ). A fold over first tab  32  is formed on the top  14  adjacent the first fill hole  28 . The first tab  32  has a bottom surface  36  and a perimeter comprising hinge side  34  on the lid  12 , a leading edge  38  and two side edges  40 ,  42 . The hinge side  34  is on the lid  12  adjacent the first fill hole  28 . A second fill hole  44  on the top  14  shown closed by a second tab  46  sealingly connected to the top  14 . The second tab  46  is attached by welding the perimeter of the second tab  46  to the top  14  to close the second hole  44 . The second tab  46  is similar to the first tab  32 . The second tab  46  has a hinge side  34  on the top  14 , a top side  48 , a leading edge  38  and two side edges  40 ,  42 . The second tab  46  is folded over to cover the second fill hole  44  and sealingly attached to the top  14 . The tabs  32 ,  46  may also be attached to the top  14  by inserting a seal plug, welding or epoxy or the like. The lid  12  may be made of plastic or metal.  
         [0031]     Referring to  FIGS. 1 and 2 , a tamper evident seal  50  on the lid  12  comprises a first perforated strip  51  and a second perforated strip  52 . The perforated strips  51 ,  52  are adhesively attached to the lid  12  on the lid end  54  and the jar  56  on the jar end  58  (  FIG. 2 ). A perforation  60  on each strip  51 ,  52  is aligned at a bottom edge  62  of the lid  12 .  
         [0032]     The jar  56  has a sidewall  64 , an open top  66  and a closed bottom  68  forming an open cylinder shaped storage chamber  30  sealed with the lid  12 . The lid  12  is removably attached to the open top  66 . The storage chamber  30  has an axis  72  ( FIG. 3 ). A retainer  70  ( FIG. 3 ) is positioned in the jar  56 . The retainer  70  ( FIG. 3 ) has a valve pocket  189  suspended between the top  66 , the bottom  68  and in spaced relation to the sidewall  64  of the container jar  56 . The retainer  70  ( FIG. 3 ) prevents damage and contamination to the valve  69  from moving around and bumping against the jar  56 . The retainer  70  ( FIG. 3 ) holds the valve  69  submerged in a sterile solution  73  in the jar  56 . The valve  69  has a sewing ring  74  attached thereto. A valve holder  75  is removably associated with the sewing ring  74 .  
         [0033]     Referring to  FIGS. 3 and 4 , the retainer  70  has a body  82 , a shelf  80  and a cap  84 . The retainer  70  is a support structure surrounding the storage chamber  30 . The retainer  70  extends from the bottom  68  to the top  66  of the jar  56 . The shelf  80  on the retainer  70  is mounted in the storage chamber  30  in a position between the top  66  and the bottom  68  of the jar  56 . The cap  84  is attached to the body adjacent the shelf  80 . The valve is held in a fixed position between the shelf  80  and the cap  84 . The retainer  70  is in the jar  56  to support the valve pocket  189  in a position spaced from the sidewall  64  and between the top  66  and bottom  68  of the jar  56  during shipment, handling and storage. The valve  69  sits in the valve pocket  189  with the sewing ring  74  on the shelf  80 .  
         [0034]     The first and second perforated strips  51 ,  52  have the perforation  60  aligned with the bottom edge  62  of the lid  12 . Referring to  FIGS. 3 and 4 , an adhesive  98  is placed on the inside  100  of the lid end  54  to thereby attach the lid end  54  of each perforated strip  51 ,  52  to the lid  12 . The perforated strips  51 ,  52  further comprise ajar end  58  having adhesive  98  on the inside  100  to adhere the jar end  58104  to the jar  56 . A flag section  102  between the lid end  54  and the perforations  60  is masked during manufacture to prevent adhesive  98  from covering the flag section  102  of the perforations  60 . Each perforated strip  51 ,  52  has an outside  106  for printing information about the seal or the contents of the jar. The perforated strips  51 ,  52  are made from a flexible paper or plastic material having a coloring to contrast with the lid  12  and the jar  56 . One preferred embodiment is a panatone yellow strip. Product labels on the lid  12  and jar  56  may be placed over the ends  54 ,  58104 .  
         [0035]     Referring to  FIG. 5 , the body  82  has a base  108 , a ledge  110  and an upper wall  114 . The ledge is formed between the base  108  and the upper wall  114 . The base  108  has a first end  109  on the bottom  68  of the jar  56  and a second end  112  on the ledge  110 . The upper wall  114  extends from the ledge  110  opposite the base  108  to a lid end  116 . When the retainer is in the jar  56 , the base  108  and upper wall  114  form a hollow structure concentric with the storage chamber  30 . The base is on the jar bottom  68  and the lid end  116  is adjacent to and may bear against the lid  12 .The ledge  110  is between the base  108  and the lid end  116 . The upper wall  114  has a valve side  118  and ajar side  120 .  
         [0036]     The upper wall  114  has a lock guide  121  formed therein for engaging the cap  84  and guiding the cap  84  to a locked position. The lock guide  121  has a cam surface  122  formed at an angle to the ledge  110  to guide the cap  84  toward the ledge  110  and into a locked position  115  ( FIG. 3 ). The upper wall  114  has a lock adapter  123  formed therein for capturing and removably retaining the cap on the body  82 . A locating slot  124  is formed in the upper wall  114 . The locating slot  124  opens at the lid end  116  and extends through the upper wall  114  to a position adjacent the ledge  110 . The locating slot  124  has an open end  126 , a closed end  128  and two spaced edges  130 ,  131  forming a slot  124  extending from adjacent the ledge  110  and opening at the lid end  116  for engaging the shelf  80 .  
         [0037]     Preferably, the present invention includes indicia or identification means for the valves. In the embodiment of  FIG. 5 , the upper wall  114  has a tag pocket  132  on the jar side  120  for retaining a serial number tag  142  on the body  82 . The tag pocket  132  has a bottom  134 , a first side  136  and second side  138 . The tag pocket  132  is open between the first side  136  and the second side  138  to allow the serial number tag  142  to be read from outside the body  82 . The tag pocket  132  has open top  140  for insertion and removal of the serial number tag  142 . The serial number tag  142  has a tether  145  attached between the tag  142  and the valve  69  body  82 . A tag post  144  is formed on the body  82  adjacent the open top  140  to keep the serial number tag in the pocket  132 . The tag post has a spacer  146  and a lip  148 . The tag  142  is placed in the tag pocket  132  and is captured between the tag pocket bottom  134  and the tag post lip  148 . The serial number tag  142  may have a numeric identification embossed thereon, a barcode or other identifying marks. The serial number tag  142  may alternatively be a RF Id or other passive or active electronic marker used to identify objects. Also alternatively, the identification means or indicia may comprise a bar code, that is preferably not physically attached to the valve. Other embodiments may include attaching a tag to hooks or pegs on the retainer. In another embodiment, the identification means may comprise engraving, etching, embossing or printing indicia such as a serial number or bar code directly on the retainer or valve holder.  
         [0038]     Referring to  FIG. 6 , a shelf  80  having an aortic valve configuration for supporting an aortic style valve  69  ( FIG. 8 ) is shown. In the aortic configuration, the shelf  80  has a support ring  150 , an outer flange  152  and an inner flange  154 . The support ring  150  has an inside  156 , an outside  158 , a top edge  161  and a bottom edge  162 . The support ring  150  is cylindrical. The support ring  150  is axially aligned in the storage chamber  30 .  
         [0039]     The outer flange  152  has inner edge  165  on the outside  158  of the support ring  150 , a top  151  and a bottom  153 . The outer flange  152  extends outwardly from the support ring  150 . The outer flange  152  is disposed between the valve pocket  189  and the jar container  56 . The outer flange  152  has a plurality of drain holes  160  formed therein by drilling or molding. Each drain hole  160  has a periphery  162163  defined by the edge of the drain hole  160 . The drain holes  160  extend from the top  151  to the bottom  153  of the outer flange  152 .  
         [0040]     Continuing to refer to  FIG. 6 , the inner flange  154  forms a bottom to the valve pocket  189 . Inner flange  154  has an outer edge  178  on the inside  156  of the support ring  150  adjacent the bottom edge  162 . The inner flange  154  has a top  180 , a bottom  182  and a drain hole  184 . The drain hole  184  has an edge  186  and an axis  188 . The inner flange  154  and the support ring  150  form a valve pocket  189  on the shelf  80 . The valve  69  is positioned in the valve pocket  189  to protect from damage. The configuration of  FIG. 6  illustrates the valve pocket  189  with the inner flange  154  acting as the bottom surface. The valve pocket  189  is circumferentially surrounded by the support ring  150 .  
         [0041]     A locating tab  164  extends from the outer edge  166  of the outer flange  152 . The locating tab  164  is sized to slidably fit in the locating slot  124  in the upper wall  114  of the body  82 . A plurality of snap fingers  168  are formed along the outer edge  166 . The snap fingers  168  have a standoff  170  and a latch  172 . The latch  172  is spaced from the bottom  153  of the outer flange  152 . The snap fingers  168  are made of a resilient material such as PVC or other plastic compounds and may be molded as part of the shelf.  
         [0042]     A larger size aortic valve configuration shelf  80  is shown in  FIG. 6   a . The shelf  80  has an outer flange  152  located at the top edge  161  of the support ring  150 . The valve pocket  189  is enlarged by a larger diameter support ring  150  and a more narrow outer flange  152 . The drain holes  160  are formed adjacent to and with the snap fingers  168 . In this embodiment, the drain hole periphery  162163  is part of the outer edge  166 . The snap fingers  168  append from the drain hole periphery  162163 . A drain channel is formed in the snap finger  168  to help drain liquid past the shelf  84 . The outer flange  152  spaces the valve pocket  189  from the sidewall  64  and engages the body  82  by attaching to the ledge  110 . The support ring  150  surrounds the valve pocket  189 . The outer edge  166  bears against the body  82  ( FIG. 5 ) to space the support ring  150  away from the retainer.  
         [0043]     An alternate preferred embodiment is shown in  FIG. 6   b  comprising a shelf  80   a  having a mitral valve configuration. The mitral valve configuration for supporting a mitral style valve  69   a  has an open bottom on valve pocket  189 . The mitral valve configuration shelf  80   a  comprises a support ring  150  and an outer flange  152 . The support ring  150  has an inside  156 , an outside  158 , a top edge  161  and a bottom edge  162 . The outer flange further comprises an outer edge  166 , a top  151  and a bottom  153 . The outer flange  152  is on the top edge  161  and extends outward to engage the body  82 . The support ring  150  extends from the bottom  153  of the outer flange  152 . The outer flange  152  has a plurality of drain holes  160  extending through the flange from the top  151  to the bottom  153 . Each drain hole  160  has a periphery  162163  defined by the edge of the drain hole  160 . The drain holes  160  extend through the shelf  80  at the outer flange  152 . The drain holes  160  may be round or other shapes to allow liquid to flow past the shelf  80 .  
         [0044]     The inside  156  of the support ring  150  defines the valve pocket  189  for containing the portion of the valve  69   a  hanging below the outer flange  152 . The mitral valve  69   a  ( FIG. 9 ) sits in the valve pocket  189  having the sewing ring  74  on the outer flange  152  and the leaflets extending or dangling between the sewing ring  74  and the bottom of the container, or away from the valve holder  75 .  
         [0045]     A larger size version of the mitral configuration shelf  80   a  of  FIG. 6   b  is shown in  FIG. 6   c  having the outer flange  152  located at the top edge  161  of the support ring  150 . The larger valve size requires a larger diameter support ring  150 . The drain holes  160  are formed in the outer flange  152  along the outer edge  166 . The snap fingers  168  are formed in the periphery of the drain holes  160 . In this embodiment, the drain hole periphery  162163  is part of the outer edge  166  defined by an indent or notch. The snap fingers  168  append from the drain hole periphery  162163 .  
         [0046]     Referring to  FIG. 7 , the cap  84  has a shell  190  and a handle  192 . The cap  84  configured to removably attach to the upper wall  114  ( FIG. 5 ) by a quarter turn lock. The shell  190  has a generally cylindrical shaped wall  194  having a top  198  and a bottom  200 . A lock  202  is formed on the wall  194 . The lock  202  is sized and positioned to slidably engage the body  82  ( FIG. 5 ) as is well known in the art of quarter turn fasteners. The cap  84  may be attached to the lid  12 . The handle  192  is radially attached to the shell  190  having a valve positioner  204  thereon.  
         [0047]     The valve positioner  204  is attached to and spaced from the shell  190 . The handle  192  has a first end  196206  attached to the inside of the shell  190 . The valve positioner  204  comprises a retaining ring  206  and a locating peg  208 . The locating peg  208  has end  210  on the peg  208 . The valve positioner  204  appends from the handle  192  to encircle and capture the handle adapter  76  ( FIG. 3 ) with the retaining ring  206  and the locating peg  208 .  
         [0048]     Referring to  FIG. 8 , a retainer  70  for an aortic valve  69  is shown in exploded perspective. The retainer has a body  820  with a ledge  110  between the first end  109  and second end  112  base  108  and upper wall  114 . The shelf  80  is selected for the valve  69  size and configuration to be packaged. The aortic configuration shelf  80  has an outer flange  152 , a support ring  150  and an inner flange  154 . The valve  69  is attached to a sewing ring  74  on a valve holder  75 . The valve holder  75  has a handle adapter  79 . The handle adapter  79  has threaded hole  81  for threadably attaching a valve handle  210212  to the valve holder  75 . The valve handle  210212  may be attached by threads, a snap fit or other releasable fastening method. The cap  84  has a lock  202  and a valve positioner  204 .  
         [0049]     The shelf is attached to the ledge  110  by the snap fingers  168  and the locating tab  164 . The sewing ring  74  is on the inner flange  154 . The valve  69  is surrounded by the support ring  150 . The handle adapter  79  is oriented toward the lid end  116  to engage the cap  84  and facilitate insertion of the handle  210212  for removing the valve  69  from the retainer. The stent posts leaflets  149  of the valve  69  are shown in aortic configuration positioned above the sewing ring  74 . The cap  84  is concentrically inserted into the body along at the second lid end  1162 . The cap engages the valve  69  at valve holder  75  with the valve positioner  204  ( FIG. 3 ). The valve is held between the shelf  80  and the cap  84 . The retainer  70  having the valve  69  inside is placed in the jar container  56 .  
         [0050]     The handle  192  is used to move the retainer  70  in and out of the jar container  56 . The sterilizing solution  73  drains through the drain holes  160 ,  184 . After removal from the container  56 , the retainer  70  may be used to hold the valve  69  outside of the container prior to for rinsing. The handle  192  is turned a quarter turn to unlock the cap  84  from the body  82 . The cap  84  is removed from the body  82 . The valve handle  210212  is screwed into the handle adapter  79 . The valve  69  is removed from the system to be prepared for use.  
         [0051]     Referring to  FIG. 9 , a retainer  70  and a valve  69   a  having an mitral configuration is valve is shown in exploded perspective. The retainer  70  has a body  820  with a ledge  110  between the base  108  and the upper wall  114 . The shelf  80   a  is selected for the mitral valve  69   a  size and configuration to be packaged. The mitral configuration shelf  80   a  has an outer flange  152  and a support ring  150 . The mitral valve  69   a  is attached to a sewing ring  74  on a valve holder  75 . The valve holder  75  has a handle adapter  79 . The handle adapter  79  has threaded hole  81  for threadably attaching a valve handle  210212  to the valve holder  75 . The valve handle  210212  may be attached by threads, a snap fit or other releasable fastening method. The cap  84  has a lock  202  and a valve positioner  204 .  
         [0052]     The shelf  80   a  is attached to the ledge  110  by the snap fingers  168  and the locating tab  164 . The sewing ring  74  is on the outer flange  152 . The stent posts leaflets  149   a  of the valve  69   a  are shown in mitral configuration positioned below the sewing ring  74 , away from the valve holder  75 . The valve  69   a  is surrounded by the support ring  150  having the stent posts leaflets  149   a  extending toward the base  108 . The handle adapter  79  is oriented toward the lid end  116  upper wall  114  to engage the cap  84  and facilitate insertion of the handle  210212  for removing the valve  69   a  from the retainer  70 . The cap  84  is concentrically inserted into the body  82  along at the lid second end  1162 . The cap  84  engages the valve holder  75  with the valve positioner  204 . The mitral valve  69   a  is held between the shelf  80  and the cap  84 . The retainer  70  having the valve  69   a  inside is placed in the jar container  56 .  
         [0053]     In use, the valve  69  is manufactured having a sewing ring  74  circumferentially attached. A valve holder  75  is removably attached to the sewing ring  74 . The valve  69  is sterilized. The appropriate shelf  80  is selected and sterilized with the body  82 , cap  84 , jar  56  and lid  12 . The shelf  80  is inserted into the body  82  having the locating tab  164  in the slot  124  and the snap fingers  168  on the ledge  110 . The valve  69  is placed in the valve pocket  189  resting on the sewing ring  74  and oriented with the handle adapter  796  toward the lid end  116  of the body  82 . The cap  84  is concentrically inserted into the body  82  having the valve  69  between the shelf  80  and the cap  84 . The handle adapter  796  is adjusted to engage the valve positioner  204  and the cap is turned to lock the cap  84  into the body  82 .  
         [0054]     The retainer  70  having the valve  69  contained therein is placed in the jar  56  and the lid  12  is attached. The sterilized solution is dispensed into the container through one or more fill holes  328 ,  44  to prevent spilling or splashing on sealing surface of the lid  12  or the jar  56 . The respective tab  32 ,  46  adjacent each fill hole is bent over to cover the fill hole and is ultrasonically welded to the lid  12  to seal the fill hole. The tamper evident seal  50  is attached over the jar  56  and the lid  12 .  
         [0055]     The apparatus  10  with the valve  69  therein is shipped to a facility for use in a patient. The jar  56  is removed from the box and the outside of the jar  56  may be sterilized. The surgery worker grasps the jar  156  and applies an opening force (A) to a flat on the grip surface  18 . The tamper evident seal tears at the perforations  60  and the lid  12  is unscrewed from the jar  56 . The retainer  70  is removed from the jar allowing the sterilizing fluid  73  to drain through the drain holes  160 ,  184 . The valve  69  may be rinsed while held in the retainer  70 .  
         [0056]     The worker grasps the body  82  and the cap handle  192  and turns the cap handle  192  with respect to the body  82 . The cap  84  releases from the body  82  and is removed. A valve handle  210212  is attached to the handle adapter  796 . The valve  69  is removed from the retainer  70  attached to the handle  210212  and further rinsed and prepared for use.  
         [0057]     It will be appreciated that the present invention is suitable for use with a variety of different types of valves such as aortic, tricuspid, pulmonic or mitral valves. The valve is preferably oriented in the jar retainer so that the handle can be conveniently attached directly to the valve holder, without having to re-orient the valve. This minimizes the chance for valve contamination during preparation for surgical implantation.  
         [0058]     Although the invention has been described above in connection with particular embodiments and examples, it will be appreciated by those skilled in the art that the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.