Patent Publication Number: US-2005126948-A1

Title: Package for surgical implant

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
      This is a continuation of application Ser. No. 10/183,804 filed Jun. 26, 2002. 
    
    
     BACKGROUND OF THE INVENTION  
      This invention relates to a package for containing a surgical implantable device, particularly an ophthalmic device for implanting in the human eye. Various devices for implanting in the eye are known. As examples, devices for sustained delivery release of a pharmaceutically active ingredient into the back-of-the-eye are disclosed in the following patents, the disclosures of which are incorporated herein by reference: U.S. Pat. Nos. 6,375,972; 5,773,019; 5,378,475; 6,001,386; and 6,217,895. 
    
    
     DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is an exploded top perspective view of a package according to various preferred embodiments of this invention, including a medical device and lidstock.  
       FIG. 2  is a bottom schematic perspective view of the package shown in  FIG. 1 .  
       FIG. 3  is a top perspective view of the package of  FIG. 1  including lidstock.  
       FIG. 4  is side view of the package of  FIG. 1 .  
       FIG. 5  is a top view of the package of  FIG. 1 .  
       FIG. 6  is a cross-section view taken along line  6 - 6  of  FIG. 5 .  
       FIG. 7  is a top perspective view of a second package.  
       FIG. 8  is a top perspective view of a third package.  
       FIG. 9  is a top perspective view of a fourth package.  
       FIG. 10  is a top perspective view of a fifth package.  
       FIG. 11  is a top view of a medical device shown in  FIG. 1 .  
       FIG. 12  is a side view of the device of  FIG. 11 . 
    
    
     SUMMARY OF THE INVENTION  
      This invention provides a package for storing an implantable medical device during storage and shipping. The package comprises a first flange extending upwardly from an upper surface and defining a containment region for containing the device, wherein the containment region includes a support surface for supporting the device in the containment region. The package further comprises a second flange extending upwardly from the upper surface, wherein the second flange completely surrounds the first flange and includes an upper surface for sealing of lidstock thereto.  
      According to preferred embodiments, the package comprises a recess extending below the device support surface in the containment region, such that the recess permits insertion of a surgical gripping tool below this device support surface. The first flange may have the form of two protrusions extending upwardly from the package upper surface and defining the containment region, for example, the recess may then have the form of an elongated groove in the package upper surface that separates the two protrusions and extends transversely to the containment region. Preferably, these two protrusions are both arcuate.  
      The package may further include ribs that facilitate steadying or gripping the package during removal of the lidstock. The ribs may extend upwardly from the same upper surface from which the second flange extends, or the ribs may extend from a second package upper surface at a different elevation than the first package upper surface.  
      According to preferred embodiments, the package includes a holding receptacle for holding the device after removal from the containment region. For example, the holding receptacle may have the form of a groove formed in the package upper surface and located between the ribs.  
      The device is preferably a device implantable in the human eye, wherein the containment region is sized to contain such a device while preventing excessive movement of the device during storage and shipping. Accordingly, the containment region preferably has a maximum length of 10 mm. For packages including two first flange protrusions, the maximum length between inner surfaces of the two protrusions is 10 mm, and the maximum width between inner surfaces of an individual protrusion is 10 mm, more preferably 5 mm.  
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
      FIGS.  1  to  6  illustrate a package  100  according to various preferred embodiments. Package  100  includes a top planar surface  101  with front and rear vertical sidewalls  102 ,  103  extending downwardly from planar surface  101  and serving to support the package on a work surface.  
      The package is designed to contain a sterile device  10  during shipping and storage, wherein sterility of the device is maintained and the device is protected from damage. Outer flange  105  extends upwardly from planar surface  101 . For the embodiment shown in FIGS.  1  to  6 , flange  105  is generally diamond-shaped with rounded corners. Flange  105  includes an upper surface  106 . After placing device  10  in the package, lidstock  20  is hermetically sealed against surface  106 , so that the package assembly assumes the configuration shown in  FIG. 3 . Surface  106  may be flat or arcuate. The lidstock  20  may be hermetically sealed against surface  106  by conventional heat sealing. Representative materials for lidstock  20  include vapor and moisture impermeable materials such as plastics or metallic laminates. Lidstock  20  will generally be slightly larger than the outer perimeter of flange  106  so that portions of the lidstock overhand flange  106 . Such overhanging portions of lidstock  20  allow a user to grip the overhanging portion when removing the lidstock  20  to access the device. An advantage of the diamond-shaped flange  106  in FIGS.  1  to  6  is that the lidstock may be pulled from multiple points, i.e., from each corner of the flange, depending on the preference of the user. The embodiment shown in FIGS.  1  to  6  includes ribs  107 ,  108  protruding upwardly from surface  101 . A user may place a thumb or fingers on these ribs while removing lidstock  20  with the other hand in order to steady the package on a support surface.  
      Package  10  includes inner flanges  110 , protruding upwardly from surface  110  and contained inside the boundary defined by outer flange  106 , serving to closely contain device  10  while stored in the container. In other words, inner flanges  110  form a containment region and prevent device  10  from moving excessively during shipping and storage, thus minimizing the risk of damaging device  10 . Also, inner flanges  110  ensure that the device  10  is presented in a predetermined configuration after removing the lidstock  20  from the package, this configuration best seen in  FIG. 5 . For the illustrated embodiment, flanges  110  are arcuately shaped. A representative device  10  is illustrated in  FIGS. 11 and 12 . For the illustrated embodiment, device  10  has a sustained release portion  12  in which a drug is encased, and a suture tab portion including a suture hole  15 . The length of the device is indicated by “L” and the width of the device is indicated by “W”. It is preferred that the maximum length of the containment region bounded by the inner surfaces of the two flanges  110  is no greater than 2.5 mm of the length of the device (more preferably no greater than 2 mm), and/or the maximum width of this containment region bounded with the inner surfaces of each flange  110  is no greater than 2.5 mm of the width of the device (more preferably no greater than 2 mm), in order to protect the device from excessive movement. It is further preferred that at least one of the length and width is no greater than 1 mm than the respective length or width of the implant device. As an example, for a device implantable in the eye having a length of about 5.3 mm, the maximum length of the containment region between the inner surfaces of the two flanges  110  should be no greater than 7.8 mm (7.2 mm being suitable); for such a device having a width of about 2.0 mm, the maximum width of the containment region between the inner surfaces of an individual flange  110  should be no greater than 4.5 mm (2.8 mm being suitable). If desired, the lidstock  20  may be also sealed against upper surfaces of inner flanges  110 .  
      In this embodiment, package  100  includes a recess  112  extending downwardly from surface  110 , contained inside the boundary defined by outer flange  106  and extending between inner flanges  110 . In other words, device  10  rests on a pair of surfaces defining device support surface  115 , best seen in  FIG. 6 , bounded within flanges  110 . In removing the device  10  from the package, a surgeon will typically grip the device with tweezers or another type of surgical gripping tool. Recess  112  permits the surgeon to insert the tweezers or tool below the device and device support surface  115  on which the device rests. Stated differently, the surgeon is not required to grip the device with the very tip of the tweezers or tool. In contrast, in various other packages for small medical devices, the devices rest entirely on a flat or concave surface, requiring the surgeon to access the device with the tool tip. It has been found that providing access below the device is less awkward and facilitates easier removal and handling. In the illustrated embodiment, recess  112  is an elongated groove extending transversely to device support surfaces  115  and separating inner flanges  110  from each other.  
      For the embodiment illustrated in FIGS.  1  to  6 , the package  100  further includes a receptacle  120  for holding the device after removing it from the containment region. After removing the device, a surgeon may wish to temporarily set down the device, and receptacle  120  provides a convenient receptacle for doing so. Also, as explained in more detail below, the entire package  100  is preferably sterile, so receptacle  120  provides a sterile surface for placing the device. In the illustrated embodiment, after removing the device  10  from the containment region, the surgeon will add sutures to the suture tab  12  on the device, the sutures for suturing the device to eye tissue.  FIG. 5 , in addition to illustrating device in the containment region resting on pedestal surface  115 , illustrates device  10  in receptacle  120  with the added sutures  13  resting on ribs  107 ,  108 . The device may be held in receptacle  20  while the surgeon readies the eye for implantation of the device. In this embodiment, receptacle  120  has the form of a generally rectangular groove extending below surface  101  and located between ribs  107  and ribs  108 .  
      Package  100  may be molded from a plastic such as polycarbonate, polypropylene or polystyrene. In packaging the device  10  in package  100 , the device  10  is placed in the containment region of the package, and lidstock  20  is sealed against flange  105 , so that the assembly assumes the configuration shown in  FIG. 3 . Then, the entire assembly is sterilized, for example, with heat. It is preferred that the assembly is then placed in a sterile pouch conventionally used to store surgical instruments.  
       FIG. 7  illustrates an alternate embodiment of package  700 . In this embodiment, the package  700  is supported on a work surface by a single vertical sidewall  702  extending downwardly from top planar surface  701 . Also, this embodiment lacks ribs in the vicinity of receptacle  720 .  
       FIG. 8  illustrates another alternate embodiment of package  800 . In this embodiment, the package  800  is supported on a work surface by front and rear legs  802 ,  803  extending downwardly from top planar surface  801 .  
       FIG. 9  illustrates an alternate embodiment of package  900 . In this embodiment, the package  900  includes ribs  907  to facilitate a user steadying the package while removing lidstock, but lacks a holding receptacle in the vicinity of ribs  907 . Also, this embodiment includes a chevron-shaped lidstock-sealing flange  905 . For this embodiment, it would be recommended that a user remove lidstock by gripping the lidstock in the vicinity of the pointed end of the chevron-shaped flange and pulling the lidstock backward.  
       FIG. 10  illustrates an alternate embodiment of package  600 . In this embodiment, the flange  605  and rear vertical wall  603  extend from a first planar surface  601 , whereas holding receptacle  620 , ribs  607 ,  608 , and front vertical wall  602  extend from a second planar surface  630 .  
      While the invention has been described with reference to various preferred embodiments, other alternate embodiments and variations will be evident to a person of ordinary skill in the art.