Abstract:
An intraocular lens implant packaging system equipped with a mechanism for holding and folding a foldable intraocular lens implant having been packaged and sterilized therein. The packaging system includes a bottle or vial, a sealing apparatus, and a retainer member that removably locks onto the bottle and maintains the sealing apparatus in proper sealing alignment over an open end of the bottle. The intraocular lens implant stored within the bottle is protected during sterilization, storage and transportation such that the intraocular lens is not dislocated or damaged before its intended use.

Description:
FIELD OF THE INVENTION 
     The present invention relates to an intraocular lens (IOL) implant packaging system, and more particularly, to a foldable IOL storage container equipped with means for holding and folding a foldable IOL having been packaged therein. 
     BACKGROUND OF THE INVENTION 
     For many years, the usual method of treating a diseased intraocular lens has been to remove the diseased lens and replace it with an IOL implant. Two surgical procedures have each been found useful in the removal of a diseased lens, i.e., extracapsular cataract extraction and phacoemulsification. Extracapsular cataract extraction involves the removal of a diseased lens in a relatively intact condition through the use of forceps or an instrument similar thereto. Phacoemulsification involves contacting a diseased lens of an eye with a vibrating cutting tip of an ultrasonically driven surgical handpiece to emulsify the lens. Once emulsified, the lens is aspirated from the eye. Both surgical procedures require the cornea (or sclera) and the anterior lens capsule of the eye to be opened to allow access to the interior of the lens capsule. Once within the lens capsule, the diseased lens is removed and an IOL implant is positioned therein. Originally, extracapsular cataract extraction was the preferred and most commonly used surgical technique for intraocular lens removal. However, over time surgeons found that by reducing the size of the incision made in the cornea and lens capsule, or capsular bag, complications were also reduced. Postoperative complications commonly associated with large incision ocular surgery include for example induced astigmatism. Accordingly, today, phacoemulsification is the more popular and most commonly used surgical technique for intraocular lens removal due in part to the relatively small incision required to be made through the cornea and lens capsule. 
     Once diseased lens tissue is removed from the lens capsule of an eye, an IOL implant is typically introduced. A typical IOL implant includes an optic portion and at least one support member or haptic for positioning and supporting the IOL within the lens capsule or capsular bag. The diameter of the optic portion varies depending on the design of the IOL within the range of about 5 millimeters (mm) to 7 mm. It is a goal of the surgeon to make and utilize as small of an incision as possible, such as about 3 mm, during the removal of diseased lens material. If a 5 to 7 mm rigid IOL were to be implanted in a lens capsule, the surgeon would have to widen a 3 mm incision significantly to allow the IOL to be inserted. However, such an enlargement of the incision would reduce one of the advantages of phacoemulsification surgical technique. Therefore, foldable IOLs have been developed which may be folded, inserted into an eye&#39;s capsular bag and then released or unfolded with minimal or no widening of the original approximately 3 mm incision. 
     As known to those skilled in the art, foldable IOLs generally are made from polyurethane elastomers, silicone elastomers, hydrogel polymers, collagen compounds, organic gel compounds, synthetic gel compounds or a combination thereof. The resultant IOL preferably has a soft foldable lens optic portion. However, lenses that are soft and foldable can in some cases be difficult to fold using known folding and insertion devices due to surface tackiness. However, most foldable lenses described above may be rolled, compressed or folded by a special syringe or forceps, and then placed into an eye&#39;s capsular bag by releasing the same without enlarging the original incision. IOL folding devices are described in detail in U.S. Pat. Nos. 5,281,227, 5,290,293, and 5,607,433. While such folding and insertion devices work well for many of the IOLs manufactured from the materials discussed above, the same is not true for all foldable IOLS depending on the particular composition and /or design of the IOL. Furthermore, many such folding and insertion devices are bulky and require much practice to perfect the use thereof. 
     In order for a surgeon to fold an IOL without the aid of a special folding device such as those described above, forceps or a similar type tool is used to remove the IOL from the IOL packaging. A second tool or forceps is then used to fold the IOL. The folded IOL is then typically transferred for proper gripping to a third tool or set of forceps for insertion into the capsular bag of an eye. Such a technique, while safe and effective, requires a great deal of practice to perfect. 
     Accordingly, a long felt need exists for an inexpensive tool or method that allows a surgeon to easily remove an IOL from its packaging, fold the IOL and implant the same within an eye without numerous transfers between tools. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention is a packaging system for IOL implants. The preferred embodiment of the subject packaging system includes a bottle or vial, a sealing apparatus and a cap member which removably locks onto the bottle and maintains the sealing apparatus in proper sealing alignment over an open end of the bottle. The sealing apparatus is generally a disk with one planar surface thereof having two arms extending therefrom. The arms are designed to provide a pair of jaw members for holding an IOL. A removable retainer member extends around a portion of the jaw members to retain the IOL in proper orientation between the jaw members by maintaining the relative position of the jaw members. The retainer member protects the IOL within the bottle during sterilization, storage and transportation such that the IOL is not dislocated or damaged before its intended use. 
     In using the subject packaging system, the cap member is removed from the bottle. The sealing apparatus is then removed from the bottle and inverted so that the arms extend upwardly. The retainer member is removed from around and between the jaw members such as by twisting in a counter-clockwise direction and then lifting the same. Once the retainer member is removed, the arms may then be squeezed together so that the jaw members move in closer proximity to one another. In bringing the jaws in closer proximity, the IOL is supported therebetween in a folded position. A pair of insertion forceps or the like is then used by a surgeon to remove the folded IOL from its packaging for insertion within a patient&#39;s eye. 
     Accordingly, it is an object of the present invention to provide packaging for an IOL, which protects the same from damage. 
     Another object of the present invention is to provide a single storage, holding and folding device for a foldable IOL. 
     Another object of the present invention is to provide an IOL folding device, which is easy to use. 
     Another object of the present invention is to provide IOL packaging that keeps a foldable IOL wet, free of contamination, and protected from damage during sterilization, storage and handling. 
     Another object of the present invention is to provide IOL packaging that delivers an accurately and precisely folded wet IOL to a surgeon and to eliminate the need for a separate folding tool. 
     Still another object of the present invention is to provide IOL packaging that requires the use of only one hand to fold the lens so that the surgeon&#39;s other hand can hold insertion forceps for removal of an IOL therefrom for insertion into a patient&#39;s eye. 
     These and other objectives and advantages of the present invention, some of which are specifically described and others that are not, will become apparent from the detailed description, drawings and claims that follow wherein like features are designated by like numerals. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a preferred embodiment of the IOL packaging system of the present invention; 
     FIG. 2 is a side plan view of the sealing apparatus of the IOL packaging system of FIG. 1 in an inverted position with the retainer member removed; 
     FIG. 3 is a side plan view of the sealing apparatus of the IOL packaging system of FIG. 2 rotated along its axis 90 degrees; 
     FIG. 4 is an enlarged side plan view of the sealing apparatus of FIG. 2 taken along line  4 — 4 ; 
     FIG. 5 is an enlarged top plan view of the sealing apparatus of FIG. 3 with an IOL shown in phantom lines; 
     FIG. 6 is an enlarged side plan view of the retainer member removed from the sealing apparatus of FIG. 1 in an inverted position; 
     FIG. 7 is an enlarged bottom plan view of the retainer member of FIG. 6; 
     FIG. 8 is an enlarged top plan view of the retainer member of FIG. 6; 
     FIG. 9 is a perspective view of the IOL packaging system of FIG. 1 illustrating separation of the cap member; 
     FIG. 10 is a perspective view of the IOL packaging system of FIG. 9 illustrating withdrawal of the sealing apparatus; 
     FIG. 11 is an enlarged perspective view of the sealing apparatus of FIG. 1 in an inverted position; 
     FIG. 12 is a perspective view of the sealing apparatus of FIG. 11 illustrating separation of the retainer member; 
     FIG. 13 is a perspective view of the holder portion of the sealing apparatus of FIG. 12 illustrating compression thereof; and 
     FIG. 14 is a perspective view of the compressed holder portion of FIG. 13 illustrating removal of a folded IOL therefrom. 
    
    
     DETAILED DESCRIPTION 
     As best illustrated in FIG. 1, the preferred embodiment of the IOL packaging system of the present invention is generally designated at  10 . Packaging system  10  consists of a bottle or vial portion  12 , sealing apparatus  14  and cap member  16 . Bottle portion  12  consists of a generally tubular body portion  18  having an interior surface  20 , exterior surface  22  and opposed ends  24  and  26 . Opposed end  24  is closed by a generally disc-shaped base member  28  having interior surface  30  and exterior surface  32 . Opposed end  26  is open. Interior surfaces  20  and  30  define interior bottle volume  21 . 
     Although bottle portion  12  is illustrated as generally tubular, any other geometric shape which allows for easy placement of the same in a larger container such as a box with a plurality of other bottle portions  12  for shipping and/or storage would likewise be suitable. Examples of other suitable geometric shapes include but are not limited to square, rectangle or triangle, each of which would help prevent the bottle if tipped from rolling around on a table or tray within a sterile field of a surgical room. Additionally, bottle portion  12  in the preferred embodiment is made of clear transparent glass which is preferred to allow for visual inspection of the contents without having to open bottle portion  12 . It is also possible however, that bottle portion  12  be opaque and/or made of other suitable materials such as but not limited to various plastic or resin materials. 
     Bottle portion  12  works in conjunction with sealing apparatus  14 . Sealing apparatus  14  consists generally of a holder portion  34  as best illustrated in FIGS. 2 through 5, and a retainer member  36  as best illustrated in FIGS. 6 through 8. Holder portion  34  and retainer member  36  are preferably constructed of plastic although other sterilizable materials could be used such as but not limited to stainless steel. Holder portion  34  and retainer member  36  may each be constructed of various components as described in detail below or be of a more preferred molded unitary construction. Holder portion  34  generally comprises a disk portion  38  having interior surface  40  and exterior surface  42 . Extending from exterior surface  42  of disk portion  38  is handle base  44 , which has exterior surface  46 . Extending from exterior surface  46  is handle  48 . Handle  48  may have any number of suitable configurations, which allows gripping thereof and removal of holder portion  34  from bottle volume  21 . Handle  48  in the preferred embodiment is generally a planar tab having opposed planar surfaces  50 , attached edge  52  attached to exterior surface  46  and opposed free edge  54 . Planar surfaces  50  are preferably textured in some manner such as with gripping grooves  56  to facilitate gripping of handle  48 . 
     Extending from interior surface  40  of disk portion  38  is base support  60 . Base support  60  is again generally disk shaped and has attached surface  66  and free surface  68 . Around the periphery  58  of base support  60  at attached surface  66  is a groove  70  for accepting the interior edge  72  of gasket  74  shown in FIGS. 2 and 3 in phantom lines. Extending from free surface  68  of base support  60  are opposed arm members  62 . Opposed arm members  62  have attached edges  76 , free edges  80 , opposed planar interior surfaces  82  and rounded exterior surfaces  84 . Exterior surfaces  84  are rounded to follow the periphery  58  of base support  60 . Exterior surfaces  84  of opposed arm members  62  are also preferably concavely contoured with respect to free edges  80  and attached edges  76  at mid regions  86  for easy grasping. 
     Free edges  80  of opposed arm members  62 , have in general jaw members  88 . Jaw members  88  comprise flange members  90 , optic supports  92 , free ends  94 , lens notches  96 , alignment pins  98  and positioning grooves  100 . 
     Flange members  90  each have opposed attached edges  102  and free edges  104 . Attached edges  102  are attached to interior surfaces  82  of opposed arm members  62  at right edges  106  so flange members  90  are perpendicular to arm members  62  and form a plane with free edges  80 . Flange members  90  are approximately 50 to 75 but more preferably approximately 66 percent as wide as the width of interior surfaces  82 . Exterior edges  108  of flange members  90  have the same degree of curvature as rounded exterior surfaces  84  so as to form a continuous arc therewith. Extending from planar surfaces  110  of flange members  90 , are optic supports  92 . 
     Optic supports  92  are generally tabs approximately 30 to 60 but more preferably approximately 50 percent as wide as the width of planar surfaces  110  and are positioned along free edges  104  and left free edges  112  of flange members  90 . Opposed arcs  114  are formed in free edges  116  of optic supports  92  and free edges  104  of flange members  90 . Opposed arcs  114  form an opening  101  through which the diopter power of IOL  130  may be measured without having to remove IOL  130  from the apparatus. Raised alignment pins  98  extend perpendicularly from planar surfaces  118  near right free edges  120  of optic supports  92 . Also extending from planar surfaces  118  are free ends  94 . Free ends  94  are formed to have lens notches  96  at the attached bases  122  thereof. Free ends  94  have planar surfaces  124  opposite attached bases  122  and have positioning grooves  100  formed therein. Extending outwardly from exterior edges  126  of free ends  94  and in the same plane as planar surfaces  124  are locking tabs  128 . Opposite interior planar surface  127  of locking tabs  128  on free edges  80  is ridge  129 . 
     Referring to FIG. 5, a top view of holder portion  34  illustrates in general jaw members  88  with IOL  130  shown in phantom lines positioned therebetween. IOL  130  as illustrated, consists generally of an optic portion  132  and at least one haptic  134 . A foldable IOL such as IOL  130  may be folded along an axis of optic  132  equal distance between and perpendicular to haptics  134 . By folding IOL  130  in such a manner, the width of IOL  130  is generally decreased by approximately fifty percent. This width reduction of IOL  130  allows the same to be implanted through a smaller incision through the cornea and anterior lens capsule of an eye. 
     Best illustrated in FIGS. 6 through 8, is retainer member  36  of sealing apparatus  14 . The preferred embodiment of retainer member  36  consists of a disk portion  140  having opposed interior and exterior planar surfaces  142  and  144  respectively. An aperture  146  is formed through the center of disk portion  140 . Groove  148  is formed around aperture  146  on interior planar surface  142 . Within groove  148  are at least two but most preferably three pin members  150 . Extending outwardly from the outer edge  152  of disk portion  140  in the same plane as interior and exterior planar surfaces  142  and  144  are opposed tab members  154 . Tab members  154  have opposed interior and exterior planar surfaces  156  and  157  respectively. Extending perpendicularly from interior planar surfaces  156  along free edges  158  of tab members  154  are locking arms  160 . Locking arms  160  and free edges  158  are rounded to follow the contour of rounded exterior surfaces  84  of arm members  62 . Locking arms  160  have opposed interior and exterior surfaces  162  and  164  respectively and free edges  166 . Extending perpendicularly from interior surfaces  162  at free edges  166  are lock tabs  170 . Extending perpendicularly from exterior surface  167  of lock tabs  170  are positioning tips  169 . Extending perpendicularly from interior surfaces  156  between free edges  158  and groove  148  are locking pins  172 . Also between free edges  158  and groove  148 , at least one but preferably two apertures  174  are formed through tab members  154 . Apertures  174  provide a means for fluid flow in the area surrounding optic portion  132  to prevent possible damage to IOL  130 . Extending perpendicularly from exterior surfaces  144  and  157  are grip wings  180 . 
     As best illustrated in FIG. 1, bottle  12  and sealing apparatus  14  are removably locked into position with cap member  16 . Cap member  16  comprises a disk member  182  having interior planar surface  184  (not shown), exterior planar surface  186  and free edge  188 . Free edge  188  is reduced at four opposed points to form four flattened edges  190  thereon. Extending perpendicularly from interior planar surface  184  along free edges  188  and flattened edges  190  is skirt member  192 . Skirt member  192  has interior surface  194  (not shown) which is of a generally circular cross-section and exterior surface  196  which is of a generally eight-sided cross-section. Interior surface  194  is threaded  198  (not shown) for removable engagement with threaded means  200  located on exterior surface  22  near open end  26  of bottle portion  12 . Although in the preferred embodiment of the subject IOL packaging system  10  threaded means are depicted for purposes of engaging cap member  16  and bottle portion  12 , any means of engagement capable of maintaining sterility known to those skilled in the art would be suitable. Gripping grooves  202  may be applied to all or a portion of exterior surface  196  for easy manipulation of cap member  16  during use. Aperture  204  is formed in the center of disk member  182 . Likewise, at least one but most preferably four holes  206  are formed in disk member  182  preferably between free edges  188  and aperture  204 . Holes  206  provide means for steam penetration into cap member  16  during sterilization of the fully assembled packaging system  10 . Any alternative placement of holes  206  in cap member  16  that would serve this purpose would likewise be suitable. 
     The preferred embodiment of the IOL packaging system of the present invention is assembled or manufactured by first placing IOL  130  in jaw members  88  as best illustrated in FIG.  5 . IOL  130  is properly positioned in jaw members  88  when optic  132  is supported on optic supports  92  and positioned within lens notches  96  so as to allow haptics  134  to extend freely over flange members  90 . Exterior edges  108  of flange members  90  are several millimeters to the exterior of haptics  134  to protect haptics  134  from possible damage during sterilization, shipping, storage and end use, such as but not limited to during the removal of sealing apparatus  14  from bottle  12 . Alignment pins  98  prevent IOL  130  from any substantial movement such as sliding out of lens notches  96 . Retainer member  36  is then locked onto holder portion  34  by placing locking pins  172  within positioning grooves  100  and rotating the same using grip wings  180  to position lock tabs  170  between free edges  80  and locking tabs  128 . Lock tabs  170  are maintained between free edges  80  and locking tabs  128  by positioning tips  169 . Positioning tips  169  can not slip over ridge  129  to release lock tabs  170  without manual force being applied. Pin members  150  prevent any substantial movement of IOL  130  between holder portion  34  and retainer member  36 . Retainer member  36  serves to protect IOL  130  and to maintain jaw members  88  in proper position and alignment during sterilization, shipping and storage. 
     After retainer member  36  is locked onto holder portion  34  forming sealing apparatus  14 , the same is placed within bottle volume  21 , which may contain deionized water, saline solution or other desired fluid. Sealing apparatus  14  is positioned within bottle  12  so as to allow gasket  74  to rest on end  26  of bottle portion  12 . Cap member  16  is then placed over sealing apparatus  14  whereby exterior surface  46  of handle base  44  and handle  48  extend outwardly through aperture  204 . Skirt member  192  of retainer member  16  removably engages bottle portion  12  with threaded means  198  and  200  to form an air tight seal  201  (not shown) between sealing apparatus  14  and bottle portion  12 . IOL  130  packaged in the subject packaging system  10  as describe above may be sterilized, by any suitable method known to those skilled in the art such as by autoclaving, shipped and stored until use. It is contemplated that cap member  16  may be constructed and used without aperture  204  in a case where sealing apparatus  14  has no handle  48 . In such a case, sealing apparatus would be manipulated using disk portion  38 . It is further contemplated that in such a case, cap member  16  and sealing apparatus  14  could be constructed as a unitary device whereby the same would be manipulated using cap portion  16 . 
     In using the subject IOL packaging system  10  as best illustrated in FIGS. 9 through 14 and beginning with FIG. 9, cap member  16  is first removed from bottle portion  12 . Cap member  16  is removed from bottle portion  12  by rotating cap member  16  counter-clockwise relative to bottle portion  12  to disengage threaded means  198  and  200 . Upon disengaging threaded means  198  and  200 , seal  201  maintaining the sterility of bottle volume  21  and its contents is broken. As illustrated in FIG. 10, after the removal of cap member  16 , sealing apparatus  14  may be removed from bottle volume  21 . Sealing apparatus  14  is removed from bottle volume  21  by grasping handle  48  and lifting the same out of bottle volume  21 . As illustrated in FIGS. 11 and 12, the sealing apparatus  14  is inverted such that handle  48  is positioned below retainer member  36 . Retainer member  36  is then removed from holder portion  34  by grasping grip wings  180  and rotating the same approximately twenty-five degrees counter-clockwise with respect to holder portion  34 . In rotating retainer member  36 , lock tabs  170  are released from their locked position between free edges  80  and locking tabs  128 . Once lock tabs  170  are released from their locked position, retainer member  36  may be lifted off holder portion  34 . Locking pins  172  which extend into positioning grooves  100  prevent retainer member  36  from being over-rotated or rotated clockwise when removing the same from holder portion  34 . 
     Referring now to FIG. 13, the folding operation of holder portion  34  is illustrated. Arm members  62  are grasped by the user in the area of contour of mid regions  86  using the fingers of one hand. Arm members  62  are gently squeezed or biased toward one another in a non-planar, e.g., radial motion. IOL  130  positioned with optic  132  between lens notches  96  is squeezed between lens notches  96  which causes IOL  130  to be folded along a predetermined fold axis  210 . As illustrated in FIG. 14, IOL  130  folded along fold axis  210  may now be removed from between lens notches  96  with a pair of forceps  212  or tool similar thereto. 
     As described above, the IOL packaging system of the present invention provides an easy and reliable means for storing, holding and folding a foldable IOL implant. The present description is provided for purposes of illustration and explanation. It will be apparent to those skilled in the art that modifications and changes may be made to the preferred embodiment described herein without departing from its scope and spirit.