Abstract:
A system designed to store an implant together with the tools necessary to implant the stored implant, and a method of using said system. Such system includes an implant storage tool adapted to retain the implant within a storage container. The implant storage tool is operable to provide an implant applicator.

Description:
[0001]     This application is a Continuation of application Ser. No. 10/290,721, filed on Nov. 8, 2002, which is a division of application Ser. No. 09/660,371 filed on Sep. 12, 2000, now U.S. Pat. No. 6,543,610. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a system for packaging, handling and applying implants. Additionally, this invention relates to a method for introducing a corneal implant to the corneal surface.  
       BACKGROUND OF THE INVENTION  
       [0003]     Current methods and devices used to store small, delicate, and normally transparent implants entail free-floating the implant in a volume of storage fluid contained within a storage bottle or other container. This manner of storage is oftentimes used to preserve retinal transplants, brain tissue transplants, corneal implants, tissue biopsies and any other delicate biological specimen. Free-floating storage, however, subjects a stored specimen or implant to fluid agitation, which can severely and irreparably damage the integrity of the stored material. In addition, isolating transparent specimens from the storage fluid is difficult to achieve.  
         [0004]     Corneal implants are especially susceptible to the above described problem. Corneal implants are used to correct visual disorders such as Myopia or near-sightedness, Hyperopia or far-sightedness, Presbyopia or difficulty in accommodating a change in focus, and Astigmatism. To correct these disorders, the implant is introduced into the body of the cornea in known ways, such as after a flap is formed and an under surface of the cornea is exposed. The implant, changes the shape of the cornea and alters its refractive power. These implants are generally made of various types of hydrogels, but can include other polymers, tissue implants, or the like. In the past, storing the corneal implant required free-floating the implant in a volume of storage fluid contained within a storage container. To retrieve the implant, one had to first locate the implant within the fluid, and then remove the implant using a filter device or sequestering tool. In the case of a corneal implant, locating the implant is complicated by both the size and transparency of the implant. For instance, a corneal implant generally has a diameter of about 4.0 to 7.0 mm and a center that is normally fabricated having a thickness ranging from 25 to 50 microns. Due this minuscule size, physically grasping the implant from the storage fluid using tweezers, or the like, is simply not practical.  
         [0005]     Successful isolation of a corneal implant, or other specimen, generally requires the use of a sieve to separate the implant from the fluid. Isolating the implant in this manner, however, subjects the implant to mechanical forces, which could lead to a loss of the implant. If not damaged, the transparent implant must still be located on the sieve surface and retrieved. The implant must therefore be grasped using tweezers, forceps, or the like. Imparting such force upon the implant, however, can also damage the implant. Using force imparting tools to hold the implant is therefore not desirable. Current isolation techniques are therefore difficult, time-consuming and create additional steps, which can also lead to implant contamination. Thus, it is desired to have an implant storage and handling system, which allows the user to rapidly and successfully retrieve the implant for prompt implantation.  
         [0006]     Current devices used to deposit an implant onto the cornea surface generally deposit the corneal implant onto the cornea surface in a bunched or folded conformation. Aligning the implant in planar relation to the cornea surface requires the surgeon to manipulate or tease the implant so as to remove any folds or bends in the implant. Problematically, the step of unfolding the implant on the cornea surface can cause serious trauma to the cornea surface. This trauma can lead to the formation of edema, or other deleterious responses that lead to rejection or displacement of the implant.  
         [0007]     Thus, there is believed to be a demonstrated need for a unitary packaging and handling system that provides the desired storage capabilities, easy retrieval of the specimen from that storage, and tools that are operable to retrieve and utilize the specimen without causing damage to the specimen or an implantation site. There is also an additional need for a more effective method for implanting a corneal implant onto a cornea surface.  
       SUMMARY OF THE INVENTION  
       [0008]     The present invention relates to an implant packaging and handling system which includes a storage bottle having an opening to receive a volume of implant storage fluid, and an implant holding tool designed to retain the implant in fluid communication with the implant storage fluid. A storage bottle stopper holds the implant holding tool, so that a portion of the implant holding tool is immersed within the storage fluid upon placement of the stopper into the bottle, placing the implant in fluid communication with the storage fluid. The implant holding tool includes a retaining member detachably mounted to an implant applicator tool. Together they define an enclosure for retaining the implant in a secure, known storage position.  
         [0009]     The implant applicator tool has an arcuate-shaped applicator surface with a plurality of openings. The arcuate shaped surface is contoured to correspond to the curvature of the cornea surface, which aids in the proper implantation of the implant to the cornea surface. In one embodiment, the applicator surface has one or more recessed surfaces designed to hold and center the implant on the applicator surface. One or more recessed grooves are also provided to allow fluid to flow between the implant and the applicator surface.  
         [0010]     The openings have numerous advantages. The openings provide continuous fluid communication between a retained implant and the implant storage fluid. Upon removal from storage, the openings enable the user to unfold and orient the implant by gently passing fluid through the openings so as to float the implant into a desired central position on the applicator tool surface. Once so positioned, the user is then able to aspirate the fluid/from between the implant and the applicator tool, thereby resting the implant firmly against the applicator tool surface. The applicator tool also includes a central opening providing the user with a reference point for centering the applicator surface, and thus, the implant onto the surface of the cornea.  
         [0011]     The present invention also relates to a method of implanting a corneal implant using the implant packaging and handling system. The initial step includes surgically preparing the cornea surface for implantation. Next, the implant and implant holding tool are retrieved from the storage bottle, and the retaining member removed so as to provide an applicator tool together with implant. The applicator can then be attached to a handle for ease of use. The implant is then properly aligned on the applicator tool and deposited onto the surgically prepared cornea surface. Finally, the cornea is restored.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]     A better understanding of the invention can be obtained from the detailed description of exemplary embodiments set forth below, when considered in conjunction with the appended drawings, in which:  
         [0013]      FIG. 1  is a partial sectional view of the implant packaging and handling system of the present invention;  
         [0014]      FIG. 2  is a schematic representation of the implant applicator tool fastened to a retaining member, providing the implant storage tool of the present invention;  
         [0015]      FIG. 3  is a schematic representation of the implant applicator tool of the present invention;  
         [0016]      FIG. 4  is a schematic representation of the retaining member adapted to form an implant retaining enclosure when fastened to the implant applicator tool of  FIG. 3 ;  
         [0017]      FIG. 5  is a bottom view of a stopper used to seal the storage bottle of the present invention, showing the implant storage tool engagement slot in an open position;  
         [0018]      FIG. 6  is a cross-sectional view through the stopper of  FIG. 5  taken on line  10 - 10 ;  
         [0019]      FIG. 7  is a partial sectional view of the bottle stopper positioned within the storage bottle, showing the implant storage tool engagement slot in a closed position;  
         [0020]      FIG. 8  is a cross-section at view through the stopper and storage bottle of  FIG. 7  taken on line  20 - 20 ;  
         [0021]      FIG. 9  is a schematic illustration of the implant applicator tool secured to a handle;  
         [0022]      FIG. 10  is a side view of the implant applicator tool secured to a handle, showing the curved surface of the implant applicator tool, which corresponds with the contour of the cornea surface;  
         [0023]      FIG. 11  is a schematic representation of an implant applicator tool having a central opening for aligning the applicator tool with the visual or pupillary axis of the eye;  
         [0024]      FIG. 12  is a schematic representation of an implant applicator tool having a recessed surface defining a central opening and adjacent alignment slot;  
         [0025]      FIG. 13  is a schematic representation of a retaining member adapted to engage with the applicator tools shown in  FIGS. 9 and 12 ;  
         [0026]      FIGS. 14   a ,  14   b ,  14   c ,  14   d  and  14   e  are cross-sectional views of a human eye illustrating the method of introducing an implant to the cornea surface using the implant applicator tool of the present invention. 
     
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS  
       [0027]      FIGS. 1 through 14   e  of the drawings show an implant packaging and handling system  10  of the present invention. As illustrated in  FIG. 1 , the preferred system  10  includes a cylindrical storage bottle  11  for holding implant storage fluid (not indicated). The bottle  11  is sealed by a stopper  12  having an upper cap portion  14  and a plug portion  13 , which is adapted to detachably couple to an implant storage tool  15 . A protective safety seal  17  provides tamper resistance and maintains the stopper  12  in sealed relation to the bottle  11 .  
         [0028]      FIGS. 2 through 4  show a retaining member  16  and implant applicator tool  19 , which together define the implant storage tool  15 . As illustrated, the retaining member  16  is adapted to detachably engage the implant applicator tool  19 , thereby defining an enclosure  41  operable to retain the implant. Both the retaining member  16  and the applicator tool  19  include a plurality of openings  18  and  22 , respectively, which allow storage fluid to communicate into the implant retaining enclosure  41 . As shown in  FIG. 1 , the implant retaining enclosure  41  is located on the end of storage tool  15  that is distal to the stopper  12  such that the enclosure  41  is immersed in implant storage fluid when the storage tool  15  is inserted into the bottle  11 . When the implant is stored, the enclosure  41  of storage tool  15  holds the implant in the storage fluid, while also providing a user with ready access to the implant. The user simply removes the stopper  12 , thereby removing the storage tool  15  from the bottle  11 , and detaches the retaining member  16  from the applicator  19  to access the implant.  
         [0029]     As illustrated in  FIG. 3 , applicator tool  19  has a handle attachment arm  20  connected through a body portion  21  to an implant applicator member  45 . The body portion  21  is preferably shaped to provide a broad handling surface. For instance,  FIGS. 2 and 3  show a body portion  21  having a broad elliptical shape, which allows a user to more easily manipulate the applicator tool  19 . As shown, the implant applicator member  45  includes an applicator surface  42  having a plurality of openings  22  to provide fluid communication between the applicator surface  42  and an implant resting thereon. Openings  22  further allow the user to release the implant from the applicator surface  42 . More particularly, the user can impart force upon the implant by passing through the opening  22  either a flow of fluid or a cantilever so as to forcibly separate the implant from the applicator member surface  42  (as is shown in  FIG. 14 ).  
         [0030]     In a preferred embodiment, the applicator surface  42  has a central opening  23  to help the user align the applicator surface  42  along the visual or optical axis of the eye. As shown, the centrally positioned opening  23  defines a circular opening having a diameter greater than the diameter of the surrounding openings  22 . In this way, the user is provided with a central point of reference, which enables the user to align the applicator surface  42  with the optical axis of the eye, and thus, properly position the implant.  
         [0031]     In another embodiment, the applicator tool  19  may include an applicator alignment notch  24  positioned integral to the surface  42  of the applicator member  45 . For instance,  FIGS. 3 and 12  show the notch  24  extending inwardly towards the centrally positioned alignment opening  23 . In this embodiment, the notch  24  is used to align the implant on the cornea surface  39 , as well as release the implant from the applicator surface  42 . Specifically, the notch  24  is dimensioned to allow a cantilever, or like instrument, to pass through the notch, thereby allowing the user to impart force against an implant held on the applicator surface  42 . Specifically, the user lifts the application tool  19  away from the cornea surface while simultaneously imparting downward force on the implant through the notch  24  so as to release the implant. One skilled in the art will understand that various notch positionings can be incorporated into the applicator member  45  without departing from the scope of the present invention.  
         [0032]     As shown in  FIG. 2 , the retaining member  16  has an outer surface  44  defining a plurality of openings  18  that provide fluid communication to an implant retained by the enclosure  41 .  FIG. 4  shows a retaining member  16  disengaged from the applicator tool  19  shown in  FIG. 3 . To secure the retaining member  16  to the applicator tool  19 , the retaining member  16  is provided with attachment tabs  26   a - c  adapted to insert into corresponding attachment slots  25   a - c  integral to the applicator tool  19 . In use, the retaining member  16  is attached to the applicator tool  19  by simply inserting the tabs  26   a - c  into the respective corresponding slots  25   a - c , and then positioning the bottom surfaces  28  of retaining member side walls  43  against the applicator surface  42 . In a preferred embodiment, at least one side wall  43  has an overlapping flexible portion  27  adapted to bend about the distal edge of the applicator surface  42 , thereby securely clamping the retaining member  16  to the applicator tool  19 . To remove the retaining member  16 , the user merely unclamps the flexible portion  27  by bending it away from the applicator tool  19 , and lifting the member  16  so as to disengage tabs  26   a - c  from slots  25   a - c.    
         [0033]     As illustrated in  FIGS. 9, 11 ,  12  and  13 , an alternative attachment tab  26  and attachment slot  25  can also be used with the present invention. For instance,  FIG. 12  shows an applicator tool  19  having four separate attachment slots  25 , while in comparison  FIG. 3  shows an applicator tool  19  having three separate attachment slots  25   a - c . It will be understood by those skilled in the art that various embodiments for attachment slots  25  and tabs  26  can be incorporated into the applicator tool  19  and retaining member  16  without deviating from the scope of the present invention.  
         [0034]     As illustrated in  FIGS. 5 through 8 , a preferred embodiment of system  10  includes a bottle stopper  12  adapted to receive and securely hold the handle attachment arm  20  of the applicator tool  19 . The stopper  12  preferably includes an upper cap portion  14  and a plug portion  13  dimensioned to insertably seal the bottle  11 .  FIG. 5  shows the stopper plug portion  13 , which is not inserted into a storage bottle opening  46  (shown in  FIG. 8 ). In comparison to  FIG. 5 ,  FIG. 7  shows the plug  13  inserted into the storage bottle opening  46 . As illustrated by  FIGS. 5 and 7 , plug portion  13 , when removed from bottle opening  46 , adopts an elliptical shape by distending in an outwardly direction along line the  10 - 10 . Likewise, inserting stopper  12  into bottle opening  46  causes the outer diameter of plug portion  13  to conform to the inner diameter of the inner bottle surface  34 . In this way, the plug portion  13  becomes inwardly compressed along line  30 - 30 . Referring to  FIGS. 6 and 8 , cross-section views are shown of stopper plug portion  13  in an out-of-bottle elliptical shape and an in-bottle compressed circular shape, respectively. The utility of this embodiment is described in more detail below.  
         [0035]     An engagement slot  32  is located integral to plug portion  13  in an orientation perpendicular to line  10 - 10 . As illustrated in  FIGS. 5 through 8 , the engagement slot  32  opens or closes in response to either the removal or insertion of the plug portion  13  from the bottle opening  46 , respectively. Referring to  FIGS. 5 and 6 , the engagement slot  32  is shown in an open position. More particularly, when the user removes the stopper  12  from bottle opening  46 , the plug portion  13  adopts an unrestrained elliptical shape by distending outwardly along the line  10 - 10  for opening slot  32 . In this way, the engagement arm  20  of the applicator tool  19 , which is held by the engagement the slot  32 , is easily separated from slot  32  once the stopper  12  is removed from the storage bottle  11 . By way of comparison,  FIGS. 7 and 8  show the engagement slot  32  adopting a closed conformation upon insertion of the stopper  12  into the bottle opening  46 . As shown in  FIG. 7 , insertion of the stopper  12  into the bottle  11  causes the outer surface  47  of the plug portion  13  to conform to the inner diameter of the bottle opening surface  34 , which imparts force in the direction of the line  30 - 30 . In this way, the slot  32  is forced into a tight, closed conformation. Thus, the engagement arm  20  of the applicator tool  19  is held by a slot  32  in a secure position when the stopper  12  is inserted into the bottle  11 . The stopper  12  is preferably made of silicone rubber, or other elastomeric material.  
         [0036]      FIGS. 9 and 10  show an applicator tool  19  attached to a handle  30 . The applicator tool attachment arm  20  detachably mounts to the handle  30  through a handle fastener  31 . It will be understood by those skilled in the art that numerous types of handles and handle fasteners are available that can be used with the applicator tool  19  without departing from the scope of the present invention.  
         [0037]     As illustrated by  FIG. 10 , the implant applicator member  45  has a curved applicator surface  42 , which corresponds to the curvature of the cornea implant site. This curved surface allows the user to position the curved applicator surface  42  evenly across the cornea surface, enabling the implant to be more evenly deposited onto the cornea surface. Referring to  FIGS. 9 and 12 , each applicator member  45  is shown having a recessed applicator surface  29 . As shown, the recessed surface  29  is preferably circular, thereby allowing a substantially circular implant to be centrally positioned on the applicator member  45 . In addition, the central opening  23  which is centered relative to the perimeter of the circular recess  29 , provides the user with a reference point for alignment of the applicator member  45  with the pupil diameter. In this way, the implant can be properly aligned on the cornea surface.  
         [0038]      FIG. 11  shows an applicator tool  19  having an applicator surface  42  with recessed grooves  29  to allow fluid to flow between the applicator surface  42  and an implant supported on the surface  42 . It should be understood by one skilled in the art that alternatively dimensioned recesses and grooves can be formed in the applicator surface  42  without departing from the scope of the present invention. It is advantageous to provide fluid flow between the surface  42  and the implant to enable the user to more easily manipulate the implant while it is on the applicator surface  42 . During storage, for example, the implant may come to rest in various folded and bunched conformations. Once the retaining member  16  is removed, the user can manipulate the implant into its desired conformation by gently passing a volume of fluid through the openings  22  and  23 . More particularly, the implant will overlap a small volume of fluid, thereby allowing the user to floatingly realign the implant on the applicator surface  42 . After the implant is aligned, the fluid can be removed by simply touching the underside of the applicator member  45  with a cotton swab, or like absorbent material.  
         [0039]      FIGS. 12 and 13  show an alternative embodiment of an applicator tool  19  and a retaining member  16 , respectively. In this embodiment, the retaining member  16  includes four attachment tabs  26  that detachably insert into four corresponding applicator tool attachment slots  25 . As shown, the tool  19  and the retaining member  18  include fluid communication openings  22  and  18 , respectively. It should be understood that various combinations of tabs, slots, alignment and openings can be incorporated into the tool  19  and the member  16  without deviating from the scope of the present invention.  
         [0040]      FIGS. 14   a  through  14   e  illustrate the steps of the claimed method of implanting an implant to an exposed surface of the cornea using the system of the present invention. The first step, shown in  FIG. 14   a , involves the surgical preparation of a portion of the outer surface of the cornea  38  of the eye to form a corneal flap  37 , which remains attached to the cornea  38  by way of a hinge  36 . This surgical step is commonly known in the art as a lamellar dissectomy, and is typically performed using a keratome (not shown). In a preferred embodiment, the flap is cut deeply enough to dissect the Bowman&#39;s membrane portion of the cornea  38 . Surgically preparing a corneal flap of 100 to 200 microns, typically 160 to 180 microns, operates to eliminate tension caused by the Bowman&#39;s membrane. This step reduces the possibility of implant extrusion due to pressure generated within the cornea  38 , which may be caused by the implant. As illustrated, it is preferable to leave the corneal flap  37  attached by way of a hinge  36 , thereby allowing the flap  37  to be replaced in the same orientation as before the cut.  
         [0041]     After the surface  39  is prepared, the surgeon deposits the implant  40  onto the surface  39  using the applicator  19 . To retrieve the applicator tool  19 , the surgeon first removes the protective seal  17  from around the bottle opening. The implant holding tool  15  is then removed from within the bottle  11  by removing the stopper  12 , which holds the storage tool  15 . The storage tool  15  is easily separated from the stopper  12  by holding the tool  15  about the body portion  21  and disengaging the tool  15  from the now opened slot  32 . Next, the tool arm  20  can be attached to a handle  30 , and the retaining member  16  removed. Removing the member  16  presents the implant  40  to the surgeon for implantation. The surgeon is able, therefore, to retrieve an implant  40  from a storage bottle  11  without having to use, at the risk of damaging or losing the implant, a grasping tool, such as tweezers or surgical forceps.  
         [0042]     The surgeon then properly aligns the implant  40  on the applicator surface  42  by preferably passing liquid through the openings  22 . At this step, the surgeon may gently guide the implant  40  to its proper alignment on the surface  42  using a cannula  35 , or other similar device. The implant  40  is positioned on the applicator surface  42  by drawing off the fluid located intermediate to the implant  40  and the applicator surface  42 . This can be done by placing a cotton swab, or other absorbent material, against the underside of applicator member  45 , which draws off the fluid through openings  22 .  
         [0043]     As shown in  FIG. 14   b , the corneal flap  37  is pulled away from the cornea implantation surface  39 . The implant  40  is then positioned over the cornea implantation surface  39  by holding the applicator tool  19  in a generally horizontal position over the surface  39  with the implant  40  facing the surface  39 . As shown, the applicator member  45  has an arcuate shaped applicator surface  42 , which matches the curved shaped of the cornea surface  39 . In this way, as illustrated in  FIG. 14   c , the applicator member  45  can be evenly placed over the cornea surface  39 , reducing trauma to the surface  39 . Specifically, the implant  40  is evenly adhered to the surface  39 , reducing the need for any manipulation of the implant  40  on the surface  39 , which could traumatize the eye as is described above.  
         [0044]     Referring to  FIG. 14   d , the implant  40  is deposited onto the surface  39  by gently lifting the applicator tool  19  away from the surface  39 . As shown, the implant  40  remains adhered to the surface  39 . The use of a cannula  35  operable to pass a volume of fluid flow through opening  22 , however, can be used to ensure proper deposition of the implant  40  onto surface  39 . As shown in  FIG. 14   e , once the implant is deposited onto the surface  39 , the corneal flap  37  is replaced.  
         [0045]     Various embodiments of the of the present invention have been described herein. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention as disclosed and claimed.