Abstract:
A shipping system for a medical device, such as implantable lens for an eye, is provided that may be reconfigured from a shipping mode into an injection mode without manually handling the contained lens or other device. Upon manufacture, a lens may be placed within the system assembly in the shipping configuration. While in the shipping configuration, the lens is kept in its desired shape and within a selected environment. Upon arrival at the destination, the user may attach fittings for injection of the device into a body. The process of changing from the shipping to the injection mode deforms the device into a shape suitable for injection.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates to medical apparatus. More specifically, this invention relates to a container for a foldable device, such as an intraocular lens, that enables a physician to inject the device directly into an eye without removing the device from the shipping container. 
     2. Description of Related Art 
       FIG. 1  shows the basic structure of an eye. Eye  20  has natural lens  10 , which is partially exposed at pupil  12  underneath cornea  14 . Around pupil  12  is iris  16 . Lens  10  is attached to ciliary body  18  within sclera  22 . Other tissue, such as choroid  24 , retina  26  and fovea  28  are also present. Finally, optic nerve  30  carries optical signals from eye  20  to the brain. 
     For various reasons, such as cataract or injury, the natural lens of an eye may need replacement. Synthetic lenses for replacement are available from various manufacturers, who make the lens to the required optical characteristics. Intraocular lenses are made from three types of materials: silicone, hydrophobic (normally made of an acrylic) and hydrophilic. Silicone and acrylic lenses are shipped dry, whereas hydrophilic lenses are shipped in a wet condition. The index of refraction of the materials increases in the order: silicone, hydrophobic (acrylic) and hydrophilic. Hydrophilic lenses exhibit better biological compatibility and produce less inflammation after insertion into a patient&#39;s eye. While hydrophilic lenses are more beneficial, the cost and wet-storage requirements mean that, in many situations, lenses with a lower refractive index (but dry-shipped) are used instead of hydrophilic lenses. One of the advantages of dry-shipped lenses is that the lens can be shipped pre-loaded for injection. 
     Hydrophilic lenses are shipped in a sterile solution to preserve sterility and physical characteristics. Upon arrival at the medical facility, the lens is removed from its shipping container and placed in a device that is used to inject the lens into an eye. Unfortunately, the lens must be handled manually to transfer it from the shipping container to the injection device. The transfer from shipping container to the injection device introduces the potential for contamination of the lens. Moreover, the transfer procedure is often tedious and time-consuming. There is, therefore, a need in the art to eliminate problems associated with moving a lens from its shipping container to an injection device, thereby enabling greater use of hydrophilic intraocular lenses and other implantable devices. 
     SUMMARY OF INVENTION 
     The present invention is a shipping and storage container for a medical implant, such as a lens for an eye. The present invention is constructed and arranged so that it is quickly and efficiently reconfigured from a shipping mode into an injection device without manually handling the implant itself. Upon manufacture, the medical implant is placed within the present invention in its shipping configuration. While in the shipping configuration, the medical implant can be kept in its desired (undistorted) shape within a suitable fluid and protected by the body of the container. Upon arrival at the medical facility, a physician may attach one or more injection related fittings to the container (e.g., a syringe plunger and injection needle). The technician or physician may then operate the device to transition the container from the shipping configuration to the injection configuration. The injection configuration of the present invention forms the medical implant into a shape suitable for injection. The present invention thus obviates the need for a technician or physician to handle the medical implant directly before injection into the patient, thereby precluding a potential source of contamination and reducing the time necessary to perform the medical procedure. The present invention is generally applicable for medical devices that are folded before insertion into a patient. 
     The present invention may be susceptible to various modifications and alternative forms. Specific embodiments of the present invention are shown by way of example in the drawings and are described herein in detail. It should be understood, however, that the description set forth herein of specific embodiments is not intended to limit the present invention to the particular forms disclosed. Rather, all modifications, alternatives, and equivalents falling within the spirit and scope of the invention as defined by the appended claims are intended to be covered. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       Referring now to the drawings, the details of the preferred embodiments of the present invention are illustrated. 
         FIG. 1  is an illustration of an eye. 
         FIG. 2A  is an end elevation view of one form of an intraocular lens. 
         FIG. 2B  is a plan view of the intraocular lens of  FIG. 2A . 
         FIG. 3A  is a side elevation view of an intraocular lens holder of one embodiment of the present invention. 
         FIG. 3B  is a plan view of the intraocular lens holder of  FIG. 3A . 
         FIG. 3C  is a front elevation view of the intraocular lens holder of  FIG. 3A . 
         FIG. 4A  is a front elevation view of one embodiment of folding guides in the transport configuration. 
         FIG. 4B  is a front elevation view of one embodiment of folding guides in the injection configuration, after they have been moved to fold a device. 
         FIG. 5  is a front elevation view of the driving element of one embodiment of the invention. 
         FIG. 6A  is a front elevation view of the body of one embodiment of the invention. 
         FIG. 6B  is a plan view of the body of one embodiment of the invention with lens holder. 
         FIG. 7A  is a perspective view showing placement of the lens holder in the bottom of the body to assemble the apparatus of the invention. 
         FIG. 7B  is a perspective view showing placement of a lens in the lens holder. 
         FIG. 7C  is a perspective view showing placement of folding guides around the lens holder to assemble the apparatus of the invention. 
         FIG. 7D  is a perspective view showing placement of a driving element over the folding guides to assemble the apparatus of the invention. 
         FIG. 7E  is a perspective view of the apparatus showing removal of the lens holder. 
         FIG. 7F  is a perspective view of the apparatus showing closure of the folding guides. 
         FIG. 8A  is a center cross-section of the assembly of one embodiment of the invention in a shipping configuration. 
         FIG. 8B  is a center cross-section of the assembly of one embodiment of the invention after removal of the lens (or other device) holder. 
         FIG. 8C  is a center cross-section of the assembly of one embodiment of the invention after movement of the driving element to fold a lens. 
         FIG. 9  is a perspective view of an assembly for insertion of a lens into an eye. 
     
    
    
     DETAILED DESCRIPTION 
     Referring now to the drawings, the details of exemplary embodiments of the present invention are schematically illustrated. Like elements in the drawings will be represented by like numbers. 
     Referring to  FIG. 2A , a front elevation view of an intraocular lens with optic  210  and haptic  218  is illustrated. A plan view of the lens and haptics is shown in  FIG. 2B . The lens may have side plates  212 , orientation tab  213  and foot plates  214 . 
       FIG. 3A  shows optic  210  with its haptics fitted onto lens holder  230 . Lens holder  230  has base  232  and legs  234  and  236 . The legs have channels  235  and  237 , respectively, within which lens haptics  218  are placed to secure the lens for shipping, as illustrated in  FIG. 3B .  FIG. 3C  shows a front elevation view of optic  210  as it sits within the legs of lens holder  230 . Lens holder  230  may be adapted for any lens or other device that is to be folded and inserted through an opening or incision into a patient. 
       FIG. 4A  illustrates lens folding guides  220  and  222 . Right folding guide  220  has shoulder  221  and semi-cylindrical concave inner face  228 . Left folding guide  222  may be a mirror image of right folding guide  220 , with the former having shoulder  223  and semi-cylindrical concave face  226 . Lens folding guides  220  and  222  may have keys  224 , which are used to keep the folding guides oriented correctly during transition from the shipping mode to the injection mode, as described below.  FIG. 4B  shows the folding guides  220  and  220  in the injection mode, with the folding guides moved together. By forcing folding guides  220  and  222  together, respective concave faces  228  and  226  may force a lens to deform into a round cylinder, much like rolling one&#39;s tongue. In any case, a lens is deformed into a cylinder that is small enough to be inserted through an incision in an eye. If needed, friction-reducing additives may be used on surfaces to reduce friction as a lens or other device is deformed for insertion or is displaced from the folding guides. 
       FIG. 5  shows driving cam  240 . Driving cam  240  has internal shoulders  241  and  243  that may be constructed and arranged to fit slideably against shoulders  221  and  223  of folding guides  220  and  222  ( FIG. 4A ). Driving cam  240  may have sides  244  and  246  that fit within a body, and two or more detent tabs  248 . 
       FIG. 6A  is a front elevation view of “U” shaped body  250 . Body  250  has a bottom  252  and sides  254  and  256  that mate with the sides  244  and  246 , respectively, of driving cam  240  ( FIG. 5 ). Each side  254  and  256  is fitted with a openings  258  and  259  into which the detents  248  of driving cam  240  fit. Body  250  has openings  255  within bottom  252  ( FIG. 6B ). Openings  255  are constructed and arranged to accommodate legs  234  and  236  of lens holder  230 . Lens holder  230  may have any shape adapted to hold a foldable medical device. Front and back members  260  of body  250  may have attached thereto track guides  225 , which may be disposed to allow key  224  ( FIG. 4 ) to slide between track guide  225  and bottom  252  of body  250  as lens guides ( FIG. 4 ) move to deform an implantable device before it is displaced from body  250 . Although folding guides  220  and  222  are illustrated to form a cylindrical-shaped medical device after folding, it should be understood that other cross-sectional shapes may be formed, such as elliptical or rectangular. 
       FIGS. 7A ,  7 B,  7 C,  7 D,  7 E and  7 F illustrate by isometric views the assembly and use of lens shipping, storage and injection system  1000 . Referring to  FIG. 7A , within injection system assembly  1000 , body  250  is equipped with two rectangular upper shipping mode openings  258  and two rectangular lower injection mode openings  259 . Each of openings  258  and  259  can be made of any convenient shape, but are intended to be constructed and arranged to accommodate tab  248  of driving cam  240  ( FIG. 5 ), with one tab  248  within one hole  258  when assembly  1000  is in the shipping mode, and one tab  248  each within one hole  259  when assembly  1000  is in the injection mode. The shape of tab  248  is constructed and arranged to fit within either of the holes  258  and  259  so that the driving cam  240  can be moved from the shipping mode to the injection mode by deformation of either or both of driving cam  240  or sides  254  and  256  of body  250 . While assembly  1000  may be disposable, alternate embodiments may be designed for reloading and reuse. 
     Referring again to  FIG. 7A , lens holder  230  may be inserted into body  250  through separate holes in bottom  230 . Other shapes of lens holder  230  may be used. As illustrated in  FIG. 7B , optic  210  and haptics  218  may then be placed on lens holder  230 . Folding guides  220  and  222  may be placed within body  250 , as illustrated in  FIG. 7C . Then, driving cam  240  may be inserted into body  250 , as illustrated in  FIG. 7D  until tabs  248  engage in the retaining slots  258 , at which point system  1000  is in the shipping mode. The system may then be placed in a sealed container, which may contain a liquid suitable for storing and shipping the lens. 
     Upon receipt of system  1000  by the user, the system  1000  must be transitioned from the shipping mode to the injection mode. To make the transition, the user simply removes lens holder  230  by detaching it from the bottom of the body  250 , as illustrated in  FIG. 7E . Once lens holder  230  is detached, the lens is suspended within body  250  between folding guides  220  and  222 . The user then may depress driving cam  240  downward until tabs  248  are engaged with lower slots  259 , as illustrated in  FIG. 7F . In the process of depressing driving  240 , folding guides  222  and  222  are pushed together as illustrated in the lower half of  FIG. 7F . The inner concave shape of folding guides  220  and  222 , within which sits optic  210 , forces lens  210  to fold into a round shape that is suitable for injecting. 
       FIGS. 8A ,  8 B and  8 C show cross-sections halfway between front and back of the assembled device of system  1000 . When assembly  1000  is received by the user, the first step in the preparation process is to remove lens holder  230  from body  250 . To do so, the user grasps base  232  of lens holder  230  and pulls lens holder  230  away from the bottom of body  250  so that the legs  234  and  236  of the lens nest  230  are withdrawn through  250 . During the removal step, lens  210 , unable to slip out between the folding guides  220  and  222 , is detached from lens holder  230  and comes to rest within the concave faces  226  and  228  of folding guides  222  and  220 , respectively. 
     Referring to  FIG. 8A , base  232  of lens holder  230  is shown at the bottom adjacent to the underside of the body  250 . Locking nub  239  may be used to hold lens holder  230  in position within body  250 . Detents  248  of driving cam  240  are locked within upper openings  258  of body  250  to secure driving cam  240  in the shipping mode. In  FIG. 8B , lens holder  230  has been removed, as shown in  FIG. 7E . Shoulder  223  of folding guide  222  is mated to the shoulder  243  of the driving cam  240 . 
     Once lens holder  230  has been removed, the user may press down on the top of driving cam  240  until detents  248  move from upper holes  258  to lower holes  259 .  FIG. 8C  shows the apparatus in the injection mode, after the user has moved the detents to the lower holes and the folding guides together. As lens  210  and haptics  212  are now contained within the concave faces  226  and  228 , lens  210  and haptics  212  are rolled into the injection position as folding guides  220  and  222  are brought together. Once in the injection mode, an injection device, such as a syringe, can be attached to assembly  200  at one end, and an injection needle can be attached to the opposite end so that when the plunger of the syringe is operated, the lens is forced into the needle and then into a patient&#39;s eye, as shown in  FIG. 9 . 
     Referring to  FIG. 9 , needle  924  may be attached to one end of body  250  and a syringe, such as the stylus type syringe  940 , may be attached to the opposite side of body  250 . Syringe  940  may be collinear with folding guides  220  and  222  such that when the plunger of syringe  940  is pressed, a gelled fluid or, alternatively, a silicone-tipped push rod  941  in syringe  940  forces optic  210  into needle  924  for injection into a patient&#39;s eye. 
     In another embodiment, only one folding guide may be used. For instance, the concave inner face that was opposing one folding guide, such as guide  222  of  FIG. 10C , can be part of body  250 . Consequently, only one movable folding guide ( 220 ) would be needed. Driving cam  240  can be modified appropriately to move only one folding guide. 
     The material or materials for the components of system  1000  are preferably capable of withstanding high temperatures, such as those encountered in an autoclave. Moreover, the material for the shipping container should be such that it does not leach into the solution surrounding the lens, lest the lens be contaminated by the container material. Possible materials include polyolefins, nylon, Teflon and other plastics. 
     In another embodiment, a slipping agent (a material to reduce friction between surfaces) may be applied to one or more of the components of system  1000  to aid in the transition and/or injection processes. Such slipping agent may be any of or a combination of known slipping agents. 
     The body  250  of the system  1000  may contain a solution, such as saline, that provides a suitable environment for a medical implant (e.g., a lens). Body  250  may be sealable for shipping, or, instead, body  250  in the shipping mode may be placed within a sealable container for transport to the user. During shipment, system  1000  may or may not have the injection mechanism  924  or the injection actuation mechanism  940  attached to body  250 . 
     The present invention has been described in terms of specific exemplary embodiments. In accordance with the present invention, the parameters for a system may be varied, typically with a design engineer specifying and selecting them for the desired application. Further, it is contemplated that other embodiments, which may be devised readily by persons of ordinary skill in the art based on the teachings set forth herein, may be within the scope of the invention, which is defined by the appended claims. The present invention may be modified and practiced in different but equivalent manners that will be apparent to those skilled in the art and having the benefit of the teachings set forth herein.