Abstract:
The present invention relates to a container system ( 200 ) for storing an intraocular lens ( 90 ). The container system ( 200 ) comprises a container ( 210 ) for storing a lens ( 90 ) and a heating device ( 220 ) for heating the lens ( 90 ) in the container ( 210 ). A heated lens ( 90 ) is more supple and can be rolled up better and smaller, such that a cut opening in an eye can be further reduced.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a container system for storing an intraocular lens to be implanted. 
       BACKGROUND OF THE INVENTION 
       [0002]    Intraocular lenses are lens implants or artificial lenses to replace the natural lens of a human eye. They are in particular used to replace the lenses of an eye affected by cloudiness (cataract) of the lens. By surgery, the affected lenses are removed and the intraocular lenses are inserted. Insertion into the eye is accomplished by means of a so-called injector, for example. It is important in this context that the surgical incision through which an intraocular lens is implanted is as small as possible (e.g. about 2.5 mm). This can provide for a fastest possible healing process without complication and possibly also avoids the need for suture. 
         [0003]    To be able to implant intraocular lenses which generally have a diameter of about 5 to 7 mm, the lenses must be foldable so as to fit through the small incision of about 2.5 mm. 
         [0004]    An injector for folding and inserting a folded lens into the human eye is, for example, described in international patent application WO 2011/155887 A1. The content of this patent application, in particular with respect to the magazine described therein is fully incorporated into the present patent application by reference. 
         [0005]    What is described therein is an injector for implanting or inserting a temporarily folded intraocular lens, which injector can be used to insert the folded lens into the lens capsula of the eye through an incision of the required size of about 2.5 mm in the eye. 
         [0006]    In one embodiment, the magazine with a lens loaded therein is connected to the injector only shortly before the operation, for loading the injector system. Thus, the lens can be loaded into the magazine in advance, under controlled conditions, for example by a manufacturer of lenses. The loaded magazine may then be stored under sterile conditions in a storage container, for example in a blister package which is preferably filled with a sterile liquid. 
       GENERAL DESCRIPTION OF THE INVENTION 
       [0007]    Against this background described above, the present invention is based on the object to even further improve the introduction of the lens into the eye. 
         [0008]    In particular it should be possible to roll up a lens to be implanted even smaller. 
         [0009]    These objects are achieved by the container system according to the independent claim. Advantageous embodiments are specified by the subject matter of the dependent claims, the description and/or the drawings. 
         [0010]    It has been found that the temperature of the lens plays an important role for the folding of the lens, the insertion of the lens into the eye, and/or for the deployment (unfolding) of the lens. A heated lens is much more supple and flexible and can be rolled up smaller, so that a cut opening (incision) in the eye can be further reduced. Moreover, a warm lens will deploy faster after having been inserted into the eye. 
         [0011]    Generally, the invention therefore contemplates to enhance the storage container described in the prior art and briefly referred to as container below, so that it is provided with a heating device. 
         [0012]    In detail, the invention provides a container system for heating and/or storing a lens, which comprises the following components: a container for storing at least one lens pre-loaded in a magazine, and a heating device integrated in the container, and/or a connection device for a heating device, for heating the lens pre-loaded in the magazine within the container. Preferably, the lens is an intraocular lens intended to be implanted into the eye. 
         [0013]    In contrast to the prior art, the magazine is not placed in a heating bath. Rather, according to a first variant of the invention the container is equipped or produced with the heating device. The heating device is integrated with the container. Heating device and container form a functional unit. 
         [0014]    According to a second variant of the invention, the container is not directly equipped with the heating device. The container is provided with the connection device for the heating device. The connection device is integrated with the container. Connection device and container constitute or form a functional unit. The heating device is provided separately in this case. It may for instance be designed as a kind of charging station to which the container can be connected via its connection device. 
         [0015]    According to the invention, the lens as such is not stored or storable in the container but rather is pre-loaded in a magazine and/or on the injector. The magazine is or can be placed in the container together with the lens stored in the magazine, optionally together with the injector. In particular, in the first embodiment it is possible in this way to directly connect the magazine to an injector after opening of the container. In the second embodiment it is possible to stably position the pre-loaded injector in the container to be able to heat the magazine and the lens. 
         [0016]    In a first embodiment, a magazine including a lens is already disposed in the container in the closed state thereof. In particular, the container system is characterized by the fact that the magazine together with the lens is positioned in the closed container. After opening of the container, the magazine can be connected to the injector. This is particularly suitable for hydrophilic lenses since they are stored in a solution. 
         [0017]    Hydrophobic lenses may also be positioned and stored in this manner. However, both types of lenses may as well be disposed and stored outside of the container to be placed and heated in the container indirectly, via the preloaded injector, prior to operation, ready for the operation. 
         [0018]    In a second embodiment, the container initially does not contain a lens. However, it may already be filled with a liquid. It is only for heating that the lens pre-loaded in the magazine is introduced into the open container then. 
         [0019]    The magazine is introduced into the container together with the lens stored in the magazine and is already pre-mounted on the injector in this case. The container system is characterized such that the magazine together with the lens can preferably be reliably positioned in the open container. The magazine is already connected to the injector in this case. This is particularly suitable for hydrophobic lenses since such lenses can be stored together with the magazine and/or the injector preferably without being immersed in a solution. 
         [0020]    In a further embodiment, the container has a receptacle area for the magazine and/or for a portion of the injector. The receptacle area preferably has a shape substantially conforming to the magazine and/or the front portion of the injector. According to one variant, the receptacle area may be substantially tailored for the magazine and/or a portion of the injector. A substantially precisely fitting shape reduces or avoids the risk of damage to the injector, the magazine and/or the lens, in particular when the injector is being inserted into the container. 
         [0021]    In one embodiment the container is provided as a stably upright standing container. This reveals a further advantage of the container. It provides a stable support condition for the injector coupled to the magazine, in which condition the now pre-loaded injector can be provided on the operating table ready for use until required by the user. 
         [0022]    As already mentioned above, the lens or the lens together with the magazine may in particular be stored in the container in a liquid. An example of such a storage liquid is a sterile saline solution. The liquid volume is, for example, in the order of less than 20 ml, or less than 10 ml, preferably from 4 ml to 5 ml. 
         [0023]    The heating device is preferably adapted to heat the lens to a target temperature in a range from about 25° C. or 30° C. to 40° C., preferably from 37° C. to 40° C. This should be possible in particular starting at a starting temperature in a range from about 4° C. to about 25° C. According to one embodiment, the target temperature should be reached after about 30 seconds and/or the target temperature should substantially be maintained over a period of about 1 minute to about 10 minutes. 
         [0024]    The container system according to the invention may be provided as a single-use system or as a reusable system. This is in particular dependent on whether the heating device can be recharged after use, for example. Both variants may already contain the lens or may be loaded with the lens before use. This is particularly dependent on whether a hydrophobic or a hydrophilic lens is used. 
         [0025]    In one embodiment, the heating device comprises a latent heat storage which may for example be based on saturated salt solutions such as sodium acetate, and/or on paraffin. A latent heat storage has particular advantages in that it is cheap, easy to be integrated, can be operated without external or internal power supply, can moreover be sterilized, e.g. autoclaved, without significant damage, and/or may even be reused. In particular, the latent heat storage can be recharged during sterilization, in particular by autoclaving, without separate heat supply. 
         [0026]    According to another embodiment of the heating device, it comprises an electric heating device. The power supply required therefore should preferably be provided by a battery or an accumulator. Preferably, the power supply should not be provided by an external power supply. This type of heating in particular provides the advantage that a precise target temperature can be maintained over a prolonged period. 
         [0027]    The heating device may be disposed on an outer surface of the container. The heating device is, for example, provided as a kind of charging station into which the container can be introduced and heated. In this embodiment, the heating device is connectable to the container via the connection device thereof. 
         [0028]    In a preferred embodiment, the heating device is arranged on an outer surface of the container. In one embodiment, for example, the heating device is integrated with the container. This allows to provide a compact system. 
         [0029]    Preferably, the heating device has a switch for being activated. The heating device may be configured to be activated manually or automatically. 
         [0030]    In one embodiment, the heating device and the container are coupled or can be coupled to each other in a manner so that the heating device is activated or turned on when the container is being opened. In another embodiment, the heating device and the lid of the container are coupled or can be coupled to each other so that upon opening or removal of the lid, the heating device is activated. 
         [0031]    As already mentioned above, in one embodiment the container or the container system is configured so as to stand stably even if the injector is connected to the magazine. 
         [0032]    In particular for improving the stability and/or handling of the container system, the lower surface of the container has a larger cross section than a central region of the container. 
         [0033]    In a first embodiment, the container has a preferably substantially planar lower surface and/or an upper surface inclined relative to the lower surface. 
         [0034]    In a second embodiment, the container has a preferably substantially planar first side wall that is inclined relative to the lower surface, and/or a second side wall opposed to the first side wall, which is inclined relative to the lower surface and preferably has a step. In particular due to the step the containers can be reliably held by the user when tearing off the lid. Preferably, the planar side wall and the lower surface enclose an angle al of 90°&lt;α1 ≦120°. 
         [0035]    In a third embodiment, a longitudinal axis L of the receptacle area is inclined relative to the lower surface of the container. Preferably in that case, the longitudinal axis L of the receptacle area and the lower surface enclose an angle α2 of 90°&gt;α2 &gt;60°. 
         [0036]    The container system of the invention may be used for storing one lens alone, a magazine including the lens, and/or even an entire injector system. The dimensions and/or shapes of the container systems are dependent, inter alia, on the design of an intraocular lens to be implanted and/or of a magazine. The container system is for instance suitable for all soft foldable intraocular lenses. Such lenses are, for example, composed of acryl, silicone, and/or hydrogel. The container system may be used for hydrophilic lenses, in particular those having a water content from 22% to 50%, and/or for hydrophobic lenses which are usually less flexible. 
         [0037]    For specifying the dimensions, the following parameters are introduced (for this see  FIGS. 4 . c  and  4 . d ): height Z, length Y, and width X. To obtain a compact container system, the following values are possible, for example: 20 mm ≦X ≦50 mm, preferably 30 mm ≦X ≦40 mm, and/or 60 mm ≦Y ≦100 mm, preferably 75 mm ≦Y ≦85 mm, and/or 50 mm ≦Z ≦90 mm, preferably 60 mm ≦Z ≦80 mm. 
         [0038]    In a further embodiment of the invention, the container and/or the magazine are made substantially transparent. This in particular permits to visually check the insertion of the injector into the container and/or into the magazine. 
         [0039]    The heating device and/or the connection device for the heating device may be provided in integrated form in and/or on the container. However, it is also possible to retrofit conventional containers with a heating device according to the invention and/or with a connection device according to the invention for a heating device. 
         [0040]    Therefore, a kit for retrofitting a container for assembling a container system according to at least one of the embodiments described above is also within the scope of the invention. The kit comprises a heating device connectable to the container and/or connection device for a heating device connectable to the container for heating a lens pre-loaded in a magazine within the container. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0041]    The present invention will now be described in more detail by way of the following exemplary embodiments. For this purpose, reference is made to the accompanying drawings. The same reference numerals in the individual drawings refer to the same parts. 
           [0042]      FIG. 1  shows an injector system in its assembled state with loaded magazine. 
           [0043]      FIG. 2  is a perspective exterior view illustrating the loading of the injector system with the magazine which is contained in a schematically illustrated container with integrated heating device. 
           [0044]      FIGS. 3 . a  and  3 . b  are perspective exterior views illustrating the connection of the container to a non-integrated heating device. 
           [0045]      FIGS. 4 . a  to  4 . d  are different views illustrating the container in which the magazine is stored. 
           [0046]      FIGS. 5 . a  and  5 . b  are perspective views illustrating the injector system preferably pre-loaded with a magazine in a condition introduced in the container system (transparently shown here). 
           [0047]      FIGS. 6 . a  to  6 . e  are perspective views illustrating the insertion of an injector into the container system pre-loaded with a magazine and removal thereof. 
           [0048]      FIG. 7  is a perspective view illustrating the insertion of an injector pre-loaded with a magazine into the empty containers system. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0049]      FIG. 1  shows an injector system  100  in its assembled state. The modules that make up the injector system  100  include a housing  10 , a slider  20 , a needle  30 , and a magazine  40 . 
         [0050]    The magazine  40  is placed on the needle  30 , preferably plugged thereto. For example, needle  30  and magazine  40  are snap-connected to each other. Magazine  40  is preferably loaded with a lens  90 , and lens  90  is secured in the magazine  40  by retaining flap  60  before the magazine  40  is mounted to the injector  100  or the needle  30 , respectively (for this see  FIG. 2 ). 
         [0051]    Prior to an initial operation of the injector  100 , first the storage container  210  is opened. For this purpose, the lid  211  is peeled off from the end faces  213 , for example (for this see  FIG. 2 ). The magazine  40  is mounted to the needle  30  in this case by dipping the injector  100  into the storage container  210 , at least the needle  30  thereof, and plugging the magazine  40  to the needle  30 . This offers the advantage that the sterile conditions are maintained for prolonged periods and that the transport channel of the needle  30  is wetted with the storage liquid  212 , so that the lens  90  and the slider  20  will slide better in the needle  30 . 
         [0052]    Furthermore,  FIG. 2  schematically illustrates the heating device  220  according to the invention. By way of example, a container system  200  according to a first embodiment is illustrated comprising a container  210  with integrated heating device  220 . The heating device  220  is disposed on the outer surface of container  210 . The heating device  220  is integrated with the container  210 . Container  210  and heating device  220  constitute or form a functional unit. For example, the material for a latent heat storage may be filled in a cavity of the container  210 , for example on the left and/or right side, and in particular a small metal plate (not shown) may be incorporated in the outer wall of the container  210 . The small plate performs the function of a switch. By pressing the small plate, heating is initiated. Activation may for example as well be effected when the lid  211  is opened, by some sort of coupling not shown in the figures. Preferably, the invention provides a container system  200  for storing a lens  90 , which comprises a container  210  with at least one lens  90  stored in the container  210 , and with a heating device  220  for heating the lens  90  within the container  210 . The heating by heating device  220  is achieved through the container  210 . 
         [0053]      FIG. 2  illustrates the heating device  220  as a unit preferably permanently connected to the container  210 . However, heating device  220  may as well be provided as a kind of kit which can be used for retrofitting a conventional container  210 , which is however not shown in the figures. 
         [0054]      FIGS. 3 . a  and  3 . b  show a container system  200  according to a second embodiment, comprising a container  210  with integrated connection device  221  for a non-integrated heating device  220 . The heating device  220  is provided, for example, as a kind of charging station to which the container  210  can be connected via its connection device  221  and then heated. To this end, the container  210  is, for example, moved toward heating device  220  ( FIG. 3 . a ).  FIG. 3 . b  shows the final connected state. 
         [0055]    The figures show the connection device  221  as a unit preferably permanently connected to the container  210 . However, connection device  221  may as well be provided as a kind of kit, in particular in combination with the heating device  220 , which can be used for retrofitting a conventional container  210 , which is however not shown in the figures. 
         [0056]      FIGS. 4 . a  to  4 . d  show different perspectives of an empty container  210  for a magazine  40 . The container  210  is shown in different perspectives with the lid  211  already peeled off. The container  210  is designed as an upright standing item  210 . The upright standing item  210  serves to support or temporarily store the preloaded injection system  100  (for this see also  FIGS. 5 . a  and  5 . b ). The magazine  40  can be mounted onto the injector  100  by inserting the injector  100  into the container  210 . The side walls have recesses in which a heating device  220  may be placed, which is not shown here. The material of the container  210  comprises for instance polypropylene. The lid  211  is for instance provided by a metal, preferably aluminum. Such a closed container system  200  comprising container  210  and a latent heat storage as a heating device  220  furthermore meets the requirements of autoclaving. The lid may as well be omitted or may be semipermeable so as to meet the requirements of further sterilization methods, such as, e.g., ethylene oxide (EtO) or gamma radiation. 
         [0057]      FIGS. 4 . c  (perspective side view) and  4 . d  (top  216  plan view) show the dimensions of a container system  200  according to the invention. For this purpose, height Z, length Y, and width X are introduced here. In particular in order to provide a compact container system  200 , the following values are possible: 33 mm ≦X ≦37 mm and/or 77 mm ≦Y ≦83 mm and/or 67 mm ≦Z ≦71 mm. In  FIG. 4 . d,  the Z-axis extends perpendicularly to the sheet plane. 
         [0058]    In particular to improve stability and/or handling, the upper surface  216  and side walls  217  and  218  are inclined with respect to the lower surface  215  of the container  200 . Side wall  217  is inclined by an angle al with respect to the lower surface  215 . An upper portion of side wall  218  is also inclined by the angle α 1  relative to the lower surface  215 . Preferably, 95°α1 110°. Furthermore, the longitudinal axis L of the receptacle area  214  is inclined relative to the lower surface  215  by an angle α 2 . Angle α 2  is preferably 85°&gt;α2 &gt;75°. 
         [0059]    The lower surface  215  of container  210  has a larger cross section than a central region of the container  210 . In particular to this end, a step  219  is provided in side wall  218 . Due to the laterally projecting step  219  the container  210  can be safely held by a user. 
         [0060]      FIGS. 5 . a  and  5 . b  illustrate the container system  200  with inserted magazine  60  and injector  100 . Container  210  is designed as an upright standing item. It stands stably. That is to say, with or without the injector  100  inserted, the center of gravity perpendicular of the container system will intersect with the bearing surface of the container system  200  and/or the bearing surface of the container  210 . The container system with the injector inserted can for instance be provided on the operating table ready for use and stably. The magazine  60  together with the lens  90  may have already been contained in the closed container  210 . 
         [0061]    After opening of the container  210  the injector  100  was then introduced into the magazine (for this see  FIGS. 6 . a  to  6 . e ). However, it is as well possible that the closed container  210  was initially provided without lens  90 . The magazine  60  was then introduced into the opened container  210  together with the lens  90  and the injector  100 , for being heated (for this see  FIG. 7 ).  FIGS. 5 . a  and  5 . b  illustrate a further advantage. In addition to the heating of the lens  90  to increase flexibility thereof, the needle  30  is also heated to the target temperature. The so enhanced flexibility of the needle  30  in turn contributes to an improvement in the surgical process by allowing for a smaller incision and facilitating the introduction of otherwise less flexible lenses  90 . This may further be promoted by using slide-enhancing processes. The latter may be achieved by a coating or blooming process. 
         [0062]    Finally,  FIGS. 6 . a  to  7  again illustrate different configurations in which the container system  200  may be provided or operated. 
         [0063]    First,  FIGS. 6 . a  to  6 . e  show the introduction of an injector  100  into a container system  200  which is pre-loaded with a magazine  40 .  FIG. 6 . a  shows the container  210  with the lid  211  already peeled off.  FIG. 6 . b  moreover illustrates the injector  100  which is inserted into the container  210  and the magazine  40  in the direction of the arrow.  FIG. 6 . c  shows an enlarged view of the approached injector  100 , shortly before connection.  FIG. 6 . d  corresponds to  FIG. 5 . b  and shows the injector  100  in the state connected to magazine  40 . It can be seen that not only the magazine  40  is received in the receptacle area  214 . A portion of the injector is also received in the receptacle area  214 , here the needle  30  and/or the folding body  51 , by way of example.  FIG. 6 . e  illustrates retraction of the injector  100  now loaded with the magazine  40 . This variant is particularly suitable for hydrophilic lenses, but also for hydrophobic lenses  90 . 
         [0064]    Finally,  FIG. 7  illustrates an empty container system  200 . In this case, the container  210  is not pre-loaded with a magazine  40 . By contrast, the injector  100  is already loaded with a magazine  40  here. The so pre-loaded injector  100  is introduced into the container  210  with its front end, in the direction of the arrow, for heating the lens  90  stored the magazine  40 . Container  210  may be empty or may be filled with a liquid  212 , for example. In the latter case, the container  210  may have been filled with the liquid  212  already beforehand or may have been filled with the liquid  212  after having been opened. This variant is particularly suitable for hydrophobic lenses  90 . 
         [0065]    It will be apparent to those skilled in the art that the above embodiments have been described by way of example only. The invention is not limited to these embodiments but may rather be modified in many ways without departing from the spirit of the invention. 
         [0066]    Features of individual embodiments may be combined with each other as well as with the features mentioned in the general part of the description. 
       List of Reference Numerals 
       [0067]      10  Injector body, or injector housing, or housing, or handset 
         [0068]      11  Handle on injector body 
         [0069]      20  Slider, or plunger, or lens slider 
         [0070]      21  Handle, or slider handle 
         [0071]      30  Needle, or tube for insertion into the eye, or body for discharging the lens 
         [0072]      31  Transport channel or advance channel 
         [0073]      40  Magazine or container for storing the lens 
         [0074]      50  Folding flap, or folding plate support, or flap 
         [0075]      51  Folding body, or folding plate, or folding rib 
         [0076]      60  Retainer, or retaining flap, or flap 
         [0077]      90  Lens, or intraocular lens 
         [0078]      100  Injector, or injector system, or applicator 
         [0079]      100   a  Front end of injector 
         [0080]      100   b  Rear end of injector 
         [0081]      200  Container system 
         [0082]      210  Container 
         [0083]      211  Lid of container 
         [0084]      212  Storage liquid 
         [0085]      213  Engagement surface for container lid 
         [0086]      214  Receptacle area for the magazine in the container and/or for a front portion of the injector 
         [0087]      215  Lower surface of the container 
         [0088]      216  Upper surface of the container 
         [0089]      217  First, preferably flat side wall of the container 
         [0090]      218  Second side wall of the container 
         [0091]      219  Step or kink in second side wall 
         [0092]      220  Heating device 
         [0093]      221  Connection device for heating device