CONTAINER SYSTEM FOR HEATING AN INTRAOCULAR LENS

Description

[0001] The present invention relates to a container system for heating and storing an intraocular lens to be implanted. Background of the invention

[0002] Intraocular lenses are lens implants or artificial lenses used to replace the natural lens of a human eye. They are primarily used to replace diseased lenses in the eye that have become cloudy (cataracts). The diseased lenses are surgically removed, and the intraocular lenses are inserted. These are inserted or inserted into the eye using a device called an injector. It is important that the surgical incision through which an intraocular lens is implanted is as small as possible (for example, approximately 2.5 mm). This ensures the fastest and most complication-free healing process possible, and in some cases, no sutures are required.

[0003] In order to implant intraocular lenses, which generally have a diameter of approximately 5 to 7 mm, they must be foldable so that they can fit through the small incision of approximately 2.5 mm.

[0004] An injector for folding and inserting a folded lens into the human eye is mentioned, for example, in international patent application WO 2012 / 155887 A1. This application describes an injector system for implanting or

[0005] The procedure for inserting a temporarily folded intraocular lens is described, with which the folded lens can be inserted into the lens capsule of the eye through an incision in the eye with the required size of approximately 2.5 mm.

[0006] In one embodiment, the lens-loaded magazine is connected to the injector system for loading shortly before the surgery. The lens loading of the magazine can thus be performed in advance under controlled conditions, for example, by a lens manufacturer. The loaded magazine can then be stored in a sterile storage container, for example, a blister pack, which is preferably filled with a sterile liquid. Devices for heating an intraocular lens are also known from the documents US 2011 / 264102 A1 and US 6,398,789 B1 known. General description of the invention

[0007] Against the background described above, the object of the present invention is to further improve the insertion 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 tasks are solved by the container system with the features of patent claim 1.

[0010] Advantageous embodiments are the subject of the dependent claims, the description, and / or the drawings. It has been found that the temperature of the lens plays a significant role in folding the lens, inserting the lens into the eye, and / or unfolding the lens. A heated lens is significantly more pliable and flexible and can be rolled up smaller, allowing an incision in the eye to be further reduced in size. Furthermore, a warm lens can unfold more quickly after insertion into the eye.

[0011] In general, the invention therefore provides for the further development of the storage container described in the prior art, hereinafter briefly the container, in such a way that it is provided with a heating device.

[0012] According to the invention, a container system for heating and storing a lens is provided, comprising the following components: a container for storing at least one lens preloaded in a magazine and a heating device integrated into the container for heating the lens preloaded in the magazine in the container.

[0013] According to the invention, the lens is an intraocular lens to be implanted into the eye.

[0014] In contrast to the prior art, the magazine is not placed in a heat bath. Instead, according to the invention, the container is provided or manufactured with the heating device. The heating device is integrated into the container. The heating device and container are or form a functional unit.

[0015] According to the second variant of the disclosure, the container is not provided directly with the heating device. The container is provided with the connection device for the heating device. The connection device is integrated into the container. The connection device and container are or form a functional unit. In this case, the heating device is provided separately. It can, for example, be designed as a type of charging station to which the container can be connected via its connection device. According to the invention, the lens is not stored or storable as such in the container, but is located in a magazine and / or is preloaded on the injector. The magazine is positioned or positionable in the container together with the lens stored in the magazine, optionally including the injector. In particular, this makes it possible in the first embodiment to connect the magazine directly to an injector after the container has been opened.In the second version, it is possible to position the preloaded injector stably in the container in order to heat the magazine and the lens.

[0016] In a first embodiment, a magazine with a lens is already positioned in the container in its closed state. In particular, the container system is characterized in that the magazine is positioned together with the lens in the closed container. The magazine can be connected to the injector after the container is opened. This is particularly suitable for hydrophilic lenses, since these are stored in a solution.

[0017] Hydrophobic lenses can also be positioned and stored in this way. Both lenses can also be positioned and stored outside the container in order to be positioned and heated indirectly in the container via the pre-loaded injector prior to the operation. In a second embodiment, there is initially no lens in the container. However, it can already be filled with a liquid. The lens pre-loaded in the magazine is only inserted into the then opened container for heating. The magazine is inserted into the container together with the lens stored in the magazine and is already pre-assembled on the injector. The container system is characterized in that the magazine can be positioned, preferably securely, together with the lens in the opened container. The magazine is already connected to the injector.This is particularly suitable for hydrophobic lenses, as they can be stored together with the magazine and / or the injector, preferably without being in solution.

[0018] In a further embodiment, the container has a receiving area for the magazine and / or a section of the injector. According to the invention, the receiving area is designed to substantially correspond to the magazine and / or the front section of the injector. According to the invention, the receiving area is designed to substantially precisely fit the magazine and / or a section of the injector. A substantially precisely fitting shape reduces or avoids the risk of damage to the injector, the magazine, and / or the lens, particularly when the injector is inserted into the container.

[0019] According to the invention, the container is provided as a standing container. This reveals a further advantage of the container. It offers the injector connected to the magazine a secure stand in which the now preloaded injector can be kept ready for use on the operating table until requested by the user. In particular, as already explained above, the lens or the lens together with the magazine can be stored in a liquid in the container. An example of such a storage liquid is a sterile saline solution. The liquid volume is, for example, on the order of less than 20 ml or less than 10 ml, preferably from 4 ml to 5 ml.

[0020] The heating device is preferably configured to heat the lens to a target temperature in a range of approximately 25°C or 30°C to 40°C, preferably from 37°C to 40°C. This should be possible, in particular, starting from a starting temperature in a range of approximately 4°C to approximately 25°C. In one embodiment, the target temperature should be reached after approximately 30 seconds and / or the target temperature should be substantially maintained for a period of approximately 1 minute to approximately 10 minutes.

[0021] The container system can be provided as a single-use or reusable system. This depends primarily on whether the heating device can be recharged after use, for example. Both variants can already contain the lens or have it added prior to use. This depends particularly on whether a hydrophobic or hydrophilic lens is used.

[0022] In one embodiment, the heating device comprises a latent heat storage device. This can be based, for example, on saturated salt solutions, such as sodium acetate, and / or paraffin. A latent heat storage device offers the particular advantages of being inexpensive, easy to integrate, able to operate without an external or internal power supply, able to be sterilized (e.g., autoclaved) without significant damage, and / or even able to be reused. In particular, the latent heat storage device can be charged during sterilization, particularly by autoclaving, without a separate heat supply.

[0023] According to a further embodiment of the heating device, it comprises an electric heating device. The required power supply should preferably be provided by a battery or accumulator. Preferably, the power supply should not be provided by an external power supply. This type of heating offers the particular advantage that a target temperature can be maintained precisely and over a longer period.

[0024] The heating device can be arranged on an exterior side of the container. The heating device is provided, for example, as a type of charging station into which the container can be inserted and heated. In this embodiment, the heating device is connectable to the container via its connection device.

[0025] In a preferred embodiment, the heating device is arranged on an outer side of the container. For example, in one embodiment, the heating device is integrated into the container. This makes it possible to provide a compact system. The heating device preferably has a switch for activation. The heating device can be activated manually or automatically. In one embodiment, the heating device and the container are or can be coupled to one another in such a way that the heating device is activated or switched on when the container is opened. In a further embodiment, the heating device and the lid of the container are or can be coupled to one another in such a way that the heating device is activated when the lid is opened or removed.

[0026] As already explained above, in one embodiment, the container or container system is stable, even when the injector is connected to the magazine. In particular, to improve the stability and / or handling of the container system, the underside of the container has a larger cross-section than a central region of the container.

[0027] In a first embodiment, the container has a preferably substantially flat underside and / or an upper side inclined relative to the underside.

[0028] In a second embodiment, the container has a first side wall that is inclined relative to the underside and is preferably substantially flat, and / or a second side wall that is inclined relative to the underside and preferably has a step, which is opposite the first side wall. In particular, the step allows the user to securely hold the container when tearing off the lid. Preferably, the flat side wall and the underside form an angle α1 of 90° < α1 < 120°.

[0029] In a third embodiment, a longitudinal axis L of the receiving area is inclined relative to the underside of the container. Preferably, the longitudinal axis L of the receiving area and the underside enclose an angle α2 of 90° > α2 > 60°. A lens alone, a magazine with the lens and / or even an entire injector system can be stored in the container system according to the invention. The dimensions and / or shapes of the container systems depend, among other things, on the design of an intraocular lens to be implanted and / or a magazine. The container system is suitable, for example, for all soft, foldable intraocular lenses. These are made of acrylic, silicone and / or hydrogel, for example. The container system can be used for hydrophilic lenses, in particular with a water content of 22% to 50%, and / or for hydrophobic lenses, which are generally less flexible.

[0030] To characterize the dimensions, the following parameters are introduced (see also the Figures 4.c and 4.d) : The height Z, the length Y and the width X. For example, to obtain a compact container system, the following values ​​can be present: 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 < 800 mm.

[0031] In a further embodiment of the invention, the container and / or the magazine are designed to be substantially transparent. This allows, in particular, the insertion of the injector into the container and / or the magazine to be visually inspected.

[0032] The heating device and / or the connection device for the heating device can be provided integrated in and / or on the container. However, it is also possible to retrofit conventional containers with a heating device and / or a connection device for a heating device. Therefore, the scope of the invention also includes a kit for retrofitting a container for constructing a container system according to at least one of the embodiments described above. The kit comprises a heating device connectable to the container and / or a connection device connectable to the container for a heating device for heating a lens preloaded in a magazine in the container.

[0033] The present invention will be explained in detail using the following exemplary embodiments. Reference is made to the accompanying drawings. The same reference numerals refer to the same parts in the individual drawings.

[0034] Fig. 1 . shows an injector system in its assembled state with a loaded magazine.

[0035] Fig. 2 illustrates in a perspective external view the loading of the injector system with the magazine, which is positioned in a schematically shown container with integrated heating device. Fig. 3.a and 3.b illustrate in a perspective external view the connection of the container to a non-integrated heating device. Fig. 4.a to 4.d illustrate in different views the container in which the magazine is stored.

[0036] Fig. 5.a and 5.billustrate in a perspective view the injection system, preferably preloaded with a magazine, in a state inserted into the container system (shown transparently here).

[0037] Fig. 6.a to 6.e illustrate in a perspective view the insertion of an injector into the container system preloaded with a magazine and its removal.

[0038] Fig. 7 illustrates in a perspective view the insertion of an injector preloaded with a magazine into the empty container system. Detailed description of the invention:

[0039] Figure 1 shows an injector system 100 in the assembled state. The modules for constructing the injector system 100 include a housing 10, a slide 20, a cannula 30, and a magazine 40.

[0040] The magazine 40 is positioned on the cannula 30, preferably plugged in here. For example, the cannula 30 and the magazine 40 are connected to each other in a snap-in manner. The magazine 40 is preferably equipped with a lens 90, and the lens 90 is secured in the magazine 40 with the retaining flap 60 before the magazine 40 is pulled onto the injector 100 or the cannula 30 (see the Figure 2 ).

[0041] Before starting up the injector 100, the storage container 210 is first opened. For this purpose, for example, the cover 211 is pulled off the end faces 213 (see Figure 2). The magazine 40 is mounted on the cannula 30 by immersing the injector 100 at least via its cannula 30 into the storage container 210 and placing the magazine 40 onto the cannula 30. This offers the advantages that sterile conditions are maintained for a long time and the transport channel of the cannula 30 is moistened with the storage liquid 212, so that the lens 90 and the slider 20 can slide better in the cannula 30. In addition, Figure 2The heating device 220 according to the invention is shown schematically. Shown as an example is a container system 200 according to a first embodiment comprising a container 210 with an integrated heating device 220. The heating device 220 is positioned on the outside of the container 210. The heating device 220 is integrated into the container 210. The container 210 and the heating device 220 are or form a functional unit. For example, the material for a latent heat storage device can be filled into a cavity of the container 210, for example on the left and / or right side, and in particular a metal plate (not shown) can be introduced into the outer wall of the container 210. The plate assumes the function of a switch. Heating is initiated by pressing the plate. Activation can also take place, for example, via a coupling (not shown in the figures) when the lid 211 is opened.Preferably, the invention provides a container system 200 for storing a lens 90, comprising a container 210 with at least one lens 90 stored in the container 210 and a heating device 220 for heating the lens 90 in the container 210. The heating by means of the heating device 220 takes place via the container 210. In . Figure 2 The heating device 220 is shown as a unit connected, preferably permanently, to the container 210. However, the heating device 220 can also be provided as a type of kit with which a conventional container 210 can be retrofitted. This, however, is not shown in the figures. Figures 3.a and 3.bshow a container system 200 according to a second embodiment comprising a container 210 with an integrated connection device 221 for a non-integrated heating device 220. The heating device 220 is provided, for example, as a type of charging station to which the container 210 can be connected via its connection device 221 and then heated. For this purpose, the container 210 is moved, for example, in the direction of the heating device 220 ( Figure 3.a ). The Figure 3.b shows the final connected state.

[0042] In the figures, the connection device 221 is shown as a unit that is preferably permanently connected to the container 210. However, the connection device 221 can also be provided, particularly in conjunction with the heating device 220, as a type of kit with which a conventional container 210 can be retrofitted. This, however, is not shown in the figures. Figures 4.a to 4.dshow an empty container 210 for a magazine 40 in different perspectives. The container 210 is shown in different perspectives with the lid 211 already removed. The container 210 is designed as a stand element 210. The stand element 210 serves as a storage area for the pre-loaded injection system 100 or for temporary storage (see also the Figures 5.a and 5.b). The magazine 40 can be pulled onto the injector 100 by inserting the injector 100 into the container 210. In the side walls there are recesses in which a heating device 220 (not shown here) can be positioned. The material of the container 210 comprises, for example, polypropylene. The lid 211 is provided, for example, by a metal, preferably aluminum. Such a closed container system 200 with container 210 and a latent heat storage device as the heating device 220 also meets the requirements of autoclavability. The lid can also be omitted or made semi-permeable, so that the requirements of other sterilization methods, such as, for example, ETO or gamma radiation, are met.

[0043] The Figures 4.c(in a perspective side view) and 4.d (top view of the top side 216) show the dimensions of a container system 200 according to the invention. For this purpose, the height Z, the length Y and the width X are introduced here. In particular, in order to have a compact container system 200, the following values ​​can be present: 33 mm < X < 37 mm and / or 77 mm < Y < 83 mm and / or 67 mm < Z < 71 mm. The Z-axis runs in Figure 4.d perpendicular to the sheet plane.

[0044] In particular to improve stability and / or handling, the top side 216 and the side walls 217 and 218 are inclined relative to the bottom side 215 of the container 210. The side wall 217 is inclined by an angle α1 relative to the bottom side 215. An upper section of the side wall 218 is also inclined by the angle α1 relative to the bottom side 215. Preferably, 95° < α1 < 110°. Here, too, the longitudinal axis L of the receiving area 214 is inclined by an angle α2 relative to the bottom side 215. The angle α2 is preferably 85° > α2 > 75°. The bottom side 215 of the container 210 has a larger cross-section than a central region of the container 210. In particular for this purpose, a step 219 is provided in the side wall 218. The laterally projecting step 219 allows the container 210 to be held securely by a user.

[0045] The Figures 5.a and 5.billustrate the container system 200 with inserted magazine 60 and injector 100. The container 210 is designed as a standing element. It is stable. This means that when the injector 100 is inserted and not inserted, the center of gravity of the container system strikes the support surface of the container system 200 and / or the support surface of the container 210. The container system can be held ready for use with the inserted injector and in a stable manner, e.g., on the operating table. The magazine 60 may already have been in the closed container 210 together with the lens 90.

[0046] After opening the container 210, the injector 100 was inserted into the magazine (see the Figures 6.a to 6.e ). However, the closed container 210 may also have been initially provided without the lens 90. The magazine 60 was then inserted together with the lens 90 and the injector 100 into the opened container 210 for heating (see Figure 7,). In the Figures 5.a and 5.b A further advantage is presented. In addition to heating the lens 90 to increase its flexibility, the cannula 30 is also heated to the target temperature. The resulting increased flexibility of the cannula 30, in turn, contributes to an improvement in the surgical procedure, allowing for a smaller incision and easier insertion of otherwise less flexible lenses 90. This can also be supported by the use of lubrication-enhancing procedures. The latter can be achieved using a "coating" or "blooming" procedure.

[0047] The Figures 6.a to 7 Finally, illustrate various configurations in which the container system 200 can be provided or operated.

[0048] First, the Figures 6.a and 6.e the insertion of an injector 100 into a container system 200 which is preloaded with a magazine 40. Figures 6.ashows the container 210 with the lid 211 already removed. In Figure 6.b The injector 100 is also shown, which is inserted into the container 210 and the magazine 40 in the direction of the arrow. Figure 6.c shows an enlarged view with the approximated injector 100 shortly before connection. Figure 6.d corresponds Figure 5.b and shows the injector 100 in the state connected to the magazine 40. It can be seen that not only the magazine 40 is received in the receiving area 214. A part of the injector is also received in the receiving area 214, here, for example, the cannula 30 and / or the folding body 50. Figure 6.e illustrates the removal of the injector 100 now loaded with the magazine 40. This variant is particularly suitable for hydrophilic, but also for hydrophobic lenses 90. Finally, Figure 7an empty container system 200. The container 210 is not preloaded with a magazine 40 here. Instead, the injector 100 is already loaded with a magazine 40. The preloaded injector 100 is inserted into the container 210 via its front side in the direction of the arrow to heat the lens 90 stored in the magazine 40. The container 210 can, for example, be empty or filled with a liquid 212. The container 210 can either be prefilled with the liquid 212 or filled with the liquid 212 after opening. This variant is particularly suitable for hydrophobic lenses 90. List of reference symbols:

[0049] 10Injector body or injector housing or housing or handpiece 11Handle on the injector body 20Slider or piston or lens slider 21Handle or slider handle 30Cannula or insertion tube into the eye or removal body for the lens 31Transport channel or advance channel 40Magazine or container for storing the lens 50Folding flap or folding plate support or flap 51Folding body or folding plate or folding rib 60Holder or holding flap or flap 90Lens or intraocular lens 100Injector or injector system or applicator 100aFront of the injector 100bRear of the injector 200Container system 210Container 211Container lid 212Storage fluid 213Contact surface for the container lid 214Receiving area for the magazine in the container and / or for a front section of the Injector 215Bottom of the container 216Top of the container 217First, preferably flat,Side wall of the container 218Second side wall of the container 219Step or bend of the second side wall 220Heating device 221Connection device for heating device,

Claims

1. A container system (200) for heating and storing an intraocular lens (90) to be implanted in an eye, comprising a container (210) in the form of a standing container; a cartridge (40) with at least one intraocular lens (90) preloaded in the cartridge (40) and / or an injector (100) on which the intraocular lens is preloaded; wherein the container (210) is designed for storing at least the intraocular lens (90) preloaded in the cartridge (40) and / or in the injector (100) and comprises a heating means (220) integrated in the container (210) for heating the intraocular lens (90) inside the container (210), and wherein the cartridge (40) or the injector (100) is located in the container (210) together with the intraocular lens (90) accommodated in the cartridge (40) and / or in the injector (100); characterized in that the container (210) has an accommodation area (214) for the cartridge (40) and / or for a portion of the injector (100), which is designed to fit substantially precisely to the cartridge (49) and / or to a front portion of the injector (100).

2. The container system (200) according to the preceding claim, characterized in that the intraocular lens (90) is preloaded on the injector (100) and is accommodated in the container (210) along with the injector (100).

3. The container system (200) according to any one of the preceding claims, characterized in that the cartridge (40) is accommodated in the container (210) in a closed state of the container (210).

4. The container system (200) according to any one of the preceding claims, characterized in that the container (210) is prefilled with a liquid (212) for storing and heating the lens (90).

5. The container system (200) according to any one of the preceding claims, characterized in that the heating means (220) is adapted for heating a lens (90) accommodated in the cartridge (40) to a temperature in a range from 25 °C to 40 °C.

6. The container system (200) according to any one of the preceding claims, characterized in that the heating means (220) comprises a latent heat storage or an electrical heating means.

7. The container system (200) according to any one of the preceding claims, characterized in that the heating means (220) is arranged at an outer surface of the container (210).

8. The container system (200) according to any one of the preceding claims, characterized in that the heating means (220) has a activation switch, wherein the heating means (220) can be activated manually or automatically.

9. The container system (200) according to any one of the preceding claims, characterized in that the heating means (220) and the container (210) are coupled to one another in such a way that the heating means (220) can be activated when the container (210) is connected or opened.

10. The container system (200) according to any one of the preceding claims, characterized in that the container (210) has a lid (211), wherein the heating means (220) and the lid (211) of the container (210) are or can be coupled to one another in such a way that the heating means (220) can be activated when the lid (210) is opened.

11. The container system (200) according to any one of the preceding claims, characterized in that a bottom side (215) of the container (210) is larger in cross section than a central portion of the container (210).

12. The container system (200) according to any one of the preceding claims, characterized in that the container (210) has a bottom side (215) and a top side (216) inclined relative to the bottom side (215), and in that the container (210) has a first side wall (217) inclined relative to the bottom side (215) and a second side wall (218) inclined relative to the bottom side (215).

13. The container system (200) according to any one of the preceding claims, characterized in that the container (210) has an accommodation area (214) for the cartridge (40), which corresponds to a portion of the injector (100).

14. The container system (200) according to any one of the preceding claims, characterized in that a longitudinal axis (L) of the accommodation area (214) is inclined relative to the bottom side (215) of the container (210).