Container device with an ophthalmic injector containing an intraocular lens

Description

[0001] The invention relates to a container device comprising an ophthalmic injector having an intraocular lens.

[0002] Intraocular lenses (IOLs) are typically divided into two groups: hydrophobic intraocular lenses, which absorb less than 1 percent water, and hydrophilic intraocular lenses, which absorb more than 1 percent water. Hydrophobic intraocular lenses can be folded at room temperature, with their foldability being ensured by their chemical composition and not by water, which acts as a plasticizer. In contrast, hydrophilic lenses, which typically contain about 25 percent water by weight, can be folded at room temperature due to the absorbed water, which acts as a plasticizer.

[0003] It is generally accepted that hydrophilic intraocular lenses must be soaked in water or physiological saline during storage to ensure sufficient hydration, which is necessary for folding at room temperature. Therefore, such intraocular lenses are packaged in such a fluid, in which they can remain for up to five years prior to implantation without altering their optical, mechanical, and chemical properties.

[0004] Intraocular lenses are typically implanted during cataract surgery using an implantation device commonly referred to by those skilled in the art as an ophthalmic injector. The intraocular lens is preferably stored in a preloaded state within the injector to minimize the risk of surgical failure due to operator error. The intraocular lens is stored in a humid environment to ensure adequate hydration.

[0005] For this purpose, at least a portion of the ophthalmic injector, which contains the preferably preloaded intraocular lens, is stored in a container filled with fluid. The fluid can be water or balanced salt solution (BSS).

[0006] Such systems are described, for example, in US 2007 / 0 250 068 A1, WO 2010 / 105 678 A1, WO 2013 / 159 045 A1, US 2011 / 0 245 840 A1 and WO 2021 / 062 568 A1.

[0007] However, such systems have several disadvantages. Firstly, a user's sterile gloves can become damp when removing the injector from the water bath, which can increase the risk of contamination, as bacteria can be more easily transferred from moist surfaces. Secondly, damp hands make handling an injector more difficult, which can lead to problems during surgery. Furthermore, fluid can spill out of the system, resulting in a humid surgical environment.

[0008] In this context, reference is made to US 5 616 184 A, US 2009 / 0 057 167 A1, US 2002 / 0 029 981 A1 and DE 10 2014 005 719 A1.

[0009] A container device according to the preamble of claim 1 is known from document US 2015 / 114855.

[0010] It is an object of the invention to provide a container device that allows the ophthalmic injector containing the intraocular lens to be removed in a suitable manner from the fluid-filled container without the fluid escaping from the container device, thus keeping the environment of the container device dry. In addition, the aim is to ensure that a user presents the lowest possible risk of contamination after removing the ophthalmic injector from the container device. It is also an object of the invention to provide a generic container device that offers greater safety if the container device is accidentally knocked over, whereby the aim is to ensure that the fluid remains largely in the container device, thus keeping the operating environment outside the container device substantially dry.Furthermore, the aim is to ensure that the container device of this type can be manufactured in a simple and cost-effective manner and consists of as few individual parts as possible.

[0011] The object is solved by the subject matter of claim 1. Advantageous developments of the invention are the subject matter of the dependent claims.

[0012] The container device according to the invention comprises an ophthalmic injector having an intraocular lens, and a first container at least partially filled with a fluid, wherein the intraocular lens is surrounded by the fluid, and the first container is provided with a lid that seals the first container in a fluid-tight manner and is detachably connected to the first container. The container device additionally comprises a second container coupled to the first container. A fluid-tight closure is provided between the first container and the second container, wherein the lid is coupled to the closure by means of a coupling device, and upon release of the lid from the first container, the closure is configured by means of the coupling device to move from a closed position to an open position, such that the fluid can flow from the first container into the second container.

[0013] The container device thus contains an injector containing an intraocular lens. Additionally, the container device has a first container that is at least partially filled with a fluid. The first container is equipped with a lid that seals the first container in a fluid-tight manner and is detachably connected to the first container. The lid thus prevents the fluid from escaping from the first container when the lid is closed. However, the lid can be removed from the first container, thereby opening the first container.

[0014] The intraocular lens is surrounded by the fluid contained in the first container. This is essential because hydrophilic intraocular lenses must be kept hydrated during storage, ensuring that the intraocular lens remains foldable. The injector can therefore be partially or entirely surrounded by the fluid. Furthermore, the injector can be partially or entirely contained in the first container.

[0015] Furthermore, the container device comprises a second container coupled to the first container. The first container and the second container are thus connected to each other.

[0016] According to the invention, a fluid-tight closure is located between the first container and the second container, the lid being connected to the closure by means of a coupling device. The closure is designed to move from a closed position to an open position by means of the coupling device when the lid is detached from the first container, so that the fluid can flow from the first container into the second container. When the lid is closed, the fluid is therefore located in the first container. The closure between the first container and the second container is closed. As soon as the lid is detached, the closure opens by means of the coupling device so that the fluid can flow into the second container. After that, there is no longer any fluid in the first container.

[0017] This ensures that the fluid is transferred from the first container to the second container. The ophthalmic injector containing the intraocular lens can be removed from the first container without the user having to reach into the fluid. Furthermore, after removing the ophthalmic injector from the container device according to the invention, the user faces a low risk of contamination. Even if the container device is accidentally knocked over, this ensures that the fluid largely remains in the container device and the surrounding area remains essentially dry. Due to the few components, the container device according to the invention can be manufactured simply and cost-effectively.

[0018] The fluid can be water or a balanced salt solution (BSS).

[0019] The coupling device can be, among other things, a cord, a band, a string, a rope, or a tensile connection in the form of a wire. The coupling device can also be a part of the first container, which is connected to the lid. The fluid-tight closure can also be a part of the first container. A wall of the first container, which is a side wall or a bottom wall of the first container, can have a first wall region with a first thickness and a second wall region with a second thickness. The fluid-tight closure can be formed at least partially by a part of the wall of the first container, wherein the closure is at least partially delimited by the second wall region. The second thickness is smaller than the first thickness, such that a predetermined breaking point is provided around the closure.When the lid is opened, the tensile force is transferred via the coupling device to the closure, which breaks open at the part of the wall of the first container that has the second thickness, moving the closure from a closed position to an open position. This allows the fluid to flow into the second container.

[0020] If the fluid-tight closure is attached to a side wall, the container device can be designed very compactly. The bottom wall can then be designed so small that only the injector fits on it, eliminating the need for additional space on the bottom wall for the closure.

[0021] According to a further development of the invention, the fluid-tight closure has a surface area, wherein the surface area of ​​the closure has a size in a range of 50% to 20% of the surface area of ​​a wall of the container device, wherein the wall is a side wall or a bottom wall. The surface area of ​​the closure can also have a size in a range of 20% to 10% of the surface area of ​​a wall of the container device, or a size in a range of 10% to 1% of the surface area of ​​a wall of the container device, or a size in a range of 1% to 0.2% of the surface area of ​​a wall of the container device. This ensures that if the container device is accidentally knocked over when the closure is in the open position, the fluid remains partly in the second container or can only leak out with a delay.This increases safety by ensuring that the area surrounding the container device remains essentially dry in the event of such an accidental tipping over. Furthermore, it ensures that the fluid can flow sufficiently quickly from the first container to the second container.

[0022] The fluid-tight closure is preferably designed as a one-way valve. This advantageously ensures that the fluid can no longer flow back from the second container into the first container. The fluid thus remains entirely in the second container thanks to the one-way valve. A further advantage of this is that no active action is required by the user of the container device according to the invention to enclose the fluid separately from the injector. This further increases safety when handling the container device, as it provides a high degree of certainty that no fluid can escape from the second container into the operating environment.

[0023] According to a further development of the invention, a first pressure exists in the first container and a second pressure in the second container. In a preferred embodiment, the second pressure is lower than the first pressure, which ensures that, when the lid is opened, the fluid can flow from the first container into the second container more quickly than if the same pressure prevailed in both containers. This allows the user of the container device to remove the injector from the first container relatively quickly without having to reach into the fluid.

[0024] In a further embodiment, at least one wall of the second container, which is a side wall or a bottom wall of the second container, has at least one zone which has a lower spring constant than a region of the wall surrounding this zone. This advantageously ensures that when the pressure in the second container increases, the volume of the second container can increase relative to the volume of the first container. The resulting positive effect is that a larger proportion of the fluid can reach the second container, even if the volume of the second container is initially kept as small as possible with the lid closed in order to save space for transport purposes.

[0025] The second container preferably has a fluid-absorbing device. The fluid-absorbing device can be, among other things, a sponge, silica gel, a desiccant, or another water-absorbing agent. This advantageously ensures that the fluid can be held in the second container in such a way that it is no longer freely movable. For example, it prevents the fluid in the second container from fluctuating in the event of a spatial displacement. This also reduces the risk of the fluid flowing out of the second container into its surroundings in the event of significant movement in the space.

[0026] Furthermore, it is possible for the lid to seal the second container in a fluid-tight manner and to be detachably connected to the second container. The first container is thus located within the second container, which advantageously makes the container device relatively compact.

[0027] Preferably, the coupling device is part of the first container, resulting in a one-piece construction of the coupling device with the first container. One end of this coupling device is connected to the closure, so that by applying a tensile force to the coupling device, the closure, which also forms part of the first container, can be broken open.

[0028] Further advantages and features are explained with reference to the following figures, in which show: Fig. 1 is a schematic representation of a cross-sectional view of a container device according to a first embodiment of the invention in a closed position; Fig. 2 is a schematic representation of the cross-sectional view of the container device according to the first embodiment in an open position; Fig. 3 is a schematic representation of a plan view of the container device according to the first embodiment; Fig. 4 is a schematic representation of a cross-sectional view of the container device according to a second embodiment of the invention in a closed position; Fig. 5 is a schematic representation of the cross-sectional view of the container device according to the second embodiment in an open position; Fig. 6 is a schematic representation of a cross-sectional view of the container device according to a third embodiment in a closed position;Fig. 7 is a schematic representation of a cross-sectional view of the container device according to the third embodiment in an open position; and Fig. 8 is a schematic representation of a plan view of the first container with a first wall region and a second wall region.

[0029] In Fig. 1 A schematic representation of a cross-sectional view of a container device 1 according to a first embodiment is shown in a closed position. The container device 1 has an ophthalmic injector 2 in which an intraocular lens 3 is located. The intraocular lens 3 is preferably in a prestressed state.

[0030] The container device 1 further comprises a first container 4, in which the ophthalmic injector 2 is located. The first container 4 is at least partially filled with a fluid 5, wherein the intraocular lens 3 is completely surrounded by the fluid 5. This ensures that the intraocular lens 3 remains hydrated during storage. A hydrophilic intraocular lens 3 thus remains easily foldable. It is evident that the injector 2 can be partially or entirely surrounded by the fluid 5.

[0031] The first container 4 has a lid 6, which seals the first container 4 in a fluid-tight manner and is detachably connected to the first container 4. The lid 6 thus ensures that the fluid 5 cannot escape from the first container 4 when the lid 6 is closed. The lid 6 can be at least partially detached from the first container 4 by a user in such a way that the first container 4 is opened at least in a partial area. With the lid 6 opened in this way, the ophthalmic injector 2, in which the intraocular lens 3 is located, can be removed from the first container 4.

[0032] The container device 1 further comprises a second container 7, which is coupled to the first container 4. The first container 4 is thus connected to the second container 7. In the Fig. 1In the first embodiment shown, the first container 4 is located inside the second container 7, which makes the container device 1 relatively compact. In this embodiment, the lid 6 seals the second container 7 in a fluid-tight manner in addition to the first container 4. Furthermore, the lid 6 is also detachably connected to the second container 7.

[0033] A fluid-tight closure 8 is located between the first container 4 and the second container 7. The fluid-tight closure 8 ensures that the fluid 5 cannot flow from the first container 4 into the second container 7 if the closure 8 is in a closed position.

[0034] The second container 7 has at least one wall 10, in particular a side wall, in which at least one zone 11 exists, which has a lower spring constant than a region of the wall 10 surrounding this zone 11. The zone 11 is thus more elastic than the region surrounding this zone 11. Thus, when a force resulting from increasing pressure within the second container 7 is applied, the zone 11 can expand relative to the surrounding region, whereby the volume of the second container 7 increases relative to the volume of the first container 4. This has the advantage that a larger proportion of the fluid 5 can flow into the second container 7, although the volume of the second container 7 is kept as small as possible when the lid 6 is closed in order to save space as much as possible during transport of the container device 1. The zone 11 can be designed in the form of a bellows or as a fanfold.Zone 11 may also be made of a different material than the material surrounding the area of ​​this Zone 11.

[0035] Additionally, a fluid-absorbing device 12 is located within the second container 7. The fluid-absorbing device 12 can at least partially absorb the fluid 5 as soon as the fluid 5 flows from the first container 4 into the second container 7. The fluid 5 is at least partially stored in the second container 7 by means of the fluid-absorbing device 12, whereby the fluid 5 is at least partially bound and can no longer move freely in the second container 7. This reduces the amount of fluid 5 that can leak out of the second container 7 in the event of a spatial relocation, such as tilting the second container 7. This reduces the likelihood of the area surrounding the container device 1 becoming humidified if the container device 1 is accidentally knocked over.

[0036] As already mentioned above, the fluid 5 can flow from the first container 4 into the second container 7. For this purpose, the lid 6 is coupled to the fluid-tight closure 8 by means of a coupling device 9. As soon as the lid 6 is detached from the first container 4, the closure 8 is opened. The closure 8 thus moves from a closed position to an open position by opening the lid 6 by means of the coupling device 9. When the closure 8 is open, the fluid 5 flows from the first container 4 into the second container 7. This situation is in Fig. 2 to recognize.

[0037] In Fig. 2is a schematic representation of the cross-sectional view of the container device 1 according to the first embodiment in an open position. By opening the lid 6, the closure 8 is opened by means of the coupling device 9 and the fluid 5 flows from the first container 4 into the second container 7, so that subsequently no fluid 5 is located within the first container 4. In this situation, the ophthalmic injector 2 can be removed from the container device 1 without the user coming into contact with the fluid 5. The fluid 5 can be at least partially absorbed in the second container 7 by the fluid-absorbing device 12, thereby reducing the amount of freely movable fluid 5.

[0038] In addition, in this embodiment, opening the lid 6 creates a pressure equalization between the first container 4 and the second container 7. Before the lid 6 is opened, the pressure inside the second container 7 is lower than the pressure inside the first container 4. If the lid 6 is then opened, the zone 11 located on the wall 10 of the second container 7, which has a lower spring constant than the area of ​​the wall 10 surrounding this zone 11, expands, so that the volume of the second container 7 increases relative to the volume of the first container 4.

[0039] In Fig. 3 is a schematic representation of a plan view of the container device 1 according to the Fig. 1shown first embodiment. It is shown that in the first embodiment the first container 4 is located in the second container 7, whereby the container device 1 is designed to be relatively compact. The injector 2 is preferably fixed within the first container 4, which ensures safe transport of the container device 1 and thus of the intraocular lens 3. When the lid 6 is open, i.e. when the closure 8 is in the open position, the intraocular lens 3 is no longer surrounded by the fluid 5 and the injector 2 can be removed from the container device 1 without the user having to reach into the fluid 5. In addition, the fluid-absorbing device 12 is shown in the second container 7. It is further shown that the base area of ​​the fluid-tight closure 8 has a size which is approximately 0.4% of the base area of ​​the container device 1.

[0040] Fig. 4shows a schematic representation of a cross-sectional view of the container device 1 according to a second embodiment in a closed position. Although the container device 1 also has a first container 4 and a second container 7, which are coupled to one another, i.e., connected to one another, the first container 4 in the second embodiment, unlike in the first embodiment, is not located in the second container 7. In this embodiment, the lid 6 only closes the first container 4. In contrast to the first embodiment, the lid 6 does not close the second container 7 and is also not detachably connected to the second container 7.

[0041] The ophthalmic injector 2, which contains the intraocular lens 3 and is surrounded by the fluid 5, is located in the first container 4. In the closed position, in which the fluid-tight closure 8 connected to the lid 6 is arranged such that the fluid 5 cannot flow from the first container 4 into the second container 7, different pressures prevail in the first container 4 and in the second container 7. More precisely, there is a higher pressure in the first container 4 than in the second container 7, so that by opening the lid 6, whereby the closure 8 moves from the closed position to the open position by means of the coupling device 9, the fluid 5 reaches the second container 7 more quickly. This open position is in Fig. 5 shown.

[0042] Fig. 5shows a schematic representation of the cross-sectional view of the container device 1 according to the second embodiment in the open position. By opening the lid 6, pressure equalization takes place between the first container 4 and the second container 7, whereby the zone 11 of the wall 10, which has a lower spring constant than a region of the wall 10 surrounding this zone 11, expands and the volume of the second container 7 increases. The fluid 5 flows into the second container 7 and is at least partially absorbed by the fluid-absorbing device 12.

[0043] In Fig. 6is a schematic representation of a cross-sectional view of the container device 1 according to a third embodiment in a closed position. In the third embodiment, the coupling device 9 is a part of the first container 4, which is connected to the lid 6. The fluid-tight closure 8 is also a part of the first container 4. A wall of the first container 4, which here is a bottom wall, has a first wall region 13 with a first thickness and a second wall region 14 with a second thickness. The fluid-tight closure 8 is, in this embodiment, at least partially formed by a part of the bottom wall of the first container 4, wherein the closure 8 is at least partially delimited by the second wall region 14. The second thickness is smaller than the first thickness, whereby the closure 8 has a predetermined breaking point. The second wall region 14 can be designed as a ring segment, as a circumferential circular ring, see Fig. 8, or be formed as a circular surface. If the second wall area 14 is formed as a circular surface, this circular surface is the closure 8. When the lid 6 is opened, the tensile force is transferred by means of the coupling device 9 to the closure 8, which breaks open at the second wall area 14 of the first container 4, which has the second thickness, so that the closure 8 moves from a closed position to an open position. This open position is in Fig. 7 Once broken at the predetermined breaking point, the closure 8 can no longer return to its closed position. The container device 1 is therefore intended for single use only.

[0044] Fig. 7shows a schematic representation of the cross-sectional view of the container device 1 according to the third embodiment in the open position. By opening the lid 6, the tensile force is transferred to the fluid-tight closure 8 by means of the coupling device 9. As a result, the closure 8 breaks open at the second wall region 14 of the first container 4, which has the second thickness, so that the closure 8 moves from a closed position to an open position. This ensures that the fluid 5 can flow from the first container 4 into the second container 7, so that subsequently no fluid 5 is located within the first container 4. Once the fluid 5 has been received in the second container 7, the ophthalmic injector 2 can be removed from the first container 4 without the user coming into contact with the fluid 5.The fluid 5 can be at least partially absorbed in the second container 7 by the fluid-absorbing device 12, thereby reducing the amount of freely movable fluid 5.

[0045] Preferably, opening the lid 6 results in pressure equalization between the first container 4 and the second container 7. Before the lid 6 is opened, the pressure inside the second container 7 is lower than the pressure inside the first container 4. If the lid 6 is then opened, the fluid 5 can flow quickly and reliably into the second container 7. On the wall 10 of the second container 7, a zone 11 is preferably provided which has a lower spring constant than the region of the wall 10 surrounding this zone 11, so that the volume of the second container 7 increases relative to the volume of the first container 4 when the fluid 5 flows from the first container 4 into the second container 7. List of reference symbols

[0046] 1Container device 2Ophthalmic injector 3Intraocular lens 4First container 5Fluid 6Lid 7Second container 8Fluid-tight closure 9Coupling device 10Wall 11Zone 12Fluid-absorbing device 13First wall area of ​​the first container 14Second wall area of ​​the first container

Claims

1. Container device (1), having: - an ophthalmic injector (2) which has an intraocular lens (3), - a first container (4), which is at least partially filled with a fluid (5), wherein the intraocular lens (3) is surrounded by the fluid (5), and the first container (4) is provided with a lid (6) which closes the first container (4) in a fluid-tight manner and which is releasably connected to the first container (4), - a second container (7), which is coupled to the first container (4), characterized in that a fluid-tight closure (8) is provided between the first container (4) and the second container (7), wherein the lid (6) is coupled to the closure (8) by means of a coupling device (9), and, when the lid (6) is released from the first container (4), the closure (8) is configured, by means of the coupling device (9), to pass from a closed position to an open position, such that the fluid (5) can flow from the first container (4) into the second container (7).

2. Container device (1) according to Claim 1, wherein the closure (8) has a surface area, and the surface area of the closure (8) has a size in a range of 50% to 20% of the surface area of a wall of the container device (1), or 20% to 10% of the surface area of a wall of the container device (1), or has a size in a range of 10% to 1% of the surface area of a wall of the container device (1), or has a size in a range of 1% to 0.2% of the surface area of a wall of the container device (1).

3. Container device (1) according to Claim 1 or 2, wherein the closure (8) is a one-way valve.

4. Container device (1) according to any of the preceding claims, wherein in the first container (4) there is a first pressure and in the second container (7) there is a second pressure, the second pressure being lower than the first pressure.

5. Container device (1) according to any of the preceding claims, wherein at least one wall (10) of the second container (7) has at least one zone (11) which has a lower spring constant than a region of the wall (10) surrounding this zone (11).

6. Container device (1) according to any of the preceding claims, wherein the second container (7) has a fluid-absorbing device (12).

7. Container device (1) according to any of the preceding claims, wherein the lid (6) closes the second container (7) in a fluid-tight manner and is releasably connected to the second container (7).

8. Container device (1) according to any of the preceding claims, wherein the coupling device (9) is part of the first container (4).