Ophthalmic injector with couplable distal component and proximal component, and method for preparing the injector

Abstract

The invention relates to an injector (1) having an IOL (30), a liquid (31), and a distal injector component (2) which has a component storage state and comprises a housing (10) in which the IOL and the liquid are situated in the component storage state, said housing forming an injector tip (4), via which the IOL is to be inserted into the capsular bag of an eye in an insertion direction (20), and delimiting a proximal opening (5); a closure (6) which, in the component storage state, closes the injector tip such that the liquid cannot exit the housing via the injector tip; and a cover (7) which, in the component storage state, closes the proximal opening such that the liquid cannot exit the housing via the proximal opening. The injector also has a proximal injector component (3), having a plunger (14) which is longitudinally movably mounted in the proximal injector component, said injector having a use state in which the closure does not close the injector tip, the cover does not close the proximal opening, the proximal injector component is detachably coupled to the distal injector component, and the plunger is designed to be inserted into the housing via the proximal opening and to move the IOL out of the injector via the injector tip.

Description

[0001]Ophthalmic Injector with Connectable Distal and Proximal Components and Method for Preparing the Injector. The invention relates to an ophthalmic injector with an intraocular lens and a method for preparing the injector. In cataract treatment of an eye, conventionally only a small incision is made in the cornea of ​​the eye, large enough to allow the tip of an injector to be inserted through the incision. After the incision has been made in the cornea, the eye's lens is usually fragmented by phacoemulsification and then aspirated from the capsular bag of the eye. An intraocular lens is then inserted into the eye using the injector. To prepare the injector, conventionally a liquid is introduced into the injector to wet the intraocular lens.Traditionally, a syringe filled with the liquid is used to inject the solution into the injector. A disadvantage of this method is that the syringe must be disposed of after the cataract treatment, generating additional waste. Furthermore, preparing the injector is prone to errors. For example, the amount of liquid in the injector may be too low, potentially damaging the intraocular lens during insertion. Additionally, the position of the intraocular lens can be altered during insertion, resulting in the lens not folding correctly and again potentially damaging it during insertion. Therefore, it would be desirable to develop an ophthalmic injector that allows for simple preparation of the injector for cataract treatment.The object of the invention is therefore to provide an injector that can be easily prepared for cataract treatment. Furthermore, the invention provides a method for preparing the injector. The ophthalmic injector according to the invention comprises an intraocular lens, a liquid, an insertion direction, a distal injector component, and a proximal injector component. The distal injector component has a component storage state and also includes a housing, a closure, and a cap. The intraocular lens and the liquid are arranged in the housing in the component storage state. The housing forms an injector tip through which the intraocular lens is inserted into the capsular bag of an eye in the insertion direction and defines a proximal opening. In the component storage state, the closure seals the injector tip so that the liquid cannot escape from the housing via the injector tip.In its storage state, the cap seals the proximal opening, preventing fluid from escaping the housing through this opening. The proximal injector component contains a piston that is longitudinally displaceable within it. In its operating state, the injector is configured with the cap and cap open, the proximal injector component detachably connected to the distal injector component, and the piston positioned to be inserted into the housing through the proximal opening and to propel the intraocular lens out of the injector via the injector tip. By removing the cap from the injector tip and the cap from the proximal opening, and then returning the injector to its operating state, it can be easily prepared for cataract treatment.Introducing the fluid into the injector is unnecessary because the fluid is already contained within the housing along with the intraocular lens. This eliminates the need for a separate syringe containing the fluid, thereby reducing the amount of waste generated during cataract treatment. The injector preferably has a storage configuration in which the distal injector component is in its component storage state and the proximal injector component is not coupled to the distal injector component. It is preferred that the proximal injector component is spaced apart from the distal injector component in this storage configuration.According to the invention, the piston has a longitudinal end which, in the operating state, is the longitudinal end of the piston located in the insertion direction. The closure is designed to be attached to this longitudinal end of the piston after it has been removed from the injector tip. When the closure is attached to the longitudinal end of the piston, it acts as a piston head. The closure thus fulfills a dual function as both closure and piston head. This further reduces the amount of waste. The closure is preferably softer than the piston. This allows the closure to be compressed when it is pushed into the injector tip by the piston. The closure preferably has a first closure recess, which is cylindrical and designed such that the longitudinal end of the piston can be inserted into this first closure recess to attach the closure to the piston.It is conceivable that, in the component's storage state, the injector tip is arranged within the first closure recess, and that, in the operating state, the piston end is arranged within the first closure recess. The closure preferably has a second closure recess, which is annular in shape and into which the injector tip is inserted in the component's storage state. It is conceivable that, in the component's storage state, the injector tip is arranged within the second closure recess, and that, in the operating state, the piston end is arranged within the first closure recess. It is preferred that the closure has a first surface and a second surface facing away from the first surface, with the first closure recess being incorporated into the first surface and the second closure recess being incorporated into the second surface.This makes it possible to grasp the distal injector component with the injector tip positioned in the first closure recess using one hand and to insert the longitudinal end of the piston into the second closure recess. This represents a particularly simple method for attaching the closure to the piston. Preferably, the distal injector component has a hinged cap by means of which the cap is pivotably attached to the housing. This allows the cap to be pivoted from a first position, in which the cap closes the proximal opening, to a second position, in which the cap is removed from the proximal opening and the proximal opening is exposed. The housing preferably has a housing projection that forms part of a cap snap closure, by means of which the cap releasably closes the proximal opening in the component's storage state.The housing projection is preferably part of an injector snap closure, by means of which the proximal injector component is detachably attached to the distal injector component in the operating state. The fluid preferably comprises an ophthalmic viscoelastic and / or water, or consists entirely of the viscoelastic. In particular, the fluid may comprise or be a physiological saline solution. The physiological saline solution may contain a buffer.The inventive method for preparing an ophthalmic injector comprises the following steps: a) providing the inventive ophthalmic injector or a preferred embodiment thereof, wherein the distal injector component is in the component storage state; b) removing the closure from the injector tip; b1) attaching the closure to the piston; c) removing the cover from the proximal opening; d) coupling the proximal injector component with the distal injector component, thereby establishing the operational state. In the case that the stopper has the first closure recess provided in the first surface and the second closure recess provided in the second surface, it is conceivable that the longitudinal end of the piston is first inserted into the first closure recess before the injector tip is removed from the second closure recess.The housing thus acts like a handle, making it particularly easy to attach the closure to the piston. The invention is explained in more detail below with reference to the accompanying schematic drawings. These show: Figure 1 a first perspective view of a distal injector component of an ophthalmic injector according to the invention, Figure 2 detail I from Figure 1, Figure 3 a second perspective view of the distal injector component, Figure 4 detail II from Figure 3, Figure 5 a perspective view of a distal injector component and a proximal injector component of the injector, Figure 6 a perspective view of a first embodiment of a cutaway closure of the distal injector component, Figure 7 a perspective view of a second embodiment of the cutaway closure, and Figure 8 a longitudinal section through a portion of the injector.An ophthalmic injector 1 comprises an intraocular lens 30, a fluid 31, an insertion direction 20 (see Figures 1, 5, and 8), a distal injector component 2, and a proximal injector component 3. The distal injector component 2 has a component storage state, as shown in Figure 3. The distal injector component 2 also includes a housing 10 (see Figures 1, 3 to 5, and 8), a closure 6 (see Figure 3), and a cap 7 (see Figures 1 to 4). The intraocular lens 30 and the fluid 31 are arranged in the component storage state within the housing 10. The housing 10 forms an injector tip 4 through which the intraocular lens is inserted into the capsular bag of an eye via the insertion direction 20. Furthermore, the housing 10 limits a proximal opening 5. The closure 6 closes the injector tip 4 in the component storage state, so that the liquid cannot escape from the housing 10 via the injector tip 4.In the component's storage state, the cover 7 closes the proximal opening 5, preventing the liquid from escaping the housing 10 via the proximal opening 5. The proximal injector component 3 has a piston 14 (see Figures 5, 8) which is arranged in the proximal injector component 3 so as to be longitudinally displaceable, in particular longitudinally displaceable in the insertion direction 20. The injector 1 has a usage state (see Figure 8) in which the closure 6 does not seal the injector tip 4, the cover 7 does not seal the proximal opening 5, the proximal injector component 3 is detachably coupled to the distal injector component 2, and the piston 14 is configured to be inserted into the housing 10 via the proximal opening 5 and to displace the intraocular lens from the injector 1 via the injector tip 4. The distal injector component 2 can be designed such that, in this component storage state, the fluid 31 cannot escape from the housing 10.The fluid can contact the intraocular lens. The component storage state and the usage state are mutually exclusive. The distal injector component 2 can be a disposable component. The proximal injector component 3 can be a reusable and fully sterilizable component. This can reduce the amount of waste generated during cataract treatment. Alternatively, the proximal injector component 3 could be a disposable component. The injector 1 can have an injector storage state in which the distal injector component 2 is in the component storage state and the proximal injector component 3 is not coupled to the distal injector component 2. The usage state and the injector storage state are mutually exclusive. The proximal injector component 3 can be positioned at a distance from the distal injector component 2 in the injector storage state.Figure 3 shows that the closure 6 can contact the injector tip 4 in the component storage state. The closure 6 can be partially positioned in the insertion direction 20 in front of the injector tip 4. Furthermore, the closure 6 can be positioned outside the injector tip 4, in particular in which case an additional closure is provided to prevent the liquid 31 from flowing out. The closure 6 can, for example, have a recess in the form of a cylinder (see Figure 6) or an annular gap (see the upper recess in Figure 7), with the injector tip 4 being positioned in the recess in the component storage state. The closure 6 can, for example, be made of or comprise silicone.As can be seen in Figure 8, the piston 14 can have a longitudinal end 21 which, in the operating state, is the longitudinal end of the piston 14 located in the insertion direction 20. The closure 6 is designed to be attached to the longitudinal end 21 of the piston after it has been removed from the injector tip 4. When the piston 14 is moved in the insertion direction 20, the closure 6 attached to the longitudinal end 21 can contact the intraocular lens 30 located in the distal injector component 2. The closure 6 can be softer than the piston 14 and, in particular, softer than the longitudinal end 21. Figures 6 to 8 show that the closure 6 can have a first closure recess 15 which is cylindrical and which is designed so that the piston longitudinal end 21 can be inserted into the first closure recess 15 for attaching the closure 6 to the piston 14.In the first embodiment of the closure 6, shown in Figure 6, the closure 6 has no further recess, so that in the component's storage state, the injector tip 4 is arranged in the first closure recess 15. In contrast, in the second embodiment of the closure 6, shown in Figures 7 and 8, the closure 6 has a second closure recess 16, which is annular in shape and into which the injector tip 4 is inserted in the component's storage state. The closure 6 can have a first surface and a second surface facing away from the first surface, with the first closure recess 15 being incorporated into the first surface and the second closure recess 16 being incorporated into the second surface. This allows the first closure recess 15 and the second closure recess 16 to be accessed in opposite directions.As can be seen from Figures 1 to 3, the distal injector component 2 can have a hinge 8 by means of which the cover 7 is pivotably attached to the housing 10. In Figures 1 to 3, the cover 10 is shown in a first position in which the cover 10 closes the proximal opening 5. The proximal opening 5 can be located at the proximal end of the housing 10, see Figure 8. By means of the hinge 8, the cover 8 can be pivoted from the first position to a second position (not shown in Figures 5 and 8) in which the proximal opening 5 is exposed, so that the interior of the housing 10 is accessible in the insertion direction 20 via the proximal opening 5. The distal injector component 2 can have a lid fastening means by which, in the component storage state, the lid 7 releasably closes the proximal opening 5, i.e., by means of the lid fastening means, the lid 7 can be releasably held in the first position.The lid fastening means can, for example, be a lid snap lock 9, see Figures 1 to 4. It is conceivable that the housing 10 has a housing projection 11 that is part of the lid snap lock 9. The lid snap lock 9 can have a rib 12 of the lid 10, wherein, in the component's storage state outside the housing 10, the rib 12 projects from the lid 7 towards the injector tip 4. The lid snap lock 9 can further have a snap-lock projection 13 of the lid 10, wherein, in the component's storage state, the snap-lock projection 13 projects from the rib 12 towards the housing 10 and clamps the housing projection 11, thus holding the lid 10 in the first position. If the rib 12 together with the snap-lock projection 13 is bent away from the housing 10, the lid 10 can be pivoted into the second position.The injector 1 can have an injector fastening means by which, in the operating state, the proximal injector component 3 is detachably attached to the distal injector component 2. The injector fastening means can, for example, be at least one injector snap lock 17, see Figure 8. It is conceivable that the housing projection 11 is part of the injector snap lock 17. The proximal injector component 2 can have a web 18, wherein the web 18 projects towards the injector tip 4 in the operating state. The injector snap lock 17 can further have a snap lock projection 19 of the proximal injector component 3, wherein the snap lock projection 19, in the operating state, extends from the web 18 towards the housing 10 and clamps the housing projection 11, so that the distal injector component 2 and the proximal injector component 3 are coupled.If the bridge 18 is bent away from the housing 10 together with the snap-lock projection 19, the distal injector component 2 and the proximal injector component 3 can be decoupled by moving the distal injector component 2 and the proximal injector component 3 away from each other. The method for preparing an ophthalmic injector 1 for cataract treatment comprises the steps: a) providing the injector 1 with the distal injector component 2 in the component storage state; b) removing the closure 6 from the injector tip 4; c) removing the cover 7 from the proximal opening 5; d) coupling the proximal injector component 3 to the distal injector component 2, thereby establishing the use state. The method may also include the step: b1) attaching the closure 6 to the piston 14.In step b1), it is conceivable that, in the case that the closure 6 has the first closure recess 15 arranged in the first surface and the second closure recess 16 arranged in the second surface, the injector tip 4 remains in the second closure recess 16 while the housing 10 is gripped with one hand and the piston 14 is inserted into the first closure recess 16. Only then is the closure 6 removed from the injector tip 4.Reference Symbol List 1 Injector 2 Distal injector component 3 Proximal injector component 4 Injector tip 5 Proximal opening 6 Closure 7 Cover 8 Film hinge 9 Cover snap closure 10 Housing 11 Housing projection 12 Cover ridge 13 Cover snap closure projection 14 Piston 15 First closure recess 16 Second closure recess 17 Injector snap closure 18 Proximal injector component ridge 19 Proximal injector component snap closure projection 20 Insertion direction 21 Piston longitudinal end 30 Intraocular lens 31 Liquid.

Claims

Claims 1. Ophthalmic injector (1) comprising an intraocular lens (30), a liquid (31), an insertion direction (20), a distal injector component (2) having a component storage state, and a housing (10) in which the intraocular lens (30) and the liquid (31) are arranged in the component storage state, forming an injector tip (4) through which the intraocular lens (30) is to be inserted into the capsular bag of an eye in the insertion direction (20), and which defines a proximal opening (5), a closure (6) which, in the component storage state, closes the injector tip (4) so ​​that the liquid (31) cannot escape from the housing (10) via the injector tip (4), and a cover (7) which, in the component storage state, closes the proximal opening (5) so that the liquid (31) cannot escape from the housing (10) via the proximal opening (5). can escape from the housing (10), and a proximal injector component (3) which has a piston (14),the injector (1) is arranged to be longitudinally displaceable in the proximal injector component (3), wherein the injector (1) has a state of use in which the closure (6) does not close the injector tip (4), the cover (7) does not close the proximal opening (5), the proximal injector component (3) is detachably coupled to the distal injector component (2), and the piston (14) is arranged to be inserted into the housing (10) via the proximal opening (5) and to displace the intraocular lens from the injector (1) via the injector tip (4), wherein the piston (14) has a longitudinal end (21) which, in the state of use, is the longitudinal end of the piston (14) arranged in the insertion direction (20), wherein the closure (6) is arranged after the closure (6) has been removed from the injector tip (4), at which to be attached to the piston longitudinal end (21).

2. Injector (1) according to claim 1, wherein the closure (6) has a first closure recess (15),which is cylindrical in shape and which is designed such that, The piston longitudinal end (21) can be inserted into the first closure recess (15) for attaching the closure (6) to the piston (14).

3. Injector (1) according to claim 2, wherein the closure (6) has a second closure recess (16) which is annular and in which the injector tip (4) is inserted in the component's storage state.

4. Injector (1) according to claim 3, wherein the closure (6) has a first surface and a second surface which is arranged facing away from the first surface, wherein the first closure recess (15) is provided in the first surface and the second closure recess (16) is provided in the second surface.

5. Injector (1) according to any one of claims 1 to 4, wherein the distal injector component (2) has a film hinge (8) by means of which the cover (7) is pivotably attached to the housing (10). 6.Injector (1) according to any one of claims 1 to 5, wherein the housing (10) has a housing projection (11) that forms part of a lid snap closure (9) by means of which, in the component storage state, the lid (7) releasably closes the proximal opening (5).

7. Injector (1) according to any one of claims 1 to 6, wherein the fluid comprises an ophthalmic viscoelastic and / or water.

8. Method for preparing an ophthalmic injector (1), comprising the steps of: a) providing an injector (1) according to any one of claims 1 to 8, wherein the distal injector component (2) is in the component storage state; b) removing the closure (6) from the injector tip (4); c1) attaching the closure (6) to the piston (14). c) Removing the cover (7) from the proximal opening (5); d) Coupling the proximal injector component (3) with the distal injector component (2), thereby establishing the operational state.

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