INJECTOR FOR INTRODUCING AN INTRAOCULAR LENS

Description

[0001] The invention relates to an injector for inserting an intraocular lens into the capsular bag of an eye.

[0002] A hydrophilic intraocular lens (IOL) must be stored in an aqueous medium to ensure its stability. An injector used to insert the IOL into the capsular bag has a coating that facilitates the lens's movement within the injector. This is particularly important at points on the injector where the IOL is highly compressed. Because the coating dissolves upon contact with water, the injector, unlike the IOL, must be stored dry. Therefore, the IOL is conventionally stored in a first sterile package, and the injector in a second sterile package. Before inserting the IOL into the capsular bag, it must be manually inserted into the injector. However, this carries a risk of contamination of the IOL and / or the injector during insertion.

[0003] WO 2008 / 036597 A2 describes a shipping device for a medical device.

[0004] The object of the invention is therefore to create an injector with an intraocular lens in which the aforementioned problems are overcome.

[0005] According to a first embodiment of the injector according to the invention, the injector comprises a cylinder having a first cylinder section and a second cylinder section arranged side by side in the longitudinal direction of the cylinder, a receptacle arranged between the two cylinder sections, and an insertion component arranged in the receptacle, as well as an intraocular lens, a storage fluid, a housing, a folding chamber arranged inside the housing in which the intraocular lens is surrounded by the storage fluid, and a lid that seals the folding chamber against the first cylinder section and is attached to the housing, wherein the insertion component is configured to release the folding chamber from the lid and thus open it by means of a movement of the housing relative to the folding chamber, and to deform the folding chamber and thereby fold the intraocular lens.

[0006] According to a second embodiment of the injector according to the invention, the injector comprises a cylinder having a first cylinder section and a second cylinder section arranged side by side in the longitudinal direction of the cylinder, a receptacle arranged between the two cylinder sections, an insertion component arranged in the receptacle, an intraocular lens, a storage fluid, a housing, a folding chamber arranged within the housing in which the intraocular lens is surrounded by the storage fluid, a lid that seals the folding chamber against the first cylinder section, and a first component on which the lid is arranged, and a second component, wherein the injector is configured to release the folding chamber from the lid and thus open it by means of a movement of the first component relative to the folding chamber.and by moving the second component relative to the folding chamber to deform the folding chamber and thereby fold the intraocular lens.

[0007] In both embodiments, the intraocular lens is arranged together with the storage fluid in the folding chamber, with the lid preventing the storage fluid from flowing into the first cylinder section. This allows the cylinder to be stored dry, ensuring that a coating provided in the first cylinder section, which facilitates the sliding of the intraocular lens in the injector, has long-term storage stability.

[0008] Because the insert component containing the intraocular lens is already positioned in the receptacle, the entire injector, including the intraocular lens, can be sterilized and then shipped in a single package. Inserting the intraocular lens into the injector is no longer necessary, thus reducing the risk of contamination compared to a conventional injector. Since, in the first embodiment, the folding chamber is opened by moving the housing relative to the folding chamber, and in the second embodiment, by moving the first component relative to the folding chamber, it is not necessary to manually handle the lid to remove it in either embodiment.Furthermore, according to the first embodiment, the housing is a relatively large component compared to the lid, making it significantly easier to handle by hand and thus easier to operate. In addition, the folding chamber fulfills two functions in both embodiments: firstly, it stores the intraocular lens before the injector is operated, and secondly, it folds the intraocular lens during operation. According to the first embodiment, the folding chamber can be opened and deformed by a single movement of the housing relative to the folding chamber. According to the second embodiment, the folding chamber can be opened and then deformed sequentially by two movements: first, the movement of the first component relative to the folding chamber, and then the movement of the second component relative to the folding chamber. This can be achieved by first, deforming, and then opening the folding chamber.

[0009] In both embodiments, it is preferred that the injector has a cannula and that the first cylinder section is arranged between the cannula and the folding chamber. Because the intraocular lens passes through the first cylinder section on its way to the cannula during operation of the injector, the coating is located there. Therefore, it is particularly important to seal the folding chamber against the first cylinder section with the lid to prevent contact between the coating and the storage fluid.

[0010] In both embodiments, it is preferred that the insert component has a further cover that seals the folding chamber against the second cylinder section. Particularly preferably, the further cover functions like the main cover.

[0011] For the first embodiment, it is preferred that the injector has a locking device configured to fix the position of the folding chamber in the receptacle. This allows the position of the folding chamber relative to the injector to be set such that the cover is aligned with the first cylinder section and the second cylinder section, so that during operation of the injector, a piston of the injector can slide in the first cylinder section, in the second cylinder section, and in the folding chamber.

[0012] According to the invention, in the first embodiment, the housing has an outer housing contact surface and the receptacle has a receiving contact surface, wherein the outer housing contact surface and the receiving contact surface are in contact with each other and their normals form a first angle other than 90° with an insertion direction for the insert component, in which the insert component is to be inserted into the receptacle to assemble the injector. The position of the insert component is determined by means of the outer housing contact surface and the receiving contact surface, and to complete the injector assembly, the insert component is to be inserted into the receptacle until the outer housing contact surface and the receiving contact surface make contact.In the case where a locking device is provided, it is preferred that the locking device engages and thus fixes the position of the folding chamber in the receptacle as soon as the outer housing contact surface and the receptacle contact surface make contact. To perform the movement of the housing relative to the folding chamber, the housing is moved, particularly by hand, in the opposite direction to the insertion direction. The first angle is particularly preferably from 0° to 60°.

[0013] For the first embodiment, it is preferred that the housing has an inner housing contact surface configured to contact and deform the folding chamber when the housing is moved relative to the folding chamber. Particularly preferably, the normal of the inner housing contact surface includes a second angle other than 90° with an insertion direction for the insert component. Most preferably, the second angle is from 0° to 60°. Particularly preferably, the housing has two of these inner housing contact surfaces, arranged on opposite walls of the housing and in a mirror-symmetrical arrangement. This advantageously allows for symmetrical deformation of the folding chamber.

[0014] In the first embodiment, it is preferred that the insert component is configured such that, when the housing moves relative to the folding chamber, the cover remains attached to the housing, thus opening the folding chamber. This is an advantageously simple design for opening the folding chamber.

[0015] According to the invention, in the second embodiment, the first component is a housing within which the folding chamber is arranged. The housing thus has a dual function: firstly, it encloses the folding chamber, and secondly, it supports the lid. It is particularly preferred that the housing has a handle. This makes it easier to grip the housing by hand, and thus an operator of the injector can more easily move the first component relative to the folding chamber than would be possible without the handle.

[0016] For the second embodiment, it is preferred that the insertion component is configured such that, during the movement of the first component relative to the folding chamber, the cover remains attached to the first component, thus opening the folding chamber. This is an advantageously simple design for opening the folding chamber.

[0017] In the second embodiment, it is preferred that the second component is a slide configured to contact and deform the folding chamber when the slide is moved relative to the folding chamber. The slide is particularly preferably mounted so as to be longitudinally displaceable on the receptacle.

[0018] For the second embodiment, it is preferred that the injector has a locking device configured to fix the position of the folding chamber in the receptacle. This allows the position of the folding chamber relative to the injector to be set so that the cover is aligned with the first cylinder section and the second cylinder section, enabling a piston of the injector to slide in the first cylinder section, the second cylinder section, and the folding chamber during operation.

[0019] For both embodiments, it is preferred that the storage liquid comprises water. It is particularly preferred that the storage liquid consists essentially of water or is an aqueous salt solution with an isotonic salt concentration. The aqueous salt solution may also contain a buffer.

[0020] For both embodiments, the inventive method for manufacturing the injector comprises the following steps: a) Manufacturing the insert component; b) Manufacturing the injector without the insert component; d) Inserting the insert component into the receptacle; e) Sterilizing the injector with the insert component inserted into the receptacle.

[0021] It is preferred that the process includes step c) prior to step d): c) Sterilizing the insert component and the injector without the insert component, in particular wherein the sterilization is steam sterilization.

[0022] Preferably, steps a) and b) are carried out under cleanroom conditions.

[0023] It is preferred that sterilization in step e) is carried out using gamma radiation and / or ethylene oxide.

[0024] Two preferred embodiments of the injector according to the invention are explained below with reference to the accompanying schematic drawings. Figure 1 shows an insertion component of a first embodiment of the injector in a storage state of the injector. Figure 2 The insert component is shown. Figure 1 in an operating state of the injector. Figure 3 shows the first embodiment of the injector in its storage state. Figure 4 shows the first embodiment of the injector in its operating state. Figure 5 shows a second embodiment of the injector in a storage state. Figure 6 shows a first section of the injector in its storage state. Figure 7 shows the excerpt from Figure 6 in an operating state of the injector. Figure 8 shows a second section of the injector with an undeformed folding chamber. Figure 9 shows the excerpt from Figure 8with a deformed folding chamber.

[0025] How it looks Figures 1 to 4As can be seen, according to the first embodiment, an injector 1 comprises a cylinder 3, a receptacle 4, and an insertion component 2. The cylinder 3 has a first cylinder section 21 and a second cylinder section 22, which are arranged side by side in the longitudinal direction of the cylinder 3, and the receptacle 4 is arranged between the two cylinder sections 21 and 22. The insertion component 2 is arranged in the receptacle 4. The insertion component 2 also comprises an intraocular lens, a storage fluid, a housing 5, a folding chamber 6 arranged within the housing 5 in which the intraocular lens is surrounded by the storage fluid, and a cover 7. The cover 7 seals the folding chamber 6 against the first cylinder section 21 and is attached to the housing 5.The insertion component 2 is designed to expose the folding chamber 6 from the cover 7 by means of a movement of the housing 5 relative to the folding chamber 6, and thus to open it, as well as to deform the folding chamber 6 and thereby fold the intraocular lens.

[0026] The insert component 2 can have an additional cover that seals the folding chamber 6 against the second cylinder section 22. This additional cover can be identical in construction to cover 7 and function in the same way. It is conceivable that the folding chamber 6 has an opening 25 that is sealed by cover 7, and another opening that is sealed by the additional cover.

[0027] The injector 1 can have a locking device designed to fix the position of the folding chamber 6 in the receptacle 4. It is conceivable that, in the fixed position of the folding chamber 6, the opening 25 and the further opening are aligned with the cylinder 3, so that, during operation of the injector 1, a piston of the injector 1 can extend into the first cylinder section 21, the second cylinder section 22 and the folding chamber 6, and thus the intraocular lens can be conveyed by means of the piston from the folding chamber 6 to a cannula 23 of the injector 1.

[0028] The locking device can, as is also the case in Figures 1 and 2The assembly is shown to have a groove 13 and a projection (not shown) that engages in the groove 13 to engage the locking device. One of the groove 13 and the projection is located on the folding chamber 6, and the other is located on the receptacle 4. The folding chamber 6 may have a folding chamber pin 11 projecting outwards relative to the folding chamber 6, on which one of the groove 13 and the projection is located. The locking device may also have a groove-limiting projection 12, which has a first flank 15 that limits the groove 13, and a second flank 16 that forms an angle of less than 90°, in particular less than 60°, with the first flank 15. The normal of the first flank 15 may be arranged parallel to the insertion direction 14.When the insertion component 2 is inserted into the receptacle 4, the projection on the second flank 16 can slide easily, and as soon as the projection has passed the second flank 16, it engages in the groove 13, causing the locking device to engage.

[0029] As in Figures 3 and 4 As shown, the housing 5 has an outer housing contact surface 17 and the receptacle 4 has a receiving contact surface 18, wherein the outer housing contact surface 17 and the receiving contact surface 18 are in contact with each other and their normals form a first angle other than 90° with an insertion direction 14 of the inserting component 2, in which the inserting component 2 is to be inserted into the receptacle 4 to assemble the injector 1. When the outer housing contact surface 17 and the receiving contact surface 18 are in contact with each other, the injector 1 is in a storage state which is Figure 3It is conceivable that the locking device engages and thus fixes the position of the folding chamber 6 in the receptacle 4 as soon as the outer housing contact surface 17 and the receptacle contact surface 18 are in contact with each other when the insert component 2 is inserted into the receptacle 4 and the injector 1 is thus in the storage state.

[0030] Figures 1 to 4 show that the insertion component 2 can be configured such that, when the housing 5 is moved relative to the folding chamber 6, the cover 7 remains attached to the housing 5. Thus, the insertion component 2 is configured to open the folding chamber 6. To bring the injector 1 into an operating state, the housing 5 must be moved from its storage state in the opposite direction to the insertion direction 14, as shown in Figure 4 is shown. Figure 1 shows the insert body 2 in its storage state and Figure 2 shows the insertion body 2 in its operating state. Figure 1It is evident that the lid 7 seals the folding chamber 6 in the storage state. Figure 2 This shows that in the operating state, the folding chamber 6 is exposed by the cover 7 because the cover 7 remains attached to the housing 5. To attach the cover 5 to the housing 5, as shown in Figures 1 to 4 As shown, the housing 5 has a cap 8 which is attached to the remaining housing 5, and the cover 7 is clamped between the cap 8 and the remaining housing 5.

[0031] Figures 1 and 2Show that the housing 5 can have an inner housing contact surface 24 configured to contact and deform the folding chamber 6 when the housing 5 is moved relative to the folding chamber 6. The normal of the inner housing contact surface 24 can include a second angle other than 90° with an insertion direction 14 for the insert component 2, in which the insert component 2 is to be inserted into the receptacle 4. In particular, the second angle is from 0° to 60°. Furthermore, the housing 5 can have two of these inner housing contact surfaces 24, arranged on opposite walls of the housing and in a mirror-symmetrical arrangement. The folding chamber 6 can be made of a flexible material. It is also conceivable that the folding chamber 6 has predetermined breaking points that are configured to break during deformation of the folding chamber 6.

[0032] The folding chamber 6 can be constructed as shown in Figures 8 and 9 The figure shows that the folding chamber 6 can, for example, have an oval cross-section. The folding chamber 6 has a first folding chamber projection 29 and a second folding chamber projection 30, which project into the interior of the folding chamber 6 and are spaced apart from each other. Immediately adjacent to the first folding chamber projection 29 and the second folding chamber projection 30, a predetermined breaking point 31a, 31b is arranged, so that when the folding chamber 6 is deformed, the section of the folding chamber 6,The section located between the first folding chamber projection 29 and the second folding chamber projection 30 is separated from the remaining part of the folding chamber 6. Furthermore, the first folding chamber projection 29 and the second folding chamber projection 30 contact each other after deformation. The remaining part of the folding chamber 6 may have additional predetermined breaking points 32a, 32b, which allow for greater deformation of the folding chamber 6 than would be possible without these additional predetermined breaking points 32a, 32b.

[0033] How it looks Figures 3 and 4As can be seen, the receptacle 4 can have four walls, arranged in a rectangular shape in the top view, within which the insert component 2 is positioned. Furthermore, the first cylinder section 21 can have a first cylindrical projection 19, which is located at the end of the first cylinder section 21 facing the insert body 2 and projects radially outwards from the first cylinder section 21. Similarly, the second cylinder section 22 can have a second cylindrical projection 20, which is located at the end of the second cylinder section 22 facing the insert body 2 and projects radially outwards from the first cylinder section 22. The first cylindrical projection 19 and the second cylindrical projection 20 provide additional support for the insert component 2 in the longitudinal direction of the cylinder 3.

[0034] How it looks Figures 5 to 7As can be seen, according to the second embodiment, an injector 1 comprises a cylinder 3, a receptacle 4, an insert component 2, and a second component. The cylinder 3 has a first cylinder section 21 and a second cylinder section 22, which are arranged side by side in the longitudinal direction of the cylinder 3. The receptacle 4 is arranged between the two cylinder sections 21 and 22. The insert component 2 is arranged in the receptacle 4 and comprises an intraocular lens, a storage fluid, a housing 5, a folding chamber 6 arranged within the housing 5 in which the intraocular lens is surrounded by the storage fluid, a cover 7 that seals the folding chamber 6 against the first cylinder section 21, and a first component to which the cover 7 is attached.The injector 1 is designed to expose the folding chamber 6 from the cover 7 by means of a movement of the first component relative to the folding chamber 6 and thus to open it, and to deform the folding chamber 6 by means of a movement of the second component relative to the folding chamber 6 and thereby fold the intraocular lens.

[0035] The insert component can have an additional cover that seals the folding chamber against the second cylinder section 22. This additional cover can be identical in construction to cover 7 and function in the same way. It is conceivable that the folding chamber 6 has an opening 25 that is sealed by cover 7, and another opening that is sealed by the additional cover.

[0036] The injector 1 can have a locking device designed to fix the position of the folding chamber 6 in the receptacle 4. It is conceivable that, in the fixed position of the folding chamber 6, the opening 25 and the further opening are aligned with the cylinder 3, so that, during operation of the injector 1, a piston of the injector 1 can extend into the first cylinder section 21, the second cylinder section 22 and the folding chamber 6, and thus the intraocular lens can be conveyed by means of the piston from the folding chamber 6 to a cannula 23 of the injector 1.

[0037] The locking device can, as is also the case in Figures 8 and 9The folding chamber 6 has a recess (not shown) and a locking projection 26, which engages in the recess to lock the locking device into place. One of the locking projection 26 and the recess is located on the folding chamber 6, and the other is located on the receptacle 4. The folding chamber 6 may have a folding chamber pin 11 projecting outwards relative to the folding chamber 6, on which one of the locking projection 26 and the recess is located. The locking projection 26 may have a first flank 27, the normal of which is substantially parallel to the insertion direction 14, and a second flank 28, which forms an angle of less than 90°, and in particular less than 60°, with the first flank 27.When the insertion component 2 is inserted into the receptacle 4, the area adjacent to the recess can easily slide on the second flank 28 and as soon as the area adjacent to the recess has passed the second flank 28, the locking projection 26 engages in the recess, causing the locking device to engage.

[0038] Figures 5 to 7 Show that the first component is a housing 5 within which the folding chamber 6 is arranged. The housing 5 can be arranged to be longitudinally displaceable within the receptacle 4. Furthermore, the housing 5 can have a handle 9 that projects from the housing 5 away from the receptacle 4. Figure 5 Figure 1 shows a storage state of the injector in which the cover 7 seals the folding chamber 6. The insertion component 2 is designed so that when the first component moves relative to the folding chamber 6, the cover 7 remains attached to the housing 5, thus opening the folding chamber 6. Figure 7Figure 1 shows the case where the movement of the housing 5 relative to the folding chamber 6 brings the injector 1 from the storage state to an operating state of the injector 1 and thereby exposes the folding chamber 6 from the cover 7.

[0039] How it looks Figures 8 and 9As can be seen, the second component can be a slide 10, which is configured to contact and deform the folding chamber 6 when the slide 10 is moved relative to the folding chamber 6. The slide 10 can be mounted on the receptacle 4 so as to be longitudinally displaceable parallel to the insertion direction 14. Furthermore, the slide 10 can also extend beyond the receptacle 4 so that it can be manually pressed from outside the receptacle 4. The slide 10 can have a first arm 33a, a second arm 33b, and a web 34 connecting the first arm 33a to the second arm 33b. The first arm 33a and the second arm 33b are each arranged in a region at opposite ends of the folding chamber 6, so that the slide 10 is configured to deform the folding chamber 6 symmetrically.

[0040] Folding chamber 6 can be made of a flexible material. It is also conceivable that folding chamber 6 has predetermined breaking points designed to break when folding chamber 6 is deformed. In Figures 8 and 9The figure shows that the folding chamber 6 can, for example, have an oval cross-section. The folding chamber 6 has a first folding chamber projection 29 and a second folding chamber projection 30, which project into the interior of the folding chamber 6 and are spaced apart from each other. A predetermined breaking point 31a, 31b is arranged immediately adjacent to each of the first folding chamber projection 29 and the second folding chamber projection 30, so that when the folding chamber 6 is deformed, the section of the folding chamber 6 located between the first folding chamber projection 29 and the second folding chamber projection 30 is separated from the remaining part of the folding chamber 6. Furthermore, the first folding chamber projection 29 and the second folding chamber projection 30 make contact after deformation.The folding chamber 6 can have further predetermined breaking points 32a, 32b in the remaining part, which allow a greater deformation of the folding chamber 6 than would be the case without the further predetermined breaking points 32a, 32b. Reference symbol list

[0041] 1 Injector 2 Insertion component 3 Cylinder 4 Receptacle 5 Housing 6 Folding chamber 7 Cover 8 Cap 9 Handle 10 Slider 11 Folding chamber pin 12 Groove limiting projection 13 Groove 14 Insertion direction 15 First flank 16 Second flank 17 Outer housing contact surface 18 Receptacle contact surface 19 First cylinder projection 20 Second cylinder projection 21 First cylinder section 22 Second cylinder section 23 Cannula 24 Inner housing contact surface 25 Opening 26 Snap-in projection 27 First flank 28 Second flank 29 First folding chamber projection 30 Second folding chamber projection 31a Break point 31b Break point 32a Further break point 32b Further break point 33a First arm 33b Second arm 34 Bridge

Claims

1. Injector having a cylinder (3), which has a first cylinder portion (21) and a second cylinder portion (22), which are arranged next to each other in the longitudinal direction of the cylinder (3), a receptacle (4), which is arranged between the two cylinder portions (21, 22), and an insert component (2), which is arranged in the receptacle (4) and which has an intraocular lens, a storage liquid, a housing (5), a folding chamber (6) which is arranged within the housing (5) and in which the intraocular lens is arranged so as to be surrounded by the storage liquid, and a cover (7) which seals the folding chamber (6) with respect to one of the first cylinder portion (21) and the second cylinder portion (22) and is fastened to the housing (5), wherein the insert component (2) is configured, by means of a movement of the housing (5) relative to the folding chamber (6), to free the folding chamber (6) from the cover (7) and thereby open it, and to deform the folding chamber (6) and thereby fold the intraocular lens, characterized in that the housing (5) has an outer housing contact surface (17) and the receptacle (4) has a receptacle contact surface (18), wherein the housing contact surface (17) and the receptacle contact surface (18) bear against each other and their normals enclose a first angle different than 90° with respect to an insertion direction (14) of the insert component (2), in which direction the insert component (2) is to be inserted into the receptacle (4) in order to assemble the injector (1).

2. Injector according to Claim 1, wherein the housing (5) has an inner housing contact surface (24) which is configured to contact and deform the folding chamber (6) when the movement of the housing (5) relative to the folding chamber (6) is carried out.

3. Injector according to Claim 1 or 2, wherein the insert component (2) is configured such that, during the movement of the housing (5) relative to the folding chamber (6), the cover (7) remains fastened to the housing (5) in order thereby to open the folding chamber (6) .

4. Injector having a cylinder (3), which has a first cylinder portion (21) and a second cylinder portion (22), which are arranged next to each other in the longitudinal direction of the cylinder (3), a receptacle (4), which is arranged between the two cylinder portions (21, 22), an insert component (2), which is arranged in the receptacle (4) and which has an intraocular lens, a storage liquid, a housing (5), a folding chamber (6) which is arranged within the housing (5) and in which the intraocular lens is arranged so as to be surrounded by the storage liquid, a cover (7) which seals the folding chamber (6) with respect to one of the first cylinder portion (21) and the second cylinder portion (22), and a first component on which the cover (7) is arranged, and a second component, wherein the injector (1) is configured, by means of a movement of the first component relative to the folding chamber (6), to free the folding chamber (6) from the cover (7) and thereby open it, and, by means of a movement of the second component relative to the folding chamber (6), to deform the folding chamber (6) and thereby fold the intraocular lens, characterized in that the first component is the housing (5), within which the folding chamber (6) is arranged.

5. Injector according to Claim 4, wherein the insert component (2) is configured such that, during the movement of the first component relative to the folding chamber (6), the cover (7) remains fastened to the first component in order thereby to open the folding chamber (6) .

6. Injector according to Claim 4 or 5, wherein the second component is a slide (10) which is configured to contact and deform the folding chamber (6) when the movement of the slide (10) relative to the folding chamber (6) is carried out.

7. Injector according to Claim 6, wherein the slide (10) is mounted in a longitudinally displaceable manner on the receptacle (4).

8. Injector according to one of Claims 1 to 7, wherein the injector (1) has a latching device which is configured to fix the position of the folding chamber (6) in the receptacle (4).