DEVICE FOR RECEIVING AN INTRAOCULAR LENS AND METHOD FOR FOLDING AN INTRAOCULAR LENS
20240008975 ยท 2024-01-11
Inventors
Cpc classification
A61F2002/1681
HUMAN NECESSITIES
International classification
Abstract
The invention relates to a device for receiving an intraocular lens with a lens body and at least one haptic, the device containing a first half-shell and a second half-shell which are each connected in an articulated manner to one another at a first of the longitudinal sides of the same by means of a first joint and can be moved relative to one another from an open position to a closed position, the inner surfaces of the half-shells forming a storage surface. In the open position, the half-shells form an open chamber for positioning or storing the lens in the relaxed state, and in the closed position, the half-shells form an enclosed chamber for positioning or storing the lenses in a folded state and for ejecting the lenses along the longitudinal extent of the half-shells.
Claims
1. A loading device for receiving and folding an intraocular lens with a lens body and at least one haptic, comprising: a first half-shell having a first inner surface and a second half-shell which are having a second inner surface, the first and second half-shells connected in an articulated manner to one another at a first longitudinal side of the first half-shell and the second half shell by a first joint, the first half-shell and the second half shell configured to be movable relative to one another from an open position to a closed position, the first and second inner surfaces of the first and second half-shells forming a storage surface, wherein in the open position, the first and second half-shells form an open chamber for positioning or storing the lens in a relaxed state, and in the closed position, the first and second half-shells form an enclosed chamber for positioning or storing the lens in a folded state and for ejecting the lens along a longitudinal extent of the first and second half-shells, whereby a recess is formed in at least one of the first and second half-shells, which recess is open at least from an inside of the at least one of the first and second half-shell and is configured for receiving a front haptics of the lens in the closed position of the first and second half-shells.
2. The loading device of claim 1, wherein in the closed position of the first and second half-shells, the recess forms a secondary space arranged longitudinally to the enclosed chamber and is configured so that the front haptic of the lens can be accommodated therein and the optics of the lens are positioned in the enclosed chamber.
3. The loading device of claim 1, wherein at least one of the first and second half-shells is provided with a support for the front haptic, the support configured for guiding a free end of the front haptic.
4. The loading device of claim 3, wherein the support and the recess are configured and cooperate in such a way that upon closing of the first and second half-shells (17, 19), from the open position to the closed position, the front haptic increasingly extends beyond the support and out of the forming closed chamber to come to rest in the recess in the closed position.
5. The loading device of claim 1, further comprising wings respectively arranged on a second longitudinal side of the first and second half-shells, so that the first and second half-shells can be moved relative to one another from the open position to the closed position by the wings and by rotation about the joint, wherein the recess continues at least in one of the wings.
6. The loading device of claim 1, wherein each half-shell is provided with at least one slide rail, wherein the at least one slide rail is configured for guiding the lens body and optionally an end of a rear haptic.
7. The loading device of claim 1, further comprising a cover member pivotably arranged longitudinally to the first half-shell, the cover member, in an open position, covers the open chamber, and in a closed position, is positioned substantially outside the enclosed chamber.
8. The loading device of claim 1, wherein the loading device comprises a cartridge for insertion into an injector or an injector housing.
9. An injector, comprising: an injector housing with a loading device comprising: a first half-shell having a first inner surface and a second half-shell having a second inner surface, the first and second half-shells connected in an articulated manner to one another at a first longitudinal side of the first half-shell and the second half shell by a first joint, the first half-shell and the second half shell configured to be movable relative to one another from an open position to a closed position, the first and second inner surfaces of the first and second half-shells forming a storage surface; wherein in the open position, the first and second half-shells form an open chamber for positioning or storing the lens in a relaxed state; and wherein in the closed position, the first and second half-shells form an enclosed chamber for positioning or storing the lens in a folded state and for ejecting the lens along a longitudinal extent of the first and second half-shells; whereby a recess is formed in at least one of the first and second half-shells, which recess is open at least from an inside of the at least one of the first and second half-shells and is configured for receiving a front haptic of the lens in the closed position of the first and second half-shells, a nozzle mounted upstream of the loading device; and a plunger longitudinally displaceable in the injector housing toward the nozzle, wherein the loading device is equipped with a chamber that can be pushed through by the plunger for ejecting a lens, wherein at least in the closed position of the first and second half-shells, an edge is arranged on a nozzle side of the half-shells, by which an edge of a front haptic is pressed or alternatively folded into a folded lens between legs of a folded lens body when the lens is pushed forward.
10. The injector of claim 9, wherein the edge delimits the recess toward the nozzle, and is formed at a nozzle inlet.
11. A method of folding an intraocular lens comprising: using a loading device having a storage surface having a front, nozzle-near region and a rear, nozzle-far region defined by at least a first half-shell and a second half-shell, the two half-shells connected in an articulated manner with one another by a first joint; placing a lens on the storage surface, by bringing a lens body of the lens onto the storage surface, such that, with respect to the lens body, a front haptic of the lens is positioned in the front region of the storage surface near the nozzle; and bringing the two half-shells together via the first joint, by guiding the two half-shells toward one another by rotation about the first joint, whereby the lens body is folded approximately in a center so that the lens body that was initially substantially lenticular in a relaxed state is pressed into a shape with two legs folded toward one another, wherein during folding of the optical lens body, the front haptic escapes from a space between the half-shells that close around the lens body by a free end of the haptic slipping into a recess provided in at least one of the half-shells.
12. The method of claim 11, wherein the space formed between the closing half-shells is cylinder-shaped, and the recess is formed in such a way that the haptic can escape from the space on a cylinder surface side.
13. The method of claim 11, wherein the lens is oriented on the storage surface in such a way that the front haptic of the lens comes to be situated over the joint such that a haptic attachment is positioned over the first half-shell and an end of the haptic is positioned over the second half-shell.
14. The method of claim 11, wherein the lens is inserted into a cavity in an un-tensioned state.
15. The method of claim 11, wherein the optical lens body is enclosed at its edges by the two half-shells and is folded together with the half-shells in approximately a same direction.
16. The method of claim 11, wherein upon closing of a loading chamber, an optic and rear haptic lower whereas a front haptic is guided into the recess.
17. A method for folding an intraocular lens and ejecting the lens through an injection nozzle, comprising: folding the lens having a lens body, whereby the lens body is folded approximately in a center such that the lens body which was initially substantially lenticular in a relaxed state is pressed into a shape with two legs folded toward one another; pushing the folded optical lens body toward the injection nozzle, wherein the folded lens is increasingly compressed by an increasing constriction in a direction toward the injection nozzle; and during a push toward the injection nozzle, pulling along a front haptic that was initially positioned in a recess and clamping the front haptic in a gap between the legs of the folded lens body, which gap narrows further as injection moves forward.
18. The method of claim 17, wherein the front haptic is pulled along and drawn out of the recess over an edge, whereby the front haptic is clamped into a gap between the legs of the folded lens body that continues to narrow as the lens is pushed forward.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0062] Further embodiments of the invention result from the following description on the basis of the figures. The following figures, which are not true to scale, schematically show:
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DETAILED DESCRIPTION OF THE FIGURES
[0072] In the following, identical reference numbers stand for identical or
[0073] functionally identical elements (in different figures).
[0074]
[0075]
[0076]
[0077] An injector is a surgical tool with a sleeve-like housing 1 and a plunger 9 (
[0078] The cartridge 3 has a front end 5, i.e., located near the nozzle, and a rear end 7, i.e., located far from the nozzle (
[0079]
[0080] Intraocular lenses essentially consist of an optical lens body 41 (also called optics) and one or more haptics 43, 44, such as a first and a second haptic 43, 44 (
[0081] To accommodate the front haptic 43, the edge 21 extending longitudinally of the half-shell 13 is offset or downsized in its longitudinal extent in a partial area 21 or, in other words, forms an offset so that, when the half-shells 13, 15 are in the closed position, the inner surface 17 of the first half-shell 13 has a breach (or opening) 90 in the channel wall defined by the edges 21, 21 and 23. The offset may be continued into the wing surface, for example such that the wing thickness is reduced below the offset. Thus, in the closed position of the half-shells 13, 15, i.e. when the edges 21 and 23 or the wings 25 and 27 are closest to one another or, as the case may be, substantially in contact with one another, there is a recess 91 at the side of the loading channel 39 which extends from the edges 21, 23 between the wings 25, 27. The breach 90 or alternatively the recess 91 are configured to allow the front haptic 43 to escape from the loading channel 39 that is being formed when the lens body 41 is folded. The said offset and thereby the breach 90 or the recess 91 that results in the closed position are expediently arranged on the nozzle side or at least near the nozzle side (i.e., in the front part of the cartridge 3), so that the front haptic 43 can escape from the channel space 39 into the recess 91 through the breach 90 formed by the offset edge 21 (gap between edge 21 and 23) when the optics are folded.
[0082] The breach 90 or the recess 91 is expediently accessible at least from the inside of the half-shell 17, 19, in particular from the enclosed chamber 39, whereby the recess is suitable for receiving a front haptic 43 of the lens in the closed position of the half-shells 13, 15. Whereas the lens 41 is positioned folded in the chamber 39 after closure of the wings 25, 27 (i.e., in closed position), the front haptic 43 is positioned in the recess 91.
[0083] To the extent that wings 25, 27 adjoin edges 21, 23, recess 91 may continue from edge 21 into the wing 25. In the practical embodiment, the wing 25 is provided with a smaller wall thickness in a partial area, so that the recess 91 results on the inner surface 26 of the wing 25.
[0084] Optionally, the recess 91 is open not only toward the half-shell inner side 17 but also toward the nozzle side.
[0085] Although in the illustrated embodiment example the breach 90 or the recess 91 is created in edge 21 and wing 25 of the first half-shell 13, alternatively or additionally a corresponding recess could be created in edge 23 and wing 27. In a further alternative embodiment, a functionally similar recess elsewhere in a half-shell 13 or 15, for example as a continuous hole (not shown), could expediently be applied in the half of the cartridge 3 closer to the nozzle, and/or close to the edge 21 or 23.
[0086] When the injector is loaded, the relaxed interocular lens, in particular its optics 41, rests expediently between the longitudinal edges 21, 23, and/or on a guide structure of the storage surface 17, 19, the guide structure consisting here, for example, of slide rails 35, 37 which are formed longitudinally on the storage surface 17, 19. The slide rails 35, 37 are designed in particular as ribs.
[0087] The two longitudinal edges 21, 23 are suitably fitted with longitudinally oriented strips 49, 51 (strip 51 is also referred to as guide rail in the following). The strips 49, 51 are both suitably transversely curved to the longitudinal direction and, if necessary, have tapered longitudinal sides. The curvature of the strips 49, 51 is such that, when the cartridge is closed, the two strips complement one another to form a semicircular bulge which extends into the closed channel 39. In lateral continuation of the inner surfaces 17, 19 at the respective longitudinal edge 21, 23, the strips 49, 51 form a mating surface to the respective inner surface 17, 19, whereby a kind of internal groove 53, 55 is formed on both sides at the respective longitudinal edge 21, 23 (
[0088] The procedure for loading the lens in the device or alternatively loading chamber according to the invention is, for example, as follows: the lens is loaded into the loading chamber by advancing the optics 41 under the strip or guide rail 51 into the preloaded position. During this process, the haptics can already be somewhat prefolded, under slight tension. The haptics are prefolded in the direction of the optics. However, they can also be preloaded in relaxed state and prefolded in the further course of loading by the end user via the silicone stamp 10 of the piston. The front haptic 43 is placed on the guide rail 51, which is designed, in particular deep enough, so that the haptic cannot fall down on its own, in contrast to common loading chambers (such as in WO 2015/070358 A2). For example, the guide rail 51 is continuous and extends substantially in a straight line, so that the haptic 43 is raised slightly above the plane of extension of the lens body 41 by being lifted onto the guide rail 51.
[0089] If, alternatively, the front haptic 43 was to come to lie in the same plane as the optic 41, then the guide rail in a front area 103 (i.e., on the nozzle side) lies lower than in the rear area (i.e., on the plunger side) or alternatively is correspondingly located lower. The area 103 can optionally be designed as a separate shelf, which is in particular separated from a strip 51 and, if necessary, offset from the longitudinal axis of the strip.
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[0091] For example, whereas the inner surfaces 17, 19, in particular the slide rails 35, 37, serve as supporting surfaces for the optics 41 in the relaxed state (
[0092] The supporting surface for the front haptic 43 on the strip 51 of the second half-shell 15 and the edge offset 21, which defines the breach 90 or alternatively the recess 91 of the first half-shell 13, are matched to one another in such a way that, when the two half-shells 13, 15 are closed to form the closed channel 39, the front haptic 43 passes over the strip 51 (or, according to the alternative embodiment, over the separate supporting surface 103) into the breach 90 and thus the recess 91.
[0093] The strip 51 shown here has a multifunctional purpose. Like the strip 49, it serves together with the latter as a guide structure for inserting the lens and as a folding aid in that, when the wings 25, 27 are closed, they force the optic 41, which lies under the strips 49, 51, to bend downwards toward the first joint 29. In addition, the ledge 51 serves as a guide for the front haptic 43, firstly during insertion of the lens into the loading device, whereby the front end of the front haptic 43 is inserted on the ledge in the longitudinal direction thereof, and secondly during closing, whereby the front haptic is guided transversely across the ledge 51 out of the closing chamber 36.
[0094] Previously, it was important that the haptics did not come to rest on the guide rail, since they would then become trapped between the wings during closing and tear off when the lenses were pushed forward. According to this disclosure, however, it is intended that the front haptic 43 rest on the guide rail 51. When the wings 25, 27 are closed, the lens or alternatively its body 41 folds into a U shape. The front haptic 43 can thereby slide between the wings 25, 27, where due to the recess 91 a cavity is created in which the front haptic 43 comes to freely rest (i.e., unclamped). When the front haptic 43 lies freely, it is pulled back as soon as the optic 41 is pushed forward. In doing so, it is pulled lengthwise out of the cavity into the optic 41, which is folded in a U-shape but still open at the top (hence the U shape). The further the lens is pushed forward, out of the loading chamber in the direction of the nozzle 11, the more the U closes in the narrowing passage and the front haptic 43 is enclosed between the legs of the U-shaped folded optic 41.
[0095] As shown in
[0096] After the lens has exited into the eye, the previously folded optic 41 opens and releases the haptic 43.
[0097] The folding process described here with controlled clamping of the front haptic 43 in the folded optic 41 results in a delayed release of the front haptic 43 during unfolding when compared to the folding process in conventional devices with folding or wing chambers, so that the front haptic 43 is only released in the eye when the optic 41 unfolds. Due to the provision of a loading chamber with a breach 90 in the wall 17 of the loading channel 39 and a recess 91 extending from the breach 90 along the length of the loading channel 39, the entire folding process (folding and unfolding) is modified, in particular without the need for further components.
[0098]
[0099] A closure 73, in particular a snap closure, is formed on the wings 25, 27.
[0100] A plug-in device 75 is formed on the half-shell 15. This plug-in device 75 is used for insertion into an opening of an injector housing 1. Struts 77, 77 with barbs, for example, serve as insertion means. This creates a solid connection between these parts after the cartridge 3 has been inserted into the injector housing 1.
[0101] The injector shown in
[0102] In summary, the following can be stated:
[0103] A device for folding an intraocular lens has two half-shells 13, 15 connected by a hinge 29, which can be moved relative to one another and closed against one another, e.g. by means of wings 25, 27 formed on the half-shells 13, 15, in order to fold an inserted intraocular lens and at the same time keep it ready for ejection in a loading carrier channel which is formed by closing the half-shells 13, 15. Between the edges 21, 23 of the half-shells 13, 15, which are closed against one another, a recess 91 is formed on the nozzle side, into which the front haptic 43 deviates when the optic 41 is folded. The edge 92, which is located on the nozzle side in front of the recess 91 and is designed in such a way that when the lens is ejected from the loading chamber, the front haptic 43 is pulled out of the recess 91 and over the edge 92 and, due to the resulting pressure on the front haptic 43, the haptic 43 is folded in the sandwich between the folded but upwardly open (toward the recess) optics legs. As a result, it is now possible to also bring preloaded lenses into a sandwich fold making use of wing cartridges (then, in particular, by folding together of wings) or more generally of hinged cartridges for the purpose of injection into an eye, which results, upon injection through the nozzle, in the unfolding of the haptics only taking place with the unfolding of the optics (i.e., not before the unfolding of the optics). This device also enables the aforementioned form of front haptic folding, even in the case of a loading chamber that is separate from the rest of the injector.
[0104] In order to avoid a clamping of the lens and in particular of its haptics 43, 44 when closing the half-shells 13, 15, the cartridge 3 can be equipped with a cover member 45, as detailed in WO 2015/0730358 A2. A cover member pivotally arranged on the longitudinal wing side of the first of the two half-shells serves to cover an interocular lens which is inserted between the half-shells in the open position of the half-shells. The cover member thereby longitudinally covers an open chamber formed by the half-shells and simultaneously protects the lens or alternatively holds it in position. Upon closing of the two half-shells, the cover member slides over the edge of the second half-shell, so that as soon as the two half-shells are in the closed position, the cover member is positioned substantially outside the chamber defined by the two half-shells. The cover member is (and remains) attached to the first half-shell in both the open position and the closed position. This system has the advantage of reducing the risk of the lens haptic becoming trapped during folding.
[0105] The cover member 45 is movably arranged or alternatively fastened to the longitudinal edge 21 of the first half-shell 13, in particular in a movable or foldable manner (similar to a single-leaf swing door). The cover member 45 is advantageously designed as a lid plate, in particular as a flat, dimensionally stable lid plate. In an open position of the cartridge 3, the cover member 45 spans the storage surface 17, 19 from the longitudinal edge 21 of the first half-shell 13 to the longitudinal edge 23 of the second half-shell 15.
[0106] The cover member 45 is advantageously movably fixed to the longitudinal edge 21 of the first half-shell 13 via a second joint 47. Expediently, the joint 47 is a hinge, in particular a film hinge, and is configured as a bending groove or folding region.
[0107] The axes of rotation of the first and second joints 29 and 47 are aligned parallel to one another.
[0108] The cover member 45 closes toward the longitudinal edge 23 due to gravity and/or spring tension in the second joint 47. Since the cover member 45 is structurally self-supporting (i.e., sufficiently rigid), in the open position of the cartridge 3 a covered chamber 46 is formed between the first half-shell 13, the second half-shell 15 and the cover member 45. The second joint 47 is arranged on a strip 49 projecting from the longitudinal edge 21 of the first half-shell 13. On the opposite side, i.e., on the longitudinal edge 23 of the second half-shell 15, a second protruding strip 51 is formed, which serves as a support for the cover member 45 when the cartridge 3 is open. The tapering longitudinal side of the strip 49 expediently merges into a film hinge.
[0109] The strip 49 is formed with a concave bending groove on the outside of the chamber. In particular, the bending groove has a linear material displacement in the longitudinal direction of the first half-shell 13, whereby the ability to bend of the material is produced. This allows the cover member 45 to be folded toward the first wing 25 in an articulated manner. In particular, the bending groove functions as a film hinge.
[0110] The longitudinal edge 23, i.e., in particular the strip 51, on the second half-shell 15 and the free end 58 of the cover member 45 are configured in such a way that when the two wings 25, 27 are pressed together (i.e., when the wing handles are brought together by hand), the cover member 45 or its free end 58 are pushed forward and slide along the wing surface 28. The strip 51 can thus form a kind of cover member add-on.
[0111] In the closed position of the cartridge 3 (
[0112] During the closing process of the cartridge 3, in which the wings 25, 27 of the cartridge 3 are brought together, the cover member 45 slides from its latching position at the edge 23 onto the inner wing surface 28 of the second wing 27 and along this wing surface 28 out of the cavity 46 being closed or alternatively out of the cavity 39 being formed.
[0113] With respect to the cover member, the device is, in particular, characterized by the following features: [0114] a cover member 45 is pivotably arranged longitudinally on the first of the two half-shells 13, which cover member in the open position covers the open chamber 46 and in the closed position is positioned substantially outside the enclosed chamber 39. [0115] the cover member has, on the nozzle side, an edge development 99 which is set back with respect to a nozzle sided end face of the half-shells 13, 15, set back in such a way that, when the lens is inserted, the front haptic of the lens is not covered by the cover member, whereas the optics of the lens are covered by the cover member. [0116] the cover member 45 is set back relative to a nozzle sided end face of the half-shells 13, 15 to such an extent that, when a lens is inserted, the front haptic 43 is not covered by the cover member, whereas the optic 41 is covered. [0117] the cover member 45 is plate-shaped. [0118] the cover member 45 is pivotably arranged on the longitudinal edge 21 of the first half-shell 13. [0119] the cover member 45 is connected to the first half-shell 13 via a second joint 47, which is designed, for example, as a hinge, in particular as a film hinge. [0120] a bending groove is formed on the cover member surface deviating from the inner surface 17 of the first half-shell 13. [0121] a cover member add-on 51 is formed on the longitudinal edge 23 of the second half-shell 15. [0122] upon closing of the two half-shells 13, 15, the cover member 45 slides over the longitudinal edge 23 of the second half-shell 15 out of the closing chamber 46. [0123] in the closed position of the half-shells 13, 15, the cover member 45 is positioned substantially outside the enclosed chamber 39 between the wing handles 25, 27. [0124] the recess 91 on the first wing 25 has an edge development 97 which, in the closed position, essentially follows the nozzle sided edge development 99 of the cover member 45 or (in comparison with the nozzle sided edge development 99 of the cover member 45) is set back further from the nozzle sided end face of the half-shells 13, 15. [0125] in the closed position, the cover member 45 substantially lies outside the enclosed chamber 39 and between the wings 25, 27. [0126] that the cover member 45 is designed as structurally self-supporting. [0127] in the process step for bringing together the two half-shells 13, 15, the cover member 45if presentis clamped until the two longitudinal edges 21, 23 of the two half-shells 13, 15 mutually come into contact against each other.
[0128] Whereas specific embodiments have been described above, it is obvious that different combinations of the embodiment possibilities shown can be used, insofar as the embodiment possibilities are not mutually exclusive.
[0129] Whereas the invention has been described above with reference to specific embodiments, it is apparent that changes, modifications, variations and combinations can be made without departing from the spirit of the invention.