Intraocular lens receiving device and method of folding an intraocular lens
Patent Information
- Application Number
- KR1020217018792
- Authority / Receiving Office
- KR · KR
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-11-19
- Filing Date
- 2019-11-19
- Publication Date
- 2026-09-01
- Estimated Expiration
- Not applicable · inactive patent
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Figure 112021070080103-PCT00001_ABST
Abstract
Description
Technology Field
[0001] The present invention relates to an intraocular lens receiving device and a method for folding an intraocular lens. Background Technology
[0002] In cataract surgery, artificial lenses, so-called intraocular lenses, are inserted into the lens sac of the eye by standard procedures today.
[0003] During surgery, an incision of typically 2 to 4 mm is made in the eye, through which the natural lens is first removed and then the implant is positioned. For insertion, the intraocular lens is inserted into the lens capsule through the incision in a folded state. As soon as the folded lens is inserted into the lens capsule, it unfolds back into its original shape.
[0004] Artificial lenses commonly used today consist of an optical lens body and two or more haptics that typically protrude peripherally from the optical lens body at a right angle to the optical axis of the lens body, and the haptics act as position springs for the lens body within the lens capsule. For example, there are two haptics facing each other on the lens body, each protruding outward in a spiral shape from the lens body in the same direction. This form of haptic, which is the most commonly used globally, is known in the industrial field as an open c-loop haptic.
[0005] With improved surgical tools and implants, surgeons can make very small incisions. The removal of the natural lens of the eye can today be performed through an incision of less than 2 mm. However, this is only meaningful if an intraocular lens can be inserted through such a small incision.
[0006] Recently, lens carriers or cartridges have been developed that can be ejected by an injector after lenses are loaded for the insertion of intraocular lenses.
[0007] Examples of such lens carriers or cartridges and injectors are disclosed, for instance, in U.S. Patent Publications No. 6267768, No. 5810833, No. 6283975, No. 6248111, No. 4681102, No. 5582614, No. 5499987, No. 5947975 and No. 6355046, and in European Patent Publication No. 1290990B1, U.S. Patent Application Publication No. 2004 / 0199174A1, European Patent Application Publication No. 1905386A1 and International Publication No. 03 / 045285A1.
[0008] In an injector device according to U.S. Patent Publication No. 4681102, a cartridge formed as a folding device for a lens and an injector nozzle are separate parts. The cartridge can be inserted into an injector housing, and the injector nozzle can be screwed into the front of the injector housing.
[0009] According to the injector device according to U.S. Patent Publication No. 5582614 and most previously known injector devices such as U.S. Patent Publications No. 6267768, No. 5810833, No. 6283975 and No. 6248111, the cartridge exists as an integral unit having a folding device.
[0010] Intraocular lenses are supplied by the manufacturer in sterile packaging and, if necessary, submerged in liquid. Depending on the lens material, storage in liquid may be required to protect the lens from dehydration. During surgery, the lens is removed from the packaging, which is a sterile area, and must be inserted into the injector's loading device or an injector equipped with the provided cartridge, or alternatively, mounted. The lens is a highly sensitive structure that can be easily damaged while being transferred to the cartridge, during folding, or during ejection from the injector nozzle. The haptics surrounding the lens's optic components are particularly at high risk of damage. Specifically, when the lens is ejected from the injector, there is a risk that one of the two haptics may get pinched and torn, or that the anterior haptics may unfold too early into the eye ahead of the lens body, as described below.
[0011] A general cartridge design as disclosed in European Patent Publication No. 1290990B1, International Publication No. 03 / 045285, European Patent Application Publication No. 1905386A1, U.S. Patent Publication No. 5582614 and U.S. Patent Publication No. 5499987 has two half shells connected by a single hinge, regardless of whether they have a groove or gripping means for securing the edge of the lens.
[0012] For example, International Publication No. 03 / 045285A1 discloses a method for inserting an intraocular lens into the lens capsule of the eye, in which overpressure is generated to eject the lens floating in a lubricant from an injector nozzle. A compressible and deformable piston continuously adapts to the anterior narrowing of the nozzle channel. As the lens moves, it continues to fold and has a very small diameter at the end of its path. Due to the deformability of the piston, the end of the nozzle channel can be kept very narrow, and consequently, only a very small incision is required. A kit for performing this process includes a lens carrier and a lens. The lens is placed in the lens carrier in a tension-free state. The lens and lens carrier are preferably carried by a holder and sterilely packaged in a package until the use of the hydrophilic lens in a liquid that protects the lens from dehydration. During surgery, the lens stored with the lens holder is removed from the pack, inserted into an injector, and folded. Subsequently, a lubricant is filled through the channel. This allows the lens to be injected into the lens capsule of the eye to be operated on.
[0013] Generally, systems for prefolded lenses and systems for non-prefolded lenses can be distinguished from the prior art. In systems for non-prefolded lenses, the lens is initially folded during the process of ejection for injection. An example of such a system in which the lens is not prefolded is disclosed in U.S. Patent No. 8,668,734B2. In this disclosure, a cartridge consisting of two half-molds is used, and the lens is inserted into the mold when the mold is opened. This system also has a lateral recess with respect to the ejection direction of the piston for rear haptics, while the front haptics are mounted at the end. However, there exist systems in which the lens is mounted into the loading chamber from the rear when it is not yet formed or when unfolded (e.g., U.S. Patent No. 5,810,833). The rear opening into which the lens is inserted is at least as wide and high as the lens itself. As long as a piston with a deformable tip (typically made of silicone or TPE) is used, this piston tip must fill the entire volume of the rear opening to prevent the rear of the two haptics from steamrolling against the tip and becoming jammed. A large-volume deformable piston tip generates high system forces when the piston advances to the maximum taper region of the cartridge tip. The final force can be greater than the force generated by the lens itself. Additionally, the expandability or compressibility of a bulky piston tip limits the minimum required inner diameter of the front nozzle tip. For this reason, systems where the lens folds before ejection or pre-folds for injection are still frequently used today. In particular, a winged cartridge (as disclosed in, for example, U.S. Patent Publication No. 6,267,768, U.S. Patent Publication No. 6,248,111, U.S. Patent Publication No. 5,947,975 or U.S. Patent Publication No. 4,681,102) is used for this purpose and always consists of at least two half shells that are open from the start.The lens is pre-folded when at least two half shells are closed, and thus exists in the loading chamber in a pre-folded state. Pre-folding the lens along with the haptics by closing the winged cartridge reduces the internal volume of the closed winged cartridge by nearly half, allowing for the use of smaller deformable piston tips, thereby inducing a smaller incision force for the same inner diameter of the cartridge tip or generating a smaller incision force for the same incision force by using a smaller cartridge inner diameter. A disadvantage of this system for pre-folding the lens is that the lens haptics, in the worst case the optics, can become trapped between the two wings of the cartridge when they are closed. The trapped haptics typically tear while pushing the lens further forward, which corresponds to the loss of the entire lens.
[0014] A winged cartridge for receiving an intraocular lens in a loading chamber is disclosed in International Publication No. 2015 / 070358 A2. The winged cartridge consists of first and second half shells, each half shell having a wing handle on its longitudinal side. The two half shells are articulated with each other on their respective wingless longitudinal sides by a first joint and can be moved relative to each other from an open position to a closed position, and the two half shells form an ejection channel for the intraocular lens in the closed position. Additionally, the present disclosure describes an anterior c-loop haptic that is pre-folded by an anterior haptic that is blocked at the nozzle side by a stopper, and is pressed against the optic by advancing the stamp and directly advancing the lens. This prevents the anterior haptic from being injected into the eye in an elongated form. Initially, the haptic is in an arc shape, but the longer the haptic, the more the arc shape is compressed while advancing further from the nozzle. Depending on the haptic design, the haptic may be "folded" somewhat in the middle of its length, and accordingly, the folded but still elongated haptic enters the eye. Due to this folding, the length of the haptic may still be half, which can be considered by the surgeon as a preventive measure against possible damage to the lens capsule.
[0015] In the case of hydrophilic lenses, if the anterior haptic is pressed only against the optic on the nozzle side of the wing-shaped cartridge, there is a problem where the anterior haptic spreads out very quickly in the eye before the optic itself enters the eye. In the worst case, the haptic essentially becomes stretched when it enters the eye. Since the lens body behind the haptic follows the movement of the haptic, it can rotate 180° when it enters the eye (upward to downward, downward to upward). In this case, it is very inconvenient for the surgeon because the lens must be rotated into a tight quarter to correct the rotated lens in the eye.
[0016] In both of the above situations, it is desirable to release the anterior haptic by ensuring that the haptic is not only pressed against the nozzle-side optic but also placed over the optic, thereby allowing the haptic to be grasped or, alternatively, surrounded by the edge of the optic during folding or, alternatively, during the folding of an additional optic, and then unfolding the haptic when the optic is deployed in the eye after being injected. This type of folding is also referred to as sandwich folding. This is the most common form of haptic folding in all cartridges that function without pre-folding (and thus without wings), where folding occurs only during ejection through the internal shape of the cartridge. Typical embodiments of such cartridges without pre-folding are disclosed in International Publication No. 2014 / 74860A1 and European Patent Publication No. 2916769B1. The anterior haptic is placed on the optic by an operator (operating nurse or surgeon) through a small slit already located at the rear end of the cartridge when the lens is inserted into the cartridge. This form in which an operator mounts the lens regardless of the injector system used is called a non-preloaded injector. On the other hand, a preloaded lens is a lens that has already been placed in the injector's loading chamber and sterilized by the lens manufacturer. The cartridge according to International Publication No. 2014 / 074860A1 can only be used with non-preloaded lenses because the lens containing the haptic must be stored in the loading chamber in advance in a relaxed position and for the entire lifespan of the product, and also requires the end user (operating nurse or surgeon) to actively thread the anterior haptic through a slot at the end of the cartridge. Similarly, U.S. Patent Publication No. 2009 / 0270876 discloses a closed cartridge mounted from the rear. In the present invention as well, active operation and mounting must be performed by the end user, and relaxed preloading is not possible.
[0017] On the other hand, when using pre-folding systems (e.g., including winged cartridges), until recently it was difficult to position the haptic on the optic to enable sandwich folding for both pre-mounted and non-pre-mounted lenses. That is, the haptic is fixed in a way that allows it to be separated from the optic from the eye for the first time, meaning that during the pre-folding stage, both the optic and the haptic are positioned in a U-shape, and consequently, the forward haptic does not reach the top of the lens optic in a controlled and reproducible manner even during further advancement of the lens, but rather remains mostly pressed against the optic. Furthermore, in the case of winged cartridges, if the haptic is successfully pre-positioned in the optic device, the risk of the forward haptic becoming trapped between the wings when the loading chamber closes increases dramatically.
[0018] Indian Patent Application Publication No. 3562 / CHE / 2014 ("Leading Haptic Positioner for Pre-mounted Intraocular Lens (IOL) Delivery System" by RD Thularsiraj) presents a sandwich folding method starting from a pre-mounted system. This sandwich folding for a pre-mounted system operates by manually placing a haptic on an optic through a manual sliding hook or slider inserted into a loading chamber through a nozzle tip. As soon as the wing of the loading chamber is closed, the hook is pulled back.
[0019] The disadvantages of this method are that it makes the system more expensive by requiring at least two additional components, and that it inevitably creates two additional steps for the surgeon to perform: advancing the slider and subsequently withdrawing it. Since pre-fitting systems are often compared based on the number of preparation steps, this presents a competitive disadvantage along with the additional cost.
[0020] Another disadvantage of this concept is that this method is used only for fully pre-loaded lenses (typically used for hydrophobic lenses). However, it cannot be used for so-called semi-preloaded lenses (typically used for hydrophilic lenses). In the latter case, the lens is actually pre-loaded into the loading chamber, but at least the loading chamber is stored in the liquid separately from the rest of the injector. Because the slider is positioned at the nozzle, the hook at the end of the slider cannot be positioned in contact with the lens stored separately in the loading chamber. When inserting the loading chamber into the injector after removing it from the liquid, the hook must be retracted through the slider to a point where it does not hinder the insertion of the loading chamber into the injector. Due to limited size constraints, it is difficult to ensure that a retracted hook accurately grips and positions the haptic. Since the haptic is typically already applied (positioned) on the hook at the factory, this problem does not occur with fully pre-loaded lenses.
[0021] Another disadvantage of this concept is that, since the hook must be inserted through the nozzle, the maximum size of the hook and slider is limited to the nozzle size at the end. When the incision is very small, the inner diameter of the tip can be in the range of 1 mm to 1.5 mm, resulting in very delicate hook and slider shapes. As the system is designed more delicately, it becomes more difficult to create a reliable system that stably captures and places haptics. The problem to be solved
[0022] The object of the present invention is to provide an alternative device or system for a pre-mounted intraocular lens such that the fore-haptic does not protrude or alternatively protrude when ejected from an injector nozzle or alternatively injected into the eye. In particular, it is desirable to securely and reproducibly place the fore-haptic of the lens (particularly a c-loop lens) onto the optic for injection into the eye, and in particular, to secure the fore-haptic in a sandwich form so that it does not protrude or protrude during injection. Another object of the present invention is to create an alternative device or system that maintains the fore-haptic together with the optic for as long as possible when the lens is injected into the eye, so that the haptic only spreads as far as possible from the optic in the eye only when the optic is unfolded. It is desirable that this object be achieved in a manner that does not require additional parts, additional costs, or additional application steps. The system, or alternatively the device, must be suitable for use with fully pre-mounted lenses and semi-pre-mounted lenses. The system is also designed to work with a winged cartridge, specifically a winged chamber that can be inserted into an injector housing.
[0023] Another objective of the present invention is to provide a device for easily mounting an intraocular lens that avoids the disadvantages of the described known systems and methods. Another objective of the present invention is to provide a device for folding the intraocular lens without damaging it during folding and / or injection. Furthermore, an optimized device should be provided in relation to the operational steps for preparing the lens and injector. In particular, as few operational steps as possible should be performed on the device after delivering the lens and injector or immediately before surgical intervention. Additionally, the device should be provided to require as few additional parts as possible, and in the best case, to achieve the aforementioned objectives without having any additional parts compared to existing injectors, and thus without incurring additional costs. Another objective of the present invention is to create a device that requires only a small incision in the eye. means of solving the problem
[0024] According to the present invention, the object of the present invention is solved by an apparatus for receiving and folding an intraocular lens, in particular a loading apparatus, comprising a lens body and at least one haptic. The apparatus comprises a first half shell and a second half shell, wherein the half shells are articulated with each other at their respective first longitudinal sides through a joint and can be moved relative to each other from an open position to a closed position, and the inner surfaces of the half shells form storage surfaces, wherein in the open position, the half shells form an open chamber for placing or storing a lens (in particular, for placing or storing a lens in a relaxed state), and in the closed position, the half shells form a closed chamber (in particular, a cylinder chamber) (on the shell side) for placing or storing a lens (in particular, for placing or storing a lens in a folded state) and discharging a lens along the longitudinal direction of the half shells. The apparatus is advantageously characterized in that a recess is formed in at least one of the half shells, said recess is open at least within the half shell and is suitable for receiving anterior haptic of the lens in the closed position of the half shells.
[0025] The present invention ensures that the front haptic of a pre-mounted lens having a c-loop haptic is positioned at the optic of the loading chamber, and in particular, when using a loading chamber composed of two half shells connected to each other in a safe and reproducible manner, particularly in a sandwich form by a hinge, the haptic can be initially unfolded only when the optic is unfolded from the eye. In particular, when the lens is inserted into the eye, the front haptic cannot be separated from the optic, i.e., the lens body, until the optic begins to unfold.
[0026] The features of the advantageous embodiments listed below, either alone or in combination with one another, lead to further improvements of the invention and the apparatus according to its application.
[0027] Advantageously, in the closed position of the half shells, the recess is arranged laterally with respect to the closed chamber and forms an area, particularly an auxiliary space, in which the anterior haptic of the lens can be accommodated internally and the optic of the lens is configured to be located in the closed chamber.
[0028] Advantageously, each half shell is provided with at least one slide rail, and at least one slide rail is suitable for guiding the end of the lens body and optionally the rear haptic. As a result, the position of the lens body, i.e., the optic, in the device is more reliably predetermined. In particular, the sliding slide is used for the purpose of guiding the ejection of the lens from a closed chamber or alternatively from an injector.
[0029] At least one of the half shells, preferably the second half shell, is provided with a support for a forward haptic, which is advantageous because it is suitable for guiding the forward haptic, particularly the free end of the forward haptic. During loading or for storage, the free end of the forward haptic may be placed on the support in a substantially relaxed state. This support for guiding the forward haptic is preferably positioned parallel to slide rail(s) for guiding the lens body, and the slide rails are preferably located deeper in the open chamber than the support for guiding the forward haptic. The support for the forward haptic may be designed on the longitudinal edge of the second half shell as an edge strip protruding into the open chamber. The support is preferably designed as a continuous guide structure arranged parallel to the slide rail(s). Thus, the forward haptic placed on the support is not placed coplanar with the optic of the open chamber but is elevated relative to the surface on which the optic is placed. Alternatively, the support can be designed as a separate holder on the side of the device near the nozzle, as needed. In particular, the support can be lowered on the side near the nozzle so that the forward haptic is coplanar with respect to the optic when placed on the support.
[0030] For convenience, the support and the concave part are configured and cooperate so that when closing the half shell from the open position to the closed position, the front haptic (43) gradually extends beyond the support and outside the closed chamber and settles in the concave part when in the closed position.
[0031] For convenience, at the closed position of the half shells, the closed chamber substantially forms a channel, in particular a loading channel or alternatively an exhaust channel. The closed chamber substantially forms a cylindrical channel, the shell side is substantially formed by the half shells, and the recess forms an opening on the shell side. The recess for receiving the front haptic of the lens preferably forms a side opening in the channel extending forward of the channel in which the front haptic of the lens can be received.
[0032] Advantageously, the wings are arranged on the second longitudinal side of each of the two half shells, particularly on the longitudinal edge of each of the half shells, so that the half shells are moved relative to each other from an open position to a closed position by the wings and by external rotation around the joint, and preferably the concave portion is continuous in at least one of the wings.
[0033] Preferably, the recess is intended to prevent the haptic from being substantially compressed or blocked when the haptic slides into the recess while the half shells are closed. The recess is arranged within the wing, and preferably, it is convenient for the recess to be arranged to substantially adapt to the dimensions of the haptics when the half shells are in the closed position.
[0034] It is more convenient for the recess to be arranged to be formed on two substantially parallel surfaces (particularly, the inner surfaces of the two wings), wherein the parallel surfaces (preferably formed substantially by the wings) have a mutual distance that is at least equal to or greater than the thickness (or diameter) of the haptic at the closed position of the half shell, preferably not exceeding five times or more preferably two times the thickness of the haptic. Preferably, the recess between the substantially parallel surfaces is wide and deep enough so that when the haptic slides into the recess located in the space spanning the width and depth, the haptic is at least not substantially caught, pinched, or blocked.
[0035] Optionally, a cover member may be pivotally provided longitudinally on the first half shell of the two half shells, and the cover member may cover the open chamber when the half shells are in the open position and be located outside the substantially closed chamber when the half shells are in the closed position.
[0036] Optionally, closures, particularly snap closures, can be formed on the wings.
[0037] Optionally, a plug-in device for insertion into a receiving opening of the injector housing may be formed in one of the half shells. Preferably, the plug-in device is provided in the second half shell.
[0038] The device may be integral. From a manufacturing perspective, it is advantageous for the device to be integral and preferably manufactured of plastic. In this case, injection molding technology may be used.
[0039] For convenience, the device may be designed as a cartridge for insertion into an injector, particularly an injector housing. Advantageously, the device according to the present invention may be a component integrated into the injector.
[0040] The present invention further discloses an injector having an injector housing for use with a device formed as a cartridge as described above, and a plunger that can be displaced in the longitudinal direction within the injector housing.
[0041] Additionally, an injector is further disclosed having an injector housing in which a loading device is provided, a nozzle mounted upstream of the loading device, and a plunger that can be displaced longitudinally from the injector housing toward the nozzle, wherein the loading device is equipped with a chamber that can be penetrated by a plunger for releasing a lens, and the loading device is designed to have particularly foldable half shells as described above. In the injector, at least in the closed position of the half shells, a folding edge is located or provided on the nozzle side of the half shells, and through the folding edge, forward haptics are pressed or folded into the folded lens, particularly between the legs (or leg flaps) of the folded lens body, when the lens is pushed forward or folded.
[0042] The folding edge is preferably provided between the loading device and the nozzle inlet of the nozzle, in particular between the recess of the loading device and the nozzle inlet adjacent thereto. For example, the folding edge is formed at the nozzle inlet, whereby the nozzle inlet of the nozzle may, for convenience, come into contact with the loading device, in particular the recess of the loading device. Alternatively, the folding edge may be formed between the loading device and the nozzle by being formed on at least one half shell or on a housing instead of the nozzle inlet of the nozzle. In a design where the nozzle and the loading device are made as a single unit, the folding edge may be positioned between the nozzle area and the loading area for convenience.
[0043] In the closed position of the half shells, it is convenient for the folding edge to be positioned on the nozzle side so that the forward haptic is folded when the lens is pushed forward, or alternatively, to be pressed between the legs of the folded lens body, particularly between the legs of the folded lens body.
[0044] A method for folding an intraocular lens is further disclosed, comprising the following steps:
[0045] - A storage surface having a front portion, a nozzle proximity region, and a rear portion, wherein the nozzle proximity region is formed by at least a first half shell and a second half shell, and the two half shells are connected to each other in an articulated manner by a first joint,
[0046] - A step of applying the lens to the storage surface (particularly by placing the lens or sliding the lens over it) by bringing the lens body onto the storage surface so that the front haptic of the lens is positioned on the front part of the storage surface close to the nozzle with respect to the lens body.
[0047] - A step of bringing the two half shells together through the first joint by guiding the two half shells toward each other by rotation around the first joint (i.e., by folding the wings together) so that the lens body is folded at the front and rear of the central portion and the lens body, which was substantially in the form of a lens in the relaxed state, is pressed into a form having two legs that fold toward each other. According to this invention, the method is characterized in that when the optic lens body is folded, the front haptic comes out of the space between the half shells that closes the periphery of the lens body by the free end of the haptic sliding into a recess provided for this purpose in at least one of the half shells.
[0048] Advantageously, the space created between the closed half shells is substantially cylindrical in shape, and the concave portion is created so that the haptic can escape from the space on the side of the cylinder surface.
[0049] Advantageously, the lens is oriented on the storage surface such that the front haptic is placed over the joint, so that the base of the haptic connecting the haptic to the optic lens body is positioned on the first half shell and the end of the haptic is positioned on the second half shell.
[0050] Advantageously, the lens can be inserted into the cavity in a relaxed state. This means that the lens can be inserted into the device (especially manually) without bending or folding the lens, and without any externally applied physical tension.
[0051] It is convenient for the lens to be placed on the inner surfaces of the two half-shells, especially after manual insertion. This means that the lens rests on the inner surface of each half-shell at at least one point.
[0052] For convenience, each half shell may be equipped with a support designed, for example, with slide rails.
[0053] For convenience, the optic lens body is edged by two half shells and can be folded together with the half shells in almost the same direction.
[0054] Preferably, in the step of the process of assembling two half shells together, the process includes the step of assembling them together until the two longitudinal edges of the two half shells come into contact with each other (fixed if a cover member is present).
[0055] According to the present invention, the optic and optionally the rear haptic descend when the loading chamber is closed, while the front haptic is guided into the recess.
[0056] A method for folding an intraocular lens and discharging it through an injection nozzle is further disclosed, comprising the following steps:
[0057] -Preferably, by folding the lens according to the method described above, the lens body is folded at the front and rear of the central portion, and the lens body, which was substantially in the shape of a lens in a relaxed state, is pressed into a form having two legs that fold toward each other.
[0058] - A step of pushing a folded optic lens body toward a spray nozzle so that the folded lens becomes increasingly compressed as the contraction in the direction toward the spray nozzle increases. The method for folding and ejecting is characterized in that, particularly when pushed toward the spray nozzle, a front haptic initially located in a recess is pulled and fixed in a gap between the legs of the folded lens body, and said gap becomes narrower as the injection moves forward. Accordingly, for convenience, the front haptic is pulled and brought out to the outside of the recess on the edge, thereby fixing the front haptic in a gap between the legs of the lens body that continues to narrow as the lens is pushed forward (especially due to applied pressure).
[0059] The device according to the present invention can be used for a relatively small incision in the eye (particularly an incision with a diameter of less than 2.5 mm, preferably less than 2.2 mm, more preferably less than 2 mm, most preferably less than 1.5 mm). This is possible because the device according to the present invention has a loading chamber for a folded lens to be injected, and the loading chamber is closed (in the longitudinal direction) by surrounding the lens like a jacket. The lens is pre-folded internally with a particularly small cross-sectional diameter and can be injected through a narrow cannula and, as described, through a particularly small incision. In a particularly advantageous manner, the device is used with a deformable stamp, in particular a silicone stamp (e.g., a stamp according to International Publication No. 03 / 045285A1).
[0060] Further advantages and objectives of the present invention will become clear from the following description. Brief explanation of the drawing
[0061] Another preferred embodiment of the present invention arises from the following descriptions based on the drawings. The accompanying drawings, which are not of actual scale, schematically illustrate the following: FIG. 1 is a perspective view of a loading device according to the present invention in an open position in which an intraocular lens is received; FIG. 2 is a front view of a loading device according to the present invention in an open position in which an intraocular lens is received; FIG. 3 is a front view of a loading device according to the present invention in a closed position; FIG. 4 is a front view of a loading device according to the present invention in a closed position where the intraocular lens is in place; FIG. 5 is a perspective view of a loading device according to the present invention in a closed position; FIG. 6 is a perspective view of an alternative loading device according to the present invention in an open position in which an intraocular lens is received; FIG. 7 is a perspective view of an injector having a nozzle and a loading device according to the present invention inserted in a closed position; FIG. 8 is a perspective view of an arrangement of a loading device according to the present invention in a closed position having a nozzle portion at the front (a loading chamber in which the loading device is received in an injector or integrated with the arrangement according to FIG. 7); FIG. 9 is a longitudinal cross-sectional view passing through an array of a charging device according to the present invention in a closed position with an upstream nozzle portion. Specific details for implementing the invention
[0062] In the following, the same reference numerals indicate identical or functionally identical elements (in different drawings).
[0063] FIGS. 1 to 5 illustrate a device according to the present invention in the form of a cartridge (3) that can be inserted into an injector housing (1). Alternatively, the device according to the present invention may be part of an injector or may be permanently integrated with or formed in the injector.
[0064] Figure 7 shows an injector with a cartridge (3) inserted.
[0065] FIG. 8 shows the arrangement of cartridges (3) and nozzles (11) as seen in an injector.
[0066] The injector is a surgical instrument having a sleeve-type housing (1) and a plunger (9) (Fig. 7) that is received in the housing so as to be displaceable in the axial direction, the plunger (9) can be pushed forward toward a nozzle (11), and the nozzle (11) is formed at the rear end of the injector housing (1) and is positioned in front of the plunger (9). Preferably, an elastic stamp (10) is fitted to the plunger (9). Preferably, the jacket of the housing (1) is provided with a recess, and a lens carrier, i.e., the cartridge (3) described in particular herein, can be mounted therein in such a way that the plunger (9) can be pushed through it during ejection. The cartridge (3) is connected substantially behind the nozzle (11). Alternatively, the injector housing may be equipped with an integrated loading chamber, in which case the integrated loading chamber may be designed to be inserted into the housing in a manner substantially similar to the cartridge described herein. The lens carrier or cartridge (3) preferably has a cylindrical loading channel (39) (Figs. 3 to 5), to which an injector nozzle (11) (the distal end of the lens carrier) tapered toward the tip is axially connected (Fig. 8). The lens carrier or cartridge (3) is placed or inserted into and held in the injector housing (1) so that the plunger (9) is aligned with the loading channel. The plunger (9) can be pushed forward by manually pushing the plunger end (81). When the plunger (9) is pushed forward, the plunger (9) enters the loading channel (39) and pushes out the injector stored inside through the injector nozzle (11) to be injected, for example, into the eye.
[0067] The cartridge (3) has a front end (5) located near the nozzle and a rear end (7) located far from the nozzle (Figs. 1, 7 and 8). When inserted into the injector housing (1), the plunger (9) can be pushed from the rear end (7) into the cartridge (3) and through the cartridge (3) toward the front end (5) of the cartridge (3) and further into the injection nozzle (11).
[0068] FIG. 1 illustrates a loading device according to the present invention advantageously designed as an insertable cartridge (3) that can be inserted into an injector such as that shown in FIG. 7. The cartridge (3) comprises two half shells (13 and 15), the two half shells (13 and 15) being designed in particular in the form of cylinder segments and connected to each other in an articulated manner extending longitudinally. The two articulated half shells (13 and 15) together form a double half shell. Each half shell (13, 15) has an open half channel inside having an inner surface (17 or alternatively 19). The inner surfaces (17 and 19) together form a storage surface. The storage surface (17, 19) is longitudinally limited by a first edge (21) formed on the first half shell (13) and a second edge (23) formed on the second half shell (15). Each half shell (13, 15) has an edge (21) or, alternatively, an edge (23) on the side away from the first joint (29). Advantageously, wings (25, 27) are arranged on each edge (21, 23). The half shells (13 and 15) are connected to each other longitudinally via a first joint (29), which is designed, for convenience, as a hinge or film hinge. The two half shells (13 and 15) are accordingly adjacent to each other laterally, particularly longitudinally (or joined together via the first joint (29)), in such a way that the inner surfaces (17 and 19) of the two half shells (13 and 15) are placed side by side with each other, and form a common storage surface (17, 19). As used herein, “longitudinal” means in a straight line along the extension or in a straight line with the half channel. The cartridge (3) can be moved from an open position to a closed position by means of the joint (29).In the open position (Figs. 1 and 2), the two half shells (13 and 15) form a storage surface (17, 19) upon which an intraocular lens can be placed and, if necessary, stored without tension. When the cartridge (3) is closed, the longitudinal edges (21 and 23) of the two half shells (13 and 15) come into contact with each other, and accordingly, the intraocular lens placed on the storage surface (17, 19) is captured and folded. In the closed position (Figs. 3, 4 and 5), the two half shells (13 and 15) together form the aforementioned loading channel (39), which serves to keep the lens in a state ready for insertion into the eye, with the sides essentially closed.
[0069] The intraocular lens basically consists of an optic lens body (41) (also referred to as "optic") and one or more haptics (43, 44), preferably in the most common embodiment, first and second haptics (43, 44) having a flexible design that protrudes in a spiral shape (particularly in the same direction in a spiral shape) from the periphery of the lens body (41) in the lens plane (Fig. 1). The haptic region connecting the haptics to the lens (41) may be referred to as a haptic accessory, for example, indicated by reference numeral "93". The free end (95) of the haptics may be referred to as a haptic end or haptic tip. In the open position of the half shells (13, 15), the lens is placed on the storage surface (17, 19) such that the first haptic (43) (including the accessory (93) and tip (95)) is positioned on the nozzle side relative to the lens body (41) (also called the "front haptic"), while the second haptic (44) (also called the "rear haptic") is positioned away from the nozzle.
[0070] To accommodate forward haptics (43), the edge (21) extending longitudinally of the half shell (13) is offset or reduced longitudinally in a partial region (21'). That is, when the half shells (13, 15) are in a closed position, the offset is formed so that the inner surface (17) of the first half shell (13) has a breach (90) (or opening) in the channel wall defined by the edges (21, 21' and 23). The offset continues to the wing surface, for example, so that the thickness of the wing is reduced under the offset. Accordingly, in the closed position of the half shells (13, 15), that is, where the edges (21 and 23) or wings (25 and 27) are closest to each other, or in some cases can substantially come into contact with each other, a recess (91) is present on the side of the loading channel (39) extending from the edges (21', 23) between the wings (25, 27). The rupture (90) or alternatively the recess (91) is configured so that the forward haptic (43) can exit from the loading channel (39) formed when the lens body (41) is folded. The above offsets and the corresponding rupture (90) or the concave (91) that creates a closed position are positioned for convenience on the nozzle side or at least near the nozzle side (i.e., the front part of the cartridge (3)), so that when the optic is folded, the front haptic (43) can exit from the channel space (39) into the concave (91) through the rupture (90) formed by the offset edge (21') (the gap between the edges (21' and 23)).
[0071] Since the rupture portion (90) or the concave portion (91) is accessible for convenience at least inside the half shells (13, 15), particularly in the closed chamber (39), the concave portion is suitable for accommodating the front haptic (43) of the lens in the closed position of the half shells (13, 15). While the lens (41) is positioned folded in the chamber (39) after the wings (25, 27) are closed (i.e., in the closed position), the front haptic (43) is positioned in the concave portion (91).
[0072] Up to the extent that the wings (25, 27) are adjacent to the edges (21, 23), the concave portion (91) may extend from the edge (21) to the wing (25). In an actual embodiment, the wing (25) is provided to have a smaller wall thickness in a partial area so that the concave portion (91) is formed on the inner surface (26) of the wing (25).
[0073] Optionally, the recess (91) is opened not only toward the inner side of the half shell (17) but also toward the nozzle side.
[0074] In the illustrated embodiment, a rupture (90) or a depression (91) is created on the edge (21) and wing (25) of the first half shell (13), but alternatively or additionally, a corresponding depression may be created on the edge (23) and wing (27). According to a less preferred alternative, a functionally similar depression located elsewhere in the half shell (13 or 15), such as a continuous hole (not shown), may be applied to the half shell of the cartridge (3) closer to the nozzle, preferably closer to the edge (21 or 23).
[0075] When the injector is mounted, the relaxed intraocular lens, in particular its optic (41), is placed for convenience between the longitudinal edges (21, 23), preferably on a guide structure of the storage surface (17, 19), and the guide structure may be composed of, for example, a slide rail (35, 37) formed longitudinally on the storage surface (17, 19). The slide rails (35, 37) are designed particularly as ribs.
[0076] Two longitudinal edges (21, 23) are fitted to longitudinally oriented strips (49, 51) (the strips (51) are also referred to as guide rails below). Both strips (49, 51) are appropriately curved transversely with respect to the longitudinal direction and have tapered longitudinal sides as needed. The curvature of the strips (49, 51) causes the two strips to complement each other when the cartridge is closed, forming a semicircular bulge that extends into the closed channel (39). In the lateral continuum of the inner surface (17, 19) at each longitudinal edge (21, 23), the strips (49, 51) form a bonding surface with respect to each inner surface (17, 19), thereby forming a kind of inner groove (53, 55) on each longitudinal edge (21, 23) on both sides (Fig. 3). The strips (49, 51) or, in particular, the grooves (53, 55) formed accordingly (and optionally the slide rails (35, 37)) can cooperate as a guide system for inserting and folding the lens, in particular the lens body (41). The strips (49, 51) may be continuous in the longitudinal direction (Fig. 1) or interrupted (Fig. 6). For convenience, the guide system is set to be parallel to the longitudinal range of the half shells (13, 15). The strip (51) on the second half shell (15) preferably protrudes sufficiently far into the half shell (15) so that the tip (95) of the front haptic (43) is positioned on the strip (51), while at the same time the lens body may be placed on both sides on the inner surfaces (17, 19) below the strips (49, 51), in particular below the slide rails (35, 37).
[0077] The device according to the present invention, or alternatively, the method of mounting a lens in a loading chamber, is as follows: the lens is mounted into the loading chamber by advancing the optics (41) under the strip (51) or guide rail to a pre-mounted position. In this process, the haptic may be pre-folded slightly by receiving some tension. The haptics are preferably pre-folded in the direction of the optics. However, they may also be pre-mounted in a relaxed state and pre-folded during an additional loading process by the end user via the silicone stamp (10) of the piston. The forward haptic (43) is preferably placed in the strip (51), which is designed to be particularly deep so that the haptic cannot fall off on its own, unlike a conventional loading chamber (e.g., International Publication No. 2015 / 070358A2). For example, the strip (51) is continuous and substantially extended in a straight line, so that the haptic (43) is lifted onto the strip (51) and rises slightly above the plane of the extension of the lens body (41).
[0078] Alternatively, if the front haptic (43) is positioned in the same plane as the optic (41), the guide rail of the front region (103) (i.e., nozzle side) is positioned lower than the rear region (i.e., plunger side) or is correspondingly positioned lower. The region (103) can be optionally designed as a separate shelf that is separated particularly from the strip (51') and offset from the longitudinal axis of the strip as needed.
[0079] FIG. 6 illustrates an alternative loading device in which this type of area (103) for the front haptic (43) is set lower on the nozzle side than the support surface defined by the strip (51) of FIG. 1. The front haptic (43) and the optic (41) are mounted coplanarly with respect to the sliding rail (37) for the optic (41), and the separate support surface (103) for the front haptic (43) is correspondingly designed to match each other. This may be particularly advantageous for long-term storage depending on the material of the lens.
[0080] For example, the inner surfaces (17, 19), particularly the slide rails (35, 37), serve as support surfaces for the optic (41) in a relaxed state (Fig. 1), while the strip (51) can serve as a support surface for the front haptic (43) in a relaxed state. When the loading chamber is closed, the strips (49 and 51) press the optic and rear haptic below and cause the optic and rear haptic to fold downward (i.e., deflect toward the first joint (29), see Fig. 3), and the front haptic (43) seated on the strip (51) extends through the side rupture (90) or extends into the side recess (91) of the loading channel formed.
[0081] The support surface for the forward haptic (43) on the strip (51) of the second half shell (15) and the edge offset (21') forming the rupture (90) or alternatively the concave (91) of the first half shell (13) are matched with each other, and accordingly, when the two half shells (13, 15) are closed to form a closed channel (39), the forward haptic (43) passes through the rupture (90) across the strip (51) (or, according to an alternative embodiment, across a separate support surface (103)) and accordingly passes through the concave (91).
[0082] The strip (51) described herein has a multi-functional purpose. Like the strip (49), the strip (51) acts as a guide structure for inserting a lens and as an auxiliary device in that it presses the optic (41) placed under the strips (49, 51) to bend down the joint (29) when the wings (25, 27) are closed. Additionally, the strip (51) first serves to guide the front haptic (43) while inserting the lens into the loading device so that the front end of the front haptic (43) is inserted into the ledge in its longitudinal direction, and secondly serves as a guide for the front haptic (43) while closed so that the front haptic exits the closing chamber (36) and is guided across the strip (51).
[0083] Conventionally, it was important that the haptics not be seated on the guide rails, because while closed, the haptics would be trapped between the wings and would be torn when the lens is pushed forward. However, according to the present disclosure, the front haptic (43) is positioned on the strip (51). When the wings (25, 27) are closed, the lens, or alternatively its body (41), is folded into a "U" shape. This allows the front haptic (43) to slide between the wings (25, 27), creating a cavity between them in which the front haptic (43) is freely seated (i.e., not fixed) due to the recess (91). When the front haptic (43) is freely seated, the front haptic is pulled backward immediately as the optic (41) is pushed forward. Accordingly, they exit the cavity and are pulled longitudinally into an optic (41) that is folded into a “U” shape but still has its top open (hence “U” shape). As the lens is pushed forward toward the outside of the loading chamber toward the nozzle (11), the “U” shape becomes more closed in the narrowed passage, and the forward haptic (43) is surrounded between the legs of the U-shaped folded optic (41).
[0084] As illustrated in FIG. 1, the concave portion (91) (i.e., the rupture portion (90) or alternatively the rupture portion (90) having the concave portion (91)) is preferably formed on one half shell (here, the first half shell (13)). The strip (51) is formed on a corresponding area of the other half shell (here, the second half shell (15)) (i.e., a corresponding area that overlaps in the longitudinal or alternatively axial range of the loading device). Consequently, the area of the strip (51) (here, in particular the front or substantially nozzle-side area of the strip (51)) is on the opposite side of the rupture portion (90) that forms an opening on the chamber side facing the concave portion (91).
[0085] After the lens is discharged into the eye, the pre-folded optic (41) opens and releases the haptic (43).
[0086] The folding process described herein is such that the forward haptic (43) is controlled and fixed in the folded optic (41), and compared to the folding process of a conventional device having a folding or wing chamber, the release of the forward haptic (43) is delayed while the optic (41) is unfolded, so that the forward haptic (43) can be released from the eye only when the optic (41) is unfolded. By providing a rupture (90) in the wall (17) of the loading channel (39) in the loading chamber and a recess (91) extending from the rupture (90) along the length of the loading channel (39), the entire folding process (folding and unfolding) is modified, in particular, without the need to provide additional components.
[0087] FIG. 8 illustrates an arrangement of a cartridge (3) having a direct upstream nozzle (11). FIG. 9 illustrates a longitudinal cross-section through the arrangement of FIG. 8. The longitudinal cross-section shows a loading channel (36) of the cartridge (3) and a loading channel connected to a nozzle channel (101). The loading channel (36) and the nozzle channel (101) form a passage for a lens, which is pre-folded in the loading channel and then continuously folded and pressed more strongly in the nozzle channel (101), which narrows as it passes from the nozzle inlet (105) to the nozzle outlet (107). A recess (91) is located on the side of the loading channel (36). An edge (92) is provided in the region of the recess (91) at the transition from the loading channel (36) to the nozzle channel (101). The edge (92) forms a spatial boundary between the recess (91) and the nozzle channel (101). In particular, the nozzle inlet (105) (i.e., the inlet to the nozzle channel) forms a boundary edge (92) in the area of the recess (91), and when the lens is pushed forward, the forward haptic of the lens extended into the recess (91) is pulled over the edge (92). For convenience, the edge (92) is arranged in a manner that substantially crosses the longitudinal range of the half shell, or crosses the injection direction, or alternatively, crosses the emission direction. By this edge (92), the forward haptic (43) is pushed and folded into a "U" shape that is still partially open, or is pushed and folded between the legs of the folded lens when the lens is pushed forward (partially, when pushed from the loading chamber (39) toward the nozzle (11), and accordingly leads to a sandwich fold as the folded lens is pushed further forward. Accordingly, the edge (92) between the nozzle channel (101) and the concave portion (91) may also be referred to as a folding edge.
[0088] A closure (73), particularly a snap closure, is formed on the wings (25, 27).
[0089] A plug-in device (75) is formed on the half shell (15). The plug-in device (75) is used to insert into the opening of the injector housing (1). For example, struts (77, 77') with barbs are used as the means of insertion. The plug-in device (75) creates a solid connection between these parts after the cartridge (3) is inserted into the injector housing (1).
[0090] The injector illustrated in FIG. 7 is substantially composed of an injector housing (1) and a plunger (9), said plunger (9) is displaceable within the housing to transport and discharge a lens. In the illustrated embodiment, the cartridge (3) and, in some cases, the injector nozzle (11) represent individual parts that can be inserted into the injector housing (1), but they can also be designed as a single part. The plunger (9) is mounted in an initial position in the injector housing and is preferably fixed so as not to interfere with the insertion of the cartridge (3). By operating the piston at the piston end (81), the inserted lens can be discharged by pushing the plunger (9).
[0091] In summary, it can be explained as follows:
[0092] A folding device for an intraocular lens has two half shells (13, 15) connected by a hinge (29), and the half shells can be moved relative to each other, that is, closed relative to each other through wings (25, 27) formed on the half shells (13, 15) to fold the inserted intraocular lens and simultaneously prepare for the ejection of the lens from the loading carrier channel formed by the closed half shells (13, 15). Between the edges (21, 23) of the half shells (13, 15) closed relative to each other, a recess (91) is formed on the nozzle side through which the forward haptic (43) exits when the optic (41) is folded. Due to the resulting pressure on the edge (92) and the front haptic (43), which are positioned on the nozzle side in front of the recess (91) and designed so that the front haptic (43) is pulled from the recess (91) and over the edge when the lens is ejected from the loading chamber, the haptic (43) is folded (toward the recess) but sandwich-folded between upwardly open optic legs. Consequently, it has become possible to sandwich-fold the pre-mounted lens using wing-type cartridges (particularly by folding the wings together), or more generally, to sandwich-fold the lens using hinge-type cartridges for the purpose of injecting the lens into the eye, so that the haptic unfolds only when the optic unfolds when injected through the nozzle (i.e., not before the optic unfolds). This device also enables the front haptic to be folded in the aforementioned manner in the case of a loading chamber separated from the rest of the injector.
[0093] To prevent the haptics (43, 44) from being clamped when closing the lens and, in particular, the half shells (13, 15), the cartridge (3) may be provided with a cover member (45) as described in detail in International Publication No. 2015 / 0730358A2. The cover member, pivotably provided on the longitudinal wing side of the first half shell of the two half shells, serves to cover the intraocular lens inserted between the half shells in the open position of the half shells. Accordingly, the cover member covers the open chamber formed by the half shells longitudinally while protecting the lens or, alternatively, holding the lens in place. When the two half shells are closed, 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 formed by the two half shells. The cover member is attached to the first half shell in both the open and closed positions (preferably, it is attached and maintained). This system has the advantage of reducing the risk of lens haptics getting trapped while folding.
[0094] The cover member (45) is movably arranged or alternatively fixed to the longitudinal edge (21) of the first half shell (13), particularly in a movable or foldable manner (similar to a single-leaf swing door). The cover member (45) is advantageously designed as a lid plate, particularly a flat and dimensionally stable lid plate. In the open position of the cartridge (3), the cover member (45) extends across the storage surfaces (17, 19) from the longitudinal edge (21) of the first half shell (13) to the longitudinal edge (23) of the second half shell (15).
[0095] Advantageously, the cover member (45) is movably fixed to the longitudinal edge (21) of the first half shell (13) through the second joint (47). Preferably, the joint (47) is a hinge, in particular a film hinge, and is composed of a bending groove or a folding area.
[0096] The rotation axes of the first and second joints (29, 47) are preferably aligned parallel to each other.
[0097] The cover member (45) is closed toward the longitudinal edge (23) due to gravity and / or spring tension of the second joint (47). Because the cover member (45) is structurally magnetic (i.e., sufficiently rigid), the covered chamber (46) at the open position of the cartridge (3) is formed between the first half shell (13), the second half shell (15), and the cover member (45). The 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 preferably arranged on a strip (49) protruding 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), it is preferable to form a second protruding strip (51) that serves as a support for the cover member (45) when the cartridge (3) is open. The longitudinal side of the strip (49), preferably tapered, is joined by a film hinge for convenience.
[0098] The strip (49) is preferably formed to have a concave bending groove on the outside of the chamber. In particular, the bending groove has a linear material displacement along the length of the first half shell (13), thereby creating a bending performance of the material. With this configuration, the cover member (45) can be folded toward the first wing (25) in an articulated manner. In particular, the bending groove acts as a film hinge.
[0099] The longitudinal edge (23), specifically the strip (51), on the free end (58) of the second half shell (15) and the cover member (45) is pushed forward and slides along the wing surface (28) when the two wings (25, 27) are pressed together (i.e., when the wing handles are manually gathered). Thus, the strip (51) can form an add-on of the cover member.
[0100] In the closed position of the cartridge (3) (Fig. 3), the cover member (45) is placed substantially outside the closed chamber (39) formed by the chamber (46) and preferably between the wings (25, 27). During the closing process of the cartridge (3) where the wings (25, 27) of the cartridge (3) come together, the cover member (45) slides from the latching position of the edge (23) onto the inner wing surface (28) of the second wing (27) and slides along this wing surface (28) to the outside of the closed cavity (46) or, alternatively, to the outside of the cavity (39) being formed.
[0101] With respect to the cover member, the device has the following features in particular:
[0102] - A cover member (45) is pivotally provided in the first half shell (13) of the two half shells in the longitudinal direction, and in the open position, the cover member covers the open chamber (46), and in the closed position, the cover member is located outside the substantially closed chamber (39).
[0103] - The cover member has an edge development (99) that is retracted relative to the nozzle side end surface of the half shells (13, 15) on the nozzle side, preferably so that when the lens is inserted, the front haptic of the lens is not covered by the cover member and the optic of the lens is covered by the cover member.
[0104] - The cover member (45) is retracted relative to the nozzle side end surface of the half shells (13, 15) to the extent that when the lens is inserted, the front haptic (43) is not covered by the cover member, and the optic (41) can be covered.
[0105] - The cover member (45) is in the form of a plate.
[0106] - The cover member (45) is pivotably arranged on the longitudinal edge (21) of the first half shell (13).
[0107] - The cover member (45) is connected to the first half shell (13) through a second joint (47) designed, for example, as a hinge, particularly a film hinge.
[0108] - A bending groove is formed on the cover member surface that is offset from the inner surface (17) of the first half shell (13).
[0109] - A cover member strip (51) is formed on the longitudinal edge (23) of the second half shell (15).
[0110] - When the two half shells (13, 15) are closed, the cover member (45) slides from the closed chamber (46) over the longitudinal edge (23) of the second half shell (15).
[0111] - In the closed position of the half shells (13, 15), the cover member (45) is located substantially outside the closed chamber (39) between the wing handles (25, 27).
[0112] - The concave portion (91) on the first wing (25) essentially follows the nozzle-side edge development (99) of the cover member (45) in the closed position, or has an edge development (97) further away from the nozzle-side end face of the half shells (13, 15) (compared to the nozzle-side edge development (99) of the cover member (45).
[0113] - In the closed position, the cover member (45) is placed outside the substantially closed chamber (39), preferably between the wings (25, 27).
[0114] - The cover member (45) is designed to be structurally self-supporting.
[0115] - In the process step of assembling the two half shells (13, 15), the cover member (45) (if present) is fixed until the two longitudinal edges (21, 23) of the two half shells (13, 15) come into mutual contact with each other.
[0116] Although specific embodiments have been described above, it is evident that different combinations of the described embodiments may be used, provided that the embodiments are not mutually exclusive.
[0117] Although the present invention has been described above with reference to specific embodiments, it is evident that changes, modifications, variations, and combinations may be made without departing from the principles of the invention. Explanation of the symbols
[0118] 1 Injector housing 3 cartridges 5. Front (or front) of the cartridge 7. Back of cartridge (or rear end) 9 Plunger (also referred to as piston) 10 stamps 11 Infusion cannula or nozzle 13th 1st Half Shell 15 Second Half Shell 17 The first inner surface, i.e., the inner surface of the first half shell 19 The second inner surface, i.e., the inner surface of the second half shell 21. The longitudinal edge of the loading area of the first half shell, i.e., the first longitudinal edge 21' Offset edge region of the first half shell (part of the first longitudinal edge (21)) 23. The longitudinal edge of the loading area in the second half shell, i.e., the second longitudinal edge 25 1st Wing 26 Wing surface of the first wing 27 Second Wing 28 Wing surface of the second wing 29. First joint, especially the film hinge 35 1st slide rail 36 closed chambers 37 Second slide rail 39 Loading channel designed as a closed chamber and closed channel 41 Optic lens body (also referred to as lens body or optic) 43 Forward Haptic 44 rear haptic 45 Cover missing 46. An open chamber covered by a cover member as needed. 47 Second joint, especially film hinge 49 The first edge strip, i.e., the edge strip on the longitudinal edge of the first half shell 51, 51' The second edge strip, that is, the edge strip on the longitudinal edge of the second half shell, also referred to as the guide rail 53 Groove 1 55 2nd Groove 58 Free end of cover member 71 Free end of cover member 73 closure 75 Plug-in Devices 77, 77' struts 81 Plunger end (piston end) Rupture of the inner wall with a half-shell in the 90-degree closed position 91 Concave part 92 edge or folding edge 93 Haptic accessories connecting haptics to the optic lens body, in particular accessories for front haptics 95 The haptic tip, also referred to specifically as the free end of the haptic. 97 Development of the lateral edge of the wing's concave portion 99 Face side edge deployment without cover 101 Nozzle Channel 103 Alternative separate support surface for forward haptics 105 Nozzle inlet 107 Nozzle Exit
Claims
Claim 1 A loading device for receiving and folding an intraocular lens having a lens body and at least one haptic, comprising a first half shell (13) and a second half shell (15), wherein the half shells are each articulated with each other at first longitudinal sides through a joint (29) and can be moved relative to each other from an open position to a closed position, the inner surfaces (17, 19) of the half shells form a storage surface, wherein in the open position, the half shells (13, 15) form an open chamber (46) for arranging or storing the lens in a relaxed state, wherein in the closed position, the half shells (13, 15) form a closed chamber (36) for arranging or storing the lens in a folded state and discharging the lens along a longitudinal extension of the half shells (13, 15), and wherein at least one of the half shells (13, 15) has a front haptic (43) of the lens in the closed position of the half shells (13, 15). A loading device characterized by forming a recess (91) that accommodates, wherein the recess is open at least within the half shell, and in the closed position of the half shells (13, 15), the recess (91) forms an area arranged on the side with respect to the closed chamber (36) and configured such that the front haptic of the lens can be accommodated inside and the optic of the lens is positioned in the closed chamber (36). Claim 2 A loading device according to claim 1, wherein the concave portion (91) extends forward of the closed chamber (36). Claim 3 A loading device according to claim 1 or 2, wherein at least one of the half shells (13, 15) is provided with a strip (51) or a support surface (103) for the forward haptic (43), and the strip (51) or the support surface (103) guides the forward haptic. Claim 4 A loading device according to claim 3, wherein the strip (51) or support surface (103) and the recess (91) are formed and cooperate such that when the half shells are closed from the open position to the closed position, the front haptic (43) extends further beyond the strip (51) or support surface (103) to the outside of the closed chamber (36) and settles in the recess (91) at the closed position. Claim 5 A loading device according to claim 1, wherein wings (25, 27) are respectively provided on the second longitudinal side of two half shells (13, 15), so that the half shells (13, 15) can be moved relative to each other from the open position to the closed position through the wings (25, 27) and by rotation around the joint (29), and the concave portion (91) is retained in at least one of the wings (25, 27). Claim 6 A loading device according to claim 1, wherein each of the half shells (13, 15) is provided with at least one slide rail (35, 37), and at least one slide rail guides the lens body and the end (44) of the rear haptic. Claim 7 A loading device according to claim 1, wherein a cover member (45) is pivotally arranged in the longitudinal direction on the first half shell (13) of the two half shells, and the cover member covers the open chamber (46) in the open position and is located outside the closed chamber (36) in the closed position. Claim 8 A loading device according to claim 1, characterized by being composed of a cartridge for insertion into an injector. Claim 9 An injector having an injector housing (1) having a loading device (3) having foldable half shells (13, 15) according to claim 1, a nozzle (11) mounted upstream of the loading device (3), and a plunger (9) capable of being displaced longitudinally toward the nozzle (11) within the injector housing (1), wherein the closing chamber (36) of the loading device can be pushed by the plunger (9) to release an intraocular lens, and at least at the closing position of the half shells (13, 15), an edge (92) is arranged on the nozzle side of the half shells (13, 15), and the forward haptic of the lens is pressed by the edge (92) or folded when the lens is pushed forward into the folded lens. Claim 10 In claim 9, the injector is characterized in that the edge (92) is formed at the boundary between the concave portion (91) and the nozzle side. Claim 11 A method for folding an intraocular lens comprises: providing a storage surface (17, 19) having an anterior portion, a nozzle proximity region, and a rear portion, wherein the nozzle proximity region is formed by at least a first half shell (13) and a second half shell (15), and the two half shells (13, 15) are articulated with each other by a first joint (29); and placing the lens on the storage surface (17, 19) such that the lens body (41) of the lens is positioned on the storage surface (17, 19) such that the front haptic (43) of the lens is positioned on the anterior portion of the storage surface adjacent to the nozzle with respect to the lens body (41). The method includes the step of bringing the two half shells (13, 15) together through the first joint (29) by guiding the two half shells (13, 15) toward each other by rotation around the first joint (29), so that the lens body (41) is folded at its central portion and pressed into a form having two legs that fold toward each other, such that the lens body (41), which was in a lens shape in a relaxed state, is pressed; and while the optic lens body (41) is folded, the front haptic (43) exits from the space between the half shells (13, 15) that closes the periphery of the lens body by means of a free end (95) of the haptic that slides into a recess (91) provided in at least one of the half shells (13, 15); and at the closed position of the half shells (13, 15), the recess (91) is arranged laterally with respect to the closing chamber (36) and the front haptic of the lens is received inside. A method characterized in that the optic body of the lens forms an area configured to be located in the closed chamber (36). Claim 12 A method according to claim 11, wherein the space formed between the closed half shells is in the shape of a cylinder, and the concave portion (91) is created to allow the front haptic (43) to exit from the space on the surface side of the cylinder. Claim 13 A method according to claim 11, wherein the lens is oriented on the storage surface such that the front haptic (43) is positioned over the joint (29), thereby positioning the haptic accessory (93) over the first half shell (13) and the end (95) of the haptic over the second half shell (15). Claim 14 A method according to claim 11, characterized in that the lens is inserted into the cavity (46) in a relaxed state. Claim 15 A method according to claim 11, wherein the optic lens body (41) has its edges surrounded by two half shells (13, 15) and is folded in the same direction together with the half shells (13, 15). Claim 16 A method according to claim 11, characterized in that when the loading chamber is closed, the optic lens body and the rear haptic descend and the front haptic is guided into the concave portion (91). Claim 17 A method according to claim 11, characterized in that the concave portion (91) extends forward of the closed chamber (36). Claim 18 A method for folding an intraocular lens and pushing it toward an injection nozzle, comprising: a folding step in which the lens body (41) is folded at its central portion by folding according to any one of claims 11 to 17, so that the lens body (41), which was in the form of a lens in a relaxed state, is pressed into a form having two legs that fold toward each other; and a step of pushing the folded optic lens body toward the injection nozzle so that the folded lens becomes increasingly compressed as the contraction in the direction toward the injection nozzle increases, wherein when pushing toward the injection nozzle, a front haptic (43) initially located in the concave portion (91) is pulled and fixed in the gap between the legs of the folded lens body (41), the gap becomes narrower as the lens is pushed forward, and the front haptic (43) is pulled out to the outside of the concave portion (91) on the edge (92) while being pulled, thereby the lens that continues to narrow as the lens is pushed forward. A method characterized by being fixed in the gap between the legs of the main body (41).
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