Patent Application
20240008975
This invention relates to a device for receiving an intraocular lens and a method for folding an intraocular lens.
In cataract operations, artificial lenses, so-called intraocular lenses, are nowadays inserted into the capsular sac of the eye as a standard procedure.
During the operation, an ocular incision of typically 2 to 4 mm is made, through which the natural lens of the eye is first removed and then the implant is placed. For insertion, the artificial lens is inserted through the incision into the capsular sac in a folded state. As soon as the folded lens is inserted into the capsular sac, it unfolds back to its original shape.
The artificial lenses commonly used today consist of an optical lens body and, as a rule, two or more haptics projecting peripherally from the optical lens body at right angles to the optical axis of the lens body, which haptics serve as position springs for the lens body in the capsular sac. For example, there are two haptics which are arranged opposite one another on the lens body, each of which projects outward in a spiral manner in the same direction from the lens body. This haptic form, which is the most commonly used in the world, is known in the industry as open c-loop haptics.
Improved surgical tools and implants allow surgeons to make noticeably smaller incisions. Removal of the natural lens of the eye can nowadays be performed through incisions of less than 2 mm. However, this only makes sense if the intraocular lens can also be inserted through such a small incision.
Lens carriers or cartridges, in which a lens can be loaded and then ejected from the lens carrier by means of an injector have been developed in recent years for the insertion of an intraocular lens.
Examples of such lens carriers or cartridges and injectors are known, for example, from the patent specifications U.S. Pat. Nos. 6,267,768, 5,810,833, 6,283,975, 6,248,111, 4,681,102, 5,582,614, 5,499,987, 5,947,975, 6,355,046 and EP 1 290 990 B1, as well as the disclosures US 2004/0199174 A1, EP 1 905 386 A1 and WO 03/045285 A1.
In the injector device according to U.S. Pat. No. 4,681,102, the cartridge, which is formed as a folding device for the lens, and the injector nozzle, are separate parts. The cartridge can be inserted into the injector housing, whereupon the injector nozzle can be screwed onto the front of the injector housing.
In the injector device according to U.S. Pat. No. 5,582,614 and most of the previously known injector devices, such as U.S. Pat. Nos. 6,267,768, 5,810,833, 6,283,975 and 6,248,111, the cartridge exists as an integral unit with a folding device and an injector nozzle.
Intraocular lenses are supplied by the manufacturer in sterile packaging and, if necessary, in a liquid bath. Depending on the lens material, storage in a liquid may be necessary to protect the lens from dehydration. During the operation, the lens must be removed from the packaging in the sterile area and inserted or alternatively loaded into the loading device of an injector or directly into an injector with the cartridge provided. The lenses are very sensitive structures which can easily be damaged during transfer to a cartridge, during folding or during ejection from the injector nozzle. The risk of damage is particularly high for the haptics surrounding the optical part of the lens. In particular, when the lens is ejected from the injector, there is a risk that one of the two haptics will be pinched and consequently torn off, or that the front haptic will prematurely spread into the eye ahead of the lens body, which can be problematic, as shown below.
A common cartridge design, as shown by EP 1 290 990 B1, WO 03/045285 A1, EP 1 905 386 A1, U.S. Pat. Nos. 5,582,614 and 5,499,987, has two half-shells connected by a single hinge, whether or not with grooves or gripping means for clasping the edges of the lens.
For example, disclosure WO 03/045285 A1 shows a method for inserting an intraocular lens into the capsular sac of the eye, in which an overpressure is created to eject a lens floating in a lubricant from the injector nozzle. A compressible and deformable piston continuously adapts to the forward narrowing of the nozzle channel. The lens continues to fold as it travels and has a very small diameter at the end of its path. Because of the deformability of the piston, the end of the nozzle channel can be kept very narrow, consequently only a very small incision is required. A kit for performing the procedure contains a lens carrier and a lens. The lens is located in the lens carrier in a tension-free state. The lens and lens carrier may be carried by a holder and sterilely packed in a package until use, in the case in point a hydrophilic lens in a liquid that protects the lens from dehydration. During the operation, the lens holder together with the lens stored within is removed from the pack, inserted into the injector and folded. A lubricating fluid is then filled up through the channel. The lens can now be injected into the capsular sac of the eye to be treated.
In general, systems for prefolded lenses and systems for non-prefolded lenses can be distinguished in the prior art. In the systems without prefolded lenses, the lenses are only first folded during the ejection process for injection. An example of such a system without prefolded lenses is disclosed in U.S. Pat. No. 8,668,734 B2. In this disclosure, a cartridge consisting of two mold halves is used, into which the lens is inserted when the mold is open. This system also provides a recess laterally to the direction of ejection of the piston for the rear haptic, whereas the front haptic is mounted distally. There are, however, systems used in which the lens, when still unformed or alternatively unfolded, is loaded from the rear into a loading chamber (as shown, for example, in U.S. Pat. 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 (usually made of silicone or TPE) is used, then this piston tip must fill the entire volume of the rear opening so as to not run the risk of steamrollering the rear of the two haptics with this piston tip and thus getting it caught. The large volume of the deformable piston tip leads to high system forces when the piston is advanced into the maximum tapered area of the cartridge tip. The resulting forces can even be greater than the forces caused by the lens itself. In addition, the expandability or compressibility of the voluminous piston tip limits the minimum necessary inner diameter of the front nozzle tip. For this reason, systems in which the lenses are folded or alternatively prefolded for injection, prior to the ejection process, are still frequently used today. In particular, winged cartridges (as disclosed, for example, in U.S. Pat. Nos. 6,267,768, 6,248,111, 5,947,975 or U.S. Pat. No. 4,681,102) are used for this purpose, which always consist of at least two initially opened half-shells. The lens is prefolded when the at least two half-shells are closed and is thus present in the loading chamber in a prefolded state. The prefolding of the lens together with haptics by means of closing of the winged cartridge reduces the inner volume of the closed winged cartridge to almost half and thus allows the use of smaller deformable piston tips, which induces smaller incision forces for the same inner diameter of the cartridge tip or bring about the use of smaller cartridge inner diameters and thus smaller incisions for the same incision force. The disadvantage of these systems for prefolding the lenses is that the lens haptics in particular, and in the worst case even the optics, can become trapped between the two wings of the cartridge when they are closed. Trapped haptics usually tear off when the lens is pushed further forward, which is tantamount to a total loss of the lens.
A winged cartridge for receiving an intraocular lens in a loading chamber is presented In the disclosure WO 2015/070358 A2. The winged cartridge is formed by a first and a second half-shell, each half-shell having a wing handle on the longitudinal side. The two half-shells are connected in an articulated manner to one another at the respective wingless longitudinal side, by means of a first joint and can be moved relative to one another from an open position to a closed position, wherein the two half-shells form an ejection channel for an interocular lens in the closed position. Further, the disclosure describes that a front c-loop haptic is prefolded by the front haptic, which is blocked on the nozzle side by a stopper, being pressed against the optic by advancing the stamp and indirectly by advancing the lens. This prevents the front haptic from being injected into the eye in a stretched form. Initially, the haptic forms a bow, but the longer the haptic, the more this bow is compressed during further advancement in the nozzle. Depending on the haptic design, this can result in the haptic being more or less “folded” in the middle of its length, and in doing so the folded, but still lengthwise stretched haptic enters the eye. Due to this folding, the haptic can then still only have half its length, which can be considered disturbing by the operating surgeons with regard to possible capsular sac damage.
With hydrophilic lenses, there is also the problem that the front haptic, if it is only pressed against the optic on the nozzle side in a winged cartridge, unfolds very quickly in the eye, even before the optic itself enters the eye. In the worst case, this results in a haptic that is basically stretched when it enters the eye. The lens body following behind the haptic follows the movement of the haptic and can therefore rotate 180° when it enters the eye (upper side down and lower side up). This is very disturbing for the surgeon, since they must rotate the lens in the eye in tight quarters to correct the situation.
In both of the above situations, it would be desirable for the front haptic to not only be pressed up against the optic on the nozzle side, but rather to rest on the optic in such a way that the haptic is grasped or alternatively enclosed by the edges of the optic during folding or alternatively further folding of the optic and can only unfold when the optic unfolds in the eye after injection, thereby releasing the front haptic. Such folding is also called sandwich folding. It is the most typical form of haptic folding in all cartridges that function without pre-folding (and therefore without wings) and the folding occurs only and exclusively during ejection through the internal geometry of the cartridge. WO 2014/74860 A1 and EP 2′916′769 B1 describe a typical embodiment of such a cartridge without prefolding. The front haptic is placed on the optic by the operator (operating room nurse or surgeon) by means of the small slit at the rear end of the cartridge already when inserting the lens into the cartridge. This form of loading a lens by the operator, irrespective of the injector systems used, is referred to as a non-preloaded injector. Preloaded lenses, on the other hand, are those that have already been placed in the loading chamber of the injector by the lens manufacturer and sterilized along with it. A cartridge according to WO 2014/074860 A1 can only be used for non-preloaded lenses, since the lens including the haptic must already be stored in the loading chamber in a relaxed position and for the entire lifespan of the product, whereas WO 2014/074860 requires the active threading of the front haptic through the slot at the end of the cartridge by the end user (operating room nurse or surgeon). Similarly, the disclosure US 2009/0270876 also shows a closed cartridge to be loaded from the rear. Here too, an active operation and loading by the end user is required. A relaxed preloading is also not possible here.
With a prefolded system (i.e. with a winged cartridge), on the other hand, it has been extremely difficult up to now for both preloaded and non-preloaded lenses to place the haptics on the optics in such a way that sandwich folding can be achieved, i.e. the haptic is clamped in such a way that it can only first detach from the optic in the eye, this since during the prefolding step, both the optic and the haptic are brought into a U-shape and the front haptic thus does not reach the top of the lens optic in a controlled and reproducible manner even during further advancement of the lens, but rather continues to mostly still only be pressed against the optic. In addition, with winged cartridges, the risk of the front haptic becoming trapped between the wings when the loading chamber is closed increases dramatically, if the haptic has previously been successfully placed on the optic.
Disclosure 3562/CHE/2014 (Indian patent application under examination titled “Leading Haptic Positioner for Preloaded IOL Delivery System” by R. D. Thularsiraj) presents a method for sandwich folding starting from a preloaded system. This sandwich folding for a preloaded system works in such a way that the haptic is manually placed on the optic by means of a manually sliding hook or slider, which is inserted into the loading chamber through the nozzle tip. As soon as the wings of the loading chamber have been closed, the hook is pulled out again.
Disadvantages of this method are that at least two additional components are required, making the system more expensive, and for the physician, two additional steps are inevitably created by advancing the slider and later withdrawing it. Since preloaded systems are often compared with one another on the basis of the number of preparation steps, this together with the additional costs represents a competitive disadvantage.
Another disadvantage of this concept is that this approach is only used for fully preloaded lenses (usually used for hydrophobic lenses). However, it is not usable for so-called semi-preloaded lenses (usually used for hydrophilic lenses). In the latter case, the lens is indeed preloaded in the loading chamber, but at least the loading chamber is stored separately from the rest of the injector in liquid. Since the slider is located in the nozzle, the hook at the end of the slider cannot be positioned in contact with the separately stored lens in the loading chamber. When the loading chamber is inserted into the injector after removal from the storage liquid, the hook must be retracted through the slider to a point where it does not interfere with insertion of the loading chamber into the injector. Due to the limited size relationships, it is difficult to accomplish that a far-retracted hook will accurately grip and position the haptic. This problem does not exist with fully preloaded lenses, since the haptic is usually already applied (positioned) to the hook at the factory.
Another disadvantage of this concept is that the hook must be inserted through the nozzle, so the maximum size of the hook and slider is the size of the nozzle at its tip. For very small incisions, the inner diameter of a tip can be in the range from 1 mm to 1.5 mm, resulting in very delicate hook and slider geometries. The more delicate the system is designed, the more difficult it is to create a reliable system that reliably captures and positions the haptics.
The purpose of this invention is to provide an alternative device or system for preloaded intraocular lenses in which the front haptic does not protrude or alternatively project when ejected from the injector nozzle or alternatively injected into an eye. In particular, it would be desirable to place the front haptic of lenses, especially c-loop lenses, securely and reproducibly on the optics for injection into an eye, especially in such a way that the front haptic does not project or protrude during injection, but rather is clamped in the sandwich. A further purpose of this invention is to create an alternative device or system which, when injecting a lens into an eye, keeps the front haptic with the optic as long as possible, so that, as far as possible, the haptic unfolds from the optic only in the eye and this may be only when the optic unfolds. This purpose is to be solved in such a way that no additional parts, no additional costs and no additional application steps may be required. The system or alternatively the device shall be suitable for fully preloaded as well as semi-preloaded lenses. The system is also intended to function in conjunction with winged cartridges, in particular wing loading chambers which can be inserted into injector housings.
A further purpose of this invention is to provide a device for easy loading of an intraocular lens, which avoids the disadvantages of the described known systems and methods. It is further purpose of this invention to provide a device which folds an intraocular lens without damaging it during folding and/or injection. Furthermore, a device is to be provided which is optimized as regards the manipulation steps for the preparation of lens and injector. In particular, as few manipulation steps as possible should need to be carried out on the device after delivery of the lens and injector or alternatively immediately before the surgical intervention. In addition, a device should be provided which requires as few additional components as possible, in the best case, even without any additional components when compared to existing injectors, and thus fulfills the above-mentioned objectives without generating additional costs. Another goal is to create a device that requires only small incisions in the eye.
According to the invention, the purpose is solved by a device, in particular a loading device, for receiving an intraocular lens, having a lens body and at least one haptic. The device comprises a first half-shell and a second half-shell, which are respectively connected in an articulated manner to one another at a first of their longitudinal sides by a first joint and can be moved relative to one another from an open position to a closed position, wherein the half-shells in the open position form an open chamber for positioning or storing the lens (esp. for positioning or storing the lens in the relaxed state), and in the closed position the half-shells form an enclosed (on the shell side) chamber (in particular a cylindrical chamber) for positioning or storing the lens (in particular for positioning or storing the lens in the folded state) and for ejecting the lens along the longitudinal extent of the half-shells. The device is advantageously characterized in that in at least one of the half-shells a recess is formed which is open at least from the inside of the half-shell and which is suitable to receive a front haptic of the lens in the closed position of the half-shells.
The invention has the advantage that the reservoir ensures that the front haptic of a preloaded lens with c-loop haptic is positioned on the optic in the loading chamber, in particular when using a loading chamber consisting of two half-shells connected to one another by a hinge, in such a secure and reproducible manner, in particular in the sandwich, that the haptic can only first unfold when the optic also unfolds in the eye. In particular, when a lens is injected into an eye, the front haptic cannot detach from the optic, i.e., the lens body, until the optic begins to unfold.
The advantageous embodiment features listed below, alone or in combination with one another, lead to further improvements of the device according to the invention and its application.
Advantageously, in the closed position of the half-shells, the recess forms an area, in particular a secondary space, which is arranged longitudinally to the enclosed chamber and is expediently configured such that the front haptic of the lens can be accommodated therein whereas the optics of the lens are positioned in the enclosed chamber.
Advantageously, each half-shell is equipped with at least one slide rail, the at least one slide rail being suitable for guiding the lens body and optionally the end of the rear haptic. As a result, the position of the lens body, i.e., the optics, in the device is more reliably predetermined. In particular, the sliding slide serves the purpose of guiding the ejection of the lens from the enclosed chamber or alternatively from an injector).
It is particularly advantageous that at least one of the half-shells, such as the second half-shell, is provided with a support for the front haptic, the support being suitable for guiding the front haptic, in particular the free end of the front haptic. During loading or for storage, the free end of the front haptic may be placed on the support in a substantially relaxed state. This support for guiding the front haptic may be placed parallel to the slide rail(s) for guiding the lens body, the slide rails may be located deeper in the open chamber than the support for guiding the front haptic. The support for the front haptic can be designed on the longitudinal edge of the second half-shell as an edge strip projecting into the open chamber. The support may be designed as a continuous guide structure arranged parallel to the slide rail(s). A front haptic resting on the support thus does not lie in a coplanar plane with the optics in the open chamber, but rather is elevated relative to the plane in which the optics lie. The support can alternatively be interrupted and/or, if necessary, be designed as a separate holder on a side of the device close to the nozzle. In particular, the support may be lowered on the side near the nozzle such that the front haptic, when resting on the support, is coplanar with respect to the optic.
Expediently, the support and the recess are configured and cooperate in such a manner that, upon closing of the half-shells from the open position to the closed position, the front haptic (43) extends increasingly beyond the support and out of the closed chamber that is formed, so as to come to rest in the recess when in the closed position.
Expediently, the chamber that is enclosed in the closed position of the half-shells substantially forms a channel, in particular a loading channel or alternatively an ejection channel. The enclosed chamber substantially forms a cylinder-like channel, the shell side of which is substantially defined by the half-shells, wherein the said recess forms an opening in the shell side. The recess for receiving the front haptic of the lens may form a lateral opening in the channel extending to the front side of the channel, in which the front haptic of the lens can be received.
Advantageously, wings are respectively arranged on a second longitudinal side of the two half-shells, in particular on the respective longitudinal edge of the half-shells, so that the half-shells can be moved relative to one another from an open position to a closed position by means of the wings and by rotation about the joint, wherein the recess may continue in at least one of the wings.
The recess may be such that the haptic is not substantially compressed or blocked when sliding into the recess during the closing of the half-shells. It is expedient that the recess is arranged on the inside of the wing and in such a way that, when the half-shells are in the closed position, the recess may be substantially adapted to the dimensions of the haptics.
It is further convenient that the recess is arranged such that it is formed in two substantially parallel surfaces (in particular, the inner surfaces of the two wings), wherein the said parallel surfaces (which may be substantially formed by the wings) have a reciprocal distance in the closed position of the half-shells which is at least equal to or exceeds the thickness (or diameter) of the haptic and optionally does not exceed five times or, optionally twice the thickness of the haptic. The recess between the substantially parallel surfaces is at least sufficiently wide and deep that the haptic is not substantially jammed, pinched or blocked when sliding into the recess located in the space spanning the width and the depth.
Optionally, a cover member may be pivotally disposed longitudinally on the first of the two half-shells, which cover member covers the open chamber when the half-shells are in the open position and is positioned substantially outside the enclosed chamber when the half-shells are in the closed position.
Optionally, a closure, in particular a snap closure, may be formed on the wings.
Optionally, a plug-in device for insertion into a receiving opening of an injector housing may be formed on one of the half-shells. Optionally, the plug-in device is provided on the second half-shell.
The device can be in one piece. From a manufacturing point of view, it is advantageous if the device is in one piece and may be made of plastic. Injection molding technology can be used in this case.
The device can expediently be designed as a cartridge for insertion into an injector, in particular into an injector housing. Advantageously, the device according to the invention may be an integral part of an injector.
Further disclosed herein is an injector having an injector housing and a plunger longitudinally displaceable in the injector housing for use with a device configured as a cartridge as described above.
Further disclosed is an injector having an injector housing with a loading device provided therein, a nozzle located upstream of the loading device, and a plunger longitudinally displaceable toward the nozzle in the injector housing, wherein the loading device is equipped with a chamber which can be pierced by means of the plunger for the purpose of ejecting a lens, wherein the loading device is designed as described above, in particular with collapsible half-shells. The injector is characterized in that, 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, through which the front haptic is pressed or folded into the folded lens, in particular between the legs (or leg flaps) of the folded lens body, when the lens is pushed forward or folded in. The folding edge limits the recess toward the nozzle.
The folding edge may be provided between the loading device and the nozzle inlet of a nozzle, and, in particular, between the recess of the loading device and the nozzle inlet adjacent thereto. By way of example, the folding edge is formed at the nozzle inlet, expediently where the nozzle inlet of a nozzle abuts the loading device and in particular the recess of the loading device. Alternatively, the folding edge could be formed on at least one of the half-shells instead of on the nozzle inlet of the nozzle, or on the housing, so that it is formed between the loading device and the nozzle. In designs in which the nozzle and loading device are made in one piece, the folding edge is expediently placed between the nozzle area and the loading area.
It is expedient that in the closed position of the half-shells, the folding edge is positioned on the nozzle side in such a way that when the lens is pushed forward, the front haptic is folded or alternatively pressed into the folded lens, in particular between the legs of the folded lens body.
Further disclosed is a method of folding an intraocular lens comprising the steps of:
Advantageously, the space created between the closing half-shells is substantially cylindrical, and the recess is created in such a way that the haptic can escape from the space on the side of the cylinder surface.
Advantageously, the lens is oriented on the storage surface in such a way that the front haptic of the lens comes to lie above the joint in such a way that the base of the haptic, which connects the haptic to the optical lens body, is positioned above the first half-shell and the end of the haptic is positioned above the second half-shell.
Advantageously, the lens can be inserted into the cavity in a relaxed state. This means that the lens can be inserted into the device (in particular by hand) without externally applied mechanical tension, in particular without bending or folding the lens.
It is expedient that the lens rests on the inner surfaces of the two half-shells, especially after manual insertion. This means that the lens rests at least on the inner surface of each half-shell at one point.
It is expedient that each half-shell is equipped with a support, e.g., designed as slide rails.
It is expedient that the optical lens body is enclosed at its edges by the two half-shells and is folded together with the half-shells, in particular in approximately the same direction.
In the process step involving bringing the two half-shells together, the process may include bringing them together until the two longitudinal edges of the two half-shells abut against one another (whereby a cover member—if present—is clamped).
According to the invention, the optics and optionally the rear haptics are lowered when the loading chamber is closed, whereas the front haptics are guided into the recess.
Further disclosed is a method for folding an intraocular lens and ejecting the lens through an injection nozzle, comprising the steps of:
The device according to the invention can be used with relatively small incisions in the eye (in particular incisions with a diameter of less than 2.5 mm, optionally less than 2.2 mm, less than 2 mm, or less than 1.5 mm). This is possible because the device according to the invention has a loading chamber for a folded lens to be injected, which encloses the lens like a jacket and is thus closed (longitudinally). The lens is prefolded therein to a particularly small cross-sectional diameter and can be injected by means of a narrow cannula and through a—as described—particularly small incision. In a particularly advantageous manner, said device is used with a deformable stamp, in particular a silicone stamp (e.g., according to the disclosure document WO 03/045285 A1).
Additional advantages and objectives of this invention will be apparent from the following description.
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:
In the following, identical reference numbers stand for identical or
functionally identical elements (in different figures).
An injector is a surgical tool with a sleeve-like housing 1 and a plunger 9 (
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 (
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 (
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.
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.
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.
Optionally, the recess 91 is open not only toward the half-shell inner side 17 but also toward the nozzle side.
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.
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.
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 (
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.
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.
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 (
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.
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.
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.
As shown in
After the lens has exited into the eye, the previously folded optic 41 opens and releases the haptic 43.
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.
A closure 73, in particular a snap closure, is formed on the wings 25, 27.
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.
The injector shown in
In summary, the following can be stated:
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.
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.
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.
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.
The axes of rotation of the first and second joints 29 and 47 are aligned parallel to one another.
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.
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.
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.
In the closed position of the cartridge 3 (
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.
With respect to the cover member, the device is, in particular, characterized by the following features:
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.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 01429/18 | Nov 2018 | CH | national |
This application is a national phase entry under 35 U.S.C. § 371 of PCT/CH2019/050026 filed Nov. 19, 2019, which claims priority to Swiss Patent Application No. 01429/18 filed Nov. 19, 2018, the entirety of each of which is incorporated by the reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CH2019/050026 | 11/19/2019 | WO |
