EP1434541A2

EP1434541A2 - Device for folding an intraocular lens and system for storing an intraocular lens

Info

Publication number: EP1434541A2
Application number: EP02782893A
Authority: EP
Inventors: Thomas Herberger; Gerd Van Der Heyd; Arthur Messner
Original assignee: Humanoptics AG
Current assignee: Humanoptics AG
Priority date: 2001-10-12
Filing date: 2002-10-11
Publication date: 2004-07-07
Also published as: WO2003044946A2; US20040199174A1; WO2003044946A3; AU2002347005A8; AU2002347005A1

Abstract

The device forms part of an injection system for injecting a foldable intraocular lens (56) into a human eye. The device comprises a folding area (4) having two pivotable half-shells that are connected to one another, which can be moved from an initial open position to a closed final position. According to the invention, a film-like loop (14) is provided, said loop being fixed to the first half-shell (8a) by one fixing end (16) and being displaceably guided in the second half-shell (8b). In the initial open position, a locating area (22) for the IOL (56) is formed between the loop (14) and both half-shells (8a,8b). The half-shells (8a,8b) can be moved in the direction of their final position by pulling the displaceably guided loop (14). The arrangement of a loop (14) makes it possible to achieve safe and gentle folding of the IOL (56). The arrangement of the loop (14) also makes it possible to store the unfolded IOL (56) in the folding area (4).

Description

description

Device for folding an intraocular lens and storage system for an intraocular lens

The invention relates to a device for folding an intraocular lens with a folding area which has two pivotable half shells which can be pivoted from an open starting position into a closed end position, in which they enclose a guide channel for the intraocular lens between them. The invention further relates to a storage system for an intraocular lens.

The device is used to implant a foldable intraocular lens (hereinafter referred to as IOL). With the device, which can optionally be supplemented by additional components to form an implantation system, the implantation of a temporarily folded IOL is to take place through an approximately 3 mm cut opening in the capsular bag of a patient suffering from cataracts.

In operations of the above The size of the incision required to insert the foldable IOL into the eye is of great importance. To ensure an optimal healing process, it should be as small as possible (approx. 3 mm). The only way to meet this requirement is to "fold" the IOL. There are generally three different systems or methods for implanting the IOL.

In a first system, a container is used in which the IOL is folded, then removed using tweezers and then taken over with the implantation tweezers in the folded state and inserted into the capsular bag. DE 40 39 119 C1 describes a container for this system that is designed to be suitable for folding the IOL. With this system, however, the risk of the lens falling must be taken into account, since it is under mechanical tension when folded. In addition, the surgical method requires some practice. According to a second system it is provided to fold the IOL in a folding device and to insert the folding device together with the folded IOL in an injection aid, a so-called injector. The injector provides axial propulsion and possibly a further reduction in the cross-section of the lens to be injected. Such a system is described, for example, in EP 0 785 760 B1 or in US 4,681,102 A. According to WO 96/15743, it is also provided that the insertable folding device can also be used as a container for the lens, so that the IOL is not moved by one separate container in the folding device is necessary and the otherwise existing risk of falling does not exist. In the case of the folding processes taking place in the folding devices, destruction of the implant cannot be ruled out, but this can only be ascertained when the implant is in the patient's eye.

In a third injection system, the folding device and the injector form a unit, so that the insertion process is not required. Such a system can be found, for example, in DE 36 10 925 A1.

Handling systems for an IOL, in which it is held in a specific shape or brought into such a shape with the aid of a thin film or tape, are known for example from US Pat. No. 5,976,150 A and US Pat. No. 4,917,680.

The invention has for its object to ensure a safe and gentle folding of the IOL and a high level of operational safety.

The object is achieved according to the invention by a device for folding an intraocular lens according to claim 1. It is provided that the device has two pivotably connected half-shells in a folding area, which can be pivoted from an open starting position into a closed end position. In the closed end position, the two half-shells enclose a guide channel for the IOL between them. Furthermore, a film-like band loop is provided in the device, which is fastened to the first half-shell with a fastening end and is displaceably guided on the second half-shell. It is in the open starting position between the Band loop and the two half-shells formed a receiving space for the IOL. The half-shells can be displaced in the direction of their end position, that is to say towards one another, by pulling on the slidably guided belt loop. The strap loop enables or supports the folding of the IOL in a very simple manner.

With such a device, a particularly safe and gentle folding of an IOL is guaranteed. For this purpose, this is first inserted into the receiving area and is already securely protected and held in this state by the strap loop, which closes the receiving space from the top. In the next step, the belt loop is pulled in one pull direction so that the two half-shells are pivoted towards each other. The IOL in the recording room is automatically folded. Since the IOL is already somewhat jammed between the half-shells and the strap loop in the starting position, the IOL cannot slip.

In a preferred development, the two half-shells each abut one another with their outer longitudinal edges in the closed end position. At the same time, the strap loop is fastened with its fastening end to the longitudinal edge of the first half-shell and guided on the longitudinal edge of the second half-shell. This has the advantage that when the two half-shells are folded together, the receiving space, which is delimited at the top by the belt loop, is continuously and continuously reduced to the guide channel formed in the end position. It is therefore impossible for a section of the IOL to be clamped between the two longitudinal edges when the two half-shells are folded together.

A guide slot is preferably provided in the region of the second half-shell with a view to reliably guiding the band loop.

According to an expedient development, the inside of one of the two half-shells is provided with a step, as seen in a cross section perpendicular to the longitudinal direction of the half-shells. On the one hand, this acts in the manner of a stop on which the still unfolded IOL is supported before the actual folding process and is held stationary. The step also represents a sudden reduction in the cross-sectional diameter. One end of the IOL lies in the folding process the step and the IOL is practically rolled up until its second end also reaches the step area. The second end can advantageously be guided past the first end of the IOL, which is located radially further outward, so that the IOL is wound up overall in the manner of a spiral.

Conveniently, a side flap extending along the channel axis is provided to form the step enabling the application of an edge of the IOL, which side flap can be guided from a front or outer position in the radial direction, that is to say towards the center of the receiving space, into a retracted position. Due to its ability to be moved or swiveled, the side flap can be pushed towards the channel axis of the folding area after folding, so that the step is re-formed and there are smooth and smooth surfaces both inside the channel axis and on the outer circumference of the folding area. The side flap can be locked in the retracted position for a safe folding process.

According to an advantageous alternative embodiment, the fastening end is followed by a section of the belt loop, which is articulated to the remainder of the belt loop at a kink that is parallel to the guide channel, and which in the open starting position is directed radially outwards, i.e. away from the half-shell , is oriented. A pocket protruding from the first half-shell is thereby formed. The first unfolded IOL is inserted into this pocket with one end. During the folding process, i.e. when pulling on the belt loop, the fastening end on the one hand and the transition point between the section and the remaining piece on the one hand each form a kink, which has the function of a pivot axis. The end of the IOL lying in the pocket is thereby particularly securely converted into a predefined curvature.

Further preferred configurations are set out in the subclaims.

The object is further achieved according to the invention by a storage and transport system for an IOL, in which a container for holding and Storage of the device according to the invention is provided. The IOL is inserted into the receiving area of the folding area in the open starting position.

Due to the design with the strap loop, the folding area can be used in a particularly simple and safe manner as a storage area for the IOL, since the IOL can already be slightly pinched between the two half-shells and the strap loop in the open starting position, so that it is held securely , In the case of hydrophilic IOLs, the container is expediently filled with a suitable storage liquid, into which the device together with the IOL are inserted.

According to a preferred development, the folding area is formed in one piece with an injection channel and, in a further preferred embodiment variant, is formed in one piece with an injector housing of an injector. One-piece is understood here to mean that the individual elements form a non-detachable structural unit. Due to the special design of the folding area with the belt loop, each of these units is also suitable for the storage and transport purpose described. With regard to the hygienic requirements, the units are designed in particular as disposable items.

Exemplary embodiments of the invention are explained in more detail below with reference to the figures. Each shows in schematic representations:

1a shows a perspective view of a one-piece structural unit, consisting of a folding area and an adjoining injection channel in a first variant, FIG. 1b shows a structural unit according to FIG. 1a in a second variant,

Fig. 2 is a perspective view of an injector, the injector housing formed as a one-piece unit

Thrust channel, the folding area and the injection channel includes 3 to 9 each show a section through a folding area of the variant according to FIG. 1a to illustrate the folding process of the IOL, FIGS. 10 to 15 each show a section through a folding area of the other

1b to illustrate the folding process of the

IOL,

16 to 19 different cross-sectional variants for an injection channel,

Fig. 20 shows an injector housing for inserting a unit according to the

1 a or 1b is provided,

21 shows a possible tweezer geometry for inserting the IOL in the folding area,

22 shows a container for storing an IOL inserted in a folding area,

23 to 26 different embodiments of a push stamp,

27 to 30 different embodiments of the front end of an injection channel.

In the figures, parts with the same effect are each provided with the same reference symbols.

The two one-piece units according to FIGS. 1a and 1b comprise one

Injection channel 2 and a folding area 4, which are firmly connected to one another and are an integral plastic injection-molded part. The folding area 4 has two half-shells 8a, 8b which are connected to one another via a film hinge 6 and which extend along a channel axis 10. The half-shells 8a, 8b are connected at their mutually facing longitudinal edges via the film hinge 6. On its outer longitudinal edges 12a, 12b facing away from one another, a film-like band loop 14 is fastened with its fastening end 16 in one half-shell 8a (hereinafter referred to as first half-shell 8a). In the other half-shell 8b (hereinafter referred to as the second half-shell 8b), a guide slot 18 for the strap loop 14 is introduced in the region of the longitudinal edge 12b, which is enclosed between the second half-shell 8b and a handle 20 adjoining it. The band loop 14 is a film-like and flexible flat element, preferably made of plastic. The band loop 14 is passed through the guide slot 18, so that a receiving space 22 for an intraocular lens 56 (IOL, see FIGS. 4 to 9 and 11 to 15) is formed between the half-shells 8a, 8b. By pulling the band loop 14, the first half-shell 8a becomes around the one defined by the film hinge 6

Swivel axis pivoted toward the second half-shell 8b until the two outer longitudinal edges 12a, 12b rest on one another. The two half-shells 8a, 8b are transferred from their open starting position into a closed end position, in which they enclose a guide channel 24 between them. The receiving space 22 thus merges into the guide channel 24 (cf. the closed end position, FIGS. 8, 9 and 15).

In the area of the fastening end 16, the strap loop 14 has a latching recess 26 (FIG. 1a) with which it can interact with a corresponding latching element (not shown) on the outside of the second half-shell 8b or the grip piece 20, so that the strap loop 14 in a predetermined position can be attached. Likewise, transverse locking webs 27 are arranged on the outside of the band loop 14 and cooperate with the guide slot 18 in such a way that the band loop 14 can no longer slide back through the guide slot 18 counter to the pulling direction.

The belt loop 14 can also have further structures that support the folding process, such as roughening on the inside thereof facing the receiving space 22.

In the first embodiment variant according to FIG. 1a, the band loop 14 is designed without kinks and edges and runs approximately in a tangential direction with respect to the semicircular first half-shell 8a. In contrast to this, in the embodiment variant according to FIG. 1b, the band loop 14 is divided into a section 14a and a remaining section 14b. This configuration forms two kinks 15a, 15b, which are aligned parallel to the guide channel 24 and each act in the manner of a hinge. In the open starting position shown, in which the two half-shells 8a, 8b are opened next to one another, this extends Section 14a in an approximately radial direction outward from the film hinge 6, so that a pocket 28 is formed between the section 14a and the remaining piece 14b, which overlaps the first half-shell 8a outwards. In the exemplary embodiment according to FIG. 2, a handle stub 30 is connected to the first half-shell 8a.

The injection area 2 adjoins the folding area 4, which can also be referred to as the loading area, and has an injection tip 32 at the distal end, that is to say the front end facing away from the folding area 4. The injection channel 2 has a taper of the outer diameter in the direction of the injection tip 32, which is step-like (FIG. 1a) or conical (FIG. 1b). The inside diameter of the injection channel 2 can also taper, preferably steadily and evenly, that is to say without edges and steps.

The structural unit formed from the folding area 4 and the injection channel 2 is used for insertion into an injector housing 38, as is shown, for example, in FIG. 20.

In a preferred embodiment according to FIG. 2, an injector 36 is provided, in which the injector housing 38 comprises a thrust channel 40 and an abutment 42 together with the folding area 4 and the injection channel 2 as an integral unit and in particular as an injection molded part. A push rod 44 is guided in the push channel 40 and has a pressure plate 46.

FIGS. 3 to 9 show a section through the folding area 4 similar to the embodiment shown in FIG. 1a. Here, both half-shells 8a, 8b are adjoined by grip pieces 20 which serve to simplify handling. The second half-shell 8b has a radial step 48 on its inner surface, which serves as a kind of stop for the IOL 56 and supports its folding process. In the exemplary embodiment, the radial step 48 is formed by a side flap 50 which can be pivoted into the receiving space 22 in the radial direction. For this purpose, the side flap 50 is connected to the second half-shell 8b only on one side, leaving a compensation space 52, via a further film hinge 54. The side flap 50 enables the step 48 after the half-shells 8a, 8b have been closed To remove the pivoting of the side flap 50 again, so that there is no discontinuity inside or outside.

The folding process of the IOL 56 in the embodiment variant based on FIG. 1a is explained below with reference to FIGS. 3 to 9. 3 the

Folding area 4 still shows in the initial state without IOL 56, according to FIG. 4, the still unfolded IOL 56 is inserted into the receiving space 22, which is supported with its one lens end 62 on the step 48. It is placed in this position by the clinical staff prior to implantation. However, it is preferably stored in this position, so that the clinical personnel do not have to insert the IOL 56 into the folding area 4 during the operation, as a result of which errors in handling the IOL 56 are avoided. Next, a suitable amount of viscoelastic material is introduced into the receiving space 22 surrounding the IOL 56. This can be done through additional filler holes as well as through the other existing openings. With the help of this measure, the later required sliding property of the folded IOL 56 in the injection channel 2 and on its way there is improved.

The next step is to pull the strap loop 14 in the pulling direction 60 at the free end 58. 5 to 9 show how the actual folding of the IOL 56 takes place. First, the IOL 56 buckles in the direction of the first half-shell 8a shown on the right in FIG. 5. In the other figures it can be seen how the cross-sectional area presented to the IOL 56 in the folding area 4 is continuously reduced by continuous pulling. 7 and 8 show how the lens ends 62 slide past one another due to the step 48 present in the second half-shell 8b and come to lie in the manner shown in FIG. 8 in the manner of a spiral. The side flap 50 can now be pushed in the direction of the channel axis 10 by actuation from the outside until a continuously running channel profile results. The folding area 4 is now in its closed end position, in which the guide channel 24 is formed by the abutting half-shells 8a, 8b. The strap loop 14 can then be fastened to the outside of the second half-shell 8b via the latching recess 26 shown in FIG. 1a. The exact way in which the IOL 56 moves from the unfolded to the folded state depends on a large number of influencing factors, such as, for. B. the lens geometry. However, it is always the case that the IOL 56 lies under the strap loop 14 during the complete folding process, which eliminates the risk of pinching lens parts. The way in which the folding takes place specifically does not affect this property, which therefore also allows the folding of various IOL types.

The folding process in the alternative embodiment based on FIG. 1 b is explained with reference to FIGS. 10 to 15. The side flap 50 shown in FIGS. 3 to 9 is not necessary in this embodiment variant. The alternative embodiment variant has the additional advantage that the strap loop 14 first extends horizontally with its portion 14a in the radial direction away from the receiving space 22 and has the two kinks 15a, 15b. First, the IOL 56 is in the starting position shown in FIG. 11. In this starting position, the IOL 56 can already be under a slight mechanical pretension, which supports rolling in the desired direction. By continuously pulling the end 58 of the belt loop 14, a rolling movement of the IOL 56 is initiated in a defined direction via the pocket 28 of the belt loop 14 defined by the kinks 15a, 15b (cf. FIG. 12). 13 to 15 show how the further folding process takes place in this alternative embodiment.

Since the folding method described here with the band loop 14 allows the cross-section of the IOL 56 to be reduced to the minimum achievable level, in contrast to other injection systems, a conical progression of the injection channel 2 is not absolutely necessary for the refolding of the IOL 56. The risk of the IOL 56 being destroyed during the final axial propulsion in the injection channel 2 is thus reduced to a minimum. However, the use of a conical injection channel 2 is still possible in principle and is also independent of its cross-sectional shape. The use of the belt loop 14 has, in addition to the particularly secure folding that is gentle on the IOL 56, the additional advantage that the IOL 56 is already securely held in the receiving space 22 in the open starting position, as shown in FIG. 4 or 11. Therefore, the folding area 2 with the strap loop 14 is also particularly advantageously suitable for storing and transporting the IOL 56. So that the IOL is held sufficiently securely in the receiving space 22, the strap loop 14 can be tightened somewhat and locked in this state via the locking webs 27 are so that the IOL 56 is biased somewhat and thereby clamped in the receiving space 22.

This storage in the folding area 4 is possible both with hydrophobic and with hydrophilic foldable materials. In the latter variant, a suitable container system is provided which prevents the IOL 56 from dehydrating during storage. An embodiment of a container 64 of such a container system is shown in FIG. 22. In the illustrated container 64, the liquid is prevented from escaping by sealing by means of a metal foil 66 fastened by welding, for example ultrasound welding, but preferably thermal welding. This container 64 also serves as transport packaging. Furthermore, the inner contour of the container 64 is designed in such a way that the folding area 4 containing the IOL 56 has few possibilities of movement. The storage and transport of the IOL 56 are also possible in the design form shown in FIG. 2. The folding area 4 and the injection channel 2 (FIG. 1a or 1b) are integrated in this embodiment. In all of these methods, manual individual handling of the IOL 56 for insertion in the folding area 4 is eliminated. The last-mentioned variant with storage in the injector 36 is particularly user-friendly - and in connection with a disposable injector - also advantageous with regard to sterility, since the clinical Personnel simply remove the injector 36 with the inserted IOL 56 from a germ-free protective packaging and pull the IOL 56 by pulling on the strap loop 14.

Alternatively, of course, the IOL 56 can be stored in a conventional manner in a separate container, from which it must then be used by the clinical staff in the folding area 4. Again, it doesn't matter which foldable material the IOL 56 is made of. The insertion is carried out with the aid of a suitable manipulation instrument, in particular a pair of tweezers 65, as shown in FIG. 21.

The geometry of the individual elements can be different

Geometry variants are used. It should be noted that in addition to injury to the IOL 56 during handling, the risk of injury to the patient's eye must be kept low. For this purpose, the end of the injection channel 2 facing the patient has a continuous geometry. In the case of the step 48 used for folding according to FIG. 3, this does not therefore continue to the distal end, that is to the injection tip 32. For this purpose, as shown in FIGS. 3 to 9, the movable side flap 50 is provided. The advantage thus achieved is that the geometry of a thrust ram 68 (cf. FIG. 20) can be adapted well to the internal geometry of the injection channel 2 shown in FIG. 9. The step 48 is restored by inserting the device into the injector, the inner contour of the injector being designed such that the movable side flap 50 is pressed radially in the direction of the channel axis 10 and the step 48 disappears. If an integrated embodiment, as shown in FIG. 2, is used, the step 48 is reduced by means of a shell-shaped element which is pushed over the injector and presses the side flap in the direction of the channel axis 10. If the proposed folding area 4 is realized without the side flap 50 shown in FIGS. 3 to 9 or also without step 48, this adjustment process is omitted.

The contour of the injection channel 2 used does not necessarily have to be circular in shape. Possible embodiments are shown in FIGS. 16 to 19, which, however, do not conclusively indicate the possible geometric shapes. It is of crucial importance for all geometrical forms that the distal end of the injection channel 2 has no sharp edges. Sharp edges on the outer surface pose an increased risk of injury to the patient's eye, and sharp edges on the inside can damage the IOL 56. The quadrangular contour shape with rounded edges shown in FIG. 18 represents only one possible embodiment of these geometry variants and can in principle be expanded to an n-square basic shape with round edges in each case. When using an embodiment according to FIG. 1 a or 1 b, this is inserted with closed folding area 4, as is shown, for example, in FIGS. 9 and 15, in an open front area 67 of injector housing 38, similar to that shown in FIG. 20 , The open front area 67 adjoins a handle part 70. The initially wide opening merges into a longitudinal slot 69. The assembly is connected to the injector housing 38 in a sufficiently stable manner. For this purpose, for example, an interference fit is provided between the handle pieces 20 of the folding area 4 and the longitudinal slot 69. The folded area 4 is thus inserted into the longitudinal slot 69 in the direction of the channel axis 10 in the closed final state with the two folded handle pieces 20. The half-shells 8a, 8b are guided and held in the front area 67. The injector housing 38 with the structural unit arranged therein, consisting of the folding area 4 and the injection channel 2, forms an injector. When using an injector 36 according to FIG. 2, an insertion process is omitted.

In the next step, the push rod 44 is pushed forward in the direction of the channel axis 10 until the push punch 68, which can be seen in FIG. 20 and is arranged on the end of the push rod 44, has contact with the folded IOL 56. This is then first pushed out of the folding area 4 into the injection channel 2.

The doctor can then inject the IOL 56 into the prepared patient's eye by first inserting the injection tip 32 of the injection channel 2 into an incision. By continuously pushing the pushing punch 68 onto the IOL 56, the IOL 56 can then be implanted in the prepared capsular bag of the patient's eye. It is irrelevant whether this is done by direct pressure on the rear pressure plate 46 or whether a radial rotary movement is converted into a linear movement (method steps not shown).

The devices used for the implantation are preferably made of a material suitable for disposable items. Alternatively, the injector housing 38 according to FIG. 20 can also be designed for repeated use. In this case, it must then be cleaned and sterilized after each use. In addition, the devices used also have a suitable ergonomic design. Different embodiments of the pushing punch 68 are shown in FIGS. 23 to 26. 23, a thrust ram 68a is essentially cylindrical and is adapted to the guide channel 24 and the injection channel 2. The two channels 2, 24 preferably have the same inside diameter that remains constant along the channel axis 10. The thrust ram 68a shown in FIG. 23 is specially designed for an injection channel 2 which is only minimally conical. The three further design forms allow the IOL 56 to be pushed through an injection channel 2 with a greater conicity with a low risk of pinching. The reason for this is that the respective push stamp 68b-68d is deformable. 24 and 25, the thrust ram 68b, 68c has a thickened head region 71, in the central inner region of which a bulge is provided, so that a particularly annular thrust ram tip 72, which is easily compressible, protrudes from the edge. The embodiment shown in FIG. 24 differs from the one shown in FIG. 25 in that cavities 74 in the interior of the thrust ram 68b make it possible to reduce the radial cross section with less effort. 26, a push plate 76 is arranged at the front end, which is inclined at an angle relative to the channel axis 10. The push plate 76 is therefore not perpendicular to the channel axis 10. If the injection channel contour tapers in such a way that a more circular cross-sectional profile changes to an increasingly elliptical cross-sectional profile towards the distal end, the push plate 76 can push the proposed geometry away from it Compensate arrow direction 78 without leaving gaps between injection channel 2.

28 to 30 show different design variants for the injection tip 32, which have a suitable shape for easy penetration into the eye. A possible embodiment is the beveling of the distal injection channel end to be seen in FIGS. 1a, 1b and 2 to form the injection tip 32, which is shown again in FIG. 27. 28 to 30 show further alternative designs. According to FIG. 28, unlike according to FIG. 27, the injection channel 2 is not straight but bevelled to one side along a curved line 80. In a further variant of the tapering of the injection channel 2, beveling on both sides takes place in the direction of the channel axis 10, as is shown in FIGS. 29 and 30. It is not necessary for the foremost tip to lie on the central channel axis. Asymmetric sharpening is also possible. In the embodiment according to FIG. 29, the tapering is carried out in a straight line, according to FIG. 30 it is executed curved in the manner shown.

When penetrating the incision, there are two basic options with the embodiments shown. First, when using geometries such as those shown in FIGS. 27 and 28, the surgeon can slightly raise the upper half of the incision in order to make room for the increasing cross section of the injection tip 32. Alternatively, it is also possible to pull the incision apart through the contour even while the injection tip 32 is being pushed axially into the patient's eye. Suitable for this are the embodiments shown in FIGS. 29 and 30 and the injection tip 32 according to FIG. 28, which is inserted into the eye rotated by 180 °, so that its long side 81 faces the patient's eye.

For the production of the injection system described, it is advisable to use polymer materials with the usual manufacturing processes. In general, however, it is also possible to use other materials. The material of the foldable IOL 56 to be implanted is also not important for the function of the system if the material fulfills the need for foldability.

LIST OF REFERENCE NUMBERS

Injection channel 44 push rod

Folding area 46 pressure plate

Film hinge 48 step a, 8b half shells 50 side flap 0 channel axis 52 compensation space 2a, 12b longitudinal edges 54 further film hinge 4 strap loop 56 intraocular lens (IOL) 6 fastening end 58 end of the strap loop 8 guide slot 60 pulling direction 0 handle 62 lens end 2 receiving space 64 container 4 guide channel 65 tweezers 6 locking recess 66 metal foil 7 locking web 67 frontal area 8 pocket 68,68a-d pushing stamp 4a section 69 longitudinal slot 4b remnant 70 handle 5a, 15b kink 71 head area 8 pocket 72 pushing stamp tip 0 handle stub 74 cavity 2 injection tip 76 push plate 6 injector 78 arrow direction 8 injector housing 80 line 0 slide channel 81 long side 2 abutments

Claims

Expectations

1. Device for folding an intraocular lens (56) with a folding area (4) which has two s half-shells (8a, 8b) which are pivotally connected to one another and which can be pivoted from an open starting position into a closed end position in which they have a guide channel (24 ) for the intraocular lens (56) between them, characterized in that a film-like band loop (14) is fastened to the first half shell (8a) with a fastening end (16) and is displaceably guided on the second half shell (8b), wherein in In the open starting position between the band loop (14) and the two half-shells (8a, 8b), a receiving space (22) for the intraocular lens (56) is formed, and the half-shells (8a, 8b.) by pulling on the displaceably guided band loop (14) ) in direction 5 whose end position can be shifted.

2. Device according to claim 1, characterized in that the two half-shells (8a, 8b) in the closed end position each have 0 with their outer longitudinal edges (12a, 12b) and that

Band loop (14) is fastened to the longitudinal edge (12b) of the first half-shell (8a) and is guided on the longitudinal edge (12b) of the second half-shell (8b).

3. Device according to claim 1 or 2, 5, characterized in that a guide slot (18) for guiding the band loop (14) is provided in the region of the second half-shell (8b).

4. Device according to one of the preceding claims, 0 characterized in that - in a cross section perpendicular to the channel axis (10)

Half shells (8a, 8b) - the inside of one of the two half shells (8b) has a step (48) for placing an edge of the intraocular lens (56).

5. The device according to claim 4, characterized in that the one half-shell (8b) has a along the channel axis (10) extending side flap (50) which from a front position in which the step (48) is formed in a radial Direction, towards the channel axis (10), can be guided into a retracted position.

6. The device according to claim 4, characterized in that the side flap (50) can be locked in the retracted position.

7. Device according to one of the preceding claims, characterized in that a section (14a) of the strap loop (14) adjoins the fastening end (16), which is articulated with a remnant at a kink (15b) aligned parallel to the guide channel (24) (14b) the band loop (14) is connected and, in the open starting position, is oriented in the radial direction to the outside, so that the receiving space (22) has a pocket (28) projecting from the first half shell (8a).

8. Device according to one of the preceding claims, characterized in that at least one of the two half-shells (8a, 8b) is followed by a handle (20) or handle stub (30).

9. Device according to one of claims 1 to 7 or according to claim 8, characterized in that the strap loop (14) is designed for attachment to the outside of one of the half-shells (8a, 8b) of the handle stub (30).

10. Device according to one of the preceding claims, characterized in that that the band loop (14) is guided on the second half-shell (8b) in such a way that the band loop (14) cannot slide back against a pulling direction (62) of the band loop (14).

11. The device according to any one of the preceding claims, characterized in that at least on one of the half-shells (8a, 8b) and / or on the band loop (14) one or more through holes are made for introducing viscoelastic. 0

12. Device according to one of the preceding claims, characterized in that an injection channel (2) is provided which forms an integral unit with the folding area (4) and is flush with the guide channel (24). 5

13. Device according to one of the preceding claims, characterized in that it comprises an injector housing (38) with a push channel (40) for a push rod (44), the folding region (4), the injection channel (2) 0 and the injector housing ( 38) form a one-piece unit, in which the

Folding area (4) between the push channel (40) and the injection channel (2) is arranged.

14. Device according to one of the preceding claims, s characterized by a deformable thrust ram (68, 68a-d) for pushing a folded intraocular lens (56) in the guide channel (24).

15. Device according to one of the preceding claims, o characterized in that an injection channel (2) is provided, the front end of which has an injection tip (32) which is tapered substantially onto the channel center of the injection channel (2).

16. Storage and transport system for an intraocular lens (56), characterized in that a container (64) for receiving and storing the device according to s one of the preceding claims is provided in the open starting position, wherein in the receiving space (22) of the folding area (4) the intraocular lens (56) is inserted.

17. Storage and transport system according to claim 16, 0 characterized in that the device is stored together with the intraocular lens (56) in the container (64) in a liquid and that the container (64) is sealed.

5 18. Storage and transport system according to claim 16, characterized in that the device is stored dry together with the intraocular lens (56) in the container (64) and that the container (64) is sealed.

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