WO1998010717A1

WO1998010717A1 - Artificial, deformable intraocular eye lens

Info

Publication number: WO1998010717A1
Application number: PCT/DE1997/001893
Authority: WO
Inventors: Volker Rasch
Original assignee: Potsdamer Augenklinik Im Albrecht-Von Graefe-Haus Gmbh
Priority date: 1996-09-09
Filing date: 1997-08-26
Publication date: 1998-03-19
Also published as: DE19637693A1; AU4449997A

Abstract

An artificial intraocular eye lens (8) with a deformable optical zone (2) for implantation during a cataract operation has a lens and four angular elastic haptic elements (3) joined to the lens, mutually separated at their periphery and arranged in a direction of rotation, so that in the folded state the haptic elements (3) come to lie in the implantation area (4) without additional manipulations. The invention provides an artificial intraocular eye lens which can be inserted without problems through a as small as possible sclerocorneal or corneal implantation opening in the eye, which can be easily unfolded without substantially stressing the contacted eye structures, which can be easily rotated in the implantation site, namely the capsula lentis, the ciliary sulcus or iridocorneal angle and reliably centered while only slightly tensioning the capsula.

Description

Deformable artificial intraocular eye lens.

The invention relates to a deformable artificial intraocular eye lens with a deformable optical zone part for implantation during a cataract operation, which has a lens and a haptic connected to it from a plurality of angular elastic support elements.

Such artificial eye lenses are used to replace the natural human lens when the latter has been removed. After implantation, the artificial intraocular eye lens serves as a device for optical correction of the eye instead of the natural lens. This surgical implantation of an artificial intraocular eye lens after the removal of the natural human lens is a method for optical correction that has already proven itself successfully in the field of ophthalmology. In the known artificial intraocular eye lenses, there are different designs which are based on the various methods by which the implant is fastened and stabilized within the eye in such a way that the central lens body is held in a stable position with respect to the pupil and the optical axis of the eye . The type of artificial intraocular lens is classified according to the position of the implant within the eye, depending on whether the implantation is in the anterior chamber, in the iris plane or in the posterior chamber, here in the sulcus ciliaris or capsule sac. The artificial intraocular eye lens can be attached by:

1. Two or three points of contact of the eye lens with the tissue.

2. Four points of contact of the tissue with the eye lens.

3. Tissue contact in broad arches with overall curved loops.

4. Clamp the eye lens to the iris.

5. Sew the eye lens onto the iris.

6. Attachment of the attachment parts of the eye lens within the posterior capsular bag, which then results in traps around the eye lens.

The first three attachment methods, ie two or three-point attachment, four-point attachment or attachment in wide arches, are based on the pressure against the tissue at these points for attaching the eye lens. This method of attachment, which works with point contact and pressure, can be used in the anterior chamber in the chamber angle and in the rear eye chamber in both the sulcus and the capsular bag. Artificial intraocular eye lenses can be used for both primary implantation at the time the natural human lens is removed and secondary implantation, which is a second, separate surgical procedure after the natural human lens has been removed in a previous surgical procedure is used. Some of the currently available intraocular eye lenses can be used for either primary or secondary implantation. Currently available artificial intraocular eye lenses offer a variable degree of symmetry and flexibility in the overall construction and in the fasteners that serve to hold the central optical lens body in position with respect to the pupil and the optical axis. It is known that some degree of flexibility is desired because it alleviates many problems, such as post-operative sensitivity, allows less tissue irritation within the eye when the eye makes various bends during natural movement and reduces possible injuries. However, it is also known that excessive flexibility in the attachment of the artificial intraocular eye lens can be a disadvantage because the excessive flexibility causes movement of the eye lens with resultant tissue irritation, chronic inflammation and damage to the eye, which can later result that the implant is no longer accepted by the eye, causes a possible loss of vision and may have to be removed. Currently available models of artificial intraocular eye lenses have an overall solid one-piece construction from one material or generally from two or three materials, the central lens body being made of one material such as polymethyl methacrylate, whereas the peripheral bearing parts are made of another material such as "Prolene" , exist and the materials are mechanically connected to the central lens body.

Such intraocular lenses are made both from solid material (PMMA) and in the form of foldable lenses (HEMA, silicone, acrylic), which are available either dry or in a moist medium. Lenses made of solid material have the disadvantage, which is particularly serious for the patient, that when they are implanted in the eye, an implantation opening corresponding to the diameter of the intraocular lens (approx. 5 to 7 mm) is required, while in the case of foldable lenses, only one implantation opening of approx. 2 , 8 to 3.2 mm diameter is required.

Folding lenses with two haptics are known. In all haptic constructions of the folding lenses known to date, the haptics protrude from the folding plane when folded, which causes problems when inserted into the implantation opening in the eye or the lenses are difficult to fold, such as those in DE-OS 33 03 803 described lens.

Further disadvantages of intraocular lenses with two haptics, as are described, for example, in DE-OS 32 46 677 and in EPA 0246216, are poor Stability of their seat and in the localized and therefore relatively high pressure stress of the eye tissue.

Furthermore, so-called "boat lenses" are known, in which the haptics are molded onto the lens in the form of relatively wide elements, as well as lenses which are provided with a holding part formed concentrically around the actual lens. Such a lens is described in DE-OS 33 03 803. In the former, the same disadvantages of the lenses with two haptics occur, in the latter the adhesion of the front and rear capsule sheets is deteriorated, and poorer centering is also a disadvantage.

DE-OS 27 49 726 describes an artificial intraocular eye lens which can be used in one embodiment in the rear eye chamber and in another modified embodiment in the front eye chamber. In the first embodiment, the mounting part of the second position-setting part can be modified in order to sew it onto the iris in front of it or to be able to fasten it in the manner of a card tab without sewing on the iris. In both cases, however, the bearing part of the first position setting part remains unchanged and therefore the eye lens is also arranged in the rear eye chamber. This eye lens therefore requires two different embodiments for use in the anterior or posterior chamber. In addition, it has only a limited degree of flexibility because the storage part of the first position setting part is unlikely to be movable relative to its base. A certain degree of flexibility is desirable for the reasons set out above.

GB 20 55 585 and US Pat. No. 42 54 509 describe artificial intraocular eye lenses which can only be used in the anterior chamber. Although these lenses have flexibility, this is limited by the extent to which the lens body can move forward. Forward movement of the lens body can be dangerous for the cornea. In addition, these known lenses have a four-point attachment, which can lead to the fact that the pressure on the tissue is concentrated in the four rather narrowly delimited points, which can lead to tissue damage.

From US-PS 43 61 913 Fig.l an artificial eye lens with a lens body and three support elements is known, one of which is designed as a closed bracket with both ends on the edge of the lens body, extending over a sector of the lens body, and of which the two other support elements are attached to the edge of the lens body opposite the bracket. This known eye lens has two further, on the side opposite the closed bracket, also trained bracket. All temples are curved outwards. The total width of the two last mentioned brackets is larger than the diameter of the lens body, so that the eye lens can only be inserted through the pupil into the rear eye chamber by stretching the iris, since folding of the lens is also not possible. After insertion into the posterior chamber of the eye, the three support elements lie only in three relatively small places on the adjacent tissue, so that in patients with a small chamber diameter there is an overstretching of the tissue in one direction and corresponding traumatic changes in the tissue up to the severing of the tissue rear chamber wall can come.

An artificial eye lens is known from FIG. 12 of the same publication, which has two closed brackets which are fastened on opposite sides of the lens body and which extend over a sector of the lens body and have a concave region drawn in towards the lens body. Due to the shape of these two brackets, this lens can easily be inserted through the pupil into the rear chamber of the eye. The distances between the two support points of the two brackets are, however, comparatively small due to their construction, so that, with a small diameter of the eyes, the tissue can also be overstretched in one direction and, with a relatively large diameter, the lens body can be decentered.

Finally, an artificial eye lens is known from FIG. 10 of the cited document, which has two hook-shaped brackets bent to one side. With this eye lens, the pressure exerted on the edge of the rear eye chamber is distributed over a greater length of the two hook-shaped brackets, but it can only be introduced into the rear eye chamber by turning through the pupil, which is not only relatively difficult, but also that Eye more at risk than just inserting it.

DE-OS 34 15 815 describes an artificial eye lens in which the closed bracket has a concave region drawn in towards the lens body and the two other support elements are designed as hook-shaped brackets bent on opposite sides. This lens has the disadvantage that it cannot be rotated or folded when inserted.

DE-AS 10 34 325 describes a lens which is arranged in the front eye chamber and is held by elastic loops lying in the front eye chamber angle. This intraocular lens is easy to use, its correct fit can be easily checked at any time, and displacements can be determined immediately. However, it is disadvantageous that the loops, if they are elastically deformed by the forces exerted by the eye or eye chamber angle, bulge perpendicular to the plane of the iris in the direction of the cornea and can come into contact with the extremely sensitive inside of the cornea or bring the lens part into contact with this inside. This bulge is further promoted by the fact that the forces exerted by the angle of the eye chamber have a component directed towards the cornea.

In order to exclude contact with the inside of the cornea with certainty, the loops have been arranged in the rear eye chamber despite great difficulties when inserting them, the optical lens part being able to be positioned in both the front and rear eye chambers (DE-OS 30 13 177) and S-shaped loops can be used (NL - OS 80 04 782, corresponds to the subsequently published DE OS 30 32 144). In order to ensure that the loop maintains its position parallel to the iris regardless of the forces exerted on it by the eye, DE-OS 31 52 759 proposes a lens with two loops, the wire-shaped material of which has a cross-sectional area with a relatively large and perpendicular for this purpose has a relatively small dimension, the large dimension being oriented approximately perpendicular to the plane of the iris. Due to the shape of the two brackets, this lens can be easily inserted through the pupil into the rear chamber of the eye, but the distances between the two support points of the two brackets are comparatively small by design, so that there is overstretching of the tissue in the eyes with a small diameter in one direction and with a relatively large diameter, the lens body can decenter.

From the SU authorship certificate 545 352 an artificial eye lens is known, in which the presence of the lens and support feet outside the pupil is assumed and the lens body is provided with at least one loop-shaped foot for the execution of a seam that holds the eye lens on the rainbow skin. There is a possibility of dislocation when dilating the pupil if the lens is inserted into the iris.

To simplify the technique of implanting a lens and its reliable fixation, another artificial eye lens has been developed, which is known from the SU copyright certificate 858 819. In this eye lens, the upper loop-shaped foot represents two lobes that lie opposite each other in the upper half of the horizontal lens plane, while the plane of this loop-shaped foot is inclined at an angle of 5-8 degrees to the lens plane in order to achieve a resilient effect . There is a lower support leg. The disadvantage of this known eye lens is that it requires the formation of a large coloboma (with a length of up to 4 mm) in the upper part of the iris with subsequent application of a supramid suture, which significantly increases the duration of the surgical intervention and additional technical difficulties during implantation. In a lens known from US-PS 41 10 848, the shape of the two support loops is essentially the same except for a notch in a support loop. The notch is sewn onto the iris of the eye. Because the lens loops are rigid, inserting the lens requires a fairly large deformation of the iris and capsule, which can damage the eye. Furthermore, the contact area of the support loops with the inside of the capsule is small, as a result of which the lens can shift due to vibrations that occur when walking or running.

From the foregoing it can be seen that the development of surgical techniques is of particular interest which only require relatively small incisions in the ocular tissue to remove cataracts (OS - PS 40 02 169 and 39 96 935). However, one of the main disadvantages of the rigid intraocular lens is that the insertion of the lens requires a relatively large incision in the ocular tissue. Among other things, this surgical procedure leads to a relatively high complication rate. The considerable dangers of implanting a rigid lens are an increased risk of infection, detachment of the retina and laceration of the eyepiece tissue, particularly with regard to the pupil. There is therefore a significant need for intraocular lens implants which offer the clinical advantage of relatively small incisions, but whose optical area has a fixed focal length and which maintain a prescribed shape in the implanted state, so that one can use safe and more expedient surgical techniques and a comfortable fit keeps in mind.

The main disadvantage of conventional fastening systems is that they usually require either the use of sutures to position the lens within the eye (usually by attachment to the iris) or the use of relatively stiff support flanges that hold the lens in place without a suture. However, the manipulations required to fix the lenses using sutures or rigid pressure flanges increase the surgical trauma of the eye. There may also be postoperative lens displacement in these two systems. For example, the suture material can break and the lens can migrate out of the desired position. The relatively stiff pressure flanges or spacers of conventional "seamless" designs can injure the eye tissue during surgical lens manipulations. In addition, these stiff pressure elements / support flanges can pass through the damaged areas after the operation and thus allow the lens to shift again in the operated eye. The known folding lenses are either difficult to fold by flat haptics or the haptic elements protrude from the implantation zone when folding and / or passing through the incision of the implantation opening in the eye, which complicates the implantation and an additional risk of injury to the eye and a risk of damage to the Haptics are inherent. The invention is therefore based on the problem of creating an artificial intraocular eye lens which allows problem-free passage through the smallest possible sclerocorneal or corneal implantation opening in the eye, as well as a simple unfolding process with little stress on the touched structures of the eye, a slight turning at the implantation site, So in the capsular bag, sulcus or chamber angle and a safe centering with easy opening of the capsule. In addition, the mechanical stress on the eye tissue by the fastening elements of the lens should be kept low.

This object is achieved by the features specified in the characterizing part of claim 1.

Advantageous developments of the invention are specified in the subclaims.

The described lens structure according to the invention has a deformable optical zone region, through which the lens can be deformed by folding to a width of approximately 50% of the cross-sectional diameter of the optics when inserted into the eye. After insertion, the lens returns to its original full size and fixed focal length. It can therefore be used through smaller incisions in the eye tissue than is possible with a rigid lens of comparable size. It has four angular elastic haptic elements connected to it for four-zone support or storage, which are separated peripherally from one another, all arranged in one direction of rotation in such a way that the haptic elements come to lie in the implantation area without additional manipulations in the folded state.

The haptic elements advantageously have a long curved area which extends on a peripheral line around the center of the eye lens. This results in a more precise fixation and centering of the lens and a lower contact pressure by the haptic elements on the eye tissue.

The haptic elements are arranged in the upper and lower area of the lens at an angle to the vertical center line. This angle can be variable and is advantageously between 10 and 45 degrees.

The haptic elements can have notches or holes which are suitable for enabling suture fixation, for example in the sulcus ciliaris.

The haptic elements can also have openings that are suitable for inserting instruments for positioning and rotating the implant. These openings are advantageously arranged in their surfaces close to the lens. In order to bring about a change in their flexibility and to improve a desired scarring and fixing when the capsular bag is fibrosed, the haptic elements can be interrupted once or several times, expediently by holes which are provided in suitable locations depending on the desired degree of change.

Furthermore, the haptic elements can have additional devices, e.g. Have holes that are suitable to enable a connection to other implants, such as a capsule clamping ring or other implanted systems.

The invention is explained below with reference to a preferred embodiment shown in the figures.

1 schematically shows an intraocular lens according to the invention

2 schematically shows a folded intraocular lens according to the present invention

The lens structure 1 according to the invention, shown schematically in FIG. 1, has a deformable optical zone region 2, by means of which the lens can be deformed by folding to a width of approximately 50% of the cross-sectional diameter of the optics when inserted into the eye. It has four angular elastic haptic elements 3 connected to it for a four-zone support or support, which are separated peripherally from one another, all arranged in one direction of rotation in such a way that the haptic elements come to rest in the implantation area 4 without additional manipulations, such as that, when folded is shown in Fig. 2. The implantation area can be straight or curved. It is essential that no parts of the haptic elements 3 protrude from it. The haptic elements 3 advantageously have a long curved region 5, which extends on a peripheral line 6 around the center 7 of the optics 8. This results in a more precise fixation and centering of the optics 8 and a low contact pressure by the haptic elements 3 on the eye tissue. The haptic elements 3 are arranged in the upper and lower region of the lens at an angle 9 to the vertical center line 10. This angle 9 can be variable and is advantageously between 10 and 45 degrees. The haptic elements 3 advantageously have notches 11 or holes 12 which are suitable for enabling suture fixation, for example in the sulcus ciliaris. They can also additionally have openings 13 which are suitable for introducing instruments for positioning and rotating the implant. These openings are advantageously arranged in their surfaces 14 close to the optics 8. In order to bring about a change in their flexibility and to improve a desired scarring and fixing when the capsular bag is fibrosed, the haptic elements 3 can be interrupted once or several times, for example by holes (not shown) which are provided at suitable locations depending on the desired degree of change . Furthermore, the haptic elements can have additional devices, not shown, for example holes, which are suitable for enabling a connection to other implants, such as a capsule clamping ring or other implanted systems.

The invention creates an artificial intraocular eye lens that allows a problem-free passage through the smallest possible sclerocorneal or corneal implantation opening in the eye, as well as a simple unfolding process with little stress on the touched structures of the eye, a slight rotation at the implantation site, i.e. in the capsular bag, sulcus or chamber angle and secure centering with easy opening of the capsule. In addition, the mechanical stress on the eye tissue by the fastening elements of the lens should be kept low.

reference numeral

1 lens structure

2 zone area

3 haptic element

4 implantation area

5 area

6 peripheral line

7 center point

8 eye lens

9 angles

10 center line

11 notch

12 holes

13 opening

14 area

Claims

claims

1. Deformable artificial intraocular eye lens with a deformable optical zone part for implantation during a cataract operation, which has a lens and a haptic connected to it from several angular elastic support elements, characterized in that it has four haptic elements (3) for a four-zone support or storage which are peripherally separated from one another, are all arranged in one direction of rotation in such a way that the haptic elements (3) come to lie in the implantation region (4) without additional manipulations in the folded state.

2. Intraocular eye lens according to claim 1, characterized in that the haptic elements (3) have a curved region (5) which extends on the peripheral line (6) around the center (7) of the intraocular eye lens (8).

3. Intraocular eye lens according to claim 1, characterized in that the haptic elements (3) in the upper and lower region of the intraocular eye lens (8) are arranged at an angle (9) to the center line (10), which is between 10 and 45 degrees.

4. Intraocular eye lens according to claim 1, characterized in that the haptic elements (3) have notches (11) or holes (12) for suture fixation.

5. Intraocular eye lens according to claim 1, characterized in that the haptic elements have openings (13) for introducing instruments for positioning and rotating the implant in their surfaces (14).

6. Intraocular eye lens according to claim 1, characterized in that the haptic elements are interrupted one or more times to change their flexibility.

7. Intraocular eye lens according to claim 1, characterized in that the haptic elements have devices for producing connections to other implants.

8. Intraocular eye lens according to claim 7, characterized in that the Vorrichtimgen are perforations.

9. Intraocular eye lens according to one of the preceding claims, characterized in that haptics and optics consist of the same material.

10. Intraocular eye lens according to one of the preceding claims, characterized in that haptics and optics each consist of different material.

CORRECTED SHEET (RULE 91) ISA / EP