DE19637693A1 - Deformable artificial intraocular eye lens - Google Patents

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

The invention relates to a deformable artificial intraocular eye lens with a deformable optical zone part for implantation during cataract surgery, the one Lens and a haptic connected to it made of several angular elastic Has support elements.

Such artificial eye lenses are used as a replacement for the natural human lens used when the latter has been removed. The artificial intraocular eye lens serves after the implantation instead of the natural lens as a device for optical correction of the Eye. This surgical implantation of an artificial intraocular eye lens after the Removing the natural human lens is an optical correction procedure that has already proven itself successfully in the field of ophthalmology. With the known Artificial intraocular eye lenses, there are different designs that focus on the Different procedures are based by which the implant is fastened within the eye and is stabilized that the central lens body with respect to the pupil and the optical Axis of the eye is held in a stable position. The type of artificial intraocular lens is classified according to the location of the implant within the eye after whether the implantation in the anterior chamber, in the iris plane or in the posterior chamber of the eye, here in the sulcus ciliaris or capsular bag.

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

The first three attachment methods, i.e. H. the two- or three-point attachment, the 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 fastening method, when working with point contact and pressure can be in the anterior chamber in the chamber angle and in the posterior chamber of the eye both in the sulcus and in the Capsular bag can be applied.  

Artificial intraocular eye lenses can be used both for primary implantation. H. to Implantation at the time the natural human lens is removed as well Secondary implantation, which is a second, separate surgical procedure after the natural human lens has already been removed in previous surgery has been used. Some of the intraocular eye lenses currently available can be used either for primary implantation or for secondary implantation. Currently available artificial intraocular eye lenses offer a variable one Degree of symmetry and flexibility in the overall construction and in the fastening parts, which serve the central optical lens body with respect to the pupil and the to keep the optical axis in position. As is known, there is a certain degree of flexibility desirable because it has many problems, such as post-operative sensitivity, mitigates, allowing less tissue irritation within the eye when the eye makes various bends during the natural movement and possible Injuries reduced. However, it is also known that excessive flexibility in Attaching the artificial intraocular eye lens can be a disadvantage because of the excessive flexibility a movement of the eye lens with resulting Tissue irritation, chronic inflammation and eye damage is what can later lead to the implant no longer being accepted by the eye, one possible vision loss and may need to be removed.

Currently available models of artificial intraocular eye lenses have a total a solid one-piece construction made of one material or generally of two or three Materials, wherein the central lens body consists of a material such as Polymethyl methacrylate, whereas the peripheral storage parts are made of a different material, such as "Prolene", and the materials with the central lens body are mechanically connected.

Such intraocular lenses are made of both solid material (PMMA) and in the form of foldable lenses (HEMA, silicone, acrylic), either dry or in damp Medium are available. Lenses made of solid material show that especially for the Patient serious disadvantage; that when they are implanted in the eye an implantation Opening according to the diameter of the intraocular lens (approx. 5 to 7 mm) required is, while with foldable lenses only an implantation opening of approx. 2.8 to 3.2 mm Diameter is required.

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

Further disadvantages of intraocular lenses with two haptics, such as those described in DE OS 32 46 677 and described in EPA 0246216 consist in the defective  Stability of their seat and in the localized and therefore relatively high Compression of the eye tissue.

Furthermore, so-called "boat lenses" are known, in which the haptics on the lens are molded in the form of relatively wide elements, as well as lenses with a are molded concentrically around the actual lens holding part. Such Lens describes DE-OS 33 03 803. In the former, the same disadvantages of the lenses occur with two haptics; the latter is the gluing of the front and rear Capsule leaf deteriorates, poorer centering is also a disadvantage record.

DE-OS 27 49 726 describes an artificial intraocular eye lens in one Embodiment in the posterior chamber and in another modified Embodiment can be used in the anterior chamber. In the first Embodiment can indeed the storage part of the second position setting part be modified to sew it on the iris in front of it or in the manner of a Map rider can be attached to the iris without sewing. In both cases, however, remains the storage part of the first position setting part unchanged and therefore also the Eye lens arranged in the back eye chamber. So with this eye lens are for Use two different in the anterior or posterior chamber Embodiments required. It also instructs only a limited degree Flexibility on; because the bearing part of the first position fixing part against its The base is unlikely to be mobile. A certain degree of flexibility is however from the above reasons outlined.

GB 20 55 585 and US-PS 42 54 509 describe artificial intraocular eye lenses which can only be used in the front eye chamber. These lenses do have Flexibility on; however, this is determined by the extent to which the lens body adjusts itself can move forward, limited. The forward movement of the lens body can for that Cornea become dangerous. In addition, these known lenses have a four point attachment to; which can lead to pressure on the fabric in the four right narrowly focused points, which can lead to tissue damage.

From US-PS 43 61 913 Fig. 1, an artificial eye lens with a lens body and three support elements is known, one of which is formed as a closed bracket with both ends on the edge of the lens body, extending over a sector of the lens body, and from which the two other support elements are attached to the edge of the lens body opposite the bracket. This known eye lens has on the side opposite the closed bracket two further, equally designed brackets. 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 into the posterior eye chamber by stretching the iris through the pupil, since folding of the lens is also not possible. After insertion into the rear eye chamber, the three support elements rest only on three relatively small places on the adjacent tissue; so that in patients with a small chamber diameter, the tissue can be overstretched in one direction and corresponding traumatic changes in the tissue can occur, including the severing of the posterior chamber wall.

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 back chamber of the eye. The distances between the two support points of the two brackets are, by design, relatively small, so that with a small diameter of the eyes it can also lead to over-stretching of the tissue in one direction and with a relatively large diameter to decenter the lens body.

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 area drawn in towards the lens body and the two other support elements than hook-shaped brackets bent to opposite sides are trained. This lens has the disadvantage that it is neither rotated nor when inserted can be folded.

DE-AS 10 34 325 describes a lens in the anterior chamber is arranged and by elastic loops in the anterior chamber angle is held. This intraocular lens is easy to use, its correct fit at all times easy to check and relocations can be determined immediately. However, it is disadvantageous that the Loops when they are exerted by the forces exerted by the eye or the angle of the eye chamber be deformed elastically, bulge perpendicular to the plane of the iris towards 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 will still be there favors that the forces exerted by the angle of the eye chamber are directed towards the cornea Own component.

In order to exclude contact with the inside of the cornea with certainty, you have the Loops in the rear eye chamber despite great difficulties arranged with the optical lens part in both the front and in the rear Eye chamber can be positioned (DE-OS 30 13 177) and S-shaped curved Loops can be used (NL-OS 80 04 782, corresponds to the post-published DE OS 30 32 144). To achieve that the loop is independent of the eye the forces exerted maintain their position parallel to the iris is described in DE-OS 31 52 759 proposed a lens with two loops, the wire-shaped material one Cross-sectional area with a relatively large and perpendicular to it a relatively small Dimension has, the large dimension approximately perpendicular to the plane of the iris is oriented. Due to the shape of the two brackets, this lens is easily through the pupil can be inserted into the back chamber of the eye, the distances between the two Support points of the two brackets are relatively small due to their construction, so that if the diameter of the eyes is small, the tissue is overstretched in one direction and come with a relatively large diameter to decenter the lens body can.

An artificial eye lens is known from SU copy 545 352, in which the Presence of lens and support feet outside the pupil is assumed and the Lens body with at least one loop-shaped foot for making a seam is provided, which holds the eye lens to the iris. Here is the Possibility of dislocation, when dilating the pupil, provided the lens is in the Iris penetration is introduced.

To simplify the technique of implanting a lens and make it more reliable Another artificial eye lens fixation has been developed from the SU copyright certificate 858 819 is known. In this eye lens, the upper one is loop-shaped Foot two lobes that are in the horizontal plane of the lens in the upper half of each other lie opposite, while the plane of this loop-shaped foot is below the lens plane is inclined at an angle of 5-8 degrees to achieve a resilient effect. There is one lower support leg available. The disadvantage of this known eye lens is that it the formation of a large coloboma (up to 4 mm long) in the upper part of the iris with subsequent application of a supramid suture, which requires the duration of the operative Intervention significantly extended and additional technical difficulties with the Implantation creates.  

In a lens known from US-PS 41 10 848, the shape of the two support loops is in essentially the same except for a notch in a support loop. The notch will turn on sewn on the iris of the eye. Since the support loops of the lens are rigid, it requires insertion The lens has a fairly severe deformation of the iris and capsule, causing the eye can be damaged. Furthermore, the contact surface of the support loops with the inside the capsule is small, causing the lens to shake due to shocks like when walking or may run, shift.

From the foregoing it can be seen that the development of surgical techniques Of particular interest is the only relatively small incisions in the ocular tissue to remove cataracts (OS-PS 40 02 169 and 39 96 935). One of The main disadvantage of the rigid intraocular lens, however, is that the lens is inserted requires a relatively large incision in the ocular tissue. This surgical Among other things, the 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 that offer the clinical advantage of relatively small incisions, their optical range however, has a fixed focal length and a prescribed one when implanted Maintain shape so that you can use safe and more convenient surgical techniques as well gets a comfortable fit in the eye.

The main disadvantage of conventional fastening systems is that they usually either the use of sutures to position the lens inside the eye (usually by attaching it to the iris) or using relative require rigid support flanges that hold the lens in place without a seam. The for Fix the lenses using sutures or rigid pressure flanges the manipulations required increase the surgical trauma of the eye. There may also be a postoperative lens shift in these two systems surrender. For example, the suture may break and the lens may be out of the desired one Allow Sollage to emigrate. The relatively stiff pressure flanges or spacers Conventional "seamless" designs can remove the eye tissue during the operational lens manipulations. You can also do this after surgery Stiff pressure elements / support flanges pass through the damaged areas and thus enable 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 through the incision when folding and / or passing through Implantation opening in the eye out of the implantation zone, what the implantation difficult and an additional risk of injury to the eye and damage harbors a danger to the feel.

The invention is therefore based on the problem of an artificial intraocular eye lens create a problem-free passage through the smallest possible sclerocorneal or corneal implantation opening in the eye, as well as a simple unfolding operation with little stress on the touched structures of the eye, a slight turning on the Implantation location, i.e. in the capsular bag, sulcus or chamber angle and a safe centering with a slight opening of the capsule. In addition, the mechanical load on the Eye tissue can be kept low by the fasteners of the lens.

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

Advantageous developments of the invention are specified in the subclaims.

The described lens structure according to the invention has a deformable optical Zone area on; by inserting the lens into the eye by folding it onto a Width of about 50% of the cross-sectional diameter of the optics can be deformed. After this Insert the lens back to its original full size and fixed focal length. It can therefore be used through smaller incisions in the eye tissue than with one rigid lens of comparable size is possible. It has four associated with it angular elastic haptic elements for a four-zone support or support, the peripherally separated from each other, all arranged in one direction of rotation so that in folded the haptic elements without additional manipulations in the implantation area to come to rest.

The haptic elements advantageously have a long curved area; who is on a peripheral line extends around the center of the eye lens. This results in a more precise fixation and centering of the lens and a low contact pressure due to the Haptic elements on the eye tissue.

The haptic elements are at an angle to the top and bottom of the lens vertical center line. This angle can be variable and is advantageous between 10 and 45 degrees.

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

The haptic elements can also have openings that are used to insert Instruments for positioning and rotating the implant are suitable. These openings are advantageously arranged in their surfaces close to the lens.  

To bring about a change in their flexibility and a desired scarring and Fixing the fibrosis of the capsular bag can improve the haptic elements be interrupted once or several times, expediently by holes which, depending on the desired degree of change can be provided at suitable locations.

Furthermore, the haptic elements can still additional devices, for. B. holes, have, which are suitable, a connection to other implants, such as a Capsule clamping ring or other implanted systems.

The invention is described below with reference to a preferred one shown in the figures Embodiment explained in more detail.

Fig. 1 shows schematically an intraocular lens according to the invention.

The Fig. 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 ; 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. It has four angular elastic haptic elements 3 connected to it for 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 lie in the implantation region 4 in the folded state without additional manipulations, as 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 additional devices, not shown, for. B. holes, which are suitable to enable a connection to other implants, such as a capsule clamping ring or other implanted systems.

The invention creates an artificial intraocular eye lens, the one Easy passage through the smallest possible sclerocorneal or corneal Implantation opening allowed in the eye, as well as a simple unfolding process with low stress on the touched structures of the eye, a slight turning on the Implantation location, i.e. 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 is kept low by the fastening elements of the lens will.

Reference list

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 (10)

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 therewith from several angular elastic support elements, characterized in that it has four haptic elements ( 3 ) for a four-zone support or storage which are separated peripherally 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 ) 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 inserting 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 to change their flexibility are interrupted one or more times.   7. intraocular eye lens according to claim I, characterized in that the haptic elements Devices for making connections to other implants exhibit. 8. Intraocular eye lens according to claim 7, characterized in that the devices Are pierced. 8. Intraocular eye lens according to one of the preceding claims, characterized characterized in that haptics and optics are made of the same material. 9. Intraocular eye lens according to one of the preceding claims, characterized characterized in that haptics and optics each consist of different material.