WO1988006430A1

WO1988006430A1 - Intraocular lens

Info

Publication number: WO1988006430A1
Application number: PCT/FR1988/000119
Authority: WO
Inventors: Claire Lecoq
Original assignee: Claire Lecoq
Priority date: 1987-03-06
Filing date: 1988-03-03
Publication date: 1988-09-07
Also published as: FR2611487A1; FR2611487B1

Abstract

An opthalmological surgical device comprises a supporting element integral with the sclerotic, and a supported element consisting of an intraocular lens attached to the supporting element after being introduced separately into the eye. The lens attached in this manner is in the aqueous humour, and is not in contact with the intraocular structures, in particular the uvea. In the case of a supporting system with four points of sclerotic penetration and in the simplest embodiment, the supporting element is U-shaped with an intrasclerotic (22) horizontal arm (13) and two vertical arms (11) the end (14) of which is attached to the sclerotic on the opposite side to the horizontal arm. Viewed from the pupil (5), a lens (19) of the required strength is attached to this kind of rigid intraocular framework, the lower part of the lens being rigidly attached (18) to one of the two vertical arms, and the upper part (20) being sutured to the other arm. The device according to the invention is designed to correct errors of refraction, in particular aphacia and myopia.

Description

Intraocular lens

The present invention relates to a device composed of a carrier element secured to the sclera, and a carried element consisting of an intraocular len tille attached to the carrier element after having been introduced into the eye independently. This device is intended to be used in eye surgery for the treatment of refractive disorders, in particular aphakia (absence of the lens) and myopia.

The placement of a lens inside the eye to compensate. such vision loss is an old dream that has taken a long time. shape. These intraocular lenses have brought about an already considerable change. Before them, operated cataracts were corrected by glasses fitted with large converging lenses. These glasses are uncomfortable, have significant optical disadvantages and cannot correct unilateral aphakia. It is not the same for pre-corneal lenses (contact lenses), which induce much less magnification and have led to marked improvement, but which have other kinds of disadvantages: intolerance making the apparatus impossible, difficulties in handling, weariness and abandonment in the young unilateral aphake. We find these two modes of correction for refractive disorders other than aphakia such as myopia, hyper¬ metropia, astigmatism. For all these cases, glasses or contact lenses are effective but remain palliative and demanding means since they require constant wearing. They can be lost, damaged or sources of various troubles: poor tolerance, eye injury by broken frame or shards of the glass, rare but serious lens accidents (corneal ulcerations with secondary infection or even perforation). In severe myopia, far vision with lens correction is often poor. Finally, the costs and economic impacts of these means of correction, which must often be renewed, are not negligible. For centuries, we had resigned ourselves to correcting these refractive disorders by glasses alone, the alternative of contact lenses being fairly recent. We have moved to a much more active approach with surgical treatment and in particular intraocular lenses (also called implants, intraocular implants or even artificial lenses when it comes to replacing the lens). They were originally designed for the correction of apha¬ kia, but their use can also be considered with the lens in place. These lenses are described as a central part called optics and a peripheral part called haptics. This haptic allows fixation inside the eye where it is essential that the lens is well stabilized without which big troubles arise. There are various categories of lenses, depending on the position of the optics relative to the pupil (pre or retropupillary), and according to the support of the haptic, which is an element essential. (Recall that in the cataract operation the extraction of the lens is either intra-capsular ie total, -some supports cannot be used then-, or extra-capsular in which case the peripheral and posterior parts of the capsular bag are left in place ). This support cleJLa lens can be this capsular bag, the iridociliary angle, the iris, the iridocorneal angle. The fixation can also be mixed, for example iris and capsular, or even associating a scleral attachment and a support on one of the intraocular structures. These lenses provide a comfortable vision, close to that of a normal eye, and without the slightest subjection since the correction, made inside the eye, is permanent and final. They are therefore almost ideal, in theory. In practice, a considerable number of works and various tests have already been done, multiple models have been proposed, -more than four hundred a.hour: .current-, with the forms of hapti Qu _^ - -the most diverse and very varied fixing methods. - However, the disadvantages, difficulties and complications of implantation remain, constituting a vast whole which we will try to summarize for the understanding of the explanations which will follow, relating to the interest of the invention.

These drawbacks are linked in particular to the fixing system. The longest used iris len¬ tilles, long used the most, have been accused of promoting inflammatory reactions and a formidable complication that is cystoid macular edema (damage to the macula, essential area of the retina allowing precise vision ), because of greater contact with the uveal tissue and too much mobility. Lenses with anterior fixation, in the iridocorneal angle, despite improvements, retain many disadvantages: risks of irritation of the angle with synechiae, oedematous corneal decompensation, hypertonia by different mechanisms. This angular fixation leads to an unsolved difficulty: that of the need for a perfect match between the diameters of the lens and the anterior chamber, otherwise serious complications will ensue. There is therefore difficulty in choosing the optimal size, and necessity of storage of multiple lenses in different sizes for each power. An attempt has been made to improve this angular fixation by making it scleral, either by insertion of the periphery of the haptic inside the sclera or even beyond, either by sutures connected to the lens, but without success: more extensive angular synchia, scleral section according to the principle of the butter cutting wire if the fixation is tight, fixation ineffectiveness if the suture is loose with too much mobility of the lens. Finally, lenses with support behind the iris, the most recommended at the present time, can also induce complications, mainly in the lungs, especially if the support is ciliary. The capsular support, in particular, has ment the disadvantage of requiring the conservation of more anterior capsule which will secondarily cloud and interfere with the control of the peripheral retina. Finally, these two methods of posterior fixation, ciliary or capsular, which require extra-capsular extraction of the crystal, have the disadvantage of being deemed to be rather difficult to perform for operators with little training. Regardless of the method of attachment, certain disadvantages of intraocular lenses remain poorly resolved. The optics are most often made of polymethylmethacrylate, well tolerated in the eye but on condition of the imperative qualities of manufacturing of the material and machining of the implants. At the slightest failure in this respect, serious complications arise: strong inflammatory reactions, haemorrhages, glaucoma, cystoid macular edema. Tests have been made with other materials, such as glass, which is interesting, but poses difficulties for haptics and fixation. Polymethylmethacrylate has two significant disadvantages. The first is the impossibility of its sterilization by a simple means, such as the autoclave; soda, long used, has been gradually replaced by ethylene oxide which has at least as many disadvantages and in particular: expiration date, need for degassing maneuvers, persistence of micro-particles irritating to the eye. second drawback is the risk of putting in place a lens whose power does not correspond to that on which we believe we can count. Such errors have been reduced by strengthening controls at manufacturers, but not completely eliminated. Now it is not. not possible to do an intraoperative check because of sterilization problems And most manufacturers do not engrave on the optics the dioptric power of their lenses because it increases the technical difficulties for the finish. For the correction of refractive disorders other than aphia, such as myopia, we encountered the same difficulties, which are in fact reinforced because the presence of the lens then strongly limits the solutions to fix the lens whose optics and haptics must in this case be placed in front of the iris. Thus, despite the hope aroused by intraocular lenses, attempts to implant in such indications have come to a short end because the difficulties are even less resolved than for aphakia. Still with regard to the explanations which will follow, relating to the interest of the invention, let us add that other surgical solutions have been proposed. Several types of interventions have recently been developed which are grouped under the name of corneal refractive surgery and which aim to modify the dioptric power of the cornea, either by acting in its very thickness, or by proceeding to its face. anterior and em- bending in both cases lenses of human corneal material cut to measure. These interventions make it possible to correct aphakia, myopia, hyper¬ metropia. To this technique is added the radial keratotomy, for minor myopia and certain astigmatisms, which consists in making deep incisions of the cornea to modify, its radius of curvature by flattening it a little. Mention will also be made, with regard to myopia, of certain attempts at action on the sclera, as well as the extractions of transparent lens. But all of these techniques have major drawbacks. The extraction of a clear lens poses serious retinal risks in large myopics with a particularly fragile retina. Interventions with scleral action, with too imprecise and mediocre results, are currently abandoned. Radial keratotomy does not give constant and visible results, can lead to various complications and has the irreversible handicap of leaving permanent scars on an intact cornea. It is the same for other techniques, certainly more attractive, of corneal refractive surgery. These also have the disadvantage of being more complex, at least for intra-corneal actions, and above all of very limited distribution as long as human corneal tissues are used. One currently very advanced line of research is to try to develop transparent synthetic elements of replacement, which would allow a large-scale dissemination of these methods, with therefore intra or epi-comean lenses. However, we obviously come up against the enormous difficulty that tolerance of the cornea in the long term constitutes for such materials. Even if the difficulties were all resolved, there would still be the inevitable drawback of having to disrupt this structure as extraordinary in its transparency, as exceptional, therefore as worthy of respect as the cornea is.

All of these explanations given before approaching the description of the device specific to the invention will have been long, both with regard to the state of the art at the present stage, and with the drawbacks of the techniques hitherto used, but it is s is a complex issue. Refractive eye surgeries are increasing in our time. These interventions have functional, optical and not strictly medical indications in the sense that. it has been understood up to now, ie of cure or prevention of an active disease. These distinctions will probably no longer apply in a century, but it is understandable that they currently preoccupy many ophthalmologists who have to face a situation of such considerable change. In any case, it is important that such operations be reliable, involve the minimum possible risk and be the subject of good information to the candidate for intervention. - 5 - In summary, at the moment it turns out that:

- All intervention techniques for refractive purposes have serious drawbacks, and it is ultimately the solution of intraocular lenses which seems the most effective, the least aggressive for the cornea. - For the correction of aphakia, these lenses, while giving generally positive results, all have drawbacks themselves. There is no ideal implant. No method of attachment is free from defects

- For the correction of disorders other than aphakia, such as myopia, these drawbacks are even more difficult to overcome, and in practice these lenses are not used for such indications, the number of which would however be potentially much greater.

- The disadvantages of these intraocular lenses are linked to the fact that they must include fixing elements. The need for this haptics also hinders the achievement of certain improvements in optics.

The device according to the invention makes it possible to reduce or avoid these disadvantages. While ensuring good fixation, it eliminates the need for the lens to have a support on one of the intraocular structures and therefore improves the tolerance of this lens by the eye. It largely resolves the difficulty associated with variations in the dimensions of the anterior segment of the eye and allows the use of a standard size lens, which will remain well centered. It opens up the field to the manufacturing of lenses providing better visual comfort (isiconia), and to the use of more efficient materials making it possible to obtain safer lenses (easier sterilization and power control). For the correction of aphakia it can be used regardless of the mode of extraction of the lens, whether the implantation is secondary or immediately, and it is no longer subject to anatomical restrictions specific to each of the different methods of fixing conventional implants. It can also be used for the correction of other refractive errors such as myopia. All these advantages are due to the fact that the device according to the invention comprises two elements, a carrying element and a carried element. The carrier element, or fixator, is tightly attached to the wall of the eyeball; and it is united, an essential fact, without the constitution of extended secondary adhesions in the iridocorneal angle due to too large an opening of the sclera, and without secondary mobilization through it. This carrier element constitutes a kind of rigid frame on which the carried element will be fixed, that is to say the lens placed inside the eye. Thus, although it integrates therapeutically in the group of intraocular lenses, the device according to the invention is completely different from the modes the hitherto used. (The load-bearing element can, at the limit, and without danger for the intraocular structures, be placed in isolation, without an associated lens, but then no longer useful in the absence of secondary implantation. The worn element could also theoretically be placed in isolation inside the eye, like the other current lenses, but then without any stability and therefore with danger for the intraocular structures). Supporting element and worn element are in summary associated and must be adapted to each other, which implies the need for new lenses designed to be fixed to this carrying element, and different from Q all intraocular lenses. described to date, to the knowledge of the inventor.

To hold this bearing element, a scleral fixation is required, and a single fixation zone is sufficient. But the supported element then likely to be too mobile, it is preferable to ^r have two areas of attachment to the sclerotia 5 diametrically opposite re since the aim is to keep a ri¬ gide material secured to the sclera and really carrier in this circular space which is that of the anterior segment of the eye. Within all of these two diametrically opposite first saw areas there may be four points of scleral penetration of the carrier element, or only three 0 or two. A number greater than four is possible, without limitation and without departing from the scope of the invention, within the two zones which are first sawn, or even by increasing their number. However, such increases only lengthen and complicate the implementation operation. These considerations apply of course, without departing from the scope of the invention, for the worn element, ie the lens, the methods of attachment of which to the carrying element may vary depending on the method of attachment of the latter at the sclera. For the carrier element as for the element carried, the best of these variants are generally the simplest both for the installation and for the manufacture. 0 The accompanying drawings illustrate by way of nonlimiting example two embodiments of the device according to the present invention. In these drawings:

- Figure 1 is a front view of a part of the device, representing the carrier element, in the situation where it will be placed in the eye.

FIG. 2 is an anterior view of the other part of the device, showing the element worn, i.e. the lens to be fixed inside the eye.

- Figure 3 shows a previous schematic view of the device, with only the carrier element shown in Figure 1 in place inside the eye.

- Figure 4 is a schematic anterior view of the entire device shown in Figures £ and 2, in place inside the eye. 0 - Figure 5 is an anterior view of the eyeball on which we placed a time dial to indicate what mean expressions used in ophthalmology such as scleral opening at noon, or at 6 o'clock.

- Figure 6 shows the element worn, ie the lens to be fixed inside the eye, corresponding to the carrier device of Figure 7. - Figure 7 shows the two segments, diametrically opposite, constituting the carrier element of the device according to the invention, with a variant of scleral perforation at only two points, instead of four as in FIGS. 3 and 4.

- Figure 8 shows a schematic front view of the device shown in Figures 6 and 7, in place inside the eye.

- Figure 9 is a sagittal vertical section of the anterior part of the eye, showing the intraocular situation of the device of Figure 8, in a variant concerning the union of the worn element - carrier element. Only the anterior part of the eyeball is shown very diagrammatically in FIGS. 3, 4, 5, 8 and in section 9, and all the details are not reproduced. Reference can be made to conventional textbooks for the description and the anatomical plates of an eyeball. The numbers 1 and 2 refer respectively to the cornea and the sclera. The number 4 designates the iris, the 5 the pupil, the 7 the anterior chamber of the eye, the 8 the iridocorneal angle with the sawdust spur, the 28 the ciliary body, the 10 the surgical limbus, zone junction between cornea and sclera, where the conjunct which covers the sclera is inserted and is not shown here. In these figures, the lens has a diameter of the order of five millimeters. It can in practice be a little reduced, or much larger, depending on preferences and taking into account an important point which is that of the subsequent control of the peripheral retina (possible through a lens but better if the we • can go outside).

The device, object of the invention, will now be described under one of its simplest variants, in the case of scleral penetration at four points (Figures 1 to 4). It comprises a bearing element having the shape of the letter U. The two vertical branches 11 have first their lanceolate end 14, slightly curved according to the scleral curvature and provided or not with an orifice 15. Then they are of the most diameter reduced possible in the area intended to remain intra-scleral. They then have a slight curvature with posterior concavity and each have a small bulge which is not located at the same height: on one branch it is at the upper third union middle third, on the other at the middle third union - lower third. The lowest has a notch or orifice 18 slightly flattened oblique at the bottom and outside. The highest located is provided with an orifice 17 oriented from front to rear. Near its junction with the horizontal branch, each branch ver- again is as fine as possible in this other zone which will also be intra-scleral 16. The horizontal branch 13 of the U ^" is narrow, thin, flattened, molded on the convexity of the sclera and concentri¬ that at the limbus The two vertical branches having been introduced through the sclera and having passed through the anterior chamber to finally come out again by perforating the sclera, diametrically opposite the entry point, each of their ends will be fixed to the sclera by a suture preventing any withdrawal by sliding towards the interior of the eye.A good stabilization is thus obtained and will be even better when the scar will have fixed the four narrow passages thus practiced through the sclera. of this kind of frame fixed at its two ends to the wall of the globe is intraocular, immersed in aqueous humor, without any contact with the eye tissues in particular the iris, such is the first part of the device according to the invention. The second part is constituted by the worn element, ie the lens 19, which will have been introduced by conventional means. It has a circular shape but can also be triangular, quadrangular, pentagonal, hexagonal, etc. It has in addition two small extensions: one is a thin and short oblique rod 21 designed to be engaged in the notch or the orifice (the lowest located) of one of the two vertical branches of the load-bearing element; the other extension 20, at the diametrically opposite point, is provided with a small orifice intended to be applied opposite that (the highest located) existing on the other vertical branch of the carrier element, so that a simple su¬ ture allows a close union of the element worn with the carrier element. Thus is fixed inside the eye a lens which therefore does not rest on any intraocular structure.

A second variant of the device according to the invention will now be described where this time the carrier element has only two points of penetration into the sclera (Figures 6 to 8). This load-bearing element is made up of two almost identical segments. Each segment has a thin and flattened base 29, curved, concentric with the limbus and molded on the convexity of the sclera. This base has orifices 30 or simple notches, allowing solid fixation by scleral sutures. On this base is implanted a thin rod 32 intended to be introduced into the eye. It is at the junction with the base that the rod is thinnest, in the zone which must remain intra-scleral 31. The body of this rod is then more spread out, a little different, - this is the only difference here - , for each of the two segments: the rod of the segment intended to be the highest located is provided with a narrow orifice 33 allowing the passage of a suture. Finally, the end of each rod is slightly threaded to facilitate penetration into the eye. The set of the two seg- with sufficient rigidity, the curvature of each of them, its position on the sclera, and the orientation of the rod are such that there is no risk of racking in towards the cornea or in back towards the iris or even the lens. The worn element, meanwhile, is not made up of two parts like the carrier element, but consists of a simple lens 24 of circular shape or not, as for the U-shaped device previously studied. This lens has two small diametrically opposite extensions 25, 27 of different length. Their end is of the male type, intended to be engaged in the female rod of each of the two segments of the carrier element. The upper extension 25 is provided with an orifice 26 which will be brought opposite that 33 appearing on the rod of the carrier element. A simple suture uniting these two orifices makes it possible to join the whole. In summary, in this second variant, the bearing element res¬ seems to the two abutments of a bridge whose deck would be represented by the lens (this connection increasing the stability of the assembly but each of the two parts related to a abutment being fixed, solid and can be left alone in the eye, without harm to him). In the first large variant described above, of the U-shaped system, the comparison of the bridge remains valid, but then with an apron resting on two truss masters and not on two abutments. The second variant has for it to require only two points of scleral penetration, the first to be even more stable, with certainly four points instead of two but even finer. Other major variants of the device according to the invention, with two and four points of scleral penetration, but with one, three or more than four, can thus be described, which all remain within the scope of the invention.

We will now describe the installation of the device according to the invention in a standard intervention protocol, with four points of scleral penetration (FIG. 4), the operative indication having been given after complete assessment which will in particular determine the power of the lens to be placed in the eye. After measuring the corneal diameter, which gives an estimate of that of the anterior chamber, the conjunctiva is opened either at limb 10 or at a distance, from 10hY _z to 13hY ₂ and from 4h ¹ ^ to 7h ^. One cleaves two scleral flaps 22 with a limbic hinge, one lower, the other upper, a few millimeters wider than tall. The subsequent times are those of a conventional intervention: upper limbic incision, realization of two lateral lateral iridectomies, extraction of the lens according to the planned methods, if it is a cataract operation. Otherwise, if one intervenes for example for myopia, in a phake with clear lens, there is obviously no contact with this lens and one pursues with a pupil previously put in miosis (narrowed). If there has been extraction of the lens, this miosis is caused before continuing. The anterior chamber is filled with a transparent viscous substance with buffering power, as is routine. Then simultaneously introduced the ex¬ end 14 of the two vertical branches 11 of the U-shaped carrier element, at the rear of the lower limb, in the bottom of the sawdust cleavage zone prea¬ lably practiced. We can use an easy handling instrument consisting of a small handle carrying two pointed rods forming a fork, which

LO facilitates scleral perforation and serves as a guide so that the opposite perforation is well diametrically and is not offset from the meridian chosen as the axis of the carrier element, here from 6 am to 12 noon. The scleral perforation must be done at a precise point so that the two vertical branches of the U penetrate into the anterior chamber 7 just backwards.

15 re of the spur sawdust 8, so as to avoid the cornea 1 in front, the iris 4 and its vessels in arrlèèe. It can be guided by transillumination, of conventional practice and which shows with precision the projection of the bottom of the angle 8 on the external sclera 2. Finally, it can be preceded by a covering in front of the area which will be perforated, in order to reduce the

20. limited risk of minimal bleeding. (The "fork device for perforating can also be equipped for this action." Once introduced into the eye, the two vertical branches 11 are gently pushed up, parallel to the iris and a little in front of it, passing on either side of pupil 5, equidistant from pupil center, their ends 14

25 then again cross the sclera, again at the bottom of the angle just behind the spur, but this time from inside to outside to appear under the upper sawdust flap, at the bottom of the sawdust cleavage area. These ends are then secured to the sclera by a suture. The horizontal branch 13 of the U is well wedged in the bottom of the area of

30 lower sawdust cleavage and does not need to be sutured. We then come back to the upper limbic incision (which may have been partially closed literally, or on the contrary slightly enlarged, depending on the intervention performed). The lens 19 is introduced into the anterior chamber 7, as is usual. The lower oblique extension 21 of this lens is inserted into

35 the notch or oblique orifice 18 located in the lower half of one of the vertical branches of the U. The orifice placed on the upper extension 20 of the lens is then brought opposite that 17 located on the upper half of the other vertical branch of the U, and they are secured by a suture made of non-absorbable thread and well tolerated inside the eye (according to

40 a conventional procedure used to suture the iris). This suture must be tight enough to prevent movement of the lens which is blocked. The buffering sub ± ance is then evacuated, the sclera carefully closed by an overlock, the limbic opening sutured by separate stitch or overlock in such a way that there is as little as possible 5 me astigmatis. Finally, the conjunctiva is sutured, or replaced with diathermy, the intervention ending with the local administration of an antibiotic and an anti-inflammatory.

From this description of setting up a U-shaped carrier element, one can envisage that of other variants such as that of the carrier system with only two points of scleral penetration, previously described, and being limited to operating times specific to this model (Figure 8). The rod of each of the two carrier elements 32 is successively introduced into the anterior chamber, each element being fixed to the sclera by its base 29 which is provided with orifices for sutures 30. The lens 24 is then placed in the chamber anterior 7. Its upper extension 25 is introduced into the upper rod in which it can slide over a greater length than for the lower rod. Once the upper extension 25 is fully engaged, the lens 24 is gently pushed down and the lower extension 27 is locked in the lower rod. The orifice of the upper rod 33 is then in-level ^'• - to that of the upper extension 26 of the lens, and a single suture secures the assembly. It is also possible to use a reverse system with female type extensions on the lens, the two rods of the carrier system being of the mat type (FIG. 9). 25 The two protocols which have just been described have only been for information and explanatory purposes, many other ways of proceeding can be used, depending on the various modifications made to the device, and without going beyond the ambit of the invention. Some of these modifications will now be considered, without limitation. The bearing element 30 in U can be introduced into the eye along the axis of other meridians or in core in the opposite direction, that is to say from noon to 6 am, the end of the two vertical branches being then sutured in lower sclera and no longer superior, (the attachment of the lens to the carrier element being adapted accordingly). This suture can be done through an orifice 35 located at the flattened end of each of the branches or so that it encloses the base of the lanceolate end 14. This method of attachment to the sclera is replaceable by a bar joining each end of the two vertical branches 11 according to various procedures (embedding, micro-rivet, cleat, suture, etc.), the main thing being that a good connection of the entire device to the sclera is obtained . It is preferred- rable to practice a sawdust flap 22 at the adequate depth to main¬ hold intra-scleral this connection of the carrier element with the wall of the giobe. The duration of the intervention is increased but the protection is better than if this carrier element was directly applied to the external surface of the sclera, with the risk of irritation or even conjunctival opening, especially in elderly patients with thin and frail conjunctiva. Variants exist, as shown schematically in Figure 3, as to the number of scleral flaps: for example two small 23 instead of one facing each vertical branch of the U. To avoid any risk of scleral necrosis, the carrier element should preferably have an openwork horizontal bar, remaining within the limits of sufficient strength. Recall that the current lenses weigh only a few milligrams in air, even less in water, and that there is no traction or force support exerted by the lens on this carrier element which must only be blocked in the sclera. The joining of the two ends of the vertical branches of the U can also be obtained by means of another U-shaped piece which fits into the previous one according to the male plug-female plug principle, and is therefore introduced above at midday, -in the case taken for type of description. Nor is it mandatory that the carrier element and the Qported element are in the anterior chamber: they can be behind the iris, in the correction of aphakia; the extraction of the lens must then have been extra-capsular, the carrier element must have a 'slight posterior convexity, and one or two inferior peripheral iridectomies must be added for the passage of the rods of the carrier element and 5 depending on their number.These variants of the supporting element imply even more variants of the worn element. They can be classified into two groups depending on whether or not the attachment of the lens is easily removable without having to modify the carrier element. Thus in the U-shaped system which has been described, the lens is quickly and easily removable 0 (and replaceable) by simple change of suture. Such a situation is desirable if a phakic patient is operated for his myopia for whom one seeks maximum correction accuracy: a change can take place immediately during the intervention as soon as the new refraction is verifiable. This change may also be necessary years later if it is necessary to intervene again this time for cataracts. The removal of the lens will then facilitate the extraction of this cataract and allow the fitting of another lens adapted to the new needs. On the contrary, in the event of an immediate intervention with aphakia, the advantage of the possibility of easy ablation of the single lens is less. So in the variant with two U-shaped elements, sliding one inside the other, can we use a blocking such that the lens can only be removed with the carrier system or at least one of its two elements. There are therefore many variants of lenses, which cannot be detailed but all fall within the scope of the invention, depending on their method of attachment to the carrier element, with groove, hook, clip, micro-screw, lock, press button, pinching, blocking after sliding, with curved side tabs per¬ putting insertion and fixing without risk of subsequent displacement during movements of the globe, etc., all these variants having the common denominator to ensure stable fixing. About them, other perspectives are possible concerning bifocal lenses. In the actu¬ el state, an intraocular lens cannot provide both distance and near vision correction. A theoretical solution would exist, within the framework of the device, where the lens would slide in a U-shaped carrier element, with stop at the top and bottom to limit its stroke, and small magnetic part allowing the lens to be placed in high or low position and stay there through a notch: low position the upper segment of the lens allow ^the a vision; in the upper position the lower segment (double focus) would allow near vision. The transition to one or the other position would be done thanks to a slightly more powerful magnet integrated for example in a signet ring that the subject would pass before his eye according to his needs. Although technically feasible, such a variant is probably too futuristic and runs up against the objection represented by the delicate question of the legitimacy of the innovation planned, having regard to the services actually rendered in relation to the risks involved. additional costs incurred.

This reservation does not concern the other variants which have just been exposed in a non-exhaustive manner, but it leads to review the drawbacks of the device according to the invention, which could be objected to. The need for intervention and an intraocular approach always implies a risk of infection, statistically exceptional but no less formidable; these infectious complications are not specific to the invention and relate to all the other surgical methods proposed in an attempt to correct refractive errors; even contact lenses simply placed on the cornea carry this unavoidable risk, which can only be avoided by limiting oneself to glasses worn for centuries. In any intervention with refractive aim also exists the risk of creating an astigmatism, which is obviously a height; however, this risk is minimal, provided there is operational experience and thoroughness in the placement, monitoring and possible removal of sutures on request; we now also have operating keratometers, and '' such interventions for intraocular lenses remain in any case less astigmatogenic than refractive comedian interventions. The difficulty of certain maneuvers, when setting up the device according to the invention, could also be presented as a drawback; in fact, it is not superior to that of other ocular procedures commonly performed at present; these maneuvers are moreover facilitated by the use of buffering substances in the anterior chamber of the eye. The objection of additional duration required by the cleavage then the subsequent closure of the scleral flaps is not admissible: even before the current stage of quality of both local and general anesthesia, it has been a long time since, especially in ophthalmology, the the need for thoroughness has prevailed over the need for rapidity, and it is not possibly a few additional minutes of work which must be incriminated when a treatment is carried out on an organ as important as an eye. can have consequences for the patient over decades of life. The risk of pupillary blockage is eliminated thanks to peripheral iridectomies and the slight curvature of the carrier element so that the lens is fixed a little distance from the pupil. The risk of a minimal bleeding, at the introduction into the anterior chamber of the parts of the carrier element passing through the sclera, is undeniable but not serious and readable by a hemostasis appropriate to the apparatus used. The possibility of a minimal temporary filtration of aqueous humor towards the exterior, along the intra-scleral stems, also exists: it is reduced thanks to the narrowing 16.31 of the carrier element and by the real - 5 sation of a careful closure of the scleral flaps, and it is stopped quickly with the development of scleral scarring. The fineness of these stems, which it has been emphasized that they should pierce the sclera only behind the spur, can also only cause very limited changes in the iridocorneal angle, without comparison with what one observes with certain current lenses of the anterior chamber. In summary, these drawbacks are incommensurate with the important advantages of the device according to the invention previously exposed.

The device which is the subject of the invention can therefore be used in eye surgery for the treatment of refractive errors. In aphakia 5 it is particularly indicated in certain cases where, because of significant associated post-traumatic lesions, it is not possible to hold a lens by any of the methods of fixation used to date. But it can also be used in other cases of aphakia. It is moreover usable in other refractive disorders, when a clear lens is in place, in myopia, hyperopia, or even cer- strong astigmatisms. In hyperopia, however, there is reason to consider this use with reservations if the anterior chamber is shallow and the angle irido-Korean is narrow. In myopia - the potential applications - they are quantitatively important, especially in the case of unilaterality and in high myopia. In all other cases the indications must be carefully weighed according to each patient.

The execution of the device according to the invention must aim at the greatest technical perfection possible and in particular in the choice of materials. For the element worn, ie the lens, this material must be transparent, well tolerated by the eye, and machinable so as to obtain lenses of well defined powers in a wide range with progressions of the order of a quarter or half diopters, to meet all needs, the lenses can be convex, concave, toric. For the load-bearing element, the materials must have the same qualities. That of transparency is however less important here, especially on the periphery, than that of rigidity and solidity. We can also use metals, isolated or alloy, some of the rest of which have already been used inside the eye for various implant models: gold, platinum, titanium stainless steel, etc. The variants of the carrier element may be linked to the quality of the material used: if it is for example malleable and partially foldable, it is possible in the case of the U-shaped system, after installation, to bend the end of the two vertical branches to make the carrier element even better secured to the sclera. Similarly, depending on the transparent material used, the methods of anchoring to the carrier element will vary. They will in particular differ depending on whether this material is rigid and more easily breakable, or else retains a certain flexibility and tolerates actions of the stapling or embedding type, after low pressure or slight force passage. The variety of these transparent materials is quite large: glass, numerous polymers, or any other material: synthetic already used or being the result of future inventions. By far the most widely used polymer since the start of implantation is polymethylmethacry¬ late methyl. Compared to it, glass has the advantage of being easier to sterilize; it is heavier but has a higher index making it possible to produce thinner, but also more elaborate lenses, for example with engraved power while having a good finish, or with the interpo¬ sition of an air strip for research better isiconia (reconstruction of an image as close as possible to that received by the normal eye): the carrier device according to the invention allows this improvement since it frees the need for haptics building on one of the constituents of the eye. It can also be used with very flexible allowing the manufacture for example of hydrogel or silicone lenses. An equally important point concerning the manufacture of the carrying element as well as of the element carried is that of the variations in the diameter of the anterior chamber according to the individuals. Thus in the case of the U-shaped system, elements carrying the appropriate length will be suitable for the majority of eyes of standard size, but it is no longer the same for eyes deviating too far from the average dimensions. There are therefore several solutions: - either use foldable or breakable materials (at the end of the device) to thus adapt even to the smallest diameters - or use methods of attachment of the lens on the carrier element which allow the latter to always remain well centered, these two solutions being able to be combined - or else to manufacture carrier elements of different size making it possible to cope with all eventualities. This major difficulty is found in the implants of the anterior chamber, a difficulty which in the case of the latter solution the device according to the invention erases almost entirely; because the progress compared to these conventional implants is considerable: we are certainly thus led to make a carrier element in two or, at most, three different sizes; but only the carrier element is concerned, the whole range of lenses in different powers remaining standard dimensions, while for conventional lenses it takes for each power two, three or four different diameters. Finally, in addition to the best possible material must also be required, as quality criteria, sufficient strength and stiffness associated with a minimum weight and size. In short, it is necessary to obtain the most perfect miniaturization possible, this miniaturization being the result of all the eye surgery which is microsurgery.

In summary, the device according to the invention brings progress to the field of eye surgery. Intraocular lenses seem to be the most logical, least traumatic way to the cornea, for the surgical correction of refractive errors. It is no less logical that these lenses, in order to benefit from the best quality and the best possible tolerance, have no contact with the intraocular structures, in particular the uvea, that they simply bathe in the aqueous humor. and are therefore fixed only thanks to a support element solida¬ rised to the sclera.

It goes without saying that the present invention has only been described and shown for information and explanatory purposes but is in no way limitative and that it is capable of various variants and modifications, some of which have only been envisaged, without departing from its frame.

Claims

1. Ophthalmic surgical device allowing the fixing of a lens inside the eye, characterized in that it consists of a carrier element and a worn element, the carrier element being secured to the wall of the eyeball by forming a rigid frame which bathes in the aqueous humor and does not touch any intraocular structure, the worn element consisting of a lens introduced independently of the carrying element and which will be attached to it and to it alone without any contact there either with the intraocular structures and thus bathing only as the carrier element in the aqueous humor, carrier element and carried element forming a unit adapted to each other and used to correct, thanks with the intraocular lens, aphakia and other refractive disorders such as myopia, hyperopia, astigmatism.

2. Device according to claim 1 characterized in that the carrier element, the internal part of which will be intraocular, has an external part which, secured to the wall of the globe by attachment to the sclera and regardless of the number of fixing zones, is of curved shape, molded on the conex of the sclera, with sufficient rigidity and solidity to ensure the stability of the element carried while having the smallest possible volume.

3. Device according to claims 1 and 2, characterized in that, with regard to the carrier element, in the case of four points of scleral penetration, the basic model has the shape of the letter U with two vertical branches (it ) and a horizontal branch (13), the horizontal branch being narrow, thin, perforated while remaining sufficiently solid, flattened, molded on the sclera and concentric with the limbus, the two vertical branches having the thinnest diameter possible compatible with solidity Sufficient in the area following their union with the horizontal branch is intended to remain intra-scleral (16), these two vertical branches then having an overall curvature with slightly posterior concavity and each having a small bulge not located at the same height, the lowest being at the middle third-bottom third union and having a notch or oblique orifice at the bottom and outside (18), the highest located at the middle third-upper third union and being in turn provided with a hole (17) oriented from front to back, said vertical branches then being both before their termination again the finest possible in the zone which will be intra-scleral, then finally having a lanceolate end (14) adapted to the scleral curvature and provided or not with an orifice (15), it being understood that this end of each of these two branches ver- ticales will be fixed to the sclera by a suture cleared that they have been introduced into the eye through the sclera and then have passed through the anterior chamber to finally come out again by perforating the sclera diamé¬ trally opposite the point d 'entry, the horizontal branch meanwhile remaining well stabilized because being wedged in the bottom of the scierai cleavage pre¬ prepared for it, these two vertical supporting branches framing the pupil, in front of which will be placed the element carried intended to be attached to the load-bearing element, and which can be compared to the two main beams of a bridge whose deck is formed by the lens.

4. Device according to claims 1, 2 and 3, characterized in that, with regard to the carrier element with four points of scleral penetration, the two ends of the vertical branches of the U-shaped element peu¬ vent, a once crossed the sclera, be curved no longer sagittally but laterally depending on the material used, can especially be modified with the addition of a bar joining them together using procedures such as fitting, micro-rivet, cleat, suture, or even thanks to another U-shaped piece which fits into the previous one on the male-female-plug principle and part of which will therefore also be introduced inside the eye, so that good attachment is always obtained this carrier element on the wall of the eyeball.

5. Device according to claims 1 and 2, characterized in that, with regard to the carrier element, in the case of two points of scleral penetration, the basic model consists of two segments, part of which will be introduced into the eye at two diametrically opposite points, each segment having a thin base, flattened, curved, molded on the sclè¬ re and concentric with the limb, perforated 'notches or orifices (30) but sufficiently rigid, being able be securely fixed by scleral sutures, on which is implanted a rod (32) as thin as possible while remaining solid in the portion intended to be intra-scleral (31), rod whose body extends a little then in the part intraocular, the segment of _t stined to be the highest located in the eye having at this location a small orifice (33) oriented from front to back for the passage of a suture, said rod finally terminating , while being slightly tapered at the end, according to the male or female mode, the assembly of the two segments leaving in the center a free space facing the pupil, where the carried element intended to be attached to the carrying element will be placed, said assembly being able to be compared with the two abutments of a bridge between which will be thrown the apron constituted by the worn element, ie the lens.

6. Device according to claims 1, 2, 3 and 4, characterized in that, with regard to the element carried, in the case of a carrier element with four scleral penetration points, this worn element is constituted by a len¬ tille (19) which will be introduced into the eye independently of the carrier element by another way so as not to create extended synechiae in the angle iridocorneal, this lens of adequate dimensions having a circular shape but which can be different such as triangular, quadrangular pentagonal, hexagonal, octagonal, this comportantsntille also comprising two small extensions, one being a thin and short oblique rod (21) designed to be engaged in the notch or orifice (the lowest located) of one of the two vertical branches of the carrier element exposed to claim 3, the other extension placed at the diametrically opposite point being provided a small orifice (20) intended to be applied opposite that (the highest located) existing on the other branch of the carrier element, a simple suture connecting these last two ori profits permitting union ^narrow the element carried on the carrier, this union may also be provided by hook, clip, micro-screws, lock, snap, gripping, locking in groove after sliding, side tabs bent to insertion then fixing, so that a stable fixing of the lens carried to the carrier element is always ensured.

7. Device according to claims 1, 2, 5, and 6, characterized in that, on the subject of the element carried, in the case of a carrier element with two points of scleral penetration, this element carried is constituted by a lens (24) whose methods of introduction into the eye are similar to those set out in claim 6 and which has a circular shape or not, this lens of adequate dimensions having two extensions (25, 27) diametrically opposite, of the male type, designed to be engaged in the female rod of each of the two segments of the carrier element, the extension des¬ tined to be engaged in the uppermost rod being provided with an orifice (26 ) which will be brought next to that appearing on the rod of the carrier element (33), a simple suture uniting these two orifices making it possible to solidify the assembly, this fixing being also possible by hooks or even extensions of female type on the l entille matching male-type pins on each of the two carrier segments, so that is always assured - "a ^stable fixation of the lens carried on the carrier element..

8. Device according to any one of the preceding claims, characterized in that the carrying element and carried element are made of transparent materials, well tolerated by the eye and capable of being machined, so as to obtain lenses of well defined power. in an extended range due to meet all needs with progressions of the order of a quarter or half a diopter, materials such as glass or polymethyl methacrylate, or even hydrogel or silicone as regards the lens which can be flexible, the quality of transparency being less fundamental for the carrier element especially in the peripheral part where there may be association with an isolated metal or alloy, well tolerated by the eye, such as stainless steel, gold , platinum, titanium, the solidity of the carrier device having to be sufficient for a minimum weight and size in the context of the possible miniaturization meil¬, and it being specified that, in the context of this manufacture with the most suitable materials, the load-bearing elements can be supplied in different dimensions allowing the use of a lens of standard size which remains standard regardless of the dimensions of the eye

10.

9. Device according to any one of the preceding claims, characterized in that, whatever the methods of attachment of the carrier element co me of the element worn or the characteristics of the materials used, the len¬ tilles intra- eyepieces due to their respective optical properties will be convex, concave, toric, isoconical, or also bifocal in

15 sliding along the carrier element thanks to a magnetization and notches fixing the lens in turn in the high or low position.

10. Apparatus according to any preceding claim ca¬ terized in that, support and supported element member being non seule¬ ment in the room antërie _^ ure of the eye but also behind the iris

20 in aphakia, the carrier element in its intraocular part then has a slight posterior convexity.