WO1988006430A1 - Intraocular lens - Google Patents

Intraocular lens Download PDF

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Publication number
WO1988006430A1
WO1988006430A1 PCT/FR1988/000119 FR8800119W WO8806430A1 WO 1988006430 A1 WO1988006430 A1 WO 1988006430A1 FR 8800119 W FR8800119 W FR 8800119W WO 8806430 A1 WO8806430 A1 WO 8806430A1
Authority
WO
WIPO (PCT)
Prior art keywords
lens
carrier
eye
element
scleral
Prior art date
Application number
PCT/FR1988/000119
Other languages
French (fr)
Inventor
Claire Lecoq
Original Assignee
Claire Lecoq
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to FR87/03061 priority Critical
Priority to FR8703061A priority patent/FR2611487B1/en
Application filed by Claire Lecoq filed Critical Claire Lecoq
Publication of WO1988006430A1 publication Critical patent/WO1988006430A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses

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

Lentil e intraocular

The present invention relates to a device composed of a por¬ tor element secured to the sclera, and a member carried consisting of a len tille intraocular attached to the carrier after being introduced into the eye independently. This device is intended for use in eye surgery for the treatment of refractive errors, notam¬ ment aphakia (no lens) and myopia.

The establishment of a lens inside the eye to alleviate. Such a vision defect is an old dream that has been slow to. shape. These intraocular lenses already brought a considerable change. Before them, the cataract surgery were corrected by glasses équi¬ SOEP large converging lenses. These glasses are uncomfortable, have significant drawbacks optical in¬ and can not correct the unilateral aphakia It is not the same for the pre-contact lenses (contact lenses), which induce a much lower magnification and brought a net tion improvements, but have other kinds of drawbacks: the impossible intolérancesrendant equipment, handling difficulties, weariness ec aban¬ donation in young unilateral aphakic. We find these two modes of correction is for refractive disorders other than aphakia such as myopia, hyper¬ métropie, astigmatism. In all these cases, spectacle lenses or contact lenses are effective but remain palliative and exacting means as requiring constant port. They can be lost, damaged or sources of various problems: poor tolerance, eye injury or breakage of the frame shards of glass, rare but serious accidents lens (ul¬ cérations cornea with secondary infection or perforation). Dans.les myopia distance vision with glasses correction is often poor. Finally, costs and economic implications of these's correction means that you often repeat are not negligible. They had resigned for centuries to correct these refractive errors with glasses alone, the alternative contact lenses is fairly recent. We went to a much more active approach with surgical treatment including intraocular lenses (also called implants, intraocular implants or artificial crystalline when it comes to replace the lens). They were originally designed for the correction of the kie apha¬, but their employment may also be considered with lens in place. We describe these lenses called an optical central part- and part pé¬ riphérique called haptics. This haptic allows the attachment within the eye where it is essential that the lens is well stabilized otherwise occur in big trouble. There are various types of lenses, depending on the position of the optics relative to the pupil (or pre Re- tro-pupillary), and depending on the media of the haptic, which is an essential element. (Recall that in the cataract lens extraction is either intracapsular ie total, -some supports are not then utilisables- or extracapsular which case up is allowed to the rear portions of the capsular bag périphériqueset ). This lens holder can be cleJLa this capsular bag, the irido-ciliary angle, iris, an¬ gle iridocorneal. The attachment may also be mixed, eg iris and the capsular, or associating a fastener scleral and a support on one of the intraocular structures. These lenses provide a vision conforta¬ cable, similar to that of a normal eye, and without any subjection since the correction made to the interior of the eye is permanent and definitive. They are therefore almost ideal in theory. In practice, a number considéra¬ wheat various work and testing has been done, many models have fl proposed -more than four hundred à.l'heure: .actuelle- with forms of hapti Qu ^ - -les.plus diverse and very varied fixing -modes. - But disadvantages, difficulties and complications of the implantation remain consti¬ killing a wide range that we will try to summarize for compréhen¬ sion explanations that follow, concerning the value of the invention.

These disadvantages are particularly related fixing system. The iris len¬ daughters to support, the most used long time, have been accused of promoting inflammatory responses and a serious complication that is cystoid macular edema (damage to the macula, an essential area of ​​the retina permitting clear vision ), due to greater contact with the uveal tissue and excessive mobility. The lens attachment anté¬ higher in the anterior chamber angle, despite improvements, retain many disadvantages angle irritation risks with adhesions, edematous corneal decompensation, and hypertension by various mécanis¬ my. This angular attachment causes an unresolved problem: that of the need for a perfect match between the diameters of the lens and anterior chamber, otherwise serious complications will ensue There is therefore difficult to select the optimal size, and the need for storage of multiple lenses in different sizes for each power has been tried to improve this angular fixing by making the scleral or by inserting the periphery of the haptic within the sclera or even au above, or by sutures connected to the lens, but without success sy- angular néchies more extensive scleral section according to the principle of the wire cheesewire if the fastener is tightened, fixing inefficiency if the suture is too loose with mobility of the lens. Finally lentil¬ rear support to the iris, the most recommended at this time, can also lead to complications, especially in lammatoires, surprising all the media for ciliary. The capsular support, meanwhile, has in particular lies the disadvantage of requiring the preservation of more anterior capsule that will secondarily become opaque and interfere with control of the re tine device. Finally the two posterior fixation methods, ciliary or capsule, which require extracapsular extraction flax crystallized, have the disadvantage of being judged execution rather difficult for untrained operators. Regardless of the method of attachment, some disadvantages of intraocular lenses are poorly resolved. The lens is usually methyl polymethylmethacrylate, but well tolerated in 1'oeil provided compelling qualities of manufacturing the material and machining of implants. The slightest failure in this regard serious complications occur: strong reactions in lammatoires, hé'morragies, glaucoma, cystoid macular edema. Tests have been made with other materials, such as glass, which is interesting, but poses problems for haptics and fixation. Methyl polymethylmethacrylate aut two significant disadvantages. The first is the impossibility of stérilisati by simple means, such as an autoclave; soda, long used, was gradually replaced by the ethylene oxide that has at least as many disadvantages in particular: expiration date, need Manoe lips degassing micro particles irritating persistence to the eye. second disadvantage is the risk of setting up a lens whose power does not correspond to that on which it is believed to have. Such errors were reduced by tighter controls among manufacturers, but not completely eliminated. Now it is not. not possible to make intraoperative verification because of problems Sterilization And most manufacturers do not engrave on the optical power Diop stick their lenses as this increases the technical difficulties for finishing. For the correction of other refractive disorders that kie aph, such myopia, we encountered the same difficulties, which are actually strengthened because the presence of crystalline limit so strongly so lutions to attach the lens whose optics and haptics must in this case be placed in front of the iris. Thus, despite the hopes raised by intraocular lenses, settlement attempts in such in¬ dications were cut short because the difficulties are even less well read than réso¬ 1'aphakie. Still on the explanations that follow, concerning the inte ret of the invention, adding that other surgical solutions have been proposed. Have recently been developed several types of interventions that are grouped under the name of corneal refractive surgery and which aim to change the refractive power of the cornea, or by acting in its thickness the same, either by carrying on its face anterior and by employing in both cases of human corneal lens material tailored. These interventions used to correct aphakia, myopia, hyper¬ métropie. In this technique adds radial keratotomy for myo¬ minor pies and some astigmatism, which is to practice deep corneal incisions to modify its radius of curvature in the Ĭ platissant a bit. Also suitable, about myopia, some action attempts on the sclera, as well as extraction of transparent lens. But all these techniques have serious drawbacks. The extrac¬ tion of a clear lens which poses severe risks in older retinal myopic to particularly fragile retina. Interventions scleral action, too vague and poorly, are currently abandon¬ born. Radial keratotomy does not give consistent results and visible pré¬, may cause various complications and the irreparable disability leave permanent scarring on the cornea that was intact. The same is true of other techniques, certainly more attractive to corneal refractive surgery. They have the additional disadvantage of being more complex achievement, at least for intra-corneal actions, especially very limited distribution as it will appeal to human corneal tissue. A currently most advanced research path is to try to develop transparent synthetic elements rempla¬ cement, which would allow a broad dissemination of these methods, so with lenses or intra-corneal spike. But one encounters évidem¬ lies the enormous dif culty is that long-term tolerance of the cornea to such materials. Even the difficulties would they be all resolved, there would be the inevitable inconvenience of disrupting this extraordinary structure of its transparency, so exceptional, so as worthy of respect as is the cornea.

All these explanations provided before discussing the description of the device incorporated with the invention have been long, as about the state of the art at this stage as technical disadvantages that jus¬ then used but s 'This is a complex question. Eye surgeries referred refractive multiply our time. But these interventions have functional order indications, optical, and not strictly medical in the sense. was heard until now, ie, cure or prevention of progressive disease. These distinctions will no proba¬ ably longer appropriate in an age, but it is understood that currently concern the number of ophthalmologists who have to face such a significant change in circumstances. It is important in any case that such opéra¬ tions are reliable, have the minimum possible risks and are subject to good information from the candidate to the intervention. - 5 - In summary, at present, it appears that:

- All interventions refractive techniques described have significant drawbacks, and it is finally the solution lenses intra-res oculai¬ that seems most effective, less aggressive to the cornea. - For the correction of aphakia, these lenses while giving RESUL generally positive states, all have their own disadvantages. There is no ideal implant. No method of attachment is free from defects

- For the correction of other disorders that aphakia, such myopia, the disadvantages are even more difficult to overcome, and practice these len tilles are not used for such indications, the number would be yet potentially much greater.

- The disadvantages of these intraocular lenses are related to what it should include fasteners. The need for this haptic discomfort also achieve some improvements for the op tick.

The device of the invention allows to reduce or avoid these disadvantages in¬. While ensuring good attachment, it removes the need for the lens to have a bearing on one intraocular structures and so- improves tolerance of this lens from the eye. It regulates much of the difficulty associated with changes in size of the anterior segment of the eye and allows a standard size lens, which remain centered. He opens the lens manufacturing the field providing a better visual comfort (iséiconie), and the use of high performance material to obtain safer lenses (sterilization of power and control easier). For the correction of aphakia it can be used irrespective of the lens extraction mode, the implantation is secondary or immediately, and it is no longer subject to strictions res¬ anatomic specific to each of the different modes of fixa¬ tion of conventional implants. It can also be used to correct other refractive disorders such as myopia. All these advantages are due to the fact that the device according to the invention comprises two elements a carrier element and a carried element. The carrier, or fixer, is tightly secured to the wall of the eyeball; and it is fastened, is essentially without formation of secondary adhesions extended into the iridocorneal angle due to excessive opening of the sclera, and without secondary mobilization through it. This carrier forms a sort of rigid frame on which will be fixed 1'élément worn, that is to say, the lens setting up within the eye. Thus, although it inté¬ grant, therapeutically, in the group of intra-oculai- res lenses, the device according to the invention completely differs from the mode- hitherto used. (The wearer may at the limit member, and harmless to the intraocular structures, be implemented in isolation without len¬ tille associated -but then useless either in the absence of secondaire- tion implanta¬ . the focused element could also theoretically be placed in isolation 5 inside the eye, like other existing lenses, but then no stability and therefore with danger to intraocular structures). bearing member and supported member are associated abstract and wind doi¬ be adapted to one another, which implies the need for new lenses designed to be fixed to this support element, and different from all the Q intraocular lenses described to date, to the knowledge of the inventor.

To keep this support element must scleral fixation, and it only takes one attachment area. But the element carried 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 actually bearer in this circular space that is one of the anterior segment of the eye. Within all of these two first diametrically opposed sclera zones there may be four scleral penetration points of the supporting element, or 0 only three or two. A number greater than four is possiblç, without limitation and without departing from the scope of the invention, even within the two areas first scleral or increasing their number. But such increases are not only lengthen and complicate the implementation process. These considéra¬ tions valent course, without departing from either the scope of the invention, 5 to the borne element, ie the lens, the details of which attachment to the carrier can vary depending on the method of attachment of it to the sclera. For the carrier as to the worn element, the best of these variants are generally simpler both for the establishment for the manufacture. 0 The accompanying drawings illustrate by way of non-limiting example, two embodiments of the device according to the present invention. In these drawings:

- Figure 1 is a front view of part of the device, showing the bearing member, in the position where it will be placed in the eye.

- Figure 2 is a front view of the other part of the device, represented 5 feeling the borne element, ie the lens to be attached to the interior of the eye.

- Figure 3 shows a front schematic view of the device with LEMENT seu¬ the carrier shown in Figure 1 in place within the eye.

- Figure 4 is a front schematic view of the entire device shown in Figures 2 and £, in place within the eye. 0 - 5 is a front view of the eyeball on which was placed a clock display to indicate the meaning of the expressions used in ophthalmology, such as scleral opening to noon or 6 o'clock.

- Figure 6 shows the borne element, ie the lens to be attached to the inté¬ laughing of the eye, corresponding to the carrier device of Figure 7. - Figure 7 shows the two segments diametrically opposed constituting the carrier element of the device according to the invention with variant perfora¬ tion scleral only at two points instead of four as in fi¬ gures 3 and 4.

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

- Figure 9 is a vertical sagittal cut of the anterior portion of the eye showing the intraocular location of the device of Figure 8, in a variant on the union supported member - bearing member. Only the anterior portion of the eyeball is represented very schematically in Figures 3, 4, 5, 8 and 9 on the cup, and all the details are not reproduced. One can refer to standard textbooks for des¬ specification and anatomical charts of an eyeball. The numbers 1 and 2 relate respectively to the cornea and the sclera. The numeral 4 designates the iris, the pupil 5, 7 the anterior chamber of the eye 8 the iridocorneal angle with the scleral spur, ciliary body 28, 10 surgical blade, zone junction between cornea and sclera, where the inserts tive conjunctural that covers the sclera and is not shown here. In these figures, the lens has a diameter of about five millimeters. It can be that in the prac slightly reduced, or greater, depending on the preferences and e into account an important point which is that the subsequent control of the peripheral retina (possible through a lens but better if • we can go outside).

The device, object of the invention, will now be described in the data u its simplest variant, in the case of a scleral penetration at four points (1 to 4). It comprises a bearing member having the shape of the letter U. The two vertical legs 11 have their first lancet end 14 slightly curved in the scleral curvature and provided or not with an orifice 15. Then they are the most diameter reduces possible in the area to stay intra-scleral. They then have a slight curvature concave posterior and each have a small bulge that is not located at the same height on a branch is the third union supérieu third way, the other to the union middle third -Third lower. Lowest has a notch or a slightly flattened oblique orifice 18 down and off. Topmost is provided with an orifice 17 oriented forward ar- Rière. Near its junction with the horizontal leg, each ver- tical leg is again as thin as possible in this other area that will also intra-scleral 16. The horizontal branch 13 of the U "is for its narrow, thin, flattened, molded onto the convexity of the sclera and concentri¬ that the limbus. the two vertical branches having been introduced through the sclera and having passed through the anterior chamber and finally out again by perforating the sclera, diametrically opposite the point of en¬ tree, each end will be fastened to the sclera with a suture preventing withdrawal by sliding towards the inside of the eye. a good stabilization is obtained and will be even better when the cicatri- tion will set the four narrow passages and charged through the sclera. most of this kind of armature fixed at both ex¬ trémités to the wall of the globe is intraocular, baignan t in the aqueous humor, without any contact with the ocular tissues including the iris. This is the first part of the device according to the invention. The second part is constituted by the borne element, ie the lens 19, which has been intro¬ duced by conventional route. It has a circular shape but may be triangular, square, pentagonal, hexagonal, etc. It has in addition two small extensions: one is a thin and short oblique rod 21 con¬ ceived to be engaged in the notch or orifice (lowermost) of one of the two vertical branches of the bearing member; the other prolonge¬ ment 20, to the point diametrically opposite, is provided with a small orifice intended to be applied next to the (topmost) existing on au¬ be vertical leg of the supporting element, of such that a single su¬ ture allows close union of the member carried to the carrier. Thus is set to 1'intérieur eye lens which therefore rests on no 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 (figures6 to 8). This carrier consists of two almost identical seg- ments. Each segment 29 comprises a thin base and tie apla¬, curved, concentric with the blade and integrally formed on the convexity of the sclera. This base has 30 or simpleséchancrures orifices, enabling solid fixation scleral sutures. On this basis sets up a thin rod 32 to be inserted into the eye. It is at the junction with the base the rod is the thinnest in the region to remain intra-scleral 31. The body of this rod is then further spread, somewhat different, here the only -that Difference for each of two segments: the rod segment to be topmost is provided with a narrow orifice 33 permet¬ as the passage of a suture. Finally the end of each rod is a little ef- spun to facilitate penetration into the eye. The set of two piston rings having sufficient rigidity, the curvature of each of them, his pla¬ cage on the sclera, and the orientation of the stem are such that there is no risk racking forward towards the cornea or back toward the iris or the lens. The common element, meanwhile, is not killed Consti- two parts as the carrier element, but consists of a single lens 24 of circular shape or not, as for the device U étu¬ dié before. This lens has two small projections 25, 27 opposed LEMENT diamétra¬ and different length. Their end is of 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 that will be brought opposite the set 33 on the shaft of the carrier member. A simple suture uniting the two holes allows to fasten all. In summary, in this second variant, the carrier appears to res¬ two abutments of a bridge whose deck would be represented by the lens (this connection to increase the stability of the assembly, each of the two parties related to an abutment being fixed, solid and can ultimately be left alone in the eye without damaging it). In the pre¬ Mière large variation previously described, the U-system comparison of the bridge remains valid but then with apron resting on two main trelles Pu and not on two abutments. The second variant for it to require only two points of scleral penetration, the first to be even more sta¬ wheat, certainly with four points instead of two but even finer. On the other major variants of the device according to the invention, two to four points of scleral penetration, but one, three or more than four, can thus be described, all of which remain within the scope of the invention.

We will now describe the implementation of the device according to the inven¬ tion in a standard response protocol with four points of péné¬ scleral tration (Figure 4), the operation indication having been laid after complete assessment will include determine the power of the lens to be placed in the eye. After measurement of the corneal diameter, which allows to obtain an estimate of one of the anterior chamber, opening the conjunctiva or the blade 10 is at a distance, 10hY z l3hY 2 and 4 hours at 7 ^ 1 ^. Cleaved in two parts scleral limbic hinge 22, one lower and one supé¬ laughing, a few millimeters wider than tall. Subsequent time are those of a classic response: superior limbic incision, réa¬ lisation two iridectomies lateralized devices, lens extraction as planned, if there is a cata¬ racte operation. Otherwise, if one occurs for example myopia, in a phakic lens for clear, we obviously do not touch the lens and we follow with pour¬ pupil up beforehand miosis (narrowed). If there was ex¬ traction of the lens, it causes this miosis before continuing. The previous cham¬ fiber is filled with a viscous material transparent to 5 dabbing, as routine. then introduced simultaneously ex¬ Tremite 14 of the two vertical branches 11 of the carrier element U, ar¬ Rière the lower blade, in the bottom of the cleavage site scleral préa¬ viously practiced. Can be facilitated by an instrument of easy handling cons¬ titué a small carrier handle two pointed ends of the fork, which

OL facilitates the scleral perforation and serves as a guide for the opposite perforating the well is diametrically and is not offset relative to the meridian selected as the axis of the bearing member, here-6h 12h. Scleral perforation must be at a specific point such that the two vertical U bran¬ tasks penetrate into the anterior chamber 7 just arriè-

15 re scleral spur 8, so as to prevent the cornea 1 forwards, iris 4 and its vessels arrlèèe. It can be guided by transillumination, traditional practice and shows precisely the projection of the angle of the bottom 8 of the sclera 2 external. Finally, it can be preceded by a cau- rtérisation next to the area that will be perforated to reduce the

20. risk, limited, with minimal bleeding. (The "fork device for punching can also be equipped for this action). Once inserted into the eye, the two vertical branches 11 are gently pushed upwards, parallel to the iris and slightly ahead of it, from both au¬ be of the pupil 5, equidistant from the pupillary center. Their ends 14

25 then pass through the sclera again, again deep in the corner just behind the spur, but this time from within outwards to appear in the upper scleral flap at the bottom of the scleral cleavage area. These ends are then secured to the sclera with a suture. The horizontal branch 13 of the U-turn is firmly seated in the bottom of the region of

30 lower scleral divide and does not need to be sutured. It then returns to the upper limbal incision (who will. 'Been partly closed la¬ téralement, or slightly enlarged contrary, according to the operation performed). Introducing the lens 19 in the anterior chamber 7, as habi¬ tual. Inserting the lower oblique extension 21 of the lens in

35 the notch or the oblique orifice 18 located in the lower half of one of the vertical arms of the U. The orifice placed on the upper extension 20 of the lens is then brought opposite the one 17 located on the upper half on the other vertical branch of the U, and is secured by the suture in a nonabsorbable suture and well tolerated in the eye (as

40 standard procedure used to suture the iris). This suture should be tight enough to prevent any movement of the lens that is well blocked. The sub ± dence buffering is then evacuated, sclera mi¬ nutieusement closed with a continuous suture, the limbic opening sutured by separate point, or running suture so there is the least possible 5 astigmatis me. The conjunctiva is finally sutured or replaced with diathermy, the inter¬ vention ending with the local administration of an antibiotic and an anti-inflammatory.

From this implementation description of a bearer channel member, it is conceivable that other variations such as the carrier 10 sys- tem to only two points of scleral penetration, previously described, and limited to specific operating time in this model (Figure 8). The stem of each of the two support elements 32 is successive¬ ment introduced into the anterior chamber, each member being secured to the sclera by its base 29 which is provided with openings for sutures 30. The lens 24 is placed in the chamber 15 then 7. Its anterior extension supé¬ laughing 25 is introduced into the upper rod in which it can smooth cou¬ over a greater length than the lower rod. Once fully engaged the upper extension 25, the lens 24 is gently pushed downwards and the lower extension 27 is locked in the lower rod 20. 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. One can also use a reverse system with prolongementsde female type on the lens, the two rods por tor system being matt-type (Figure 9). 25 Both protocols viennnent described above have only been for information and explanation, many other ways of proceeding used Etan, depending on the various changes to the device, without departing from the scope of the invention. Some of these changes will now be considered, without limitation. The carrier 30 U-shaped part can be inserted into the eye according to the axis other meridians or core in the opposite direction, that is to say, from noon to 6 hours, the end of the two vertical branches being then sutured to sclera less and not more than (the adhesion of the lens to the carrier element being adapted accordingly). This suture may be through a port 35 located at 15 the flattened end of each branch or such that it encloses the base of the lancet tip 14. This mode of attachment to the sclera is replaceable a strip together from each end of the two vertical branches 11 according to various procedures (embedding, micro-rivet, cleat, suture, etc.), the essential being that is obtained a good 40 securing the entire device to the sclera . It is preferable to perform a scleral flap 22 to the proper depth for main¬ keep intra-scleral this connecting the carrier element with the wall of giobe. The 1'intervention time is thereby increased but the protection is better than if the support element is directly applied to the outer 5face sclera, while with risk of irritation or even conjunctival opening, especially in elderly patients thin conjunctiva and fra¬ gile. Variants exist, as is shown diagrammatically in Figure 3, on the number of scleral components: for example two small 23 instead of one in front of each vertical branch of the U. To avoid 0sclérale necrosis, the carrier element should preferably have a perforated horizontal bar, remaining within the limits of adequate strength. Recall that the current lenses weigh only a few milligrams in 1'air, less still in the water, and there is no tension or support force exerted by the lens on the support element that should only be in 5bloqué sclera. The interlocking of the two ends of the vertical branches of the U may also be obtained by another U-shaped part which fits into the above according to the principle male-female plugs sheets, and is introduced on top noon, -in the case took to type des¬ scription. It is not a mandatory element and Qporté carrier element are in the anterior chamber: they may be behind the iris, in the correction of aphakia; extraction of the lens must have been extra-capsular, the carrier should have a mild posterior convexity, and must be added one or two lower iridectomies péri¬ pheric for passing the rods of the carrier and 5 according to their nombre.Ces variants of the carrier involve variants of the element carried even more numerous. They can be classified into two groups depending on whether the attachment of the lens or is not easily amo¬ vible without changing the carrier element. Thus, in the U-system has been described, the lens is rapidly and readily removable 0 (and replaceable) by simply changing suture. Such a situation is desirable if it operates for its phakic myopic patients for whom re¬ seeks maximum precision correction: a changementpeut occur immediately during the procedure once the new refraction is verifiable. This change may also be necessary for years 5tard whether to intervene again this time for cataract. Removal of the len¬ daughter then facilitate the extraction of the cataract and allow the establishment of another lens adapted to new needs. On the contrary, in case of intervention from the outset with aphakia, the interest in the possibility of easy abla¬ tion of the single lens is smaller. Thus, in the variant with two U-shaped elements sliding one inside the other, can we use a blocking system such that the lens can not be withdrawn with the por¬ tor system or at least one of its two components. So there are many variants of lenses, which can not be detailed, but all fall within the scope of the invention, depending on their mode of attachment to the carrier elemen with throat, hook, clip, micro screws, lock, snap, gripping, locking after sliding, with side tabs bent per¬ making insertion and fixing without the risk of subsequent movement during movement of the globe, etc., all of these variants with the common denominator to ensure a stable fixation. On their way, other perspectives are possible for bifocal lenses. In the state actu¬ el intraocular lens can ensure both the correction for distance vision and near. A theoretical solution exist as part of the device, where the lens would slide in a carrier channel member with abutting top and bottom to limit its stroke, and small magnetic part for 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; high position infé¬ laughing segment (bifocal) allow near vision. The move to either position would be through a magnet slightly more powerful built such a signet ring that the subject would pass before his eye according to its needs. Although feasible technically, such a variant is probably too futuristic and faces the objection represented by the delicate question of the legitimacy of the pro¬ thrown innovation, given the actually rendered services to the risks SUP- plementary incurred.

This reserve does not apply to other variants which have been exposed but are not limited to it leads to review the in¬ disadvantages of the device according to the invention, which could be objected. The need for intervention and intraocular first days always involve a risk of infection, statistically exceptional, but no less formidable; these infectious complications are not specific to the inven¬ tion and apply to any other surgical methods proposed to try to correct refractive errors; even contact lenses simply placed on the cornea must have this risk, we can not avoid that limited solely glasses worn for centuries. In any work-based refractive surgery is also a risk of creating an astigmatism, which is obviously a shame; this risk is very small, provided that there is operating experience and thoroughness in installation, monitoring and eventual removal of sutures to de- mande; it has also now operating keratometers, and 'such interventions for intraocular lenses are in any case less astigmatogènes that the refractive corneal interventions. The difficulty of certain maneuvers during the implementation of the tif disposi¬ according to the invention may also be presented as a 5 disad- deny; it is actually not higher than other ocular procedures commonly practiced at present; these maneuvers are moreover facilitated by the use of subtances tamponnantes in the anterior chamber of the eye. The objection of additional time required by the cleavage and subsequent closure of the scleral flap is not receva- ble: even before the current stage of quality of both local and general anesthesia, a long time ago that, especially in ophthalmology, need for thoroughness outweighed that of speed, and it is not possible a few extra minutes of work that must be criminalized as it implements, on such an important organ one eye, a 5 treatment can have the patient of the consequences of decades of life. The pupillary block risk is eliminated through iridescence dectomies devices and the slight curvature of the carrier element permet¬ as a fixation of the lens somewhat distancede the pupil. The risk of minimal bleeding, the introduction into the anterior chamber relationship to the parties of the carrier through the sclera, is undeniable but little serious and liraitable by proper hemostasis in the equipment used. The possibility of a minor temporary filtration of aqueous humor to the exté¬ laughing, along the intra-scleral rods, are also: it is ré¬ pick through constrictions 16,31 of the carrier element and assure that - 5 tion of careful closure of scleral flaps and is quickly stopped with the development of the scleral wound. The fineness of these rods, which has emphasized that they should pierce the sclera in back of the spur, can also cause very limited changes in the anterior chamber angle, without comparison with what 0 we observed with some existing lens anterior chamber. In summary these drawbacks are not commensurate with the significant benefits of dispesitif according to previously exposed invention.

The object of the invention device can be used in eye surgery for the treatment of refractive errors. In aphakia 5 is particularly suitable in some cases where, due to significant post-traumatic lesions, it is not possible to hold a lens by any fastening methods used to date. But it is also used in other cases of aphakia. It is also employabledans other refractive errors, while a 0 clear lens is in place, in myopia, hyperopia or astigmatism cer- tain strong. In hyperopia there however instead of en¬ sider this job with reservations if the anterior chamber is shallow and narrow iridocorneal angle corπéen. In myopia-les applications poten- they are quantitatively important, especially in case of unilateral and myopia. In all other cases the instructions must be carefully considered depending on each patient.

The implementation of the device according to the invention must tend to the greatest possible perfection technically and especially in the choice of materials. For the borne element, ie the lens, the material must be transparent, well tolerated by the eye, and machined so as to obtain well-defined lens power over a wide range with progres¬ sions of the order of quarter or half-diopter, to meet all needs, the lenses can be convex, concave, rings. For Ȭ lement carrier materials should have the same qualities. This transparency is however less important here, especially in the periphery, as rigidity and strength. One can thus also use metal, isolated or alloy, some of the rest have been used inside the eye for various implant models: gold, platinum, titanium stainless steel, etc. Variants of the carrier can be linked to the quality of the material used: if e.g. malleable and partially collapsible, it can in the case of the U-system, after positioning, laterally curving the end of the two vertical branches to make the carrier more preferably secured to the sclera. Similarly, depending on the transparent material employed, the anchoring modes to the carrier will vary. They will particularly differ that this material is rigid and easily breakable, or keep some flexibility and tolerate actions like stapling or embedding, after low pres¬ sion or light forced passage. The variety of transparent materials is quite big: glass, many polymers or other synthetic material .: already being used or the fact of future inventions. Lepolymère by far the most used since the beginning of the implementation is the polyméthylméthacry¬ methyl late. Compared to him, the glass has the advantage of being the faci¬ to be sterilized; it is heavier but has a higher index to achieve thinner lenses, but also more elaborate, for exam- pie powerfully etched while having a good finish, or interpo¬ sition of a search for air lamella better iséiconie (recons¬ tution of nearest possible picture of that received by the eye nor¬ evil): the carrier device according to the invention allows improved since this releases the need for a haptic resting on one of the eye components. It can also be appealed to very soft materials for manufacturing, for example, or silicone hydrogel lenses. An equally important point regarding the manufacture of the carrier élé¬ ment as 1'élément common is that variations in the diameter of the anterior chamber in different individuals. Thus in the case of système__ U-carrying elements of adequate length to suit the majority of eyes of standard size, but it is even more eye deviating too average dimensions. There are therefore several so¬ lutions - or use of foldable or breakable materials (extré¬ moth-eaten of the device) to adapt well even smaller diameters - either use snap modes of lens on the por¬ tor element that allow it to always remain centered, these two solutions can be combined - or make por¬ elements ers of different sizes to deal with all éventuali¬ sides. Here we find this major difficulty chamber implants ante higher, difficulty in the case of the latter solution the device 1'invention gum almost entirely; as progress against these conventional implants is considerable: it is certainly well fa¬ have to scrub a carrier element in two or at most three different sizes; but only the carrier is concerned, the range of lenses of different powers remaining standard sizes, whereas for conventional lenses must for each power two, three or four different diameters. Finally, besides the best possible material should also be required, as quality criteria, a sufficient strength and ri¬ gidité associated with minimal weight and bulk. In short it is necessary to get as perfect as possible miniaturization, this miniaturization is the fact of all eye surgery which is a micro-surgery.

In summary the device according to the invention provides a progress maine do¬ eye surgery. Intraocular lenses seem the most logical, least traumatic toward the cornea, for surgical correction of refractive errors. It is equally logical that these lenses to get the best quality and the best tolerance, have no contact with the in¬ tra-ocular structures including uveal, they simply bathe in the aqueous humor and are thus secured only by a carrier solida¬ RISE sclera.

It goes without saying that the present invention has been described and shown for information and explanation but by no means limiting and is capable of various modifications, some of which seu_ cost were been considered, without leaving its frame.

Claims

1. Ophthalmological surgical apparatus for attaching a lens inside the eye, characterized in that it consists of u-bearing member and a supported member, the carrier element being secured to the wall eyeball by forming a rigid reinforcement which is immersed in the aqueous humor and receives no intraocular structure, élé¬ ment carried consisting of a lens introduced independently of the supporting elemen and which will be attached to it and it alone without any contact with either there intraocular structures and therefore immersed only as the carrier in the aqueous humor, bearing member and supported member forming an assembly adapted to one another and used to correct, through the intraocular lens, aphakia and other refractive errors such as myopia, hyperopia, astigmatism.
2. Device according to claim 1 characterized in that the carrier element, the internal part is going to be intraocularly, has an outer portion which, joined to the wall of the globe by attachment to the sclera and regardless of the number of fixing areas, is of curved shape, molded on the con¬ vexité of the sclera, with a sufficient stiffness and strength to as¬ Surer the stability of the supported element while having the lowest possible volume.
3. Device according to claims 1 and 2, characterized in that on the carrier element, in the case of four points of scleral penetration, the base model has the shape of the letter U with two vertical branches (it ) and a horizontal leg (13), the horizontal leg being narrow, thin, perforated while remaining sufficiently strong, flattened, molded on the sclera and concentric with the blade, the two vertical legs having the thinnest possible diameter consistent with strength suffi¬ health in the area subsequent to their union to the horizontal leg is intended to remain intra-scleral (16), these two vertical legs then having an overall curvature slightly posterior concavity and each having a small non bulge located at the same height, the lowest being 1'union middle third lower third and having a notch or orifice in an oblique downwards and outwards (18), the highest being located union upper third middle third and itself being provided with a ori¬ fice (17) oriented from front to rear, said vertical legs being then both before termination finer possi¬ ble again in the area to be intra-scleral, and finally having a lancet 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 will be fixed ver- ticales to the sclera with a suture cleared they have been introduced into the eye through the sclera and have passed through the anterior chamber and finally out again by perforating the sclera diamé¬ tralement opposite the entry point, the horizontal branch for its remaining well stabilized because being wedged in the bottom cleavage scleral pré¬ ready for him, the two vertical branches framing carriers the pupil, which will be placed before the eleme nt worn for attachment to the carrier, and can be compared with two main girders of a bridge whose deck is constituted by the lens.
4. Device according to claims 1, 2 and 3, characterized in that on the carrier element at four points of scleral penetration, both ends of the vertical branches of the U-shaped member peu¬ wind, After crossing the sclera, not be curved sagittally but laterally in the material used, especially peuvert be modified with the addition of a strip from the interlock according to procedures such as embedding, micro-rivet, cleat, suture, or alternatively with another U-shaped part which fits into the above according to the principle male-female plugs specifications and part of which will therefore then also be introduced into the interior of the eye, so that is always obtained a good fastening this bearing member to the wall of eyeball.
5. Device according to claims 1 and 2, characterized in that on the carrier element, in the case of two points of scleral penetration, the basic pattern consists of two segments of which a part will be introduced into the eye in two diametrically opposite points, that Cha- segment having a base (29) thin, flat, curved, molded on the re sclè¬ and concentric to the limbus, perforated indentations or openings (30) but sufficiently rigid, could be securely fixed by scleral sutures, on which implanteune rod (32) as thin as possible while remaining in the solid portion to be intra-scleral (31), whose rod corp spreads a little later in the part intraocular, t Stine segment to be topmost in the eye at this location having a small orifice (33) aligned from front to rear for the passage of a suture, said rod ter¬ undermining finally while being slightly tapered end, as the male or female user, the set of two segments leaving the center free space in front of the pupil, which will be placed the carried element to be attached to the carrier element, said assembly being compared with the two a bridge abutments between which is cast apron constituted by the borne element, ie the lens.
6. Device according to claims 1, 2, 3 and 4, characterized in that, on the supported member, in the case of a carrier for four-point scleral penetration, the supported element comprises a len ¬ tille (19) that will be introduced into the eye independently of the element por tor by another route so as to avoid creating synechiae extended in the iridocorneal angle, this adequate size lens having a circular shape but may be different such as triangular, quadrangulair pentagonal, hexagonal, octagonal, this ϋsntille further comprising two small extensions, one being a thin and short oblique rod (21) adapted to be engaged in the notch or orifice ( lowermost) of one of the two vertical branches of the carrier exposed to the cation revendi- 3, the other extension positioned diametrically opposite point being provided with a small orifice (20) provided for ê be applied next to the (topmost) existing on the other arm of the carrier element, a simple suture connecting these two orifices allowing a union narrow the element carried on the carrier, this union may also be provided by hook, clip, micro-screws, lock, snap, gripping, locking after sliding in groove side tabs bent to insertion and fixation, so that always ensured a stable fixation of the lens carried on the carrier element.
7. Device according to claims 1, 2, 5, and 6, characterized in that, on the supported member, in the case of a bearing member from two points of scleral penetration, this common element is constituted by a len¬ tille (24), the methods of introduction into the eye are similar to those disclosed in claim 6 and which has a circular shape or not, this adequate dimensions lens having two extensions (25, 27) diametrically opposed male type, intended to be engaged in the stem fe¬ melle each of the two segments of the carrier element, the extension des¬ Tine be engaged in the highest located rod being provided with an orifice (26 ) that will be brought opposite the one on the shaft of the carrier member (33), a single suture uniting these two orifices for so- lidariser overall, this attachment may also be made by hooks or extensions female type on the entille matching male-type pins on each of the two carrier segments, so that is always ensured. - "a stable fixation of the lens carried on the carrier element.
8. Device according to any one of the preceding claims charac- terized in that the bearing member and supported member are made of transparent materials, well tolerated by the eye and can be machined so as to obtain well defined power lenses in a range éten¬ due to meet all requirements with increases of the order of a quarter or half-diopter, materials such as glass or polymethyl methacrylate, methyl or hydrogel or silicone regarding the lens that can be flexible, the quality of transparency is less fundamental to the carrier element especially in the peripheral portion where there may be asso¬ ciation to an insulated metal or alloy well tolerated by the eye, such as stainless steel, gold, platinum, titanium, strength of the carrier device must be sufficient to 5 weight and minimum bulk in the context of the meil¬ Leure miniaturization possible, and it being specified that in the context of such manufacture with the most suitable materials, the carrier elements can be provided in different sizes for employing a lens size remaining for its standard regardless of the dimensions oe
10.
9. Apparatus according to any preceding claim cara terized in that, irrespective of the modes of attachment of the supporting element co me of the supported member or the characteristics of the materials used, the daughters intra len¬ eye due to their respective optical properties will be convex, concave, toric, iséoconisantes, or also in bifocal
15 sliding along the support element with a magnetization and notch fixing the lens in turn into high or low position.
10. Apparatus according to any preceding claim ca¬ terized in that bearing member and supported member can be 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.
PCT/FR1988/000119 1987-03-06 1988-03-03 Intraocular lens WO1988006430A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR87/03061 1987-03-06
FR8703061A FR2611487B1 (en) 1987-03-06 1987-03-06 ophthalmic surgical device consists of a carrier element and a door element which is an intraocular lens

Publications (1)

Publication Number Publication Date
WO1988006430A1 true WO1988006430A1 (en) 1988-09-07

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ID=9348673

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/FR1988/000119 WO1988006430A1 (en) 1987-03-06 1988-03-03 Intraocular lens

Country Status (2)

Country Link
FR (1) FR2611487B1 (en)
WO (1) WO1988006430A1 (en)

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EP1747769A2 (en) * 2005-07-26 2007-01-31 Visioncare Ophthalmic Technologies, Inc. Intraocular devices
US7727277B2 (en) 2002-12-17 2010-06-01 Visioncare Ophthalmic Technologies Inc. Intraocular implants
US7918886B2 (en) 2006-05-25 2011-04-05 Visioncare Ophthalmic Technologies Inc. Double insertion intraocular implant

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GB2416993A (en) * 2004-08-11 2006-02-15 Dinesh Verma Opthalmic prosthesis

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GB810232A (en) * 1956-07-31 1959-03-11 Nissel And Company Ltd G Improvements in artificial intraocular lenses
US4134161A (en) * 1977-03-16 1979-01-16 Bayers Jon Herbert Adjustable intraocular lens
US4296501A (en) * 1980-07-14 1981-10-27 Kelman Charles D Intraocular lens and method of making the same
US4327450A (en) * 1981-02-09 1982-05-04 Girard Louis J Method of intraocular implanting an artificial lens
US4409690A (en) * 1981-09-24 1983-10-18 Gess Lowell A Intraocular lenses
US4463458A (en) * 1982-11-08 1984-08-07 Vision Laboratories Inc. Intraocular lens and implantation method
US4596578A (en) * 1984-01-30 1986-06-24 Kelman Charles D Intraocular lens with miniature optic

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Publication number Priority date Publication date Assignee Title
GB810232A (en) * 1956-07-31 1959-03-11 Nissel And Company Ltd G Improvements in artificial intraocular lenses
US4134161A (en) * 1977-03-16 1979-01-16 Bayers Jon Herbert Adjustable intraocular lens
US4296501A (en) * 1980-07-14 1981-10-27 Kelman Charles D Intraocular lens and method of making the same
US4327450A (en) * 1981-02-09 1982-05-04 Girard Louis J Method of intraocular implanting an artificial lens
US4409690A (en) * 1981-09-24 1983-10-18 Gess Lowell A Intraocular lenses
US4463458A (en) * 1982-11-08 1984-08-07 Vision Laboratories Inc. Intraocular lens and implantation method
US4596578A (en) * 1984-01-30 1986-06-24 Kelman Charles D Intraocular lens with miniature optic

Cited By (6)

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Publication number Priority date Publication date Assignee Title
US7727277B2 (en) 2002-12-17 2010-06-01 Visioncare Ophthalmic Technologies Inc. Intraocular implants
US7736390B2 (en) 2002-12-17 2010-06-15 Visioncare Ophthalmic Technologies Inc. Intraocular implants
US7776087B2 (en) 2002-12-17 2010-08-17 Visioncare Ophthalmic Technologies Inc. Intraocular implants
EP1747769A2 (en) * 2005-07-26 2007-01-31 Visioncare Ophthalmic Technologies, Inc. Intraocular devices
EP1747769A3 (en) * 2005-07-26 2007-04-04 Visioncare Ophthalmic Technologies, Inc. Intraocular devices
US7918886B2 (en) 2006-05-25 2011-04-05 Visioncare Ophthalmic Technologies Inc. Double insertion intraocular implant

Also Published As

Publication number Publication date
FR2611487B1 (en) 1989-06-09
FR2611487A1 (en) 1988-09-09

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