WO2000021467A1 - Accommodative intraocular implant - Google Patents

Accommodative intraocular implant Download PDF

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Publication number
WO2000021467A1
WO2000021467A1 PCT/FR1999/002445 FR9902445W WO0021467A1 WO 2000021467 A1 WO2000021467 A1 WO 2000021467A1 FR 9902445 W FR9902445 W FR 9902445W WO 0021467 A1 WO0021467 A1 WO 0021467A1
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WO
WIPO (PCT)
Prior art keywords
wing
lens
capsular bag
implant
implant according
Prior art date
Application number
PCT/FR1999/002445
Other languages
French (fr)
Inventor
Khalil Hanna
Original Assignee
Humanoptics Ag
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
Application filed by Humanoptics Ag filed Critical Humanoptics Ag
Priority to AU60949/99A priority Critical patent/AU6094999A/en
Publication of WO2000021467A1 publication Critical patent/WO2000021467A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1624—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside
    • A61F2/1629—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus having adjustable focus; power activated variable focus means, e.g. mechanically or electrically by the ciliary muscle or from the outside for changing longitudinal position, i.e. along the visual axis when implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • A61F2/1648—Multipart lenses

Definitions

  • Intraocular accommodative implant Intraocular accommodative implant.
  • the present invention relates to an implant intrao ⁇ lar to be implanted in place of the natural lens after a cataract operation.
  • Accommodation is the process by which the eye focuses on close objects by means of controlled deformation and increased curvature of the lens surfaces.
  • the mechanism of accom ⁇ modation comes from the contraction of the ciliary muscle which releases the tensions of the zonule and allows the lens to take a more round shape.
  • the ciliary muscle is relaxed, the zonule is under tension and the lens is under maximum stress thus taking a flatter shape. All individuals lose their ability to generally accommodate during their fifties and must wear corrective lenses for reading or for close work, this being called presbyopia.
  • Presbyopia is due to several factors, including the change of all the components of the apparatus accommodative: curing of the lens forming material that makes this lens is less deformed ⁇ ble and change in its geometry produced by the continuous believe ⁇ ciency of crystalline. These changes account for a large part in the reduction of accommodation with age and the occurrence of presbyopia.
  • the clouding of the lens is called cata ⁇ racte; this leads to loss of vision.
  • the most common cause of cataracts is age.
  • the most common surgical procedure is cataract surgery with implantation of a polymeric intraocular lens.
  • the opaque lens is removed through a circular, central opening on the anterior capsule called capsulorhexis.
  • the opening is usually five to six millimeters in diameter and begins about two thousand very from the anterior insertion of the zonule.
  • Phacoemulsification is the process by which the lens material is ultrasonically fragmented which is then removed by aspiration.
  • a synthetic polymethylmethacrilate (PMMA) or flexible and foldable acrylic or silicone-based lens is then inserted inside the capsular bag.
  • the optical power of the intraocular lens is generally chosen to minimize the patient's post-operative refractive impairment, but the focusing power of the lens is fixed, which does not allow accommodation to be obtained.
  • the German company ORCHER has offered an intraocular lens which is implanted in the capsular bag.
  • This lens comprises a central optical part of approximately five and a half millimeters surrounded by a thin skirt extending towards the rear of the optical part with orifices, this skirt being bordered by a circular reinforcing ring with notches.
  • the total diameter of this implant is ten millimeters. This implant bears against the peripheral internal part of the anterior capsule.
  • the present invention sets out implement a lens in two parts, namely a capsular tensioner which supports an optical part one and the other being introduced successively ⁇ in the capsular bag
  • the object of the invention is an accommodative intraocular implant comprising a lens with a central optical part and a peripheral part for holding the latter in the capsular bag and for transmitting to the optical part the forces and displacements of the equatorial part.
  • the peripheral part is an annular piece in the form of a gutter open inwards with a posterior wing in contact with the posterior wall and an anterior wing in contact with the remaining peripheral part of the anterior wall of the capsular bag, the front wing comprising at least two hook-shaped legs projecting radially from the edge of the wing
  • the optical part is itself a disc-shaped part comprising at least two openings in its peripheral zone by means of which it is suspended from the annular part
  • the annular piece which, in the normal state, is of large diameter, can be folded in a small footprint in order to be able to be introduced through a corneal incision of limited length
  • the optical part is then an implant of much smaller diameter (of the order of seven millimeters) which can also be introduced folded through this small corneal incision
  • the front wing of the annular part has, in the vicinity of its root, an annular zone of increased flexibility. This zone can be produced by thinning the wall of the wing at this point. It is understood that thus the optical part is suspended from a wing which is easily movable in the manner of a lever transforming in displacements the deformations of the equatorial part of the capsular bag due to the forces which it undergoes on the part of the zonule Elles then play the role of a lever which, when the capsular bag is subjected to the tension of the zonule (far vision), pushes the optical central part backwards, thus modifying the refractive power of the eye in the direction a decrease allowing an infinite focus
  • the ciliary muscle that is to say when the zonule is relaxed, the equatorial part of the capsular bag tends to shrink ir in diameter by its own elasticity, which forces the gutter to open, and in particular the for
  • FIG. 1 is a sectional view of an implant according to the invention
  • FIG. 2 is an external perspective view of the optical part of the implant
  • FIG. 3 is a perspective view of the external annular part of the implant forming the tension of the capsular bag
  • Figures 4 and 5 illustrate in partial section, the two states of the implant during near vision ( Figure 4) and during far vision ( Figure 5).
  • the implant according to the invention shown in Figures 1 to 3 comprises two parts.
  • a first annular outer part 1 the section of which is in the form of a gutter open towards the inside, which has an anterior wing 2 and a posterior wing 3.
  • the anterior wing 2 has two legs 4 and 5, in the case of diametrically opposite, which protrude inside the edge of this wing and which are shaped into hooks inside the volume of the gutter. These hooks 4 and 5 are intended to retain the optical part of the implant.
  • This optical part is formed by a disc-shaped part 6, here biconvex, separated from the annular part 1.
  • This part 6 has two through holes 7 and 8 in which the hooks 4 and 5 can be freely accommodated.
  • the internal shape of the hooks is such that it practically prevents any movement of the optical disc relative to the hooks along the optical axis so that a displacement of the hooks of which a component extends parallel to this axis causes a corresponding movement of the optical disc.
  • the internal shape of the hooks 4 and 6 is angular to form stops at the part of the disc external to the orifices 7 and 8 which is housed inside the hook.
  • the outside diameter of the part 6 is greater than the diameter of the edge of the wings 2 and 3, so that when the part 6 is housed inside the gutter, it cannot spontaneously escape from it
  • the diameters of the edges of the wings 2 and 3 are not equal, the diameter the largest being that of the edge of the fore wing 2
  • the bottom of the gutter 1 that is to say the part which connects the two wings and which has the maximum outside diameter (from nine and a half millimeters to ten millimeters, diameter which corresponds to the equatorial diameter of the capsular bag of a man in his thirties), is of a greater thickness than that which constitutes the wings 2 and 3
  • This dimension (9, 5 -10mm) makes it possible to take into account the fact that at the time of the operation, the patient generally being at least 60 years old, the lens of the lens is of an increased volume compared to that which it had when the patient was younger Replacement in the capsular bag of the crystal material - linien by the implant according to the invention, therefore of equatorial diameter smaller than that of the bag at the time of the operation, leaves the bag with the possibility of partially retracting on the ring
  • This retraction lies in a decrease in the loosening zonulair fibers es that the magnification of the natural lens had caused.
  • the establishment of the implant according to the invention inside the capsular bag consists in folding over itself the annular piece 1 so as to reduce its bulk in section so as to be able to introduce it into the capsular bag through an incision corneal of short length.
  • the part 1 Once the part 1 is placed in the bag because of its own elasticity, it forms a holding element for this bag to adjust its equatorial diameter to a value close to that which the lens had when the patient was old. 'about thirty years. Fixing the equatorial diameter of the capsular bag to this dimension, i.e. limiting its partial retraction, is placing it in an optimal situation to benefit from the maximum range of motion of the ciliary muscle transmitted to this bag by the zonule, as explained above.
  • an adequate part size 1 from a preoperative measurement of the equatorial diameter of the lens (by a known method, for example by ultrasound) from which we will have subtracted between 0.5 and 0, 75 mm to determine the suitable outside diameter of the part 1.
  • the optical part 6 is then put in place by introducing it into the gutter 1 and, by means of a special tool, by forcing the hooks 4 and 5 inside the orifices 7 and 8.
  • the parts 1 and 6 of the implant are made of a flexible and pliable material known in itself such as an acrylic or silicone-based polymer.
  • the back 4a and 5a of the hooks 4 and 5 is in the extension of the external surface of the front wing 2.
  • the hooks can therefore perfectly match what remains of the front wall of the bag capsular.
  • the zone of connection of the hooks to the wing 2 is effected by a thin part which constitutes a sort of pseudo-articulation of the hooks with respect to the annular part 1. This zone marked 10 in the figure 1 and 11 to FIGS. 4 and 5.
  • Figure 4 is a partial sectional view of the implant according to the invention placed in the capsular bag 12, in the accommodation being that is to say in its form taken under the effect of elastic retraction of the equatorial zone of the capsular bag due to the fact that the zonule 13 is relaxed (ciliary muscle contracted).
  • FIG 5 there is shown the state taken by the implant of the invention when the ciliary muscle is relaxed, that is to say that the zonule 13 is tight, this tension having the effect of flattening the area equatorial of the capsular bag 12, this flattening causing a pivoting towards the inside of the gutter of the hooks 4 and 5 around the zone of great flexibility 11.
  • the optical part 6 of the implant is pushed towards the back of the eye, which affects the overall power of the system in the sense of a decrease, which is the case during accommodation to infinity.
  • the invention may take other embodiments. For example, one can install more than two hooks (three or four) for hanging the optical part in the annular part.

Abstract

The invention concerns an accommodative intraocular implant comprising a lens with a central optical part and a peripheral part maintaining same in the capsular bag. The peripheral part is an elastically deformable annular piece (1) shaped like a groove opening inwards with a rear wing (3) in contact with the rear wall and a front wing (2) in contact with the remaining peripheral part of the capsular bag front wall, the front wing (2) comprising at least two tabs (4 and 5) shaped like clasps radially projecting from the wing edge. As for the optical part, it is a disc-shaped lens (6) comprising at least two openings (7 and 8) in its peripheral zone whereby it is maintained by the clasps (4, 5) of the annular piece (1). The invention is applicable in ophthalmology.

Description

Implant intraoculaire accommodatif . Intraocular accommodative implant.
La présente invention concerne un implant intrao¬ culaire destiné à être implanté aux lieu et place du cristallin naturel à la suite d'une opération de la cataracte . L'accommodation est le processus par lequel l'oeil met au point sur les objets rapprochés au moyen d'une déformation contrôlée et d'une augmentation de la courbure des surfaces du cristallin. Le mécanisme d'accom¬ modation parvient de la contraction du muscle ciliaire qui relâche les tensions de la zonule et permet au cristallin de prendre une forme plus ronde. A l'inverse, lorsque l'oeil met au point à l'infini, le muscle ciliaire est relâché, la zonule est sous tension et la lentille est sous une contrainte maximale prenant ainsi une forme plus plate. Tous les individus perdent leur aptitude à accommoder généralement au cours de la cinquantaine et doivent porter des verres correcteurs pour lire ou pour des travaux rapprochés, ceci étant appelé la presbytie.The present invention relates to an implant intrao ¬ lar to be implanted in place of the natural lens after a cataract operation. Accommodation is the process by which the eye focuses on close objects by means of controlled deformation and increased curvature of the lens surfaces. The mechanism of accom ¬ modation comes from the contraction of the ciliary muscle which releases the tensions of the zonule and allows the lens to take a more round shape. Conversely, when the eye develops infinitely, the ciliary muscle is relaxed, the zonule is under tension and the lens is under maximum stress thus taking a flatter shape. All individuals lose their ability to generally accommodate during their fifties and must wear corrective lenses for reading or for close work, this being called presbyopia.
La presbytie est due à plusieurs facteurs, notamment au changement de toutes les composantes de l'appareil accommodatif : durcissement du matériau formant le cristallin qui fait que ce cristallin est moins déforma¬ ble et changement dans sa géométrie produit par la crois¬ sance continue du cristallin. Ces changements comptent pour une grande part dans la réduction de l'accommodation avec l'âge et la survenance de la presbytie.Presbyopia is due to several factors, including the change of all the components of the apparatus accommodative: curing of the lens forming material that makes this lens is less deformed ¬ ble and change in its geometry produced by the continuous believe ¬ ciency of crystalline. These changes account for a large part in the reduction of accommodation with age and the occurrence of presbyopia.
L' opacification du cristallin est appelée cata¬ racte ; cela conduit à la perte de la vision. La cause la plus commune de la cataracte est l'âge. L'opération de la cataracte avec implantation d'une lentille intraoculaire en polymère est la procédure chirurgicale la plus commune. La lentille opaque est retirée au travers d'une ouverture circulaire et centrale sur la capsule antérieure appelée capsulorhexis . L'ouverture est habituellement de cinq à six millimètres en diamètre et commence environ à deux milli é- très de l'insertion antérieure de la zonule. La phacoémul- sification est le procédé par lequel on fragmente par ultrasons le matériau cristallinien qui est ensuite retiré par aspiration. Une lentille synthétique en polymétylméta- crilate (PMMA) ou souple et pliable en polymère acrylique ou à base de silicone est ensuite insérée à l'intérieur du sac capsulaire. La puissance optique de la lentille intraoculaire est généralement choisie pour minimiser la déficience réfractive post-opératoire du patient mais le pouvoir de mise au point de la lentille est fixe, ce qui ne permet pas d'obtenir une accommodation.The clouding of the lens is called cata ¬ racte; this leads to loss of vision. The most common cause of cataracts is age. The most common surgical procedure is cataract surgery with implantation of a polymeric intraocular lens. The opaque lens is removed through a circular, central opening on the anterior capsule called capsulorhexis. The opening is usually five to six millimeters in diameter and begins about two thousand very from the anterior insertion of the zonule. Phacoemulsification is the process by which the lens material is ultrasonically fragmented which is then removed by aspiration. A synthetic polymethylmethacrilate (PMMA) or flexible and foldable acrylic or silicone-based lens is then inserted inside the capsular bag. The optical power of the intraocular lens is generally chosen to minimize the patient's post-operative refractive impairment, but the focusing power of the lens is fixed, which does not allow accommodation to be obtained.
De nombreux essais ont été tentés pour restaurer au moins partiellement l'aptitude à l'accommodation avec une lentille intraoculaire. C'est ainsi que le document US 5 607 472 propose une lentille en au moins deux parties, une première partie postérieure apportant la principale fraction de puissance optique à la lentille portant devant elle une seconde partie déformable qui est reliée au centre à la première partie et qui est reliée en périphérie au bord de l'ouverture de capsulorhexis. Outre le fait que cette lentille est complexe, la liaison de la seconde partie au bord de l'ouverture de la paroi antérieure du sac capsulaire est loin d'être pratiquée avec succès.Numerous attempts have been made to restore at least partially the ability to accommodate with an intraocular lens. Thus the document US Pat. No. 5,607,472 proposes a lens in at least two parts, a first posterior part bringing the main fraction of optical power to the lens carrying in front of it a second deformable part which is connected in the center to the first part. and which is connected at the periphery to the edge of the capsulorhexis opening. Besides the fact that this lens is complex, the connection of the second part to the edge of the opening of the anterior wall of the capsular bag is far from being successfully practiced.
La société allemande ORCHER a proposé une lentille intraoculaire qui est implantée dans le sac capsulaire. Cette lentille comprend une partie optique centrale d'environ cinq millimètres et demi entourée par une jupe fine s 'étendant vers l'arrière de la partie optique avec des orifices, cette jupe étant bordée par un anneau de renforcement circulaire avec des encoches. Le diamètre total de cet implant est de dix millimètres. Cet implant porte contre la partie interne périphérique de la capsule antérieure. Ainsi, quand la zonule, par l'intermédiaire du muscle auxiliaire, exerce une tension sur la circonférence du sac capsulaire, la lentille est déplacée vers l'arrière, ce qui change la réfraction de l'oeil L'évaluation clinique de cette technique a fait apparaître que les modifications du pouvoir réfractif de l'oeil sont limitées En plus de cette possibilité limitée d'accommo- der, la procédure d'implantation demande une incision plus longue que celle nécessaire à implanter des lentilles pliables non accommodâtîvesThe German company ORCHER has offered an intraocular lens which is implanted in the capsular bag. This lens comprises a central optical part of approximately five and a half millimeters surrounded by a thin skirt extending towards the rear of the optical part with orifices, this skirt being bordered by a circular reinforcing ring with notches. The total diameter of this implant is ten millimeters. This implant bears against the peripheral internal part of the anterior capsule. Thus, when the zonule, via the auxiliary muscle, exerts a tension on the circumference of the capsular bag, the lens is moved backward, which changes the refraction of the eye Clinical evaluation of this technique has shown that the modifications of the refractive power of the eye are limited In addition to this limited possibility of accommodating, the procedure implantation requires a longer incision than that necessary to implant non-accommodating foldable lenses
Pour pallier l'inconvénient des lentilles accom- modatives existantes qui résident principalement dans le fait qu'il convient de pratiquer une incision large dans la cornée pour pouvoir introduire une telle lentille dont le diamètre extérieur et souvent voisin de dix millimètres la présente invention met en oeuvre une lentille en deux parties à savoir un tendeur capsulaire qui supporte une partie optique l'un et l'autre étant introduit successive¬ ment dans le sac capsulaireTo overcome the drawback of existing accommodating lenses which mainly reside in the fact that a wide incision should be made in the cornea in order to be able to introduce such a lens whose outside diameter and often close to ten millimeters, the present invention sets out implement a lens in two parts, namely a capsular tensioner which supports an optical part one and the other being introduced successively ¬ in the capsular bag
Plus précisément l'invention a pour obi et un implant intraoculaire accommodatif comprenant une lentille avec une partie optique centrale et une partie périphérique de maintien de celle-ci dans le sac capsulaire et de transmission à la partie optique des forces et déplacements de la partie équatoriale du sac capsulaire résultant du changement d'état du muscle ciliaire Selon l'invention, la partie périphérique est une pièce annulaire en forme de gouttière ouverte vers l'intérieur avec une aile postérieure au contact de la paroi postérieure et une aile antérieure au contact de la partie périphérique restante de la paroi antérieure du sac capsulaire, l'aile antérieure comportant au moins deux pattes en forme de crochets en saillie radiale du bord de l'aile La partie optique est quant à elle une pièce en forme de disque comportant au moins deux ouvertures dans sa zone périphérique au moyen desquelles elle est suspendue à la pièce annulaireMore specifically, the object of the invention is an accommodative intraocular implant comprising a lens with a central optical part and a peripheral part for holding the latter in the capsular bag and for transmitting to the optical part the forces and displacements of the equatorial part. of the capsular sac resulting from the change in state of the ciliary muscle According to the invention, the peripheral part is an annular piece in the form of a gutter open inwards with a posterior wing in contact with the posterior wall and an anterior wing in contact with the remaining peripheral part of the anterior wall of the capsular bag, the front wing comprising at least two hook-shaped legs projecting radially from the edge of the wing The optical part is itself a disc-shaped part comprising at least two openings in its peripheral zone by means of which it is suspended from the annular part
La pièce annulaire qui, à l'état normal, est de grand diamètre, peut être pliée dans un faible encombrement afin de pouvoir être introduite au travers d'une incision cornéenne de longueur limitée La partie optique est alors un implant de diamètre beaucoup plus réduit (de l'ordre de sept millimètres) qui peut être également introduit plie au travers de cette petite incision cornéenneThe annular piece which, in the normal state, is of large diameter, can be folded in a small footprint in order to be able to be introduced through a corneal incision of limited length The optical part is then an implant of much smaller diameter (of the order of seven millimeters) which can also be introduced folded through this small corneal incision
Dans un mode de réalisation préféré de l'invention, l'aile antérieure de la partie annulaire comporte au voisinage de sa racine une zone annulaire de flexibilité augmentée Cette zone peut être réalisée par un amincisse ment de la paroi de l'aile à cet endroit On comprend qu'ainsi la partie optique est suspendue a une aile qui est facilement mobile à la manière d'un levier transformant en déplacements les déformations de la partie équatoriale du sac capsulaire dues aux forces qu'elle subit de la part de la zonule Elles jouent alors le rôle d'un levier qui, lorsque le sac capsulaire est soumis à la tension de la zonule (vision de loin) , repousse la pièce centrale optique vers l'arrière, modifiant ainsi la puissance réfractive de l'oeil dans le sens d'une diminution permettant une mise au point a l' infini En revanche, lorsque le muscle ciliaire est contracté, c'est-à-dire lorsque la zonule est relâchée, la partie équatoriale du sac capsulaire tend à se rétrécir en diamètre par son élasticité propre, ce qui force la gouttière à s'ouvrir, et notamment l'aile antérieure a remonter vers la cornée tirant ainsi vers l'avant de l'oeil la partie optique de la lentille dans le sens d'une augmentation de la puissance réfractive du système II s'agit alors de l'accommodation pour mettre au point sur des objets proches D'autres caractéristiques et avantages de l'in¬ vention ressortiront de la description d'un de ses modes de réalisation donnés ci-apres à titre d'exemples non limita¬In a preferred embodiment of the invention, the front wing of the annular part has, in the vicinity of its root, an annular zone of increased flexibility. This zone can be produced by thinning the wall of the wing at this point. It is understood that thus the optical part is suspended from a wing which is easily movable in the manner of a lever transforming in displacements the deformations of the equatorial part of the capsular bag due to the forces which it undergoes on the part of the zonule Elles then play the role of a lever which, when the capsular bag is subjected to the tension of the zonule (far vision), pushes the optical central part backwards, thus modifying the refractive power of the eye in the direction a decrease allowing an infinite focus On the other hand, when the ciliary muscle is contracted, that is to say when the zonule is relaxed, the equatorial part of the capsular bag tends to shrink ir in diameter by its own elasticity, which forces the gutter to open, and in particular the forewing has to go up towards the cornea thus pulling towards the front of the eye the optical part of the lens in the direction of an increase in the refractive power of the system II is then a question of accommodation for the development on nearby objects other features and advantages of the in ¬ vention emerge from the description of one of its embodiments given below by way of nonlimiting examples
Il sera fait référence aux dessins annexés parmi lesquels - la figure 1 est une vue en coupe d'un implant conforme à l'invention,Reference will be made to the accompanying drawings, among which FIG. 1 is a sectional view of an implant according to the invention,
- la figure 2 est une vue extérieure en perspective de la partie optique de l'implant, - la figure 3 est une vue en perspective de la pièce annulaire extérieure de l'implant formant tendeur du sac capsulaire,FIG. 2 is an external perspective view of the optical part of the implant, FIG. 3 is a perspective view of the external annular part of the implant forming the tension of the capsular bag,
- les figures 4 et 5 illustrent en coupe partielle, les deux états de l'implant lors de la vision de près (figure 4) et lors de la vision de loin (figure 5) .- Figures 4 and 5 illustrate in partial section, the two states of the implant during near vision (Figure 4) and during far vision (Figure 5).
L'implant selon l'invention représenté aux figures 1 à 3 comporte deux pièces . Une première pièce extérieure annulaire 1 dont la section est en forme de gouttière ouverte vers l'intérieur, qui possède une aile antérieure 2 et une aile postérieure 3. L'aile antérieure 2 possède deux pattes 4 et 5, dans le cas de figure diamétralement opposées, qui font saillie à l'intérieur du bord de cette aile et qui sont conformées en crochets à l'intérieur du volume de la gouttière. Ces crochets 4 et 5 sont destinés à retenir la partie optique de l'implant. Cette partie optique est formée par une pièce 6 en forme de disque, ici biconvexe, séparée de la pièce annulaire 1. Cette pièce 6 possède deux orifices 7 et 8 traversants dans lesquels peuvent être librement logés les crochets 4 et 5. On notera à ce propos que la forme intérieure des crochets est telle qu'elle empêche pratiquement tout mouvement du disque optique par rapport aux crochets le long de l'axe optique de sorte qu'un déplacement des crochets dont une composante s'étend parallèlement à cet axe entraîne un déplacement correspondant du disque optique. Dans le cas représenté, la forme intérieure des crochets 4 et 6 est anguleuse pour former des butées à la partie du disque extérieure aux orifices 7 et 8 qui est logée à l'intérieur du crochet . On notera que le diamètre extérieur de la pièce 6, de l'ordre de sept millimètres, est supérieur au diamètre du bord des ailes 2 et 3 , de sorte que lorsque la pièce 6 est logée à l'intérieur de la gouttière, elle ne peut spontanément s'en échapper Les diamètres des bords des ailes 2 et 3 ne sont pas égaux, le diamètre le plus grand étant celui du bord de l'aile antérieure 2The implant according to the invention shown in Figures 1 to 3 comprises two parts. A first annular outer part 1, the section of which is in the form of a gutter open towards the inside, which has an anterior wing 2 and a posterior wing 3. The anterior wing 2 has two legs 4 and 5, in the case of diametrically opposite, which protrude inside the edge of this wing and which are shaped into hooks inside the volume of the gutter. These hooks 4 and 5 are intended to retain the optical part of the implant. This optical part is formed by a disc-shaped part 6, here biconvex, separated from the annular part 1. This part 6 has two through holes 7 and 8 in which the hooks 4 and 5 can be freely accommodated. propos that the internal shape of the hooks is such that it practically prevents any movement of the optical disc relative to the hooks along the optical axis so that a displacement of the hooks of which a component extends parallel to this axis causes a corresponding movement of the optical disc. In the case shown, the internal shape of the hooks 4 and 6 is angular to form stops at the part of the disc external to the orifices 7 and 8 which is housed inside the hook. It will be noted that the outside diameter of the part 6, of the order of seven millimeters, is greater than the diameter of the edge of the wings 2 and 3, so that when the part 6 is housed inside the gutter, it cannot spontaneously escape from it The diameters of the edges of the wings 2 and 3 are not equal, the diameter the largest being that of the edge of the fore wing 2
Le fond de la gouttière 1, c'est-à-dire la partie qui relie les deux ailes et qui a le diamètre extérieur maximal (de neuf millimètres et demi à dix millimètres, diamètre qui correspond au diamètre équatorial du sac capsulaire d'un homme d'une trentaine d'années), est d'une épaisseur plus importante que celle qui constitue les ailes 2 et 3 Le choix de cette dimension (9, 5 -10mm) permet de prendre en compte le fait qu'au moment de l'opération, le patient étant en général âgé de 60 ans au moins, la lentille cristallinienne est d'un volume accru par rapport à celui qu'elle avait lorsque le patient était plus jeune Le remplacement dans le sac capsulaire du matériau cristal - linien par l'implant selon l'invention, donc de diamètre équatorial plus petit que celui du sac au moment de l'opération, laisse au sac la possibilité de se retracter partiellement sur l'anneau La conséquence de cette rétraction réside dans une diminution du relâchement des fibres zonulaires que le grossissement du cristallin naturel avait causé. Il s'ensuit que les changements d'état du muscle ciliaire sont mieux transmis à la partie équatoriale du sac capsulaire. En d'autres termes la diminution de ce relâchement permet de transmettre à la capsule une plus grande partie de l'amplitude du déplacement du muscle ciliaire que celle transmissible à la capsule naturelle qui avait grossi.The bottom of the gutter 1, that is to say the part which connects the two wings and which has the maximum outside diameter (from nine and a half millimeters to ten millimeters, diameter which corresponds to the equatorial diameter of the capsular bag of a man in his thirties), is of a greater thickness than that which constitutes the wings 2 and 3 The choice of this dimension (9, 5 -10mm) makes it possible to take into account the fact that at the time of the operation, the patient generally being at least 60 years old, the lens of the lens is of an increased volume compared to that which it had when the patient was younger Replacement in the capsular bag of the crystal material - linien by the implant according to the invention, therefore of equatorial diameter smaller than that of the bag at the time of the operation, leaves the bag with the possibility of partially retracting on the ring The consequence of this retraction lies in a decrease in the loosening zonulair fibers es that the magnification of the natural lens had caused. It follows that changes in the condition of the ciliary muscle are better transmitted to the equatorial part of the capsular bag. In other words, the reduction in this relaxation makes it possible to transmit to the capsule a greater part of the amplitude of the movement of the ciliary muscle than that transmissible to the natural capsule which had grown.
La mise en place de l'implant selon l'invention à l'intérieur du sac capsulaire consiste à replier sur elle-même la pièce annulaire 1 de manière à en réduire l'encombrement en section afin de pouvoir l'introduire dans le sac capsulaire par l'intermédiaire d'une incision cornéenne de faible longueur. Une fois la pièce 1 mise en place dans le sac du fait de son élasticité propre, celle- ci forme un élément de maintien de ce sac pour ajuster son diamètre équatorial à une valeur proche de celle que le cristallin avait lorsque le patient était âgé d'une trentaine d'années. Fixer le diamètre équatorial du sac capsulaire à cette dimension, c'est-à-dire limiter sa rétraction partielle, c'est le placer dans une situation optimale pour bénéficier de l'amplitude maximale des mouvements du muscle ciliaire transmis à ce sac par la zonule, comme expliqué ci-dessus. Pour obtenir ce résultat, on aura choisi une dimension de pièce 1 adéquate, à partir d'une mesure préopératoire du diamètre équatorial du cristallin (par une méthode connue, par exemple par ultrason) à laquelle on aura soustrait entre 0,5 et 0,75 mm pour déterminer le diamètre extérieur de la pièce 1 qui convient .The establishment of the implant according to the invention inside the capsular bag consists in folding over itself the annular piece 1 so as to reduce its bulk in section so as to be able to introduce it into the capsular bag through an incision corneal of short length. Once the part 1 is placed in the bag because of its own elasticity, it forms a holding element for this bag to adjust its equatorial diameter to a value close to that which the lens had when the patient was old. 'about thirty years. Fixing the equatorial diameter of the capsular bag to this dimension, i.e. limiting its partial retraction, is placing it in an optimal situation to benefit from the maximum range of motion of the ciliary muscle transmitted to this bag by the zonule, as explained above. To obtain this result, we will have chosen an adequate part size 1, from a preoperative measurement of the equatorial diameter of the lens (by a known method, for example by ultrasound) from which we will have subtracted between 0.5 and 0, 75 mm to determine the suitable outside diameter of the part 1.
On met ensuite en place la partie optique 6 en l'introduisant dans la gouttière 1 et , au moyen d'un outil spécial, en forçant les crochets 4 et 5 à l'intérieur des orifices 7 et 8.The optical part 6 is then put in place by introducing it into the gutter 1 and, by means of a special tool, by forcing the hooks 4 and 5 inside the orifices 7 and 8.
Bien entendu les parties 1 et 6 de l'implant sont dans un matériau souple et pliable connu en lui-même tel qu'un polymère acrylique ou à base de silicone. On aura remarqué aux figures 1 et 3 que le dos 4a et 5a des crochets 4 et 5 est dans le prolongement de la surface extérieure de l'aile antérieure 2. Les crochets peuvent donc ainsi épouser parfaitement ce qui reste de la paroi antérieure du sac capsulaire. On aura également remarqué que la zone de liaison des crochets à l'aile 2 s'effectue par une partie de faible épaisseur qui constitue une sorte de pseudo-articulation des crochets par rapport à la pièce annulaire 1. Cette zone repérée 10 à la figure 1 et 11 aux figures 4 et 5. Dans le mode de réalisation des figures 4 et 5 , on a illustré l'effet de levier amplificateur de mouvement joué par les crochets 4 et 5 lors d'une tension des fibres zonulaires 13.Of course the parts 1 and 6 of the implant are made of a flexible and pliable material known in itself such as an acrylic or silicone-based polymer. It will have been noted in FIGS. 1 and 3 that the back 4a and 5a of the hooks 4 and 5 is in the extension of the external surface of the front wing 2. The hooks can therefore perfectly match what remains of the front wall of the bag capsular. It will also be noted that the zone of connection of the hooks to the wing 2 is effected by a thin part which constitutes a sort of pseudo-articulation of the hooks with respect to the annular part 1. This zone marked 10 in the figure 1 and 11 to FIGS. 4 and 5. In the embodiment of FIGS. 4 and 5, the amplifying leverage of movement played by hooks 4 and 5 when tensioning the zonular fibers 13.
La figure 4 est une vue en coupe partielle de l'implant selon l'invention mis en place dans le sac capsulaire 12, à l'étant d'accommodation c'est-à-dire dans sa forme prise sous l'effet de la rétraction élastique de la zone équatoriale du sac capsulaire du fait que la zonule 13 est relâchée (muscle ciliaire contracté) .Figure 4 is a partial sectional view of the implant according to the invention placed in the capsular bag 12, in the accommodation being that is to say in its form taken under the effect of elastic retraction of the equatorial zone of the capsular bag due to the fact that the zonule 13 is relaxed (ciliary muscle contracted).
A la figure 5 on a représenté l'état pris par l'implant de l'invention lorsque le muscle ciliaire est relâché, c'est-à-dire que la zonule 13 est tendue, cette tension ayant pour effet d'aplatir la zone équatoriale du sac capsulaire 12, cet aplatissement provoquant un pivotement vers l'intérieur de la gouttière des crochets 4 et 5 autour de la zone de grande flexibilité 11. On comprend que dans cet état la partie optique 6 de l'implant se trouve repoussée vers l'arrière de l'oeil, ce qui affecte la puissance globale du système dans le sens d'une diminution, ce qui est le cas lors d'une accommodation à l'infini. L'invention peut prendre d'autres formes de réalisation. Par exemple, on peut mettre en place plus de deux crochets (trois ou quatre) de suspension de la pièce optique dans la pièce annulaire . In Figure 5 there is shown the state taken by the implant of the invention when the ciliary muscle is relaxed, that is to say that the zonule 13 is tight, this tension having the effect of flattening the area equatorial of the capsular bag 12, this flattening causing a pivoting towards the inside of the gutter of the hooks 4 and 5 around the zone of great flexibility 11. It is understood that in this state the optical part 6 of the implant is pushed towards the back of the eye, which affects the overall power of the system in the sense of a decrease, which is the case during accommodation to infinity. The invention may take other embodiments. For example, one can install more than two hooks (three or four) for hanging the optical part in the annular part.

Claims

REVENDICATIONS 1. Implant intraoculaire accommodatif comprenant une partie optique centrale et une partie périphérique de maintien de celle-ci dans le sac capsulaire et de transmis- sion à la partie optique des forces et déplacements de la partie équatoriale du sac capsulaire résultant des changements d'état du muscle ciliaire, caractérisé en ce que la partie périphérique est une pièce (1) annulaire en matériau élastiquement déformable en forme de gouttière ouverte vers l'intérieur avec une aile postérieure (3) au contact de la paroi postérieure et une aile antérieure (2) au contact de la partie périphérique restante de la paroi antérieure du sac capsulaire, en ce que l'aile antérieure (2) comporte au moins deux pattes (4 et 5) en forme de crochets en saillie radiale du bord de l'aile et en ce que la partie optique est quant à elle une lentille (6) en forme de disque comportant au moins deux ouvertures (7 et 8) dans sa zone périphérique au moyen desquelles elle est maintenue par les crochets (4, 5) de la pièce annulaire (1) . CLAIMS 1. An accommodative intraocular implant comprising a central optical part and a peripheral part for holding the latter in the capsular bag and for transmitting to the optical part the forces and displacements of the equatorial part of the capsular bag resulting from changes in state of the ciliary muscle, characterized in that the peripheral part is an annular piece (1) of elastically deformable material in the form of a gutter open inwards with a rear wing (3) in contact with the rear wall and an anterior wing ( 2) in contact with the remaining peripheral part of the front wall of the capsular bag, in that the front wing (2) has at least two legs (4 and 5) in the form of hooks projecting radially from the edge of the wing and in that the optical part is a lens (6) in the form of a disc comprising at least two openings (7 and 8) in its peripheral zone by means of which el the is held by the hooks (4, 5) of the annular part (1).
2. Implant intraoculaire selon la revendication2. Intraocular implant according to claim
1, caractérisé en ce que la zone de raccordement (11) de chaque crochet (4, 5) à l'aile antérieure est de flexibi¬ lité augmentée.1, characterized in that the connection zone (11) of each hook (4, 5) at the front wing is increased flexibi ¬ ity.
3. Implant selon la revendication 1 ou la reven- dication 2, caractérisé en ce que le dos (4a, 5a) de chaque crochet (4, 5) est situé dans le prolongement de la face externe de l'aile antérieure (2) .3. Implant according to claim 1 or claim 2, characterized in that the back (4a, 5a) of each hook (4, 5) is located in the extension of the external face of the front wing (2) .
4. Implant selon l'une des revendications précédentes, caractérisé en ce que chaque crochet (4, 5) coopère avec la lentille sans jeu dans la direction de l'axe optique de l'implant.4. Implant according to one of the preceding claims, characterized in that each hook (4, 5) cooperates with the lens without play in the direction of the optical axis of the implant.
5. Implant selon l'une des revendications précédentes, caractérisé en ce que la partie de liaison (9) des deux ailes de la pièce annulaire est d'épaisseur supérieure à la plus grande épaisseur de chacune des ailes. 5. Implant according to one of the preceding claims, characterized in that the connecting part (9) of the two wings of the annular part is of thickness greater than the greatest thickness of each of the wings.
6. Implant selon l'une des revendications précédentes, caractérisé en ce que le diamètre de la lentille (6) est inférieur au diamètre équatorial interne de la pièce annulaire (1) et est supérieur au diamètre du bord de chaque aile (2, 3) . 6. Implant according to one of the preceding claims, characterized in that the diameter of the lens (6) is less than the internal equatorial diameter of the annular part (1) and is greater than the diameter of the edge of each wing (2, 3 ).
PCT/FR1999/002445 1998-10-15 1999-10-12 Accommodative intraocular implant WO2000021467A1 (en)

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FR2784575B1 (en) 2000-12-22

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