WO1999002106A1 - Flexible single-piece intraocular implant - Google Patents

Flexible single-piece intraocular implant Download PDF

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Publication number
WO1999002106A1
WO1999002106A1 PCT/FR1998/001380 FR9801380W WO9902106A1 WO 1999002106 A1 WO1999002106 A1 WO 1999002106A1 FR 9801380 W FR9801380 W FR 9801380W WO 9902106 A1 WO9902106 A1 WO 9902106A1
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WO
WIPO (PCT)
Prior art keywords
haptic
optical part
eye
intraocular implant
connecting element
Prior art date
Application number
PCT/FR1998/001380
Other languages
French (fr)
Inventor
Marc Weiser
Denis Gantin
Original Assignee
Corneal Industrie
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 Corneal Industrie filed Critical Corneal Industrie
Priority to EP98933747A priority Critical patent/EP0994683A1/en
Publication of WO1999002106A1 publication Critical patent/WO1999002106A1/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
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics

Definitions

  • the present invention relates to a flexible monobloc intraocular implant.
  • intraocular implants can be classified into two main categories depending on the nature of the material with which they are made.
  • rigid intraocular implants which are produced most often using PMMA and in which the elasticity of the haptic part is obtained by giving it a shape allowing its elastic deformation.
  • flexible intraocular implants which are manufactured with a material which is most often a hydrophilic acrylic or a silicone-based compound.
  • the advantage of flexible intraocular implants is that, for their introduction into the eye, the optical part which is itself flexible can be folded, which allows implantation in the eye of the system through a reduced corneal incision.
  • a manual technique which consists in a first step of folding the intraocular implant and in particular its optical part and of maintaining with the aid of pliers the optical part in its folded state and of introducing the implant folded through the incision inside the eye.
  • a second implantation process consists in using an injector.
  • This device comprises a first folding zone in which the optical part and the haptic part of the implant are folded in particular using a piston and an insertion part of tubular shape with a reduced diameter in which the implant previously folded is maintained in this folded form for introduction into the interior of the eye.
  • the haptic part of flexible intraocular implants there are also two main embodiments.
  • the so-called shuttle-shaped implants in which the haptic part consists of two diametrically opposite elements of relatively large size and the free end of which rests on the internal wall of the eye in an arc of long circle. Due to the conformation of the haptic part, these implants lend themselves well to placement using an injector since the haptic part is folded at the same time as the optical part. However, they often have the disadvantage of causing an arch effect when they are placed in the eye, which risks causing an axial displacement of the optical part over time.
  • haptic part in the form of a handle or in the form of a haptic element having a reduced length support on the wall of the eye, this avoids the effect of arch, but this form of haptic part is poorly suitable for the use of an injector because of the great difficulty in correctly folding the haptic part at the same time as the optical part.
  • An object of the present invention is to provide a flexible monobloc intraocular implant having a haptic part whose areas of contact with the internal wall of the eye are multiple but reduced and which, however, is well suited to the use of a injector for its placement in the eye.
  • the monobloc intraocular implant made of flexible material comprising a substantially circular optical part and a haptic part
  • said haptic part consists of two haptic assemblies disposed substantially symmetrically with respect to a diameter of the optical part, each haptic assembly consisting of:
  • haptic members each comprising a first end secured to the periphery of the optical part and a second end intended to come into contact with the internal wall of the eye, said haptic members forming an angle between them less than 100 degrees ;
  • connecting element having two ends, each end being connected to one of the haptic members, said connecting element having no connection with the optical part and not being in contact with the internal wall of the eye when said implant is placed in the eye.
  • each haptic member comprises a solid arm comprising at its second end a recessed portion surrounded by a rim comprising an elastically deformable contact portion.
  • FIG. 1 is a side view of the implant of Figure 1;
  • FIG. 3 is a front view of the intraocular implant of Figure 1 after its placement in a capsular bag having a first diameter Dl;
  • FIG. 4 is a view similar to that of Figure 3 in the case where the diameter of the capsular bag D2 is less than the diameter Dl.
  • the intraocular implant comprises an optical part 10 which is substantially circular and whose diameter in this embodiment is equal to 6 mm.
  • the intraocular implant also comprises two haptic assemblies respectively referenced 12 and 14 which are connected to the periphery 10a of the optical part and which are arranged symmetrically with respect to a diameter X, X 1 of the optical part 10.
  • the two haptic assemblies 12 and 14 being identical, we will simply describe the haptic assembly 12.
  • the haptic assembly 12 also includes a connecting element 20 which connects the haptic members 16 and 18.
  • the haptic members 16 and 18 are arranged substantially symmetrically with respect to the diameter Y, Y 'of the optical part, this diameter Y, Y' being orthogonal to the diameter X, X '.
  • each haptic member 16 or 18 comprises a recessed portion 22 which is surrounded on its major part by an elastically deformable rim 24 which thus constitutes the ends 16b and 18b.
  • Each haptic member 16 or 18 also comprises a solid arm 26, one end of which constitutes the end 16a, 18a of the haptic member and the other end of which 26a is connected to the flange 24 and at the same time forms part of the periphery of the recess 22.
  • the outer edge of each arm 26 is tangentially connected to the periphery of the optical part.
  • the connecting element 20 is in fact connected in the end region 26a of the arms 26 of the haptic members.
  • This connection zone referenced 28 therefore constitutes a relatively massive part with the ends 26a of the arms 26.
  • the connecting element 20 has no contact with the periphery 10a of the optical part, the connecting element 20 defining with the arms 26 and the periphery of the optical part an opening 30.
  • the rays joining these contact points at the center O of the optical part make an angle at the center a which is of the order of 60 °. More generally, this angle at the center a is preferably between 30 and 100 ° and more preferably between 45 and 75 degrees.
  • the width e of the flanges is of the order of 0.15 mm, while, as best shown in FIG. 2, the thickness h in a direction orthogonal to the optical plane of the implant is l '' order of 0.37 mm. More generally, the thickness h is at least equal to 1.5 times the width 1 and more preferably at least equal to twice this width.
  • the haptic members have a thickness h 'of the order of 0.25 mm and that, at rest, the ends of the haptic members are arranged on a circle with diameter D '.
  • the diameter D ' is adapted to the dimensions of the capsular bag, in which the implant must be placed. In the example considered, the diameter D 'is equal to 11.25 mm.
  • FIG. 2 shows that the median plane of the haptic assemblies coincides with the optical plane of the optical part 10.
  • the thickness of each haptic member increases from the periphery of the optical part towards the end free from the organ.
  • Figures 3 and 4 show the deformation of the ends of the haptic organs when the implant is placed in the capsular bag.
  • the diameter of the capsular bag D1 is 10.5 mm
  • the diameter of the capsular bag D2 is 10 mm.
  • the connecting elements 20 are configured in such a way that, when the implant is placed in the eye, the connecting elements are not in contact with the inner wall of the eye. This contact only occurs at the ends of the haptic organs.
  • the flexible material used to make the one-piece implant is a crosslinked copolymer of hydroxylethyl methacrylate (HEMA) and ethyl methacrylate (EMA).
  • HEMA hydroxylethyl methacrylate
  • EMA ethyl methacrylate
  • Such a material has an average modulus of elasticity of the order of 0.78 MPa slightly higher than that of a HEMA poly. It should also be added that the invention would not be departed from if the haptic organs had a different configuration. They must be able to develop the elastic effect required when the implant is placed in the eye and that the two haptic organs of the same haptic assembly are connected by a band or connecting element.

Abstract

The invention concerns a flexible single-piece intraocular implant made from a supple material comprising a substantially circular optical part (10) and a haptic part, characterised in that said haptic part consists of two haptic assemblies (12, 14) arranged substantially symmetrical relative to the optical part diameter, each haptic assembly consisting of: two haptic members (16, 18) capable of elastic deformation each comprising a first end (16a, 18a) integral with the optical part periphery and a second end (16b, 18b) designed to be urged in contact with the eye internal wall, said haptic members forming between them an angle of less than 100° at the centre; and a linking element (20) with two ends, each end being connected to one of the haptic members, said linking element having no link with the optical part and no contact with the eye internal wall when said implant is set in the eye.

Description

Implant intraoculaire monobloc souple. Flexible monobloc intraocular implant.
La présente invention a pour objet un implant intraoculaire monobloc souple. On sait que les implants intraoculaires peuvent être rangés dans deux grandes catégories selon la nature du matériau avec lequel ils sont fabriqués. On distingue d'une part les implants intraoculaires rigides qui sont réalisés le plus souvent à l'aide de PMMA et dans lesquels l'élasticité de la partie haptique est obtenue en donnant à celle-ci une forme permettant sa déformation élastique. On distingue d'autre part des implants intraoculaires dits souples qui sont fabriqués avec un matériau qui est le plus souvent un acrylique hydrophile ou un composé à base de silicone.The present invention relates to a flexible monobloc intraocular implant. We know that intraocular implants can be classified into two main categories depending on the nature of the material with which they are made. On the one hand, there are rigid intraocular implants which are produced most often using PMMA and in which the elasticity of the haptic part is obtained by giving it a shape allowing its elastic deformation. On the other hand, a distinction is made between so-called flexible intraocular implants which are manufactured with a material which is most often a hydrophilic acrylic or a silicone-based compound.
Comme cela est également bien connu, l'intérêt des implants intraoculaires souples est que, pour leur introduction dans l'oeil, la partie optique elle- même souple peut être pliée, ce qui permet l'implantation dans l'oeil du système à travers une incision cornéenne de dimension réduite.As is also well known, the advantage of flexible intraocular implants is that, for their introduction into the eye, the optical part which is itself flexible can be folded, which allows implantation in the eye of the system through a reduced corneal incision.
En ce qui concerne la technique de mise en place des implants intraoculaires souples dans l'oeil, on peut distinguer deux grands procédés. D'une part, on trouve une technique manuelle qui consiste dans une première étape à plier l'implant intraoculaire et notamment sa partie optique et à maintenir à l'aide d'une pince la partie optique dans son état plié et à introduire l'implant plié par l'incision à l'intérieur de l'oeil. Un deuxième procédé d'implantation consiste à utiliser un injecteur. Cet appareil comporte une première zone de pliage dans laquelle la partie optique et la partie haptique de l'implant sont pliées notamment à l'aide d'un piston et une partie d'insertion de forme tubulaire avec un diamètre réduit dans laquelle l'implant préalablement plié est maintenu dans cette forme pliée en vue de son introduction à l'intérieur de l'oeil.With regard to the technique for placing flexible intraocular implants in the eye, two main methods can be distinguished. On the one hand, there is a manual technique which consists in a first step of folding the intraocular implant and in particular its optical part and of maintaining with the aid of pliers the optical part in its folded state and of introducing the implant folded through the incision inside the eye. A second implantation process consists in using an injector. This device comprises a first folding zone in which the optical part and the haptic part of the implant are folded in particular using a piston and an insertion part of tubular shape with a reduced diameter in which the implant previously folded is maintained in this folded form for introduction into the interior of the eye.
En ce qui concerne la partie haptique des implants intraoculaires souples, on trouve également deux modes principaux de réalisation. On trouve d'une part les implants dits en forme de navette dans lesquels la partie haptique est constituée par deux éléments diamétralement opposés de dimension relativement importante et dont l'extrémité libre est en appui sur la paroi interne de l'oeil selon un arc de cercle de longueur importante. Du fait de la conformation de la partie haptique, ces implants se prêtent bien à une mise en place à l'aide d'un injecteur puisque la partie haptique est pliée en même temps que la partie optique. En revanche, ils présentent souvent l'inconvénient de provoquer un effet de voûte lorsqu'ils sont mis en place dans l'oeil, ce qui risque d'entraîner un déplacement axial de la partie optique au cours du temps. L'autre type de partie haptique en forme d'anse ou en forme d'élément haptique présentant un appui de longueur réduite sur la paroi de l'oeil, on évite ainsi l'effet de voûte, mais cette forme de partie haptique est mal adaptée à l'utilisation d'un injecteur en raison de la grande difficulté qu'il y a à plier correctement la partie haptique en même temps que la partie optique.With regard to the haptic part of flexible intraocular implants, there are also two main embodiments. On the one hand, there are the so-called shuttle-shaped implants in which the haptic part consists of two diametrically opposite elements of relatively large size and the free end of which rests on the internal wall of the eye in an arc of long circle. Due to the conformation of the haptic part, these implants lend themselves well to placement using an injector since the haptic part is folded at the same time as the optical part. However, they often have the disadvantage of causing an arch effect when they are placed in the eye, which risks causing an axial displacement of the optical part over time. The other type of haptic part in the form of a handle or in the form of a haptic element having a reduced length support on the wall of the eye, this avoids the effect of arch, but this form of haptic part is poorly suitable for the use of an injector because of the great difficulty in correctly folding the haptic part at the same time as the optical part.
Un objet de la présente invention est de fournir un implant intraoculaire monobloc souple présentant une partie haptique dont les zones de contact avec la paroi interne de l'oeil sont multiples mais réduites et qui, cependant, est bien adapté à l'utilisation d'un injecteur pour sa mise en place dans l'oeil.An object of the present invention is to provide a flexible monobloc intraocular implant having a haptic part whose areas of contact with the internal wall of the eye are multiple but reduced and which, however, is well suited to the use of a injector for its placement in the eye.
Pour atteindre ce but selon l'invention, l'implant intraoculaire monobloc réalisé en matériau souple comprenant une partie optique sensiblement circulaire et une partie haptique se caractérise en ce que ladite partie haptique consiste en deux ensembles haptiques disposés sensiblement symétriquement par rapport à un diamètre de la partie optique, chaque ensemble haptique consistant en :To achieve this object according to the invention, the monobloc intraocular implant made of flexible material comprising a substantially circular optical part and a haptic part is characterized in that said haptic part consists of two haptic assemblies disposed substantially symmetrically with respect to a diameter of the optical part, each haptic assembly consisting of:
- deux organes haptiques élastiquement déformables comportant chacun une première extrémité solidaire de la périphérie de la partie optique et une deuxième extrémité destinée à venir au contact de la paroi interne de l'oeil, lesdits organes haptiques faisants entre eux un angle au centre inférieur à 100 degrés ; et- two elastically deformable haptic members each comprising a first end secured to the periphery of the optical part and a second end intended to come into contact with the internal wall of the eye, said haptic members forming an angle between them less than 100 degrees ; and
- un élément de liaison présentant deux extrémités, chaque extrémité étant raccordée à un des organes haptiques, ledit élément de liaison n'ayant pas de liaison avec la partie optique et n'étant pas en contact avec la paroi interne de l'oeil lorsque ledit implant est mis en place dans l'oeil.a connecting element having two ends, each end being connected to one of the haptic members, said connecting element having no connection with the optical part and not being in contact with the internal wall of the eye when said implant is placed in the eye.
On comprend que, grâce à la présence de l'élément de liaison dans chaque ensemble haptique, on pourra obtenir commodément lors de l'utilisation de l'injecteur le pliage de la partie haptique en même temps que le pliage de la partie optique puisque le piston de l'injecteur coopère avec ces éléments de liaison.It is understood that, thanks to the presence of the connecting element in each haptic assembly, it will be possible to conveniently obtain, when using the injector, the folding of the haptic part at the same time as the folding of the optical part since the injector piston cooperates with these connecting elements.
Selon un mode préféré de réalisation, chaque organe haptique comporte un bras massif comprenant à sa deuxième extrémité une portion évidée entourée par un rebord comportant une portion de contact élastiquement déformable. D'autres caractéristiques et avantages de l'invention apparaîtront mieux à la lecture de la description qui suit d'un mode de réalisation de l'invention donné à titre d'exemple non limitatif. La description se réfère aux figures annexées, sur lesquelles : - la figure 1 est une vue de face d'un implant intraoculaire monobloc souple selon l'invention ;According to a preferred embodiment, each haptic member comprises a solid arm comprising at its second end a recessed portion surrounded by a rim comprising an elastically deformable contact portion. Other characteristics and advantages of the invention will appear better on reading the following description of an embodiment of the invention given by way of non-limiting example. The description refers to the appended figures, in which: - Figure 1 is a front view of a flexible monobloc intraocular implant according to the invention;
- la figure 2 est une vue de côté de l'implant de la figure 1 ;- Figure 2 is a side view of the implant of Figure 1;
- la figure 3 est une vue de face de l'implant intraoculaire de la figure 1 après sa mise en place dans un sac capsulaire présentant un premier diamètre Dl ; et- Figure 3 is a front view of the intraocular implant of Figure 1 after its placement in a capsular bag having a first diameter Dl; and
- la figure 4 est une vue similaire à celle de la figure 3 dans le cas où le diamètre du sac capsulaire D2 est inférieur au diamètre Dl.- Figure 4 is a view similar to that of Figure 3 in the case where the diameter of the capsular bag D2 is less than the diameter Dl.
En se référant tout d'abord aux figures 1 et 2, on va décrire un mode préféré de réalisation de l'implant intraoculaire souple monobloc. Comme le montre la figure 1, l'implant intraoculaire comprend une partie optique 10 sensiblement circulaire et dont le diamètre dans ce mode de réalisation est égal à 6 mm. L'implant intraoculaire comporte également deux ensembles haptiques respectivement référencés 12 et 14 qui sont raccordés à la périphérie 10a de la partie optique et qui sont disposés symétriquement par rapport à un diamètre X, X1 de la partie optique 10. Les deux ensembles haptiques 12 et 14 étant identiques, on décrira simplement l'ensemble haptique 12. Celui-ci est essentiellement constitué par deux organes haptiques 16 et 18, chaque organe haptique présentant une première extrémité 16a, 18a raccordée à la périphérie 10a de la partie optique et une deuxième extrémité 16b, 18b élastiquement déformable et destinée à venir au contact de la paroi interne de l'oeil lorsque l'implant est mis en place dans l'oeil. L'ensemble haptique 12 comporte également un élément de liaison 20 qui raccorde les organes haptiques 16 et 18. Les organes haptiques 16 et 18 sont disposés sensiblement symétriquement par rapport au diamètre Y, Y' de la partie optique, ce diamètre Y, Y' étant orthogonal au diamètre X, X'. Comme le montre la figure 1, chaque organe haptique 16 ou 18 comprend une portion évidée 22 qui est entourée sur sa plus grande partie par un rebord élastiquement déformable 24 qui constitue ainsi les extrémités 16b et 18b. Chaque organe haptique 16 ou 18 comporte également un bras massif 26 dont une extrémité constitue l'extrémité 16a, 18a de l'organe haptique et dont l'autre extrémité 26a est raccordée au rebord 24 et constitue en même temps une partie de la périphérie de l'évidement 22. Le bord externe de chaque bras 26 est raccordé tangentiellement à la périphérie de la partie optique.Referring first to Figures 1 and 2, we will describe a preferred embodiment of the flexible intraocular implant in one piece. As shown in FIG. 1, the intraocular implant comprises an optical part 10 which is substantially circular and whose diameter in this embodiment is equal to 6 mm. The intraocular implant also comprises two haptic assemblies respectively referenced 12 and 14 which are connected to the periphery 10a of the optical part and which are arranged symmetrically with respect to a diameter X, X 1 of the optical part 10. The two haptic assemblies 12 and 14 being identical, we will simply describe the haptic assembly 12. This is essentially constituted by two haptic organs 16 and 18, each haptic organ having a first end 16a, 18a connected to the periphery 10a of the optical part and a second end 16b, 18b elastically deformable and intended to come into contact with the internal wall of the eye when the implant is placed in the eye. The haptic assembly 12 also includes a connecting element 20 which connects the haptic members 16 and 18. The haptic members 16 and 18 are arranged substantially symmetrically with respect to the diameter Y, Y 'of the optical part, this diameter Y, Y' being orthogonal to the diameter X, X '. As shown in Figure 1, each haptic member 16 or 18 comprises a recessed portion 22 which is surrounded on its major part by an elastically deformable rim 24 which thus constitutes the ends 16b and 18b. Each haptic member 16 or 18 also comprises a solid arm 26, one end of which constitutes the end 16a, 18a of the haptic member and the other end of which 26a is connected to the flange 24 and at the same time forms part of the periphery of the recess 22. The outer edge of each arm 26 is tangentially connected to the periphery of the optical part.
Comme le montre la figure 1, l'élément de liaison 20 est en fait raccordé dans la région d'extrémité 26a des bras 26 des organes haptiques. Cette zone de raccordement référencée 28 constitue donc une partie relativement massive avec les extrémités 26a des bras 26. On voit de plus que l'élément de liaison 20 n'a aucun contact avec la périphérie 10a de la partie optique, l'élément de liaison 20 définissant avec les bras 26 et la périphérie de la partie optique une ouverture 30. On voit également que, dans un même ensemble haptique, si l'on considère les points de contact des extrémités 18b et 16b des organes haptiques, les rayons joignant ces points de contact au centre O de la partie optique font un angle au centre a qui est de l'ordre de 60°. Plus généralement, cet angle au centre a est de préférence compris entre 30 et 100° et, de préférence encore entre 45 et 75 degrés.As shown in Figure 1, the connecting element 20 is in fact connected in the end region 26a of the arms 26 of the haptic members. This connection zone referenced 28 therefore constitutes a relatively massive part with the ends 26a of the arms 26. It can also be seen that the connecting element 20 has no contact with the periphery 10a of the optical part, the connecting element 20 defining with the arms 26 and the periphery of the optical part an opening 30. It can also be seen that, in the same haptic assembly, if we consider the points of contact of the ends 18b and 16b of the haptic organs, the rays joining these contact points at the center O of the optical part make an angle at the center a which is of the order of 60 °. More generally, this angle at the center a is preferably between 30 and 100 ° and more preferably between 45 and 75 degrees.
Le maintien en place de l'implant intraoculaire à l'intérieur de l'oeil est assuré par une force élastique développée par la déformation des rebords 24 des extrémités évidées des organes haptiques. Pour favoriser cette déformation, la largeur e des rebords est de l'ordre de 0,15 mm, alors que, comme le montre mieux la figure 2, l'épaisseur h selon une direction orthogonale au plan optique de l'implant est de l'ordre de 0,37 mm. Plus généralement, l'épaisseur h est au moins égale à 1,5 fois la largeur 1 et de préférence encore au moins égale à deux fois cette largeur. On voit également sur cette figure que, à proximité de la périphérie 10a de la partie optique, les organes haptiques ont une épaisseur h' de l'ordre de 0,25 mm et que, au repos, les extrémités des organes haptiques sont disposées sur un cercle de diamètre D'. Le diamètre D' est adapté aux dimensions du sac capsulaire, dans lequel l'implant doit être mis en place. Dans l'exemple considéré, le diamètre D' est égal à 11,25 mm. La figure 2 montre que le plan médian des ensembles haptiques est confondu avec le plan optique de la partie optique 10. En outre, on comprend que l'épaisseur de chaque organe haptique va en augmentant depuis la périphérie de la partie optique vers l'extrémité libre de l'organe. Les figures 3 et 4 montrent la déformation des extrémités des organes haptiques lorsque l'implant est mis dans le sac capsulaire. Dans le cas de la figure 3, le diamètre du sac capsulaire Dl est de 10,5 mm, alors que dans le cas de la figure 4, le diamètre du sac capsulaire D2 est de 10 mm. Il est important de constater que les éléments de liaison 20 sont configurés de telle manière que, lorsque l'implant est mis en place dans l'oeil, les éléments de liaison ne sont pas en contact avec la paroi interne de l'oeil. Ce contact ne se produit qu'aux extrémités des organes haptiques.The holding in place of the intraocular implant inside the eye is ensured by an elastic force developed by the deformation of the edges 24 of the hollowed-out ends of the haptic organs. To promote this deformation, the width e of the flanges is of the order of 0.15 mm, while, as best shown in FIG. 2, the thickness h in a direction orthogonal to the optical plane of the implant is l '' order of 0.37 mm. More generally, the thickness h is at least equal to 1.5 times the width 1 and more preferably at least equal to twice this width. It can also be seen in this figure that, near the periphery 10a of the optical part, the haptic members have a thickness h 'of the order of 0.25 mm and that, at rest, the ends of the haptic members are arranged on a circle with diameter D '. The diameter D 'is adapted to the dimensions of the capsular bag, in which the implant must be placed. In the example considered, the diameter D 'is equal to 11.25 mm. FIG. 2 shows that the median plane of the haptic assemblies coincides with the optical plane of the optical part 10. In addition, it can be understood that the thickness of each haptic member increases from the periphery of the optical part towards the end free from the organ. Figures 3 and 4 show the deformation of the ends of the haptic organs when the implant is placed in the capsular bag. In the case of FIG. 3, the diameter of the capsular bag D1 is 10.5 mm, while in the case of FIG. 4, the diameter of the capsular bag D2 is 10 mm. It is important to note that the connecting elements 20 are configured in such a way that, when the implant is placed in the eye, the connecting elements are not in contact with the inner wall of the eye. This contact only occurs at the ends of the haptic organs.
On voit bien sur ces figures 3 et 4 que l'effet élastique est obtenu par la déformation du rebord 24 des quatre organes haptiques. L'effort élastique se développe ainsi sensiblement selon des rayons de la partie optique et n'intéresse qu'une zone relativement limitée Zl de la paroi interne de l'oeil. Ces efforts sont développés dans la partie optique. Toutefois, du fait de chaque ensemble haptique défini, deux zones de contact Zl, on obtient une très bonne stabilité de l'implant après sa mise en place dans l'oeil tout en évitant l'effet de voûte rencontré le plus souvent avec les implants intraoculaires monoblocs souples du type "navette".It is clear from these Figures 3 and 4 that the elastic effect is obtained by the deformation of the rim 24 of the four haptic members. The elastic force thus develops substantially along radii of the optical part and concerns only a relatively limited zone Z1 of the internal wall of the eye. These efforts are developed in the optical part. However, due to each defined haptic set, two contact zones Zl, very good stability of the implant is obtained after it has been placed in the eye while avoiding the arch effect most often encountered with implants. flexible monoblock intraoculars of the "shuttle" type.
De préférence, le matériau souple utilisé pour réaliser l'implant monobloc est un copolymère réticulé de méthacrylate d'hydroxyléthyle (HEMA) et de méthacrylate d'éthyle (EMA). Un tel matériau a un module d'élasticité moyen de l'ordre de 0,78 MPa légèrement supérieur à celui d'un poly HEMA. II faut également ajouter qu'on ne sortirait pas de l'invention si les organes haptiques avaient une configuration différente. Il faut qu'ils soient capables de développer l'effet élastique requis lorsque l'implant est mis en place dans l'oeil et que les deux organes haptiques d'un même ensemble haptique soient reliés par une bande ou élément de liaison. Preferably, the flexible material used to make the one-piece implant is a crosslinked copolymer of hydroxylethyl methacrylate (HEMA) and ethyl methacrylate (EMA). Such a material has an average modulus of elasticity of the order of 0.78 MPa slightly higher than that of a HEMA poly. It should also be added that the invention would not be departed from if the haptic organs had a different configuration. They must be able to develop the elastic effect required when the implant is placed in the eye and that the two haptic organs of the same haptic assembly are connected by a band or connecting element.

Claims

REVENDICATIONS
1. Implant intraoculaire monobloc réalisé en matériau souple comprenant une partie optique (10) sensiblement circulaire et une partie haptique, caractérisé en ce que ladite partie haptique consiste en deux ensembles haptiques (12, 14) disposés sensiblement symétriquement par rapport à un diamètre de la partie optique, chaque ensemble haptique consistant en :1. One-piece intraocular implant made of flexible material comprising an optical part (10) substantially circular and a haptic part, characterized in that said haptic part consists of two haptic assemblies (12, 14) arranged substantially symmetrically with respect to a diameter of the optical part, each haptic assembly consisting of:
- deux organes haptiques (16, 18) élastiquement déformables comportant chacun une première extrémité (16a, 18a) solidaire de la périphérie de la partie optique et une deuxième extrémité (16b, 18b) destinée à venir au contact de la paroi interne de l'oeil, lesdits organes haptiques faisant entre eux un angle au centre inférieur à 100 degrés ; et- two elastically deformable haptic members (16, 18) each comprising a first end (16a, 18a) secured to the periphery of the optical part and a second end (16b, 18b) intended to come into contact with the internal wall of the eye, said haptic organs forming between them an angle at the center less than 100 degrees; and
- un élément de liaison (20) présentant deux extrémités, chaque extrémité étant raccordée à un des organes haptiques, ledit élément de liaison n'ayant pas de liaison avec la partie optique et n'étant pas en contact avec la paroi interne de l'oeil lorsque ledit implant est mis en place dans l'oeil.- a connecting element (20) having two ends, each end being connected to one of the haptic members, said connecting element having no connection with the optical part and not being in contact with the internal wall of the eye when said implant is placed in the eye.
2. Implant intraoculaire selon la revendication 1, caractérisé en ce que chaque organe haptique (16, 18) comprend un bras massif qui comporte à sa deuxième extrémité une portion évidée (22) entourée par un rebord (24) comportant une portion de contact élastiquement déformable.2. Intraocular implant according to claim 1, characterized in that each haptic organ (16, 18) comprises a solid arm which has at its second end a recessed portion (22) surrounded by a flange (24) comprising an elastically contact portion deformable.
3. Implant intraoculaire selon la revendication 2, caractérisé en ce qu'une partie dudit rebord (24) est raccordée à la périphérie de la partie optique par un bras (26) dont la largeur dans le plan optique est très supérieure à celle de la portion de contact du rebord.3. Intraocular implant according to claim 2, characterized in that a part of said flange (24) is connected to the periphery of the optical part by an arm (26) whose width in the optical plane is much greater than that of the contact portion of the rim.
4. Implant intraoculaire selon la revendication 3, caractérisé en ce que chaque extrémité de l'élément de liaison (20) est raccordée au bras (26) d'un des organes haptiques (16, 18), par quoi une ouverture (30) est ménagée entre la périphérie de la partie optique (10) et l'élément de liaison et les deux bras d'un même ensemble haptique.4. Intraocular implant according to claim 3, characterized in that each end of the connecting element (20) is connected to the arm (26) of one of the haptic organs (16, 18), whereby an opening (30) is formed between the periphery of the optical part (10) and the connecting element and the two arms of the same haptic assembly.
5. Implant intraoculaire selon la revendication 4, caractérisé en ce que les extrémités de l'élément de liaison (20) sont raccordées aux bras (26) à proximité de l'extrémité desdits bras qui entoure en partie ledit évidement (22).5. Intraocular implant according to claim 4, characterized in that the ends of the connecting element (20) are connected to the arms (26) near the end of said arms which partially surrounds said recess (22).
6. Implant intraoculaire selon l'une quelconque des revendications 2 à 5, caractérisé en ce que la portion de contact présente une épaisseur (h) selon la direction de l'axe optique de l'implant supérieure ou égale à 1,5 fois la largeur (1) de la portion de contact. 6. intraocular implant according to any one of claims 2 to 5, characterized in that the contact portion has a thickness (h) according to the direction of the optical axis of the implant greater than or equal to 1.5 times the width (1) of the contact portion.
PCT/FR1998/001380 1997-07-08 1998-06-29 Flexible single-piece intraocular implant WO1999002106A1 (en)

Priority Applications (1)

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EP98933747A EP0994683A1 (en) 1997-07-08 1998-06-29 Flexible single-piece intraocular implant

Applications Claiming Priority (2)

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FR9708650A FR2765797B1 (en) 1997-07-08 1997-07-08 FLEXIBLE MONOBLOCK INTRAOCULAR IMPLANT
FR97/08650 1997-07-08

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US6200344B1 (en) 1999-04-29 2001-03-13 Bausch & Lomb Surgical, Inc. Inraocular lenses
US6190410B1 (en) * 1999-04-29 2001-02-20 Bausch & Lomb Surgical, Inc. Intraocular lenses
US6461384B1 (en) * 1999-06-17 2002-10-08 Bausch & Lomb Incorporated Intraocular lenses
US6342073B1 (en) * 1999-12-30 2002-01-29 J. Stuart Cumming Intraocular lens for posterior vaulting
FR2814671B1 (en) * 2000-10-02 2003-04-04 Biotech INTRAOCULAR LENSES
US8523942B2 (en) 2011-05-17 2013-09-03 James Stuart Cumming Variable focus intraocular lens
US9295545B2 (en) 2012-06-05 2016-03-29 James Stuart Cumming Intraocular lens
US8734512B2 (en) 2011-05-17 2014-05-27 James Stuart Cumming Biased accommodating intraocular lens
US9918830B2 (en) 2010-06-21 2018-03-20 James Stuart Cumming Foldable intraocular lens with rigid haptics
US9585745B2 (en) 2010-06-21 2017-03-07 James Stuart Cumming Foldable intraocular lens with rigid haptics
US9295544B2 (en) 2012-06-05 2016-03-29 James Stuart Cumming Intraocular lens
US10736732B2 (en) 2010-06-21 2020-08-11 James Stuart Cumming Intraocular lens with longitudinally rigid plate haptic
US9351825B2 (en) 2013-12-30 2016-05-31 James Stuart Cumming Semi-flexible posteriorly vaulted acrylic intraocular lens for the treatment of presbyopia
US9295546B2 (en) 2013-09-24 2016-03-29 James Stuart Cumming Anterior capsule deflector ridge
US9615916B2 (en) 2013-12-30 2017-04-11 James Stuart Cumming Intraocular lens

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EP0994683A1 (en) 2000-04-26
FR2765797A1 (en) 1999-01-15

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