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EP1581152A1 - Capsular tension ring, method for making a capsular tension ring and capsular ring and intraocular lens assembly - Google Patents

Capsular tension ring, method for making a capsular tension ring and capsular ring and intraocular lens assembly

Info

Publication number
EP1581152A1
EP1581152A1 EP03815709A EP03815709A EP1581152A1 EP 1581152 A1 EP1581152 A1 EP 1581152A1 EP 03815709 A EP03815709 A EP 03815709A EP 03815709 A EP03815709 A EP 03815709A EP 1581152 A1 EP1581152 A1 EP 1581152A1
Authority
EP
European Patent Office
Prior art keywords
ring
annular body
capsular
ring according
flexible material
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP03815709A
Other languages
German (de)
French (fr)
Inventor
Christophe Chassain
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ioltechnologie Production SARL
Original Assignee
Ioltechnologie Production SARL
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 Ioltechnologie Production SARL filed Critical Ioltechnologie Production SARL
Publication of EP1581152A1 publication Critical patent/EP1581152A1/en
Withdrawn legal-status Critical Current

Links

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
    • 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
    • A61F2/1694Capsular bag spreaders therefor

Definitions

  • the present invention relates to capsular rings which are intended to be implanted in the capsular bag, after the removal of the lens affected by cataracts, in association with an intraocular lens intended to replace the lens.
  • tension rings have been adopted to maintain the shape of the capsular bag and to limit the post-operative retraction thereof.
  • capsular rings have been made to combat opacification of the posterior capsule of the capsular bag which is at the origin of the secondary cataract making the posterior capsule opaque and necessitating the opening thereof by YAG laser beam. to restore visual acuity.
  • Opacification of the posterior capsule has two aspects: first there are the fibroses corresponding to an in situ metaplasia of the anterior epithelial cells. It is a complication that can reach 40% of cases of cataract removal with replacement of the lens. It turns out that fibrosis has little effect on visual acuity. There are also Elschnig pearls that form from germ cells remaining at the equator of the capsular bag after surgery. These cells migrate along the posterior capsule and form opaque pearls which are the main cause of the decrease in visual acuity linked to the opacification of the posterior capsule.
  • Tension rings are normally ineffective in constituting a barrier to cell migration because they are often devoid of sharp edges or square edges and / or of too small axial or anteroposterior dimensions allowing the insertion of zonular fibers. on the capsule thus maintaining an open germinal equatorial zone.
  • Anti-opacification capsular rings are also known.
  • the vast majority of anti-clouding capsular rings offered on the market are made of polymethylmethacrylate (PMMA) which is a rigid and hard material allowing to obtain sharp edges, or square edges, effective as a barrier to cell migration.
  • PMMA polymethylmethacrylate
  • the handling of such rings by the surgeon poses a serious problem because of their very high rigidity and their high elasticity which makes them dangerous during introduction and deployment in the capsular bag. Indeed, when a clamp is used, after passing through a corneal or sclerocorneal incision, a first end is introduced by the rhexis into the capsular bag over approximately 270 °, then the remaining part is folded back inside the rhexis before being released.
  • the ring When an injector is used, the ring is positioned in a tube and moved by means of a sliding hook passing through the hole of the eyelet located at one and / or the other end of the ring.
  • the strand of the ring of rigid material, such as PMMA, after loosening, can violently strike the equatorial zone of the capsular bag with a risk of damage to the bag or tears of the zonules attached to the outside of the bag capsular at the equator.
  • capsular rings must necessarily be of the open type. Indeed, configured in closed rings, the corneal or sclerocorneal incision would be far too large to allow rapid healing expected by surgeons and their patients.
  • EP-A- 0.884.031 describes an open capsular ring in general C shape with sharp edges to produce a "wedge" effect during the retraction of the capsular bag, which makes it possible to block the migration of epithelial cells.
  • the capsular rings described in this document have a substantial axial or anteroposterior width of 0.7 mm and a width of 0.2 mm to cover the entire width of the equatorial zone of the capsular bag, from which the cells propagate. .
  • a capsular ring of large axial width opposes fibrosis and prevents the capsular joining or symphysis essential to stop the migration of epithelial cells, or even Elschnig pearls, on the posterior capsule inside the zone corresponding to the periphery of the optics of the intraocular lens implanted to replace the lens.
  • the symphysis is also advantageous in that it allows stabilization of the intraocular lens positioned in the bag.
  • the object of the invention is a capsular ring which provides a barrier to equatorial cell migration to the posterior capsule which is capable of overcoming the drawbacks of known anti-clouding capsular rings.
  • a capsular ring implantable in the equatorial region of a capsular bag after removal of the cataract, comprising an open or closed annular body, the annular body having a sharp edge on the large majority of the circumference and an axial width of between approximately 0.3 and 0.6 mm, and preferably approximately 0.5 mm, characterized in that the annular body, including the sharp edges, is made of rigid material on the majority of the circumference, and in that the annular body comprises at least one junction of flexible material between two segments of the annular body of rigid material.
  • the junction (s) made of flexible material constitutes a preferential folding zone.
  • a first end, called the front end, of the ring is introduced and the ring is pushed by rotating it in the bag until introduction about three-quarters of the annular body.
  • the annular body is divided by the junction (s) of flexible material into two or more rigid segments allowing an easier gesture to control by avoiding large amplitude movements liable to produce lesions.
  • the sharp edges of the segments extend over at least about 90% of the circumference of the annular body.
  • these junctions made of flexible material providing increased flexibility to allow the ring to better adapt to the configuration of the tube, typically rectilinear, or with a very large radius of curvature with respect to the radius of the capsular ring, without risk of cracking of the annular body, each of the segments of rigid material of the implant being relatively weakly stressed.
  • the first end, or front end, of the capsular ring with an open contour comprises a terminal part, without eyelet, of flexible material and slightly re-entering which reduces, even eliminates, the risk of perforating the bag
  • the other, or second, end, or rear end which is preferably provided with an eyelet tab.
  • a single junction When a single junction is provided, it is preferably arranged about 300 ° from the front end.
  • three junctions are provided, arranged at approximately 120 ° from each other.
  • Such a ring is particularly intended for implants whose optics with a square peripheral edge, that is to say with at least one sharp edge and two or more haptic elements capable of bearing on the current part of the rigid segments of the capsular ring, ensuring both good stability and good centering.
  • the periphery of the optical part it provides a second effective barrier against cell migration thanks to the symphysis of the anterior and posterior capsules, and this despite an axial width of the capsular ring sufficient to block the proliferation of epithelial cells in the equatorial zone.
  • a closed capsular ring preferably two junctions made of flexible material are provided which allow a marked ovalization, or flattening, of the implant and therefore the introduction of the ovalized, or flattened, ring through a corneal incision or sclero-cornea much smaller than what can be done with a closed contour ring made of rigid material.
  • Such a capsular ring with the vast majority of its sharp edges made of rigid or hard material is more effective as a barrier to cell migration than a capsular ring with closed outline made of flexible material.
  • FIG. 1 shows a first embodiment of a capsular ring, according to the invention, with open outline
  • FIG. 4 is an elevational view of the capsular ring of Figures 1 to 3;
  • FIG. 5 shows the first embodiment implanted in the capsular bag after retraction of the bag and symphysis of the anterior and posterior capsules;
  • FIG. 6 shows a second embodiment of a capsular ring according to the invention, with open outline
  • FIG. 7 shows a folding mode according to the first embodiment
  • FIG. 8 shows a third embodiment of a capsular ring, according to the invention, with closed contour
  • FIG. 9 shows a set of the capsular ring open contour in one piece with an intraocular lens.
  • the capsular ring 10 shown in Figures 1 to 5 comprises an annular body 11a open contour, substantially circular.
  • the diameter of the ring in the state of rest will be greater than that of the capsular bag in which it is intended to be implanted and in practice of approximately 10.5 to 11.5 mm.
  • the running part of the annular body links a first end 13, a second end 14. In the state of rest, the ends are spaced circumferentially from one another by about 0.5 mm.
  • the annular body has a substantially rectangular radial section whose axial dimension is approximately 0.5mm, and which is greater than the radial dimension which is between 0.1 and 0.3 mm and preferably approximately 0.15 mm (see Figure 3).
  • the external surface 15 of the annular body is preferably substantially a straight cylinder extending between two sharp edges or square edges 16 and 17.
  • the first end 13 which, in practice, is the front end by which the capsular ring is introduced into the capsular bag through a sclerocorneal incision and the rhexis in the anterior capsule, is made of flexible material, so that '' in case of contact of its free edge with the tissues of the capsular bag, the risk of accidental perforation is reduced. In addition, its flexibility will facilitate its passage over the equatorial zone of the capsular bag when the ring is gradually pushed circumferentially along the equatorial zone of the capsular bag.
  • This first end is slightly curved and re-entrant with the rounded free edge thicker than the current part of the body of the ring.
  • the second end 14 comprises an eyelet tab of the type known per se offset inwards and capable of receiving the hook of a handling instrument making it possible to modify the position of the ring in the capsular bag or for hooking it to a capsular ring injector rod, also known per se.
  • the annular body 11 is largely made of a rigid or hard material, with a low hydrophilicity or hydrophobic rate, and in particular PMMA.
  • the annular body 11. comprises two annular segments 18A, 18B, the first annular segment 18A preferably having a circumferential extent greater than about 260 ° and less than about 320 ° and preferably about 300 ° and the second annular segment 18B having a circumferential extent of about 55 °.
  • the junction or block 19 has a rectangular section, preferably square, with an outer surface having substantially preferably the shape of a straight cylinder extending between two sharp edges or square edges in continuity with the sharp annular edges 16, 17 of the segments.
  • the substantially square section of the junction 19 is larger than that of the current part of the annular segments, and therefore of the annular body, and has an axial dimension of approximately 0.4 to 0.5 mm and a radial dimension of approximately 0.4 to 0.5 mm, the parts of the segments 18A, 18B adjoining the junction having the same cross section as the latter
  • the circumferential extent of each of the junctions will be between 0.5 and 6% of the circumference of the ring.
  • the opposite edges of the parts adjoining the junction converge radially towards the inside of the annular body.
  • the outer surface of the annular body preferably preferably has the shape of a straight cylinder from one end to the other, whether it is the junction (s) of flexible material or the segments of material rigid, including the parts adjoining the junctions.
  • the capsular ring according to this embodiment is in practice made by selective chemical structural modification, according to the process described in EP 1003446 from an annular body whose geometry corresponds to that of the final annular body in particular by molding, machining from a puck or blank as used for the manufacture of intraocular lenses.
  • the initial annular body is made of flexible material and then the hardness or rigidity of the zones corresponding to the desired segments is obtained by the selective chemical structural modification of the corresponding parts of the initial annular body.
  • the flexible material of the annular coips that is to say the junction (s) and the first end, are preferably obtained from random methyl methacrylate-methacrylate and hydroxyethylmethacrylate (MMA-HEMA) copolymers crosslinked by addition of a multifunctional agent such as diethylene glycol dimethacrylate.
  • the rigid material of the lens is preferably based on PMMA.
  • the initial annular body is made of rigid material and then the zones corresponding to the desired junctions are obtained by selective chemical structural modification. In both cases, there will be covalent bonds between the flexible material and the rigid material of the annular body. Thanks to this manufacturing process, the structural integrity of the ring is also much higher than what could be obtained by conventional methods.
  • the flexible material constituting the junction (s) may have a glass transition temperature of approximately 35 ° C., so that the ring has a folded configuration facilitating its insertion through the incision and the rhexis and another specific configuration deployed corresponding to that of the ring implanted in the capsular bag.
  • the flexible material can be a shape memory material.
  • the first segment 18 A is pushed around the equatorial zone until the junction 19 reaches the rhexis and then the second segment 18B is folded inside the capsular bag in an oblique plane or transverse to the general plane of the first segment 18 A before being released, thus allowing the relatively short second segment 18B to find its place in the equatorial zone and this without risk of damage to the bag or tearing of the zonules thanks to the extent reduction of the second segment and the damping effect of the flexible material junction which reduces the impact of the segment with the tissue of the capsular bag.
  • the diameter of the capsular ring is chosen so that it is slightly in compression against the equatorial zone of the capsular bag at the time of its implantation. This compression would have the effect of closing the capsular ring by bringing its ends closer together, the first end 13 passing outside the second end 14 thus forming a very slight recess at the level of the covering of the ends 13, 14, as shown in Figure 5.
  • the resulting discontinuity is minimized thanks to the small thickness and the inherent flexibility of the first end 13 which tends to collapse radially between the end 14 and the capsular tissue at the equator.
  • the capsular bag tends to shrink, of the order of 0.5 mm to 1.5 mm in diameter, which has the effect of increasing the length of covering.
  • Such a capsular ring can also be implanted by an injector of the type known per se.
  • an injector has a substantially rectilinear or even curved housing with a very large radius relative to that of the capsular ring. Thanks to junction 19, the stresses induced by the substantially rectilinear or slightly curved deployment of the ring are greatly reduced, thus minimizing the risk of cracking and in particular when the capsular ring is loaded in the injector and delivered in sterile packaging intended to be opened at the time of use, that is to say months after their packaging.
  • an intraocular lens 31 of the type described in patent FR-A-2,745,711 with three haptic elements 32 with large window extending from the periphery of the optics 31 forms an assembly with the capsular ring according to the first embodiment.
  • the ring is therefore also advantageously used for centering and positioning the intraocular lens in the capsular bag.
  • the axial width of the interior surface of about 0.5 mm according to the preferred embodiment, constitutes a good support for the haptic elements of the intraocular implant.
  • the anterior and posterior sheets or capsules come together. Since the axial width of the capsular ring is preferably limited to about 0.5 mm, i.e. between 0.45 and 0.55 mm, it does not prevent the symphysis of the capsules and more particularly at the periphery of the optical part of the intraocular lens. As shown in FIG. 5, the optical part 33 of the intraocular lens 31 has, on the posterior surface, at least one sharp edge or square edge 34 which penetrates slightly into a fold of the tissue of the posterior capsule thus forming a second barrier to the migration of epithelial cells, or Elschnig beads, thus preventing clouding of the posterior capsule behind the optic element and the formation of a secondary cataract.
  • the capsular ring according to the embodiment of Figure 6 differs from the embodiment of Figures 1 to 5 only by the presence of three junctions.
  • the annular body has a junction 19B arranged diametrically opposite the ends 13, 14 of the open annular body, two other junctions, 19 A, 19C being located at approximately 120 ° from the junction 19B.
  • the plurality of junctions are regularly spaced around the circumference of the open ring.
  • the junctions 19A and 19C are therefore at about 60 ° from the respective ends 13, 14.
  • the main part and the junctions made of flexible material have the same radial section.
  • the two relatively short segments 24A, 25A are first folded preferably inwards (but possibly outwards) of the two relatively long segments 24B, 25B and the segments are brought closer or pivoted around junction 19B.
  • the short segments 24A, 25 A can simply be brought towards each other but, preferably, a pair of segments 25A, 25B are slightly offset (in the axial direction) behind the other pair of segments 24A, 24B in order to minimize the size of the segments 24A and 24B being more in line with the segments 25B, 25A (not shown) and this thanks to the flexibility of the central junction 19B.
  • the four segments are therefore introduced simultaneously through the incision and then they enter the capsular bag through the rhexis. It is then that the two short segments 24A, 25A are preferably released first, successively or simultaneously, then the two long segments 24B, 25B folded around the junction 19B are released. Thanks to a plurality of junctions, the surgeon has different manipulations and possible sequences for the introduction and deployment of the segments in the capsular bag. In addition, there remains the possibility of introduction by means of an injector.
  • the capsular ring 10 has a closed contour. To this end, it preferably comprises two junctions 19 made of flexible material diametrically opposite.
  • the configuration of the segments 18A, 18B, in rigid material as well as the junctions 19 in flexible material is that described with reference to FIGS. 1 to 5, except as regards the extent of the segments and the removal of the ends.
  • Such a ring has the advantage of maintaining its diameter despite the retraction of the capsular bag on the one hand and on the other hand, thanks to its sharp edges or square edges along the segments of rigid material, it provides an excellent barrier to the cell migration, given the perfect continuity of the two sharp edges around the entire circumference of the ring.
  • Such a ring with closed contour can however be introduced by an incision of relatively small size, of the order of 3.5 mm, although necessarily larger than that necessary for the introduction of a capsular ring with open contour which is of 'order of 2.5 mm, thanks to the two junctions 19 made of flexible material which allow the ovalization or flattening of the ring with a major axis passing through the clamped junctions between the jaws of a clamp.
  • the ovalized or flattened ring is introduced into the capsular bag by one of these junctions, passing through the cormian or sclerocorneal incision and then through the rhexis, continuing to push on the other junction, the part of the ring present in the bag will open and come to conform to the shape of the equator. It is then necessary to push further on the rear junction so as to make it enter the circle of the rhexis before releasing it so that it takes its place in the capsular bag.
  • the junctions act as a shock absorber to absorb part of the energy released when the ring is released into the capsular bag.
  • the implantation of the ring is followed by the implantation of the intraocular lens, in accordance with current practice with forceps or injector.
  • the haptic elements of the intraocular lens are in contact or bear against the interior annular surface of the current part of the ring, that is to say offset with respect to the junctions and the parts of the segments adjoining them.
  • an optic 40 made of flexible material is formed in one piece with the capsular ring 10. In the rest position of this capsular ring / intraocular lens assembly, the optic is slightly off center with respect to the axis of the capsular ring. ;
  • the link 45 comprises a first straight haptic part 46 extending at an oblique angle, preferably neither radial nor tangential, from the periphery of the optics 40 followed by a second haptic part 47 curved with a recess 48 open circumferentially towards the second end of the ring before joining the inner edge of the first end 13 of the ring 10.
  • the recess 48 of complementary shape is capable of receiving the second end of the eyelet tab when the two ends come together, following the postoperative capsular retraction. He goes . It goes without saying that such an assembly can also be produced by selective chemical modification.
  • this capsular and optical ring assembly is also made easy by the junction 19 between the segments 18 A, 18B.
  • This implantation begins with the introduction of the ring, not by its first end 13 but by its second end 14 and once the capsular ring is largely in place in the equatorial zone, the folded optics and the haptic part are released, allowing the optics to find its place and kept centered relative to the capsular ring implanted in the equatorial zone, and therefore, centered relative to the capsular bag.
  • the capsular ring can be impregnated beforehand with an anti-proliferation product and in particular 5-FU.
  • the impregnation and release process after implantation of the ring is preferably in accordance with the teachings of patent application WO 98/25652.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention concerns a capsular tension ring implantable in the equatorial region of a capsular bag after cataract ablation comprising an open or closed annular body and including sharp edges and an axial width ranging between about 0.3 and 0.6 mm, or preferably about 0.5 mm. The annular body of the capsular tension ring, including the sharp edges, is made of a rigid material for the major part of the circumference, and comprises at least one joint made of flexible material between two segments of the annular body made of rigid material. The invention also concerns an assembly comprising a capsular tension ring and an intraocular implant of the type including a central optical part and a peripheral haptic part comprising one or several haptic elements extending radially from the optical part, the optical part having a peripheral edge with a sharp ridge on its rear surface. Such an implantable capsular tension ring is prepared by chemical modification either of the segments of the annular body made of rigid material, from a flexible material, or the joints made of rigid material from a flexible material.

Description

Anneau capsulaire, procédé de fabrication d'un anneau capsulaire et ensemble anneau capsulaire et lentille intraoculaire Capsular ring, method of manufacturing a capsular ring and assembly of the capsular ring and intraocular lens
La présente invention concerne les anneaux capsulaires qui sont destinés à être implantés dans le sac capsulaire, après l'ablation du cristallin atteint de cataracte, en association avec une lentille intraoculaire destinée à remplacer le cristallin.The present invention relates to capsular rings which are intended to be implanted in the capsular bag, after the removal of the lens affected by cataracts, in association with an intraocular lens intended to replace the lens.
De tels anneaux appelés "anneaux de tension" ont été adoptés pour maintenir la forme du sac capsulaire et pour limiter la rétraction post-opératoire de celui-ci.Such rings called "tension rings" have been adopted to maintain the shape of the capsular bag and to limit the post-operative retraction thereof.
Plus récemment, des anneaux capsulaires ont été réalisés pour lutter contre l'opacification de la capsule postérieure du sac capsulaire qui est à l'origine de la cataracte secondaire rendant la capsule postérieure opaque et nécessitant l'ouverture de celle-ci par faisceau laser YAG pour restaurer l'acuité visuelle.More recently, capsular rings have been made to combat opacification of the posterior capsule of the capsular bag which is at the origin of the secondary cataract making the posterior capsule opaque and necessitating the opening thereof by YAG laser beam. to restore visual acuity.
L'opacification de la capsule postérieure présente deux aspects : il y a d'abord les fibroses correspondant à une métaplasie in situ des cellules épithéliales antérieures. C'est une complication qui peut atteindre 40 % des cas d'ablation de la cataracte avec remplacement du cristallin. Il s'avère que les fibroses retentissent peu sur l'acuité visuelle. Il y a en outre les perles d'Elschnig qui se forment à partir des cellules germinatives subsistant à l'équateur du sac capsulaire après l'intervention chirurgicale. Ces cellules migrent le long de la capsule postérieure et forment des perles opaques qui sont la principale cause de la baisse d'acuité visuelle liée à l'opacification de la capsule postérieure.Opacification of the posterior capsule has two aspects: first there are the fibroses corresponding to an in situ metaplasia of the anterior epithelial cells. It is a complication that can reach 40% of cases of cataract removal with replacement of the lens. It turns out that fibrosis has little effect on visual acuity. There are also Elschnig pearls that form from germ cells remaining at the equator of the capsular bag after surgery. These cells migrate along the posterior capsule and form opaque pearls which are the main cause of the decrease in visual acuity linked to the opacification of the posterior capsule.
Les anneaux de tension sont normalement inefficaces pour constituer une barrière à la migration cellulaire du fait qu'ils sont souvent dépourvus d'arêtes vives ou de bords carrés et/ou de dimensions axiales ou antéro-postérieures trop petites permettant l'insertion des fibres zonulaires sur la capsule maintenant ainsi une zone équatoriale germinative ouverte.Tension rings are normally ineffective in constituting a barrier to cell migration because they are often devoid of sharp edges or square edges and / or of too small axial or anteroposterior dimensions allowing the insertion of zonular fibers. on the capsule thus maintaining an open germinal equatorial zone.
On connaît également des anneaux capsulaires anti-opacification. La grande majorité des anneaux capsulaires anti-opacification proposés sur le marché sont réalisés en polymethylméthacrylate (PMMA) qui est un matériau rigide et dur permettant d'obtenir des arêtes vives, ou bords carrés, efficaces comme barrière à la migration cellulaire. La manipulation de tels anneaux par le chirurgien pose un sérieux problème en raison de leur très grande rigidité et de leur forte élasticité qui les rend dangereux lors de l'introduction et du déploiement dans le sac capsulaire. En effet, lorsqu'une pince est utilisée, après le passage par une incision cornéenne ou scléro-cornéenne, une première extrémité est introduite par le rhéxis dans le sac capsulaire sur environ 270°, ensuite la partie restante est rabattue à l'intérieur du rhexis avant d'être relâchée. "Anti-opacification capsular rings are also known. The vast majority of anti-clouding capsular rings offered on the market are made of polymethylmethacrylate (PMMA) which is a rigid and hard material allowing to obtain sharp edges, or square edges, effective as a barrier to cell migration. The handling of such rings by the surgeon poses a serious problem because of their very high rigidity and their high elasticity which makes them dangerous during introduction and deployment in the capsular bag. Indeed, when a clamp is used, after passing through a corneal or sclerocorneal incision, a first end is introduced by the rhexis into the capsular bag over approximately 270 °, then the remaining part is folded back inside the rhexis before being released. "
Lorsqu'un injecteur est utilisé, l'anneau est positionné dans un tube et déplacé au moyen d'un crochet coulisssant passant par le trou de l'œillet situé à l'une et/ou l'autre extrémité de l'anneau.When an injector is used, the ring is positioned in a tube and moved by means of a sliding hook passing through the hole of the eyelet located at one and / or the other end of the ring.
Dans les deux cas, le brin de l'anneau en matériau rigide, tel que du PMMA, après relâchement, peut frapper violemment la zone équatoriale du sac capsulaire avec un risque de lésions du sac ou déchirures des zonules attachées à l'extérieur du sac capsulaire à l'équateur.In both cases, the strand of the ring of rigid material, such as PMMA, after loosening, can violently strike the equatorial zone of the capsular bag with a risk of damage to the bag or tears of the zonules attached to the outside of the bag capsular at the equator.
En outre, de tels anneaux capsulaires doivent nécessairement être du type ouvert. En effet, configurés en anneaux fermés, l'incision cornéenne ou scléro-cornéenne serait beaucoup trop importante pour permettre une cicatrisation rapide attendue par les chirurgiens et leurs patients.In addition, such capsular rings must necessarily be of the open type. Indeed, configured in closed rings, the corneal or sclerocorneal incision would be far too large to allow rapid healing expected by surgeons and their patients.
Hara et coll. dans "Efficacy of Equator Rings in an Expérimental Rabbit Study", Arch. Ophthalmol, v. 113, août 1995, pp. 1060-1065, ont proposé un anneau d'anti- opacifïcation à contour fermé réalisé en matière souple, notamment en silicone, avec des bords carrés destinés à constituer une barrière à la migration cellulaire. Cet anneau permet l'introduction dans l'œil à travers une incision relativement petite de l'ordre de 4,5 mm.Hara et al. in "Efficacy of Equator Rings in an Experimental Rabbit Study", Arch. Ophthalmol, c. 113, August 1995, pp. 1060-1065, proposed an anti-opacification ring with a closed contour made of flexible material, in particular silicone, with square edges intended to constitute a barrier to cell migration. This ring allows introduction into the eye through a relatively small incision of the order of 4.5 mm.
La rigidité réduite des matériaux souples connus empêche de les utiliser pour la fabrication d'anneaux capsulaires à contour ouvert. En outre, les bords carrés d'un anneau en matière souple ne constituent pas une barrière à la migration aussi efficace que les bords carrés d'un anneau en matériau rigide, justement à cause de la souplesse du matériau qui laisse passer les cellules épithéliales.The reduced rigidity of known flexible materials prevents them from being used for the manufacture of capsular rings with open contours. In addition, the square edges of a ring made of flexible material do not constitute a barrier to migration as effective as the square edges of a ring made of rigid material, precisely because of the flexibility of the material which lets the epithelial cells pass.
EP-A- 0.884.031 décrit un anneau capsulaire ouvert en forme générale de C avec des arêtes vives pour produire un effet de "coin" lors de la rétraction du sac capsulaire, ce qui permet de bloquer la migration des cellules épithéliales. Les anneaux capsulaires décrits dans ce document ont une largeur axiale ou antéro-postérieure importante de 0,7 mm et une largeur de 0,2 mm pour couvrir toute la largeur de la zone équatoriale du sac capsulaire, à partir de laquelle les cellules se propagent. Or, un tel anneau capsulaire de largeur axiale importante s'oppose à la fibrose et empêche l'accolement ou symphyse capsulaire indispensable pour stopper la migration des cellules épithéliales, voire des perles d'Elschnig, sur la capsule postérieure à l'intérieur de la zone correspondant à la périphérie de l'optique de la lentille intraoculaire implantée en remplacement du cristallin. La symphyse est également avantageuse en ce qu'elle permet une stabilisation de la lentille intraoculaire positionnée dans le sac.EP-A- 0.884.031 describes an open capsular ring in general C shape with sharp edges to produce a "wedge" effect during the retraction of the capsular bag, which makes it possible to block the migration of epithelial cells. The capsular rings described in this document have a substantial axial or anteroposterior width of 0.7 mm and a width of 0.2 mm to cover the entire width of the equatorial zone of the capsular bag, from which the cells propagate. . However, such a capsular ring of large axial width opposes fibrosis and prevents the capsular joining or symphysis essential to stop the migration of epithelial cells, or even Elschnig pearls, on the posterior capsule inside the zone corresponding to the periphery of the optics of the intraocular lens implanted to replace the lens. The symphysis is also advantageous in that it allows stabilization of the intraocular lens positioned in the bag.
11 s'avère, en outre, que des cellules germinatives sont inévitablement présentes à l'intérieur de l'anneau capsulaire, suite à un nettoyage capsulaire incomplet en raison du myosis. Ces cellules passent facilement derrière l'optique, même si elle est munie d'une arrête postérieure vive censée constituer une barrière à cette migration. En effet, cette arrête ou bord carré n'est efficace, à défaut de symphyse capsulaire, que s'il y a contact intime avec la capsule postérieure.It turns out, moreover, that germ cells are inevitably present inside the capsular ring, following an incomplete capsular cleaning due to miosis. These cells pass easily behind the optics, even if it has a sharp posterior stop supposed to constitute a barrier to this migration. Indeed, this stop or square edge is effective, in the absence of capsular symphysis, only if there is intimate contact with the posterior capsule.
Par ailleurs, il n'existe à l'heure actuelle aucun anneau capsulaire anti-opacification en matériau rigide réalisé d'une seule pièce avec une optique destinée à remplacer le cristallin excisé qui peut être introduit et implanté dans des conditions acceptables.Furthermore, there is currently no anti-opacification capsular ring made of rigid material made in one piece with an optic intended to replace the excised lens which can be introduced and implanted under acceptable conditions.
L'objet de l'invention est un anneau capsulaire qui assure une barrière à la migration cellulaire équatoriale vers la capsule postérieure qui est apte à pallier les inconvénients des anneaux capsulaires anti-opacification connus.The object of the invention is a capsular ring which provides a barrier to equatorial cell migration to the posterior capsule which is capable of overcoming the drawbacks of known anti-clouding capsular rings.
Selon un premier aspect de l'invention, il est prévu un anneau capsulaire, implantable dans la région équatoriale d'un sac capsulaire après ablation de la cataracte, comprenant un corps annulaire ouvert ou fermé, le corps annulaire ayant une arête vive sur la grande majorité de la circonférence et une largeur axiale comprise entre environ 0,3 et 0,6 mm, et de préférence environ 0,5 mm, caractérisé en ce que le corps annulaire, y compris les arêtes vives, est réalisé en matériau rigide sur la majorité de la circonférence, et en ce que le corps annulaire comporte au moins une jonction en matériau souple entre deux segments du corps annulaire en matériau rigide.According to a first aspect of the invention, a capsular ring is provided, implantable in the equatorial region of a capsular bag after removal of the cataract, comprising an open or closed annular body, the annular body having a sharp edge on the large majority of the circumference and an axial width of between approximately 0.3 and 0.6 mm, and preferably approximately 0.5 mm, characterized in that the annular body, including the sharp edges, is made of rigid material on the majority of the circumference, and in that the annular body comprises at least one junction of flexible material between two segments of the annular body of rigid material.
La (ou les) jonction(s) en matériau souple constitue(nt) une zone de pliage préférentielle. Selon la méthode d'insertion classique d'un anneau capsulaire ouvert avec une pince, on introduit une première extrémité, dite extrémité avant, de l'anneau et on pousse l'anneau en le faisant tourner dans le sac jusqu'à l'introduction des trois quarts environ du corps annulaire. Le corps annulaire est divisé par la (ou les) jonction(s) en matière souple en deux ou plusieurs segments rigides permettant un geste plus facile à contrôler en évitant des mouvements de grande amplitude susceptibles de produire des lésions. En pratique, les arêtes vives des segments s'étendent au moins sur environ 90 % de la circonférence du corps annulaire.The junction (s) made of flexible material constitutes a preferential folding zone. According to the conventional method of insertion of an open capsular ring with pliers, a first end, called the front end, of the ring is introduced and the ring is pushed by rotating it in the bag until introduction about three-quarters of the annular body. The annular body is divided by the junction (s) of flexible material into two or more rigid segments allowing an easier gesture to control by avoiding large amplitude movements liable to produce lesions. In practice, the sharp edges of the segments extend over at least about 90% of the circumference of the annular body.
Lorsqu'un tel anneau capsulaire à contour ouvert est plus facile à introduire dans le sac capsulaire à l'aide d'un injecteur, ces jonctions en matériau souple apportant une flexibilité accrue pour permettre à l'anneau de mieux s'adapter à la configuration du tube, typiquement rectiligne, ou avec un très grand rayon de courbure par rapport au rayon de l'anneau capsulaire, sans risques de fêlure du corps annulaire, chacun des segments en matériau rigide de l'implant étant relativement faiblement sollicité.When such an open-contoured capsular ring is easier to introduce into the capsular bag using an injector, these junctions made of flexible material providing increased flexibility to allow the ring to better adapt to the configuration of the tube, typically rectilinear, or with a very large radius of curvature with respect to the radius of the capsular ring, without risk of cracking of the annular body, each of the segments of rigid material of the implant being relatively weakly stressed.
De préférence, la première extrémité, ou extrémité avant, de l'anneau capsulaire à contour ouvert, c'est-à-dire celle par laquelle on va insérer l'anneau, comprend une partie terminale, sans œillet, en matériau souple et légèrement rentrante qui réduit, voire élimine, le risque de perforer le sac. Lors de la rétraction post-opératoire du sac capsulaire, dont les forces sont amorties par la déformation de l'anneau, c'est l'autre, ou seconde, extrémité, ou extrémité arrière qui est de préférence munie d'une patte à œillet pour la manipulation de l'anneau in situ, qui peut passer à l'intérieur de cette partie terminale en matériau souple, réduisant au minimum la discontinuité circonférentielle.Preferably, the first end, or front end, of the capsular ring with an open contour, that is to say the one by which the ring is to be inserted, comprises a terminal part, without eyelet, of flexible material and slightly re-entering which reduces, even eliminates, the risk of perforating the bag During the post-operative retraction of the capsular bag, the forces of which are absorbed by the deformation of the ring, it is the other, or second, end, or rear end which is preferably provided with an eyelet tab. for handling the ring in situ, which can pass inside this terminal part of flexible material, minimizing the circumferential discontinuity.
Lorsqu'une seule jonction est prévue, elle est de préférence disposée à environ 300° de l'extrémité avant.When a single junction is provided, it is preferably arranged about 300 ° from the front end.
Selon une autre forme de réalisation, trois jonctions sont prévues, disposées à environ 120° les unes des autres.According to another embodiment, three junctions are provided, arranged at approximately 120 ° from each other.
Un tel anneau est particulièrement destiné à des implants dont l'optique à un bord périphérique carré, c'est-à-dire avec au moins une arête vive et deux ou plusieurs éléments haptiques aptes à s'appuyer sur la partie courante des segments rigides de l'anneau capsulaire, assurant à la fois une bonne stabilité et un bon centrage. Quant à la périphérie de la partie optique, elle assure une deuxième barrière efficace contre la migration cellulaire grâce à la symphyse des capsules antérieure et postérieure, et ce malgré une largeur axiale de l'anneau capsulaire suffisante pour bloquer la prolifération des cellules épithéliales dans la zone équatoriale.Such a ring is particularly intended for implants whose optics with a square peripheral edge, that is to say with at least one sharp edge and two or more haptic elements capable of bearing on the current part of the rigid segments of the capsular ring, ensuring both good stability and good centering. As for the periphery of the optical part, it provides a second effective barrier against cell migration thanks to the symphysis of the anterior and posterior capsules, and this despite an axial width of the capsular ring sufficient to block the proliferation of epithelial cells in the equatorial zone.
Pour un anneau capsulaire fermé, de préférence deux jonctions en matériau souple sont prévues qui permettent une ovalisation, ou aplatissement, marquée de l'implant et donc l'introduction de l'anneau ovalisé, ou aplati, à travers une incision cornéenne ou scléro-cornéenne bien plus petite que ce qui peut être fait avec un anneau à contour fermé en matériau rigide. Un tel anneau capsulaire avec la grande majorité de ses arêtes vives en matériau rigide ou dur est plus efficace comme barrière à la migration cellulaire qu'un anneau capsulaire à contour fermé en matériau souple.For a closed capsular ring, preferably two junctions made of flexible material are provided which allow a marked ovalization, or flattening, of the implant and therefore the introduction of the ovalized, or flattened, ring through a corneal incision or sclero-cornea much smaller than what can be done with a closed contour ring made of rigid material. Such a capsular ring with the vast majority of its sharp edges made of rigid or hard material is more effective as a barrier to cell migration than a capsular ring with closed outline made of flexible material.
Etant donné qu'en pratique les jonctions en matériau souple sont de petites dimensions, environ 0,4 à 0,5 mm, les procédés de fabrication classiques par assemblage, collage, fusion ou surmoulage des segments en matériau rigide et' des jonctions en matériau souple, seraient difficiles, voire impossibles à mettre en œuvre: C'est la raison pour laquelle une fabrication par modification sélective chimique des segments en matériau rigide à partir d'un corps annulaire initialement entièrement en matériau souple ou les jonctions d'un corps annulaire initialement entièrement en matériau rigide, selon la technologie décrite dans la demande EP- 1003446 est pour le moins très avantageuse. Il va de soi que, dans l'éventualité d'une extrémité en matériau souple, celle-ci sera obtenue de la même manière que les jonctions.Since in practice the flexible material junctions are small, about 0.4 to 0.5 mm, conventional manufacturing methods by assembling, gluing, melting or overmolding of the segments of rigid material and of the junctions of material flexible, would be difficult, even impossible to implement: This is the reason why a manufacture by selective chemical modification of the segments of rigid material from an annular body initially entirely of flexible material or the junctions of an annular body initially entirely of rigid material, according to the technology described in application EP-1003446 is at the very least advantageous. It goes without saying that, in the event of an end made of flexible material, this will be obtained in the same way as the junctions.
L'invention et ses avantages seront mieux compris à la lumière de la description suivante des modes de réalisation préférés d'un anneau capsulaire conforme à son principe, données à titre d'exemple et faite en référence aux dessins annexés dans lesquels :The invention and its advantages will be better understood in the light of the following description of the preferred embodiments of a capsular ring in accordance with its principle, given by way of example and made with reference to the appended drawings in which:
- la figure 1 représente une première forme de réalisation d'un anneau capsulaire, selon l'invention, à contour ouvert ;- Figure 1 shows a first embodiment of a capsular ring, according to the invention, with open outline;
- les figures 2 et 3 sont des coupes prises suivant des lignes II-II et III-III de la figure 1 ;- Figures 2 and 3 are sections taken along lines II-II and III-III of Figure 1;
- la figure 4 est une vue en élévation de l'anneau capsulaire des figures 1 à 3 ;- Figure 4 is an elevational view of the capsular ring of Figures 1 to 3;
- la figure 5 représente la première forme de réalisation implantée dans le sac capsulaire après rétraction du sac et symphyse des capsules antérieure et postérieure ;- Figure 5 shows the first embodiment implanted in the capsular bag after retraction of the bag and symphysis of the anterior and posterior capsules;
- la figure 6 représente une deuxième forme de réalisation d'un anneau capsulaire selon l'invention, à contour ouvert ;- Figure 6 shows a second embodiment of a capsular ring according to the invention, with open outline;
- la figure 7 représente un mode de pliage selon la première forme de réalisation ;- Figure 7 shows a folding mode according to the first embodiment;
- la figure 8 représente une troisième forme de réalisation d'un anneau capsulaire, selon l'invention, à contour fermé ; et- Figure 8 shows a third embodiment of a capsular ring, according to the invention, with closed contour; and
- la figure 9 représente un ensemble de l'anneau capsulaire à contour ouvert d'une seule pièce avec une lentille intraoculaire. L'anneau capsulaire 10 représenté sur les figures 1 à 5 comprend un corps annulaire l i a contour ouvert, sensiblement circulaire. Le diamètre de l'anneau à l'état de repos sera plus grand que celui du sac capsulaire dans lequel il est destiné à être implanté et en pratique d'environ 10.5 à 11,5 mm. La partie courante du corps annulaire l i a une première extrémité 13, une seconde extrémité 14. A l'état de repos, les extrémités sont espacées circonférentiellement l'une de l'autre d'environ 0,5 mm. Le corps annulaire a une section radiale sensiblement rectangulaire dont la dimension axiale est d'environ 0,5mm, et qui est plus grande que la dimension radiale qui est entre 0,1 et 0,3 mm et de préférence d'environ 0,15 mm (voir figure 3). La surface extérieure 15 du corps annulaire est de préférence sensiblement un cylindre droit s'étendant entre deux arêtes vives ou bords carrés 16 et 17.- Figure 9 shows a set of the capsular ring open contour in one piece with an intraocular lens. The capsular ring 10 shown in Figures 1 to 5 comprises an annular body 11a open contour, substantially circular. The diameter of the ring in the state of rest will be greater than that of the capsular bag in which it is intended to be implanted and in practice of approximately 10.5 to 11.5 mm. The running part of the annular body links a first end 13, a second end 14. In the state of rest, the ends are spaced circumferentially from one another by about 0.5 mm. The annular body has a substantially rectangular radial section whose axial dimension is approximately 0.5mm, and which is greater than the radial dimension which is between 0.1 and 0.3 mm and preferably approximately 0.15 mm (see Figure 3). The external surface 15 of the annular body is preferably substantially a straight cylinder extending between two sharp edges or square edges 16 and 17.
La première extrémité 13 qui, en pratique, est l'extrémité avant par laquelle l'anneau capsulaire est introduit dans le sac capsulaire à travers une incision scléro- cornéeene et le rhexis dans la capsule antérieure, est réalisée en matériau souple, de sorte qu'en cas de contact de son bord libre avec les tissus du sac capsulaire, le risque de perforation accidentelle est réduit. En outre, sa souplesse facilitera son passage sur la zone équatoriale du sac capsulaire lorsque l'anneau est poussé progressivement circonférentiellement le long de la zone équatoriale du sac capsulaire. Cette première extrémité est légèrement courbe et rentrante avec le bord libre arrondi plus épais que la partie courante du corps de l'anneau. Grâce à cette configuration de la première extrémité en matière souple, il n'y a pas non plus de risque d'accrochage, ni de perforation, lorsque l'anneau est introduit progressivement dans le sac capsulaire, ni de risque de perforation accidentelle du tissu capsulaire au moment du relâchement de l'un ou l'autre segment ou en tournant l'anneau lorsqu'il est introduit progressivement dans le sac capsulaire.The first end 13 which, in practice, is the front end by which the capsular ring is introduced into the capsular bag through a sclerocorneal incision and the rhexis in the anterior capsule, is made of flexible material, so that '' in case of contact of its free edge with the tissues of the capsular bag, the risk of accidental perforation is reduced. In addition, its flexibility will facilitate its passage over the equatorial zone of the capsular bag when the ring is gradually pushed circumferentially along the equatorial zone of the capsular bag. This first end is slightly curved and re-entrant with the rounded free edge thicker than the current part of the body of the ring. Thanks to this configuration of the first end made of flexible material, there is also no risk of snagging, nor of perforation, when the ring is gradually introduced into the capsular bag, nor of risk of accidental perforation of the tissue. capsular when one or the other segment is released or by turning the ring when it is gradually introduced into the capsular bag.
La seconde extrémité 14 comprend une patte à œillet du type connu en soi décalée vers l'intérieur et apte à recevoir le crochet d'un instrument de manipulation permettant de modifier la position de l'anneau dans le sac capsulaire ou pour l'accrochage à une tige d'injecteur d'anneau capsulaire, également connu en soi.The second end 14 comprises an eyelet tab of the type known per se offset inwards and capable of receiving the hook of a handling instrument making it possible to modify the position of the ring in the capsular bag or for hooking it to a capsular ring injector rod, also known per se.
Le corps annulaire 11 est en grande majorité constitué d'un matériau rigide ou dur, à faible taux d'hydrophilie ou hydrophobe, et notamment le PMMA. Dans cette forme de réalisation, le corps annulaire 11. comprend deux segments annulaires 18A, 18B, le premier segment annulaire 18A ayant de préférence une étendue circonférentielle supérieure à environ 260° et inférieure à environ 320° et de préférence d'environ 300° et le second segment annulaire 18B ayant une étendue circonférencielle d'environ 55°.The annular body 11 is largely made of a rigid or hard material, with a low hydrophilicity or hydrophobic rate, and in particular PMMA. In this embodiment, the annular body 11. comprises two annular segments 18A, 18B, the first annular segment 18A preferably having a circumferential extent greater than about 260 ° and less than about 320 ° and preferably about 300 ° and the second annular segment 18B having a circumferential extent of about 55 °.
Une jonction ou bloc 19 en matériau souple, telle que l'acrylique hydrophobe ou hydrophile, du type utilisé pour les implants intraoculaires notamment, est localisée entre les deux segments 18A et 18B. La jonction ou bloc 19 a une section rectangulaire, de préférence carrée, avec une surface extérieure ayant sensiblement de préférence la forme d'un cylindre droit s'étendant entre deux arêtes vives ou bords carrés en continuité avec les arêtes vives annulaires 16, 17 des segments. La section sensiblement carrée de la jonction 19 est plus grande que celle de la partie courante des segments annulaires, et donc du corps annulaire, et a une dimension axiale d'environ 0,4 à 0,5 mm et une dimension radiale d'environ 0,4 à 0,5 mm, les parties des segments 18A, 18B jouxtant la jonction ayant la même section transversale que cette dernière L'étendue circonférentielle de chacune des jonctions sera comprise entre 0,5 et 6 % de la circonférence de l'anneau. Pour des raisons de fabrication et de résistance mécanique, les bords opposés des parties jouxtant la jonction sont convergents radialement vers l'intérieur du corps annulaire. En tout cas, la surface extérieure du corps annulaire a de préfence sensiblement la forme d'un cylindre droit d'une extrémité à l'autre, que ce soit la (ou les) jonction(s) en matériau souple ou les segments en matériau rigide, y compris les parties jouxtant les jonctions.A junction or block 19 of flexible material, such as hydrophobic or hydrophilic acrylic, of the type used for intraocular implants in particular, is located between the two segments 18A and 18B. The junction or block 19 has a rectangular section, preferably square, with an outer surface having substantially preferably the shape of a straight cylinder extending between two sharp edges or square edges in continuity with the sharp annular edges 16, 17 of the segments. The substantially square section of the junction 19 is larger than that of the current part of the annular segments, and therefore of the annular body, and has an axial dimension of approximately 0.4 to 0.5 mm and a radial dimension of approximately 0.4 to 0.5 mm, the parts of the segments 18A, 18B adjoining the junction having the same cross section as the latter The circumferential extent of each of the junctions will be between 0.5 and 6% of the circumference of the ring. For manufacturing and mechanical strength reasons, the opposite edges of the parts adjoining the junction converge radially towards the inside of the annular body. In any case, the outer surface of the annular body preferably preferably has the shape of a straight cylinder from one end to the other, whether it is the junction (s) of flexible material or the segments of material rigid, including the parts adjoining the junctions.
L'anneau capsulaire selon cette forme de réalisation, ainsi que toutes les formes de réalisation qui seront décrites, est en pratique fabriqué par modification structurelle sélective chimique, selon le procédé décrit dans EP 1003446 à partir d'un corps annulaire dont la géométrie correspond à celle du corps annulaire définitif notamment par moulage, usinage à partir d'un palet ou flan tel que mis en œuvre pour la fabrication des lentilles intraoculaires. De préférence, le corps annulaire initial est réalisé en matériau souple et ensuite la dureté ou rigidité des zones correspondant aux segments désirés est obtenue par la modification structurelle sélective chimique des parties correspondantes du corps annulaire initial. Le matériau souple du coips annulaire, c'est-à-dire la (ou les) jonction(s) et la première extrémité sont de préférence obtenues à partir des copolymères statistiques méthacrylate de méthyle-méthacrylate et hydroxyéthylméthacrylate (MMA-HEMA) réticulés par ajout d'un agent multifonctionnel tel que le diméthacrylate de diéthylèneglycol. Le matériau rigide de la lentille est de préférence à base de PMMA. Alternativement, le corps annulaire initial est réalisé en matériau rigide et ensuite les zones correspondant aux jonctions désirées sont obtenues par modification structurelle sélective chimique. Dans les deux cas, il y aura des liaisons covalentes entre le matériau souple et le matériau rigide du corps annulaire. Grâce à ce procédé de fabrication, l'intégrité structurelle de l'anneau est également très supérieure à ce qui pourrait être obtenu par des procédés classiques. De ce fait, il est possible de plier les segments 18A, 18B en matériau rigide autour de la jonction 19, tant dans le plan général du corps annulaire, que dans un plan oblique ou transversal par rapport au plan général du corps annulaire, pour l'introduction de l'anneau capsulaire, sans risque de fêlures ou de désolidarisation entre les jonctions en matériau souple et les segments en matériaux durs ou rigides.The capsular ring according to this embodiment, as well as all the embodiments which will be described, is in practice made by selective chemical structural modification, according to the process described in EP 1003446 from an annular body whose geometry corresponds to that of the final annular body in particular by molding, machining from a puck or blank as used for the manufacture of intraocular lenses. Preferably, the initial annular body is made of flexible material and then the hardness or rigidity of the zones corresponding to the desired segments is obtained by the selective chemical structural modification of the corresponding parts of the initial annular body. The flexible material of the annular coips, that is to say the junction (s) and the first end, are preferably obtained from random methyl methacrylate-methacrylate and hydroxyethylmethacrylate (MMA-HEMA) copolymers crosslinked by addition of a multifunctional agent such as diethylene glycol dimethacrylate. The rigid material of the lens is preferably based on PMMA. Alternatively, the initial annular body is made of rigid material and then the zones corresponding to the desired junctions are obtained by selective chemical structural modification. In both cases, there will be covalent bonds between the flexible material and the rigid material of the annular body. Thanks to this manufacturing process, the structural integrity of the ring is also much higher than what could be obtained by conventional methods. Therefore, it is possible to bend the segments 18A, 18B of rigid material around the junction 19, both in the general plane of the annular body, and in an oblique or transverse plane relative to the general plane of the annular body, for the 'introduction of the capsular ring, without risk of cracks or separation between the junctions in flexible material and the segments in hard or rigid materials.
Le matériau souple constitutif de la (ou des) jonction(s) peut avoir une température de transition vitreuse d'environ 35°C, de sorte que l'anneau a une configuration repliée facilitant son insertion à travers l'incision et le rhexis et une autre configuration spécifique déployée correspondant à celle de l'anneau implanté dans le sac capsulaire. Aux mêmes fins et avec les mêmes fonctionnalités, le matériau souple peut être un matériau à mémoire de forme.The flexible material constituting the junction (s) may have a glass transition temperature of approximately 35 ° C., so that the ring has a folded configuration facilitating its insertion through the incision and the rhexis and another specific configuration deployed corresponding to that of the ring implanted in the capsular bag. For the same purposes and with the same functionality, the flexible material can be a shape memory material.
Pour l'implantation avec une pince chirurgicale le premier segment 18 A est poussé autour de la zone équatoriale jusqu'à ce que la jonction 19 atteigne le rhexis et ensuite le second segment 18B est plié à l'intérieur du sac capsulaire dans un plan oblique ou transversal au plan général du premier segment 18 A avant d'être relâché, permettant ainsi au second segment 18B relativement court de trouver sa place dans la zone équatoriale et ce sans risque de lésion du sac ou de déchirure des zonules grâce à l'étendue réduite du second segment et l'effet amortisseur de la jonction en matière souple qui diminue l'impact du segment avec le tissu du sac capsulaire.For implantation with surgical forceps the first segment 18 A is pushed around the equatorial zone until the junction 19 reaches the rhexis and then the second segment 18B is folded inside the capsular bag in an oblique plane or transverse to the general plane of the first segment 18 A before being released, thus allowing the relatively short second segment 18B to find its place in the equatorial zone and this without risk of damage to the bag or tearing of the zonules thanks to the extent reduction of the second segment and the damping effect of the flexible material junction which reduces the impact of the segment with the tissue of the capsular bag.
Le diamètre de l'anneau capsulaire est choisi de sorte qu'il soit légèrement en compression contre la zone équatoriale du sac capsulaire au moment de son implantation. Cette compression aurait pour effet de fermer l'anneau capsulaire en rapprochant ses extrémités, la première extrémité 13 passant à l'extérieur de la seconde extrémité 14 formant ainsi un très léger décrochement au niveau du recouvrement des extrémités 13, 14, tel que représenté à la figure 5. La discontinuité qui en résulte est minimisée grâce à la faible épaisseur et la souplesse inhérente de la première extrémité 13 qui tend à s'écraser radialement entre l'extrémité 14 et le tissu capsulaire au niveau de l'équateur. Par la suite, dans la période post-opératoire, le sac capsulaire a tendance à se rétracter, de l'ordre de 0,5 mm à 1,5 mm en diamètre ce qui a pour conséquence d'augmenter la longueur de recouvrement.The diameter of the capsular ring is chosen so that it is slightly in compression against the equatorial zone of the capsular bag at the time of its implantation. This compression would have the effect of closing the capsular ring by bringing its ends closer together, the first end 13 passing outside the second end 14 thus forming a very slight recess at the level of the covering of the ends 13, 14, as shown in Figure 5. The resulting discontinuity is minimized thanks to the small thickness and the inherent flexibility of the first end 13 which tends to collapse radially between the end 14 and the capsular tissue at the equator. Through thereafter, in the post-operative period, the capsular bag tends to shrink, of the order of 0.5 mm to 1.5 mm in diameter, which has the effect of increasing the length of covering.
Un tel anneau capsulaire peut également être implanté par injecteur du type connu en soi. Un tel injecteur a un logement sensiblement rectiligne, voire courbe avec un très grand rayon par rapport à celui de l'anneau capsulaire. Grâce à la jonction 19, les contraintes induites par le déploiement sensiblement rectiligne ou légèrement courbe de l'anneau sont largement réduites, minimisant ainsi le risque de fêlure et notamment lorsque l'anneau capsulaire est chargé dans l'injecteur et livré en conditionnement stérile destiné à être ouvert au moment de son utilisation, c'est-à-dire des mois après leur conditionnement.Such a capsular ring can also be implanted by an injector of the type known per se. Such an injector has a substantially rectilinear or even curved housing with a very large radius relative to that of the capsular ring. Thanks to junction 19, the stresses induced by the substantially rectilinear or slightly curved deployment of the ring are greatly reduced, thus minimizing the risk of cracking and in particular when the capsular ring is loaded in the injector and delivered in sterile packaging intended to be opened at the time of use, that is to say months after their packaging.
Après l'implantation de l'anneau capsulaire, le chirurgien positionne la lentille intraoculaire, à l'intérieur de l'anneau, les éléments haptiques qui sont en forme de C ou de J ou plats, avec ou sans fenêtre, et au nombre de deux ou trois, par exemple, chacun étant en contact ou s'appuyant contre la surface intérieure cylindrique de la partie courante du corps annulaire. (Dans l'exemple illustré à la figure 5, une lentille intraoculaire 31 du type décrit dans le brevet FR-A-2.745.711 à trois éléments haptiques 32 à grande fenêtre s'étendant à partir de la périphérie de l'optique 31 forme un ensemble avec l'anneau capsulaire selon la première forme de réalisation. L'anneau sert donc avantageusement également au centrage et au positionnement de la lentille intraoculaire dans le sac capsulaire. La largeur axiale de la surface intérieure, d'environ 0,5 mm selon la forme de réalisation préférée, constitue un bon appui des éléments haptiques de l'implant intraoculaire.After the implantation of the capsular ring, the surgeon positions the intraocular lens, inside the ring, the haptic elements which are C or J-shaped or flat, with or without window, and the number of two or three, for example, each being in contact or pressing against the cylindrical inner surface of the running part of the annular body. (In the example illustrated in FIG. 5, an intraocular lens 31 of the type described in patent FR-A-2,745,711 with three haptic elements 32 with large window extending from the periphery of the optics 31 forms an assembly with the capsular ring according to the first embodiment. The ring is therefore also advantageously used for centering and positioning the intraocular lens in the capsular bag. The axial width of the interior surface, of about 0.5 mm according to the preferred embodiment, constitutes a good support for the haptic elements of the intraocular implant.
Outre la rétraction dans la période post-opératoire, les feuillets ou capsules antérieure et postérieure se rapprochent. Etant donné que la largeur axiale de l'anneau capsulaire est de préférence limitée à environ 0,5 mm, c'est-à-dire entre 0,45 et 0,55 mm, elle n'empêche pas la symphyse des capsules et plus particulièrement à la périphérie de la partie optique de la lentille intraoculaire. Telle que représentée sur la figure 5, la partie optique 33 de la lentille intraoculaire 31 a, sur la surface postérieure, au moins une arête vive ou bord carré 34 qui pénètre légèrement dans un pli du tissu de la capsule postérieure formant ainsi une deuxième barrière à la migration des cellules épithéliales, ou perles d'Elschnig empêchant ainsi l'opacification de la capsule postérieure derrière l'élément optique et la formation d'une cataracte secondaire.In addition to the retraction in the post-operative period, the anterior and posterior sheets or capsules come together. Since the axial width of the capsular ring is preferably limited to about 0.5 mm, i.e. between 0.45 and 0.55 mm, it does not prevent the symphysis of the capsules and more particularly at the periphery of the optical part of the intraocular lens. As shown in FIG. 5, the optical part 33 of the intraocular lens 31 has, on the posterior surface, at least one sharp edge or square edge 34 which penetrates slightly into a fold of the tissue of the posterior capsule thus forming a second barrier to the migration of epithelial cells, or Elschnig beads, thus preventing clouding of the posterior capsule behind the optic element and the formation of a secondary cataract.
L'anneau capsulaire selon la forme de réalisation de la figure 6 ne diffère de la forme de réalisation des figures 1 à 5 que par la présence de trois jonctions. Le corps annulaire comporte une jonction 19B disposée diamétralement opposée aux extrémités 13, 14 du corps annulaire ouvert, deux autres jonctions, 19 A, 19C se trouvant disposées à environ 120° de la jonction 19B. Autrement dit, la pluralité de jonctions est régulièrement espacée sur la circonférence de l'anneau ouvert. Les jonctions 19A et 19C se trouvent donc à environ 60° des extrémités respectives 13, 14. La partie courante et les jonctions en matériau souple ont la même section radiale.The capsular ring according to the embodiment of Figure 6 differs from the embodiment of Figures 1 to 5 only by the presence of three junctions. The annular body has a junction 19B arranged diametrically opposite the ends 13, 14 of the open annular body, two other junctions, 19 A, 19C being located at approximately 120 ° from the junction 19B. In other words, the plurality of junctions are regularly spaced around the circumference of the open ring. The junctions 19A and 19C are therefore at about 60 ° from the respective ends 13, 14. The main part and the junctions made of flexible material have the same radial section.
Le mode d'implantation d'un tel anneau peut être le même que celui de la première forme de réalisation. Toutefois, il y a un autre mode d'implantation possible. Selon ce mode d'implantation, les deux segments relativement courts 24A, 25A sont d'abord rabattus de préférence vers l'intérieur (mais éventuellement vers l'extérieur) des deux segments relativement longs 24B, 25B et les segments sont rapprochés- ou pivotes autour de la jonction 19B. Les segments courts 24A, 25 A peuvent simplement être rapprochés les uns vers les autres mais, de préférence, une paire de segments 25A, 25B sont légèrement décalés (dans le sens axial) derrière l'autre paire de segments 24A, 24B afin de minimiser l'encombrement des segments 24A et 24B se trouvant plus au droit des segments 25B, 25A, (non illustrés) et ce grâce à la flexibilité de la jonction centrale 19B. Les quatre segments sont donc introduits simultanément à travers l'incision et ensuite ils pénètrent dans le sac capsulaire par le rhexis. C'est alors qu'on relâche de préférence d'abord les deux segments courts 24A, 25A, successivement ou simultanément, puis les deux segments longs 24B, 25B plies autour de la jonction 19B sont relâchés. Grâce à une pluralité de jonctions, le chirurgien dispose de différentes manipulations et séquences possibles pour l'introduction et le déploiement des segments dans le sac capsulaire. En outre, il lui reste la possibilité d'introduction au moyen d'un injecteur.The mode of implantation of such a ring can be the same as that of the first embodiment. However, there is another possible implementation mode. According to this embodiment, the two relatively short segments 24A, 25A are first folded preferably inwards (but possibly outwards) of the two relatively long segments 24B, 25B and the segments are brought closer or pivoted around junction 19B. The short segments 24A, 25 A can simply be brought towards each other but, preferably, a pair of segments 25A, 25B are slightly offset (in the axial direction) behind the other pair of segments 24A, 24B in order to minimize the size of the segments 24A and 24B being more in line with the segments 25B, 25A (not shown) and this thanks to the flexibility of the central junction 19B. The four segments are therefore introduced simultaneously through the incision and then they enter the capsular bag through the rhexis. It is then that the two short segments 24A, 25A are preferably released first, successively or simultaneously, then the two long segments 24B, 25B folded around the junction 19B are released. Thanks to a plurality of junctions, the surgeon has different manipulations and possible sequences for the introduction and deployment of the segments in the capsular bag. In addition, there remains the possibility of introduction by means of an injector.
On comprendra bien que le fait d'avoir trois ou davantage de jonctions réduira encore le niveau de contraintes auxquelles l'anneau capsulaire est soumis, notamment lorsqu'il doit adopter une configuration sensiblement rectiligne pour être logé dans un injecteur et stocké dans cette position pendant des semaines, voire des mois.It will be understood that having three or more junctions will further reduce the level of stresses to which the capsular ring is subjected, in particular when it must adopt a substantially straight configuration to be housed in an injector and stored in this position for weeks or even months.
Dans la forme de réalisation des figures 7 et 8, l'anneau capsulaire 10 est à contour fermé. A cette fin, il comprend de préférence deux jonctions 19 en matériau souple diamétralement opposées. La configuration des segments 18A, 18B, en matériau rigide ainsi que les jonctions 19 en matériau souple est celle décrite en référence aux figures 1 à 5, sauf en ce qui concerne les étendues des segments et la suppression des extrémités.In the embodiment of Figures 7 and 8, the capsular ring 10 has a closed contour. To this end, it preferably comprises two junctions 19 made of flexible material diametrically opposite. The configuration of the segments 18A, 18B, in rigid material as well as the junctions 19 in flexible material is that described with reference to FIGS. 1 to 5, except as regards the extent of the segments and the removal of the ends.
Un tel anneau a l'avantage de maintenir son diamètre malgré la rétraction du sac capsulaire d'une part et d'autre part, grâce à ses arêtes vives ou bords carrés le long des segments en matériau rigide, il assure une excellente barrière à la migration cellulaire, étant donné la parfaite continuité des deux arêtes vives sur toute la circonférence de l'anneau.Such a ring has the advantage of maintaining its diameter despite the retraction of the capsular bag on the one hand and on the other hand, thanks to its sharp edges or square edges along the segments of rigid material, it provides an excellent barrier to the cell migration, given the perfect continuity of the two sharp edges around the entire circumference of the ring.
Un tel anneau à contour fermé peut toutefois être introduit par une incision de taille relativement réduite, de l'ordre de 3.5 mm, bien que nécessairement plus grande que celle nécessaire à l'introduction d'un anneau capsulaire à contour ouvert qui est de l'ordre de 2.5 mm, grâce aux deux jonctions 19 en matériau souple qui permettent l'ovalisation ou l'aplatissement de l'anneau avec un axe majeur passant par les jonctions pincées entre les mors d'une pince. On introduit, dans le sac capsulaire, l'anneau ovalisé ou aplati par une de ces jonctions en passant par l'incision cormeenne ou scléro-cornéenne puis par le rhexis, en continuant de pousser sur l'autre jonction, la partie de l'anneau présente dans le sac va s'ouvrir et venir épouser la forme de l'équateur. Il est alors nécessaire de pousser encore sur la jonction arrière de manière à la faire rentrer dans le cercle du rhexis avant de la relâcher pour qu'elle prenne sa place dans sac capsulaire. Dans cette forme de réalisation également, les jonctions jouent le rôle d'amortisseur pour absorber une partie de l'énergie libérée lorsque l'anneau est relâché dans le sac capsulaire.Such a ring with closed contour can however be introduced by an incision of relatively small size, of the order of 3.5 mm, although necessarily larger than that necessary for the introduction of a capsular ring with open contour which is of 'order of 2.5 mm, thanks to the two junctions 19 made of flexible material which allow the ovalization or flattening of the ring with a major axis passing through the clamped junctions between the jaws of a clamp. The ovalized or flattened ring is introduced into the capsular bag by one of these junctions, passing through the cormian or sclerocorneal incision and then through the rhexis, continuing to push on the other junction, the part of the ring present in the bag will open and come to conform to the shape of the equator. It is then necessary to push further on the rear junction so as to make it enter the circle of the rhexis before releasing it so that it takes its place in the capsular bag. In this embodiment also, the junctions act as a shock absorber to absorb part of the energy released when the ring is released into the capsular bag.
L'implantation de l'anneau est suivie par l'implantation de la lentille intraoculaire, conformément à la pratique courante avec pince ou injecteur. Les éléments haptiques de la lentille intraoculaire sont en contact ou s'appuient contre la surface annulaire intérieure de la partie courante de l'anneau, c'est-à-dire décalée par rapport aux jonctions et les parties des segments les jouxtant.The implantation of the ring is followed by the implantation of the intraocular lens, in accordance with current practice with forceps or injector. The haptic elements of the intraocular lens are in contact or bear against the interior annular surface of the current part of the ring, that is to say offset with respect to the junctions and the parts of the segments adjoining them.
Selon une autre forme de réalisation représentée sur la figure 9, une optique 40 en matière souple est formée d'une seule pièce avec l'anneau capsulaire 10. Dans la position de repos de cet ensemble anneau capsulaire/lentille intraoculaire, l'optique est légèrement décentrée par rapport à l'axe de l'anneau capsulaire. ; According to another embodiment shown in FIG. 9, an optic 40 made of flexible material is formed in one piece with the capsular ring 10. In the rest position of this capsular ring / intraocular lens assembly, the optic is slightly off center with respect to the axis of the capsular ring. ;
Au lieu d'une première extrémité formant une partie terminale, elle constitue une liaison 45 avec l'optique 40 dont la périphérie est à bords carrés. La liaison 45 comporte une première partie haptique droite 46 s'étendant à un angle oblique, de préférence ni radial, ni tangentiel, à partir de la périphérie de l'optique 40 suivie d'une deuxième partie haptique 47 courbe avec un décrochement 48 ouvert circonférentiellement vers la seconde extrémité de l'anneau avant de rejoindre le bord intérieur de la première extrémité 13 de l'anneau 10. Le décrochement 48 de forme complémentaire est apte à recevoir la seconde extrémité de la patte à œillet lorsque les deux extrémités se rapprochent, suite à la rétraction capsulaire post-opératoire. Il va . de soi qu'un tel ensemble peut également être réalisé par modification chimique sélective. L'implantation de cet ensemble anneau capsulaire et optique est également rendue aisée par la jonction 19 entre les segments 18 A, 18B. Cette implantation commence par l'introduction de l'anneau, non par sa première extrémité 13 mais par sa seconde extrémité 14 et une fois que l'anneau capsulaire est largement en place dans la zone équatoriale, l'optique pliée et la partie haptique sont relâchées, permettant à l'optique de trouver sa place et maintenue centrée par rapport à l'anneau capsulaire implanté dans la zone équatoriale, et partant, centrée par rapport au sac capsulaire.Instead of a first end forming a terminal part, it constitutes a connection 45 with the optics 40, the periphery of which has square edges. The link 45 comprises a first straight haptic part 46 extending at an oblique angle, preferably neither radial nor tangential, from the periphery of the optics 40 followed by a second haptic part 47 curved with a recess 48 open circumferentially towards the second end of the ring before joining the inner edge of the first end 13 of the ring 10. The recess 48 of complementary shape is capable of receiving the second end of the eyelet tab when the two ends come together, following the postoperative capsular retraction. He goes . It goes without saying that such an assembly can also be produced by selective chemical modification. The implantation of this capsular and optical ring assembly is also made easy by the junction 19 between the segments 18 A, 18B. This implantation begins with the introduction of the ring, not by its first end 13 but by its second end 14 and once the capsular ring is largely in place in the equatorial zone, the folded optics and the haptic part are released, allowing the optics to find its place and kept centered relative to the capsular ring implanted in the equatorial zone, and therefore, centered relative to the capsular bag.
Quelle que soit la forme de réalisation de l'anneau capsulaire, celui-ci peut être imprégné au préalable d'un produit anti-prolifération et notamment du 5-FU. Le procédé d'imprégnation et de relargage après implantation de l'anneau est de préférence conforme aux enseignements de la demande de brevet WO 98/25652.Whatever the embodiment of the capsular ring, it can be impregnated beforehand with an anti-proliferation product and in particular 5-FU. The impregnation and release process after implantation of the ring is preferably in accordance with the teachings of patent application WO 98/25652.
Il va de soi que la présente invention n'est pas limitée aux formes de réalisation décrites ni aux matériaux préférés, mais englobe au contraire toutes variantes de structures et configurations et de matériaux compatibles avec les objets de la présente invention. It goes without saying that the present invention is not limited to the embodiments described or to the preferred materials, but on the contrary encompasses all variants of structures and configurations and of materials compatible with the objects of the present invention.

Claims

REVENDICATIONS
1 . Anneau capsulaire implantable dans la région équatoriale d'un sac capsulaire après ablation de la cataracte, comprenant un corps annulaire ouvert ou fermé, le corps annulaire ayant des arêtes vives et une largeur axiale comprise entre environ 0,3 et 0,6 mm, ou de préférence environ 0,5 mm, caractérisé en ce que le corps annulaire, y compris les arêtes vives, est réalisé en matériau rigide sur la majorité de la circonférence, et en ce que le corps annulaire comporte au moins une jonction en matériau souple entre deux segments du corps annulaire en matériau rigide.1. Capsular ring implantable in the equatorial region of a capsular bag after cataract removal, comprising an open or closed annular body, the annular body having sharp edges and an axial width of between about 0.3 and 0.6 mm, or preferably approximately 0.5 mm, characterized in that the annular body, including the sharp edges, is made of rigid material over the majority of the circumference, and in that the annular body comprises at least one junction of flexible material between two segments of the annular body of rigid material.
2. Anneau selon la revendication 1, caractérisé en ce que la largeur axiale du corps annulaire est d'environ 0,5 mm.2. Ring according to claim 1, characterized in that the axial width of the annular body is approximately 0.5 mm.
3. Anneau selon la revendication 1, caractérisé en ce que la largeur axiale du corps annulaire est entre 0,45 et 0,55 mm.3. Ring according to claim 1, characterized in that the axial width of the annular body is between 0.45 and 0.55 mm.
4. Anneau selon la revendication 1, caractérisé en ce que le corps annulaire est fermé et comporte au moins deux jonctions diamétralement opposées.4. Ring according to claim 1, characterized in that the annular body is closed and has at least two diametrically opposite junctions.
5. Anneau selon la revendication 3 ou 4, caractérisé en ce que l'étendue circonférentielle de chacune des jonctions est comprise entre environ 0.5 et 6 % de la circonférence de l'anneau.5. Ring according to claim 3 or 4, characterized in that the circumferential extent of each of the junctions is between approximately 0.5 and 6% of the circumference of the ring.
6. Anneau selon la revendication 1 ou 2, caractérisé en ce que l'anneau est ouvert et que la jonction est située entre environ 260° et environ 320° d'une première extrémité.6. Ring according to claim 1 or 2, characterized in that the ring is open and that the junction is located between about 260 ° and about 320 ° from a first end.
7. Anneau selon la revendication 6, caractérisé en ce que l'anneau ouvert a une pluralité de jonctions régulièrement espacées sur sa circonférence.7. Ring according to claim 6, characterized in that the open ring has a plurality of junctions regularly spaced around its circumference.
8. Anneau selon la revendication 7, caractérisé en ce que l'anneau ouvert a trois jonctions sensiblement à 120° les unes par rapport aux autres, et quatre segments dont deux d'une étendue circonférentielle d'environ 60° et deux d'une étendue circonférentielle d'environ 120°.8. Ring according to claim 7, characterized in that the open ring has three junctions substantially at 120 ° relative to each other, and four segments including two of a circumferential extent of about 60 ° and two of a circumferential extent of approximately 120 °.
9. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que la largeur radiale de la (ou des) jonction(s) ainsi que l'extrémité du segment jouxtant cette jonction est supérieure à la largeur radiale des segments du corps annulaire.9. Ring according to any one of the preceding claims, characterized in that the radial width of the junction (s) as well as the end of the segment adjoining this junction is greater than the radial width of the segments of the annular body .
10. Anneau selon l'une quelconque des revendications 5 à 9, caractérisé en ce qu'au moins une des extrémités du coips annulaire a une partie terminale réalisée en matériau souple, rentrante et à bord arrondi. 10. Ring according to any one of claims 5 to 9, characterized in that at least one of the ends of the annular coips has an end part made of flexible material, re-entrant and with rounded edge.
1 1 . Anneau selon l'une quelconque des revendications 7 à 10, caractérisé en ce qu'une des extrémités comporte un œillet.1 1. Ring according to any one of Claims 7 to 10, characterized in that one of the ends comprises an eyelet.
12. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que la largeur radiale du corps annulaire en dehors des parties des segment(s) jouxtant les jonctions est entre 0,10 et 0.3mm.12. Ring according to any one of the preceding claims, characterized in that the radial width of the annular body outside the parts of the segment (s) adjoining the junctions is between 0.10 and 0.3mm.
13. Anneau selon l'une quelconque des revendications 4 et 8 à 12, caractérisé en ce que l'étendue circonférentielle de chaque jonction est sensiblement la même.13. Ring according to any one of claims 4 and 8 to 12, characterized in that the circumferential extent of each junction is substantially the same.
14. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que le matériau rigide est choisi parmi le PMMA et l'acrylique et le matériau souple est choisi parmi l'HEMA, l'acrylique souple hydrophile et/ou l'acrylique souple hydrophobe.14. Ring according to any one of the preceding claims, characterized in that the rigid material is chosen from PMMA and acrylic and the flexible material is chosen from HEMA, hydrophilic flexible acrylic and / or acrylic flexible hydrophobic.
15. Anneau selon l'une quelconque des revendications 1 à 14, caractérisé en ce qu'il y a des liaisons covalentes entre le matériau souple et le matériau rigide du corps annulaire.15. Ring according to any one of claims 1 to 14, characterized in that there are covalent connections between the flexible material and the rigid material of the annular body.
16. Anneau selon l'une quelconque des revendications 1 à 14, caractérisé en ce que le matériau souple consiste en des copolymères statistiques méthacrylate de méthyle- méthacrylate et hydroxyéthylméthacrylate (MMA-HEMA) réticulés et en ce que le matériau rigide est à base de copolymères PMMA.16. Ring according to any one of claims 1 to 14, characterized in that the flexible material consists of random copolymers of methyl methacrylate-methacrylate and hydroxyethylmethacrylate (MMA-HEMA) crosslinked and in that the rigid material is based on PMMA copolymers.
17. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que le matériau rigide constitue une modification chimique du matériau souple ou inversement.17. Ring according to any one of the preceding claims, characterized in that the rigid material constitutes a chemical modification of the flexible material or vice versa.
18. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que le matériau souple constitutif de la (ou des) jonction(s) a une température de transition vitreuse d'environ 35°C.18. Ring according to any one of the preceding claims, characterized in that the flexible material constituting the (or) junction (s) has a glass transition temperature of about 35 ° C.
19. Anneau selon l'une quelconque des revendications précédentes, caractérisé en ce que le matériau souple constitutif de la (ou des) jonction(s) est un matériau à mémoire de forme.19. Ring according to any one of the preceding claims, characterized in that the flexible material constituting the (or) junction (s) is a shape memory material.
20. Ensemble comprenant un anneau capsulaire selon l'une quelconque des revendications 2 à 19 et un implant intraoculaire du type comportant une partie optique centrale et une partie haptique périphérique comportant un ou plusieurs éléments haptiques s'étendant radialement à partir de la partie optique, caractérisé en ce que la partie optique a un bord périphérique avec une arête vive sur sa face postérieure. 20. An assembly comprising a capsular ring according to any one of claims 2 to 19 and an intraocular implant of the type comprising a central optical part and a peripheral haptic part comprising one or more haptic elements extending radially from the optical part, characterized in that the optical part has a peripheral edge with a sharp edge on its rear face.
21. Ensemble selon la revendication 20, caractérisé en ce que la lentille intraoculaire et l'anneau capsulaire est en une pièce, les parties optique et haptique de la lentille intraoculaire sont réalisées en matière souple, ainsi que la liaison entre la partie haptique et une première extrémité de l'anneau.21. The assembly of claim 20, characterized in that the intraocular lens and the capsular ring is in one piece, the optical and haptic parts of the intraocular lens are made of flexible material, as well as the connection between the haptic part and a first end of the ring.
22. Ensemble selon la revendication 21, caractérisé en ce que la partie haptique comporte un décrochement en face de la seconde extrémité pour la recevoir lorsque l'anneau est sous compression.22. Assembly according to claim 21, characterized in that the haptic part comprises a recess opposite the second end to receive it when the ring is under compression.
23. Procédé de fabrication d'un anneau capsulaire implantable selon l'une quelconque des revendications précédentes, caractérisé en ce qu'on prépare le corps annulaire en matériau souple et on modifie chimiquement les segments du corps annulaire pour constituer des segments en matériau rigide, les jonctions entre ces segments restant en matériau souple.23. A method of manufacturing an implantable capsular ring according to any one of the preceding claims, characterized in that the annular body is made of flexible material and the segments of the annular body are chemically modified to constitute segments of rigid material, the junctions between these segments remaining in flexible material.
24. Procédé de fabrication selon la revendication 21, caractérisé en ce qu'une des extrémités reste également en matériau souple.24. The manufacturing method according to claim 21, characterized in that one of the ends also remains of flexible material.
25. Procédé de fabrication d'un anneau capsulaire implantable selon l'une quelconque des revendications 1 à 19, caractérisé en ce qu'on prépare le corps annulaire en matériau rigide et on modifie chimiquement une ou plusieurs zones du corps annulaire pour constituer des jonctions en matériau souple entre segments en matériau rigide.25. A method of manufacturing an implantable capsular ring according to any one of claims 1 to 19, characterized in that the annular body is prepared in rigid material and one or more zones of the annular body are chemically modified to form junctions in flexible material between segments in rigid material.
26. Procédé de fabrication selon la revendication 23, caractérisé en ce qu'une des zones modifiées chimiquement est une des extrémités du corps annulaire. 26. The manufacturing method according to claim 23, characterized in that one of the chemically modified zones is one of the ends of the annular body.
EP03815709A 2003-01-08 2003-12-30 Capsular tension ring, method for making a capsular tension ring and capsular ring and intraocular lens assembly Withdrawn EP1581152A1 (en)

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Application Number Priority Date Filing Date Title
FR0300143A FR2849592B1 (en) 2003-01-08 2003-01-08 CAPSULAR RING, METHOD OF MANUFACTURING CAPSULAR RING AND CAPSULAR RING ASSEMBLY AND INTRAOCULAR LENS
FR0300143 2003-01-08
PCT/FR2003/003942 WO2004069101A1 (en) 2003-01-08 2003-12-30 Capsular tension ring, method for making a capsular tension ring and capsular ring and intraocular lens assembly

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WO2004069101A1 (en) 2004-08-19
CN1747695A (en) 2006-03-15
AU2003303901A1 (en) 2004-08-30
CN100518691C (en) 2009-07-29
JP2006513003A (en) 2006-04-20
CA2512606A1 (en) 2004-08-19
FR2849592A1 (en) 2004-07-09
FR2849592B1 (en) 2005-03-25
JP4372016B2 (en) 2009-11-25
US20060235515A1 (en) 2006-10-19

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