Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
  • A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
  • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts

Definitions

• the present invention relates generally to the correction of vision by insertion of a corrective element in the eye and more precisely the correction of presbyopia.
• presbyopia is not only linked to the loss of flexibility of the lens during aging but is mainly due to the increase in the diameter of said lens with age.
• the crystalline lens Cr enclosed in the crystalline sac S is suspended from the sclera Se along a ring thereof disposed behind the limbus L separating the vitreous body V from the opaque body O.
• This ring is on average located at a latitude spaced 2 to 3 mm from the limbus, if we take for reference the optical axis.
• This suspension of the lens is provided by a ligament Z called a zonule attached to the ciliary body Ce.
• the dimension of the sawn ring and of the ciliary body This does not vary over time, the zonule Z is gradually relaxed during the enlargement of the lens Cr and partly loses its power of traction on the equator of the sac lens of S.
• a new surgical method has therefore been proposed for correcting presbyopia consisting in increasing the diameter of the sawn ring at the level of the ciliary body so as to tighten the zonule which will again be able to fulfill its role of deformation of the lens under the effect of contraction of the ciliary muscle and restore the accommodation power to the eye.
• SCHACHAR proposed a frustoconical ring placed by suture around the sawn ring (US patent 5,465,737).
• arcuate segments have been proposed which are placed in passers incised in the thickness of the sclera concentrically with the limbus, in line with the ciliary body, and which constitute as many stiffeners exerting a traction towards the exterior retaining the zonule.
• the Sg segment was introduced into this passer-by and rests by its feet A and B on the sclera on which it exerts support, while its bridge C exerts a pulling force towards the outside. It can be seen that the zonule is stretched Zi at the base of the force C and relaxed Z 2 at the base of the forces A and B.
• the object of the present invention is to eliminate this drawback and to propose scleral expansion segments which do not present any risk of perforation of the sclera.
• the scleral expansion segment which, in a manner known per se, consists of an arched rod intended to be placed on the sclera directly above the ciliary body, is characterized in that its free ends are of a spatula shape wider than the diameter of said rod so as to constitute wide support feet.
• the segment according to the invention is also remarkable in that:
• the feet have a radius of curvature RI corresponding to that of the sclera perpendicular to the ciliary body while the bridge has a radius of curvature R2 less than RI,
• the core consists of an injectable product
• the segment consists on the one hand of a bridge, one end of which is secured to a foot and on the other hand of a removable foot and in that complementary fixing means are arranged between the free end of the bridge and the removable foot, - the two parts include means to prevent any relative rotation of one relative to the other.
• FIG. 1 is a schematic top view of a scleral expansion segment according to a first embodiment of the invention
• FIG. 2 is a side view of the scleral expansion segment of FIG. 1,
• FIG. 3 is a top view of a scleral expansion segment according to a second embodiment of the invention
• - Figures 4a and 4b are sectional views respectively along lines AA and BB of Figure 1 ,
• FIG. 5 is a top view of a scleral expansion segment according to a third embodiment of the invention.
• FIG. 6 shows the scleral expansion segment of Figure 5 assembled
• FIG. 7a to 7c schematically show examples of arrangements in the eye of the scleral expansion segments according to the invention
• FIG. 8 is a schematic sectional view of an eye
• FIG. 9 is a partial schematic sectional view of an eye equipped with a scleral expansion segment.
• FIG 10 is a schematic perspective view from above of a third embodiment of a scleral expansion segment according to the invention.
• FIG. 11 is a side view of the exemplary embodiment of FIG. 10.
• the scleral expansion segment according to the invention consists of an arched rod having two ends forming two legs 1 and 2 connected by a cylindrical bridge 3.
• the feet 1 and 2 are formed by parts wider than the diameter of the bridge 3, in the form of spatulas, and their internal face is flattened. This arrangement allows the support of the scleral expansion segment on the sclera to be carried out on a relatively large surface, which makes it possible to considerably reduce the pressure directed towards the interior of the eye which is exerted on the surface of said sclera.
• the scleral expansion segment seen in longitudinal section, is an arcuate part having two radii of curvature.
• the feet 1 and 2 have a radius of curvature RI corresponding to that of the sclera Se at the base of the ciliary body while the bridge 3 has a radius of curvature R2 less than RI so as to pull on the sawmill passer.
• said feet have, seen from above, a generally ellipsoidal shape. Their ends are rounded in order to avoid injuring the sclera.
• the material used for the manufacture of the scleral expansion segment is a biocompatible synthetic material such as PMMA, polyhema or ceramic.
• the scleral expansion segment has a multitude of perforations 4 through which the connective tissue can develop to improve the attachment of the sclera to said correction segment, and / or serve crossing point for a possible suture if necessary.
• the creation of the orifices 4 can be replaced by providing on the surface of the scleral expansion segment a porous surface with mesh large enough to accept colonization by the connective tissue.
• a porous surface with mesh large enough to accept colonization by the connective tissue.
• Such a surface will for example be produced by coating the segment with a biocompatible synthetic material, a hydroxyapatite, a component with variable hydration, etc.
• the scleral expansion segment according to the invention can also be designed in such a way that its action is adjustable that is to say that one can modify its shape so as to adjust its effect on the zonule during installation or if it were to decrease over time.
• the scleral expansion segment comprises a core 5, 50 in one rigid material capable of retaining the shape which has been given to it, embedded in a soft material 6, 60.
• the material constituting the core 5 is preferably chosen from deformable materials with shape memory.
• the scleral expansion segment has an internal channel intended for the establishment of a core whose nature and resistance can be chosen by the practitioner in order to adapt the effect of the scleral expansion segment in the state of the eye it heals.
• the internal channel intended to contain the core can have a diameter of the order of 0.2 millimeters.
• Such a removable core can be produced in the form of a solid body which is inserted into the scleral expansion segment.
• It can also be constituted by an injectable product which is introduced into the channel formed in the scleral expansion segment, the effect of the scleral expansion segment then being adapted by modulating the pressure of the product introduced into said segment.
• the product injected into the channel of the sawing expansion segment can be a gas, or even a liquid or a gel, polymerizable or not.
• the scleral expansion segment according to the invention has feet larger than the bridge cooperating with the incised loop in the sclera in which it is placed, it is understood that the surgeon will either have to make a more incision wide, or forcefully pass one foot of the segment in the way. In the first case, it is exposed to the risk of an incorrect holding of the segment and of insufficient traction of the segment on the zonule. In the second case, he risks damaging the sclera.
• the invention provides for producing the scleral expansion segment in at least two interlocking parts and arranged so that at least one end of the bridge is free for the insertion of the segment. in the way.
• FIG. 5 Such a segment is shown in Figures 5 and 6. It consists of two parts 7 and 8 which can be fixed to each other using fixing means 9, 10.
• the first part 7 comprises a foot, the foot 1 in the embodiment shown in the drawing, while the second part 8 comprises the second foot 2 and the bridge 3.
• the end of the bridge 3 is shaped so as to constitute a fixing means 9 adapted to cooperate with a complementary fixing means 10 carried by the first part 7.
• the bridge 3 of the part 8 carries a male fixing means 9 generally in the form of a harpoon and the part 7 has a female fixing means 10 constituted by a cavity of shape complementary to the harpoon 9 .
• the segments are generally arranged by 4, arranged substantially at 90 ° directly above the ciliary body about 3mm behind the limbus (Figure 6c) but other arrangements can be adopted for example two segments in polar positions ( Figure 6a) or three segments at 120 ° ( Figure 6b).
• the scleral expansion segments have a length of the order of 3 to 5 millimeters, their foot having, for example, a width of between 1 and 2 millimeters.
• Figures 10 to 15 show various advantageous embodiments of a scleral expansion segment according to the invention. It was indicated above that the function of feet 1 and 2 was to distribute the bearing forces of the segment on the sclera over a large area, with the result of reducing the pressure directed towards the eye. In practice, the inventor has observed that the bridge exerts on the sclera a traction force towards the outside, while the feet exert by reaction an opposite force of pressure.
• the invention provides that the feet of the segment are shaped so that their contact area with the sclera is outside the plane of the zonule. More specifically, the contact area of the feet must be separated by at least 1 mm on either side of the median longitudinal axis of the bridge of the scleral expansion segment.
• the segment is made up of two parts, that is to say a one-piece main part comprising a bridge 3 associated with a foot 1 whose support parts 2a and 2b are separated in the manner of a fork, and a complementary part constituted by a removable pad 1 which has on its upper face a recess 10 in which the free end of the bridge 3 engages.
• the removable pad 1 has a general oval shape with recesses 11 at its apices forming a grip point for the tools used during the positioning of the segment.
• the terminal part of the bridge 3 which cooperates with the hole 10 of the removable pad 1 may have under its lower face, a stud, stud or boss (not shown) of shape corresponding to that of the hole 10.
• the embodiment could also be reversed, with a removable foot carrying a stud, stud or projection projecting on its upper face cooperating with a hole or recess made under the end of the bridge.
• the underside of the feet may also have a rough surface, spikes, streaks, etc.
• Figures 12 to 15 show very schematically still other embodiments of a scleral expansion segment according to the invention.
• the feet 1 and 2 are interconnected by rods 12a and 12b so as to form a one-piece frame on which the free ends of the bridge 3 are blocked in recesses 13a and 13b.
• the scleral expansion segment is in three parts, namely a bridge 3, two arched feet 1 and 2 connected by a rod 14 parallel to the bridge 3 and a second removable rod 15 arranged parallel to the rod 14 to l opposite the bridge 3 and on which the free end of the feet 1 and 2 is fixed.
• FIG. 14a represents a variant of FIG. 12, in which the feet
• 1 and 2 are not interconnected, to form a frame, but separated with their free ends facing each other.
• the useful length of the bridge 3 can be very close to the overall length of the segment, which is advantageous for keeping the length of the segments at a low value, preferably less than 8 mm, while obtaining a optimal length for the bridge.
• FIG. 14b only the feet 1 and 2 have been shown with their free ends facing away from each other and holes 16 receiving the free ends of the bridge, not shown.
• Figure 15 there is shown a single removable foot (1) in the general shape of H with the locking hole 17 of the end of the bridge, located on the middle bar of H.
• the scleral expansion segments according to the invention have the advantage of being able to be very easily deposited and modified during the operation to adapt the curvature of their bridge to the desired outward traction.
• the scleral expansion segment has a bridge in the form of a cylindrical rod but without departing from the scope of the invention, the bridge could have any other form (blade, strip, etc.). ) as soon as this bridge is connected to widened feet and / or that these feet have bearing areas arranged outside the plane of the zonule.
• the bridge can be given a section with a transverse concavity directed downwards. This arrangement allows the traction forces to be placed on the sclera with better precision compared to the zonule.
• said segments can easily be removed either by disengaging them, or by cutting them near one of the support feet.

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• Health & Medical Sciences (AREA)
• Ophthalmology & Optometry (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)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Prostheses (AREA)

Applications Claiming Priority (3)

Publications (1)

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ID=9531514

Family Applications (1)

Country Status (9)

Families Citing this family (32)

Family Cites Families (12)

• 1998
  • 1998-10-13 FR FR9812834A patent/FR2784287B1/fr not_active Expired - Fee Related
• 1999
  • 1999-10-13 JP JP2000575447A patent/JP2002527142A/ja active Pending
  • 1999-10-13 AU AU60969/99A patent/AU6096999A/en not_active Abandoned
  • 1999-10-13 CN CN99812153.3A patent/CN1323183A/zh active Pending
  • 1999-10-13 BR BR9914425-5A patent/BR9914425A/pt not_active Application Discontinuation
  • 1999-10-13 WO PCT/FR1999/002487 patent/WO2000021466A1/fr not_active Application Discontinuation
  • 1999-10-13 EP EP99947570A patent/EP1137375A1/de not_active Withdrawn
  • 1999-10-13 CA CA002346556A patent/CA2346556A1/fr not_active Abandoned
• 2001
  • 2001-04-12 US US09/833,958 patent/US6712847B2/en not_active Expired - Fee Related
  • 2001-04-12 US US09/833,903 patent/US6673111B2/en not_active Expired - Fee Related

Non-Patent Citations (1)

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