EP1443875A1 - Intraocular lenses provided with angled edges to prevent posterior capsular opacification - Google Patents

Intraocular lenses provided with angled edges to prevent posterior capsular opacification

Info

Publication number
EP1443875A1
EP1443875A1 EP02793203A EP02793203A EP1443875A1 EP 1443875 A1 EP1443875 A1 EP 1443875A1 EP 02793203 A EP02793203 A EP 02793203A EP 02793203 A EP02793203 A EP 02793203A EP 1443875 A1 EP1443875 A1 EP 1443875A1
Authority
EP
European Patent Office
Prior art keywords
intraocular lens
peripheral edge
posterior
lens according
haptic
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Withdrawn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
EP02793203A
Other languages
German (de)
French (fr)
Inventor
Joel Pynson
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.)
Bausch and Lomb Inc
Original Assignee
Bausch and Lomb Inc
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 Bausch and Lomb Inc filed Critical Bausch and Lomb Inc
Publication of EP1443875A1 publication Critical patent/EP1443875A1/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Withdrawn legal-status Critical Current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
    • 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
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • 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
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • 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
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1683Intraocular lenses having supporting structure for lens, e.g. haptics having filiform haptics
    • 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
    • A61F2002/16965Lens includes ultraviolet absorber
    • A61F2002/1699Additional features not otherwise provided for

Definitions

  • Intraocular lenses with angled edges to prevent posterior capsular clouding Intraocular lenses with angled edges to prevent posterior capsular clouding.
  • the present invention relates to intraocular lenses (IOLs) and a method of making and using them. More particularly, the present invention relates to IOLs with angled edges to prevent posterior capsular clouding in aphakic eyes from which the natural lens of the eye has been surgically removed.
  • IOLs intraocular lenses
  • Cataract extraction is one of the most commonly performed operations in the United States and around the world.
  • the eye lens is located inside a so-called capsular bag or lens capsule located in the posterior chamber of the eye.
  • an incision is made in the limbus of the eye in order to introduce a surgical instrument into the anterior chamber of the eye.
  • a capsulo-hexis procedure is followed in which a portion of an anterior membrane of the lens capsule adjacent to the iris of the eye is extracted using a cutting surgical instrument to provide direct access to the lens with cataracts from the anterior chamber.
  • the lens with cataracts is then extracted using various known methods, including phacoemulsification.
  • Phacoemulsification is a procedure that involves applying ultrasonic energy to the lens with cataracts to break the lens into small pieces that can be aspirated from the lens capsule. With the exception of the portion of the anterior membrane of the lens capsule removed during the capsulo-hexis procedure, the lens capsule remains essentially intact for the duration of an extracapsular cataract extraction. Following the extraction of the lens affected by cataracts, an implant artificial intraocular lens (IOL), as discussed in more detail below, is typically implanted within the lens capsule to mimic the refractive function of the extracted natural lens. Implants of the IOL have been used for years in the aphakic eyes from which the natural lens of the eye has been extracted.
  • IOL intraocular lens
  • IOLs Many different designs of the IOL have been developed in the past few years and have been used successfully in the eyes of the scalp. At present, successful IOL designs mainly include an optical portion with its supports, called haptics, connected to and surrounding at least part of the optical portion.
  • the haptic portions of an IOL are designed to support the optical portion of the IOL in the lens capsule, the anterior chamber, or the posterior chamber of an eye.
  • Commercially successful IOLs have been made from a variety of biocompatible materials, ranging from stiffer materials such as polymethylmethacrylate (PMMA) to more flexible materials capable of being folded or compressed such as silicones and certain acrylics.
  • PMMA polymethylmethacrylate
  • Haptic portions of the IOLs were formed separately from the optical portion and then subsequently connected to this portion by processes such as heat, physical stapling and / or chemical bonding. LIOs with haptics attached in this way are commonly called “multi-room” LIOs. IOLs are also commonly produced with haptics formed as an integral part of the optical portion in what is commonly called “monoblock” IOLs.
  • Softer, softer IOLs have grown in popularity in recent years due to their ability to compress, bend, roll or otherwise deform. These softer IOLs can be deformed before their insertion through an incision in the cornea of the eye. Following the insertion of the IOL in the eye, the IOL returns to its original form before deformation due to the memory characteristics of soft matter.
  • Softer, more flexible IOLs such as those just described can be implanted in one eye through an incision which is much smaller, i.e. 2.8 to 3.2 mm, than that necessary for more rigid IOLs, i.e. 4.8 to 6.0 mm.
  • a larger incision is necessary for more rigid IOLs because the lens must be inserted through an incision in the cornea slightly larger than that of the diameter of the optical portion of the rigid IOL.
  • stiffer IOLs have become less popular in the market as it has been found that larger incisions are associated with an increased incidence of post-operative complications such as induced astigmatism.
  • OCP posterior capsular clouding
  • Intraocular lenses (IOLs) made in accordance with the present invention have an optical portion having an outer peripheral edge and two or more, but preferably two, three or four equidistant haptic elements to support the optical portion in a patient's eye.
  • each of the haptic elements is of similar shape to obtain a "helix" effect to facilitate the implantation, rotation and centering of the IOL. The helix effect also improves accessibility inside the capsule for cleaning cortical remains.
  • Each of the haptic elements has an internal portion and an external portion. The internal portion of each haptic element comprises an enlarged fixing portion permanently connected to the external peripheral edge of the optical portion.
  • each haptic element includes a rounded free end.
  • Each haptic element comprises an elongated central portion in the form of an arc which extends between the enlarged fixing portion and the rounded free end. From the enlarged fixing portion and all along the elongated central portion in the form of an arc, the dimensions of the haptic element may be stable or may vary. The particular angular shape of the haptic elements allows the rotation of the IOLs and prevents posterior capsular clouding.
  • an object of the present invention is to provide intraocular lenses for use in aphakic eyes.
  • Another object of the present invention is to provide intraocular lenses for use in aphakic eyes capable of being implanted through a small incision.
  • Another object of the present invention is to provide intraocular lenses which prevent posterior capsular clouding.
  • Another object of the present invention is to provide intraocular lenses which allow greater ease of implantation, rotation and centering of said lenses.
  • Another object of the present invention is to provide intraocular lenses which are biocompatible for use in aphakic eyes.
  • Yet another object of the present invention is to provide intraocular lenses which are resistant to decentering inside the eyes.
  • Figure 1 is a schematic representation of the interior of a human eye comprising a natural lens and a refractive IOL implanted in the lens capsule of the eye;
  • Figure 2 is a plan view of an IOL with two haptics made in accordance with the present invention;
  • Figure 3 is a side view of the IOL of Figure 2;
  • Figure 4 is a cross-sectional view of an optical portion of the IOL of Figure 2 taken along line 4-4;
  • Figure 5 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 5-5;
  • Figure 6 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 6-6;
  • Figure 7 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 7-7;
  • Figure 8 is a plan view of another embodiment of an IOL with two haptics made in accordance with the present invention.
  • Figure 9 is a side view of the IOL of Figure 8.
  • Figure 10 is a cross-sectional view of an otic part of the IOL of Figure 8 taken along line 10-10;
  • Figure 11 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along line 11-11;
  • Figure 12 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along the line 12-12;
  • Figure 13 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along line 13-13;
  • Figure 14 is a plan view of another embodiment of an IOL with three haptics made in accordance with the present invention.
  • Figure 15 is a side view of the IOL of Figure 14;
  • Figure 16 is a cross-sectional view of an otic part of the IOL of Figure 14 taken along line 16-16;
  • Figure 17 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 17-17;
  • Figure 18 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 18-18;
  • Figure 19 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 19-19.
  • FIG. 1 is a schematic view of an eye 10 showing the structures which are related to implantation of intraocular lenses (IOL) 12 according to the present invention.
  • the eye 10 comprises an optically clear cornea 14 and an iris 16.
  • a lens capsule 18 and a retina 20 are placed behind the iris 16 of the eye 10.
  • the eye 10 also comprises an anterior chamber 22 situated in front of the iris 16 and a posterior chamber 24 located between the iris 16 and the lens capsule 18.
  • the IOL 12 is preferably implanted in the lens capsule 18 of the aphakic eye. When used in aphakic eyes, IOLs 12 are used to replace diseased natural lenses that have been surgically removed, for example after cataract surgery.
  • the eye 10 also includes an optical axis OA-OA which is an imaginary line passing through the center optic 28 of the anterior surface 30 and the posterior surface 32 of the lens capsule 18.
  • the optical axis OA-OA in the human eye 10 is generally perpendicular to a portion of the cornea 14, to the lens capsule 18 and to the retina 20.
  • the IOLs according to the present invention represented in FIGS. 2, 8 and 14, generally designated by the reference numeral 12, are designed to be implanted preferably in the lens capsule 18 of an aphakic eye. .
  • the IOL 12 has an optical portion 34 with an outer peripheral edge 36.
  • Two or more, but preferably two, three or four equidistant haptic elements 38 are preferably formed integrally on the peripheral edge 36 of the optical portion 34.
  • Each haptic element 38 has a similar shape to obtain a "helix" appearance to facilitate rotation and centering of IOL 12 during implantation inside the eye 10 and to obtain rotation of IOL 12 as described more in detail below.
  • Each haptic element 38 is manufactured so as to have an internal portion 40 and an external portion 42.
  • the internal portion 40 of each haptic element 38 comprises an enlarged fixing portion 44 preferably formed integrally and permanently connected with the external peripheral edge 36 of the optical portion 34.
  • the enlarged fixing portion 44 of each haptic element 38 can be permanently fixed to the optical portion 34 by stapling, chemical polymerization or by other methods known to those skilled in the art.
  • Each haptic element 38 also comprises on the external portion 42 a rounded free end 46 designed to avoid contact with the internal surfaces 48 of the lens capsule 18 of the aphakic eye 10.
  • the haptic elements 38 are formed with elongated, arcuate central portions 50 which extend between the enlarged attachment portions 44 and the free ends 46. As best illustrated in Figures 5-7, 11-13 and 17-19, from the enlarged fixing portion 44 and all along the elongated central portion in in the form of an arc 50, the cross section of the haptic element 38 has a trapezoidal or, alternatively, rhomboid shape in order to obtain the desired characteristics for preventing OCP.
  • the section of the haptic element 38 along lines 5/5, 6/6 and 7/7 are trapezoidal, the outer side 60 of the trapezoid having at its lower part an acute angle 52 and at its upper part an obtuse angle 71.
  • the particular shape of the haptic elements 38 produces two effects: on the one hand thanks to the acute haptic edge 52, the migration of the capsular cells along the posterior surface 32 is blocked and on the other hand thanks to the obtuse external anterior haptic edge 71, rapid shuttering between the anterior surface 30 and the posterior surface 32 is possible.
  • This closure comes from the phenomenon known as symphysis according to which, when the capsular bag has been emptied, the two walls 30 and 32 of said bag stick against one another. When they are so stick, there is no more migration of the capsular cells.
  • the acute angle 52 is between 10 and 45 °.
  • the haptic element 38 can be stable or its dimensions can vary from the enlarged fixing portion 44 and all along the central portion 50 on the plane 68-68 substantially perpendicular to the optical axis OA-OA.
  • the haptic elements 38 with regular dimensions from the enlarged fixing portion 44 and all along the central portion 50 can be illustrated in the best way by FIGS. 6, 12 and 18 and by the dimensions which are proposed there. However, due to the increasing complexity of the embodiments having varying dimensions, they are discussed in more detail below.
  • the width of the haptic element 38 gradually narrows on the plane 68-68 .
  • the anterior surface 62 Approximately toward the enlarged attachment portion 44, the anterior surface 62 has a width of about 1.2 1.4 mm.
  • the front surface 62 is preferably narrower by about 30 percent than the rear surface 64 which is preferably about 1.6 to 1.9 mm wide, as illustrated by the embodiments of the Figures 5, 11 and 17.
  • the anterior surface 62 has a width of about 1.0 to 1.2 mm .
  • the anterior surface 62 is preferably about 15 percent narrower than the posterior surface 64 which is preferably about 1.2 to 1.5 mm wide. As illustrated by the embodiments of FIGS. 7, 13 and 19, roughly towards the rounded free end 46, the anterior surface 62 and the posterior surface 64 have approximately the same width of approximately 0.5 to 1 , 0 mm.
  • the haptic element 38 has a uniform thickness all along the plane 66-66 parallel to the optical axis OA-OA.
  • the surface of the haptic internal edge 58 has a thickness of about 0.20 to 0.80 mm but, most preferably, about 0 , 34 to 0.48 mm.
  • the surface of the internal haptic edge 58 may alternatively be angular rather than perpendicular to the anterior surface of the IOL 62 and to the posterior surface of the IOL 64 for forming an acute internal anterior haptic edge 79 along the anterior surface of the IOL 62.
  • the surface of the external haptic edge 60 is angular rather than perpendicular to the anterior surface of IOL 62 and the posterior surface of IOL 64 to form an acute external posterior haptic edge 52 along the posterior surface of IOL 64.
  • the width of the haptic elements 38 can decrease on plane 68-68 while the thickness on plane 66-66 remains homogeneous.
  • LA LIO 12 is preferably produced with an optical portion 34 having a diameter of approximately 4.5 to 9.0 mm, but preferably approximately 5.0 to 6.0 mm and more precisely 6.0 mm and a thickness of about 0.2 mm to 1.0 mm, but preferably about 0.2 to 0.8 mm and more precisely 0.3 to 0.5 mm on the peripheral edge 36, as illustrated by the embodiment of FIG. 2.
  • the peripheral edge 36 of the optical portion 34 is angled rather than perpendicular with respect to the anterior surface of the IOL 62 and to the posterior surface of the IOL 64. By thus angulating the peripheral edge 36, an acute posterior optical edge 54 is formed along the posterior surface of the IOL, as best illustrated in FIGS. 10 and 16.
  • the peripheral edge 36 is arranged in the extension of the surface of the optical part 34.
  • the haptic elements 38 extend from the optical portion 34 in the form of an arc in general and their overall length increases or decreases as a function of the diameter of the otic portion 34. When the diameter of the optical portion 34 increases, the overall length of the haptic elements 38 decreases. Likewise, when the diameter of the optical portion 34 decreases, the overall length of the haptic elements 38 increases.
  • the haptic elements are formed to have a length of about 2.6 to 6.0 mm, but preferably about 3.4 to 5.5 mm and, more specifically, about 4.8 mm, measured between the center of the enlarged fixing portion 44 and the center of the rounded free end 46.
  • the IOL preferably measures between 1 1 and 13 mm in total, between the contact area 72 and the opposite contact area 72.
  • the IOL 12 is preferably positioned with the contact zones 72 of the external posterior haptic edges 52 in contact with the internal surfaces 48 of the lens capsule 18.
  • the haptic elements 38 of the IOL 12 are inclined outward to maintain constant contact between the contact zones 72 and the internal surfaces 48.
  • the central portions 50 of the haptic elements 38 are slightly bent inwards on the plane 68-68.
  • the central portions 50 therefore flex under the compressive forces because they have a reduced width compared to that of the enlarged fixing portions 44.
  • the haptic elements 38 bend at the central portions 50, the surfaces of the internal haptic edge 58 approach the external peripheral edge 36.
  • the external posterior haptic edges 52 preferably with the posterior optical edge 54 of the IOL 12 come into contact with the internal surfaces 48 of the lens capsule 18 to prevent OCP.
  • the outer posterior haptic edges 52 and the posterior optical edge 54 prevent OCP by serving as a barrier to cell migration and proliferation inside the lens 18. Therefore, when the IOL 12 is used as a refractive lens, obtains a stable and reliable refractive correction.
  • Materials suitable for the production of IOLs 12 include, but are not limited to, pliable or compressible materials such as silicone polymers, hydrocarbon and fluorinated hydrocarbon polymers, soft acrylic polymers without water content, with a low water content and with a high water content, polyesters, polyamides, polyurethane, silicone polymers with hydrophilic monomer units, polysiloxane elastomers containing fluorine and combinations thereof.
  • the preferred material for the production of LIO 12 according to the present invention is a hydrophilic or hydrophobic acrylic material such as those known to those skilled in the art.
  • Poly (hydroxyethyl methacrylate-co-hydroxyhexyl methacrylate) (poly (HEMA-co-HOHEXMA) and methyl methaciylate-hydroxyethyl methacrylate (MMA-HEMA) are the preferred hydrophilic acrylic materials useful for the manufacture of LIO 12 because of the contents of equilibrium water of between about 17 and about 27 percent by weight and the high refractive index of about 1.46 or more, which is higher than that of the aqueous humor of the eye, it i.e. 1.33.
  • a high refractive index is a desirable characteristic for the production of IOLs to impart high optical power with minimal optical thickness. By using a material with a high refractive index, visual acuity defects can be corrected using a thinner IOL.
  • Poly (HEMA-co-HOHEXMA) and MMA-HEMA are also desirable materials for the production of LIO 12 because of their mechanical strength which is suitable for withstanding considerable physical manipulation.
  • Poly (HEMA-co-HOHEXMA) and MMA-HEMA also have desirable memory properties suitable for the use of IOLs.
  • IOLs made from a material with good memory properties such as poly (HEMA-co-HOHEXMA) and MMA-HEMA unfold in an eye in a controlled rather than explosive way to take their predetermined shape. Explosive unfolding of IOLs is undesirable due to the potential damage to delicate tissue inside the eye.
  • Poly (HEMA-co-HOHEXMA) and MMA-HEMA also have non-deformability in the eye.
  • the LIO 12 can similarly be made from a variety of materials with varying physical characteristics.
  • the IOLs 12 can be manufactured to have an optical portion 34 made of a hydrophilic acrylic material with a high refractive index, haptic elements 38 made of a more rigid material than that of the optical portion 34 and contact zones 72 made of the same material as that of the optical portion 34 or of another material having a lower refractive index and a higher glass transition temperature.
  • the teachings of the present invention are preferably applied to soft or pliable IOLs made of a pliable or compressible material, it is also the same for lenses harder, less flexible made in a relatively rigid material such as polymethyl methyl acrylate (PMMA) having flexible haptics made either in the same material or in a different material.
  • PMMA polymethyl methyl acrylate
  • the optical portion 34 of the IOL 12 can be a lens with positive power between 0 and approximately +40 diopters or a lens with negative power between 0 and approximately -30 diopters.
  • the optical portion 34 can be biconvex, piano-convex, piano-concave, biconcave or concave-convex (meniscus) depending on the power necessary to obtain the central and peripheral thickness for efficient handling.
  • the optical portion 34 of the IOL 12 can be formed with a brightness reduction zone 74 having a width of about 0.25 to 0.75 mm but preferably about 0.3 to 0.6 mm and most preferably 0.5 mm adjacent to the outer peripheral edge 36 for reduced brightness when the outer peripheral edge 36 of the IOL 12 is struck by the light which enters the eye 10 in high light or at other times when pupil 76 is dilated.
  • the brightness reduction zone 74 is typically made of the same material as that of the optical portion 34, but it can be opaque, colored or conventionally designed to block or scatter light in the plane having the optical axis OA-OA.
  • LIO 12 is preferably manufactured by first producing discs of one or more materials from one or more selected materials as described in US Pat. Nos. 5,217,491 and 5,326,506. The IOL 12 can then be machined from the material discs in a conventional manner. Once machined, the IOL 12 can be polished, cleaned, sterilized and packaged using a conventional process known to those skilled in the art.
  • the IOL 12 is used in the eye 10 by making an incision in the cornea 14 and by inserting the IOL 12 in the posterior chamber 24 and by closing the incision according to the methods known to those skilled in the art.
  • IOL 12 can preferably be used in the eye 10 by making an incision in the cornea 14 and the lens capsule 18, extracting the natural lens, inserting the IOL 12 into the lens capsule 18 and closing the incision according to methods known to those skilled in the art.
  • the IOL 12 according to the present invention provides a refractive lens suitable for use in the lens capsule 18 or in the posterior chamber 24, but preferably in the lens capsule 18 because of its OCP preventive characteristics.
  • the IOL 12 has haptic elements 38 of similar shape to minimize or eliminate the decentering of the LIO 12 and the distortion of vision. The similar shape of the haptic elements 38 similarly allows the rotation of the IOL 12 for better positioning and better adjustment inside the lens capsule 18.
  • This better fitting inside the lens capsule 18 has an advantage because one or a few lens sizes suitably fit most eye dimensions 10.
  • a "universal" lens such as that according to the present invention, clinical risks for patients are minimized by poorly dimensioned lenses.
  • the need for manufacturers to produce many sizes of IOLs to adjust them to the many dimensions of eyes is eliminated, thereby reducing the costs of production of storage which result therefrom.
  • IOL 12 also benefit from IOL 12 in that they save time by eliminating the need to determine the size of each patient's eye and the costs associated with maintaining large stocks of lenses of various sizes.
  • Another characteristic of the IOL 12 illustrated by the embodiment of FIG. 14 is one or more, but preferably between one and three surface edge grooves 78.
  • the surface edge grooves 78 allow more complete surgical irrigation, and thus better cleaning of the viscoelastic residues and residues of crystalline cortex inside the lens capsule 18.
  • a fluid is circulated inside the lens capsule 18 to remove viscoelastic and various other residues.
  • the edge surface grooves 78 improve the circulation of the fluid by providing a clear path for the passage of the fluid. We therefore proceed to a more complete cleaning inside the lens capsule 18 using this reinforced fluid circulation.

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  • Engineering & Computer Science (AREA)
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  • Prostheses (AREA)

Abstract

The invention concerns an intraocular refractive lens comprising an optic portion (34) with an outer peripheral edge (36) and one or more, preferably two, three or four equidistant haptic elements (38). Each haptic element (38) has the same shape, with a trapezoid or rhomboid cross-section. The edge of the outer rear surface of each haptic element (38) and the edge of the rear optic element are shaped like acute angles to prevent posterior capsular opacification.

Description

Lentilles intraoculaires munies de bords angulés pour prévenir une opacification capsulaire postérieure.Intraocular lenses with angled edges to prevent posterior capsular clouding.
La présente invention concerne des lentilles intraoculaires (LIO) et une méthode pour fabriquer et utiliser ces dernières. Plus particulièrement, la présente invention concerne des LIO avec des bords angulés pour prévenir une opacification capsulaire postérieure dans des yeux aphaques desquels la lentille naturelle de l'œil a été extraite chirurgicalement.The present invention relates to intraocular lenses (IOLs) and a method of making and using them. More particularly, the present invention relates to IOLs with angled edges to prevent posterior capsular clouding in aphakic eyes from which the natural lens of the eye has been surgically removed.
L'extraction de la cataracte fait partie des opérations les plus couramment réalisées aux Etats Unis et dans le monde. Le cristallin oculaire est situé à l'intérieur d'un sac dit capsulaire ou capsule de cristallin situé dans la chambre postérieure de l'œil. Pour avoir accès à un cristallin atteint de cataracte, on procède de manière usuelle à une incision dans le limbe de l'œil afin d'introduire un instrument chirurgical dans la chambre antérieure de l'œil. Dans le cas de l'extraction de la cataracte extracapsulaire, on suit une procédure capsulo-hexis dans laquelle une portion d'une membrane antérieure de la capsule du cristallin adjacente à l'iris de l'œil est extraite à l'aide d'un instrument chirurgical coupant afin de ménager un accès direct au cristallin atteint de cataracte à partir de la chambre antérieure. Le cristallin atteint de cataracte est alors extrait à l'aide de diverses méthodes connues, y compris la phaco-émulsiflcation. La phaco- émulsification est une procédure qui implique l'application d'énergie ultrasonique sur le cristallin atteint de cataracte afin de casser le cristallin en petits morceaux qui peuvent être aspirés à partir de la capsule du cristallin. A l'exception de la portion de la membrane antérieure de la capsule du cristallin extraite pendant la procédure de capsulo-hexis, la capsule du cristallin reste essentiellement intacte pendant toute la durée d'une extraction de la cataracte extracapsulaire. A la suite de l'extraction du cristallin atteint de cataracte, un implant artificiel de lentille intraoculaire (LIO), comme discuté plus en détail ci- dessous, est implanté de manière caractéristique à l'intérieur de la capsule du cristallin afin d'imiter la fonction refractive du cristallin naturel extrait. On utilise depuis des années des implants de la LIO dans les yeux aphaques dans lesquels le cristallin naturel de l'œil a été extrait. De nombreuses conceptions différentes de la LIO ont été mises au point au cours des années passées et ont été utilisées avec succès dans les yeux aphaques. A l'heure actuelle, les conceptions de LIO couronnées de succès comprennent principalement une portion optique avec ses supports, appelés haptiques, reliés à et entourant au moins une partie de la portion optique. Les portions haptiques d'une LIO sont conçues pour soutenir la portion optique de la LIO dans la capsule du cristallin, la chambre antérieure ou la chambre postérieure d'un œil. Des LIO ayant un succès commercial ont été fabriquées à partir d'une variété de matières biocompatibles, allant des matières plus rigides telles que le polyméthylméthacrylate (PMMA) aux matières plus souples capables d'être pliées ou comprimées telles que les silicones et certains acryliques. Des portions haptiques des LIO ont été formées séparément à partir de la portion optique puis postérieurement reliée à cette portion par des procédés tels que la chaleur, l'agrafage physique et/ ou le collage chimique. Les LIO avec des haptiques attachées de cette manière sont communément appelées LIO "multi-pièces". Les LIO sont aussi communément produites avec des haptiques formées comme une partie intégrante de la portion optique dans ce qu'on appelle communément les LIO "monobloc".Cataract extraction is one of the most commonly performed operations in the United States and around the world. The eye lens is located inside a so-called capsular bag or lens capsule located in the posterior chamber of the eye. To gain access to a lens affected by cataracts, an incision is made in the limbus of the eye in order to introduce a surgical instrument into the anterior chamber of the eye. In the case of extracapsular cataract extraction, a capsulo-hexis procedure is followed in which a portion of an anterior membrane of the lens capsule adjacent to the iris of the eye is extracted using a cutting surgical instrument to provide direct access to the lens with cataracts from the anterior chamber. The lens with cataracts is then extracted using various known methods, including phacoemulsification. Phacoemulsification is a procedure that involves applying ultrasonic energy to the lens with cataracts to break the lens into small pieces that can be aspirated from the lens capsule. With the exception of the portion of the anterior membrane of the lens capsule removed during the capsulo-hexis procedure, the lens capsule remains essentially intact for the duration of an extracapsular cataract extraction. Following the extraction of the lens affected by cataracts, an implant artificial intraocular lens (IOL), as discussed in more detail below, is typically implanted within the lens capsule to mimic the refractive function of the extracted natural lens. Implants of the IOL have been used for years in the aphakic eyes from which the natural lens of the eye has been extracted. Many different designs of the IOL have been developed in the past few years and have been used successfully in the eyes of the apostle. At present, successful IOL designs mainly include an optical portion with its supports, called haptics, connected to and surrounding at least part of the optical portion. The haptic portions of an IOL are designed to support the optical portion of the IOL in the lens capsule, the anterior chamber, or the posterior chamber of an eye. Commercially successful IOLs have been made from a variety of biocompatible materials, ranging from stiffer materials such as polymethylmethacrylate (PMMA) to more flexible materials capable of being folded or compressed such as silicones and certain acrylics. Haptic portions of the IOLs were formed separately from the optical portion and then subsequently connected to this portion by processes such as heat, physical stapling and / or chemical bonding. LIOs with haptics attached in this way are commonly called "multi-room" LIOs. IOLs are also commonly produced with haptics formed as an integral part of the optical portion in what is commonly called "monoblock" IOLs.
Les LIO plus molles, plus souples ont connu une popularité grandissante au cours des dernières années en raison de leur aptitude à la compression, au pliage, au roulage ou à d'autres déformations. Ces LIO plus molles peuvent être déformées avant leur insertion à travers une incision dans la cornée de l'œil. A la suite de l'insertion de la LIO dans l'œil, la LIO retrouve sa forme originale d'avant la déformation en raison des caractéristiques de mémoire de la matière molle.Softer, softer IOLs have grown in popularity in recent years due to their ability to compress, bend, roll or otherwise deform. These softer IOLs can be deformed before their insertion through an incision in the cornea of the eye. Following the insertion of the IOL in the eye, the IOL returns to its original form before deformation due to the memory characteristics of soft matter.
Des LIO plus molles, plus souples comme celles qui viennent d'être décrites peuvent être implantées dans un œil à travers une incision qui est beaucoup plus petite, c'est-à-dire 2,8 à 3,2 mm, que celle nécessaire pour les LIO plus rigides, c'est-à-dire 4,8 à 6,0 mm. Une incision plus grande est nécessaire pour les LIO plus rigides parce que la lentille doit être insérée à travers une incision dans la cornée légèrement plus grande que celle du diamètre de la portion optique de la LIO rigide. Par conséquent, les LIO plus rigides sont devenues moins populaires sur le marché car on s'est rendu compte que des incisions plus grandes sont associées à une incidence accrue de complications post-opératoires telles que l'astigmatisme induit.Softer, more flexible IOLs such as those just described can be implanted in one eye through an incision which is much smaller, i.e. 2.8 to 3.2 mm, than that necessary for more rigid IOLs, i.e. 4.8 to 6.0 mm. A larger incision is necessary for more rigid IOLs because the lens must be inserted through an incision in the cornea slightly larger than that of the diameter of the optical portion of the rigid IOL. As a result, stiffer IOLs have become less popular in the market as it has been found that larger incisions are associated with an increased incidence of post-operative complications such as induced astigmatism.
Bien que l'extraction de la partie atteinte de cataracte avec remplacement par implant de la LIO offre des avantages considérables à la plupart des patients ayant une cataracte, cela n'est pas toujours le cas. On estime que jusqu'à trente pour cent (30%) de tous les patients qui reçoivent un implant de LIO à l'intérieur de la capsule du cristallin de l'œil développent ensuite une opacification capsulaire postérieure (OCP) ou des cataractes secondaires dans les cinq années qui suivent l'intervention chirurgicale. L'OCP est une opacification des implants de LIO causée par le dépôt de cellules et de fibres sur la surface postérieure de l'implant de la LIO et sur la membrane capsulaire postérieure. Ces dépôts de cellules et de fibres obstruent le passage de lumière à travers l'implant de la LIO et obscurcissent la vision du patient. La principale cause de l'OCP est la migration et la prolifération des cellules épithéliales résiduelles de lentille sur la membrane capsulaire.Although removal of the implanted cataract portion of the IOL offers considerable benefits to most cataract patients, this is not always the case. It is estimated that up to thirty percent (30%) of all patients who receive an IOL implant inside the lens capsule of the eye then develop posterior capsular clouding (OCP) or secondary cataracts in the five years after surgery. OCP is a clouding of IOL implants caused by the deposition of cells and fibers on the posterior surface of the IOL implant and on the posterior capsular membrane. These cell and fiber deposits obstruct the passage of light through the IOL implant and obscure the patient's vision. The main cause of OCP is the migration and proliferation of residual lens epithelial cells on the capsular membrane.
En raison des insuffisances observées des conceptions passées et actuelles des LIO, il existe un besoin en implants de LIO conçus pour prévenir L'OCP. Les lentilles intraoculaires (LIO) fabriquées selon la présente invention ont une portion optique ayant un bord périphérique externe et deux ou plus, mais de préférence deux, trois ou quatre éléments haptiques équidistants pour soutenir la portion optique dans un œil de patient. De préférence, chacun des éléments haptiques est de forme semblable pour obtenir un effet "d'hélice" pour faciliter l'implantation, la rotation et le centrage de la LIO. L'effet d'hélice améliore également l'accessibilité à l'intérieur de la capsule pour nettoyer les restes corticaux. Chacun des éléments haptiques possède une portion interne et une portion externe. La portion interne de chaque élément haptique comprend une portion de fixation élargie reliée en permanence au bord périphérique externe de la portion optique. La portion externe de chaque élément haptique comprend une extrémité libre arrondie. Chaque élément haptique comprend une portion centrale allongée en forme d'arc qui s'étend entre la portion de fixation élargie et l'extrémité libre arrondie. A partir de la portion de fixation élargie et tout le long de la portion centrale allongée en forme d'arc, les dimensions de l'élément haptique peuvent être stables ou peuvent varier. La forme angulaire particulière des éléments haptiques permet la rotation des LIO et prévient l'opacification capsulaire postérieure.Due to the observed shortcomings of past and current IOL designs, there is a need for IOL implants designed to prevent OCP. Intraocular lenses (IOLs) made in accordance with the present invention have an optical portion having an outer peripheral edge and two or more, but preferably two, three or four equidistant haptic elements to support the optical portion in a patient's eye. Preferably, each of the haptic elements is of similar shape to obtain a "helix" effect to facilitate the implantation, rotation and centering of the IOL. The helix effect also improves accessibility inside the capsule for cleaning cortical remains. Each of the haptic elements has an internal portion and an external portion. The internal portion of each haptic element comprises an enlarged fixing portion permanently connected to the external peripheral edge of the optical portion. The outer portion of each haptic element includes a rounded free end. Each haptic element comprises an elongated central portion in the form of an arc which extends between the enlarged fixing portion and the rounded free end. From the enlarged fixing portion and all along the elongated central portion in the form of an arc, the dimensions of the haptic element may be stable or may vary. The particular angular shape of the haptic elements allows the rotation of the IOLs and prevents posterior capsular clouding.
Par conséquent, un objet de la présente invention est de proposer des lentilles intraoculaires à utiliser dans des yeux aphaques.Therefore, an object of the present invention is to provide intraocular lenses for use in aphakic eyes.
Un autre objet de la présente invention est de proposer des lentilles intraoculaires à utiliser dans des yeux aphaques capables d'être implantées à travers une petite incision.Another object of the present invention is to provide intraocular lenses for use in aphakic eyes capable of being implanted through a small incision.
Un autre objet de la présente invention est de proposer des lentilles intraoculaires qui préviennent l'opacification capsulaire postérieure.Another object of the present invention is to provide intraocular lenses which prevent posterior capsular clouding.
Un autre objet de la présente invention est de proposer des lentilles intraoculaires qui permettent une plus grande facilité d'implantation, de rotation et de centrage desdites lentilles. Un autre objet de la présente invention est de proposer des lentilles intraoculaires qui sont biocompatibles pour être utilisées dans des yeux aphaques.Another object of the present invention is to provide intraocular lenses which allow greater ease of implantation, rotation and centering of said lenses. Another object of the present invention is to provide intraocular lenses which are biocompatible for use in aphakic eyes.
Encore un autre objet de la présente invention est de proposer des lentilles intraoculaires qui sont résistantes au décentrage à l'intérieur des yeux.Yet another object of the present invention is to provide intraocular lenses which are resistant to decentering inside the eyes.
Ces objets et d'autres objectifs et avantages selon la présente invention, dont quelques uns sont décrits de manière spécifique et d'autres non, vont être mise en évidence dans la description détaillée, dans les dessins et les revendications ci-après, dans lesquels les mêmes caractéristiques sont désignées par les mêmes chiffres.These objects and other objectives and advantages according to the present invention, some of which are described in a specific manner and others not, will be demonstrated in the detailed description, in the drawings and the claims below, in which the same characteristics are designated by the same numbers.
La figure 1 est une représentation schématique de l'intérieur d'un œil humain comprenant un cristallin naturel et une LIO réfringente implantée dans la capsule du cristallin de l'œil; La figure 2 est une vue en plan d'une LIO avec deux haptiques fabriqués selon la présente invention;Figure 1 is a schematic representation of the interior of a human eye comprising a natural lens and a refractive IOL implanted in the lens capsule of the eye; Figure 2 is a plan view of an IOL with two haptics made in accordance with the present invention;
La figure 3 est une vue latérale de la LIO de la figure 2;Figure 3 is a side view of the IOL of Figure 2;
La figure 4 est une vue en coupe transversale d'une partie optique de la LIO de la figure 2 prise le long de la ligne 4-4; La figure 5 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 2 prise le long de la ligne 5-5;Figure 4 is a cross-sectional view of an optical portion of the IOL of Figure 2 taken along line 4-4; Figure 5 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 5-5;
La figure 6 est une vue transversale d'un élément haptique de la LIO de la figure 2 prise le long de la ligne 6-6;Figure 6 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 6-6;
La figure 7 est une vue transversale d'un élément haptique de la LIO de la figure 2 prise le long de la ligne 7-7;Figure 7 is a cross-sectional view of a haptic element of the IOL of Figure 2 taken along line 7-7;
La figure 8 est une vue en plan d'un autre mode de réalisation d'une LIO avec deux haptiques fabriqués selon la présente invention;Figure 8 is a plan view of another embodiment of an IOL with two haptics made in accordance with the present invention;
La figure 9 est une vue latérale de la LIO de la figure 8;Figure 9 is a side view of the IOL of Figure 8;
La figure 10 est une vue en coupe transversale d'une partie otique de la LIO de la figure 8 prise le long de la ligne 10- 10; La figure 11 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 8 prise le long de la ligne 11-11;Figure 10 is a cross-sectional view of an otic part of the IOL of Figure 8 taken along line 10-10; Figure 11 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along line 11-11;
La figure 12 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 8 prise le long de la ligne 12- 12; La figure 13 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 8 prise le long de la ligne 13-13;Figure 12 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along the line 12-12; Figure 13 is a cross-sectional view of a haptic element of the IOL of Figure 8 taken along line 13-13;
La figure 14 est une vue en plan d'un autre mode de réalisation d'une LIO avec trois haptiques fabriqués selon la présente invention;Figure 14 is a plan view of another embodiment of an IOL with three haptics made in accordance with the present invention;
La figure 15 est une vue latérale de la LIO de la figure 14; La figure 16 est une vue en coupe transversale d'une partie otique de la LIO de la figure 14 prise le long de la ligne 16- 16;Figure 15 is a side view of the IOL of Figure 14; Figure 16 is a cross-sectional view of an otic part of the IOL of Figure 14 taken along line 16-16;
La figure 17 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 14 prise le long de la ligne 17- 17;Figure 17 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 17-17;
La figure 18 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 14 prise le long de la ligne 18-18; etFigure 18 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 18-18; and
La figure 19 est une vue en coupe transversale d'un élément haptique de la LIO de la figure 14 prise le long de la ligne 19- 19.Figure 19 is a cross-sectional view of a haptic element of the IOL of Figure 14 taken along line 19-19.
La figure 1 est une vue schématique d'un œil 10 montrant les structures qui sont en rapport avec l'implantation de lentilles intraoculaires (LIO) 12 selon la présente invention. L'œil 10 comprend une cornée optiquement claire 14 et un iris 16. Une capsule de cristallin 18 et une rétine 20 sont placées derrière l'iris 16 de l'œil 10. L'œil 10 comprend également une chambre antérieure 22 située devant l'iris 16 et une chambre postérieure 24 située entre l'iris 16 et la capsule du cristallin 18. La LIO 12 est, de préférence, implantée dans la capsule du cristallin 18 de l'oeil aphaque. Lorsqu'elles sont utilisées dans des yeux aphaques, les LIO 12 servent à remplacer les cristallins naturels malades extraits chirurgicalement, par exemple à la suite d'une opération de la cataracte. L'œil 10 comprend également un axe optique OA-OA qui est une ligne imaginaire passant à travers le centre optique 28 de la surface antérieure 30 et de la surface postérieure 32 de la capsule du cristallin 18. L'axe optique OA-OA dans l'œil humain 10 est généralement perpendiculaire à une portion de la cornée 14, à la capsule du cristallin 18 et à la rétine 20. Les LIO selon la présente invention, représentées sur les figures 2, 8 et 14, généralement désignées par le chiffre de référence 12, sont conçues pour être implantées de préférence dans la capsule du cristallin 18 d'un œil aphaque. La LIO 12 a une portion optique 34 avec un bord périphérique externe 36. Deux ou plus, mais de préférence deux, trois ou quatre éléments haptiques équidistants 38 sont formés de préférence solidairement sur le bord périphérique 36 de la portion optique 34. Chaque élément haptique 38 a une forme semblable pour obtenir une apparence "d'hélice" pour faciliter la rotation et le centrage de la LIO 12 pendant l'implantation à l'intérieur de l'œil 10 et pour obtenir la rotation de la LIO 12 comme décrit plus en détail ci-dessous.Figure 1 is a schematic view of an eye 10 showing the structures which are related to implantation of intraocular lenses (IOL) 12 according to the present invention. The eye 10 comprises an optically clear cornea 14 and an iris 16. A lens capsule 18 and a retina 20 are placed behind the iris 16 of the eye 10. The eye 10 also comprises an anterior chamber 22 situated in front of the iris 16 and a posterior chamber 24 located between the iris 16 and the lens capsule 18. The IOL 12 is preferably implanted in the lens capsule 18 of the aphakic eye. When used in aphakic eyes, IOLs 12 are used to replace diseased natural lenses that have been surgically removed, for example after cataract surgery. The eye 10 also includes an optical axis OA-OA which is an imaginary line passing through the center optic 28 of the anterior surface 30 and the posterior surface 32 of the lens capsule 18. The optical axis OA-OA in the human eye 10 is generally perpendicular to a portion of the cornea 14, to the lens capsule 18 and to the retina 20. The IOLs according to the present invention, represented in FIGS. 2, 8 and 14, generally designated by the reference numeral 12, are designed to be implanted preferably in the lens capsule 18 of an aphakic eye. . The IOL 12 has an optical portion 34 with an outer peripheral edge 36. Two or more, but preferably two, three or four equidistant haptic elements 38 are preferably formed integrally on the peripheral edge 36 of the optical portion 34. Each haptic element 38 has a similar shape to obtain a "helix" appearance to facilitate rotation and centering of IOL 12 during implantation inside the eye 10 and to obtain rotation of IOL 12 as described more in detail below.
Chaque élément haptique 38 est fabriqué de façon à avoir une portion interne 40 et une portion externe 42. La portion interne 40 de chaque élément haptique 38 comprend une portion de fixation élargie 44 de préférence formée solidairement et reliée en permanence avec le bord périphérique externe 36 de la portion optique 34. En variante, cependant, la portion de fixation élargie 44 de chaque élément haptique 38 peut être fixée en permanence à la portion optique 34 par agrafage, polymérisation chimique ou par d'autres méthodes connues de l'homme du métier. Chaque élément haptique 38 comprend également sur la portion externe 42 une extrémité libre arrondie 46 conçue pour éviter le contact avec les surfaces internes 48 de la capsule du cristallin 18 de l'œil aphaque 10.Each haptic element 38 is manufactured so as to have an internal portion 40 and an external portion 42. The internal portion 40 of each haptic element 38 comprises an enlarged fixing portion 44 preferably formed integrally and permanently connected with the external peripheral edge 36 of the optical portion 34. As a variant, however, the enlarged fixing portion 44 of each haptic element 38 can be permanently fixed to the optical portion 34 by stapling, chemical polymerization or by other methods known to those skilled in the art. . Each haptic element 38 also comprises on the external portion 42 a rounded free end 46 designed to avoid contact with the internal surfaces 48 of the lens capsule 18 of the aphakic eye 10.
Les éléments haptiques 38 sont formés avec des portions centrales allongées en forme d'arc 50 qui s'étendent entre les portions de fixation élargies 44 et les extrémités libres 46. Comme illustré de la meilleure manière sur les figures 5-7, 11-13 et 17- 19, à partir de la portion de fixation élargie 44 et tout le long de la portion centrale allongée en forme d'arc 50, la section transversale de l'élément haptique 38 a une forme trapézoïdale ou, en variante, rhomboïde pour obtenir les caractéristiques souhaitées de prévention de l'OCP.The haptic elements 38 are formed with elongated, arcuate central portions 50 which extend between the enlarged attachment portions 44 and the free ends 46. As best illustrated in Figures 5-7, 11-13 and 17-19, from the enlarged fixing portion 44 and all along the elongated central portion in in the form of an arc 50, the cross section of the haptic element 38 has a trapezoidal or, alternatively, rhomboid shape in order to obtain the desired characteristics for preventing OCP.
Comme on le voit aux figures 5 à 7, la section de l'élément haptique 38 selon les lignes 5/5, 6/6 et 7/7 sont trapézoïdales, le côté extérieur 60 du trapèze comportant à sa partie inférieure un angle aigu 52 et à sa partie supérieure une angle obtus 71.As seen in Figures 5 to 7, the section of the haptic element 38 along lines 5/5, 6/6 and 7/7 are trapezoidal, the outer side 60 of the trapezoid having at its lower part an acute angle 52 and at its upper part an obtuse angle 71.
La forme particulière des éléments haptiques 38 produit deux effets : d'une part grâce au bord haptique aigu 52, la migration des cellules capsulaires le long de la surface postérieure 32 est bloquée et d'autre part grâce au bord haptique antérieur externe obtus 71 , l'obturation rapide entre la surface antérieure 30 et la surface postérieure 32 est possible. Cette obturation provient du phénomène connu sous le nom de symphyse selon lequel, lorsque le sac capsulaire a été vidé, les deux parois 30 et 32 dudit sac se collent l'une contre l'autre. Lorsqu'elles sont ainsi coller, il n'y a plus de migration des cellules capsulaires.The particular shape of the haptic elements 38 produces two effects: on the one hand thanks to the acute haptic edge 52, the migration of the capsular cells along the posterior surface 32 is blocked and on the other hand thanks to the obtuse external anterior haptic edge 71, rapid shuttering between the anterior surface 30 and the posterior surface 32 is possible. This closure comes from the phenomenon known as symphysis according to which, when the capsular bag has been emptied, the two walls 30 and 32 of said bag stick against one another. When they are so stick, there is no more migration of the capsular cells.
De préférence l'angle aigu 52 est compris entre 10 et 45°.Preferably the acute angle 52 is between 10 and 45 °.
L'élément haptique 38 peut être stable ou ses dimensions peuvent varier à partir de la portion de fixation élargie 44 et tout le long de la portion centrale 50 sur le plan 68-68 sensiblement perpendiculaire à l'axe optique OA-OA. Les éléments haptiques 38 avec des dimensions régulières à partir de la portion de fixation élargie 44 et tout le long de la portion centrale 50 peuvent être illustrés de la meilleure manière par les figures 6, 12 et 18 et par les dimensions qui y sont proposées. Cependant, en raison de la complexité croissante des modes de réalisation ayant des dimensions variables, ils sont traités plus en détail ci-dessous.The haptic element 38 can be stable or its dimensions can vary from the enlarged fixing portion 44 and all along the central portion 50 on the plane 68-68 substantially perpendicular to the optical axis OA-OA. The haptic elements 38 with regular dimensions from the enlarged fixing portion 44 and all along the central portion 50 can be illustrated in the best way by FIGS. 6, 12 and 18 and by the dimensions which are proposed there. However, due to the increasing complexity of the embodiments having varying dimensions, they are discussed in more detail below.
Dans les modes de réalisation avec des éléments haptiques dont les dimensions varient, à partir de la portion de fixation élargie 44 jusqu'à l'extrémité libre arrondie 46, la largeur de l'élément haptique 38 se rétrécit graduellement sur le plan 68-68. A peu près vers la portion de fixation élargie 44, la surface antérieure 62 a une largeur d'environ 1 ,2 à 1,4 mm. La surface antérieure 62 est, de préférence, plus étroite d'environ 30 pour cent que la surface postérieure 64 qui a, de préférence, une largeur d'environ 1,6 à 1 ,9 mm, comme illustré par les modes de réalisation des figures 5, 11 et 17. Comme illustré par les modes de réalisation des figures 6, 12 et 18, à peu près a la mi- section 56, la surface antérieure 62 a une largeur d'environ 1,0 à 1,2 mm. La surface antérieure 62 est, de préférence, plus étroite d'environ 15 pour cent que la surface postérieure 64 qui a, de préférence, une largeur d'environ 1 ,2 à 1 ,5 mm. Comme illustré par les modes de réalisation des figures 7, 13 et 19, à peu près vers l'extrémité libre arrondie 46, la surface antérieure 62 et la surface postérieure 64 ont a peu près la même largeur d'environ 0,5 à 1 ,0 mm.In the embodiments with haptic elements whose dimensions vary, from the enlarged fixing portion 44 to the rounded free end 46, the width of the haptic element 38 gradually narrows on the plane 68-68 . Approximately toward the enlarged attachment portion 44, the anterior surface 62 has a width of about 1.2 1.4 mm. The front surface 62 is preferably narrower by about 30 percent than the rear surface 64 which is preferably about 1.6 to 1.9 mm wide, as illustrated by the embodiments of the Figures 5, 11 and 17. As illustrated by the embodiments of Figures 6, 12 and 18, approximately at mid-section 56, the anterior surface 62 has a width of about 1.0 to 1.2 mm . The anterior surface 62 is preferably about 15 percent narrower than the posterior surface 64 which is preferably about 1.2 to 1.5 mm wide. As illustrated by the embodiments of FIGS. 7, 13 and 19, roughly towards the rounded free end 46, the anterior surface 62 and the posterior surface 64 have approximately the same width of approximately 0.5 to 1 , 0 mm.
En allant de la portion de fixation élargie 44 vers l'extrémité libre arrondie 46, l'élément haptique 38 a une épaisseur homogène tout le long du plan 66-66 parallèlement à l'axe optique OA-OA. Comme illustré par les modes de réalisation des figures 5-7 et 17-19, la surface du bord interne haptique 58 a une épaisseur d'environ 0,20 à 0,80 mm mais, de manière préférée entre toutes, d'environ 0,34 à 0,48 mm. Comme illustré par les modes de réalisation des figures 11-13, la surface du bord interne haptique 58 peut, en variante, être angulaire plutôt que perpendiculaire par rapport à la surface antérieure de la LIO 62 et à la surface postérieure de la LIO 64 pour former un bord haptique antérieur interne aigu 79 le long de la surface antérieure de la LIO 62. La surface du bord externe haptique 60, comme illustré par les modes de réalisation des figures 5-7, 11- 13 et le- 19, est angulaire plutôt que perpendiculaire par rapport à la surface antérieure de la LIO 62 et à la surface postérieure de la LIO 64 pour former un bord haptique postérieur externe aigu 52 le long de la surface postérieure de la LIO 64. De manière générale, lorsque l'on va de la portion de fixation élargie 44 vers les portions externes 42, la largeur des éléments haptiques 38 peut diminuer sur le plan 68-68 alors que l'épaisseur sur le plan 66-66 reste homogène.Going from the enlarged fixing portion 44 towards the rounded free end 46, the haptic element 38 has a uniform thickness all along the plane 66-66 parallel to the optical axis OA-OA. As illustrated by the embodiments of Figures 5-7 and 17-19, the surface of the haptic internal edge 58 has a thickness of about 0.20 to 0.80 mm but, most preferably, about 0 , 34 to 0.48 mm. As illustrated by the embodiments of Figures 11-13, the surface of the internal haptic edge 58 may alternatively be angular rather than perpendicular to the anterior surface of the IOL 62 and to the posterior surface of the IOL 64 for forming an acute internal anterior haptic edge 79 along the anterior surface of the IOL 62. The surface of the external haptic edge 60, as illustrated by the embodiments of Figures 5-7, 11-13 and le- 19, is angular rather than perpendicular to the anterior surface of IOL 62 and the posterior surface of IOL 64 to form an acute external posterior haptic edge 52 along the posterior surface of IOL 64. Generally, when goes from the enlarged fixing portion 44 towards the external portions 42, the width of the haptic elements 38 can decrease on plane 68-68 while the thickness on plane 66-66 remains homogeneous.
LA LIO 12 est fabriquée de préférence avec une portion optique 34 ayant un diamètre d'environ 4,5 à 9,0 mm, mais de préférence d'environ 5,0 à 6,0 mm et plus précisément de 6,0 mm et une épaisseur d'environ 0,2 mm à 1 ,0 mm, mais de préférence d'environ 0,2 à 0,8 mm et plus précisément de 0,3 à 0,5 mm sur le bord périphérique 36, comme illustré par le mode de réalisation de la figure 2. En variante, comme illustré par les modes de réalisation des figures 8 et 14, le bord périphérique 36 de la portion optique 34 est angulé plutôt que perpendiculaire par rapport à la surface antérieure de la LIO 62 et à la surface postérieure de la LIO 64. En angulant ainsi le bord périphérique 36, on forme un bord optique postérieur aigu 54 le long de la surface postérieure de la LIO, comme illustré de la meilleure manière sur les figures 10 et 16.LA LIO 12 is preferably produced with an optical portion 34 having a diameter of approximately 4.5 to 9.0 mm, but preferably approximately 5.0 to 6.0 mm and more precisely 6.0 mm and a thickness of about 0.2 mm to 1.0 mm, but preferably about 0.2 to 0.8 mm and more precisely 0.3 to 0.5 mm on the peripheral edge 36, as illustrated by the embodiment of FIG. 2. As a variant, as illustrated by the embodiments of FIGS. 8 and 14, the peripheral edge 36 of the optical portion 34 is angled rather than perpendicular with respect to the anterior surface of the IOL 62 and to the posterior surface of the IOL 64. By thus angulating the peripheral edge 36, an acute posterior optical edge 54 is formed along the posterior surface of the IOL, as best illustrated in FIGS. 10 and 16.
Comme on le voit à la figure 10, le bord périphérique 36 est disposé dans le prolongement de la surface de la partie optique 34.As can be seen in FIG. 10, the peripheral edge 36 is arranged in the extension of the surface of the optical part 34.
Les éléments haptiques 38 s'étendent à partir de la portion optique 34 en forme d'arc d'une façon générale et leur longueur hors tout augmente ou diminue en fonction du diamètre de la portion otique 34. Lorsque le diamètre de la portion optique 34 augmente, la longueur hors tout des éléments haptiques 38 diminue. De la même façon, lorsque le diamètre de la portion optique 34 diminue, la longueur hors tout des éléments haptiques 38 augmente. De manière générale, les éléments haptiques sont formés pour avoir une longueur d'environ 2,6 à 6,0 mm, mais de préférence d'environ 3,4 à 5,5 mm et, plus précisément, d'environ 4,8 mm, mesurée entre le centre de la portion de fixation élargie 44 et le centre de l'extrémité libre arrondie 46. LA LIO mesure de préférence entre 1 1 et 13 mm au total, entre la zone de contact 72 et la zone de contact opposée 72.The haptic elements 38 extend from the optical portion 34 in the form of an arc in general and their overall length increases or decreases as a function of the diameter of the otic portion 34. When the diameter of the optical portion 34 increases, the overall length of the haptic elements 38 decreases. Likewise, when the diameter of the optical portion 34 decreases, the overall length of the haptic elements 38 increases. Generally, the haptic elements are formed to have a length of about 2.6 to 6.0 mm, but preferably about 3.4 to 5.5 mm and, more specifically, about 4.8 mm, measured between the center of the enlarged fixing portion 44 and the center of the rounded free end 46. The IOL preferably measures between 1 1 and 13 mm in total, between the contact area 72 and the opposite contact area 72.
Lors de l'implantation, la LIO 12 est de préférence positionnée avec les zones de contact 72 des bords haptiques postérieurs externes 52 en contact avec les surfaces internes 48 de la capsule du cristallin 18. Les éléments haptiques 38 de la LIO 12 sont inclinés vers l'extérieur pour maintenir un contact constant entre les zones de contact 72 et les surfaces internes 48. En positionnant ainsi la LIO 12 à l'intérieur de la capsule du cristallin 18, les portions centrales 50 des éléments haptiques 38 sont légèrement fléchies vers l'intérieur sur le plan 68-68. Les portions centrales 50 fléchissent donc sous les forces de compression du fait qu'elles ont une largeur réduite par rapport à celle des portions de fixation élargies 44. Lors de la flexion des éléments haptiques 38 aux portions centrales 50, les surfaces du bord haptique interne 58 se rapprochent du bord périphérique externe 36. Lors de l'implantation, les bords haptiques postérieurs externes 52, de préférence avec le bord optique postérieur 54 de la LIO 12 viennent au contact des surfaces internes 48 de la capsule du cristallin 18 pour prévenir l'OCP. Les bords haptiques postérieurs externes 52 et le bord optique postérieur 54 préviennent l'OCP en servant de barrière à la migration et à la prolifération cellulaire à l'intérieur du cristallin 18. Par conséquent, lorsque la LIO 12 est utilisée comme lentille réfringente, on obtient une correction réfringente stable et fiable. Les matières appropriées pour la production des LIO 12 comprennent, sans y être limitées, les matières pliables ou compressibles telles que les polymères de silicone, les polymères d'hydrocarbure et d'hydrocarbure fluoré, les polymères acryliques mous sans teneur en eau, avec une faible teneur en eau et avec une teneur élevée en eau, les polyesters, les polyamides, le polyuréthane, les polymères de silicone avec des motifs monomères hydrophiles, les élastomères de polysiloxane contenant du fluor et leurs combinaisons. La matière préférée pour la production de LIO 12 selon la présente invention est une matière acrylique hydrophile ou hydrophobe telle que celles connues de l'homme du métier. Le poly(hydroxyéthyle méthacrylate-co-hydroxyhexyle méthacrylate) (poly(HEMA-co-HOHEXMA) et le méthyle méthaciylate-hydroxyéthyle méthacrylate (MMA-HEMA) sont les matières acryliques hydrophiles préférées utiles pour la fabrication des LIO 12 en raison des teneurs en eau d'équilibre comprises entre environ 17 et environ 27 pour cent en poids et de l'indice de réfraction élevé d'environ 1 ,46 ou plus, qui est plus élevé que celui de l'humeur aqueuse de l'œil, c'est-à-dire 1 ,33. Un indice de réfraction élevé est une caractéristique souhaitable pour la production de LIO pour conférer une puissance optique élevée avec une épaisseur d'optique minimale. En utilisant une matière ayant un index de réfraction élevé, les défauts d'acuité visuelle peuvent être corrigés à l'aide d'une LIO plus mince. Le poly(HEMA-co-HOHEXMA) et le MMA- HEMA sont aussi des matières souhaitables pour la production de LIO 12 en raison de leur résistance mécanique qui est appropriée pour résister à une manipulation physique considérable. Le poly(HEMA-co- HOHEXMA) et le MMA-HEMA ont également des propriétés de mémoire souhaitables appropriées à l'utilisation des LIO. Les LIO fabriquées dans une matière possédant de bonnes propriétés de mémoire telles que celles du poly(HEMA-co-HOHEXMA)et du MMA-HEMA se déplient dans un oeil de manière contrôlée plutôt qu'explosive pour prendre leur forme prédéterminée. Le dépliage explosif des LIO n'est pas souhaitable en raison des dommages potentiels aux tissus délicats à l'intérieur de l'œil. Le poly(HEMA-co-HOHEXMA) et le MMA-HEMA ont également une indéformabilité dans l'œil.During implantation, the IOL 12 is preferably positioned with the contact zones 72 of the external posterior haptic edges 52 in contact with the internal surfaces 48 of the lens capsule 18. The haptic elements 38 of the IOL 12 are inclined outward to maintain constant contact between the contact zones 72 and the internal surfaces 48. By thus positioning the IOL 12 inside the lens capsule 18, the central portions 50 of the haptic elements 38 are slightly bent inwards on the plane 68-68. The central portions 50 therefore flex under the compressive forces because they have a reduced width compared to that of the enlarged fixing portions 44. When the haptic elements 38 bend at the central portions 50, the surfaces of the internal haptic edge 58 approach the external peripheral edge 36. During implantation, the external posterior haptic edges 52, preferably with the posterior optical edge 54 of the IOL 12 come into contact with the internal surfaces 48 of the lens capsule 18 to prevent OCP. The outer posterior haptic edges 52 and the posterior optical edge 54 prevent OCP by serving as a barrier to cell migration and proliferation inside the lens 18. Therefore, when the IOL 12 is used as a refractive lens, obtains a stable and reliable refractive correction. Materials suitable for the production of IOLs 12 include, but are not limited to, pliable or compressible materials such as silicone polymers, hydrocarbon and fluorinated hydrocarbon polymers, soft acrylic polymers without water content, with a low water content and with a high water content, polyesters, polyamides, polyurethane, silicone polymers with hydrophilic monomer units, polysiloxane elastomers containing fluorine and combinations thereof. The preferred material for the production of LIO 12 according to the present invention is a hydrophilic or hydrophobic acrylic material such as those known to those skilled in the art. Poly (hydroxyethyl methacrylate-co-hydroxyhexyl methacrylate) (poly (HEMA-co-HOHEXMA) and methyl methaciylate-hydroxyethyl methacrylate (MMA-HEMA) are the preferred hydrophilic acrylic materials useful for the manufacture of LIO 12 because of the contents of equilibrium water of between about 17 and about 27 percent by weight and the high refractive index of about 1.46 or more, which is higher than that of the aqueous humor of the eye, it i.e. 1.33. A high refractive index is a desirable characteristic for the production of IOLs to impart high optical power with minimal optical thickness. By using a material with a high refractive index, visual acuity defects can be corrected using a thinner IOL. Poly (HEMA-co-HOHEXMA) and MMA-HEMA are also desirable materials for the production of LIO 12 because of their mechanical strength which is suitable for withstanding considerable physical manipulation. Poly (HEMA-co-HOHEXMA) and MMA-HEMA also have desirable memory properties suitable for the use of IOLs. IOLs made from a material with good memory properties such as poly (HEMA-co-HOHEXMA) and MMA-HEMA unfold in an eye in a controlled rather than explosive way to take their predetermined shape. Explosive unfolding of IOLs is undesirable due to the potential damage to delicate tissue inside the eye. Poly (HEMA-co-HOHEXMA) and MMA-HEMA also have non-deformability in the eye.
De la même manière, les LIO 12 peuvent être fabriquées à l'aide d'une variété de matières ayant des caractéristiques physiques variées. Par exemple, les LIO 12 peuvent être fabriquées pour avoir une portion optique 34 faite en une matière acrylique hydrophile avec un index de réfraction élevé, des éléments haptiques 38 faits en une matière plus rigide que celle de la portion optique 34 et des zones de contact 72 faites de la même matière que celle de la portion optique 34 ou d'une autre matière ayant un index de réfraction plus faible et une température de transition du verre plus élevée. Bien que les enseignements de la présente invention soient de préférence appliqués aux LIO molles ou pliables faites dans une matière pliable ou compressible, il en est également de même pour les lentilles plus dures, moins souples faites dans une matière relativement rigide telle que le polyméthyle méthyacrylate (PMMA) possédant des haptiques souples faits soit dans la même matière soit dans une matière différente. La portion optique 34 de la LIO 12 peut être une lentille à puissance positive entre 0 et environ +40 dioptries ou une lentille à puissance négative entre 0 et environ -30 dioptries. La portion optique 34 peut être biconvexe, piano-convexe, piano-concave, biconcave ou concave- convexe (ménisque) en fonction de la puissance nécessaire pour obtenir l'épaisseur centrale et périphérique pour une manipulation efficace.LIO 12 can similarly be made from a variety of materials with varying physical characteristics. For example, the IOLs 12 can be manufactured to have an optical portion 34 made of a hydrophilic acrylic material with a high refractive index, haptic elements 38 made of a more rigid material than that of the optical portion 34 and contact zones 72 made of the same material as that of the optical portion 34 or of another material having a lower refractive index and a higher glass transition temperature. Although the teachings of the present invention are preferably applied to soft or pliable IOLs made of a pliable or compressible material, it is also the same for lenses harder, less flexible made in a relatively rigid material such as polymethyl methyl acrylate (PMMA) having flexible haptics made either in the same material or in a different material. The optical portion 34 of the IOL 12 can be a lens with positive power between 0 and approximately +40 diopters or a lens with negative power between 0 and approximately -30 diopters. The optical portion 34 can be biconvex, piano-convex, piano-concave, biconcave or concave-convex (meniscus) depending on the power necessary to obtain the central and peripheral thickness for efficient handling.
En option, la portion optique 34 de la LIO 12 peut être formée avec une zone de réduction d'éclat 74 ayant une largeur d'environ 0,25 à 0,75 mm mais de préférence d'environ 0,3 à 0,6 mm et de manière préférée entre toutes de 0,5 mm adjacente au bord périphérique externe 36 pou réduite l'éclat lorsque le bord périphérique externe 36 de la LIO 12 est frappé par la lumière qui pénètre dans l'œil 10 en cas de forte luminosité ou à d'autres moments quand la pupille 76 est dilatée. La zone de réduction d'éclat 74 est, de manière caractéristique, fabriquée dans la même matière que celle de la portion optique 34, mais elle peut être opaque, colorée ou conçue de manière conventionnelle pour bloquer ou diffuser la lumière dans le plan ayant l'axe optique OA-OA.Optionally, the optical portion 34 of the IOL 12 can be formed with a brightness reduction zone 74 having a width of about 0.25 to 0.75 mm but preferably about 0.3 to 0.6 mm and most preferably 0.5 mm adjacent to the outer peripheral edge 36 for reduced brightness when the outer peripheral edge 36 of the IOL 12 is struck by the light which enters the eye 10 in high light or at other times when pupil 76 is dilated. The brightness reduction zone 74 is typically made of the same material as that of the optical portion 34, but it can be opaque, colored or conventionally designed to block or scatter light in the plane having the optical axis OA-OA.
La LIO 12 est fabriquée de préférence en produisant d'abord des disques d'une seule ou de plusieurs matières à partir d'une ou plus matières choisies comme décrit dans les brevets US n° 5,217,491 et 5,326,506. La LIO 12 peut alors être usinée à partir des disques de matière d'une manière conventionnelle. Une fois usinée, la LIO 12 peut être polie, nettoyée, stérilisée et emballée à l'aide d'un procédé conventionnel connu de l'homme du métier.LIO 12 is preferably manufactured by first producing discs of one or more materials from one or more selected materials as described in US Pat. Nos. 5,217,491 and 5,326,506. The IOL 12 can then be machined from the material discs in a conventional manner. Once machined, the IOL 12 can be polished, cleaned, sterilized and packaged using a conventional process known to those skilled in the art.
La LIO 12 est utilisée dans l'œil 10 en pratiquant une incision dans la cornée 14 et en insérant la LIO 12 dans la chambre postérieure 24 et en refermant l'incision selon les méthodes connues de l'homme du métier.The IOL 12 is used in the eye 10 by making an incision in the cornea 14 and by inserting the IOL 12 in the posterior chamber 24 and by closing the incision according to the methods known to those skilled in the art.
Cependant, la LIO 12 peut être de préférence utilisée dans l'œil 10 en pratiquant une incision dans la cornée 14 et la capsule du cristallin 18, en extrayant le cristallin naturel, en insérant la LIO 12 dans la capsule du cristallin 18 et en refermant l'incision selon les méthodes connues de l'homme du métier. La LIO 12 selon la présente invention propose une lentille réfringente adaptée à l'utilisation dans la capsule de cristallin 18 ou dans la chambre postérieure 24, mais de manière préférée, dans la capsule du cristallin 18 en raison de ses caractéristiques préventives de l'OCP. La LIO 12 possède des éléments haptiques 38 de forme similaire pour minimiser ou éliminer le décentrage de la LIO 12 et la distorsion de la vision. La forme similaire des éléments haptiques 38 permet de la même manière la rotation de la LIO 12 pour un meilleur positionnement et un meilleur ajustage à l'intérieur de la capsule du cristallin 18. Ce meilleur ajustage à l'intérieur de la capsule du cristallin 18 présente un avantage car une ou quelques tailles de lentilles s'ajustent de manière appropriée à la plupart des dimensions d'oeil 10. En proposant une lentille 'universelle" telle que celle selon la présente invention, on minimise les risques cliniques pour les patients causés par des lentilles mal dimensionnées. De la même manière, on élimine la nécessité pour les fabricants de produire de nombreuses tailles de LIO pour les ajuster aux nombreuses dimensions d'yeux, ce qui réduit les coûts de production de stockage qui en découlent. Les ophtalmologistes bénéficient également de la LIO 12 en ce qu'ils gagnent du temps en éliminant la nécessité de déterminer la dimension de l'œil de chaque patient et les coûts associés au maintien de larges stocks de lentilles de tailles diverses.However, IOL 12 can preferably be used in the eye 10 by making an incision in the cornea 14 and the lens capsule 18, extracting the natural lens, inserting the IOL 12 into the lens capsule 18 and closing the incision according to methods known to those skilled in the art. The IOL 12 according to the present invention provides a refractive lens suitable for use in the lens capsule 18 or in the posterior chamber 24, but preferably in the lens capsule 18 because of its OCP preventive characteristics. . The IOL 12 has haptic elements 38 of similar shape to minimize or eliminate the decentering of the LIO 12 and the distortion of vision. The similar shape of the haptic elements 38 similarly allows the rotation of the IOL 12 for better positioning and better adjustment inside the lens capsule 18. This better fitting inside the lens capsule 18 has an advantage because one or a few lens sizes suitably fit most eye dimensions 10. By providing a "universal" lens such as that according to the present invention, clinical risks for patients are minimized by poorly dimensioned lenses. Likewise, the need for manufacturers to produce many sizes of IOLs to adjust them to the many dimensions of eyes is eliminated, thereby reducing the costs of production of storage which result therefrom. also benefit from IOL 12 in that they save time by eliminating the need to determine the size of each patient's eye and the costs associated with maintaining large stocks of lenses of various sizes.
Une autre caractéristique de la LIO 12 illustrée par le mode de réalisation de la fig. 14 est une ou plus, mais de préférence entre une et trois rainures superficielles de bord 78. Les rainures superficielles de bord 78 permettent une irrigation chirurgicale plus complète, et ainsi un meilleur nettoyage des résidus viscoélastiques et des résidus de cortex cristallin à l'intérieur de la capsule du cristallin 18. Pendant l'irrigation chirurgicale, on fait circuler un fluide à l'intérieur de la capsule du cristallin 18 pour en enlever les résidus viscoélastiques et divers autres résidus. Les rainures superficielles de bord 78 améliorent la circulation du fluide en fournissant une voie claire pour le passage du fluide. On procède donc ainsi à un nettoyage plus complet à l'intérieur de la capsule du cristallin 18 à l'aide de cette circulation de fluide renforcée.Another characteristic of the IOL 12 illustrated by the embodiment of FIG. 14 is one or more, but preferably between one and three surface edge grooves 78. The surface edge grooves 78 allow more complete surgical irrigation, and thus better cleaning of the viscoelastic residues and residues of crystalline cortex inside the lens capsule 18. During surgical irrigation, a fluid is circulated inside the lens capsule 18 to remove viscoelastic and various other residues. The edge surface grooves 78 improve the circulation of the fluid by providing a clear path for the passage of the fluid. We therefore proceed to a more complete cleaning inside the lens capsule 18 using this reinforced fluid circulation.
Bien que certains modes de réalisation spécifiques de la présente invention soient montrés et décrits ici, il est évident pour l'homme du métier que diverses modifications peuvent être apportées sans s'écarter de l'esprit et de la portée du concept de l'invention sous-jacente et que la susdite n'est pas limitée aux formes particulières représentées et décrites ici. Although some specific embodiments of the present invention are shown and described herein, it is obvious to those skilled in the art that various modifications can be made without departing from the spirit and scope of the concept of the invention underlying and that the above is not limited to the particular forms shown and described here.

Claims

REVENDICATIONS
1. Lentille intraoculaire à implanter à l'intérieur d'un œil généralement perpendiculairement à l'axe optique de l'œil comprenant : une surface antérieure (34); une surface postérieure (64); un bord périphérique externe 36 entre ladite surface antérieure et ladite surface postérieure définissant une portion optique 34 avec au moins une portion dudit bord périphérique externe 36 et de ladite surface antérieure formant un angle obtus et au moins une portion dudit bord périphérique externe 36 et de ladite surface postérieure formant un angle aigu; deux ou plus éléments haptiques 38 de même section transversale trapézoïdale ou rhomboïdale reliés en permanence audit bord périphérique externe 36; et des bords haptiques postérieurs externes aigus 52 sur lesdits éléments haptiques 38.1. An intraocular lens to be implanted inside an eye generally perpendicular to the optical axis of the eye comprising: an anterior surface (34); a posterior surface (64); an outer peripheral edge 36 between said anterior surface and said posterior surface defining an optical portion 34 with at least a portion of said outer peripheral edge 36 and said anterior surface forming an obtuse angle and at least a portion of said outer peripheral edge 36 and said posterior surface forming an acute angle; two or more haptic elements 38 of the same trapezoidal or rhomboidal cross section permanently connected to said external peripheral edge 36; and acute external posterior haptic edges 52 on said haptic elements 38.
2. Lentille intraoculaire à implanter dans une capsule de cristallin généralement perpendiculaire à l'axe optique de l'œil pour prévenir l'opacification capsulaire postérieure comprenant: une surface antérieure (34); une surface postérieure (64); un bord périphérique externe 36 entre ladite surface antérieure (34) et ladite surface postérieure (64) définissant une portion optique 34 avec au moins une portion dudit bord périphérique externe 36 et de ladite surface postérieure formant un angle aigu; deux ou plus éléments haptiques 38 de même section transversale trapézoïdale ou rhomboïdale reliés en permanence audit bord périphérique externe 36; et des bords haptiques postérieurs externes aigus 52 sur lesdits éléments haptiques 38.2. An intraocular lens to be implanted in a lens capsule generally perpendicular to the optical axis of the eye to prevent posterior capsular opacification comprising: an anterior surface (34); a posterior surface (64); an outer peripheral edge 36 between said anterior surface (34) and said posterior surface (64) defining an optical portion 34 with at least a portion of said outer peripheral edge 36 and said posterior surface forming an acute angle; two or more haptic elements 38 of the same trapezoidal or rhomboidal cross section permanently connected to said external peripheral edge 36; and acute posterior external haptic edges 52 on said haptic elements 38.
3. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle les éléments haptiques 38 et la portion optique 34 sont tous deux formés d'une matière pliable ou compressible.3. Intraocular lens according to claim 1 or 2, wherein the haptic elements 38 and the optical portion 34 are both formed of a foldable or compressible material.
4. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière sélectionnée dans le groupe comprenant les polymères de silicone, les polymères d'hydrocarbure et d'hydrocarbure fluoré, les hydrogels, les polymères acryliques mous, les polyesters, les polyamides, le polyuréthane, les polymères de silicone avec des motifs monomères hydrophiles, les élastomères de polysiloxane contenant du fluor et leurs combinaisons.4. Intraocular lens according to claim 1 or 2, wherein said lens is formed from a material selected from the group comprising silicone polymers, hydrocarbon and fluorinated hydrocarbon polymers, hydrogels, soft acrylic polymers, polyesters, polyamides, polyurethane, silicone polymers with hydrophilic monomer units, fluorine-containing polysiloxane elastomers and combinations thereof.
5. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière acrylique hydrophile. 5. Intraocular lens according to claim 1 or 2, wherein said lens is formed from a hydrophilic acrylic material.
6. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière acrylique hydrophile qui contient entre 17 et 27 pour cent en poids d'eau.6. An intraocular lens according to claim 1 or 2, wherein said lens is formed from a hydrophilic acrylic material which contains between 17 and 27 percent by weight of water.
7. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée de poly(HEMA-co-HOHEXMA). 7. Intraocular lens according to claim 1 or 2, wherein said lens is formed of poly (HEMA-co-HOHEXMA).
8. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière ou plusieurs matières avec au moins une matière ayant un index de réfraction supérieur à 1,33.8. Intraocular lens according to claim 1 or 2, wherein said lens is formed from a material or more materials with at least one material having a refractive index greater than 1.33.
9. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière ou plusieurs matières avec au moins une matière qui est une matière acrylique.9. An intraocular lens according to claim 1 or 2, wherein said lens is formed from a material or more materials with at least one material which is an acrylic material.
10. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ladite lentille est formée dans une matière ou plusieurs matières avec au moins une matière qui est une matière silicone.10. Intraocular lens according to claim 1 or 2, wherein said lens is formed from a material or more materials with at least one material which is a silicone material.
11. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle lesdits éléments haptiques 38 ont une épaisseur homogène. 11. Intraocular lens according to claim 1 or 2, wherein said haptic elements 38 have a homogeneous thickness.
12. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle une zone de réduction d'éclat 74 est formée adjacente aux bords périphériques externes 36 de la portion optique 34.12. Intraocular lens according to claim 1 or 2, in which a brightness reduction zone 74 is formed adjacent to the external peripheral edges 36 of the optical portion 34.
13. Procédé de fabrication des lentilles intraoculaires selon la revendication 1 ou 2, comprenant : le formage d'un disque d'une ou de plusieurs matières appropriées, et l'usinage desdites lentilles à partir dudit disque.13. A method of manufacturing intraocular lenses according to claim 1 or 2, comprising: forming a disc of one or more suitable materials, and machining said lenses from said disc.
14° Lentille intraoculaire à implanter à l'intérieur d'un oeil, dans la chambre postérieure dudit oeil, perpendiculairement à l'axe optique dudit oeil comprenant : une surface antérieure ; une surface postérieure ; un bord périphérique externe 36 entre ladite surface antérieure et ladite surface postérieure définissant une portion optique 34 avec au moins une portion dudit bord périphérique externe 36 et de ladite surface postérieure formant un angle aigu; deux ou plus éléments haptiques 38 de même section transversale trapézoïdale ou rhomboïdale reliés en permanence audit bord périphérique externe 36; et des bords haptiques postérieurs externes aigus 52 sur lesdits éléments haptiques 38.14 ° Intraocular lens to be implanted inside an eye, in the posterior chamber of said eye, perpendicular to the optical axis of said eye comprising: an anterior surface; a posterior surface; an outer peripheral edge 36 between said anterior surface and said posterior surface defining an optical portion 34 with at least a portion of said outer peripheral edge 36 and said posterior surface forming an acute angle; two or more haptic elements 38 of the same trapezoidal or rhomboidal cross section permanently connected to said external peripheral edge 36; and acute external posterior haptic edges 52 on said haptic elements 38.
15. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ledit bord périphérique externe 36 et ladite surface postérieure se recoupent à un angle aigu entre lesdits éléments haptiques 38. 15. Intraocular lens according to claim 1 or 2, in which said external peripheral edge 36 and said posterior surface intersect at an acute angle between said haptic elements 38.
16. Lentille intraoculaire selon la revendication 1 ou 2, dans laquelle ledit bord périphérique externe 36 et ladite surface antérieure se recoupent à un angle obtus entre lesdits éléments haptiques 38.16. Intraocular lens according to claim 1 or 2, in which said external peripheral edge 36 and said anterior surface intersect at an obtuse angle between said haptic elements 38.
17. Lentille intraoculaire selon l'une quelconque des revendications précédentes dans laquelle les éléments haptiques (38) ont une section trapézoïdale de façon à avoir un angle aigu (52) qui bloque la migration des cellules capsulaires le long de la surface postérieure (64) de la partie optique (34).17. Intraocular lens according to any one of the preceding claims, in which the haptic elements (38) have a trapezoidal section so as to have an acute angle (52) which blocks migration. capsular cells along the posterior surface (64) of the optical portion (34).
18. Lentille intraoculaire selon l'une quelconque des revendications précédentes dans laquelle les éléments haptiques (38) ont une section rhomboïdale de façon à avoir un angle aigu (52) qui bloque la migration des cellules capsulaires le long de la surface postérieure (64) de la partie optique (34).18. Intraocular lens according to any one of the preceding claims, in which the haptic elements (38) have a rhomboidal section so as to have an acute angle (52) which blocks the migration of the capsular cells along the posterior surface (64). of the optical part (34).
19. Lentille intraoculaire selon l'une ou l'autre des revendications 17 et 18 dans laquelle la forme trapézoïdale ou rhomboïdale des éléments haptiques (38) favorise le phénomène de symphyse, c'est-à-dire l'adhérence l'une contre l'autre des parois (30) et (32) du sac capsulaire ce qui arrête complètement la migration des cellules capsulaires. 19. Intraocular lens according to either of claims 17 and 18 in which the trapezoidal or rhomboidal shape of the haptic elements (38) promotes the phenomenon of symphysis, that is to say the adhesion one against the other of the walls (30) and (32) of the capsular bag which completely stops the migration of the capsular cells.
EP02793203A 2001-10-31 2002-10-31 Intraocular lenses provided with angled edges to prevent posterior capsular opacification Withdrawn EP1443875A1 (en)

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FR0114100 2001-10-31
FR0114100A FR2831423B1 (en) 2001-10-31 2001-10-31 INTRAOCULAR LENSES PROVIDED WITH ANGULAR EDGES IN ORDER TO AVOID POSTERIOR CAPSULAR OPACIFICATION
PCT/FR2002/003754 WO2003037225A1 (en) 2001-10-31 2002-10-31 Intraocular lenses provided with angled edges to prevent posterior capsular opacification

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US20040042073A1 (en) 2004-03-04
AR037173A1 (en) 2004-10-27
JP2005507286A (en) 2005-03-17
FR2831423B1 (en) 2004-10-15
CA2464705A1 (en) 2003-05-08
FR2831423A1 (en) 2003-05-02
CN100339058C (en) 2007-09-26
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