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05/31/07 - USPTO Class 623 |  150 views | #20070123981 | Prev - Next | About this Page  623 rss/xml feed  monitor keywords

Bag-in-the-lens intraocular lens with removable optic and capsular accommodation ring

USPTO Application #: 20070123981
Title: Bag-in-the-lens intraocular lens with removable optic and capsular accommodation ring
Abstract: This invention describes an intraocular lens (IOL) design with a removable optic, which can be inserted in and removed from a haptic device. In this haptic the anterior and posterior capsules are sealed in order to have a perfect control over the lens epithelial cell proliferation which is thereby restricted to the peripheral part of the capsular bag. Additionally, a ring caliper is described as new surgical device to allow a precise sizing and centration of the anterior capsulorhexis. The removable optic allows repeatable correction of the eye focusing over time in case the optical parameters of the eye have changed due to a variety of factors. By separating the optic part from the haptic part, the optic part can easily be manufactured in any shape matching the optical errors of the eye, including the optical aberrations. The optic part can be manufactured out of any biomaterial restoring ocular accommodation. The optic part may include prismatic, astigmatic or magnification correction to improve visual performance. The optic part may consist of or include an electronic device for the purpose of artificial vision. In order to further assist the accommodative capabilities of the implant a capsular accommodation ring of specific biomechanical properties is inserted in the capsular equator. (end of abstract)



Agent: Prof Dr. Marie-jose B. Tassignon - Berchem-antwerpen, BE
Inventor: Marie-Jose B. Tassignon
USPTO Applicaton #: 20070123981 - Class: 623006120 (USPTO)

Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Eye Prosthesis (e.g., Lens Or Corneal Implant, Or Artificial Eye, Etc.), Intraocular Lens, Combined With Surgical Tool

Bag-in-the-lens intraocular lens with removable optic and capsular accommodation ring description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070123981, Bag-in-the-lens intraocular lens with removable optic and capsular accommodation ring.

Brief Patent Description - Full Patent Description - Patent Application Claims
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RELATED US PATENTS AND APPLICATIONS

[0001] This application is a continuation in part of U.S. application Ser. No. 11/110,463 filed on Apr. 20, 2005. The background of the invention is in the general field of intra-ocular lenses, in particular lenses with accommodative properties.

BACKGROUND OF THE INVENTION

[0002] In our U.S. Pat. No. 6,027,531 a description is made of a new concept of intraocular lens, implantable in the eye to replace the natural crystalline lens. This IOL is inserted in a calibrated, circular and continuous anterior and posterior capsulorhexis, of which the diameters are slightly smaller than the optical diameter of the lens in order to fit tightly in the groove defined at the periphery of the optical part by two flanges (one flange is the continuation of the anterior part of the optic and the other flange is the continuation of the posterior part of the optic). The perpendicularly oriented axes of the flanges facilitate the insertion of both anterior and posterior capsule into the groove by the surgeon and stabilize and avoid tilting of the IOL.

[0003] The IOL as described in U.S. Pat. No. 6,027,531 is being manufactured by the company Morcher, Germany. The intraocular lens has been implanted in children (7 months of age to 15 years), in young adults (16 to 21 years) and in about 200 adult eyes at this moment with a follow-up period of at least 5 years. The results of the clinical work and experience have been published and those publications are herewith incorporated by reference: [0004] Tassignon M. J., De Groot V., Vrensen G. F. J. M. (2002). Bag-in-the-lens implantation of intraocular lenses. J. Cataract Refract. Surg. 28 (7), 1182-1188 [0005] De Groot V., Tassignon M. J., Vrensen G. F. J. M. (2005). Effect of bag-in-the-lens implantation on posterior capsule opacification in human donor eyes and rabbit eyes. J. Cataract Refract. Surg. 31 (2), 398-405

[0006] These publications corroborate our hypothesis as stated in the U.S. Pat. No. 6,027,531 that secondary cataract is avoided in 100% of the cases. Secondary cataract is the most frequent complication corresponding to posterior capsule opacification (PCO) in eyes operated with the traditional lens-in-the-bag implantation technique.

[0007] Besides the long-lasting excellent optical results of 100% transparency and besides the excellent stability of the lens within the eye, the bag-in-the-lens presents the additional option to be positioned electively within the eye by the surgeon. The idea of elective positioning or centration according to a visual axis of the eye of an intraocular lens has not yet been described.

[0008] Since the publication of the U.S. Pat. No. 6,027,531, other authors have used the idea to fixate the IOL using the posterior capsule (Okada Kiyashi, U.S. Pat. No. 6,881,225), but the design is very complicated an the implantation is based on the lens-in-the-bag technique having the permanent risk that lens epithelial cells will encapsulate the IOL with proliferative tissue.

[0009] Furthermore, a large number of proposals have been made to correct the eye optics for far and for near at the time of cataract surgery. A binocular lens system was proposed by Robert Steinert (U.S. Pat. No. 6,537,317) and Lang Alan (U.S. Pat. No. 6,576,012), aiming at allowing far and near vision simultaneously. However, these IOLs are composed of two optic portions that still have the risk of cellular deposits and proliferation between the parts.

[0010] Additionally, in order to correct the optical aberrations of the eye, Theodore Weblin (U.S. Pat. No. 6,413,276) proposed a three-part IOL of which at least one part can be removed and adapted according to the ocular aberrations and repositioned in a second surgical step. This elaborated IOL also has the risk of cellular deposits at the level of the interfaces causing visual impairment with over time.

OBJECTS AND ADVANTAGES OF THE INVENTION

[0011] This invention concerns an improvement of the U.S. Pat. No. 6,027,531 in two major aspects: a new device is proposed to perform easily a calibrated, circular and continuous anterior capsulorhexis, and an intraocular lens is proposed with a removable optic. Some additional minor improvements in embodiments and surgical technique are also described.

I. Device for Anterior and Posterior Capsulorhexis Size Calibration and Positioning

[0012] To do so, a ring of 0.25 mm diameter, made of PMMA, or of any other biomaterial with memory, has been designed (FIG. 1). This ring can be inserted within the eye through a very small corneal or limbal incision (3 mm or less). Because of its memory, the ring will unfold within the eye as soon as inserted in the anterior chamber. It then will be gently applied on top of the anterior lens capsule and fixed with viscoelastics. The capsulorhexis can subsequently be initiated and the surgeon will take care to follow the internal border of the ring caliper. This ring caliper has two functions: (1) to determine a precise diameter of the anterior capsulorhexis. This can be achieved by manufacturing a ring with a precise internal diameter. (2) The ring is also to be used in order to centre the position of the anterior capsulorhexis according to the pupillary area, or to the limbus or to any other reference used to optimize centration of the anterior capsulorhexis along an optical axis of the eye (line of sight, visual axis or other axis). The optical axis can be determined according to well-established techniques described in clinical psychophysics handbooks.

II. Intraocular Lens with a Removable Optic

[0013] Starting from the initial concept of a one piece IOL (FIG. 1 A, B and C of the Prior Art), the haptic device can be separated from the optic part (FIG. 2 A, B and C). This removable and replaceable optic can be versatile in design construction and incorporate spherical, astigmatic or prismatic powers as well as customized adaptive optics correction. In addition electro-optical constructions for artificial vision or low vision purposed can be incorporated. In general such optic part can be made to resemble more the natural lens of the eye, including its GRIN properties and furthermore such design is easier for the manufacturer to produce.

[0014] Additional advantages of such removable optic include (1) intraocular correction of ametropia repeatable over time in case the axial length or corneal optical parameters have changed due to disease, age or trauma or miscalculated previous IOL power, (2) to introduce new biomaterials in the future with additional characteristics, (3) easy access for the retinal surgeon in case of complex repeat posterior segment surgeries.

[0015] The haptic device can be constructed from an opaque material to minimize intraocular scattering and glare.

III. Capsular Accommodation Ring

[0016] This invention describes a capsular accommodation ring to be used in combination with either the bag-in-the-lens (BIL) intraocular lens (IOL) of which the IOL and surgical procedure has been described in U.S. Pat. No. 6,027,531, or with the BIL-IOL with removable optic as described in this application. Both concepts will be further referred to as BIL-IOL.

[0017] The capsular accommodation ring is meant to be inserted into the capsular bag once the crystalline lens has been removed. This accommodation ring should be positioned at the level of the capsular equator. The shape of the accommodation ring is an open, U-shaped flexible ring, which is made of a biomaterial presenting similar mechanical properties compare to the human lens capsule. The mechanical properties of the lens capsule have been studied in length by Susanne Krag et al.: [0018] Krag S., Andreassen T. T. (2003). Mechanical properties of the human posterior lens capsule. Invest. Ophthalmol. Vis. Sci. 44, 691-696 [0019] Krag S., Andreassen T. T. (2003). Mechanical properties of the human lens capsule. Prog. Retin. Eye Res. 22 (6), 749-767

[0020] It is not the intention to exert any tension on the equator of the capsular bag by this accommodation ring but to restore its natural curvature. The anterior and posterior lips of this accommodation ring will support that part of the capsular equator where the anterior and posterior zonular fibres have their insertion. As a result, the physiological relationship and impact of the zonular fibres on the equatorial part of the capsular bag will be re-established. The antero-posterior movement of the BIL-IOL/capsular bag will again be possible and optimized during accommodation or relaxation of the ciliary's muscle. It should be understood that during accommodation the zonular fibres will release all tension on the equatorial capsular bag, allowing the capsular accommodation ring to take its original shape, designed to mimic the physiological curvature of the equatorial part of the capsular bag of a young adult lens during accommodation. The BIL-IOL will move forward and correct the eye for a certain degree of accommodation. In case of relaxation of the ciliary's muscle, the zonular fibres will be stretched and exert tension on the equatorial part of the capsular bag. The accommodation ring will follow this movement and the BIL-IOL will move backward, allowing optimal correction of the eye for distance. Because the mechanical properties of the accommodation ring are similar to that of the capsular bag, it is expected that the changes in physiological curvatures of the capsular equator, at the accommodation or relaxation position, will be released in comparable speed as in physiological conditions.

DESCRIPTION OF THE DRAWINGS

[0021] FIG. 1 A, B, C correspond to the prior art as described in U.S. Pat. No. 6,027,531. These figures illustrate the bag-in-the-lens in one piece comprising the optical part 14, the haptic parts 18 and 20 and the groove 16 to accommodate both the anterior and posterior capsule.

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