MXPA99005264A - Segmented scleral band for treatment of presbyopia and other eye disorders - Google Patents

Abstract

A segmented scleral expansion band adapted for implantation within or fastening to a segment of the sclera of an eye lying outside of and adjacent to the ciliary body of the eye, is formed from a number of arcuate segments, curved to match the curvature of the globe of the eye, and joined together at each end to form a complete scleral expansion band. The band is implanted in the sclera of the eye by forming circumferential tunnels, inserting the band segments through the tunnels, and joining the ends of the segments to form a complete scleral expansion band. The scleral expansion band is useful in treating presbyopia and other ocular disorders.

Description

SEGMENTED SCLERTIC BAND FOR THE TREATMENT OF PRESBIOPIA AND OTHER EYE DISORDERS RELATIONSHIP WITH OTHER APPLICATIONS This application is a continuation in part of copending application Serial No. 08 / 462,649, filed on June 5, 1995, which is a divisional of the United States' application with Serial No. 08 / 139,756 filed on October 22, 1993, now U.S. Patent No. 5,489,299, which is a divisional of U.S. Application Serial No. 07 / 913,486, filed July 15, 1992, now Patent of the United States No. 5,354,331.

BACKGROUND OF THE INVENTION 1, Field of the Invention: This invention relates to methods for the treatment of presbyopia, hyperopia, primary open-angle glaucoma and ocular hypertension and, more particularly, with methods for the treatment of these diseases by increasing the distance Effective working of the ciliary muscle. The invention also relates to the increase in the amplitude of adaptation of the eye by increasing the effective working range of the ciliary muscle and with prosthetic devices to achieve the amplitude of P1357 / 99 adaptation increased. 2, Brief Description of the Prior Art: In order for the human eye to have a clear view of objects at different distances, the effective focal distance of the eye must be adjusted to keep the image of the object focused on the retina as clearly as possible. This change in effective focal distance is known as adjustment and is carried out by the eye varying the shape of the crystalline lens. In general, in the emmetropic unsettled eye, the curvature of the lens is such that the image of distant objects is clearly formed on the retina. In the misaligned eye, nearby objects are not clearly focused on the retina because their images are behind the surface of the retina. To clearly visualize a nearby object, the curvature of the crystalline lens is increased, increasing its power of refraction and causing the image of the near object to fall on the retina. The change in the shape of the crystalline lens is carried out by the action of certain muscles and structures within the eyeball or eyeball. The lens is placed in the front of the eye, immediately behind the pupil. It has the shape of a classic biconvex optical lens, that is, P1357 / 99 has a generally circular cross section, with two convex refractive surfaces and is usually located on the optical axis of the eye, ie, in a straight line from the center of the cornea to the macula on the retina, in the posterior portion of the globe. In the misaligned human eye the curvature of the posterior surface of the lens, i.e., the surface adjacent to the vitreous body, is somehow larger than the curvature of the anterior surface. The lens and its capsule are suspended on the optical axis behind the pupil by a circular array of many radially directed elastic fibers, the zonular ligaments, which are attached at their inner ends to the lens capsule and at their outer ends to the body ciliary, a ring of muscle tissue, located just inside the outer supporting structure of the eye, the sclera. The ciliary muscle is related to the unadjusted eye and therefore assumes its largest diameter. In accordance with the classical theory of adjustment that originates with Helmholtz, the relatively large diameter of the ciliary muscle in this condition causes tension on the zonular ligaments, which in turn radially pulls out the lens capsule, causing the equatorial diameter of the lens increases slightly and decreasing the P1357 / 99 anterior-posterior dimension of the lens in the optical axis. In this way, the tension on the lens capsule causes the lens to assume a flattened state where the curvature of the anterior surface, and to a certain extent of the posterior surface, is smaller than it would be in the absence of tension. In this state, the refractive power of the lens is relatively low and the eye is focused to obtain a clear view of distant objects. When the eye is intended to be focused on a nearby object, the ciliary muscles contract. In accordance with the classical theory, this contraction causes the ciliary muscle to move forward and inward, thus relaxing the outward traction of the zonular ligaments on the equator of the lens capsule. This reduced zonular tension allows the elastic capsule of the lens to contract, causing an increase in the anterior-posterior diameter of the lens (ie, the lens becomes more spherical), resulting in an increase in the optical power of the lens. Due to topographic differences in the thickness of the lens capsule, the central anterior radius of curvature decreases more than the central posterior radius of curvature. This is the adjusted condition of the eye where the image of nearby objects falls clearly on the retina.

P1357 / 99 Presbyopia is the universal decrease in the range of adjustment typically observed in individuals over 40 years of age. In the person who has normal vision, that is, who has emmetropic eyes, the ability to focus on nearby objects is gradually lost and the individual needs glasses for tasks that require near vision, such as reading. According to the conventional opinion, the adjustment range of the aged eye decreases due to the loss of elasticity of the lens capsule and / or the sclera of the lens, due to age. Consequently, even when the radial tension on the zonular ligaments is relaxed by the contraction of the ciliary muscles, the lens does not assume a larger curvature. In accordance with the conventional opinion, it is not possible to restore by means of any treatment the adjustment power of the presbyopic eye. The loss of elasticity of the lens and the capsule has been seen as irreversible and the only solution to the problems presented by presbyopia is to use corrective lenses for close work, or bifocal lenses if corrective lenses are also required for distant vision. Certain rings and / or segments have been used in eye surgery for several purposes.

P1357 / 99 Rings and / or segments of flexible and / or elastic material, attached or prepared in situ by holding the ends of strips of material around the posterior portion of the globe, posterior to the pars plana (on the underlying retina), have been used to compress the sclera in certain posterior regions. Metal support rings, adapted to fit around the sclera, have been used as temporary support structures during surgery on the eyeballs. However, none of these known devices has been used as a surgical treatment for presbyopia and none has been adapted to the special needs of the prosthetic devices used in the treatment of presbyopia. A sclerotic band adapted to be attached to the sclera of the eye in the region of the ciliary body in order to expand the sclera in that region and thus increase the working distance of the ciliary muscle is described in the United States Patent Application No. 5,354,331, the complete disclosure of which is incorporated herein by reference. The sclerotic band of that patent is manufactured as a single unitary device that is placed on the surface of the sclera and fastened thereto, for example by suture. Although the band is effective, alternative designs that allow greater P1357 / 99 flexibility in the installation of the sclera band. Consequently, there continues to be a need for a sclerotic band for the treatment of presbyopia and other eye disorders, which allows the surgeon the opportunity for other methods for the installation or implantation of the band.

SUMMARY OF THE INVENTION An alternative design for a sclerotic band that can be implanted for the treatment of presbyopia and other disorders of the eye is found in the band of this invention, wherein a sclerotic band comprises a plurality of segments that can be assembled in the eye to form a complete sclerotic band. The invention also comprises a method for installing the segmented band, comprising the steps of forming tunnels in the sclera substance in the region covering the ciliary body, insert segments of the segmented band in the tunnels and joining the ends of the segments to form a unitary sclerotic band. Accordingly, it is an object of the invention to provide a treatment for presbyopia. A further object is to provide a treatment for presbyopia by increasing the effective working distance of the ciliary muscle in the presbyopic eye. An additional object is to provide a P1357 / 99 treatment for presbyopia by increasing the radial distance between the equator of the lens and the ciliary body. A further object is to provide a treatment for presbyopia implanted in the sclera in the region covering the ciliary body, a generally rigid band by means of which the sclera expands in the region of the ciliary body. A further object is to provide a segmented sclerotic band that can be assembled over the eye to provide a band that is generally rigid. A further object is to provide a segmented sclerotic band having segments that can be inserted into tunnels prepared in the sclera substance and assembled therefrom to provide a generally rigid band. A further object is to provide a treatment for hyperopia. A further object is to provide a treatment for primary open-angle glaucoma. A further object is to provide a treatment for ocular hypertension. * A further object is to provide a treatment to increase the range of adjustment of the eye. Additional objects of the invention will become apparent from the following description of the invention.

P1357 / 99 BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a front elevation view of the human eye with an expanding sclerotic band of the invention implanted therein. Figure 2 shows a cross section of the eye shown in Figure 1, along line 2-2. Figure 3 shows an enlarged view of the cross section of Figure 4, in the region indicated by the circle 3. Figure 4 shows a front elevation view of the segmented sclerotic band of the invention. Figure 5 shows a side elevational view of the band. Figure 6 shows an isometric view of the band. . Figure 7 shows a plan view of a segment of the band. Figure 8 shows an end view of a band segment as indicated by line 8-8 of Figure 7. Figure 9 shows a five end of a band segment, as indicated by line 9-9 of Figure 7. Figure 10 shows a cross-sectional view of a band segment along the line P1357 / 99 10-10 of Figure 7. Figure 11 shows a cross section of the fused tongue and groove portion of the segmented sclerotic band, along lines 11-11 of Figure 4.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED MODALITIES This invention is based on the theory of presbyopia that is different from the classical theory of Helmholtz. Although the scope of the invention is not bound or limited by the inventor's theory, it is the inventor's opinion that the presbyopic loss of fit is due to the decreased working distance of the ciliary muscle. This theory is described in greater detail in Patent No. 5,354,331 to which reference was made in the foregoing and which is incorporated herein by reference. Consequently, in accordance with the invention, presbyopia is treated by increasing the effective working distance of the ciliary muscle. This is achieved by increasing the distance between the ciliary muscle and the equator of the lens, increasing the diameter of the sclera in the region of the ciliary body. According to the invention, the effective working distance of the ciliary muscle is increased by implantation in tunnels or cavities surgically formed within the tissue of the sclera of the P1357 / 99, of a plurality of sclera band segments. The segments then join to form a complete sclerotic expansion band implanted, at least partially, within the sclera of the eye. The band 5 of complete sclerotic expansion is sized to be slightly larger than the sclera in the region of the ciliary body. Consequently, the sclerotic expansion band exerts an outward traction on the sclera, expanding it in this way slightly, in general, in the plane of the lens. Scleral expansion also expands, that is, increases the diameter of the ciliary body that is immediately inside or below the sclera and is anatomically attached to it. The relevant anatomy of the eye to understand the operation of the sclerotic expansion band of the invention and to locate the sclerotic cavities can be observed by referring to Figures 1-3. Figure 1 shows an eye 100 provided with a band of sclerotic expansion according to the invention. The outermost layer of the eye 100 comprises the white and resilient sclera 102 that encompasses most of the eyeball and transparent cornea 104, which constitutes the anterior segment of the outer skin. The Union The circular of the cornea and the sclera is the limbus 106. Within the eyeball, as illustrated in the cross section of Figure 2, taken along the line P1357 / 99 2-2 of Figure 1, the lens 108 is enclosed in a membranous capsule and is located immediately posterior to the iris 112, suspended centrally posterior to the pupil 114 on the optical axis of the eye. The lens 108 is suspended by zonular ligaments 115 extending between the lens capsule at the equator 110 of the lens 108 and the ciliary body 116. The ciliary body 116 lies just below the sclera 102 (i.e., just inside the sclera 102) and is attached to the inner surface of the sclera 102. As can be seen in Figure 2, the ciliary body 116 is generally in a plane 130 defined by the equator 110 of the lens 108. plane 130 can also extend to intersect sclera 102 with what forms a generally circular intersection, located approximately 2 millimeters posterior to limbus 106. According to the invention, a traction directed generally towards the outside is exerted on the sclera in the region of the ciliary body to expand the sclera 102 in that region. This expansion of the sclera 102 produces a corresponding expansion of the attached ciliary body 116 and moves the ciliary body 116 outwardly away from the equator of the lens 108, generally in the plane 130 of the equator 110 of the lens 108. Preferably, the sclera 102 is expanded approximately in the plane of the equator of lens 108. However, any P1357 / 99 expansion of the sclera 102 in the region of the ciliary body 116, that is, in the region or area of the sclera extending in some way anterior to or posterior to the plane of the equator 110 of the lens 108 is within the reach of the invention, provided that the expansion of the sclera 102 moves the ciliary body 116 away from the equator 110 of the lens 108. Normally, the expansion of the sclera will take place in the region or area from about 1.5 millimeters anterior to plane 130 of the equator of the lens 108 to approximately 2.5 millimeters posterior to that plane, ie, from about 0.5 millimeters to about 4.5 millimeters posterior to the limbus 106. Consequently, the scleral cavity or tunnel 120 will be located in that region or area of the sclera. The sclerotic band 200 of the invention is assembled from a plurality of segments 202. The assembled band 200, as can be seen in Figures 1, 4, 5 and 6, has an anterior edge 226, a trailing edge 228 and a structure of membrane 230 connecting the two edges .. To apply the desired traction outwards, on the sclera, in the region of the ciliary body, at least a circumferential portion of the band, i.e., either the leading edge 226, the edge 228 or the connecting membrane structure 230, is designed with a diameter, when the band is assembled, P13S7 / 99 slightly larger than the diameter of the sclera at the location where the band is implanted. Of course, the entire band may be slightly larger than the sclera. The outward tension on the sclera is applied in the region of the ciliary body as illustrated in Figure 2, which shows a cross section of the eye with the sclera band 200 of the invention implanted, and in Figure 3 showing a detail of the cross section of the eye as indicated by the circle of interrupted lines of Figure 2. The sclerotic expansion band 200 is shown within the tunnel 120 of the sclera, which has a base 126, an outer skirt 128, an anterior margin 122 and a posterior margin 124. The sclera band 200 within the tunnel or cavity 120 exerts an outward force on the outer skirt 128 of the scleral cavity 120 because the band is generally larger in diameter than the sclera in the area where the band is implanted. The outer skirt 128 then transfers the traction to the outside via its connection to the rest of the sclera in the anterior margin 122 and in the posterior margin 124. With this, the sclera expands in an area surrounding the ciliary body 116 and makes that the attached ciliary body 116 increases its diameter as well. Consequently, the sclerotic cavities or tunnels 120, which resemble belt buckles through which the sclerotic expansion band is screwed, are P1357 / 99 located in the region of the ciliary body, and in general, close to a plane defined by the equator of the lens. Thus, the sclerotic expansion band is positioned with respect to the antero-posterior axis of the eyeball, so that it will exert traction on the sclera which will produce a radial expansion of the ciliary body located just below or within the sclera. The sclera band and its segments are illustrated in Figures 4-11 of the drawings, where the reference numbers are consistently used in all figures. The sclera band 200 is composed of a plurality of segments 202. The band 200 is designed to be applied to the sclera of the eye by forming cavities or tunnels of the sclera, then passing a segment 202 through each of the tunnels and holding the ends of the segments together to form a complete band. Accordingly, each segment 202, as shown in Figures 9-10, has a leading edge 204, a trailing edge 206, an outer surface 208, an inner surface 210 and two side ends 212 and 214. Although the illustrated embodiment of the segment shows a continuous membrane 230 of material connecting the leading edge 204 and the trailing edge 206, the connecting structure 230 need not be a continuous structure. Any structure, for example a membrane with openings or a lattice structure is always suitable and P13E7 / 99 when the connecting structure has sufficient force to maintain the leading edge 204 and the trailing edge 206 in their relative positions to provide the necessary rigidity for the assembled band 200. In the illustrated embodiment, a lateral end 212 of each segment 202 it is provided with a tongue 216 and the other side end 214 is provided with a corresponding slot 218. After the segments are inserted through the sclerotic tunnels, the ends 212 and 214 are exposed as shown in Figure 1. Each tab 216 is then inserted into the corresponding slot 218 and the tabs 214 are then held in place. within the slots 218 to form the entire sclerotic band, as shown in Figures 1, 4 and 5. Any means for securing the segments 202 is suitable. The segments can. may be attached with an adhesive or welded or fused, or a mechanical fastener, for example a screw or rivet may be used to hold the ends of the segments 202 together. A preferred method for holding the ends together 202 when the segments are made of a material Preferred plastic such as poly (methyl methacrylate), is to weld or fuse the lower surface 218 of the tongue 216 to the lower part 222 of the groove 220 by means of ultrasonic welding. Ultrasonic welding can be carried out by conventional techniques. For example, the tongue 216 can P1357 / 99 is first placed in the slot 220, then inserting a support shoe under the end 214 of the segment 202 and applying a tool for ultrasonic welding to the tongue 216 for a sufficient time to form a welded area 224 fused (Figure 11). The segments 202 are normally sized to fit exactly in the sclerotic tunnels. A typical segment will have a width of approximately 2 millimeters and a thickness of approximately 0.25 millimeter. The length of a typical segment, measured along the circumference from one end of the main body of segment 202 to the other will be about 13 millimeters. The tongue will be approximately 3 millimeters in length. The experienced practitioner will understand that the dimensions will be adapted to the particular eye within which the sclera band will be implanted. In particular, a variety of lengths are normally made available to the surgeon so that the segments can be selected so that, when assembled in the eyeball, the entire sclerotic expansion band is of appropriate size to exert the desired traction toward the outside on the sclera and the ciliary body. If the segments 202 are made of a material with flexibility perpendicular to the surface thereof, for example, a synthetic resin material, the segments may be made flat and curved to engage with the P1357 / 99 curvature of the eyeball when the band is implanted.

If the band is made of a stiffer material it is preferred to form an appropriate bend before insertion. A typical segment of the preferred embodiment, as illustrated, will have a radius of curvature of the f-anterior edge of approximately 8.3 millimeters and a corresponding radius of curvature of the trailing edge of approximately 10.3 millimeters. The radii of the edges can be adjusted to the particular dimensions of the eye within which the band is to be implanted. Although the illustrated embodiment shows a tongue and groove design for joining the segments 202 that make up the sclera band 200, the skilled practitioner will understand that other designs may also be used. For example, a butt joint made by bonding or adhesive welding could be used. Similarly, a cover gasket or a conical splice can be used. Again, one end of segment 202 can be provided with a projection that fits into a recess or hole in the end of the adjacent segment. The ends may be shaped to have complementary shapes that fit together like pieces of a puzzle of contoured parts. In practicing the method of the invention, the surgeon first locates the region or segment or appropriate area of the sclera to be expanded, measuring a distance of preferably 2.0 millimeters posterior P1357 / 99 of limbus. The sclerotic tunnels or cavities are then formed, preferably, by the following procedure: A 2.5 millimeters clockwise and counterclockwise from each of the 45 ° eye meridians and 2 millimeters posterior to the limbus, is they make partial radial incisions to the sclerotic thickness, that is, anterior-posterior incisions that are 2 millimeters long and 350 microns deep. Using a lamellar scalpel, the sclera is dissected until the partial thickness incisions are connected so that four sclerotic cavities or belt buckles are made, which have an anterior length of 5 millimeters, and a length that extends generally axially to the eye, 2 millimeters. Thus, each cavity or belt buckle is preferably centered on the meridian 45 ° of the eye. Each tunnel is generally circumferentially directed in relation to the circle defined in general, by the intersection of the sclera with the plane of the equator of the lens, although the tunnels do not need to be exactly in that plane. A segment 202 of the sclera band 200 is then inserted into each cavity so that the ends 212 and 214 of the segments 202 are in the spaces between the cavities, as shown in Figure 1. The ends 212 and 214 of the segments 202 are then joined. In the illustrated mode, the ends are joined by fitting the P1357 / 99 tab 216 of segment 202 in slot 220 of the adjacent segment and holding the tab in the slot by means of ultrasonic welding or other joining technique as discussed above. The completed sclerotic band then produces symmetrical sclerotic expansion that will produce the desired result of increasing the effective working distance of the ciliary muscle. The illustrated embodiment of the invention illustrates a preferred embodiment of the invention making use of the four sclerotic tunnels and the four sclerotic band segments. Less or more tunnels may be used in the selection of the surgeon. It is not excluded that a single tunnel could be used with the segments of the band joined through appropriate incisions. The sclerotic band of the invention is made of a material that is sufficiently rigid to exert a force on the sclera, sufficient to produce the radial expansion required by the method of the invention and which is physiologically acceptable for long-term implantation or for the contact with eye tissues. These materials are well known in the surgical art and include suitable metals, ceramics and synthetic resins. Suitable metals include titanium, gold, platinum, stainless steel, tantalum, alloys for memorized shaping and various surgically acceptable alloys and the like. Suitable ceramics can include crystalline materials P1357 / 99 and vitreous such as porcelain, alumina, silica, silicon carbide, high strength glass and the like. Suitable synthetic materials include physiologically inert materials such as poly (methyl methacrylate), polyethylene, polypropylene, poly (tetrafluoroethylene), polycarbonate, silicone resins and the like. The segment can also be made of composite materials that incorporate a synthetic resin or other matrix reinforced with fibers of high strength material, such as for example glass fibers, boron fibers or the like. In this way, the segment can be made of reinforced glass fiber epoxy resin, reinforced carbon fiber epoxy resin, reinforced carbon fiber carbon (carbon-carbon), or the like. A preferred material for segment 202 is poly (methyl methacrylate) surgical grade. The segment of the sclerotic band of the invention can be manufactured by any conventional technique appropriate to the material used, for example, machining, injection molding, thermal molding, compression molding and the like. The use of the sclerotic band of the invention to expand the sclera in the region of the ciliary body and increase the working distance of the ciliary muscle may also be of benefit in the treatment of hyperopia in certain patients. Some young hyperopes may achieve relatively normal vision P1357 / 99 compensating its hyperopia through the natural adjustment capacity of the eye. However, to the extent that this ability declines with age, these patients find that it becomes more difficult to achieve normal vision through this process and begin to experience headaches and other symptoms, even at an age somehow less than usual for the beginning of presbyopia. Obviously, increasing the amplitude of adjustment by the method of this invention would be useful to restore the ability of these patients to compensate for their hyperopia. The method of this invention also has utility in the treatment of primary open-angle glaucoma, which shows a correlation with age in certain individuals. It has been found that, in general, the intraocular pressure (IOP - intraocular pressure) exhibits an increase, linear with the increase in age. (Armaly, M.F., On the distribution of applanation pressure I. Statistical features and the effect of age, sex, and family history of glaucoma, Archives of Ophtahalmology, Vol. 73, pp. 11-18 (1965)). Among the general population is a group of individuals who develop abnormally elevated infraocular pressures as a result of primary open-angle glaucoma, a disease that is one of the most prevalent causes of blindness in the world. In accordance with the theory of this invention, the linear increase in IOP with age is a direct result P1357 / 99 of the decrease in the distance between the equator of the lens and the ciliary muscle and the linear decrease resulting in the effective traction of the ciliary muscle. Since the ciliary muscle is inserted into the trabecular meshwork, the decrease in traction will decrease the size of the trabeculum and / or drainage pores and will result in a linear increase in intraocular pressure with age. From this point of view, patients who develop primary open-angle glaucoma may have a congenital predilection to the narrowest pores, deposition of protein in the pores and / or a smaller trabecular meshwork, so that when the ability of the ciliary muscle to exercise strength decline, after the age of around 40, tend to develop an excessively high IOP. The use of the sclera band of the invention to increase the effective working distance of the ciliary muscle and thereby increase the force it can exert when it contracts, restores the level of force exerted by the ciliary muscle on the trabecular meshwork towards a characteristic of value of a younger eye. In this way, it is expected that the tendency of an eye that is willing to develop primary open angle glaucoma with aging would be overcome and the onset of this disease would be avoided or at least postponed. Having described the invention completely, it should be understood that it can be incorporated into other forms or P1357 / 99 specific variations without departing from its spirit or essential characteristics. Consequently, the modalities described in the foregoing will be considered in all aspects as illustrative and not limiting, the scope of the invention is indicated by the appended claims rather than by the foregoing description, and it is intended that all changes that come within the meaning and equivalence range of the claims are included in it.

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Claims (30)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and, therefore, the content of the following CLAIMS t 1 is claimed as property. A segmented band of sclerotic expansion a. Adapted for its implantation or subjection within an area of the sclera of the eye that remains outside the ciliary body of the eye and adjacent thereto, the segmented sclerotic expansion band comprises: a plurality of adjacent arcuate segments, each segment having a curved leading edge and a curved posterior edge and means of Structural separation extending between the leading edge and the trailing edge and separating the edges rigidly, each segment having lateral ends provided with means for holding together the ends of the adjacent segments to form a band, the leading edges and the trailing edges forming , when assembled in the band, an anterior flange and a rear flange, respectively of the web, and the segments are dimensioned so that the anterior edge of the band will be out of at least one anterior portion of the sclerotic area and the posterior margin will be out at least a portion P1357 / 99 posterior of the sclerotic area, at least one of the anterior flange, the posterior flange and the separation means have a diameter greater than the outer diameter of the sclerotic area adjacent thereto. The sclerotic expansion band according to claim 1, wherein the fastening means comprises a tongue adapted to engage with a recess on an adjacent segment. 3. The sclerotic expansion band according to claim 2, wherein the recess is a groove. 4. The sclerotic expansion band according to claim 1, wherein the band is made of a synthetic resin. The sclerotic expansion band according to claim 4, wherein the synthetic resin is selected from the group consisting of poly (methyl methacrylate), polyethylene, polypropylene, poly (tetrafluoroethylene) and silicone resins. 6. The sclerotic expansion band according to claim 1, wherein the band is made of a reinforced composite material. The sclerotic expansion band according to claim 6, wherein the reinforced composite material is a reinforced glass fiber synthetic resin. 8. The sclerotic expansion band according to P1357 / 99 claim 6, wherein the reinforced composite material is a carbon fiber reinforced material. 9. The sclerotic expansion band according to claim 6, wherein the reinforced composite material is carbon fiber reinforced carbon. 10. The sclerotic expansion band according to claim 1, wherein the band is made of a physiologically acceptable material. The sclerotic expansion band according to claim 10, wherein the band is made of metal selected from the group consisting of titanium, platinum, gold, tantalum, stainless steel, alloys for memorized shaping and physically acceptable alloys. 12. The sclerotic expansion band according to claim 1, wherein the band is made of a ceramic material. The sclerotic expansion band according to claim 12, wherein the ceramic is selected from the group consisting of porcelain, alumina, silica, silicon carbide and high strength glass. 14. A segment of a sclerotic expansion band adapted to be assembled to form a sclerotic expansion band, the segment comprising: a curved anterior edge and a curved edge P1357 / 99 and structural separation means extending between the leading edge and the trailing edge and rigidly separating the edges, the segment has lateral ends provided with means for holding the ends to adjacent segments to form a band. The segment according to claim 14, wherein the fastening means comprises a tongue on one of the lateral ends and a groove on another of the lateral ends. 16. The segment according to claim 14, wherein the leading edge has a radius of curvature of about 8.0 to about 8.5 millimeters. The segment according to claim 16, wherein the leading edge has a radius of curvature of about 8.3 millimeters. The segment according to claim 14, wherein the trailing edge has a radius of curvature of about 10.0 to about 10.5 millimeters. The segment according to claim 18, wherein the trailing edge has a radius of curvature of approximately 10.3 millimeters. The segment according to claim 14, wherein the segment is made of a synthetic resin. P1357 / 99 21. The segment according to claim 14, wherein the synthetic resin is selected from the group consisting of poly (methyl methacrylate), polyethylene, polypropylene, poly (tetrafluoroethylene) and silicone resins. 22. The segment according to claim 14, wherein the segment is made of a reinforced composite material. The segment according to claim 22, wherein the reinforced composite material is a reinforced glass fiber synthetic resin. 24. The segment according to claim 22, wherein the reinforced composite material is a carbon fiber reinforced material. 25. The segment according to claim 24, wherein the reinforced composite material is a carbon fiber reinforced material. 26. The segment according to claim 14, wherein the segment is made of a physiologically acceptable material. The segment according to claim 26, wherein the segment is made of metal selected from the group consisting of titanium, platinum, gold, tantalum, stainless steel, alloys for memorized shaping and physically acceptable alloys. 28. The segment according to claim 14, P1357 / 99 where the segment is made of a ceramic material. 29. The segment according to claim 28, wherein the ceramic is selected from the group consisting of porcelain, alumina, silica, silicon carbide and high strength glass. 30. A method for restoring the adjustment range of an eye, comprising forming at least one circumferentially oriented tunnel in the scleral tissue of an eye in a circumferential area of the sclera that is outside the ciliary body of the eye, inserting segments of a sclerotic expansion band into the tunnels and joining the segments to form a sclerotic expansion band, each of the segments of the sclerotic expansion band having a curved anterior edge and a curved posterior edge and structural separation means that extending between the leading edge and the trailing edge and separating the edges rigidly, each segment of the sclerotic expansion band has lateral ends provided with means for holding together the ends of the adjacent segments to form a band, the edges anterior and posterior edges form, when they are assembled in the sclerotic expansion band, or n anterior flange and one flange P1357 / 99, respectively, of the band, and the segments of the scleral expansion band are disensioned so that the anterior margin of the band will be out of at least one anterior portion of the sclera and the posterior margin will be out of at least one posterior portion of the sclerotic zone, at least one of the anterior flange, the posterior flange and the separation means have a diameter greater than the outer diameter of the sclerotic area adjacent thereto. 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