WO2015006839A1

WO2015006839A1 - Intraocular prosthesis for altering the areas of greater image sharpness or for shifting the eye optical axis on the retina

Info

Publication number: WO2015006839A1
Application number: PCT/BR2013/000259
Authority: WO
Inventors: Bartholomeu Machado Nogueira AMARAL
Original assignee: Amaral Bartholomeu Machado Nogueira
Priority date: 2013-07-18
Filing date: 2013-07-18
Publication date: 2015-01-22

Abstract

The subject matter of this patent relates to a new type of special intraocular device - or artificial crystalline lens as a replacement for or addition to the natural crystalline lens or a previously implanted intraocular lens - designed for shifting the light beam focussed by the eye structures in a damaged area of the posterior pole of the retina to intact, previously determined areas containing a considerable number of rods and cones in order to improve as much as possible the vision of patients of macular diseases of various origins. The prostheses described in the present patent have a geometric shape and refractive index carefully controlled in order to ensure correct convergence and suitable alteration of the areas having the greater image projection sharpness onto the retina. Given that retinal damages have specific locations in the retina of each patient, the parameters of the intraocular prosthesis for altering the areas of greater image sharpness or for shifting the eye optical axis on the retina must be calculated to cause the alteration of the areas of greater sharpness to the areas of the retina of the individual patient which are most competent optically.

Description

"INTRAOCULAR PROSTHESIS TO CHANGE GREATER PICTURE REGIONS OR SHIFT EYE OPTICAL AXIS OVER RETINA".

Fields of this Patent:

· Considerable improvement in vision quality for people with macula diseases of various origins.

• Ophthalmology.

The subject matter of this patent relates to a novel type of special intraocular device - either artificial lens replacing or adding to the natural lens or previously implanted Intraocular Lens - designed to displace the sharply focused light beam through damaged structures of the posterior pole. retinal areas by altering the sharpest areas of the projected image on the retina to pre-determined, preserved regions containing a considerable number of cones and rods to improve the vision of macular disease carriers of various origins as much as possible.

State of the art.

Difficulties in seeing have always accompanied humanity as a cruel misery, and for the overwhelming majority of humanity the difficulty of vision comes inexorably with old age.

Others, more unfortunate, have had them from birth or childhood, or have suffered injuries or illnesses that caused them to lose all or most of their vision.

Mighty men of the Roman Empire knew no way around visual difficulties.

The earliest reference to something similar to a lens used by older people for reading comes from Marco Polo in reports of his visit to China between 1271 and 1295.

Thus, the earliest lenses available to mankind were suitable for presbyopia, poor vision of the old, or hyperopia.

Concave lenses for myopia emerged about 200 years later, according to references in Nicola Cusanus's book (1401-1464). In 1775, Benjamin Franklin, an American statesman and scientist, invented bifocal glasses; By this time, the lenses were already placed on frames that rested on the nose and ears.

From there came astigmatism-correcting lenses, and then tailor-made lenses for each patient, which could simultaneously correct astigmatism, presbyopia, or myopia.

In November 1949, Dr. Nicholas Harold Lloyd Ridley performed the first implant of an artificial Intraocular Lens - IOL, replacing a cataract lens. From that time to the present day the Intraocular Lenses have received constant improvements and are produced with flexible and foldable material, which allows implantation by about 3 mm incisions and are a valuable resource for Ophthalmology.

However, until the moment of the object of this patent emerged, several pathologies that affect the human vision deeply compromising the patient's vision, did not receive effective solutions.

These conditions are related to damage to the retina in the fovea region or, to a greater extent, the macula as a whole.

Patients affected by the pathologies described briefly below become irreversibly limited to tasks such as reading, watching television, moving alone, in short, their life quality is dramatically diminished.

1. AMD - Age Related Macular Disease: - is defined as visual loss to varying degrees due to atrophy of retinal pigment epithelium or changes associated with subretinal neovascularization in individuals usually above 50 years of age. The condition is often bilateral, but not always symmetrically. AMD causes severe vision loss, and among the 75-year-old, about 35% of them are affected to some extent.

2. Ocular Toxoplasmosis: - Congenital toxoplasmosis - acquired during pregnancy - is an endemic disease commonly leading to inflammatory destruction of the macula. The onset may occur at birth or in its late form, between 10 and 30 years of age, severely compromising vision. Central lesions corresponding to the peri-macular and papillo-macular areas constitute between 36% and 50% of late toxoplasmosis cases.

3. Macular hole: - It is a pathology that can be idiopathic or caused by causes such as high myopia, trauma, solar retinopathy and other causes.

4. Other pathologies compromise the macula such as central serosa, toxic and other maculopathies, but have lower incidence in the population.

Investigations into the use of stem cells to repair damaged regions are still in their early stages and have not yet yielded any applicable results, so it is not possible to state that this method will be able to restore a population of cones and rods equivalent to that of the region. damaged.

The currently existing optical resource for such pathologies is the use of magnifying glasses for image enlargement. This procedure, however, is extremely cumbersome and of use in very restricted situations.

Advances in the state of the art brought by the "INTRAOCULAR PROSTHESIS TO CHANGE GREATEST IMAGE REGIONS OR SHIFT THE EYE OPTICAL AXIS ON THE RETINA", object of this Patent.

The following are the anatomical, histological and physiological fields in which advances in the state of the art of the object of this patent are inserted.

1 - Anatomy of the human eye.

Figure 1 is an anteroposterior section of the human eye (1), in which we see the cornea (2), ciliary body (3), pupil (4), iris (5), ligaments (6), the lens (7), the vitreous humor (8), the sclerotic (9), the choroid (10), the retina (11), the macula (12), the fovea (13), blind spot (14), situated in the intraocular emergence of the optic nerve (15), which is also called the papilla.

Figure 2 is a schematic cross-sectional front view of the back of the human eye to be viewed compared to the front view of the intact eye, placed next to it in Figure 2, showing the fovea (13), which is approximately circular in shape and about 1.5 mm in diameter, and the macula (12), which is in the shape of a disc about 5.5 mm in diameter - with the fovea (13) at its center - composing the extrafoveal region with the rest of the retina (11); In the same Figure 2 we see the cornea (2), the pupil (4), the iris (5) and the optic nerve (15).

2 - Partial histology of the human eye.

Figure 3 schematically depicts the pattern of retinal nerve fiber pathways around the fovea (13) and the papilla or blind spot (14), at which point the optic nerve (15) enters the human eye (1). ). These fibers and nerve endings are composed of axons, dendrites and neuron endings and are connected to a population of cones and rods.

Rods and cones are photoreceptors involved in color and shape perception. Through specialized nerve endings, they turn incident light into nerve impulses that are transmitted to the brain to make up vision.

They are also responsible for peripheral vision.

The graph in figure 3B shows the distribution of cones and rods in the human retina. There is a maximum concentration of cones in the fovea region; In the graph, the center of the fovea corresponds to the point with zero degree of perimeter, decaying in the macular region and remaining lower and approximately constant in the extra-macular regions of the retina.

Rods, on the other hand, are virtually absent in the fovea and reach a high level outside this region and the rest of the retina.

The distribution of cones and rods outside the fovea region is fundamental for peripheral vision in humans.

The nuclear innovations of the subject-matter of this patent, as described below, utilize the extra-foveal light sensitivity provided by these same cones and rods involved in peripheral vision in order to partially restore vision to those with severe foveal or macular lesions arising from the aforementioned pathologies. in this report. 3 - Physiology of human vision.

Figure 3C shows in simplified schematic anteroposterior view the human eye (1), the cornea (2), the ligaments (6), the lens (7) and two rays of light - A and B - incident on the cornea (2) whose trajectories naturally converge on the fovea (13), which is the main focus of image formation in the eye; It also shows the blind spot (14) and the optic nerve (5).

The human eye behaves basically as an optical system of two conjugated lenses, the first being the cornea (2), a fixed convergence lens and the second, the crystalline (7), a variable convergence lens enabling the images of near and far objects can form equally focused on the fovea allowing clear vision.

Thus, the innovation core of the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR DISPLACING THE EYE ON THE RETINA OPTICAL", object of this Patent, refers to the use of an intraocular optical device surgically implanted in the region of the or to replace it, alter the sharper region of image that would naturally occur within the eye directly over the injured central regions and generate sharp images in other uninjured regions of the retina where the cones and rods present will grasp the images received by the thus partially restore sight to patients, with invaluable quality of life gains.

Description and illustrations and operation of the state of the art advances brought by the "INTRAOCULAR PROSTHESIS TO CHANGE THE GREATEST IMAGE REGIONS OR DISPLACE THE EYE OPTICAL AXIS ON THE RETINA", object of this Patent.

Ophthalmic examinations reveal that most patients with low or high severity macular lesions have visual perception of peripheral field. Clinical experience confirms that patients report poor visual perception in the direction of the axis of vision - which is true because objects are projected into focus over the damaged fovea / macula - but who still have the vision of the presence of objects on the periphery of the field of vision. Of course, these objects can be perceived with less precision, since since their projections on the retina are naturally away from the focal point of focus, their images are projected out of focus on the retina, albeit in preserved regions of the retina, ie usually with lower concentration of cones and rods.

The object of this patent is the use of an intraocular optical device to deflect the light beams by altering the most clearly occurring region of image formation naturally on the macula and fovea to other regions of the retina to form clear projected images outside. of the injured region.

Figure 4 is a schematic representation of a human eye (1), in anteroposterior section; In it we see the cornea (2), the ligaments (6) and the lens (7), which may be replaced or added to the devices object of this patent.

In this Figure 4 we see the blind spot (14), the optic nerve (15) and also the fovea (13) and an extra-foveal point (16), to which they were displaced, in focus previously calculated for the correct and exact manufacture of the artifact, the light rays A and B, incident on the cornea (2) and which, by the refractive conditions of the object of this patent, assumed the directions of the light rays represented in dashed form E and F and focused on the extra region. -foveal defining a new region of clear image in the extrafoveal region (16) - where, as detected in the previous examinations to such operation - there is sufficient vision capacity by the presence of cones and rods allowing an appreciable recovery of the focus vision of the patient.

Figures 5 and 6 are simplified schematic representations to allow comparison between conventional intraocular lenses and the prostheses object of the present invention.

Conventional Intraocular Lenses (18) can replace crystalline lens (7) that has become opaque due to cataract or implanted in addition to correcting high errors or refractive defects. Intraocular Lenses (18) are transparent and have a geometric shape and carefully controlled internal refractive index to ensure correct convergence and / or refractive correction of the eye.

Figure 5 illustrates the fact that current Intraocular lenses (18) direct the optical focus to the patient's fovea (13) as represented by the convergence of G and H light rays.

The "INTRAOCULAR PROSTHESIS FOR CHANGING THE GREATEST IMAGE REGIONS OR DISPLACING THE EYE OPTICAL OVER THE RETAIN" (17) may or may not replace the lens and may only be implanted in addition to the natural lens or an Intraocular Lens ( 18) previously implanted.

Figure 6 illustrates the fact that "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT EYE OPTICAL OVER THE RETAIN" (17) alters the sharper region of the projected image to the preserved retinal region as shown below. represented by the convergence of light rays I and J, thus defining greater image clarity in the extra-foveal region (16).

The present patent describes two types of intraocular prostheses which are based on the same concept and present two preferred embodiments.

The first is an intraocular prosthesis to displace the optical axis of the eye and alter the positioning of the retinal image projection, being transparent and having carefully controlled geometric shape and internal refractive index to ensure correct convergence and appropriate deviation of the optical axis of the eye.

The second, like the first, is an intraocular prosthesis for altering the sharpest regions of the projected image on the retina, and carefully controlled geometric shape and internal refractive index to ensure correct convergence, performing, In this case, the appropriate alteration of the regions where the images on the retina are most clearly formed, that is, the displacement of the optical axis on the retina. Figure 7, solution offered by the second prosthesis, illustrates the regions of greatest image clarity in the retina. In situation (a) the clearest region is represented by the area of a circle with the fovea (3) approximately at its center as the image projected naturally over the retina. In situations (b) and (c) the sharpest regions of image projection are altered by the "INTRAOCULAR PROSTHESIS TO CHANGE THE GREATEST IMAGE REGIONS OR SHIFT THE EYE OPTICAL AXIS" (17). occur in the extrafoveal region (16) and taking different form or number.

Considering that retinal damage is specifically located on each patient's retina, the "INTRAOCULAR PROSTHESIS TO CHANGE GREATER IMAGE REGIONS OR SHIFT THE EYE OPTICAL OVER THE RETINA" (17) should be calculated in its parameters to generate the appropriate deviation for focusing on the optically most competent retinal region for the subject.

As with eyeglass, dental, intraocular or orthopedic prosthesis lenses that can be found on the market, the "INTRAOCULAR DENTURE TO CHANGE THE GREATEST IMAGES OF THE IMAGE OR SHIFT THE EYE OPTICAL AXIS" (17) can be manufactured on a robotic industrial scale in short time and at affordable costs.

The lens object of the patent lens is always asymmetric and therefore its positioning within the patient's eye must be performed with the utmost precision to ensure the projection of the clear image in a previously mapped region of the retina considered uninjured. The accuracy of this positioning is fundamental for good results.

Claims

"INTRAOCULAR PROSTHESIS TO CHANGE THE HIGHER RETINAL IMAGE REGIONS", intended to partially restore vision to those with severe foveal or macular lesions, characterized by utilizing the extra-foveal light sensitivity provided by the cones and rods involved in peripheral vision and be a special intraocular device or artificial lens in place of or in addition to the previously implanted natural lens or Intraocular Lens, intended to alter the optical axis and displace the focused light beam through the damaged retinal posterior pole ocular structures to preserved regions and previously determined, which contain an appreciable number of cones and rods to form the focus outside the injured region. "INTRAOCULAR PROSTHESIS FOR CHANGING THE HIGHEST RETINAL IMAGE REGIONS" according to claim 1, characterized in that it is transparent and has carefully controlled geometric shape and internal refractive index to ensure correct convergence and correctness. appropriate deviation of the optical axis of the eye and be surgically implanted in or replacing the lens region.

"INTRAOCULAR PROSTHESIS FOR CHANGING THE LARGER IMAGE RETINAL REGIONS" according to claim 1, characterized in that it generates a new focal point which is the extrafoveal point (16).

"INTRAOCULAR PROSTHESIS FOR DISPLACING THE OPTICAL EXIS OF THE RETINAL", which is a constructive variant of the prosthesis described in the preceding claims, being a special intraocular device - either artificial crystalline in place of or in addition to the previously implanted Intraocular lens or prosthesis It is designed to partially restore vision to people with macular diseases of various origins, characterized by moving the focused light beam more clearly through the ocular structures in the damaged region of the posterior pole of the retina, altering the sharpest areas of the image. projected on the retina to previously determined and preserved regions that contain a considerable number of cones and rods, and the lens (7) may be replaced or added to this prosthesis.

5. "INTRAOCULAR PROSTHESIS FOR DISPLACING THE EYE OPTICAL SHAFT OVER THE RETINAL" according to claim 4, it is preferably designed and manufactured specifically by case-specific calculation and parameters to generate the appropriate deviation for focusing on the retina. optically more competent retinal region for the individual, shifting the light rays A and B, incident on the cornea (2) to an extra-foveal point (16), and the prosthesis (17) has geometric shape and internal refractive index carefully controlled to ensure correct convergence and appropriate alteration of the regions where the retinal images are most clearly formed.